CAMH RB and IV posts

http://www.alternans.org/


Aetna coverage 3/13/2006 http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=507
AETNA ON BOARD! Just caught a whale.

Microvolt T-Wave Alternans Testing To Be Covered by Aetna

BEDFORD, Mass.--(BUSINESS WIRE)--March 13, 2006--Cambridge Heart, Inc. (OTCBB:CAMH) today announced that Aetna has revised its Coverage Policy Bulletin (0579) on Microvolt T Wave Alternans agreeing to make it a covered benefit for its beneficiaries. The policy now states:

"Aetna considers measurement of microvolt T-wave alternans diagnostic testing using the spectral analytic method medically necessary for the evaluation of persons at risk of sudden cardiac death who meet criteria for implantable cardioverter defibrillator placement."

Aetna is one of the nations leading providers of healthcare benefits covering 14.8 million people across the country.

"We are very pleased that Aetna has taken a leading position in the coverage of our vitally important test," said David Chazanovitz, President and CEO of Cambridge Heart, Inc. "We look forward to CMS' final National Coverage Determination on MTWA later this month and to make further gains with the health insurance industry."

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Clinical Policy Bulletins T-Wave Alternans

Number: 0579
(Revised)

Subject: T-Wave Alternans
Reviewed: March 10, 2006



Important Note

This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna makes no representations and accepts no liability with respect to the content of any external information cited or relied upon in this Bulletin. The discussion, analysis, conclusions and positions reflected in this Bulletin, including any reference to a specific provider, product, process or service by name, trademark, manufacturer, constitute Aetna's opinion and are made without any intent to defame. Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information including correction of any factual error. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Aetna) for a particular member. The member's benefit plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.

Aflitzy (aka celtic)
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1087
CAMH is a long term buy
for me. I feel like the old commercial for hair treatment for men. Not only am I an investor, but I am also a client!
Last summer my daughter had the test, and fortunately it was determined that she does not need the defrib. She's 26. I bought the initial shares at .32 as I felt this company has potential. I have bought up to $2.50.
I would agree with another post that marketing is needed. It was determined that my daughter needed the surgery. Through a friend she was able to get a second appointment with a well know heart specialist. He described this test. And It was not covered by insurance. She had the test and hers was clearly that the surgery & defrib inplant was not needed. The first team of doctors is out of Stanford Univ. and they were not aware of the testing. Nor did they have the equipment.
There are 2 things that right now I see as positives for the marketing
1} insurance coverage. This will force increased awareness
2} Continued presentations at health care conferences.

I heard on the cc that the budget for this year does include increased sales presence. However, I would thing there will be a start up for training etc.

Good luck to all longs!!!

avramj98
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=639
more from cms

Follow the link here to read the entire comment from CMS. Pay particular attention to the Sensitivity and Negative Predictor Values in the research summaries. Also pay particular attention below for CMS's view on why their decision is likely to be different from BCBS's decision not to cover when they reviewed it. If this is a rehash for you oldies, sorry.\\ aj


http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=165

From the studies used to evaluate this technology, it does appear that the quality of evidence is adequate to conclude that MTWA testing using a spectral analysis algorithm can improve net health outcomes, and is reasonable and necessary for Medicare patients who are candidates for ICD placement. The reviewed literature contains a number of studies evaluating the use of MTWA in a variety of population settings, including subjects with congestive heart failure (CHF), ischemic CHF, non-ischemic CHF, dilated cardiomyopathy, hypertrophic cardiomyopathy, post MI, and in healthy subjects. The material reviewed included not only small prospective studies with a homogenous patient population, but also large systematic reviews with heterogeneous patient populations. Also included in this analysis were studies that looked specifically at MTWA s role as a risk stratification tool in patient populations similar to those in both MADIT II and SCD-HeFT.
A number of diagnostic tools are available for risk assessment. Unfortunately, some of these tools have low diagnostic usefulness. In order for a diagnostic test to be useful, it must be able to demonstrate accuracy and reliability. Commonly used measures of diagnostic accuracy include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Though some of the studies used in this assessment did not include these measures of accuracy, most did. When reviewing these measures of accuracy, MTWA demonstrated superior findings related to sensitivity and NPV when compared to other diagnostic tests used to assess risk of VTEs.
We reviewed the BCBSA technology assessment. Both CMS and BCBA use an evidenced-based medicine approach, based on specific criteria, when assessing the effectiveness of technology. Though both CMS and BCBSA have similar criteria for assessing technology, CMS must also assure that the technology has demonstrated improved net outcomes within the Medicare-eligible population.
Due to the unique characteristics of the Medicare-eligible population (i.e. elderly, and more likely to have multiple co-morbidities), sudden cardiac death has a higher potential to occur as a result of VTE in this population. The potential harms from adverse events are also more likely to occur within this population. Because of these features of the Medicare population, the potential for benefit or harm from ICD placement varies from that of the BCBA population at large, and plays a prominent role in our decision making. Indications for ICD placement also differ between the two organizations. Because of the higher potential for VTE occurrence in the Medicare population, and because CMS recognizes VTEs as an indication for ICD placement, CMS feels that the use of MTWA is reasonable and necessary to address problems related to VTE and its adverse consequences.
Based on this analysis, CMS proposes that MTWA is a useful risk stratification tool and can identify which heart patients are at negligible risk of sudden death, and who may therefore be able to avoid ICD implantation and its attendant risks.

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Bluecheapseats, there's a big difference between T-waves and Microvolt T wave alternans. T- waves have been a standard electrocardiaographic metric for better than 50 years. Standard ecg analysis focuses on T waves and S-T segment analysis in the QRST complex (Q wave is the little bump first and corresponds to atrial contraction,R-S segment is the big impulse in a heartbeat ECG, and T waves represent cardiac muscle repolarization). S-T segment prolonagation indicates that the heart muscle is having a difficult time "keeping up with the load" and T-wave abnormalities indicate that repolarization of the muscles isn't working right and might lead to abnormalities next time the heart beats. This information has been used for years to determine the use of Beta blockers (which regulate the heart rate via contolling rate of beats) or calcium channel blockers (which control the overall contractility of the muscle).

T wave alternans is a mIcrovOlt minianalysis of cardiac muscle repolarization that looks for abnormalities in how the muscle resets before beating again. This is a logical ebxt step in ecg science and the reason that some who have posted here believe that use of T wave microvolt analysis will become a standard feature in ALL ecg machines eventually. Could anyone argue that there is an eventuality in adding this part of an ecg to the standrad evaluation. It's just like the enevitability of air bags.

Disclaimer_ all of the above is from someone who is not a cardiologist.........all just my rusty recollection of the science.

aj
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1453
here's a couple of rambling thoughts......
It was not so long ago that cardiologists read their ecg's by using a compass to measure the signal on the graph paper as it appeared on the paper. Innovations over the last 20 years or so have largely been in the area of computer programs that automatically analyze the heartbeat signal and provide not only the metrics, but also much of the diagnostic impressions of the ecg study. There's not been all that much evolution of the actual interpretability of the ecg signal itself, so MTWA stands as a real innovation. The door's been opened and there's no closing it now. It's all a matter of sooner vs. later.

Another thought, CAMH has the market cornered on the specific MTWA that CMS finds useful, as well as the electrodes (another area where product development has evolved, but not really changed). I think that there is a distinct possibility that CAMH will license some of it's proprietary MTWA analysis knowledge to larger ECG manufacturers, but hold on to the proprietary electrode design(s). Either way, I anticipate future revenues from manufacture, account service AND royalties at some point.

JM2C

aj
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=2021
OK, if Shusterman and Goldberg's results do reflect TWA sensitivity to arrythmias independent of heart rate increases, there are some very clear immediate applications besides the potential for use as an ICD trigger mechanism.

The results should provide impetus for addition of MTWA to holter monitor technology. For those of you who don't know, Holter monitors are portable ECG recording devices that patients wear to provide the cario with 24hr-1week continuous readings of ECG's. Adding TWA to this readout would have obvious benefit. I'm goinf to look for info about the number of holter sudies done each year.

TWA monitoring would also be added to remote wireless ECG monitoring in hospitals. Small wireless ECG transmitters are worn by many patients in cardiac care and cardiac stepdown units. My hospital has about 20 remote unit beds and my guess is there are more than 100 of these beds in Little Rock, 20,000 of these beds nationwide. The beds stay pretty much full.

Of course, the beauty of these applications are that Cambridge will either get a stout licensing fee and/or go into the manufacturing business of these units as well. Either way, the revenue stream would be huge.

aj

Bonnie.schrodt
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The test is great, and the ICD companies hate it because they know its great. Its all political or this NCD would have been long ago and TWA would be required element of the icd registry.

The SCD-HeFT decision ruined 05 for CHI. DRs think that decision makes it mandatory for and ICD for patients with an EF less than 35 percent. The fact is Medicare will pay for it but it is in no way mandatory. Because of this Drs think that if they dont implant a SCDHeFT patient and they die that they will get sued. Anyone can sue for anything, but with 200 clinical trials and other tests that are performed helping to make the decision there will be no winnable law suit. Drs simply are practicing medicine to avoid lawsuit rather than providing the best care, most will almost admit it. Its ridiculous, in fact the fact that the SCDHeFT trial had 21% appropriate firings is pathetic, that means 8 of 10 didnt even need the ICD........and Medicare makes the whole population eligible. Another fact, a SCDHeFT patient has a lower mortality rate with a negative TWave than with an ICD. And the SCDHeFT Trial had only a 1+% alsolute reduction in mortality........almost nothing. Its all politics and its killing the progress of CHI. This NCD should be able to open things up and make this company successful. On another note, there are enough Heartwaves sold to sustain the company on sensor usage. This NCD should help the drs to use it more thus more profit for CHI. A majority of all drs who have this technology completely underutilize it.

The reason patients dont pay out of pocket is because a majority do not even know it exists. Patient education is another avenue for CHI to explore that would force DRs to consider it.

ICD companies want to delay NCD until other trials are done, thats garbage, they just want to put it off until they can think of another excuse to nix it.

Because of the reasons above,ie legality, most drs dont say NO to the technology, they just say not yet. Its a fine line trust me.
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Ive had this stock for about 2 1/2 years, I have decent knowledge of their operations from people I know who work or worked there.

On the Medtronic comments about them thinking that MTWA would result in more ICD implants:

At one point that was the their train of thought, but I can tell you that when the SCDHeFT data came out or was about to come out they basically made an about face and tried to distance themselves from CHI. They got what they wanted with that trial, basically making 1.5 million people eligible for ICD. At that point they really didnt want anything to do with CHI. They look at it as the fact that their market penetration of the ICD eligible population is only 10%-13%, so they figure its easier to grow by accessing that population rather than worry about people outside SCDHeFT that are identified by TWA...and cringe at the idea of TWA cutting down on the SCDHeFT implants due to great negative predictive value.

With this huge underpenetrated population out there they created a new position (TSS Reps) who are probably glorified pharmaceutical reps going to all the cardiologists and telling them they have to implant all the SCDHeFT patients or they will be sued if one dies, maybe not that bluntly, but probably not far off. So Cardiologists have these Medtronic people telling them that so it leads to more apprehension by the Drs to not implant based on a negative TWA test.

If you read their comments on the new policy they all say the politically correct thing.........they think TWA is a promising technology, but want to wait for ABCD, MASTER and the other two big trials out there to be completed. It is just a way to delay the inevitable that TWA should identify those in SCDHeFT population who should and shouldnt get implants. When those trials are done they will just want to delay if for some other reason, its a crock.

Medicare thinks they got railroaded into the SCDHeFT population so they may really want to limit the ICD implants since hardly any fire and the cost is ridiculous. They tried to do that with the wide QRS decision on MADITT II and it backfired, otherwise TWA would already be a required element to get an ICD. I think Medicare knows this and is going to jam TWA down their throats. I can only hope so, because it is clearly the best technology to identify people who might benefit. The gold standard of EP has a positive predictvie value of about 35%, TWA is about 25%. TWA with EF can have a positive predictive value of 49%.

Of course the greatest value to TWA is its negative predictive value of 98.6 percent. If ICD companies were smart, rather than greedy, they would see that 30% of SCDHeFT patients will never recieve ICD therapy, and that 30% will test negative with TWA. That leaves 70% to implant, which is a lot better than the current 10%. If they embrace that the Medtronics of the world could make CHI a standard of care in no time since Medicare might actually think they care. Then one of them should buy CHI and we'd all be pretty happy.

Its all political so it wont happen right away, but the NCD is huge and will set this ball in motion.If you know any cardiologist have them put up a comment, here is the link and you can read all the positive comments that are posted. http://www.cms.hhs.gov/mcd/viewnca.asp?from=basket&nca_id=165&viewAMA=N&basket=nca:00293N:165:Microvolt+T-wave+Alternans:Open:New:3
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Im pretty sure the MDT investment was more like 6M, but thats another story. SCDHeFT is less than a year old, and Im almost positive the MDT purchase was prior to that.

I am, however, 100% sure that when SCDHeFT came about the ICD companies wanted nothing to do with MTWA. They are definitley softening based on the comments prior to the NCD, but do not be mistaken, they have no interest in pursuing CHI on their own to help drive ICD revenue at this point.

However, I absolutely think after the NCD they will realize they HAVE to embrace CHI, at which point they will probably buy us and reap the benefits of sensor revenue, and increased ICDs..........and itll be pretty funny to see how they change their tune about MTWA at that point. Im in the field on a daily basis selling products to Cardiology and I ask about everything so I am very confident in this assessment.

On top of that, if you ever met an ICD rep you'd doubly agree. When I speak to them they are ususally, not always, completely brainswashed to the point that they dismiss MTWA like a red-headed stepchild. They are so dismissive that they are rude and it makes me angry to see someone so arrogant and uninformed......you can't tell me thats not coming from their corporate. They want ICD's to be put in everyone from birth.

The ones who "get it" are great to work with, the ones who don't, you should just walk away. In particular, Guidant reps are the worst, St. Jude are the best. Medtronic are middle of the road.
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I think you are pretty right on the issues before purchase. The good news is that in either case the acquisition of the Heartwave should be a positive within any practice.

First, the reimbursement is rarely below $300. Not sure if you are from Texas based on your screen name but here is TX reimbursement.

AUSTIN, TX 1.000 1.021 0.986 $327.34
BEAUMONT, TX 1.000 0.875 1.298 $287.00
BRAZORIA, TX 1.006 0.970 1.298 $314.49
DALLAS, TX 1.010 1.063 1.061 $340.10
FORT WORTH, TX 1.000 0.985 1.061 $317.38
GALVESTON, TX 1.000 0.960 1.298 $311.45
HOUSTON, TX 1.018 1.011 1.297 $326.62
REST OF TEXAS 1.000 0.873 1.138 $285.57

Another important point when looking at financially feasibility is that the physician does not have to perform tetsting as its a submaximal stress test that takes 8-12 minutes to perform plus prep. An efficient office can do 3 an hour, otherwise 2 with no diffculty. When you take into account staff, space, overhead and sensors at $74 per case you can easily justify this test. Most physicians set a block of time one day a week and more than reap a new revenue stream.

As for the liabilty issue. The NCD should nix that as any reason not to do testing. First and foremost the physicians should be doing TWA testing and using that data and all the other tests used to complete a picture that will help to make intelligent decisions with respect to ICD implantation. Second, the draft policy states:

"From the studies used to evaluate this technology, it does appear that the quality of evidence is adequate to conclude that MTWA testing using a spectral analysis algorithm can improve net health outcomes, and is reasonable and necessary for Medicare patients who are candidates for ICD placement."

IMPROVE NET HEALTH OUTCOMES AND REASONABLE AND NECESSARY ETC.........that should absolve you in any lawsuit. Just in case, the draft also says:

"Based on this analysis, CMS proposes that MTWA is a useful risk stratification tool and can identify which heart patients are at negligible risk of sudden death, and who may therefore be able to avoid ICD implantation and its attendant risks."

Not to mention the other wording that basically clears any legal doubts from anyones mind.

As for you having been approaced 2 1/2 years ago, the environment is completely different now. Better coverage, more clinical trials and a greater acceptance by EPs based on clinical trials. Since an EP would have to be implanting 24/7 and still not be able to implant everyone who is eligible, TWA is the best tool to identify the CORRECT people who should get an ICD.

I would love to know where you and your colleagues are so I can have someone contact you because TWA can be of immeasurable assistance in identifying the right patients for ICD. I beg you to call CHI and leave a message at X226.

Here is another issue. MADITT didnt even address people with EF 30-35, so all of a sudden all these people get an ICD with the SCDHeFT decision. Well what about the guy whose EF is 34 on an echo, then has a nuke study and his EF is 36 a week later. Thats a huge gray area, patients from 30-35 should definitely be TWA'd. Plus, a higher percentage of deaths come from the non-SCDHeFT population, what about them. Its a shame that some Drs practice not to get sued, rather than to provide the best care possible. Thats an indictment on societys idiotic lawsuit mentality.

The new NCD squashes any fear of losing a lawsuit.

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Unfortunately Afib is a contraindication, but only if you are always in Afib. You should speak to the Dr about arrythmias let them know you are concerned as to whether you are at higher risk for one. They will likely do a holter, nuke, and echo. While these are all good indicators you should have TWave testing performed as well. Twave would be an additional data point to help the Dr. make an intelligent decision with your care. No single test will give you the exact answer which is why the more information you can have the better the Dr. will be able to treat you. If you want to share the name of you cardiology group I can probably find out if they already have Twave equipment from some of my connections in the field.

As for helping the stock, any mention is important so the physicians are faced with the technology and know its real and that patients are aware of it. In many cases the clinical cardiologist will gloss over twave testing thinking its just for the EP. Fact is that it is for the referring physician who controls the patients that should and should not be referred to EP.

One of the biggest chanllenges to CHI is doctor awarness, believe it or not, thats first before the issues of reimbursement, staff, space etc come into play.

bluecheaps4me
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1333
Read all of these letters to the CMS, then ask yourself if you think MTWA is going to be hard to sell to them.

http://search.netscape.com/ns/boomframe.jsp?query=View+Public+Comment+for+Microvolt+T-wave+Alternan
s+(CAG-00293N&page=1&offset=0&result_url=redir?src=websearch&requestId=c6baa6e715a2ae8&c
lickedItemRank=1&userQuery=View+Public+Comment+for+Microvolt+T-wave+Alternans+%2
528CAG-00293N&clickedItemURN=https%3A%2F%2Fwww.cms.hhs.gov%2Fmcd%2Fviewpubliccomments.
asp%3Fnca_id%3D165&invocationType=-&fromPage=NSCPTop&ampTest=1&remove_url=http
s://www.cms.hhs.gov/mcd/viewpubliccomments.asp%3Fnca_id%3D165
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National ICD Registry becomes official database for Medicare
Registry will help over 1,300 hospitals monitor implantable cardioverter defibrillators
WASHINGTON, D.C. April 3, 2006 Patients and physicians across the country will now have access to better information on implantable cardioverter defibrillators (ICDs) today, as the national ICD RegistryTM becomes the official database for Medicare patients.
A partnership between the American College of Cardiology Foundation and Heart Rhythm Society, the ICD RegistryTM collects detailed information on ICD implantations to assess and improve the care of patients receiving ICDs for primary prevention therapy. Over 1,300 hospitals have been contacted and are in the process of enrolling as participants.

"The new registry for Medicare patients receiving implantable cardioverter defibrillators is helping us meet our goals of increasing patient safety and ensuring the best care possible for heart patients, " noted Stephen Hammill, MD, Chair, CMS ICD Registry National Working Group and Immediate Past President, Heart Rhythm Society.

"The ICD RegistryTM promotes a high quality of care surrounding the implantation of ICDs. Our partnership with CMS ensures that this important quality mission be accomplished and will undoubtedly lead to huge benefits for all health care stakeholders, but more importantly for our ICD patients and their families going forward." added Ralph G. Brindis, M.D., F.A.C.C., ACC-NCDR Management Board Chair.

The 2005 decision by the Centers for Medicare and Medicaid Services (CMS) to expand Medicare coverage of ICDs increased the number of eligible Medicare beneficiaries to nearly 500,000 and also required hospitals to submit data to an ICD registry as a criterion of coverage. Effective today, the national ICD RegistryTM replaces the previous CMS QNET registry, which sunsets on April 30, 2006. In addition, as of April 1, all hospitals participating in the ICD registry will be able to extend this coverage to patients diagnosed with non-ischemic dilated cardiomyopathy (NIDCM) greater than > 3 months and less than < 9 months, NYHA Class II or III heart failure, and measured LVEF < 35%. These patients did not have a covered Medicare indication until now and were previously ineligible for Medicare reimbursement. - more -

"These efforts are a part of CMS' Coverage with Evidence Development initiative, which helps ensure that patients receive access to important treatments while facilitating the collection of evidence so that doctors and patients are able to get the most benefits with the least side effects," CMS Administrator Mark B. McClellan, M.D., Ph.D. said "The Medicare aggregate data from the ICD RegistryTM will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy. Better evidence means better decisions by doctors and patients."

About the ICD RegistryTM

Launched June 30, 2005, the national ICD RegistryTM was developed through a collaboration between the American College of Cardiology Foundation and Heart Rhythm Society and is designed for participation by hospitals. The registry collects detailed information on ICD implantations and has as one of its missions helping hospitals meet CMS requirements. The purpose of the registry is to assess and improve the care of patients receiving ICDs . In addition to meeting CMS data collection requirements for ICD implantation, national ICD Registry participants receive quarterly benchmark reports that can be used to measure patient outcomes, volume and utilization.

The ICD Registry is a part of The American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR®), a comprehensive cardiac and data repository.

More information about the ICD Registry can be found at www
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This article was before the CMS MTWA coverage approval, so, common sense tells you that MTWA will be included in this data gathering, because it's "reasonable and necessary", so says CMS.

Nov 03 2005 07:45:15





Implantable Cardioverter Defibrillators
Medicare will work with the American College of Cardiology to collect data nationwide to help learn more about the use of implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death among Medicare beneficiaries, Centers for Medicare and Medicaid Services Administrator Mark B. McClellan, M.D., Ph.D., announced today.

As a result of the contract, the American College of Cardiology's National Cardiovascular Data Registry's (ACC-NCDR) ICD Registry will become the new repository of information from more than 1,300 hospitals nationwide, effective April 1, 2006 . The registry was created by a partnership between the American College of Cardiology and the Heart Rhythm Society, and has support from the implantable cardioverter defibrillator manufacturing industry, private health plans and payers, and hospital groups.

"CMS is pleased to contract with ACC-NCDR to help develop new evidence to improve care for Medicare beneficiaries who may be at risk of sudden cardiac death," Dr. McClellan said. "Through our coverage process, we are providing greater access to a potentially lifesaving treatment and greater support for doctors and patients to use this treatment effectively."

"The ICD Registry will undoubtedly lead to huge benefits for all health care stakeholders, but more importantly to our ICD patients and their families," said Ralph G. Brindis, M.D., F.A.C.C., ACC-NCDR Management Board Chair.

In January, CMS announced it would expand Medicare coverage of implantable cardioverter defibrillators based on results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), sponsored by the National Institute of Health's National Heart, Lung and Blood Institute. The January 2005 decision increased the number of Medicare beneficiaries eligible for an implantable cardioverter defibrillators by one-third to nearly 500,000, and required hospitals to submit data to an ICD registry as a criterion of coverage. Since the decision, CMS has been gathering data using its QNet platform, which the agency also uses to collect other data on healthcare quality.

CMS plans to utilize ICD Registry data, combined with that gathered through QNet, to answer the clinical questions posed in its January 2005 decision memorandum, such as whether the indications for ICD implantation in the Medicare population is similar to the patients who received ICDs in the SCD-HeFT and other trials.

In addition, other data from the ICD Registry will help analysts answer several key questions about ICD implantation, including how frequently the devices stabilize the electrical activity of the heart in different subgroups of patients. This question could only be definitively established for a subset of patients in SCD-HeFT, who clearly benefited from use of the device.

However, the evidence on benefits of ICD implantation in certain subgroups was not as strong, and it is important for doctors to get better evidence on the use of these devices for these patients as well. Many Medicare beneficiaries are older than the patients studied in SCD-HeFT, and many others who are at high risk of cardiac events do not closely match the characteristics of the group in which there was a clear benefit.

Other questions can also be addressed with the registry data, such as whether cardiac morbidity and mortality differ among patients based on clinical characteristics, device characteristics, the facility and/or the physician who implants the device.

"These efforts are a part of CMS' Coverage with Evidence Development initiative, which helps ensure that patients receive access to important treatments while facilitating the collection of evidence so that doctors and patients are able to get the most benefits with the least side effects," Dr. McClellan said. "The Medicare aggregate data from the ICD Registry will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy. Better evidence means better decisions by doctors and patients."

CMS will require hospitals to transition their current ICD data reporting activities from Quality Network Exchange ICD Abstract Tool (QNET) and to begin submitting data about their procedures to the ICD Registry . This transition must be completed by April 1, 2006.

"I am pleased CMS will contract with the ACC and HRS for the next phase of the National ICD Registry . By replacing QNET with the ACC/HRS ICD Registry , CMS has made data entry more convenient to providers. The ICD Registry will allow the medical community to assess if quality outcomes are being achieved for ICD patients, determine if appropriate patients are receiving the devices, and have the potential to play an important role evaluating device performance," said Stephen C. Hammill, M.D., F.A.C.C., immediate past president of Heart Rhythm Society, National ICD Registry Working Group Chair.

To ensure that hospitals can begin using the ICD Registry before the ICD Abstraction Tool sunsets, hospitals must contact ACC-NCDR no later than January 1, 2006 to begin the enrollment process.
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Electrophysiology studies are invasive, if I understand what I just read about electrophisiology studies, this is not MTWA, here are some warnings about electrophisiology studies from St Jude Medical.

___________________________________________________________

Complications & Risks
Electrophysiology Studies

Because electrophysiology (EP) studies require the insertion of catheters into the body, they do involve some risk.

Some people may have bleeding, swelling, or bruising where the catheters were inserted. Serious complications do sometimes occur. These include infection, damage to the heart and/or blood vessels, and blood clots. Death is very rare during these procedures.

Most patients who undergo EP studies do not experience complications, but you should be aware of the risks. If you have any questions about potential risks or your particular condition, ask your physician.
_________________________________________________________

MTWA is non-invasive, the electrophisiology is invasive.

No risk's involved with MTWA, but there are with ecectrophisiology.

The equiptment for electrophisiology is probably made by the icd makers, I'm assuming so because St Jude gave these risk warning's, and another site that I found discussing electrophisiology studies mentioned Medtronic at the bottom of the article.

Common sense tells me that that's another reason that the ICD makers tried to stonewall MTWA.

They also make their version of testing equiptment.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1564
Question: What is the role of the standard electrophysiology study (EPS) for ventricular arrhythmia risk stratification? Is T-wave alternans (TWA) useful as a risk predictor in both ischemic and nonischemic populations being considered for implantable cardioverter defibrillator (ICD) implantation?
Date Posted: 9/14/2005
Answered by: Thomas A. Burkart, M.D., F.A.C.C.
Author Disclosure: This author has nothing to disclose.
Answer: The publication of such groundbreaking ICD trials as Antiarrhythmics Versus Implantable Defibrillators (AVID),1 Multicenter Automatic Defibrillator Implantation Trial (MADIT),2 and Multicenter UnSustained Tachycardia Trial (MUSTT)3 resulted in a profound shift in the approach most physicians take to the management of their patients with ischemic cardiomyopathy and ventricular arrhythmias. One of the unintended and perhaps unexpected consequences of these trials was to cast significant doubt on the usefulness and reliability of the standard EPS in the risk stratification of these patients. The EPS was shown to have poor sensitivity and subsequently poor negative predictive accuracy in identifying the post-infarct patient with poor left ventricular ejection fraction (LVEF; <35%) who will likely do fine without an ICD.

The publication of the MADIT II trial further marginalized the role of the EPS as a means of accurately screening for risk of sudden cardiac death (SCD).4 In this trial, ICDs were implanted solely on the basis of an ischemic cardiomyopathy and an EF ≤30% with no further risk stratification. The prophylactic treatment of these patients with an ICD resulted in a 31% reduction in all-cause mortality. The inherent shortcoming of the EPS is that a positive result depends on the ability of the physician to induce ventricular tachycardia at that specific point in time. The day-to-day reproducibility of the EPS is affected by multiple variables, including the aggressiveness of the stimulation protocol required to induce the arrhythmia. We know from experience that the EPS is a poor screening tool in the nonischemic population, which has left the clinician with an uncomfortable uncertainty as to how to best manage these patients in the absence of documented syncope or sustained ventricular tachycardia. The Centers for Medicare and Medicaid Services (CMS) has now expanded coverage of ICDs to include the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)5 type patients (nonischemic dilated cardiomyopathy, New York Heart Association class II-III heart failure and measured LVEF ≤35%) for the primary prevention of SCD based on the results of this trial, which showed similar efficacy of the ICD in reducing mortality in the nonischemic population.

Yet, only a small number of patients who now qualify for the implantation of these devices will actually derive benefit from their ICD when implanted for primary prevention of sudden cardiac death. The need to find a better screening tool to accurately identify the patients at most risk and therefore most likely to derive benefit from ICD therapy, is obvious. A growing body of evidence is now supporting the use of TWA testing for risk stratification. TWA is the beat-to-beat fluctuation in the amplitude or morphology of the T wave, which has been closely associated with ventricular arrhythmias and SCD. Microvolt TWA can be measured during low-level exercise stress testing, and the test has been found to have good positive and negative predictive accuracy for future arrhythmic events.6 Even more encouraging is the fact that this predictive accuracy seems to be independent of EF or underlying cause of heart failure.7,8 In other words, it can be applied with equal accuracy in both the ischemic and nonischemic populations. TWA has also been found to be an accurate way of identifying high-risk patients for SCD following acute myocardial infarction.9 It is too early to proclaim TWA as the best means for ventricular arrhythmia risk stratification. However, there are large-scale clinical trials in progress, such as the Alternans Before Cardioverter Defibrillator (ABCD) trial, that are specifically studying the utility of TWA compared to the EPS in risk stratification.
Reference(s):
A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med 1997;337:1576-83.
Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 1996;335:1933-40.
Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med 1999;341:1882-90.
Moss AJ, Zareba W, Hall WJ, et al., on behalf of the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-83.
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-37.
Bloomfield DM, Hohnloser SH, Cohen RJ. Interpretation and classification of microvolt T wave alternans tests. J Cardiovasc Electrophysiol 2002;13:502-12.
Gold MR, Bloomfield DM, Anderson KP, et al. A comparison of T-wave alternans, signal averaged electrocardiography and programmed ventricular stimulation for arrhythmia risk stratification. J Am Coll Cardiol 2000;36:2247-53.
Bloomfield DM, Gold MR, Anderson KP, et al. T-wave alternans predicts events independent of ejection fraction and etiology of heart disease in patients undergoing electrophysiologic testing for known or suspected ventricular arrhythmias (abstr). PACE 2000;23:593.
Ikeda T, Saito H, Tanno K, et al. T-wave alternans as a predictor for sudden cardiac death after myocardial infarction. Am J Cardiol 2002;89:79-82.

Source
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1566
CFSG1 Continuity Services Yield Far-Reaching Results

In mid December 2005, Cambridge Heart s stock was trading steadily in the range of 30 cents, as it had for more than two years as one of CFSG1 s Continuity Clients . A week later, the Company announced a preliminary decision by the Centers for Medicare and Medicaid Services (CMS) to provide coverage for the Company s Microvolt T-Wave Alternans (MTWA) diagnostic test, the only non-invasive test to identify patients at risk of sudden cardiac death and thus likely to benefit from an implanted cardiac defibrillator (ICD). By mid March 2006, the stock had risen to more than $3.50, and the Company had become a darling of Wall Street.

Following a full program in 2003, Consulting for Strategic Growth 1 has maintained CAMH with its unique , believing in the business intelligence of its CEO David Chazanovitz and the potential for its unique non-invasive technology to become the gold standard for identifying candidates for ICDs.

Stanley Wunderlich, CEO of CFSG1, said, We have worked with Cambridge Heart through three years of ups and downs, and we are delighted that our confidence has proven correct. Once again, we have arranged for CAMH to present at the Rodman & Renshaw Global Health Care Conference, on May 15-16, 2006 in Monte Carlo, and we anticipate its story will receive a very exciting response.

David Chazanovitz said, Stan has been an extraordinarily loyal supporter and intelligent advisor. When I couldn t talk with anyone else, I talked with Stan. His guidance has been essential in bringing our Company to its important new growth stage.

What is the story behind the headlines?

In early 2003, with an impending war, a weak economy, and a negative balance sheet, Cambridge Heart s stock price fell to 25 cents, and the Company was de-listed from the National NASDAQ to the NASDAQ Small Cap listing. Management turned to CFSG1 for guidance.

Recognizing that Cambridge Heart needed a different investor base that understood the Company s strong near-term potential, Mr. Wunderlich urged the Company to voluntarily move from the NASDAQ Small Cap to the OTC Bulletin Board in order to quickly bring the stock value under control. The move, he explained, would eliminate potential electronic short-sellers, who dominate Small Cap trading and often pay too little attention to a company s fundamentals. Quotation on the OTCBB, where transactions must take place directly by phone rather than electronically, would bring in better-informed market makers who could recognize the enormous opportunity the Company presented.

Management took the advice and the stock price steadied, creating enough liquidity to sustain the company over the next two and a half years, allowing management to gradually build needed recognition from the medical community and insurance providers. From 2004 onward, CFSG1 provided Continuity Services, including regular counsel on business development options and various equity financing opportunities, ensuring that CAMH was well positioned to reach out to investors again as soon as the time was right.

Throughout this period, Cambridge Heart executed its business plan, keeping down costs, pursuing clinical studies, publishing positive results in leading medical journals, and creating alliances with key industry players such as Medtronic Inc. (NYSE:MDT), one of the three leading manufacturers of ICDs. In February 2005, persistence and careful management began to yield results. Blue Cross/Blue Shield of Michigan made Cambridge Heart s MTWA test a covered benefit for at-risk cardiac patient populations, becoming the latest and largest insurance plan to do so.

CMS published its final decision memo at the end of March 2006, providing the ultimate seal of approval for Cambridge Heart s MTWA diagnostic test. Anticipating this result, Aetna had decided in early March to cover the test for evaluating beneficiaries who meet criteria for implantable cardioverter defibrillator placement.

Currently, CEO Chazanovitz has been attending numerous investment luncheon meetings and conferences hosted by firms such as Bear Stearns (NYSE:BSC), Lehman Brothers (NYSE:LEH) and Emerging Growth Equities . He has also accepted an invitation by Goldman Sachs (NYSE:GS) to visit that company s vast network of broker/dealers and analysts. Interviews and stories in The Wall Street Journal, Boston Globe, Bloomberg, Reuters, and many other media have all been positive and have created a tremendous amount of investor interest in the Company.

CMS decision MTWA 3/21/2006
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=776
bingo..........we ngot it...all
http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=165

http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=165
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=781
just finished reading every word and it is everyhting we thought...only spectral method, no on mma, not at all,..so we have nooooooo competition at all..............for years!!!!!!!!!!!!!!!!!!!!!!!!!!!!great market manipulation to get shares..oh well....doesnt matter,,,,this test is nopw officially on the map....sit back and relax now...we have taken the blow, now...we move steadily...
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=809
MADE THE DOW JONES NEWS WIRE!!!

DJ US Govt OKs Reimbursement For ICD Device Screening Test


By Jon Kamp
Of DOW JONES NEWSWIRES

The U.S. Centers for Medicare and Medicaid Services has decided to provide reimbursement for use of a device that can help determine whether heart patients at risk of sudden death need a defibrillator.
The language in the CMS determination released late Tuesday specifically supports a testing method patented by Cambridge Heart Inc. (CAMH), and marks another step in the small company's effort to obtain wider insurance coverage and broader use of its testing tool in doctors' offices. The decision may also have bearing for the three major makers of implantable defibrillators - Medtronic Inc. (MDT), St. Jude Medical Inc. (STJ) and Boston Scientific Corp. (BSX) merger partner Guidant Corp. (GDT) - and the rapidly expanding market they serve.
Even with the Medicare decision, Cambridge Heart's device won't gain widespread usage among doctors until at least 80% of patients have reimbursement coverage, according to David Chazanovitz, Cambridge Heart's president and chief executive. The Medicare backing helps, though, by providing reimbursement for about 50% of patients.
"It's very validating for us," Chazanovitz said Tuesday. "CMS has in essence issued a proprietary decision for us."
At issue is Cambridge Heart's microvolt T-wave alternans, or MTWA, diagnostic tool, which some studies indicate can help predict whether a patient would benefit from having an implantable cardioverter defibrillator, or ICD. ICDs, which control dangerously rapid heartbeats, are a fast-growing and lucrative part of the medical-device sector that many companies and analysts feel is still very lightly penetrated.
According to the CMS decision, "Microvolt T-wave Alternans diagnostic testing is covered for the evaluation of patients at risk of sudden cardiac death, only when the spectral analytic method is used." The last phrase refers to Cambridge Heart's proprietary technique, Chazanovitz said.
Cambridge Heart shares closed Tuesday down 52 cents, or 15%, at $2.92. The stock has recently moved higher amid heavy volume, breaking through the $2 a share level last week and trading as high as $3.98 a share Thursday. Shares are up $1.47 so far this month.
-By Jon Kamp, Dow Jones Newswires; 312-750-4129; jon.kamp@dowjones.com

(END) Dow Jones Newswires
March 21, 2006 17:21 ET (22:21 GMT)
Copyright (c) 2006 Dow Jones & Company, Inc.- - 05 21 PM EST 03-21-

CMS National Coverage Decision can be found at www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=148

Chow et al http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=474
big news future Presentation Number:
413-6

Abstract Title:
Cost-Effectiveness of ICD Therapy and Risk Stratification With Microvolt T Wave Alternans Testing in the MADIT-II Eligible Population

Presentation Start/End Time:
Monday, Mar 13, 2006, 2:15 PM - 2:30 PM

Topic:
Defibrillation/Implantable Antiarrhythmia Devices

Author Block:
Paul S. Chan, Kenneth M. Stein, Theodore Chow, Mark Fendrick, J. Thomas Bigger, Jr., Sandeep Vijan, University of Michigan Medical Center, Ann Arbor, MI, Ohio Heart and Vascular Center, Cincinnati, OH

Background: Implantable Cardioverter-Defibrillators (ICDs) have been shown to prevent mortality in the MADIT-II population. Microvolt T-Wave Alternans (MTWA) testing has been shown to be effective in risk stratifying MADIT-II eligible patients at risk for death.
Objectives: To compare the cost-effectiveness of ICD placement with and without risk stratification with MTWA testing in the MADIT-II population.
Methods: Based on published data and hospital accounting information, cost-effectiveness of 3 therapeutic strategies in MADIT-II eligible patients were assessed using a Markov model: 1) ICD placement in all; 2) ICD placement in patients who test non-negative with MTWA testing; and 3) medical management. Outcomes of expected cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness were determined for patient lifetime.
Results: Under base-case assumptions, providing ICDs only to those who test MTWA non-negative produced a gain of 1.12 QALYs at an incremental cost of $60,100 when compared to medical therapy, resulting in an incremental cost-effectiveness ratio of $53,900/QALY. When compared with a MTWA risk stratification strategy, placing ICDs in all patients resulted in an incremental cost-effectiveness ratio of $96,700/QALY. 82% of the total potential benefit of ICDs was achieved by implanting ICDs in the 67% of patients who tested MTWA non-negative. Results were most sensitive to the effectiveness of MTWA as a risk stratification tool, MTWA negative screen rate, cost and efficacy of ICD therapy, cost of annual care, and patient risk for arrhythmic death.
Conclusion: Risk stratification with MTWA testing in MADIT-II patients improves the cost-effectiveness of ICDs. Implanting defibrillators in all MADIT-II type patients, however, is not cost-effective, with one-third of patients deriving little additional benefit at great expense.

Commercial Relationship:
P.S. Chan, None; K.M. Stein, None; T. Chow, Medtronic, Modest,I - Research Grants ; M. Fendrick, None; J. Bigger, None; S. Vijan, None.



dflawed
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=430
eh...great job...i have been all over this since christmas...i found it totally amazing that a test like this existed and yet no one used it..i was angry and dumbfounded...why? why was this not already available? and the part i wanted to add to your fine work, is the culpability of device man, and where do they stand on this issue, and the flow of their feelings on the test as the environment changes...this truly is an epic story with so many different angles, and the ended i have termed the Perfect Storm...Because all parties involved in this novel will bless MTwa, for their own needs ...at first icd man., do everyhting they can to destroy mtwa starting years ago...including pushing icds to doctors and hospitals throughout the nation because of the reimbursement factor of medicare and private payors...they were all making a fortune under the moral guise of saving patients from dieing, yet as you have said, only 19% are saved...they figured so what if people walk around with unnecessary icds, in spite of even some mortalities..hospitals, medical centers, cardio's, on down cashed in big time, and there was no way they were going to let mtwa get in the way..a conspiracy, but worse yet, it included EVERYBODY!!..THEY ALL MADE OUT..then chapter 2, all of a sudden medicare in jan 05 extends reimburement of icds to 3 fold!!.including many more patients into the potential pool of icd patients..WOW.but heres the caveate, ...they strongly suggest ,to a group of medical people put together to be a sort of board, who were in charge of making a registry to track icd patients to chart their progress, that they should INCLUDE, MTWA in their registry, as a way of doing the tracking...YET, when they drew up the plan, the OMITTED THEM, TO THE SHEGRIN, OF MEDICARE OFFICIALS..right in theor face they said, hell we are the doctors , the physicians, the hospitals, and medicare has put us together to help make sound medical decisions for patients, and they are asking US to kill our own money tree, by including them in this registry??!! NO WAY!..they said it needed more testing..after 10 years,...more testing..here medicare hands them a gift expansion, and that wasnt enough yet...MEDtronic, guidant, st jude, and the rest...unbelievable..so then medicare says hang on...the initiate with camh to file for ncd in july...leading the now at the cusp of approval..at the same time icd man. faced major recalls, followed by lawsuits, and now also bribe allegations...so they go too far, push it too much, they all get caught..but the rainbow for them is they now have a much greater population to choose from, so they can actually turn a dime, embrace mtwA,and say oh yea, look at this,...we have a test now, totally non evasive, that actually everyone should take that will totally accuratley risk stratisfy more people for icds, done by a nurse, who just reads the tape...before it was an evasive test that you only took if you really had too...now its simple...AND THE PERFECT STORM COMES ALL TOGETHER, MEDICARE GETS TOO SAVE MORE LIVES WITH MORE ICDS, MEDICARE GETS TO ELIMINATE ALL THE WASTE AND FRAUD, ICD MAN. GET TO SELL 10 TIMES AS MANY ICDS, ICD MAN. GET TO SAVE THEIR REPUTATIONS AND HELP WITH PRODUCT RECALLS USING mtwa FOR ALL RECALLS TO DETERMINE IF YOU SHOULD EVEN REPLACE YOUR DEFECTIVE ONE, HOSPITALS AND DOCTORS GET EVEN MORE MONEY, with more icds, and more recurring revenue from annual 400.00 tests for everyone..and the last two that benefit are the poor people who have suffered for no reason with meaningless icds, and the poor people that have already died, because this test wasnt available to be given to forecast their eventual death, and lastly CAMBRIDGE HEART AND THEIR LOYAL SHAREHOLDERS benefit, who have endured 10 years of battling unimaginable forces, to bring us an unimaginable test....
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=441
hello and thank you for the words...i ahve put a tremendous amount of effort into camh since i first came to know it...i was sure then, and i am surer now of what i know to be true, using many facts from many angles..the money involved is mega billions for acclaimed hospitals, medical centers, cardios, and alike...and all along their existed a testm for the past 10 years that could have saved thousands of lives for the poor people who suffered scd...the only thing they did wrong was not meet madit criteria to recieve the life saving device called an icd..if the test was available people with the ease of an ekg basically could tell if they were going to be the recipient of a future death..i am remember my brother asking me back in dec, "so you mean it can predict the future?"..it was hard to believe , but true..also it could ease your life by predicting you would probably never die from sudden cardiac test, subject of course to retesting...I have people say doctors were scared of suits if they didnt implant the icd..well i am here to tell you in an ironic twist, a total dicodamy, has evolved which is epic..with icd recalls, bribe stories, hospitals on the take, lawsuits are everywhere around us..this field is riddled with trouble, and now doctors are scared to give an unnecessary or defective icd, for fear of real justifyable lawsuits that would have merit. They all used the fear to justify all those implants..Now of course we know gdt, mdt sold defective icds that they KNEW were defective..We know now they have been allegedly bribing doctors and hospitals and offering kickbacks..We know now lawsuit commercials on cnbc are on everyday..We know now 80% of icds are useless implants. How would you feel feel if they told you you needed an icd..to live with one, even though, its simple, has been proven to be phychologically damaging to ones life outlook, and i could see the demoralizing factor, and it has lead to mortalities, in these people..And in the middle of all this doom and gloom is an opportuniy to solve EVERYONES PROBLEM..The timing of these events as they occur simutaneously are electrifying..we are right in the eye of the storm, ready to save the day..of all my investments over the years, some lousy ones in the past, and really great ones lately, this is the once in a lifetime opportunity some dream of getting..WE ARE SO LUCKY TO BE HERE..And that is why i have been so excited to share it with good people on amln board...Besides the large amount of profit potential here, the story itself needs to be told.I CALL IT "THE PERFECT STORM"
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=453
i am going to become a multi millionaire because of this stock
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=605
hmmmmmmmmmmmmmmmmmmmm...interesting

BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 8, 2003--Cambridge Heart, Inc. (OTCBB-CAMH) announced today that Eric Hecht, MD has been elected to the Company's Board of Directors increasing the number of Directors to eight.

Dr. Hecht established his well known reputation during his 10 year tenure as one of the top biotechnology analysts on Wall Street. During the period from 1992 to 2002 he was selected to the Institutional All-Star Team a total of six times making him one of the foremost experts in the industry. From 1997 to 2002, Dr. Hecht, was the senior biotechnology analyst and global coordinator of biotechnology research at Merrill Lynch. He also held a similar position from 1992 to 1996 with Morgan Stanley Dean Witter.

Dr. Hecht currently serves as the CEO of Potomac Pharma, a private specialty pharmaceutical company. He is also a director and founder of Conceptis Technologies, a privately held healthcare information company that operates the premier cardiology website TheHeart.org. Dr Hecht received his MD degree from the Albert Einstein College of Medicine in New York.

"Eric Hecht is an exciting addition to our Board," said David Chazanovitz, President and CEO of Cambridge Heart. "His unique knowledge of the industry will provide incredibly valuable insight and guidance to us as we continue to penetrate the cardiology marketplace with our Microvolt T-Wave Alternans technology."
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=625
email from cfo regarding supplies...

Dear Sandy,

With respect to your questions on inventory levels and production
quantities for the Heartwave II system, please note that we do not
make this information publicly available, so I cannot provide you
with a direct answer.

However, if I am interpreting your questions correctly, you are
wondering if we have sufficient inventory and production capacity to
fulfill an unexpected increase in demand. I can say that at this
time, obviously depending on the absolute level of any increase in
demand, we are confident that our inventory levels and production
capacities are sufficient to meet our expected revenue levels. Our
manufacturing process consists of assembling and testing finished
components and. As disclosed in the Risk Factor section of our SEC
filings (10-k) several of our components are available only from a
sole source, however, again we are comfortable that supply can meet
forecasted demand. In addition, adding additional hourly rate
workers allows us to increase our in-house capacity to assemble on
relatively short notice.

Best regards,

Roderick de Greef
CFO
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1317
what i believe will happen.........

last year cms isues a ruling that expanded icd implants to possibly 500,000 patients..but along with that they said hospitals and doctors must use a icd registry that would be set up to track patients from the beginning to the end. They must use the registry to get access to the expanded criteria..A board was set up to create a temporary registry, made up of doctors, hospitals and icd companies.The biased group was URGED by cms to include MTWA in the registry several times, including the new ncd issued for icds in JAN 05. But the biased board did not include MTWA..I have seen the form and it has QRS and LF as ways to determine icd implants..Well, now cms has contacted all doctors and hospitals that the temporary registry should not be used any longer , as of jan 30, 2006, and that the official new registry goes into effect april 30 2006..CMS has been holding seminars, MArch in atlanta for one, to instruct and teach everyone what the new registry incompasses..They have stated they have new waves of determining icd implants in the registry, and new technologies...I Have tried to find definitive proof that MTWA will on the new form april 30, but it is not published anywhere yet..I say on april 30 the new registry, will include MTWA as a criteria doctors could use for icd implants..I hope everyone here will try to investigate and searvch icd registry(yahoo) to see if we can find what the new registry has in it.They do have a web site set up but you must be a member to get into the core of its sight..Does anyone have access or knowledge?
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1407
ok...i have begun researchin the words sudden cardiac death, and t-wave, and alternans, and left out the keywords mtwa, etc..what i found is concerted effort on behalf of someone or some entity, through pr to make scd the new story, and how we need to find these poor people..better yet, theri examples are for young women and athletes dying, and mothers being quoted..they are preparing the world to make finding the 500,000 that are going to die their mission,...and they need icds, and they need easy ways to find these people...primetime, fox, newspapers,...look at all the news that came out last week..but all the stories interestingly left out the specific of mtwa..instead they broadly brought to the national attention what is coming...Im confident that this is part of a biiiiggggggggg plan...who?...acc, rhythm society, mdt, gdt, stj,...?...they are all in on it...this story is gigantic...google the keywords and see for yourself...The only thing that can stop us from mega millions is the selling of the company before the mega millions....
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1408
i understand your concerns..however i understand how it all works...stories are not going to directly mention mtwa all the time yet....but you have to look for the clues...for gods sake ,read the stories...this is all part of a concerted effort.they come from the pr firms from these groups who will benefit from icds...do you think all these news stories evolved all of a sudden by all these news people, abc, etc..No way..the writers have no idea what they are writing about..they are given these stories from the pr depts from these groups...and certainly the groups behind it are not going to directly mention mtwa, just yet, while they buy the stock and possibly the company..so they break these stories, sob stories, directed at mothers and fathers, first letting everyone know about a brewing problem with scd..then they hit us with the solution which they hint at...You would have to be totally blind to not read into those stories what i read...why all o a sudden..all these stories...do u think all these writers found this news at the same time..NOOOOOOOOOOOO..they were given to them, and with the words and scientific explanantion that they wanted to give to the writers,,do you think primetime even knows what we know..NOOOOOOOOOOOOO...do not deny yourself the obvious...keep reading about the deaths and the solutions, and how its too bad, "if my daughter had taken a simple test she would be alive"....one after the other...so when google search mtwa of course you wont get the stories...you have to look further and connect the dots...to get rich, it takes alittle more work than that...but i totally believe i am right...and remember, i told you BEFORE these news stories that we would begin to see the stories evolving, and beginning of embracing of this test...so when i see the stories come out, how can i deny the facts....i dont give a dam what the stock price does..that part will take care of itself..too many people can conttrol the price without any matter of the news..so you either have to believe or not...the wishy washy ones will make some money from hanging around, the non believers will buy high on the rush and sell low out of fear..the convicted believers who truly understand what i am telling you will make millions
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1486
Posted to Dr.Wes by DrWes on Thu, 03/23/2006 ? 8:26am
Cardiology

On 21 March 2006, the microvolt T-wave alternans as a reimbursible test to screen patients with reduced heart muscle function that might be at high risk for ventricular arrhythmias that can lead to sudden cardiac death.

So what is "microvolt t-wave alternans testing (MTWA)?" Well, the test is performed by placing special high-resolution electrodes designed to reduce electrical interference on a patient's chest prior to a period of controlled exercise. These electrodes detect TINY beat-to-beat changes in a portion of the EKG (the "T-wave") that represents a "resetting" current after the heart is stimulated. The changes are in the order of one millionth of a volt ("microvolt" range). A special mathmatical method of detecting these changes called "spectral analysis" is used to measure the timing change and amplitude change of the electrical signals. A positive test was present if the MTWA onset heart rate was =105 and all others considered indeterminate. Indeterminate tests occurred because of noise (slightly less than 10% of the time), skipped heart beats (ectopy), inability to achieve a heart rate of 105, or inability to sustain t-wave alternans during testing.

One of the better recent prospective studies to evaluate T-wave alternans was recently published by Bloomfield et al. in the Journal of the American College of Cardiology (Vol 47, No 2, 456-63): "Microwave T-wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients with Left Ventricular Dysfunction." This is a follow-up investigation that expands the applicability of the test published in Ciruclation in 2004 which looked at just ischemic cardiomyopathy patients (weak heart muscles from coronary disease). In Bloomfield et al.'s recent study, 549 patients were studied, only 1/2 of which had ischemic coronary heart disease. In this study, either positive or indeterminate tests were lumped together and compared to a negative test. Bottom line: A negative test means there is a 2.5% chance of death or arrhythmia in 2 years, vs a 12.3% (positive test) to 17.5% (indeterminate test) risk of death or cardiac arrhythmia.

What was interesting was the numbers.... 549 patients (average ejection fraction 25%), 189 had normal (negative) tests (with 4 events), 360 patients had abnormal MTWA tests (with 47 events). "Abnormal" MTWA tests included either positive (162 patients) or indeterminant (198 patients) tests.

So will ICD implant rates in patient's with low EF be decreased if this test is widely deployed? I don't think so. Given the LARGER total number of patients with positive or indeterminate tests, relative to the number of patients with negative tests in this study. If this test is widely implemented in stress labs, while the patients with negative tests might be spared an ICD, the increased screening using this test might actually INCREASE the number of implanted devices, since far more patients will have positive or indeterminate tests AND CMS seems to be willing to pay for the testing.....

--Wes

permalink | sourcelink
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STUDY SPONSOR DESCRIPTION EST TIMING
REFINE CAMH
Compare MTWA test to other non-invasive tests in 350 post-MI patients w/
EF<50% 5/06
SCD-HeFT Sub-study MDT (?) 500 patients w/ NYHA class II-III, EF<35% 5/06 or 11/06
ABCD STJ Show that MTWA test is equivalent to EP test in 540 patients w/ EF<40% 11/06
MASTER I MDT Compare outcomes in 650 MADIT II patients with and without negative MTWA test 11/06 or 3/07
MASTER II MDT Registry w/ 400 post-MI patients w/ EF >30%<40% 11/06 or 3/07
ALPHA GDT
Evaluate the predictive value of MTWA in 370 non-ischemic NYHA class II and III HF
patients 2006
CARISMA ?
Compare MTWA test to other non-invasive tests in 400 post-MI patients w/
EF<40% ?
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Recent CMS National Coverage Decision Thrust Cambridge Heart Into The Med-Tech Spotlight.

On March 28th we hosted a lunch with the CEO of Cambridge Heart (CAMH: $2.85; not rated) and Dr.
Thomas Bigger, Jr., professor of medicine and pharmacology at Columbia University and a leading
authority on risk stratification tests. CAMH manufactures a proprietary diagnostic test called a Microvolt
T Wave Alternans (MTWA) test which can identify patients who may be at risk of sudden cardiac death
(SCD) as well as those who are at low risk. In other words, CAMH s test can help determine the most
appropriate patients for ICDs in the primary prevention setting. On March 21st, the Centers for Medicare
and Medicaid (CMS) issued a final national coverage decision (NCD) for CAMH s MTWA test. In
addition to ensuring that all Medicare patients will have access to this test, the CMS decision provides
credibility for the test in our view and will likely prompt private payers to cover the test for non-Medicare
patients.

Tough To Determine The Net Impact Of The MTWA Test On The ICD Market In The Near-Term.

In the short-term, the MTWA test may accelerate the growth of the ICD market and increase the
penetration rate of ICDs because it can help physicians feel more confident that they are implanting ICDs
in the most appropriate patients. In general, the test indicates that about one-third of eligible patients are
unlikely to benefit from an ICD (excluding certain patients who cannot undergo the test and secondary
prevention patients). Once doctors identify the patients who are unlikely to benefit from an ICD, they
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may be more willing to implant an ICD in the two-thirds of patients who are more likely to benefit from
the device. The penetration rate of ICDs is currently about 20%.

We don t expect the recent CMS decision to have an immediate impact on the ICD market because: 1) the
installed base of MTWA machines is small (the current installed base is about 500 out of the roughly 8-10K cardiology practices in the U.S.); 2) CAMH still needs key private payers to cover the test before
widespread adoption occurs; and 3) some cardiologists and electrophysiologists (EPs) remain skeptical of
the MTWA test because of disappointing experiences with earlier, different tests.

Any Reduction In The Market Potential Caused By The MTWA Test Is Likely To Be Offset By
Ongoing Market Expansion Studies. In the long run, one may assume that the MTWA test will reduce
the size of the ICD market because the test indicates that about one-third of primary prevention patients
are unlikely to benefit from the device.
(~300K).

Therefore, the test could potentially reduce the market potential by about 20% (80% x 26% =
21%). We expect the results from ongoing clinical studies to become available over the next few years
(see Figure 1 at the end of this report). If these studies are positive, the eligible patient population for
ICDs will expand and help mitigate any reduction in the patient population that the MTWA test may
cause.

New Data May Lead To CMS Requiring An MTWA Test Before Implanting An ICD. Over the next
year or so, we expect data from additional studies confirming the predictive value of MTWA tests (see
Figure 2 at the end of this report). At some point, the data may become strong enough for CMS to require
a MTWA test before a physician can implant an ICD but this is at least a few years away in our view.
Even if this were to occur, we believe that the ongoing market expansion studies mentioned above would
offset any reduction in the market size caused by requiring an MTWA test.
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may be more willing to implant an ICD in the two-thirds of patients who are more likely to benefit from
the device. The penetration rate of ICDs is currently about 20%.

We don t expect the recent CMS decision to have an immediate impact on the ICD market because: 1) the
installed base of MTWA machines is small (the current installed base is about 500 out of the roughly 8-10K cardiology practices in the U.S.); 2) CAMH still needs key private payers to cover the test before
widespread adoption occurs; and 3) some cardiologists and electrophysiologists (EPs) remain skeptical of
the MTWA test because of disappointing experiences with earlier, different tests.

Any Reduction In The Market Potential Caused By The MTWA Test Is Likely To Be Offset By
Ongoing Market Expansion Studies. In the long run, one may assume that the MTWA test will reduce
the size of the ICD market because the test indicates that about one-third of primary prevention patients
are unlikely to benefit from the device.
(~300K).

Therefore, the test could potentially reduce the market potential by about 20% (80% x 26% =
21%). We expect the results from ongoing clinical studies to become available over the next few years
(see Figure 1 at the end of this report). If these studies are positive, the eligible patient population for
ICDs will expand and help mitigate any reduction in the patient population that the MTWA test may
cause.

New Data May Lead To CMS Requiring An MTWA Test Before Implanting An ICD. Over the next
year or so, we expect data from additional studies confirming the predictive value of MTWA tests (see
Figure 2 at the end of this report). At some point, the data may become strong enough for CMS to require
a MTWA test before a physician can implant an ICD but this is at least a few years away in our view.
Even if this were to occur, we believe that the ongoing market expansion studies mentioned above would
offset any reduction in the market size caused by requiring an MTWA test.
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: dr_allen_wang
Date: Thu Apr 13, 2006 3:45 pm
Subject: ICD Risk Stratification With Microvolt T-wave Alternans Testing dr_allen_wang
Offline
Invite to Yahoo! 360º

The Centers for Medicare and Medicaid Services (CMS) issued a final
national coverage decision last month establishing nationwide
Medicare coverage for microvolt T-wave alternans (MTWA) testing for
use as an additional diagnostic tool for physicians when considering
patients as candidates for prophylactic implantable cardioverter
defibrillator (ICD) therapy. In its decision memo,[1] CMS
characterized MTWA as "a useful risk stratification tool" that
can "identify which heart patients are at negligible risk of sudden
death, and therefore may be able to avoid ICD implantation and its
attendant risks."

The decision to cover reimbursement for the test was requested by
Cambridge Heart (Bedford, Massachusetts), which has been marketing
Heartwave, an MTWA test that utilizes a proprietary spectral
analysis algorithm to analyze the data and print a report for
physician interpretation, since 2002. CMS approved coverage only for
the Heartwave spectral analysis-type test, stating that "the quality
of the evidence is adequate to conclude that MTWA testing using a
spectral analysis algorithm can improve net health outcomes." But
the agency called the evidence base for other MTWA methods "smaller
and not yet convincing."

The MTWA test is a modification of electrocardiography (ECG)
exercise stress testing that is able to detect subtle variations in
the T-wave portion of the ECG associated with a higher risk of
experiencing a life-threatening ventricular arrhythmia.

CMS believes this test may be particularly beneficial in the older,
Medicare population. According to the agency, sudden cardiac death
has a higher potential to occur as a result of a ventricular
tachyarrhythmic event (VTE) in the Medicare population, and
potential harm from adverse events is more likely within this
population. As a result, the potential for benefit or harm from ICD
implantation plays a prominent role when physicians weigh treatment
options for this age group.

Although CMS ruled that MTWA "is reasonable and necessary for the
evaluation of patients at risk of sudden cardiac death," the agency
stopped short of mandating the test prior to ICD implantation. "We
do not believe that the current evidence is sufficient to require
[emphasis added by editor] that physicians use the results of MTWA
testing to select appropriate patients for ICD implantation," the
agency said. However, CMS is supporting the inclusion of MTWA
testing in subsequent clinical trials and registries to further
evaluate the technology.

CMS also is not recommending MTWA as a stand-alone test. "Across a
number of population settings, MTWA consistently demonstrates
superiority when compared with other diagnostic measures that assess
the risk of VTEs," the agency notes. "However, CMS does not believe
the evidence is sufficient to show that MTWA should be the only
diagnostic test for... stratifying high-risk patients." They note
that other parameters, such as left ventricular ejection fraction
(LVEF) and signal-averaged ECG, may be used as well.

MTWA is the First Technology-based Tool to Receive Endorsement From
CMS
Patient selection for ICD implantation has been a topic of much
discussion and considerable controversy over the past several years,
and the recent CMS coverage decision for ICD therapy has added fuel
to the ongoing fire. The CMS decision expanded the number of
eligible candidates for prophylactic ICD therapy to 500,000, which
is 2 to 3 times the number of patients who were previously covered
and is expected to create a fiscal burden that exceeds $15 billion
annually.[2] The prohibitive cost of providing this therapy to every
potential patient has led researchers to propose a number of risk
stratification methodologies, ranging from simply relying on low EF
to including QRS duration (a proposal abandoned by CMS in 2004 after
numerous complaints from physicians; see Related Links), as well as
MTWA, and biomarkers such as B-type natriuretic protein. MTWA is the
first technology-based tool to be proven in published clinical
trials, and the first to receive endorsement from CMS.

Is MTWA Testing Ready for Routine Clinical Practice?
The CMS decision follows the publication of a study in the January
issue of the Journal of the American College of Cardiology (JACC)
demonstrating the benefits of MTWA in ICD risk stratification.[3]
The study, which was the first large, prospective, multicenter trial
to investigate the usefulness of MTWA for ICD risk stratification in
heart disease patients without a history of prior arrhythmic events,
showed that MTWA can identify a large group of patients with LV
dysfunction who are at low risk for an event and thus are unlikely
to benefit from ICD prophylaxis. According to the study authors, by
using this strategy to narrow patient selection, only about 7 ICDs
would have to be implanted to save 1 life, compared with at least
double that number using current patient selection criteria (see
Related Links).

Anne B. Curtis, MD, Director of the Division of Cardiology at the
University of South Florida, and one of the JACC study authors, told
Medscape in a recent interview that patients with a negative MTWA
test can indeed be considered "a low-risk group." About one third of
patients in the JACC study were ruled out for prophylactic ICD
therapy because they were deemed low risk as a result of MTWA
testing, and Dr. Curtis believes similar results may be observed
when the test is used on a wide-scale basis. However, she expressed
doubt that risk stratification can get much better with current
tests. "One-third of patients isn't bad," she said, "but unless we
significantly improve our understanding of the pathophysiology of
heart disease in individual patients, I can't see us ever getting to
the point where we'd be able to identify a certain 5% of the
population that is at highest risk and classify everyone else at
much lower risk."

Asked if she currently uses the MTWA test on a routine basis, Dr.
Curtis said she is awaiting the results of more studies before
making that decision. "I think the [MTWA] test is useful for ruling
out ICD therapy in selected patients, particularly those who are
reluctant to have a defibrillator implanted," she said, "but I'm
personally not using it as a routine screening tool right now."

According to Dr. Curtis, who also mentioned concerns about physician
risk and liability issues with MTWA testing, further studies now
under way may help pinpoint the usefulness of the test in routine
clinical practice. "There is another study that's in the follow-up
phase right now called ABCD [Alternans Before Cardioverter
Defibrillator] and it also is looking at the use of T-wave alternans
for identifying high- and low-risk groups," she explained. "If that
study confirms these sorts of results, we may well get to the point
of being able to eliminate defibrillators in these [low-risk]
patients."

References
Centers for Medicare and Medicaid Services. Decision Memorandum for
Microvolt T-Wave Alternans Testing. Released March 21, 2006.
Available at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?
id=165. Accessed April 11, 2006.
McClellan MB, Tunis SR. Medicare coverage of ICDs. N Engl J Med.
2005;352:222-224.
Bloomfield, DM, Bigger, JT, Steinman RC, et al. Microvolt T-wave
alternans and the risk of death or sustained ventricular arrhythmias
in patients with left ventricular dysfunction. J Am Coll Cardiol.
2006;47:456-463.
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In the second commentary, a team of cardiologists at Mount Sinai in New York wrote that current guidelines for use of an ICD as primary prevention of sudden cardiac death fail to identify a large number of patients who die from sudden cardiac death -- the very patients who could benefit from a life-saving shock.


Anil Gehi, M.D., and colleagues wrote that the problem is that risk stratification relies solely on ejection fraction. An EF of less than 35% is the threshold.


They cautioned that while ejection fraction is a good prognostic marker for sudden cardiac death, "it may not be a reproducible measurement. The echocardiographic measurement of left ventricular dimensions can vary significantly in weekly repeated measurements in an individual patient. The limits of agreement may vary by as much as 8.5% above or below the mean calculated EF in repeated studies."


A better approach, they wrote, would be to develop a registry of patients with cardiac disease that would include EF as well as signal-averaged electrocardiogram, heart-rate variability, baroreflex sensitivity, heart rate profile during and after exercise, maximum oxygen consumption during exercise, microvolt T-wave alternans, and serum BNP level. Patients with or without ICDs could be entered on the registry and outcome data accumulated over time.


It would then "be possible to develop a risk score to more accurately predict sudden-cardiac death." Such a risk score, the authors concluded, might even allow clinicians to identify high-risk patients who survive myocardial infarction with a well-preserved EF, "thus making inroads into the large population of at-risk patients who would not otherwise qualify for an ICD by current guidelines
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I DONT KNOW IF I HAVE EVER BEEN MORE COMFORTABLE AND CONFIDENT, as i am in cambridge heart prospects. It is just so amazing ,...the entire story.How the icd companies have been stealing from the system, allowing ridiculous risk stratisfiers, to judge who was implanted and who wasnt. Sure theirDEVICE saves lives, but think about it.They implanted 17 people to find one true candidate. Did they tell those poor people that they probably didnt need the surgery they were about to have?.The 16 who have one, there lives will forever be changed by their awareness of the implant..Do you think they even know, till this day, that they really dont need it.?..Do you think they will ever find out?..Unbelievable..Now some might say" we have no choice, and it was worth saving the onel life"...okay..except there was and has been a choice all along..One that was easy, extremely accurate, cheap, reliable, and on and on....MTWA...but they wanted it their way..they kept it quiet, they hindered them every step of the way...The heart rythym society, the ep's, the hospitals,...they were all in on it..Until Medicare said, ENOUGH!....THEY SAID...look we gave you a bigger population to choose from, so now use MTWA, we will pay for it, find the people that really need it, and we will pay you for the icd's, although since you WILL be implanting even MORE under the new system, we are going to reduce how much we pay for the icd's by 20%...only fair, since EVERYONE knows eventually under the new system you will sell alot more icd's...Thats the unbelievable part of the story..Not only will it save the unnecessary 16, it will find the other 350,000 people that are going to die this year...There is no other story like this one.there is no other way to find the people who will die. The science is so accurate.It has been tested, and studied globally.DONT Try chart it or graph it. Cambridge Heart is at the center of the entire ICD MULTI BILLION dollar market. We have a monopoly, protected by a patent and an NCD. We have arrived here after 10 years. We've been put through hell and survived. Shortly, it will seem like the world has turned upside down on its head. The moment of embracement is near, and then MEDTRONIC, ST.JUDE, GUIDANT, AND CAMBRIDGE HEART, WILL BECOME ETERNAL SOULMATES..
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Mike Apanius

Matt Tong

Grant Steyer

Nathan Logan

Project Proposal

Introduction:

We propose to save lives and millions of dollars by implementing an annual screening of high risk individuals for T-wave alternans, as well as developing internal devices to test for alternans.

Problem:

Sudden heart failure kills one in four people and is the leading killer in western countries. Sudden cardiac death, one type of heart disease, accounts for 400,000 deaths per year. Although many of these deaths are impossible to foresee, some only occur after a detectable T-wave alternan signal. However, these T-wave alternans often go unnoticed in many patients leading to heart attacks, deaths, and expensive hospital bills.

Objectives:

The accurate diagnosis of T-wave alternans will save lives and also improve the quality of life. Avoiding costly hospital stays and treatments for heart attack patients will save money for insurance companies, employers (due to less missed work days while recovering), and patients who must pay out of pocket for parts of their treatment.

Solution:

Our proposal is that these deaths may be prevented by noninvasive detections in qualified hospitals, and by the development of defibrillators which can detect the onset of T-wave alternans. Implementing annual tests for the appearance of T-wave alternans will make it possible for doctors to treat heart attacks before they occur, and may serve to advise patients on what changes they can make in their daily lives in order to save it. While these tests will cost money, allowing preventable heart attacks will cost more due to missed work and rehabilitation costs.

Method:

We will research hospital s alternan testing equipment. Work on bringing together current research on developing an alternan test included in defibrillators. We will produce a convincing argument to persuade high risk patients that paying more for insurance coverage is worth it so they can receive preventative tests.

Resources:

www.cambridgeheart.com
Dr. David Rosenbaum and other doctors and professors
Electronic journals
Insurance data
Ohio Link
Euclid Plus
Schedule:

February 28: Gather information on history of research

March 7: Research existing hospital alternan equipment

March 14: Gather insurance information and information on internal devices

March 28: Outline

April 4: First draft

April 7: Website draft

Qualifications:

We all have previous research experience, as well as experience interviewing professors for past research projects. Matt and Mike have briefly worked with some TWA diagnostic equipment in laboratory. We have good communication skills.

Management:

Nathan Logan has management duties. He will make sure we follow through with our work and stick to our schedule, as well as finding sources of information and scheduling interviews.

Costs:

Only costs for insurance companies are to test the accuracy of our data and the necessary paper work and contacts that need to be made to set up and implement annual testing.

ehwest
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The cost of an ICD implant is over $50,000

The cost of ICD implant is over $50,000, the failure rates for implantable cardiac defibrillators (ICD's)is over 50% and operation risks faced by the first installation and the manufactures recall (a second installation) is a big waste if not needed. A relatively inexpensive, non-invasive test,by CAMH has been shown highly capable of predicting which patients with heart impairment are unlikely to have life-threatening sustained arrhythmias, and the test can be helpful with the replacement decision.

10 mil people are at risk of sudden cardiac death (SCD) and 400K will die of SCD. There are about 4 million Americans who have recurrent arrhythmias. My understanding is that if you have low blood pressure and/or certain type of irregular heart beats (arrhythmias) you qualify for an ICD. The problem is to minimumize the ICD's implants that will not be needed for the risk of SCD and maximize those people that will need it. Its obvious that the money and patient financially and physically suffering is a waste if not needed.

(CAMH) Cambridge Heart's Microvolt T-Wave Alternans Test measures subtle fluctuations in the human heartbeat, known as Microvolt T-Wave Alternans, which can be used to identify patients at risk for sudden cardiac arrest, ******the leading cause of death in the United States*******. These tiny variations, measured at one millionth of a volt, are detected under elevated heart rates, often during a typical treadmill or bicycle exercise stress test. The measurements are captured by disposable proprietary Micro-V Alternans Sensors placed on the patient s chest and transmitted to the Heartwave System for detailed analysis using proprietary algorithms.

CAMH's CEO states: Back in the 1990 s Cambridge Heart developed a technology at MIT (Massachusetts Institute of Technology), which looked for very subtle, anomalous changes in a portion of an individual s electrocardiogram called the T-Wave. The change would be seen in the shape or of the size of the T-Wave on an every other beat basis. When seen, that individual would be deemed to have Microvolt T-Wave Alternans.

In extensive *****studies over the last ten or more years,***** we ve shown that people that exhibit Microvolt T-Wave Alternans are at very elevated risk for sudden cardiac death. The flip side of that equation is also true, namely that if we do not see the Microvolt T-Wave Alternans, even if the individual is in the high risk category for Sudden Cardiac Death, then it is very unlikely that they will suffer such an event.

In similar groups of patients we ve shown that the risk of needing the defibrillator in a patient that tests Microvolt T-Wave Alternans negative is really quite small, approximately 1 to 2% on an annual basis. With a ****1-2% risk of dieing *****if you have had a negative MTWA test, this is approximately a 3x lower death rate then the ICD patients mentioned above.


CAMH state:*****Medicare pays for the Microvolt T-Wave Alternans test on a local basis;**** we ve gone to Medicare on a national basis and suggested that they should issue a payment or coverage policy Microvolt T-Wave Alternans, to make broad coverage uniform across the entire country. A broad national coverage determination by Medicare should carry some weight with the other private carriers in our effort to gain reimbursement for the test.

A lot more info at

http://www.ceocfointerviews.com/interviews/CambridgeHeart1105.htm
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CEO SAYS MEDICARE ALREADY PAYS


FROM THE CEO:
Medicare, which is the Federal insurance carrier that covers individuals 65 years and older, covers Microvolt T-Wave Alternans through local carrier decisions. This means that each local state Medicare carrier can decide if they want to pay for Microvolt T-Wave Alternans testing and for which indications. For the most part Medicare pays for the T-Wave Alternans tests across the country, with an average payment to the physician for testing in his office of about $321.00. This rate goes higher in high cost of living areas like New York, Boston and San Francisco. Many private insurance carriers also pay for the test, but there are also a number of the large private carriers that don t. Those that do not pay include carriers like WellPoint, Inc. (NYSE: WLP), which is the largest of the Blue Cross Blue Shield s units, AETNA Inc., and United HealthCare Services, Inc. However, we are very actively approaching those carriers to say, it s time that you should start paying for this test .

We ve been very fortunate in receiving assistance from the American College of Cardiology supporting the need for payment of the T-Wave Alternans test. Their Advocacy office has sent letters about T-Wave Alternans to the various insurance carriers advising them of the usefulness of TWA in predicting arrhythmic events and also predicting freedom from arrhythmic events. They have made a very important statement, which suggests that the insurance companies (who do not pay) are discouraging the use of our non-invasive technology, which may actually result in potential harm to large numbers of patients. This is due to the slowing of the adoption of our non-invasive technology and the overzealous implantation of implantable defibrillators as a primary prevention strategy for Sudden Cardiac Death. The American College of Cardiology recognizes the value of our test and we have many clinical studies to use in demonstrating clinical efficacy to the insurance companies. The challenge becomes that each insurance company becomes its own project for us.

We go to the insurance companies and meet with them to convince them that of the benefits their membership receives by having MTWA available. Unfortunately, there is no one magic formula to get all of the insurance companies to universally pay. Because of the importance we do put a significant amount of time and effort into this project. One item that I believe will help us significantly deal with Medicare. I mentioned that Medicare pays for the Microvolt T-Wave Alternans test on a local basis; we ve gone to Medicare on a national basis and suggested that they should issue a payment or coverage policy Microvolt T-Wave Alternans, to make broad coverage uniform across the entire country. A broad national coverage determination by Medicare should carry some weight with the other private carriers in our effort to gain reimbursement for the test.

No matter how good a therapy or diagnostic product is, if the physician can t make an appropriate profit it on it; it is unlikely to become routinely used. Therefore, we work diligently to make sure that the physician can get paid for the utilization of our Microvolt T-Wave Alternans test. As such working on the reimbursement issue is paramount. The other key element is to continue to supply additional clinical efficacy information to the physician. So it is a combination of clinical proof and economic value to the physician.

We ve been very fortunate in receiving assistance from the American College of Cardiology supporting the need for payment of the T-Wave Alternans test. Their Advocacy office has sent letters about T-Wave Alternans to the various insurance carriers advising them of the usefulness of TWA in predicting arrhythmic events and also predicting freedom from arrhythmic events. They have made a very important statement, which suggests that the insurance companies (who do not pay) are discouraging the use of our non-invasive technology, which may actually result in potential harm to large numbers of patients. This is due to the slowing of the adoption of our non-invasive technology and the overzealous implantation of implantable defibrillators as a primary prevention strategy for Sudden Cardiac Death. The American College of Cardiology recognizes the value of our test and we have many clinical studies to use in demonstrating clinical efficacy to the insurance companies. The challenge becomes that each insurance company becomes its own project for us.

http://www.ceocfointerviews.com/interviews/CambridgeHeart1105.htm

THEY ARE ALREADY PAYING LOCALLY FOR TEST AND THEY ARE PRESSED TO CUT COST; like $50K for a implant that won't work and is not needed any way(and who pays for the RECALL implants). You are talking about many BILLIONS of dollars per year in unneeded ICD implants. Many patient that qualify and that are exposed to the test data etc. will decide to use drugs instead of an ICD or maybe neither.

The bottom line, is there any chance that Medicare WILL NOT WANT TO GO NATIONAL with reimbursement for this test?

It's so obvious MEDICARE will go national with payments for this test. In fact, Medicare will want to make this test one of the gold standards available for Cardiologist etc when deciding whether to recommend an ICD implant.
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MD relied on the CAMH TEST for his own brother!

ONE of the comments received by MEDICARE

Commenter: Rittelmeyer, James
Title: M.D.
Organization: Winchester Cardiology
Date: 01/09/2006
Comment:
I have used T-wave Alternans in my practice for two years.
Many patients clearly need a defibrillator and many patients
clearly do not. Also, many patients fall into a gray zone. Rather
than guess in a very important moment in a patient's care, it is
very helpful to look at a test with good predictive value. The
patients and referring physicians are grateful when an informed
decision can be made. No test is perfect. But, just as when we
use a positive treadmill test to recommend expensive
revascularization to a patient, we can use the T-wave Alternans
test to recommend an ICD or not.

My own brother has structural heart disease. His treadmill
demonstrated nonsustained V-Tach on stress testing. A
negative T-wave Alternans test gave me the confidence that he
does NOT need an ICD at this point. His wife and two teenage
children are relying on me to make that decision. It would be
easy to just put an ICD in but I think it would be unnecessary.
A number of patients with an MI and an EF above 40% die of
sudden death. A positive T-wave Alternans can identify those
that are not at low risk and recommend additional testing such
as EP study. I believe, and studies so far have demonstrated,
that T-wave Alternans testing is the best test for primary
prevention of sudden death. Thank You for reading this.
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CAMH IS NOT YOUR TYPICAL BS $1 A SHARE COMPANY.

Estimated earnings per share for 2007, way OVER $1.00 !!! and just starting to accelerate.

This is a future 20 to 30 bagger, check it out !!!

Gone in 2 minutes, Sudden Cardiac Death (SCD) is a quick quiet killer. Consider A MAJOR cause of death in the industrialize countries and The NUMBER 1 cause of DEATH in the U S. The estimated U S SCD death toll for this year is 450,000, up from 300,000 in 2003. A few years ago Medicare decides that the best protection from SCD is an implantable cardioverter defibrillator (ICD). ICD s do a good job at preventing SCD deaths but there is no accurate diagnostic medical equipment or tests to determine the people who are at risk. The data from medical studies incorporating historical patterns, symptoms and tests have been disseminated to the medical world for use in analyzing those at high risk of SCD. In two major study, protective ICD s were implanted in a groups of high risk individuals and the results:

between 8% and 15% of the folks in those groups were saved from death.

The other participants also lived and would have lived even without the ICD.

In one famous study for every person saved by the ICD 12 in effect were wasted implants. At today s cost of $50,000 per implant, that one life cost $650,000 and $600,000 was virtually wasted.

***(By the end of this report, CAMH the $1.00 a share medical test equipment company is going to save Medicare and private insurers in the country and out of the country, BILLIONs of dollars every year. The more insurers save, the more CAMH makes. Wait and see!!)***


Interestingly, in the U S, although millions of people qualify ICD coverage, only about 100,000 Medicare patients per year took advantage of the implants and if you include private insurance companies etc, only about 200,000. The cost to Medicare was only about $4 Billion and the Medicare patients, about $1 billion. Estimates are 450K SCDs this year. Early in 2005 Medicare lower the bar for covering ICD implants (In fact they threw the bar away and ICD Medicare expenses are now aiming toward $20 BILLION). In 2006 they expect to pay for 200,000 ICD s, rising in the near future to 500,000 ICD s. No wonder Medicare proposed to give the MTWA test national coverage with no qualifiers. Virtually any person on Medicare will now be able to take the test, if a physician recommends it, they will cover the cost.

Right now, hanging around the U S, there are 13 million people classified as being at high risk for (SCD). This number increases yearly by the addition of 1.1 million heart attack survivors (MI s) and the 650K congestive heart failure patients (CHF) (a condition that gets progressively worse). They fit the at high risk criteria but for unknown reasons, most haven t make an effort to get an ICD. In the event this situation reverses, the system would be overwhelmed and under funded.

Basically, SCD s are caused by electrical problems and or body plumbing as well as all the variations thereof. CAMH believes on average the best their MTWA test can do is eliminate 33% of the above candidates that are determined by the test as not being at risk, it has a 98 ½ % accuracy. Even with an ICD implant you have higher then 1 ½ % chance of a SCD occurrence. The test can also confirm a high risk prognosis indicating a future SCD occurrence (meaning, you need an ICD). The accuracy of the test in this situation is about 65%. By the way the ICD implantation operation is not perfect. Although low, it still has a mortality rate, batteries go dead prematurely, every 7 years they must be changed out and there have been many repair problems, failure and factory recalls (Manufacture supplies free parts but no R&R labor. Too bad we can t substitute it for a new car with a better warranty).

It s obvious that the addition of reliable test data, that can show a no risk or can confirm a low risk, helps the patient and doctor make the right decision when contemplating an ICD implant. If data eliminates some of the unnecessary implant it adds up and can save the insurers billions of dollars yearly, not to mention the financial and physical suffering of the patient and last, but not least: It seems to me that by not administering the MTWA test, the patient if left in the dark and this could easily lead to a MALPRACTICE suit. For sure that would be the case if the test becomes a normal standard for this field. This obviously is not going to happening over night, but with over 98% accuracy it can t won t take very long.

So what s holding back the CAMH, MTWA testing? I don t know, but here are my guesstimates: Recognition by peer groups and Medicare; payment by Medicare and private insurers. Basically, they are waiting for Medicare to give the MTWA test national coverage. Right now very few doctors will accept the MTWA test results if it indicates that the ICD is not necessary. The standard is to do an ICD, from a malpractice stand point, not to implant is too risky for them. Why stick their neck out when they can play it safe. Therefore, the insurance companies see the test as an added expense with no financial return. If the doctor will not consider the MTWA test results when it reads no risk or low risk, the insurance company can not benefit. National Medicare coverage will give the test respect and eventually it may become one of the routine procedures. GE a competitor, with no studies to prove the accuracy of their instrument, it would require at least 5 years to catch-up. No big deal, for GE, buying this company would be chump change.

POTENTIAL EARNINGS! The MTWA Test Console sells for $30K. IMO, with decent volume, CAMH priced it to net out about 33% profit or $10.000 after all expenses.
After Medicare national coverage is approved on March 21,2006, revenues will depend on how fast the test is adopted by the 16000 U S Cardiologist plus a conservative estimate of 5000 other physicians including some Internalist, Cardiac Electrophysiologist and certain Primary Care Physicians. The total = 21000 divided by an average of 3 doctors per office = 7000 offices.
With any imaginative marketing they should be able to pump out a MTWA test console into 3000 offices by the end of the first full year after national Medicare (In my opinion, at least I out of the 3 cardiologist in an office is going to want a MTWA test unit, especially if the competition located in the next building or across the hall already has one). The numbers are $10K profit per test unit X 3K offices = $30 Million, net profit from MTWA test units.


The (one test only) proprietary electrode sets sells for $75. IMO, with decent volume it cost them $15. (This is equals to the retail selling price of a generic set) plus business over head etc. = $5. Total set cost = $20. Therefore the set will give them a net net net profit = $55.
Electrodes are a juicy profits item (and here comes a big profit surprise). To verify your low risk condition, you must take the test once every 12 months. Each years business adds to the next years business etc. Assume CAMH sells 1mill sets of electrodes every year, plus they receive repeat sales from the previous year. Therefore, the 2nd yr. total is 2mil, the 3rd yr. total is 3mil , the 10th year is 10 mil. Lookout MSFT, here we come. Did you think those Cardiologist will see and appreciate the advantage to their business from the yearly test program???

If MTWA testing works out as indicated, after billions of dollars in savings, will Medicare make the MTWA test mandatory prior to all ICD implants??? It could happen!!!

Now that I ve got those point out of the way, the question is how many sets of electrodes can be sold during the first full year after national coverage ?? Assuming for that year, Medicare reimburses physicians for 200K ICDs implants and private insurers do a matching 200K ICDs (I ve been told that a 50/50 ratio is about right). Further, assuming that the (above) 3000 MTWA test equip offices are providing the cardiologist to approximately 200K people (1/2 of all the Medicare and private insurers implant patients). Assume for this estimate, that prior to the ICD implant operation, these Cardiologists perform 200K MTWA tests on said patients (this works out to just about 2 patient per month per cardiologist - a very low number).
Our estimates are now, 200,000 sets of electrodes X $55. dollars per set = $11. Million, net profit from electrode sets.

Total net profit from all sales = $41 million divided by 41 million shares outstanding = $1.00 per share ( IRS taxes are sheltered by previous years losses)

*** When you include sale in other industrialized countries of the world , you can easily raise the Earnings Per Share estimates by between 50% to 100%,

The estimate we are using of 200,000 MTWA tests is a very small number in comparison to the potential testing of 13 million people roaming around that are at risk of SCD and would actually qualify for an ICD Through Medicare under their current guidelines.

As mentioned above, EACH YEAR there are close to 2 million new heart attach survivors and recently diagnosed CHF patients a large percentage are at high risk of death by SCD. 75% of the people who die of SCD show signs of a previous heart attack. 80% of SCD s victims have signs of coronary artery disease/CHF. This is a condition in which the arteries that supply blood to the heart are narrowed or blocked. Weeding out as much as a third by using the MTWA test, would reduce both the number of deaths by SCD and unnecessary ICD implants.
Physicians are becoming much more aware of the SCD risk to this group. These people on average are very involved and concerned in their medical conditions (as you can imagine). Due to their situation they are in frequent contact with their physicians. If applicable, I can t imagine their physician not discussing the ramifications of SCD, ICD and MTWA testing. I m sure this group will be a major user of this test, as they should be. Based on such a large number, you can project what that means in relation to test volume.

In today s medical world it is very common for a manufacture to by pass the physician and go direct to the general public (i.e. drug manufactures, cancer treatments etc). Specifically, It would be very easy for CAMH to promote the presents of their test and its benefits in the AARP monthly magazine (membership starts at age 50), from time to time, they could probably arrange a featured article.

For his patient and his own peace of mind, any doctor recommending an ICD, would be at the minimum remiss in not suggesting a MTWA test for consideration, prior to execution of an ICD implant.

In your evaluation, remember the progressive effect on earnings that the yearly re-testing has on the number of electrode consumed!!! This by itself will have a major effect on earnings per share growth during the first few years.

P S, worried about the Medicare decision due on March 21st.??? Then read the following:

CAMH went to Medicare asking for crumbs (a restrictive coverage of the MTWA test) and Medicare came back with a proposal offering them a carte blanche gourmet feast (no prior restrictions or qualification before taking the test). I see that as a sign, they want this test to become a popular standard. They need it to save those billions.

Any comments???????
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=405
Can CAMH ($1.10/share) have EPS of $2.61 in 2008??

U. S. only
Out of the 14 million people who are classified as being AT RISK of Sudden Cardiac Death (SCD, means sudden death in 2 minutes unless shocked by a defibrillator) 450,000 of them will die of SCD in 2006. That s a lot of people, in fact, it s the NUMBER 1 cause of DEATH in the U S. They could have avoid their death by having an Implantable Cardioverter Defibrillator (ICD) implanted at the cost of $50,000 per person, 80% to 100% paid for by their health insurer or medicare. The 14 million all qualify for this benefit and next year the number will rise to 15.5 million. For some unknown reason only about 300,000 of that group took advantage of the pesky little ICDs, the rest must have assumed it wasn t worth the trouble and decided to play out the odds of dying, which are 1 out of every 47. Of those smart 300K people, about 30,000 would have died that year if they had not received that ICD. To save those same 30k people, insurers 50% and medicare 50% spent 12 BILLION (indirectly our money from taxes and insurance premiums).

Not bad, it only cost us about $400,000 per person, but in the next few years, instead of 300K people doing the ICD thingy, it is expected to rise to 1 million people. Without inflation, that would be 40 billion dollars a year. Still 50/50 covered by medicare and private health insurers.

EACH YEAR there are close to 2 million new heart attach survivors and recently diagnosed CHF patients a large percentage are at high risk of death by SCD. 75% of the people who die of SCD show signs of a previous heart attack. 80% of SCD victims have signs of coronary artery disease/CHF. This is a condition in which the arteries that supply blood to the heart are narrowed or blocked.

Now I doubt if the other 14 to15 million or the additional 2 million (above) are going to decide this year to run in and get an ICD, but I also doubt if many do not. If you compare the estimate of 400K implants this year and 1 million in a few years with the large group of overhead potential candidates, the projection of 1 million in a few years seems under estimated. For my projection of 2008 s EPS we have to make some assumptions: #1. That all private insures follow medicare s lead and grant national coverage to CANH s, MTWA Test ( It s rare when insurers go against medicare s lead). #2. Because of malpractice suits etc, by 2007, physicians will be required to explain the benefits of the MTWA test and get a signed disclaimer prior to the installation of an ICD. #3. That there is, on average, 7000 offices each with 3 cardiologist or similar person. That the net profit per $30K MTWA test unit is $10K and that the net profit per electrodes set is $55. #4. That in 2006 sales are 1k test units and 100K electrode sets; In 2007, sales are 3000 test units and 400K electrode sets; in 2008, sales are 3000 test units and 1mil electrode sets. #5. Low risk test results are good for a year and the test must be repeated. We assume each year s low risk test patients, renew their test. #6. 2006 s taxes are offset completely by prior years losses. 2007 s and 2008 s taxes are offset completely by the profit from world wide sales, outside the U S.

2006 test units 1000, net profit = $10 mil
2006 elect sets 100k, net profit = $5.5 mil
2006 total profit $15.5 mil/41m shs = $.38 per shares

2007 test units 3000, net profit = $30 mil
2007 elect sets 400K, net profit =$22 mil
2007 elect sets retest,net profit =$5.5 mil
2007 total profit $57.5mil/41m shs = $1.40 per shares
2008 test units 3000, net profit = $30 mil
2008 elect sets 1 mil, net profit = $55 mil
2008 elect sets retest,net profit = $22 mil
2008 total profit $107mil/41m shs = $2.61 per shares
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=425
CLARIFIED AND UPDATED

Medicare (CMS) has approved payment for the CAMH's test nation wide. But the official approval is expected Mar 21st or sooner. Also known as the MTWA test, it is the only test of its type approved for payment. Private heath insurance companies will follow Medicare's lead and approve the test within 9 months, most will actually follow in a few months!! Physicians will not purchase the equipment until they are sure they will be paid by health insurers or medicare. There is no real respect or appreciation for the test results until medicare and insurers have sanctioned the test with their willingness to reimburse physicians nation wide. Outside the U S, it's the same story.

Right now, 12,000,000 people in the U S are qualified for an ICD implant. Qualified means they are at risk of Sudden Cardiac Death (SCD). (cost of the ICD is $50,000. each)

About 400,000 of these people (per year) actually receive the ICD implant (This is up from 200,000 a few years ago).

About 500,000 thousand people per year will actually DIE from Sudden Cardic Death (SCD). This number has doubled in the last 3 or 4 years. Sudden means about 2 minutes. (SCD is the number 1 cause of death in the U S.

If all 12,000,000 million were to get an ICD it would cost $600,000,000,000.00 That is $600 BILLON not million.

Each year only 1 out of 14 implanted people actually needed the ICD, the other 13 were unecessary. Because of that "little" problem, it cost $700,000.00 to save that one person.

By using the CAMH test, the ratio is reduced to 1 saved out of 7 implanted people. The cost to save that one person is reduced to $350,000. The test does this by eliminating about 36% of the candidates that show very low risk of a SCD.

Not great, but nothing else is better and it can save insurers and medicare $BILLONS. This year the ICD expense will be about $20,000,000,000 ($20 BILLION 50% covered by medicare). In the next few years it is expected to rise to $50,000,000,000.00 ($50 Billon).

Who pays the increase in health insurance premiums and income taxes for these expenses ????

It may take a few years but it's a sure bet the test will become mandatory prior to an ICD implant. And those eliminated by the test, most take the test again each year to be safe.

The Cardiologist will probably want to protect themselve from legal problems and offer the test to just about any heart patient. Especially the YEARLY 1.1 million heart attack survivors (these folks are the most susceptible to sudden death (SCD) and the yearly 700K Cronic Heart failure (CHF) survivors.

After all overhead CAMH's net profit per test station is about $18K and each one time use disposable electrode set is $50.

For 2007 I estimate a minimum of 1.5 mil electrode sets = $75 mil net and 4000 test stations = $72mil net, for a the total net profit = $146 mil (previous losses and world wide sales should cover the IRS) "divided" by 50 Mil shares = About $3 earnings per share.

Estimated $40 a share trading price
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=529
This year Medicare and other Insurers will spend about $15 Billion on ICD implants (at $50K per ICD) about 93% ($14 Billion) is unnecessary. When the MTWA test is available at most of the Cardiology practices it will eliminate 1/3 of the unnecessary implants ($4.7 Billion). This is a benefit to Medicare, insurers, patients and most Cardiologist (Most Cardiologist are not the physician doing the implants).

When the test is available at most Cardiology practices, CAMH will have EPS of $5 to $10 (before taxes) from just the U S. So where will the shares be trading $??.

As you can see from the BILLIONS of dollars involved Medicare and insurers obviously need this test in a big way. They will see that it becomes a standard. They can t afford to ignore it. So I'm in it to make the big bucks, Like a half million dollars or more

It will probably won't happen, because it will be bought out within the year. When ever you have a situation where the EPS in a couple of years will equal todays stock price, you buy the company out.

GE has a test that they have been working on, they are years away from completing the case studies and the medical reviews needed to obtain Medicare coverage and market acceptance. If GE bought this company, with their marketing/sales department already in place, they would have their money back from profits the first year. This is not a one time situation or even a one country situation. Sorry to say, Sudden Cardiac Death is going to be with us forever. The situation is not going disappear but they will still come up with new ICD Band-Aids and they will always need something to help them select the right candidate. This is just the beginning of a whole new medical specialty.

I suggest you take the long-term or wide view of it. There is no problems with this stock price until a new mouse trap comes along.

If they open it with a big pop to the upside you know they will fill in the gap. I assume a lot of the action today was institutional buying generate from Lehman Brothers Ninth Annual Global Healthcare Conference last Wednesday

Interestingly, "John W. Rowe, M.D., Executive Chairman of Aetna, is scheduled to make a presentation at the Lehman Brothers Ninth Annual Global Healthcare Conference on March 9,".

It seems Mr. Rowe is an M.D. He must of been impressed and liked what he heard at the conference in regards to CAMH's presentation. National coverage of the test by Aetna is a great motivation for the other major insurances companies to get on board or be looking pretty silly. Even more important is the Cardiologist's motivation to purchase before there is a waiting line.

"Aetna considers measurement of microvolt T-wave alternans diagnostic testing using the spectral analytic method medically necessary for the evaluation of persons at risk of sudden cardiac death who meet criteria for implantable cardioverter defibrillator placement."



THIS IS THE MOST IMPORTANT PART OF THE NEWS TODAY.

"""""medically necessary for the evaluation of persons at risk of sudden cardiac death who meet criteria for implantable cardioverter defibrillator placement.""""""

BECAUSE it almost states to the Cardiologist " that the MTWA test is a requirement" if you want Aetna to pay for the $50,000 dollar ICD implant.

And that tells the Cardiologist they must NOW PURCHASE a MTWA TESTER.

I think by the end of the first qtr, they will be backlogged with orders. In that event this stock would just fly. Probably a double from where ever it's trading at that time. I'll wait it out and see what happens, when these stocks wake-up they really move
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=948
Right now all the talk is about whether the MTWA test will help or hurt the big 3 MULTI- BILLION dollar ICD manufactures. No one has mentioned the effect this will have on CAMH. I think in a few more days, the subject may pop up and turn some heads. There has been a lot of stock changing hands which IMO is good for future stock price appreciation.

The publicity from all this controversy as to whether the MTWA test will help ICD sales versus hurt them, IMO it is a big benefit for CAMH's sales and investors interest. The general public is getting introduced to this test, it s like free advertising, and primary physicians as well as Cardios will be under some pressure to at least be knowledgeable on the subject and advise as to availability of the test. When a cardio has to tell a patient where a test is available, it's time to get one for his practice. And of course that's the name of the game.

The more health insurers to issue coverage, the easier it is to sell the MTWA test.

The stock is up over 1000% in a few months, 11 million shares traded (25% of the float). After the morning hours there was no panic selling of investors trying to hold on to their profits, that s a good indication of a change of hands into those of long term investors, in my opinion it signals signs of higher stock prices in the near future.

I'm in it for the long term, not going to throw away $20, $30, $40, $50 dollars of future profits for $1 dollar of final profit today. If this test isn't a winner with all it benefits, what is. I can't imagine a Cardio asking for something better when it doesn't exist. What s his choice, wait 10 years, to see if a superior product comes to market or cross his fingers and hope in 9 months for an after Christmas clearance sale ???? Get real !!

Recommending an ICD is a hard Question; the MTWA test is a reliable tool that can help the Cardio and patient make that decision. Cardios make big money they don t have time to study and review every gadget a salesman tries to sell. Their attitude is: if you have something good don t try to prove it to me. Prove it to the AHA , ACC or Medicare/Medicaid, if they recognize it and it s something I can use, then come back and tell me about it. Well the then is now.

The Medicare NCD recognition came close to making the MTWA test mandatory prior to an ICD implant. The need for the test in a Cardiology practice is a no brainier. It s obviously going to be a big help to both the patient and the Cardio and it s going to make money for the Cardio. Now that the NCD has basically certified the test as reliable, they really can't afford to practice without it, especially when the cost is almost negligible, like $100 month on a lease/purchase basis for a 2 or 3 physician office. I ll bet (I mean invest) my money, that they'll order it and that distribution will be very rapid. Basically I m stating this because IF I WAS A CARDIOLOGIST, I D ORDER IT.

Right now, even without a public notice of coverage, I guaranty NO health insurer will refuse to cover the test. The Cardios know this and I don t think that will delay orders.

For every 1000 units sold CAMH will make about $1 a share plus annual patient re-testing. Right now, there is a market for 15,000 units in this country and about 15,000 outside the country.

The profit margin is fantastic, when the earnings start coming in and investor s realize this is a necessity business, the PE Ratio could get dramatic.

Medtronic s made a smart move giving the test respect and worldwide recognition. Up 10% on tremendous volume.

What s Cramer take on it ? He can t knock the product, and he can t recommend it because it s a BB and under $5?
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1012
Recommending an ICD is a hard Question; besides the Ejection Fraction (EF) score, which is a JOKE, it's only correct 5% of the time, very expensive to obtain a reading and if you want a somewhat accurate readings it requires fairly major surgery. The MOST ACCURATE TEST is the CAMH test, it is a reliable tool that can help the Cardio and patient make that decision. Cardios make big money, they don t have time to study and review every gadget a salesman tries to sell. Their attitude is: if you have something good don t try to prove it to me. Prove it to the AHA , ACC or Medicare/Medicaid, if they recognize it "THEN" it may be something I can use. Well the "then", has now arrived.

* "NOTE"* "EF varies - a lot. Dr. Marc Silver agrees. It varies from minute to minute, hour to hour, and day to day. That makes measuring it less important and our actual EF number less important as well. What is important is the trend of our EF. You can spot the trend of your EF by having it measured once every so often: every 6 months or every year for a couple of years after diagnosis; less if you are stable; more if you are not."
http://www.chfpatients.com/faq/ef.htm

The Medicare NCD recognition came close to making the MTWA test mandatory prior to an ICD implant. The need for the test in a Cardiology practice is a no brainier. It s obviously going to be a big help to both the patient and the Cardio and it s going to make money for the Cardio. Now that the NCD has basically certified the test as reliable, they really can't afford to practice without it, especially when the cost is almost negligible, like $100 month on a lease/purchase basis for a 2 or 3 physician office. I ll willing to bet (or invest) my money, that Cardio's will want to lease/purchase the test equipment and that distribution will be very rapid. Basically I m stating this because IF I WAS A CARDIOLOGIST, I D ORDER IT.

I GUARANTY YOU NO HEALTH INSURER WILL REFUSE TO COVER THE MTWA TEST, even though a particular insurer has not yet made an official announcement. It's no secret that all health insurers will soon follow Medicare, the leader. Obviously, the Cardios know this and I don t think that will hurt or even delay purchase orders. With all the newspaper and magazine articles, I think the orders will be pouring in. It will still require a sales organization, but there are many that won't wait for a salesman to visit them, instead they will just phone in an order and set up an oppointment for delivery and test instruction briefing.

For every 1000 units sold CAMH will make about $1 a share plus annual patient re-testing. Right now, there is a market for 15,000 units in the U S. (according to the CEO) and IMO about 15,000 outside the country.

The profit margin is fantastic, when the earnings start coming in and investor s realize this is a necessity product, the PE Ratio could get dramatic.

For marketing their test unit, CAMH should look at SCHK and GIVN. SCHK uses PDCO (a major medical equipment supply co) to market their products and their own small sales department as closures. GIVN allows JNJ (Johnson & Johnson) to handle one of the their major product lines.

Is there any swing traders that can pin point at what price to buy.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1022
CEO tells why (important)Cardios will order the test unit!!! Answers to many questions

While the advantage of the ICD over drug therapy in those studies was shown to be statistically significant, the benefit was fairly modest in its magnitude. The largest of these studies is called SCD-HeFT (Sudden Cardiac Death in Heart Failure). It compared the use of implantable defibrillators and standard drug therapy in heart failure patients. If you had the ICD, your chance of dieing was about 5½ to 6% on an annual basis. If you were treated with drug therapy, then that number grew to a little over 7%. Therefore, the difference was not overly dramatic between ICD therapy and drug therapy, even though it was a statistically significant event. From a common sense and lay standpoint this means that you would have to place many implantable defibrillators to gain a small incremental value.

Implantable defibrillators are very expensive devices and have an enormous impact on the national healthcare budget. We can help this budgetary crisis by making the identification of patients a more efficient process. In similar groups of patients we ve shown that the risk of needing the defibrillator in a patient that tests Microvolt T-Wave Alternans negative is really quite small, approximately 1 to 2% on an annual basis. With a 1-2% risk of dieing if you have had a negative MTWA test, this is approximately a 3x lower death rate then the ICD patients mentioned above. While defibrillators are great products they have their own set of issues. In the last year there have been over 100,000 ICD recalled by the major manufacturers. The implant procedure has its own morbidity as problems can arise such as infections resulting from the procedure and the wires that go from the defibrillator to the heart are subject to breakage. Also, defibrillators are known to fire inappropriately and that is not a pleasant experience for the patient. So while they are great products, we can help risk stratify the population, to make the use of implantable defibrillators a lot more cost effective and a lot more beneficial.

CEOCFO: How do you address that particular feature, with a community that needs to understand that and act on it?
Mr. Chazanovitz: The typical cardiac patient is seen by his cardiologist, who is typically not the same doctor that implants the defibrillator (electrophysiologist). Most cardiologists today are still hesitant to refer all of the, appropriate patients, to the electrophysiologist; partially because of the issues that I have expressed with implantable defibrillators. Our presentation of Microvolt T-Wave Alternans and the Heartwave to the cardiologist serves dual purposes. If the patients tests negative then the MTWA test serves to reinforce the cardiologists to treat the patient conservatively with drug. If the patient does not test negative then we become the enabler to help the cardiologist make the decision that those people need to be referred on to the electrophysiologist for ICD implantation. Whether the test is positive or negative, the information is valuable to the cardiologist in determining the best care for his patient.

CEOCFO: So it s really a win, win.
Mr. Chazanovitz: We look at it that way all of the time and that is exactly what we like to share with our clinicians.

CEOCFO: How do you get the cardiologist to pay more attention than they have so far?
Mr. Chazanovitz: We point out to the cardiologist that while he is taking care of his patients, he can also take care of his family by using our Heartwave II test. Meaning that, no matter how good a therapy or diagnostic product is, if the physician can t make an appropriate profit it on it; it is unlikely to become routinely used. Therefore, we work diligently to make sure that the physician can get paid for the utilization of our Microvolt T-Wave Alternans test. As such working on the reimbursement issue is paramount. The other key element is to continue to supply additional clinical efficacy information to the physician. So it is a combination of clinical proof and economic value to the physician.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1082
As for the liabilty issue. The NCD should nix that as any

COPY OF A POST FROM THE PAST FROM A VERY KNOWLEDGABLE PERSON IN THE BUSINESS (so to speak)

As for the liabilty issue. The NCD should nix that as any reason not to do testing. First and foremost the physicians should be doing TWA testing and using that data and all the other tests used to complete a picture that will help to make intelligent decisions with respect to ICD implantation. Second, the draft policy states:

"From the studies used to evaluate this technology, it does appear that the quality of evidence is adequate to conclude that MTWA testing using a spectral analysis algorithm can improve net health outcomes, and is reasonable and necessary for Medicare patients who are candidates for ICD placement."

IMPROVE NET HEALTH OUTCOMES AND REASONABLE AND NECESSARY ETC.........that should absolve you in any lawsuit. Just in case, the draft also says:

"Based on this analysis, CMS proposes that MTWA is a useful risk stratification tool and can identify which heart patients are at negligible risk of sudden death, and who may therefore be able to avoid ICD implantation and its attendant risks."

Not to mention the other wording that basically clears any legal doubts from anyones mind.

As for you having been approaced 2 1/2 years ago, the environment is completely different now. Better coverage, more clinical trials and a greater acceptance by EPs based on clinical trials. Since an EP would have to be implanting 24/7 and still not be able to implant everyone who is eligible, TWA is the best tool to identify the CORRECT people who should get an ICD.

I would love to know where you and your colleagues are so I can have someone contact you because TWA can be of immeasurable assistance in identifying the right patients for ICD. I beg you to call CHI and leave a message at X226.

Here is another issue. MADITT didnt even address people with EF 30-35, so all of a sudden all these people get an ICD with the SCDHeFT decision. Well what about the guy whose EF is 34 on an echo, then has a nuke study and his EF is 36 a week later. Thats a huge gray area, patients from 30-35 should definitely be TWA'd. Plus, a higher percentage of deaths come from the non-SCDHeFT population, what about them. Its a shame that some Drs practice not to get sued, rather than to provide the best care possible. Thats an indictment on societys idiotic lawsuit mentality.

The new NCD squashes any fear of losing a lawsuit.
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Every cardiology practice in the world needs the MTWA test. It won't be long before there is a MTWA tester next to every EKG. Whatever problems a Cardiologist is able to diagnose and treat there maybe an undiagnosed situation lurking around called Sudden Cardiac Death (SCD). The treatment he is providing indirectly may also be a benefit in protecting the patient against SCD.
However, SCD may require a totally different treatment and in those situations the Cardio and the patient must decide if the odds merit making SCD the priority and the diagnosed problems a secondary consideration. In the U S, where a $60,000 ICD implant is available almost for free by the heath insurers or Medicare, the Cardio and patient must decide whether to take the ICD path or the medication route or in some cases both. The odds of mortality in both methods are very close with the ICD implant having a slight edge but the disadvantage of having to deal with product recalls, false shocks, infections, physiological factors, dead batteries, and the fact it may have to be replaced in less then 5 years with a max of 6 years.
The ICD protects against SCD and does not cure or medicate, whether it be SCD or the original diagnosed problems. It s like carrying an umbrella in case it rains, in most cases it will keep you dry until you get to your designation. In this case the designation is to stay alive while you work on the diagnosed problems (Assuming the diagnosed problems are workable). Science is already busy on stimulating the body to grow new arteries and veins as well as stem cells to repair heart muscles. STXS has already re-routed electrical channels into the heart in a precise but yet minimum invasive operation.
In most other countries the ICD cost are not covered and the Cardio has no choice but to treat the patient s risk of SCD as well as the diagnosed conditions with medications. Either way it s important to know to the best degree possible if SCD is going to be a strong possibility in the patient s future and if necessary adjust medication and treatments to vector in this factor.
Since the MTWA test is the best predictor of SCD and other standard tests enhance this predictability it makes no sense for the cardio and patient to make predictions with out it. It also makes no sense to treat a patient, without first determining to what reasonable degree a patient is subject to SCD. Therefore my prediction is that every Cardiologist in the world will need and want MTWA test equipment. Especially, from the sunny shores of China and India with their combined 2.5 billion populations and of course all other industrialized countries.
I advise you to keep an eye on this stock and the quarterly EPS numbers. CAMH seems very conservative. I expect them to follow very conservative marketing methods, with a major push after their marketing is in place and the insurers have announced coverage. The growth in revenues will look good compared to the past but the really big growth numbers will start rolling in during late 2006 and thereafter. Early adopters could speed this up by ordering direct, but the heart of the volume will come from their new sales organization. MGMT is not in a hurry, they just want to do it right. They feel if they produce in a steady and conservative manor, the stock will take care of itself, in its own time.
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FDA approval for non evasive device that just "senses" some type of physical output and has no dangerous characteristics is almost automatic. It requires a very short period of time and minimal expense. Getting Medicare or a health insurer to pay for it is another story and getting physicians to believe it is of value as well as pay for the device takes an earthquake size effort. If someone they respect uses it in their practice, then it might be an easy sell.

Studies showed alternans to be a heart rate dependent phenomenon. In addition, CAMH developed a methodology, known as the Spectral Method, which allowed measurement of alternans at the level of one microvolt.

This method was refined to create our proprietary Analytic Spectral Method which uses Micro-V Alternans Sensors that are specially designed, high-resolution, noise canceling sensors to detect minute heartbeat variations, measured at as little as one-millionth of a volt. This permits the measurement of alternans even in the presence of the noise typically encountered during exercise stress testing. These sensors allow the recording of up to four ECG signals from the same anatomical site as well as electrode-skin impedance and respiratory signal. An adaptive noise reduction algorithm combines these signals to create an enhanced ECG signal to expose previously indiscernible T-Wave alternans.

The Test

The Microvolt T-Wave Alternans test is a provocative, non-invasive, easy to perform, diagnostic test. By taking detailed ECG measurements during rest, exercise, and then rest again, the HearTwave® II System can identify the presence of Microvolt T-Wave Alternans. The appearance of Microvolt T-Wave Alternans indicates the presence of a type of cellular metabolic activity that frequently leads to ventricular tachyarrhythmias.

In most situations, the test takes less than 30 minutes to perform. Following the placement of fourteen sensors - 7 Micro-V Alternans sensors and 7 standard electrodes - in the Frank-lead configuration, the electrodes are connected to the digital ECG amplifier that leads back to the Microvolt T-Wave Alternans enabled system. At the beginning of the test, the patient is directed to begin walking on a treadmill to raise the heart rate. Patients who are unable to exercise can have their heart rates elevated pharmacologically to achieve the higher rate needed for a successful test.

The sub-maximal exercise portion of the test will be approximately 8-10 minutes. Information will be collected for the Microvolt T-Wave Alternans Test while at rest, during exercise and at rest again. Upon test completion, the system analyzes the data and provides the Alternans Report Classification, which is an automatic interpretation of the test results. The test is classified as positive, negative or indeterminate.

The Outcome

Multiple prospective clinical trials indicate that patients from broad groups of at risk populations who test MTWA negative will likely live ventricular event-free for 12 to 24 months after their initial MTWA test.

In patients who have a negative (normal) MTWA test the risk of sudden cardiac death is very low. The Negative Predictive Value of MTWA testing has been shown to be 98% accurate for follow-up periods of 12 -24 months in various clinical studies. Negative patients should be retested every 12 months as cardiac function can change over time.
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In JUST the U S this year over 10 million people are at risk for SUDDEN CARDIAC DEATH (SCD) and well over 400,000 of those people will DIE in the coming year. Each year an additional 2 million will be at risk. SCD is the number one killer in the U S and is ranked high all over the world.

Medicare covers the cost on about 50% of the U S ICD implants. These ICD's protects people against SCD. Based on a government-funded survey showing ICD implants significantly reduced Sudden Cardiac Death (SCD) in patients with even mild heart disease, last year Medicare agreed to expand coverage to an estimated 500,000 people yearly. This increase also led to expanded coverage by private insurers.

At $60K per ICD implant (parts + labor) the above estimate 500K people from medicare, equals a cost of $30 Billion for Medicare and $30 Billion for private insurers.

According to various studies, on a yearly basis, only 1 out of 18 implants are necessary. There is a MULTI BILLION dollar NEED TO FIND THAT 1 person out of 18 before they do 17 unnecessary implants (in other words each year 95% of the ICD implants operations are not necessary).

There is one simple non invasive test that is similar to an ECG/EKG, it's made by CAMH and it's called the MTWA TEST (or T-WAVE test). This device, after 10 years of studies, surveys, reviews etc has just received MEDICARE's approval to pay, on average, about $400 per test with no conditions attached.

As of March 21st 2006, if a doctor feels its necessary, no question ask, they get PAID by Medicare. This is nationwide and its referred to as an "NCD". It's hard to get an NCD, Medicare did a 1 year review of all studies and surveys. This Medicare NCD determination is important to Cardiologists because it varifies the value of the procedure and it guarantees these physicians will get paid for administering the test.

About half the private health insurers have agreed to cover the cost of this test and now because of the Medicare "NCD" on March 21st 2006, the remaining insurers will soon cover it.

Based on the expected Medicare NCD, in a few short months investors moved the stock from $.30 to $4.00. The annoucement of this "NCD" made the news in just about every newspaper, including the Wall Street Journal and every Medical Journal. (The Multi Billion dollar ICD manufactures tried to delay the Medicare decision because they are afraid it will hurt their sales). After the announcement the stock fell to about $2.40 and is now back to $3.00

Basically the MTWA test will eliminate 1/3 of the candidates that meet the requirements for a $60K ICD implant from this unnecessary and expensive operation. The test will give them knowledge but the decision on whether to go through with the ICD is still up to the patient and doctor.

Will the Cardologists thoughout the country and the world now purchase the MTWA test equipment??? If the answer is yes, it will soon be a $30 dollar stock. Until we know what the cardios will do , the stock will move up and down based on expectations.

All I can tell you now is that Cardiologist have much to gain (including certain legal advantages) and nothing to lose by purchasing the test equipment.

Physicians and especially specialist, in general, are very hard to sell. Their time is to valuable to spend investigating every new thing that comes along, so they rely on their medical associations and like to follow very standard and popular outlines. Their attitude is you go first, I'll go last. They will follow someone they respect rather then research it themselves. They are very motivated by what their neighbor or competition is doing. CAMH will continue to concentrate on the major population centers and probably make the big push when they have "all" the major insurers behind them.

But, CAMH could lucky out with accelerating sales almost immediately. Cardiologist don't like to share their patients with EP surgeons. With all the faulty ICD, there have been over 100,000 ICD recalled by the major manufacturers. In one study of 719 ICD implant patients 4 out 5 implants didn't work appropriately. The implant procedure has its own morbidity as problems can arise such as infections resulting from the procedure and the wires that go from the defibrillator to the heart are subject to breakage. Also, defibrillators are known to fire inappropriately and that is a real painful experience for the patient(Many patients are crying they want the ICD removed). And of course there are many battery problems.

These problems have led to a point where many Cardiologist keep patients and put them on drug theraphy instead of an ICD. Keeping a patient also generates additional income. If you had the ICD, your chance of dieing was about 5½ to 6% on an annual basis. If you were treated with drug therapy, then that number grew to a little over 7%. Therefore, the difference was not overly dramatic between ICD therapy and drug therapy.

However, If the cardio keeps a patient and he dies, this could mean trouble. It's conservative to have good justification and CAMH with the new NCD and studies that show a lower rate, 1%-2% risk of dieing if you have had a negative MTWA test, this is approximately a 3x lower death rate then the ICD patients. Any smart physician will want a MTWA test if for nothing other then legal reasons. Last, a fairly busy practice with just 3 cardios can make a profit equal to the purchase price in less then 15 days and have a $30,000 tax deduction to boot.

CAMH has 10 years of previous tax losses and IMO,if they sell about 1000 MTWA test units this year, they will make at least $.80 a share (taxes offset by tax losses).
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Dr. Bailey is the only electrophysiologist based in Southwest Louisiana and one of a relative handful of cardiologists who have special training and expertise in the diagnosis and treatment of cardiac arrhythmias. This makes Dr. Bailey a triple-threat in the battle against heart disease. He is Board Certified in all three fields: Internal Medicine, Cardiology and Clinical Cardiac Electrophysiology.

Dr. Bailey says when he began practicing in the early 1990s, cardiac electrophysiology was still considered to be back room voodoo magic by many physicians. Doctors figured out that arrhythmias were a leading cause of death about 30 to 40 years ago, he explains. But they didn t know how to predict who would develop the condition, and even if they could have identified those at risk, they didn t have any way to successfully treat the problem. The field has come a long way in a short time. Recent advances have profoundly affected our understanding and management of a number of common problems relating to arrhythmias.

Dr. Bailey and other experts agree that anyone who has had a heart attack or who has other serious heart conditions should be assessed for risk of (SUDDEN CARDIAC DEATH) SCD. There are a series of electrophysiology tests that can determine if electrical instability is present within the heart. If it is, implanting an ICD reduces the risk of sudden death (per year) to nearly zero.

Dr. Bailey and other experts agree that anyone who has had a heart attack or who has other serious heart conditions should be assessed for risk SCD. There are a series of electrophysiology tests that can determine if electrical instability is present within the heart. If it is, implanting an ICD reduces the risk of sudden death (per year) to nearly zero.

For a number of reasons, this screening process has not been widely adopted in current medical practice. Dr. Bailey says one reason is lack of knowledge and acceptance by doctors despite many large clinical studies showing clearly better survival. Because the developments in testing and treatment are so new and rapidly evolving, many doctors are simply not aware of the life-saving capabilities that do exist. Another reason is the lack of qualified physicians and specialized equipment. Although some of the electrophysiology tests and procedures can be performed by cardiologists, many of these are only approved for use by a trained cardiac electrophysiologist. Cost may also be a factor. Many insurance companies will only pay for the screening and treatment if the person meets stringent criteria for high risk. They may not consider the device medically necessary for someone who tests at only a moderate risk.

The question I get most often when I give talks on this subject in the community is Why hasn t my doctor had me tested? People today are used to screening for all types of other diseases. Why shouldn t we offer them the same option, especially when we are talking about the leading cause of death in the country? asks Dr. Bailey. Once people have the information, they want to do everything they can to make sure they don t die from a condition that can be identified and successfully treated.

Dr. Bailey predicts that electrophysiology testing will eventually become more of a standard instead of the exception over the next several years. Changing practice patterns of doctors is always a slow process. In this case, I think the American College of Cardiology and the American Hospital Association will be issuing guidelines to include screening for SCD in the very near future. Once the screenings become more common, we ll see the number of sudden deaths decrease.

Advances in cardiac electrophysiology are expected to continue developing at a rapid pace. Heart and Vascular Center recently began offering two new technological advancements to its patients: In Sync treatment for people with congestive heart failure and Microvolt T-wave Alternans testing ****(THIS THE TEST MADE BY CAMH)*****, a new way of identifying people at risk of sudden cardiac death.

As technology improves, Dr. Bailey says treatment of arrhythmias will become even less invasive and more accurate. Devices will become more affordable, and wider applications of technology will allow us to identify and treat more people. It s an exciting time to be involved in what has become the fastest growing field in cardiology.

Who Should Have Cardiac Electrophysiological Testing?

Persons who have had a cardiac arrest from any cause

Persons at risk of cardiac arrest. This includes, but is not limited to, those with coronary artery disease, those who have had a myocardial infarction, people with congestive heart failure or poor heart function and those with intrinsic heart muscle disease such as hypertrophic cardiomyopathy, sarcoidosis or amyloidosis

Persons with documented arrhythmias

Persons with familial heart disease such as Wolff-Parkison-White syndrome or a family history of cardiac death at a young age

Persons who have palpitations or fluttering in their chest

Persons who have had a loss of consciousness that has not been explained

Persons with congestive heart failure or poor heart function of any cause


Heart & Vascular Center Offers New Life-Saving Technology

Patients at risk for sudden cardiac arrest now have access to new technology that can detect life-threatening heart problems. Lake Charles Memorial Heart and Vascular Center is the first in Southwest Louisiana to offer the new Microvolt T-wave Alternans Test ***(made by CAMH)***, an advanced non-invasive diagnostic test to identify patients at risk for electrical malfunctions of the heart that lead to sudden cardiac arrest. Sudden cardiac arrest claims more than 300,000 lives each year in the United States and is the nation s leading cause of death .

William Bailey, M.D., cardiologist and electrophysiologist with Heart and Vascular Center, is using the new testing technology for patients with existing risk factors for sudden cardiac arrest. We are very pleased to make this important diagnostic test available to patients in Southwest Louisiana, said Dr. Bailey. Identifying patients at risk for sudden cardiac arrest has been an ongoing, frustrating challenge for physicians. With this technology, we hope to identify more patients at risk early enough to take appropriate preventative measures, lowering their risk and preventing their death from this disorder.

Unlike coronary artery disease, sudden cardiac arrest doesn t often give its victims a second chance. Most episodes become fatal within minutes of onset, with the arrest being the first noticeable symptom of the victim s electrical heart rhythm disturbance. Most victims of sudden cardiac arrest have an underlying electrical disorder that cannot be predetermined by a conventional exercise stress test. According to Dr. Bailey, this is why the new T-wave test is such an important development. The test detects tiny variations, called T-wave alternans, in the heart s rhythm, he explains. These disturbances are an extremely subtle beat-to-beat alternation in the heart s rhythm that we could not detect previously. The T-wave alternans test fills a major gap in our diagnostic capabilities, allowing us to identify and treat patients with potentially life-threatening arrhythmias.

The T-wave alternans test can be administered during an exercise stress test, a standard test for most patients considered at risk of heart disease. The stress test can identify patients at risk of ischemic heart disease or clogged arteries, but is not able to detect patients with arrhythmic heart disease or electrical problems that can lead to sudden cardiac arrest. Before the stress test begins, additional electrode patches and sensors will be applied at various places on the patient s chest and trunk. These are connected to a wire, which sends information about the heart s electrical activity during the test to the Microvolt T-wave alternans equipment. The test is administered during the exercise stress test, while the patient walks on a treadmill for a several minutes.

Once the test is completed, Dr. Bailey will interpret the results and recommend further electrophysiology testing to determine appropriate treatment programs for those patients who have the potentially life-threatening rhythmic disturbances. Treatment options may include a regimen of anti-arrhythmic drugs or beta-blockers for treatment of underlying heart disease and risk factors. For the patients at highest risk, surgical placement of a device that automatically defibrillates the heart back into a normal rhythm may be the best option.

The FDA (Food and Drug Administration) approved the T-wave alternans test last year. It is estimated that there are 10 million patients at high risk of sudden cardiac death. At this point the test is recommended for those patients with existing cardiac conditions and/or known risk factors, including:

Syncope (fainting), pre-syncope and palpitations

Coronary artery disease and previous heart attacks

Congestive heart failure

Dilated cardiomyopathy

For more information or to find out if you are a candidate for the T-wave alternans test, call Heart and Vascular Center at 474-5092 or 1-800-732-5196.
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Doc's get to keep many of the low risk ICD candidates

CMS is a branch of Medicare that manages Medicare s coverage reimbursements etc. The MTWA Test is made by CAMH.

The CMS decision follows the publication of a study in the January issue of the Journal of the American College of Cardiology (JACC) demonstrating the benefits of MTWA in ICD risk stratification.[3] The study, which was the first large, prospective, multicenter trial to investigate the usefulness of MTWA for ICD risk stratification in heart disease patients without a history of prior arrhythmic events, showed that MTWA can identify a large group of patients with LV dysfunction who are at low risk for an event and thus are unlikely to benefit from ICD prophylaxis. According to the study authors, by using this strategy to narrow patient selection, >>>>>

Anne B. Curtis, MD, Director of the Division of Cardiology at the University of South Florida, and one of the JACC study authors, told Medscape in a recent interview that patients with a negative MTWA test can indeed be considered "a low-risk group." About ******one third ******of patients in the JACC study were ruled out for prophylactic ICD therapy because they were deemed low risk as a result of MTWA testing, and Dr. Curtis believes similar results may be observed when the test is used on a wide-scale basis. However, she expressed doubt that risk stratification can get much better with current tests. "One-third of patients isn't bad," she said, "but unless we significantly improve our understanding of the pathophysiology of heart disease in individual patients, I can't see us ever getting to the point where we'd be able to identify a certain 5% of the population that is at highest risk and classify everyone else at much lower risk."

http://www.medscape.com/viewarticle/529638

http://www.medscape.com/viewarticle/527551


******* "To save ONE LIFE it currently requires 14 to 18 ICD implants but if they use the MTWA test to decide which patients should have an ICD implant it would only take 7 ICD implant operations to save that ONE LIFE." ********


The MTWA test, in a few years, could soon be saving Medicare and insurers big money, estimates run as high as 20 to 30 BILLION DOLLARS A YEAR. 1/3 of the patients tested could save the pain, anguish, danger of an ICD implant operation and in most cases they can keep on working in their job or business. Physician will get to keep many of the low risk patients that were previous sent to EP's for ICD implants and instead treat them with medical/pharmaceutical therapy, which means a steady stream of income from increased office visits for the follow up diagnoses etc.

SO HERE YOU HAVE A SITUATION WHERE MEDICARE / HEALTH INSURERS, "PATIENTS" AND THEIR PRIMARY CARE PHYSICIANS AS WELL AS THEIR CARDIOLOGIST WOULD ALL PREFER THAT ONLY THOSE 1 out of 18 THAT CAN BENEFIT FROM AN ICD IMPLANT, RECEIVE THEM.

Is there any LOGICAL doubt that CAMH's MTWA TEST will be SUCCESSFUL in the U S and all over the industrialized world.

CAMH will also do very well with a 70% average gross profit margin. My estimate of EPS are $.40 to $.80 this year and $1.00 to $2.00 next year. 2008 could be $3.00 to $4.00

Even if you don't buy now, CAMH is not a stock to forget. When the increased revenues start pouring in near the end of this year, you may want to be in this stock!!!! So either now or later, keep watching!!!!
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IF YOU ARE NEW TO THE STOCK, HERE IS A RECAP!

Cambridge Heart (CAMH) is all about their test which is used to narrow patient selection for ICD implants. The implant protects their host from Sudden Cardiac Death (SCD). They are a lifesaver if you need them, pain, suffering, a loss of time, work, money and a drag on the quality of life, if you don t.

The current selection process on a yearly basis saves ONE life for every 14 to 18 ICD implants. That means 95% of the implants are unnecessary. Each Implant, parts and labor, cost about $60K. Medicare and insurers are now spending about $18 billion a year on these ICD s and expect that number to rise to $60 billion ($60K per implant, parts & labor times ONE million people). Using CAMH s MTWA TEST for selection, the numbers change to ONE life saved out of every 7 implants. That s because the MTWA test eliminates 1/3 of the testers as not needing an ICD. Test results are good for about 24 months but a follow up test is recommended every year.

Physicians would rather treat low risk patient for the possibility of SCD in their own office versus sending them to an EP for an ICD implant operation.

The question is: will the Cardiologist, Internist or Primary Care Physician and EP s purchase the test equipment now that they have numerous verifications of its prediction value including the one that really counts, Medicare as well as a guaranteed reimbursement of approx. $400 per test?

Or if you belief as I do, a better question is why wouldn t they purchase it ???

The market for the MTWA TEST in the u s is about 18,000 practices and if they just do 1000 units this year with reasonable consumable electrodes sales they should earn between $.30 to $.70 a share. And, double or triple that for 2007.
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WHY SHOULD YOU BUY CAMH?

Cambridge Heart (CAMH) is all about their test that is used to narrow patient selection for ICD implants. The implant protects their host from Sudden Cardiac Death (SCD). They are a lifesaver if you need them, pain, suffering, a loss of time, work, money and a drag on the quality of life, if you don t.

SCD is not rare, it is considered the number ONE cause of DEATH in the U S and one of the major causes of death in most industrialized countries. In just a few years, ICD's have helped make their 3 manufactures (Medtronics, St Jude Medical and Guidant now part of Boston Scientific) into multi BILLION dollar companies.

The current selection process on a yearly basis saves ONE life for every 14 to 18 ICD implants. That means 95% of the implants are unnecessary. Each Implant, parts and labor, cost about $60K. Medicare and insurers are now spending about $18 billion a year on these ICD s implant operations and expect that number to rise to $60 billion ($60K per implant, parts & labor times ONE million people). Using CAMH s MTWA TEST for selection, the numbers change to ONE life saved out of every 7 implants. That s because the MTWA test eliminates 1/3 of the testers as not needing an ICD. Test results are good for about 24 months but a follow up test is recommended every year.

For the $18 Billion dollars spent last year in the U S on ICD's, 15,000 people are still alive but 400,000 other people never received ICD's and died. At least, 130,000 of those victims, had they been examined, would have qualified for an ICD and be alive today. In the event a MTWA test was used, the remaining 270,000 prior to January 2005 would not have qualified for an ICD. After said date Medicare and insurers changed their qualifications for ICD coverage. Sorry I don't know if they would currently qualify for an ICD but they would have showed up as being "at high risk" for SCD on a MTWA test.

Physicians would rather treat patient those that are considered at low risk for SCD with medical/drug therapy versus sending them to an EP for an ICD implant operation. The question is: WILL the Cardiologist, Internist or Primary Care Physician and EP s purchase the test equipment now that they have numerous verifications of its prediction value, including the one verification that really counts, Medicare? The answer is yes, they will, because they all need access to the test. Its not a question of early adopters or low hanging fruit, they will all need this test. There are some Cardios that will only perceive of a very limited use or need for this test and therefore will be in no hurry to purchase. Others will use it on most of their patients and it will be a part of a standard battery of tests they administer during their diagnosis. Even some very young people may need the test based their family history.

In my opinion, when the market reaches about 20% saturation the next 70% will take less then a year. In today s world the philosophy is to over test a patient definitely not under test and that coincides with what the patients wants.

If you belief as I do, a better question is why wouldn t they purchase it ??? The $400 test is not going to make a physician rich but it is very lucrative for the amount of time invested by his nurse or assistant plus they can bill for their consultation time spent discussing the test results. Presently Medicare and half the insurance companies officially guarantee payment, the remainder pays, but it will be official in a few months.

The market for the MTWA TEST in the U S is about 18,000 practices and if they just do 1000 units this year with reasonable consumable electrodes sales they should earn between $.30 to $.70 a share. Double or triple that for 2007.
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The following is a fair summary of the CAMH story. You might want to use it on other boards to promote interest in the stock.

Cambridge Heart (CAMH) is all about their test that is used to narrow patient selection for ICD implants. The implant protects their host from Sudden Cardiac Death (SCD). They are a lifesaver if you need them, pain, suffering, a loss of time, work, money and a drag on the quality of life, if you don t.

SCD is not rare, it is considered the number ONE cause of DEATH in the U S and one of the major causes of death in most industrialized countries. In just a few years, ICD's have helped make their 3 manufactures (Medtronics, St Jude Medical and Guidant now part of Boston Scientific) into multi BILLION dollar companies.

The BIG question is when are the Cardiologist, Internist, Electrophysiologist and the family primary care physician (that sideline in cardiology) going to step up and buy the best tool available for selecting those millions of people that need an ICD from all those millions that don't.

Each year narrowing the selection process down to the odds of 1 life saved for every 7 ICD's installed (cost installed is $60K each) from the current odds of 1 out of 18 will save medicare and Health Insurance Companies BILLIONS of dollar, this is big business. Using the MTWA TEST could save over 100,000 people this year and in the near future hundreds of thousands of people the risk, pain, and hardship of going through an unnecessary invasive ICD operation.

Last, the physicians themselves make a lucrative profit off the simple quick test. No qualifications or restrictions, it's covered by Medicare or the patients Health Insurance and if they DON'T send the patient for an ICD operation, it will require their services in additional medical treatment.

After the Cardiologists becomes familiar with the MTWA TEST they will find many opportunities to use it on any patient with one or more symptoms that could indicate the possibilities of SCD. Those symptoms are very broad in scope. From a SCD in the family tree history to just common complaints of headaches and lack of energy. Some Cardios will use it as a precautionary measure on most of their patients and it should become one of the standard battery of tests, like an EKG, that are administer during their initial diagnosis.

In the U S, at least 18000 practices need the MTWA test equipment. They are relatively low priced with a 70% profit margin. Each year, every 1000 units they sell means about $.50 per share in net profit and every test performed means about $56 gross profit from consumable Electrode pads. When there is complete U S saturation, about 10 million pad sales a year will maintain the company with about 1/2 billion in revenues. Revenues from outside the country should be equal to the U S numbers. If GE or JNJ owned the company, those sales numbers would be achievable within 2 years.


ICDs1/27/2005

FDA Conconcurrence for HW II 4/11/2005
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Cambridge Heart Receives FDA Concurrence for New Microvolt T-Wave Alternans [DZTGSDG]

Device

Business Editors/Health/Medical Writers
MULTIMEDIA AVAILABLE:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=4861371

BEDFORD, Mass.--(BUSINESS WIRE)--April 11, 2005--

Heartwave(R) II System Cleared for Distribution in the U.S.

Cambridge Heart (OTCBB-CAMH) today announced that it has received
clearance from the U.S. Food and Drug Administration to begin
marketing in the United States of its new Heartwave II System for the
measurement of Microvolt T-Wave Alternans (MTWA). Product availability
is immediate.
The Heartwave II System is a stand alone device to measure
Microvolt T-Wave Alternans to help predict an individual's risk of
sudden cardiac death. Unlike the original Heartwave System, the
Heartwave II does not require a host stress exercise system to control
the treadmill or to monitor the patient's ECG or electrical activity
of the heart. The Heartwave II can accomplish all of the elements
necessary to independently perform a MTWA test. Running on a Microsoft
Windows(R) XP operating system, the look and feel of the Heartwave II
is more familiar for the user. The Pentium(R) processor included in
the Heartwave II can process information up to 15 times faster than
the original Heartwave. Its substantially increased memory capacity
can store 300 times more patient studies.
"The development of this third generation Microvolt T-Wave
Alternans system is a credit to the creativity of our engineering
team," stated David Chazanovitz, President and CEO of Cambridge Heart.
"The Heartwave II came about from feedback received from our customer
base with respect to ways to increase the utility of the device. In
addition to running our clinically proven Alternans algorithm, the
system can also perform a complete stress exercise test."

Forbes 3/15/2006 http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=592
Forbes carries brief story:

Costly Heart Test Could Save Medicare Money
03.15.06, 12:00 AM ET

WEDNESDAY, March 15 (HealthDay News) -- It's not currently covered by Medicare, but a $400 test used to spot people who might need an implanted cardiac defibrillator might end up saving the agency hundreds of millions of dollars a year, researchers report.

The finding comes about a week before Medicare announces whether or not it will cover the cost of the microvolt T-wave alternans (MTWA) test, which detects small variations in the electrical impulses in the heart.

A team at the University of Michigan Health System used a computer model to calculate the potential impact of using the MTWA test to help determine which patients are at greatest risk from sudden cardiac death. Those patients would benefit most from an implanted cardiac defibrillator (ICD), which automatically restarts a stopped heart.

The researchers, who have no links to the makers of the MTWA test, concluded that using the screen could save Medicare $690 million a year. Last year, Medicare extended its coverage of ICDs to include many more heart patients -- right now, an estimated 500,000 people over age 65 are candidates.

"ICDs have been shown in several studies to be cost-effective, which means the cost is considered acceptable given the benefit to patients," study lead author and cardiology fellow Dr. Paul Chan said in a prepared statement.

"But a very expensive device can be cost-effective and still not affordable to society, if the condition it treats is highly prevalent. Our study demonstrates the potential impact of using additional factors to aid decisions about the use of expensive devices," Chan said.

The findings were presented this week at the annual meeting of the American College of Cardiology, in Atlanta.

More information

The American Academy of Family Physicians has more about ICDs.

GE and MMA http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=787
Was there ever any doubt? Life is so sweet.

From the CMS NCD straight to GE...

"A review of the literature failed to reveal any large studies using the MMA technique to detect MTWA. See sections entitled Modified Moving Average (MMA) technique for determining MTWA in the Evidence section above and the Analysis section below for a review of the evidence"

Full nationwide medicare coverage using only CAMH's patented technology.

TU

Hondagm
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1611
Chartist....
did you ever hear about razors and razor blades??
The bulk of the money comes from the blades..
The smart companies will change and improve the main(razor) from time to time....however, the $$$ come from
the blades..just like CAMH is doing now..sit back and relax.
GLTA

Howaard_the_shark
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1275
In @ $2.15 and reasons why.....

Been watching this stock since it broke $4 and as I suspected, the "buy on rumor, sell on news" light was turned-on as usual.

As CAMH went down on smaller and smaller daily volume I got more and more interested. After all, the story certainly didn't change and I am not going to waste anyone's time here re-hashing the news which is absolutely bullish without question.

As we approached the 50 DMA I started to line up my order, noting that on previous runs the 50 DMA has always not only held, but been a precursor for another up leg on CAMH's fantastic one-year stock chart.

As we neared the DMA this afternoon, which by the way was $2.10, I watched the trades click off at $2.11 repeatedly and then we moved up to the $2.20 range, retraced to $2.15 and started up again.

This is as technically bullish as it gets, folks.

My buy went in at $2.17 and the stock never looked back. As William O'Neill (foundr of IBD) said, "a good trade is a winner from the start".

Best of luck to all longs and bashers as well. Bashers you are probably going to need the help more than the longs but my crystal ball is cloudy...but I think it was a good trade today for anyone who went long or added to their positions.

Read the transcript of the last conference call if you need more information. Most of the small stock "bug-a-boos" -- outstanding warrants, cash shortages, poor management, etc. are just not there at CAMH. Medtronic is certainly looking carefully and we should also get NASDAQ approval to get re-listed very shortly as well...and we all know that is super bullish. Earnings conference call and the upcoming Cardio conferences will add enough bullish fuel to put us well past $5 in my humble sharky opinion.

I have plenty of ammo if the stock falls more as should all little sharks.

Love bites,

Howard.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1284
Reasons for CAMH sell-off:

1. Stock was up 100% in a few days, needed a "breather" and return/bounce off 50 EMA very technically bullish.

2. Day traders and momentum guys took it too far, then bailed with profits or at break-even if they weren't too astute.

3. Weak hands bailed when they saw their profits turn to losses. They got in $3+ and sold $2.90-2.40 range.

They will all be back buying higher ($3.5+) and kicking themselves for selling in the first place (see: Psychology & The Small Investor, Chapter 3).

Crystal ball cloudy but see run above $5 soon.

Love Bites,

Howard.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1292
Thanks for the Kudos -

Although I believe I am only stating the obvious. I have been in the medical field for 25-years and seen the transition from invasive to non-invasive testing in most areas of diagnosis. It is a trend you can bank on because it is a lower cost alternative and is endorsed by the real "payors" in the US healthcare system - the insurance companies.

I am just amazed that no one today has picked-up on the St. Jude/Medtronic story for what it really is...CAMH is in the right place at the right time with the right technology (all patent protected, of course).

As soon as the general public understands the medical story about diagnosis trend switching from St. Jude/ Medtronic device to CAMH this one goes to the moon -- either because sales increase dramatically or Medtronic just buys the entire company IMHO.

The longer they wait the more they are going to pay for little CAMH.

lvad_67
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1248
Two newsworthy pieces on T-wave alternans to look forward to in the upcoming weeks:

1) The Journal of the American College of Cardiology, the premier clinical cardiology in the US, will be publishing the largest patient study of microvolt T-wave alternans screening in the defibrillator eligible population the first week of May. The study followed nearly 800 patients for several years and is the first to demonstrate that T-wave alternans is an INDEPENDENT predictor of death even after adjusting for patient factors, such as age, comorbidities, and medication usage. Apparently, this study won the Parmley Prize at this journal for 2005, which is given to the best article by a young investigator each year and was recently presented at the annual American College of Cardiology meeting in March. The online version of this study is expected to show up at the website of the journal in about 2 weeks (http://www.cardiosource.com/jacc/index.asp), and the study is the perfect lead-in for the national Heart Rhythm Society (which basically involves thousands of electrophysiologists around the country) during the third week of May.

2) There is a specific session dedicated during the Heart Rhythm Society meeting (May 17-20) on T-wave alternans. I suspect the room will be packed, given the buzz on this technology. Moreover, one of the presentations will be the first of its kind-- it will specifically examine whether patients benefit from defibrillators if they screen T-wave alternans negative (normal). This is ultimately the main question driving the utility of this test.

There may be bumps along the way, but the lead-in to the JACC publication in early May and then the national Heart Rhythm Society meeting in mid-May will bring the issue of T-wave alternans to the forefront again (and therefore to the media)
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1250
Two major news pieces on T-wave altnernans:

1) A major study on T-wave alternans will be published the first week in May in the premier US cardiology journal, the Journal of the American College of Cardiology. The study followed nearly 800 patients who meet criteria for defibrillator placement and found that an abnormal T-wave alternans was an INDEPENDENT predictor of mortality. It is the largest study of T-wave alternans to date in the Medicare coverage population, and it was so good that the American College of Cardiology (which publishes the above journal) awarded it the annual Parmley Prize during its recent meeting in March. The article's online version will be made available to subscribers of the journal in mid-April.

2) This study will be a perfect lead-in for the annual Heart Rhythm Society meeting from May 17-20 (where all the electrophysiologist gather once a year). There will be a dedicated session on T-wave alternans, and in looking through the titles for that session, there is a presentation that will likely generate a lot of buzz-- "Microvolt T-wave Aleternans Identifies Patients Who Benefit from ICD Therapy". This will be the first study to examine whether patients who screen T-wave alternans normal benefit at all from defibrillators. Ultimately, this is the main driving question as to the usefulness of T-wave alternans, and the press coverage on this session is likely to generate a lot of interest.

With these two events coming up, there will likely be more interest and media coverage of T-wave alternans in the near future.

http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1270
Ehwest- The Parmley Prize publication is the one coming out in May. That presentation has not been picked up by the press yet, as the findings have only been presented once-- in November last year-- but went largely unnoticed. In fact, it is the largest study of T-wave alternans to date in this patient population.

The cost-effectiveness analysis presented last month at the annual meeting was the one picked up by the press. The 35K for a defibrillator is correct because traditional cost-effectiveness analyses take the "societal" perspective, using only Medicare reimbursement cost for a defibrillator implant with Diagnosis-Related Codes and is similar to the amount used in other cost-effectiveness analyses with defibrillators, not the $65K a hospital charges an insurer. I suspect that one will come out later this summer if it has been accepted for publication already.

The preliminary findings from the big presentation at the Heart Rhythm Society has not been released, but it should been exciting, as this is the first study to ever look at whether a patient who tests negative with T-wave alternans has no benefit from a defibrillator at all. If it shows no benefit, it provides, for the first time, evidence to the physician world, that this population truly is low-risk. The tone of the title of that presentation suggests that this is likely the finding from that study, and the presenter is the same person who won the Parmley Prize and did the cost-effectiveness analysis.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1577
Hi,

The premier clinical cardiology journal (the Journal of the American College of Cardiology, or "JACC") in the U.S. now has online in their "In Press" section an article coming out the first week of May which involves the largest study of T-wave alternans screening in patients meeting Medicare ICD criteria. This study is by far the most authoritative study of T-wave altnernas to date, controlling for multiple confounding factors, and also being the first study to demonstrate that an indeterminate T-wave test has as much (if not more) predictive power than a positive test (compared with a negative test). This article was chosen for the Parmley Prize at this journal, which is given to the best article annually for originality and substance. I have read the article and would agree.

Again, this journal issue is being shipped to cardiologists all over the country the first week of May. You can access the online site and read the article at:

http://content.onlinejacc.org/in_press.dtl

The article is the fourth down the list among those being available online as "In Press" articles, and is entitled:

"Prognostic Utility of Microvolt T-Wave Alternans in Risk Stratification of Patients With Ischemic Cardiomyopathy"

Good luck to all, as coverage of this article should provide more exposure to the test.
- - - - -
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1933
The "Holy Grail" study for microvolt T-wave alternans that has never been presented before WILL BE presented on thursday afternoon, 5/18 at this year's Heart Rhythm Society meeting, which features the leading thinkers and policy-makers for electrophysiologists in the country.

Entitled: "Microvolt T-Wave Alternans Screening in Patients with Ischemic Cardiomyopathy Identifies Differential Mortality Reduction Benefits with ICD Therapy", I have posted the abstract from the Heart Rhythm Society site itself below (accessed at "http://www.abstractsonline.com/viewer/SearchResults.asp" using search term "microvolt T-wave alternans").

Interestingly, the presenter is the same one (Paul Chan) who presented at the ACC conference in March which was on the cost-effectiveness of T-wave alternans, won the Young Investgator's Award, and got a lot of press. This guy was also mentioned on the earnings conference call by the Cambridge Heart earnings conference by the CEO last week, so I think his work is legit. Moreover, it is the first study to show that putting an ICD only makes sense in those who test t-wave abnormal, as prior studies of T-wave alternans only demonstrated that those testing T-wave alternans are at higher risk for death. Although this may be a subtle point, it is an extremely important point, as people have argued that just because one tests TWA negative that that does not mean they don't get benefit from a defibrillator. Now we have our first study ever to show that if you test negative with TWA, there is no clear benefit from a defibrillator. Wait till the press gets a hold of this presentation!!
_______________________________________________________________

Microvolt T-Wave Alternans Screening in Patients with Ischemic Cardiomyopathy Identifies Differential Mortality Reduction Benefits with ICD Therapy
Category: 09 Signal Average ECG/T-Wave Alternans
Presentation Time: Thursday, 2:45 p.m. - 3:00 p.m.
Paul S. Chan, MD, MPH, Dean Kereiakes, MD, Edward Schloss, MD, Theodore Waller, MD, Eugene Chung, MD and Theodore Chow, MD. University of Michigan School of Medicine, Ann Arbor, MI, Ohio Heart and Vascular Center, Cincinnati, OH
Presentation Number: AB14-6
Keyword: T-wave alternans, Implantable cardioverter-defibrillator
Objective: To assess if implantable cardioverter-defibrillators (ICDs) have different mortality benefits among patients with ischemic cardiomyopathy who screen microvolt T-wave alternans (MTWA) negative and non-negative (positive and indeterminate).
Background: MTWA has been proposed as an effective tool for risk stratification. However, no studies have examined whether ICD benefit differs by MTWA subgroup.
Methods: We developed a prospective multi-centered cohort of 752 patients with ischemic cardiomyopathy (LVEF<35%) and no prior history of ventricular arrhythmia, of which 392 (52%) received ICDs. Mean follow up was 18+10 months. We assessed the degree to which ICDs decreased mortality risk by MTWA subgroup with Cox proportional hazards analyses that used a propensity score for ICD receipt based on electrophysiologic variables (QRS duration, Holter, microvolt T-wave alternans, and electrophysiologic study results) and which controlled for demographic, clinical, and medication treatment variables.
Results: We identified 514 (67%) patients with a non-negative MTWA test. C-statistics for the propensity scores showed good discrimination [C=0.80 (MTWA non-negative); C=0.75 (MTWA negative)]. After multivariable adjustment, ICDs lowered all-cause mortality in MTWA non-negative [hazard ratio (HR)=0.54 (95% CI: 0.29, 0.99); p=0.045] but not in MTWA negative patients [HR=1.03 (0.23, 4.59); p=0.97], with the mortality benefit in MTWA non-negative patients largely mediated through arrhythmic mortality reduction [HR=0.33 (0.12, 0.93); p=0.036].
Conclusion: Risk stratification with MTWA testing may allow one to determine which patients benefit from ICD therapy.

Lumpy
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1304
Yahoo MDT board and dflawed,spine,bluecheaps

I took a look at the Medtronic yahoo message board and noticed how many MDT longs disagree with dflawed, sayspine and bluecheaps (all of whom are posting on that board). CAMH stock price will get a huge boost from just those MDT longs, when they finally realize what CAMH is all about. They take such offense to anything they perceive as a slight towards Medtronic that they don't even think to read up on CAMH and see if what they are being told is true. They can buy CAMH now at $2.24 or later at $4.00...$6.00...$8.00...etc.

Best regards to all longs,
Geoff
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1659
My third attempt to post great article:

Links are not working, so here is the full article.

Microvolt T-Wave Alternans Testing: It Works, It's Reimbursable, and It's Here to Stay
Technology Spotlight


By Mintu Turakhia, M.D.
Division of Cardiology & Cardiac Electrophysiology
University of California, San Francisco School of Medicine

Almost a half-million patients die of sudden cardiac death (SCD) per year in the United States alone.1 Malignant arrhythmias, including ventricular tachycardia and ventricular fibrillation, are the final common pathway of cardiac arrest in the majority of cases. Worldwide, SCD comprises 50% of overall cardiac mortality in developed countries.2 Sudden cardiac death is also the most common and often first manifestation of coronary artery disease, and out-of-hospital cardiac arrest almost always results in death. Survivors of SCD (described as "aborted SCD") frequently have high morbidity from neurologic sequelae.

Individuals at highest risk for SCD are those with a history of myocardial infarction, coronary artery disease, depressed ejection fraction, other acquired or inherited cardiomyopathies, family history of sudden death, or rare genetic defects related to cardiac conduction (e.g. long QT syndromes).

SCD is preventable with the placement of an implantable cardioverter-defibrillator (ICD). ICDs were first used as a tool of secondary prevention, initially reserved for patients with aborted SCD or with documented ventricular arrhythmias who were susceptible (on the basis of arrhythmia inducibility by programmed electrical stimulation). While clearly at risk, patients with prior arrhythmic events account for less than 5% of all cases of SCD, and identifying high-risk patients for primary prevention has been the main focus for the last decade.

During the past 25 years, a number of risk factors have been identified. These include ischemic heart disease, decreased left ventricular ejection fraction, structural heart disease (ventricular hypertrophy, dysplasia, or scar), conduction abnormalities (standard ECG or signal-averaged ECG), and electrophysiologic (EP) testing (programmed electrical stimulation in the EP lab). However, these markers are inaccurate and fail to identify a substantial portion of high-risk patients. Many of these markers also falsely predict high risk in patients who never experience SCD. At best, these studies alone or in combination, have a positive predictive accuracy of 30%.2

Recently, ejection fraction has emerged as a sole determinant of risk in patients with prior myocardial infarction. The MADIT-II trial studied patients with ejection fraction ≤30% and a history of prior (> 30 days) myocardial infarction and randomized them to an implantable defibrillator or conventional medical (antiarrhythmic) therapy.3 During an average follow-up of 20 months, the mortality rate was 19.8 percent in the medical therapy group and 14.2 percent in the defibrillator group, with an absolute risk reduction of 5.6%. SCD-HeFT was a trial that randomized patients with low EF and mild to moderate heart failure to ICD, amiodarone (an oral antiarrhythmic medication), and placebo.4 SCD-HeFT had similar results and showed a relative risk reduction of 23% with ICD therapy. The results of these trials were very promising, since on average only 20 patients needed to be treated with an ICD to save one life during a follow-up period of only a few years. These results prompted the Center for Medicare Service to cover ICD placement in Medicare patients who met the MADIT-II inclusion criteria.5

Unfortunately, most patients considered "high risk" by the entry criteria never received any benefit from the device. In MADIT-II, only 169 of 719 patients (23%) received appropriate ICD pacing or defibrillation.6 Thus 4 out of 5 patients received a device that provided no therapy, leading to excess costs and unnecessary procedural morbidity. For these reasons, strong emphasis has now been placed on increasing precision of patient selection for ICD placement.

Alternating beat-to-beat amplitude on the ECG, or electrical alternans, was recognized as a preterminal finding over 100 years ago. In the last quarter-century, it has been linked to ventricular arrhythmias and sudden cardiac death. Fluctuations in the shape and amplitude of the T-wave is associated with the development of fatal arrhythmias in animal models and has also been linked to both arrhythmia susceptibility and SCD. T-wave alternans (TWA) is generally subtle, with variation in electrical amplitude to within a few microvolts. Therefore, TWA is generally undetectable on a standard ECG, but can be detected by elaborate signal processing techniques. New machines can detect TWA to within microvolts (called Microvolt TWA or MTWA).

The MTWA device consists of a signal input (multi-lead ECG), digital amplifier, signal processor and analysis module, computer, and screen display. The machine generates a printed report at the completion of a test. MTWA is usually conducted at rest or during exercise, either with exercise treadmill, bicycle testing, or with the use of pharmacologic agents. MTWA testing can be performed in a number of settings, including physician's offices, stress and echocardiography labs, or pacemaker/device labs and clinics.

Many studies have shown that MTWA is an accurate predictor of incident arrhythmias or SCD. A recent meta-analysis of 19 prospective studies with 2,608 subjects determined that the presence of significant MTWA predicted nearly a four-fold risk of ventricular arrhythias compared to MTWA-negative patients.7 In fact, a negative MTWA study carried a low 3% risk of arrhythmic events. This was true in patients with or without CHF or MI. In fact, another pooled analysis showed that the mortality rate of MADIT-II eligible, MTWA-negative patients who did not receive ICDs are lower than the mortality of MADIT-II and SCD-HeFT trial patients who did receive ICDs.8, 9

At the American College of Cardiology 2005 Scientific Sessions, Dr. Paul Chan and colleagues presented their findings of a cost-effective analysis of a ICD therapy in MADIT-II eligible patients with and without MTWA risk stratification.10 A Markov model was used to simulate a range of variables that influence cost and benefits of ICD implantation. The result of their simulations revealed an incremental cost-effectiveness ratio (ICER) of $48,000 per quality adjusted life years (QALY) with MTWA risk stratification compared to $88,700 with an "ICDs for all" strategy. At his presentation, he said that the MTWA strategy could potentially save $700 million per year in the MADIT-2 population alone. Dr. Chan won the ACC Young Investigator Award for his work.

Based on these data, the Center for Medicare and Medicaid Services recently announced a National Coverage Determination (NCD) to cover MTWA testing for risk stratification of SCD. However, they restricted coverage only to MTWA devices that use analytic spectral testing (see below). The two major manufacturers of MTWA testing devices are Cambridge Heart (Cambridge, MA) and General Electric (Fairfield, CT).

The Cambridge Heart Inc. HearTwave II system is described as the "next generation MTWA testing plaform for hospital and office-based SCD risk stratification." The device uses the prioprietary spectral analysis method that is a requirement for Medicare reimbursement. Stress MTWA testing is optional and requires an additional upgrade module. The company also makes the older-generation CH2000 ECG machine that can be upgraded with MTWA testing capability. Unlike conventional ECG machines, the MTWA machines require purchase of proprietary leads/sensors that reflect a per patient cost.

General Electric's MTWA technology has been incorporated as an add-on algorithm module to their Marquette cardiac monitoring systems. It is designed to perform only stress MTWA testing (e.g. exercise treadmill) and requires no special electrodes or external equipment. The GE technology also measures other markers of cardiac automonic dysfunction, such as heart rate turbulence, that may offer additional prognostic value. The limitation is that GE's technology does not use spectral analysis and is therefore not covered by the CMS NCD decision.

A limitation of MTWA testing is that the test cannot be performed in patients with atrial fibrillation or patients who cannot exercise. Frequent ectopy (extra beats) also compromises accuracy.

In conclusion, there is now a large body of evidence to support the added prognostic value, clinical benefit, and cost-effectiveness of MTWA testing. A negative MTWA offers strong negative predictive value in assuring a 3% or less risk of SCD. CMS has come forth strongly in favor of use of the technology and reimbursement and a handful of private insurance companies have followed suit. Whether MTWA testing will someday be mandatory remains to be seen, but the technology is clearly here to stay.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1673
Very interesting NY Times article today:

As others have said on this board, CAMH is clearly the answer to INCREASING ICD sales. Here's the article:

Paradox of a Heart Business:
Defibrillator Sales Slow Despite
Signs of an Untapped Market

By THOMAS M. BURTON
April 24, 2006

There's a paradox at the heart of the $6 billion cardiac-defibrillator industry: fewer than 15% of patients whose lives could be saved by these electrical cardiac devices actually have them, by some estimates -- yet sales growth is slowing.

With Boston Scientific Corp. having formally closed Friday on its $27 billion acquisition of No. 2 defibrillator maker Guidant Corp., the hard work begins. The challenge of the reshaped industry will be overcoming safety concerns amid recalls, dealing with cost-cutting by federal health regulators and getting the message out about device benefits to legions of primary-care doctors. The other main players are No. 1 Medtronic Inc. of Minneapolis and St. Jude Medical Inc. of St. Paul, Minn., a close No. 3 to Boston Scientific, of Natick, Mass.

For several years, the business of making electrical devices to rein in dangerously fast heartbeats had generated annual sales gains of 20% or more, before product recalls last year slowed that growth. Much of the growth stemmed from the fact there was a large market of people with faulty hearts. About 400,000 Americans die suddenly each year of cardiac-rhythm aberrations [i.e. more than 1,000 people per day, which seems a more striking way to depict the magnitude of the medical need].

Yet medical studies in the past decade have shown that many of these people could have been identified -- and treated with defibrillators -- beforehand. A matchbox-sized defibrillator implanted under the skin can dispatch a jolt of electricity to restore normal heart rhythm, saving patients' lives.

Given that, Boston Scientific tossed in mountains of cash during a bidding war with Johnson & Johnson to buy Guidant. Now some executives think J&J may make a play for St. Jude, whose price has dwindled of late [#msg-10737155].

Both companies declined to comment. However, J&J Chairman and CEO William C. Weldon, in a letter to shareholders in March, wrote about the Guidant takeover fight and the cardiovascular-device business, saying, "We remain committed to strengthening our business in this important therapeutic category."

Boston Scientific jumps into the field just as signs are emerging that the 20% sales growth has slowed. St. Jude, in particular, announced defibrillator sales that disappointed Wall Street and suggested that Guidant had won back from St. Jude some sales it lost last year. Now, St. Jude is beefing up its sales force by 500 people, or roughly 30%. Medtronic said it will respond by increasing its cardiac-rhythm sales and sales-support personnel, which now total more than 2,000, and Boston Scientific declined to comment. Certainly, there is still room for the industry to grow.

"My understanding is that, of the potential pool of patients, about 15% of those people are actually getting the devices," said Eric N. Prystowsky, a prominent electrophysiologist -- a cardiologist specializing in heart-rhythm problems -- based in Indianapolis.

The evidence is powerful that such devices save lives in patients with congestive heart failure, or with previous heart attacks and diminished cardiac pumping power. For instance, a 2002 study conducted by researcher Arthur J. Moss at the University of Rochester and colleagues found that defibrillators reduced deaths by 31% in patients with previous heart attacks and an "ejection fraction" -- the amount of blood actually pumped out of the left ventricle with each beat -- of 30 or less. (Sixty or more would be typical of a healthy adult.)

"Defibrillators' clear advantage is that they prolong life," said William T. Abraham, chief of cardiovascular medicine at Ohio State University.

Why, then, are so many patients not getting them, especially since Medicare now widely pays for them? One big part of the answer is the product recalls in 2005 at Guidant and Medtronic, along with the attendant publicity they generated, in the view of doctors, executives and Wall Street observers. They say referring doctors, such as internists, have backed off from sending as many patients to have devices installed. "You have to bring up the confidence across the board," said Piper Jaffray medical analyst Thom Gunderson.

In a conference call last week, St. Jude chairman and CEO Daniel J. Starks forecast defibrillator-industry market growth of just 5% to 7% in this year's second quarter and 11% to 13% by the second half of 2006. He said sales will increase as "a sense of reality returns about what the real enemy is, and the real enemy is sudden cardiac death."

Recalls and bad publicity aren't the only obstacles to increasing sales in the defibrillator business, however. Another is that the federal Medicare system is calling for 22% cuts in the amount it will reimburse hospitals for defibrillator surgery. While Medicare often backs off from Draconian proposals, such a proposed cut augurs poorly. "We wouldn't be surprised to see moderation in the final rule," wrote analyst Bruce M. Nudell of Bernstein Research, "but we feel that the proposal is a harbinger of a less favorable med-tech price...environment." Mr. Gunderson thinks sales growth may well return to 20% annually but that it may take two to three years.

Another obstacle to sales is that most congestive heart-failure patients -- those who are candidates for the most sophisticated and expensive of defibrillators -- aren't being cared for by cardiologists but by primary-care physicians such as family doctors and internists.

"What we're not seeing in adequate numbers is referrals from the primary-care physician," said Dr. Abraham. He gave a speech in Ohio recently to such doctors and found they were surprised to learn that virtually every one of their patients with moderate congestive heart failure was, in fact, a candidate for a defibrillator. For the industry to grow, he said, "the marketing effort has to go to the primary-care doctors."
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1929
Charts vs. real news/fundamentals

I have no idea whether Chartist9 is right or wrong, but I don't think any of us should really concern ourselves with charting this stock. Save the charts for GE and Microsoft. Those are companies that no longer can have news that drives the stock up or down in a big way (other than earnings miss). Charts are probably helpful in determining PPS direction.

Suppose CAMH's chart does show a bearish pattern. What if you sell, only to have United Health Care announce they are covering the MTWA test the next day? Charts don't tell you anything about impending big news. Dflawed and I (as well as a few others on this board) own AMLN. On the day they announced positive results for LAR version of Byetta, the stock went from 20 to 26. No chart could have predicted that. Additionally, the share price never "filled the gap". AMLN proceeded to go over 30, then 40 a few months later.

A chart may predict short term trends, but the overwhelming amount of positive news that could happen at any moment for CAMH makes trading CAMH based on charts extremely risky. All longs should sit tight and wait for the story to unfold to everyone. We will all be very wealthy in due time (or wealthier for those of you already there).

Best regards to all, including you Chartist9,
Geoff

Max
ehwest and dflawed, we know that it is going to be approved.
CAMH will not only be reimbursed for the equipment, electrodes, and a percentage of exams, but will be fully reimbursed by each facility on software updates.

When you have statements by leading cardiologists and other recognized physicians and authorities in Congress wanting to save as much on medicine as possible. CAMH, it is a done deal. jmo

The trouble with some here is either impatient or wanting to trade. This is a "legacy stock". I don't plan on selling on share or trading one, the dividends, when they come will be fine.

I honestly believe this will become a part of a lot of the larger family practice clinics in the future. It is already being discussed by some. Most of revenue for hospital is in its ancillary area so this will be like adding ultrasound machines to clinics which wasn't done 5 to 10 years ago and is steadily growing whether they own or lease.

I do agree that physicians are not known for their financial skills but the organization now of most docs in large partnerships have the someone handling all their financial decisions is definitely being done today and being done well.

GLAL and our patience will pay off.

Later,
Max


Medtronics
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=210
MDT investment:

22-Feb-05 MEDTRONIC, INC.
Beneficial Owner (10% or more) 390,546 Direct Acquisition (Non Open Market) at $4.42 per share. $1,726,213

26-Jan-05 MEDTRONIC, INC.
Beneficial Owner (10% or more) 2,941,172 Direct Acquisition (Non Open Market) at $4.42 per share. $12,999,980

From Yahoo Finance.

TU
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=212
For clarification, Medtronic and a group of private investors invested 6.5 million in May of 2003. The 6.5 million purchased 1,470,549 Class A shares, along with warrants to purchase acquire additional shares. Each Class A share is convertible to 13 common shares at 0.34 cents/share. What you are see on Yahoo is Medtronic exercising the right to convert those class A shares. They did not buy common shares at $4.42. Yahoo automatically calculates those numbers, which normally works just fine, unless dealing with preferred stock. To my knowledge the original $$$ in May of 2003 is all MDT has invested in CAMH. The real question is: What is MDT's motivation for converting some (but not all) of their Series A shares into common?

from the CAMH SEC filings:

On May 12, 2003, the Company entered into an agreement for the sale of $6.5 million of Series A Convertible Preferred Stock (the Series A stock ) to Medtronic and a group of private investors. Under the terms of the financing, the Company issued and sold a total of 1,470,549 shares of Series A stock at a purchase price of $4.42 per share. Each share of Series A stock is convertible into 13 shares of the Company s common stock at a conversion price of $0.34 per share. As part of the financing, the Company also issued to both Medtronic and the private investors warrants exercisable for the purchase of an additional 471,703 shares of our Series A stock. Medtronic received a warrant for the purchase of an additional 67,873 of our Series A stock at an exercise price of $4.42 per share.

MTWA
In diabetes http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=265
DOES IT GET ANY BETTER .... YOU BET NEW STUFF

CAMH IS GOING TO BE A VERY BUSY COMPANY..LOOKS LIKE
JUST WONDERING WHAT ELSE IS GOING TO COME OUT, ESPECIALLY SINCE THE HEART SEEMS TO BE AN IMPORTANT PART OF THE HUMAN BODY...LOL

FEBRUARY 2006

Diabetic Medicine
Volume 23 Page 207 - February 2006 <------------- LOL..... KEEPS GETTING BETTER AND BETTER ....
doi:10.1111/j.1464-5491.2006.01799.x
Volume 23 Issue 2


Measurement of microvolt T-wave alternans, a new arrhythmic risk stratification test, in Type 2 diabetic patients without clinical cardiovascular disease
G. Molon*, G. Targher , A. Costa*, L. Bertolini , E. Barbieri* and L. Zenari

Abstract

Aims Patients with a positive microvolt T-wave alternans (TWA) are at increased risk of ventricular arrhythmias and sudden cardiac death. Although Type 2 diabetes is associated with an increased risk of these events, there is a dearth of available data on measurements of TWA in people with Type 2 diabetes.

Methods We studied 43 Type 2 diabetic volunteers who were free of diagnosed cardiovascular disease (CVD). Microvolt TWA analysis was performed non-invasively using the CH 2000 system during submaximal exercise with the patients sitting on a bicycle ergometer.

Results TWA analysis was positive in 9 (21%) patients, negative in 32 (74.4%) and indeterminate in 2 (4.6%) subjects. TWA positive patients had significantly higher HbA1c levels than those with TWA negativity (8.1 ± 0.9 vs. 7.2 ± 0.8%, P < 0.01). Age, sex, BMI, blood pressure, lipids, 24-h heart rate variability, QTc interval duration, smoking history, diabetes duration and treatment, and microvascular complication status did not differ between the groups. In regression logistic analysis, HbA1c was the only significant predictor of TWA positivity (odds ratio 5.7, 95% CI 1.3 26, P = 0.023) after controlling for potential confounders.

Conclusions These results suggest that in Type 2 diabetic patients without clinically manifest CVD, TWA positivity is common (approximately 20%) and is closely correlated with glycaemic control.

Diabet. Med. 23, 207 210 (2006)

In ischemic cardiomyopathy http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=475
Presentation Number:
924-123

Abstract Title:
QRS Duration and Microvolt T Wave Alternans Testing in Patients With Ischemic Cardiomyopathy

Presentation Start/End Time:
Sunday, Mar 12, 2006, 3:30 PM - 4:30 PM

Topic:
Clinical Electrophysiology -Ventricular Arrhythmias

Author Block:
Theodore Chow, Syed Saghir, Cheryl Bartone, Terri Booth, Paul S. Chan, Ohio Heart & Vascular Center, Cincinnati, OH, University of Michigan, Ann Arbor, MI

Background: Prior studies assessing the relative prognostic utility of microvolt T-wave alternans (MTWA) and QRS>120ms have been limited by small sample sizes and study design limitations. These studies also suggested that MTWA was not predictive in patients with QRS>120msec.
Objective: To determine the relative predictive value of MTWA and QRS>120ms for mortality in patients with ischemic cardiomyopathy, and assess whether QRS duration interacts with the prognostic accuracy of MTWA.
Methods: We developed a prospective database of 768 patients with ischemic cardiomyopathy (LVEF120ms predicted mortality risk using stratified (by ICD status) Cox proportional hazards analyses that controlled for demographic, clinical, and medication treatment variables.
Results: In our cohort, 67% of patients had a non-negative MTWA test and 32% had a QRS>120ms on ECG. Unadjusted Kaplan-Meier survival estimates showed that both a non-negative MTWA [stratified log-rank test=13.5; p=0.0002] and a QRS>120ms [stratified log-rank test= 9.7; p=0.0018] were associated with lower survival probability. After multivariable adjustment, MTWA remained an independent predictor of mortality [stratified hazard ratio=2.24 (1.33, 3.76); p=0.0023], whereas QRS>120ms was no longer predictive [stratified hazard ratio=1.51 (0.90, 2.51); p=0.12]. No significant interaction existed between ICD and MTWA status (p=0.47) or between MTWA and QRS>120ms (p=0.25).
Conclusion: MTWA, but not QRS>120ms, is predictive of mortality in patients with ischemic cardiomyopathy. QRS duration does not affect the prognostic ability of MTWA.

Keywords:
Coronary artery disease,Sudden death,Ventricular arrhythmia
Cost effectiveness http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=559
ere's today's release. When you weigh risks, results and cost effectiveness, this has to be the answer.

I am anixous for the next few days. I understand that the target is $15.00. Has anyone else gotten a different projection.

Updated:2006-03-14 10:16:22
Microvolt T-Wave Alternans Testing Improves Cost Effectiveness of ICDs
BUSINESS WIRE
BEDFORD, Mass.--(BUSINESS WIRE)----


Award Winning Presentation at American College of Cardiology shows that use of MTWA Testing in MADIT II patients can effectively reduce costs


Cambridge Heart, Inc. (OTCBB-CAMH) today reported on a presentation at The American College of Cardiology given by Dr. Paul Chan from the VA Center for Practice Management & Outcomes Research, and the University of Michigan, Ann Arbor, MI. The objective of the study was to evaluate the cost effectiveness of Implantable Cardioverter Defibrillator (ICD) therapy in MADIT II eligible patients with and without risk stratification using Microvolt T-Wave Alternans. Three treatment strategies were evaluated, medical therapy alone, ICDs for all, and the utilization of Microvolt T-Wave Alternans as a risk stratification tool to provide ICDs for non-negative MTWA patients only.


A Markov model was utilized to simulate a range of variables influencing the cost-effectiveness of ICD implantation including the initial cost of ICD implant, cost of MTWA testing, complications, ICD replacements, death rates, etc. The results of the simulations revealed an Incremental Cost Effectiveness Ratio (ICER) of $88,700 per Quality Adjusted Life Year (QALY) in the ICDs FOR ALL strategy as compared to the use of MTWA risk stratification. The use of MTWA in risk stratifying the population resulted in a $48,800 ICER as compared to medical management.


Dr. Paul Chan commenting on the study said, "We performed this analysis because the potential cost implication of ICD therapy is immense with an estimated incremental societal cost of $2.9 billion per year as compared to standard medical therapy, just for MADIT II eligible patients. As 82 % of the potential benefit of the ICDs was achieved by implanting ICDs into the 67% of patients who were MTWA non negative, the data suggests that the use of risk stratification make good sense, potentially saving $700 million per year in the MADIT II population alone."


Commenting for the company, David Chazanovitz, President and CEO of Cambridge Heart said, "We applaud Dr. Chan's efforts. The results of this study validate the common sense approach which suggests that placing expensive, life saving therapy is much more cost effective when you risk stratify the population into patients who are unlikely to benefit from the ICD from those who will benefit most from the therapy. We also congratulate Dr. Chan with the announcement at the end of the day that his study won first place in the ACC's prestigious Young Investigators Awards Competition."


MTWA for risk stratification in ICD placement June 2007
http://www.bcbs.com/betterknowledge/tec/vols/21/microvolt-t-wave-alternans.html

NCA for MTWA http://www.cms.hhs.gov/mcd/viewnca.asp?from=basket&nca_id=165&viewAMA=N&basket=nca:00293N:165:Microvolt+T-wave+Alternans:Closed:New:5

Paul11490
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1648
Thanks, Geoff. Many have cited GE's need for further clinicals. I just took a look at the comments over at CMA, and rereading this one helped my own doubts:

---------------------------------------
Commenter: Sodowick, MD, Bradford
Title: Director of Electrophysiology
Organization: The Arrhythmia Institute
Date: 01/20/2006
Comment:

Generally, CMS is to be commended for its proposal to provide national coverage for reimbursement of Microvolt T-wave Alternans (MTWA). However, restricting coverage of MTWA testing to the spectral analytic method (thus limiting coverage to a single companyâ| s product) is short-sited and does not allow coverage of other MTW systems that the FDA may approve for clinical use in the future.

As you are aware, MTWA is simply a natural phenomenon of the heart that can be used by the physician along with other information to risk stratify patients who may be at increased risk for sudden cardiac death. The method used to assess this natural phenomenon should provide an analytical result that is equivalent to that provided by other FDA-approved instruments that measure MTWA. For example, the Modified Moving Average Method has been previously cleared for sale by the FDA following an extensive demonstration that it provides results that are equivalent to the spectral analytical method. It seems clear that other methods of measuring MTWA are in development and may become available over the next few years. The FDAâ| s role is to determine if new methods are substantially equivalent to existing predicate devices. Thus, if the FDA approves a new device measuring MTWA as substantially equivalent to existing methodologies, then that device should be covered under the CMS policy. Limiting coverage to the spectral analytic method would not allow patients and their physicians to utilize potentially more cost effective tests that are cleared by the FDA and available to physicians. By definition, if the two methods are technically equivalent, then the clinical results derived from either one should apply to both.

In a sense, the issue is no different than a situation where a measurement is made by a ruler or a yardstick: so long each arrives at the same result, then it should not matter which measuring tool is used. To use another clinical example, if Medicare chooses to cover a diagnostic test, such as cholesterol, then it should not matter which methodology is used to perform the measurement, so long as each method gives an accurate result. We believe the same standard should be applied to MTWA. As a result, CMS should cover MTQA if it is performed by any methodology equivalent to existing methodologies. Thank you for the opportunity to comment.
-----------------------------------------


I see now that this comment is tightly worded. For instance, in para 2 the MMA has already been "cleared for sale" by the FDA, yet in the rest of the comment the implication is that MMA is not yet approved for TWA testing. I'm not sure what's up with that, maybe the FDA MMA approval was for other indications, but it seems to me that CMS did right on this. After all, if the FDA approves an alternate method someday, CMS can always include it in their coverage at that point. I wish I had seen this distinction more clearly a couple of months ago, as I now feel much better about our position.

Best wishes,
Paul

Wall street Journal Letter to Ed 11/1/05 http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=153
recent article Adding to position ... for long term



Wall Street Journal Letter to the Editor on Utility of Microvolt T-Wave Alternans
(published November 1, 2005; Page A17)
"A Hard Choice for Heart Patients" (Personal Journal, Oct. 12) provides an excellent discussion of failure rates for implantable cardiac defibrillators and operative risks faced by patients and their physicians when a defibrillator is recalled. A third important issue is how likely is a patient to have a life-threatening sustained arrhythmia that would benefit from ICD therapy?

An FDA recall doesn't mandate replacement of all affected ICDs because most won't fail. Deciding whether to replace an ICD is especially difficult when the patient received an ICD without having had a life-threatening rhythm disturbance, but was judged to be at high risk for one. The current method for selecting patients for ICD prophylaxis depends primarily on the presence of reduced heart pumping function, and a large and growing proportion of all ICD implants are prophylactic. But at the time patients with prophylactic ICD face a recall, fewer than 10% will have had a sustained, life-threatening rhythm disturbance.

Recently a relatively inexpensive, non-invasive test, microvolt T-wave alternans, has been shown highly capable of predicting which patients with heart impairment are unlikely to have life-threatening sustained arrhythmias, and the test can be helpful with the replacement decision. A normal test favors the decision not to replace an ICD; conversely, an abnormal test favors the decision to replace it. But T-wave alternans testing hasn't been formally tested in the setting of ICD recalls.

During an ICD recall, the likelihood of future ICD failure, probability of operative complications and patient factors should be factored into the decision to replace an ICD.

J. Thomas Bigger, M.D.
Professor of Medicine
Columbia University College of Physicians & Surgeons
New York

Robert E. Kleiger, M.D.
Professor of Medicine
Washington University in St. Louis
St. Louis

sayspine
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1091
This tiny co. has a very attractive asset in the MIT proprietary science driven product called MTWA, that just received NMC coverage with at least one private insurer also agreeing for that same coverage. Others are soon to follow. Each time its announced, the co.test will get more validation (not that it needs it by all of the studies) and the cardio world will continue to take note about the news and come to digest and embrace this test.

Everybody has their opinions and intentions for the long and short of this stock. For the longs, we need to stay focused on the positive of this test for the future as it becomes an accepted part of the cardiologist practice.

The possibility of a co. like J&J, who we all know wants to be in the ICD side of the market (failed GDT deal), possibly aligning/scooping up this co. with the purchase of someone like STJ.

The possibility of an alignment with an established ICD co. sales force to help market this product/test.

We just need this co. to think about the distribution model as well as they did on engineering and scientific side which they did masterfully. The need to take advantage of the, now much improved, marketable asset of the MTWA test with recent NMC coverage is their next hurdle. If they play this side as well, we have nothing but UP. As`soon as the news of how this company plans to ramp up its distribution/sales force and clinical support side will be of great interest to us all. I'm sure their in discussion with several different possibilities.

I've realized that shorts and day traders have their self-interest here too. Its to make money on a stock thats going to have a viotility attached to it for awhile.
Shorts and day traders love to prey on bad news and the week stomachs of some investors. Things like "see ya at 1.85" or "Take your profits now while you can" are only shorts shakeing the limbs of weak holders. I haven't seen one board that doesn't have them.

As soon as we reach a support level, and we will, Some more good news will send it back up to new highs.

Those that stay long and strong will see new highs, and shorts will make money on the weak during the corrections.
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1281
STJ lowered their expected target due to lower than anticipated sales. MTD is down in after hours tradeing. Read the Reuters article. It suggest that the slowdown is possibly due to less implants being sold because of recall problems. HHHHMMMM How many of these patients would have elected to be implanted if they had a non invasive test that would tell them that they really did probably need to take the risk of the implant. Would utilizing the MTWA test help the patient and physician make a more prudent decision?????


The story is the same. CAMH has the answer. It's called risk stratisfying the patient. I dont know where the bottom is for the stock but this company has a true value to the medical community, your family, and your freinds. It will be recognized at some point. Everything is pointing to sooner rather than later.

Hang in longs

spine
http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=1844
http://content.onlinejacc.org/cgi/content/full/47/9/1901

If the president of JACC is serious about their responsibilities, then they should all embrace MTWA testing as the "golden standard" for risk stratification. It spends valuable medical $$$ much more prudently and it will save the lives of many more people that dont know their at risk for SCD.

Come on Medtronic, St Jude, Boston Scientific, do the right thing for yourseleves and your customers before medicare does it for you. Embrace CAMH. You'll be the hero that your supposed to be.

Wellpoint Spring 2005 http://ragingbull.quote.com/mboard/boards.cgi?board=CAMH&read=571
Wellpoint, in Spring of '05.

Looks like WellPoint, which is the national consortium of Blue Cross/Blue Shield insurers, might be a tougher nut to crack. This is the statement they came up with when they merged with Anthem.

From what I can glean, they didn't think the power of the MADIT-II trial was sufficient to translate into actual patient management. They state that a 9% "failure" rate (my quotes) presents a questionable degree of accuracy for use in determining who would benefit from an ICD.

Am I reading that correctly, or have there been better studies since then?

Also, it's interesting to note the several other uses MTWA could have, even on patients recouperating from MI's, if I read that correctly.

Input on these matters would be appreciated. From what I glean here, the payors are eager to implement MTWA, for economic purposes, but there could be more resistance from the cardiac community. Ironically, this is stated by a payor, and that seems a credit to its integrity.

paul



Subject: T-Wave Alternans

Policy #: MED.00041 Current Effective Date: 04/28/2005

Status: Revised Last Review Date: 04/28/2005


Description/Scope



This policy addresses T-wave alternans, a noninvasive electrophysiologic study of the heart.



Policy Statement



Investigational/Not Medically Necessary:



T-wave alternans is considered investigational/not medically necessary for all applications, including but not limited to its use as a technique for risk stratification for arrhythmias after prior myocardial infarction, for patients with reduced ejection fraction, for patients with congestive heart failure, or as a patient selection technique for implantation of an automatic implantable cardiac defibrillator.


Rationale



T-Wave Alternans as a Patient Selection Criterion for Automatic Implantable Cardiac Defibrillator



Studies of T-wave alternans have focused on the predictive capability of this test for various arrhythmic events in many different types of patients. For example, a recent clinical trial of implantable defibrillators has potentially changed the perspective on selection and risk stratification for this particular therapy. In the MADIT-II trial implantable defibrillators were shown to be effective in patients selected solely on the basis of prior myocardial infarction and reduced ejection fraction. Prior studies of implantable defibrillators had selected patients using results of electrophysiologic testing and symptoms. Given these specific clinical trials, it becomes critical whether any risk stratification test is a useful or efficient maneuver in improving identification of patients who benefit or do not benefit from therapy. In 2003, Medicare conducted a subgroup analysis of MADIT II data that looked at the impact of QRS duration on patient outcomes. Based on this analysis, Medicare announced their intent to limit coverage of AICDs in patients meeting the criteria for the MADIT-II trial to those who additionally had a QRS duration greater than 120 ms, cutting coverage eligibility by one third. This strategy was criticized by many in the cardiac community, who pointed out the hazards of post hoc subgroup analysis. In partial response, Bloomfield and colleagues compared the predictive value of T-wave alternans with QRS in patients who would meet the MADIT II criteria. The study population was drawn from a multi-institutional study epidemiologic study examining the prognostic significance of T-wave alternans in patients with left ventricular dysfunction. Of the 549 evaluable patients in the study, 177 also met the MADIT II criteria; this subgroup formed the study group. The mean patient follow up was 20 months and the primary outcome was all cause mortality.



The two year mortality rate in patients with an abnormal T-wave alternans test was 17.8% compared with 3.8% in those with a normal T-wave alterans study. In contrast, the mortality rate for patients with a QRS duration of greater than 120 ms was not significantly different from those with a normal QRS interval. The authors of this study conclude that the T-wave alternans test is a superior risk predictor than the QRS interval. Further, the authors propose that a normal T-wave alternans test can be used to deselect patients for an AICD who would otherwise meet the criteria established by the results of the MADIT II trial. Specifically, based on the results of this analysis of 176 patients, a physician could say that there was a 95% chance that the two year mortality risk of a patient with a normal T-wave alternans test is less than 9%.



Conclusions



Subgroup analysis may be adequate to determine whether T-wave alternans can identify patients who should not have an implantable defibrillator (but who otherwise meet criteria). However, this study included only 177 patients of whom 32% (n=56) had a normal T-wave alternans. There was a 3.8% mortality (0.0-9.0 95% confidence interval) in these 56 patients, i.e., 2 patients who might have foregone implantation of an AICD based on the results of the T-wave alternans. This is a relatively small study, and while the data does suggest that the results of T-wave alternans can be used to separate those at high vs. low risk of cardiac mortality, the small size of the study is reflected in the relatively broad confidence intervals. It is unclear whether a risk of up to 9% mortality at two years would be acceptable to patients and physicians trying to decide on whether or not to undergo implantation of an AICD.



T-Wave Alternans as a Predictor of Coronary Events



Several prospective studies in different types of patients have shown that T-wave alternans is a predictor of various types of events. Ikeda and colleagues assessed T-wave alternans and SAECG in 102 patients who had suffered a myocardial infarction. A positive T-wave alternans was present in 49% of patients, an abnormal SAECG in 21%, and an ejection fraction of less than 40% in 27% of patients. During a mean follow-up of 13 months, ventricular arrhythmias occurred in 15% of patients. The probability of an arrhythmic event was 28% in patients with a positive T-wave alternans test, and 2% for a negative test. In another study by Ikeda et al., T-wave alternans was a predictor of cardiac sudden death in 834 patients who initially survived a myocardial infarction. The risk of sudden death was 7% with a positive test, and 1% with a negative test. The multivariable relative hazard was 5.9. In a study by Klingenheben et al of 107 patients with congestive heart failure, patients with a positive T-wave alternans test had a 21% risk of arrhythmic events, while patients with a negative test had no arrhythmic events.


In a retrospective study, Armoundas and colleagues compared the results of T-wave alternans and SAECG to the results of electrophysiologic studies in a series of 43 patients with a variety of diagnoses, although the majority (53%) of patients had coronary artery disease and 42% had a history of myocardial infarction. Electrophysiologic testing identified ventricular arrhythmias in 18% of patients. T-wave alternans was performed during the electrophysiology study using atrial pacing to eliminate variability in the heart rate, which can interfere with the measurement of T-wave alternans. The presence of T-wave alternans predicted electrophysiologic testing inducibility with a sensitivity of 70% and a specificity of 88%. In contrast, SAECG was not predictive of electrophysiology results.



T-wave alternans has been investigated as a risk stratification tool in patients with dilated cardiomyopathy. Adachi and colleagues performed T-wave alternans in 58 patients with dilated cardiomyopathy. T-wave alternans testing was positive in 40% of patients, negative in 43%, and indeterminate in 17%. Results of Holter monitoring were used to identify ventricular arrhythmias. Ventricular tachycardia was present in 61% of patients with positive T-wave alternans. The authors concluded that T-wave alternans may be a useful noninvasive tool for identifying high-risk patients. However, this study used Holter monitoring as the gold standard, which is not a perfect predictor of arrhythmic events. Thus, it is unclear how T-wave alternans would either supplement or replace the results of Holter monitoring, which is also a noninvasive test.



Conclusions



Studies of T-wave alternans have focused on the predictive capability of this test for various arrhythmic events in many different types of patients. However, there are not clinical studies that focus on how this information can be used in the management of the patient.