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Implantable device reduces hospitalizations for heart failure

September 1, 2009 | 11:24 am

An implantable device that shocks an erratically beating heart back into normality and works to keep both ventricles of the heart beating in synchrony has reduced hospitalizations for heart failure by 41%, according to results reported today at the European Society of Cardiology Congress in Barcelona, Spain, and reported online in the New England Journal of Medicine. The results were significantly better than preliminary results announced in June when the trial was halted prematurely.

The cellphone-sized combination device, called a CRT-D, incorporates an automated defibrillator and a cardiac resynchronization device that shocks both ventricles of the heart at the proper time to keep them beating properly. The device has been approved by the Food and Drug Administration for treating patients with severe heart disease, and about 60,000 are implanted each year in such patients. The new study is focused on patients with a milder form of heart failure, which accounts for about 70% of the 5.5 million U.S. heart failure patients. More than a million such patients die every year.36500-hi-CRT-D

Dr. Arthur J. Moss of the University of Rochester Medical Center and his colleagues studied 1,820 patients at 110 medical centers in the United States, Europe and Canada in the $38 million trial, called MADIT-CRT. About a third of the patients received only an implanted defibrillator, while the rest received the combination device. They were followed for an average of 2.7 years.

Overall, the risk of being hospitalized or dying from heart failure was reduced by 41% in patients receiving the combination device. Women's risk dropped even more, about 63%. The risk of dying from heart failure was the same in both groups, about 3% per year. The device was most effective in patients with an abnormality in their EKGs called a QRS duration of at least 150 milliseconds.

Adverse events were about the same in both groups. The primary drawback of the CRT-D is its price, estimated to be between $30,000 and $40,000 for the device plus an additional $10,000 to $15,000 for the hospital and surgeon to implant it, compared with about $20,000 for an implantable defibrillator.

In an editorial accompanying the report in the New England Journal of Medicine, Dr. Mariell Jessup of the University of Pennsylvania noted that it would require 12 implants of the device to prevent one hospitalization for heart failure. "Is this money that could be spent more wisely?" she asked.

The study was funded by Boston Scientific, which manufactures the CRT-D. Moss has received payments from the company in the past for presenting lectures.

-- Thomas H. Maugh II

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Comments (2)

Even though complaints from chronic pain patients are easier to diagnose and document we now have created a situation where doctors are under-prescribing out of fear, especially if their patient are in their last stages of life because the docs can be charged with murder if autopsies shows high traces of pain medication. I pray this madness comes to an end and I sincerely hope none of you will ever be dying in extreme pain in a hospital, nursing home or maybe at your own house while the doctor is afraid to give you that prescription or injection during your last moments. Yes, definitely keep this medication away from kids but do make it available to those who can benefit from it!

Now, even doctors are questioning the costs of medicine. But they are still ovesubscribing, not undersubscribing, as the previous commenter suggests. Example: Microvolt T-wave Alternans (MTWA) is the first economical test ($400) for Medicare to determine if it really needs to spend upwards of $67,000 for an implanted defibrillator (a 2006 report indicated a cost of $42,000+ to implant an ICD on top of the $25,000 for the ICD itself). A Columbia University study discovered that nearly a third of 170,000 defibs implanted yearly are unnecessary (where's the undersubscribing?)! That's more than $3 billion that didn't need to be spent by Medicare. MTWA was developed at MIT for NASA to determine if astronauts are susceptible to sudden cardiac arrest (SCA). It was approved by the FDA TEN YEARS AGO, has CPT and NCD reimbursement codes, is non-invasive, takes a half hour to perform and costs $400. Yet cardiologists continue to use electrophysiology (EP) that is invasive, takes two hours to perform and costs anywhere from $3,000 - $8,000. Doctors are biased to use the more expensive test. This has to change. Medicare can do its job better by paying only for MTWA where it can replace EP (MTWA cannot replace EP in all cases). Why is MTWA good enough for astronauts and professional baseball players but not good enough for John and Joan Q. Citizen? For more MTWA info, Google those capital letters and click on the third item down.



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