New devices serve a tiny population
New devices serve a tiny population
An expert comments on end-stage technology
Richard Pozen, MD, FACC, national medical director of Vivra Heart Services in Fort Lauderdale, FL, says both the LionHeart and the CardioSupport systems accomplish something of value. (Pozen is not connected to the companies that produce LionHeart or CardioSupport.)
"The LionHeart operates along the lines of a LVAD; the other seems to me to be similar to EECP [enhanced external counterpulsation] in that it uses mechanical force to assist the heart. They both make sense," he adds.
"But both these items affect such a trivial percentage — probably less than 1% — of the CHF population," says Pozen.
"You’re not looking at a therapy that’s going to be reasonable to use in a large proportion of patients. The patients these devices are directed at are very end stage, and the devices act either as a bridge to transplant or as a substitute for transplant. Neither one is looking at achieving any long-term benefits," he adds. CardioSupport is expressly a short-term system. But LionHeart too typically would not be in the patient for more than a year, because that’s the life expectancy of these patients.
Why are companies spending research money on devices that may not be reimbursed or financially successful?
"It’s like throwing spaghetti on the ceiling; if one or two devices stick, they can make companies a lot of money. I compare the devices we’re talking about to EECP. There’s no strong evidence that that technology applies to a large population, or that it helps people. There’s only anecdotal evidence. Yet EECP got FDA approval, and once that happened, it got Medicare endorsement. And it is now installed in hospitals. When patients need help, they’ll go anywhere for it."
What are the chances of third-party payers paying for these devices? "In my opinion, they may get FDA-approved, but they won’t be covered by traditional insurance companies on a routine basis. The population they benefit is too small, and those patients will die soon anyway."
Pozen says it comes down to bioethical issues. "It’s similar to the issues surrounding terminal cancer. Can you buy six months or a year by putting someone through more chemotherapy? Yes, but is it going to make a real difference?"
"If these companies spent all the money that they are spending on developing these devices on making certain that patients were taking adequate doses of ACEIs [angiotensin converting enzyme inhibitors]," says Pozen, " they’d get more bang for their buck."
He says that in his opinion, there are never going to be enough test cases for the devices to make a real clinical significance.
"Investigators may have enough cases to produce a paper and say their trial is statistically significant. But they’re not going to have a couple thousand patients who have this implanted compared to a couple thousand who don’t, and then be able to make clinically important conclusions. If you take this limited population and increase the survival of everyone by a month, that makes a very statistically significant result. But is that clinically significant?" asks Pozen.
His opinion extends to the resynchronization-defibrillator-pacing devices. (See CHF Disease Management, January 2000, pp. 1-7.) Pozen says they are for people who have arrhythmia as their primary problem.
"They combine the ICD [implantable cardioverter defibrillator] function with some coordination function. There are lots of studies that show that when you synchronize the left and right ventricles or the atrium and ventricle, there is increase in cardiac output. There’s no evidence, though, that the synchronization sustains itself for a long period of time or that it really makes a clinical difference. Patients are not saying, Now I can walk my three miles a day and can breathe better,’" adds Pozen.
He says all these devices are the tip of the iceberg. "Physiologically and biomechanically they make a lot of sense.
Will the FDA approve CardioSupport and LionHeart? Probably yes. "All [the FDA] requires is that the devices be put through the appropriate clinical testing and show efficacy and safety," he says. "The FDA doesn’t care if they will be paid for and what percentage of the population they could help."
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