"My clinical opinion is that patients are getting these implants who never should have; they are too sick to see any benefit," Hauptman said. He added that in many cases, the devices simply drive up the cost of health care to patients and taxpayers.
An Expensive Procedure
The implantable devices are designed to reduce the risk of sudden cardiac death. And for some heart failure patients they do provide a safe non-drug treatment option. But they do not work as well for high-risk patients, Hauptman and his team found.
In the study, Hauptman and his team looked at the records of nearly 28,000 patients with heart failure who underwent implantation or revision of cardioverter defibrillator or cardiac resynchronization devices at more than 200 hospitals.
The average health-care cost for patients who received one of these devices was $43,735, with costs nearly doubling if the patient died. The team identified two markers of advanced heart failure that were associated with a poorer prognosis following implantation: use of inotropic therapy (a treatment designed to alleviate symptoms of advanced heart failure by making the heart pump more vigorously) and time to procedure (patients who received the device on the first hospital day fared better than those who had extended hospital stays before implantation).
Not for Everyone
Until this recent study, there had been no clinical trials that looked at subsets of patients who may have less favorable prognoses.
"Our study, I think, adds a lot," says Hauptman. "It includes real-world cases."
The research highlights the need for improved communication between patients and their doctors. Hauptman says doctors need to take a realistic view of their patients' conditions and talk with them about whether the implants will really do any good.
Constructing a Game Plan
The American Heart Association and the American College of Cardiology have practice guidelines that require patients to have a reasonable expectation of at least one year of survival to be eligible for these devices. Hauptman says additional criteria must be put in place to help physicians determine when these devices are not, or no longer, appropriate.
If so many patients have questionable outcomes, then why are doctors continuing to perform implantations on these patients? Could it be pressure from the patient, pressure from patients' families? Is it driven by an ethic to do what ever is possible to prolong life or perhaps just fear of a malpractice suit by not having "done everything"?
All of the above, according to Hauptman. However, he adds, "our study is not designed to assess why but what is happening."
Hauptman said he hopes the findings will help improve the ways doctors decide which patients should receive implantable cardiac devices. If so, it should also make heart failure care more cost-effective.
"If cardiologists, myself included, do not start to more carefully consider how to best allocate services," Hauptman said, "it will be externally mandated for us. It is better that we evolve our practice and recognize that devices are not right for everyone."
Dr. Cindy Haines is managing editor of Healthday-Physician's Briefing and president of Haines Medical Communications Inc., a full-service medical communications and consulting firm. As a board-certified family physician, Haines is well-versed in all areas of health care, with particular interest in fitness, nutrition, and psychological health.
Her weekly column on health care issues will appear here each Friday, and you can listen to Dr. Haines' House Call on KTRS.
For information on heart failure and cardiac devices, visit the American Heart Association
For more on the American Heart Journal study: Abstract