Medical Device Daily Washington Editor
NEW ORLEANS – Cardiologists shouldn’t be in such a rush to use implantable cardioverter defibrillators (ICDs) as a cure-all, without better identification of at-risk patients.
That was the take-away message of a presentation sponsored by GE Healthcare (Waukesha, Wisconsin) as this year’s scientific sessions of the Heart Rhythm Society (HRS; Washington) got under way on Wednesday morning.
Mark Josephson, MD, Herman Dana professor of medicine at Harvard Medical School and cardiologist at Beth Israel Deaconess Medical Center (Boston) said that the technology may have reached “a point of diminishing returns.”
“Everyone in this country has jumped on this device as a primary therapy to treat those on a path to cardiac arrest and to prevent cardiac arrest,” he said. “The problem is that there has been only a relative risk reduction.”
Implantation of ICDs has increased logarithmically, according to Josephson. “That’s why we need to think about cost, especially when you consider that 90% of people may not benefit from the device,” he said.
Roughly 150,000 ICDs were implanted in 2002 at a cost of $5 billion, according to Josephson’s numbers. He predicted 200,000 device implantations in 2006.
“And that’s just the tip of what might happen unless the reimbursement structure changes and our risk stratification changes,” he added.
The Centers for Medicare & Medicaid Services (CMS; Baltimore) expanded ICD coverage in January, based on data from the results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), sponsored by the National Institutes of Health (Bethesda, Maryland) and funded by ICD manufacturer Medtronic (Minneapolis) and drug maker Wyeth Pharmaceuticals (Madison, New Jersey).
Results of the 2,500-patient trial found that ICDs cut the risk of death in heart failure patients by 23%.
Short follow-up from recent studies, such as SCD-HeFT, is “good news and bad news,” Josephson said, because short-term studies showed adequate efficacy but not long-term benefit after only a two-year follow up.
Josephson said the coverage decision was a good move, but that now the challenge will be to save billions of dollars rather than spending them.
“Let me say that I do believe that ICDs are the most effective way for preventing sudden death from a ventricular arrhythmia if you have it, and the cost is worth it if people benefit,” Josephson said. “But in order for ICDs to be widely applied to lower-risk populations, the cost must be drastically reduced and their efficiency enhanced to improve risk stratification.”
In other findings at the HRS conference concerning ICDs:
• Patients recently diagnosed with weak hearts unrelated to coronary artery disease may benefit from ICDs as much as patients with long-term, established disease, according to a new study.
While CMS guidelines issued last year allow ICDs for patients who have been diagnosed with non-ischemic cardiomyopathy (NICMP) for more than nine months, the study indicates that ICDs are equally beneficial for newly diagnosed patients.
“Our findings suggest that the CMS guidelines may not reliably discriminate patients at high risk for sudden cardiac arrest,” said Kevin Makati, MD, lead investigator and cardiologist at Tufts-New England Medical Center (Boston). “This study sheds new light on the potential benefits of ICDs for patients who have been diagnosed with weak hearts for less than nine months.”
The study evaluated 133 patients with NICMP. A total of 76 patients had their initial diagnosis for more than nine months, while 57 patients had been diagnosed for less than nine months. During a follow-up period of 27 months, no difference was found in the occurrence of treated and lethal ventricular arrhythmias.
“This study shows a clear benefit of ICDs for patients with cardiomyopathy, irrespective of when they were diagnosed,” said Stephen Hammill, MD, president of the Heart Rhythm Society. “CMS may want to revisit the coverage criteria for these patients in light of these findings.”
• Other data offering a “revisited” look at standard practice will be presented today at the conference.
Chest “thumping” over the heart has long been considered a way to terminate ventricular fibrillation (VF) and a way of resuscitating people in cardiac arrest outside of a hospital setting. But a study headed by Mark Link, MD, cardiologist at Tufts-New England Medical Center, concludes against recommending “precordial thumps to cardiac arrest victims, if external defibrillation is readily available.”
The study evaluated chest thumping in an experimental model involving 31 episodes of VF in animals. No episodes of VF were stopped with precordial thumps, while all of the episodes were terminated with an external defibrillator.
Commenting on the study, Hammill said, “It’s important to compare anecdotal evidence against scientific research so that people can be better educated about how to respond to life-threatening emergencies like cardiac arrest.”