Problems with pacemakers and implantable cardioverter devices (ICDs) are on the rise, according to a research study published last month in the Journal of the American Medical Association (JAMA), a report picked up and given front-page attention by newspapers around the country. But rather than creating alarm, those figures should actually result in greater confidence in these technologies, according to one of the makers of such devices, Medtronic (Minneapolis, Minnesota), which said it released its statement allay the fears that it said the JAMA report would raise among those implanted with ICDs. According to Medtronic, the increased number of recalls and other problems indicates better product diagnostics, not increased failures.
The JAMA article reviewed actions by the FDA to recall these devices over the past 10 years and said the number of recalls had increased during the past five years. Overall, the researchers reported 52 "advisories" from 1990 to 2000, involving 408,500 pacemakers and 114,645 ICDs "subject to recalls or safety alerts." The JAMA article did not brand the devices as unsafe, but rather said that "few deaths have been confirmed as a result of device malfunction." And it added that patients implanted with pacemakers and ICDs have "coexisting cardiac disease and deaths may be attributed to a primary cardiac abnormality rather than device malfunction." The authors did recommend more stringent research concerning the devices, both in premarket and postmarket studies – a view supported by an accompanying editorial.
Marshall Stanton, MD, medical director for Medtronic's Cardiac Rhythm Management unit, called the figures cited in the JAMA article misleading and "very unfortunate," because it could cause patients to be "unduly alarmed" about their implanted devices. He said that he had examined the company's own records of actions by the FDA and that they totaled "just over 101,000 patients" but that, of these, only .03% of the total involved in FDA safety alerts resulted in device explants. And he emphasized that the JAMA report did not follow through to determine how many of the devices had to be explanted. "We're not happy that there are recalls," Stanton said. "We'd much prefer that there aren't any." But he emphasized a very large distinction between the number of patients affected by a recall or safety alert and how many actually have a device that could have a problem.
Referring to pacemakers and ICDs as "active implantables," Medtronic's statement noted that the new self-monitoring and self-reporting features of these devices "provide early warning of potential or impending safety problems. That, plus prospective studies of devices allow us to vigilantly assess product performance." When it receives word of such problems, according to Medtronic, it "proactively" undertakes notification of physicians and regulators concerning those problems. "We are able to do this because these devices provide a wealth of information about performance in advance of malfunctions and/or failures," the company said.
Besides detailing FDA actions concerning the devices, the JAMA articles emphasizes that "the psychological impact of recalls to patients with implanted devices should not be underestimated." This concern includes the impact on the patients' families, according to the report. But Medtronic noted that the JAMA article itself was likely to cause "undue distress to patients and their families." The statement summarized various improvements in device implantation, reductions in mortality from the surgical procedure required for implantation "down to less than one-half of 1%," and much faster hospital release times. As to JAMA's editorial encouragement of a longer testing period and stricter regulation of pacemakers, Stanton said that these strategies would result in delaying patient access to the newest life-saving technologies in this sector.
Besides looking at the number of recalls, the JAMA article says that the cost of the cited safety alerts has totaled $870 million over the 10-year period studied, a figure including patient appointments, hospital stays and use of hospital procedures. While it notes that the manufacturers reimburse for replacement devices, "these costs are ultimately passed on to the health care system and are reflected in the cost of new devices." While not addressing this figure directly, Medtronic did note a large drop in the cost of device implants – from around $100,000 in 1980 to about $44,000 today.
The North American Society of Pacing and Electrophysiology (NASPE; Natick, Massachusetts), also issued a statement clearly intended to allay patient fears. While praising these technologies as life-saving, the organization called the JAMA study a look at past performance and not the result of "a new concern."
Eric Prystowsky, MD, president of NASPE and a staff member of the Indiana Heart Institute (Indianapolis, Indiana), said that he would not argue the report's statistics, but that he disagreed with its interpretation. "This is a history lesson; this is nothing new," he said, noting that his institution implants from 500 to 600 of the devices annually, and that it was a "relatively rare patient" requiring a replacement as the result of an FDA recall.