ICD recalls should be handled better

Physicians should review the risks, benefits with each patient; physician-to-patient management is needed when ICDs are recalled.

WASHINGTON — Representatives from the Food and Drug Administration, industry, physician organizations, and patient groups met recently in Washington, D.C., to discuss how to improve communication when any implantable cardioverter defibrillators are recalled.

No formal recommendations were drafted, but Mark D. Carlson, MD, associate vice president for government relations at Case Western Reserve University, called the effort a good first step.

Carlson chaired the Policy Conference on Pacemaker and ICD Performance, which was convened after a series of recalls involving Guidant devices.

The conference was divided into five separate sections with interested parties making formal presentations followed by panel discussions. Conference attendees discussed technology, performance and surveillance; post market analysis and reporting; the role of external databases in post market surveillance; risk/benefit communication; and what patients want and need to know from their physicians.

ICD malfunctions

William Maisel, MD, director of the pacemaker and ICD service at Beth Israel Deaconess Medical Center, presented new findings based on FDA databases that defined the scope of the problem.

Researchers reviewed annual reports submitted to the FDA for the years 1990 to 2002. These reports contained the number of implanted devices and detailed information concerning device malfunctions.

A malfunction was defined as a device that was explanted due to equipment failure, returned to the manufacturer and confirmed by said manufacturer to be functioning improperly. Researchers assumed that malfunctioning devices were explanted from living patients and replaced with new devices.

Between 1990 and 2002, there were 2.25 million pacemakers and 416,000 ICDs implanted in the United States. Over the same time period, there were 17,323 devices that were explanted due to malfunction — 8,834 pacemakers and 8,849 ICDs.

Rate of failure

ICDs were significantly more likely to fail with an annual rate of 20.7 per 1,000 implants compared to 4.6 per 1,000 implants for pacemakers (P<.001).

While the rate of pacemaker reimplant declined significantly during the study period, the rate of ICD failure trended down only during the first half of the 1990s and increased significantly during the second part of the study, with more than 50% of ICD failures occurring between 1999 and 2002.

These malfunctions were directly responsible for 61 confirmed deaths.

Maisel said the data he presented did not in any way diminish the value of ICDs. “Pacemakers and ICDs have saved countless lives and remain an important therapy for patients with or at risk for life-threatening arrhythmias. I do not think any of the data we’ve shown today change that fact,” Maisel said.

Patient communication

Patients, however, do not see their individual risk in terms of statistical risk/benefit and hazard ratios, and they react negatively when a device they are dependent upon for survival is under a recall, panel members said.

“It is wrong to communicate with patients based on numbers from a risk-benefit ratio,” Eric Prystowsky, MD, director of the clinical electrophysiology laboratory at St. Vincent Hospital in Indianapolis. “You need to review the risks and benefits with each individual patient and make decisions that help that patient sleep better at night.”

Tim Samsel, vice president of regulatory affairs for Medtronic’s Cardiac Rhythm Management division, said physician-to-patient management is critical because a rash of patients contacting the manufacturer directly often becomes chaotic.

“Public communication of advisories has an adverse impact on unaffected patients and potential patients,” Samsel said. “The term ‘recall’ is commonly misunderstood by patients with implantable devices and requires explanation.”

Douglas Zipes, MD, distinguished professor of medicine at the Indiana University School of Medicine and section editor of Cardiology Today’s Electrophysiology and Arrhythmia Disorders section, was a panel member. He said the key to patient communication is trust.

“Nothing replaces the personal touch of a physician, and it is very important that a level of trust is established early so that a patient is not getting their first information from the New York Times,” Zipes said.

“We need to establish with the patient the potential for device failure even before the implant. I would bet that prior to the recall, no one in this room ever thought we would need to do that, but we definitely need to start thinking about it now.”

Carlson said that the meeting was “the first of many steps that will ultimately lead to an improved device surveillance system that works from a patient’s perspective as well as an industry and physician perspective,” Carlson said.

“We now have a better understanding of the complexity of the issues before us. There are some areas where consensus exists, and there are other areas where we can continue to explore potential solutions,” he said. – by Jeremy Moore