Replacing ICDs after recalls can be risky

Clinicians should weigh risk of explantation, re-implantation against the risk of leaving an ICD in place.

BOSTON — Recall advisories for implantable cardioverter defibrillators do not seem to increase anxiety among patients, and physicians should weigh the risks associated with device removal against the theoretical risk of leaving a device in place.

Three studies were presented at the 27th Annual Scientific Sessions of the Heart Rhythm Society that address the issues raised by HRS in its recent draft recommendations on how best to handle ICD recalls.

According to the draft recommendations, industry and academia should establish standing advisory panels to analyze device performance and recommend action, and the FDA should consider eliminating the term “recall.”

In a recommendations section specific to physicians, the society said physicians should consider the risks of explantation and re-implantation of a new device when discussing with their patients how best to respond to an advisory notice.

“There really is not much data out there to answer this question though,” David Hayes, MD, chair of cardiovascular diseases at the Mayo Clinic in Rochester, told Cardiology Today.

Hayes presented a single-center study of complication rates at the HRS meeting.

“When I did a data search prior to this study, I assumed I would be able to find related studies pretty easily, but they just were not out there,” Hayes said.

Mayo clinic

Hayes retrospectively observed device replacement procedures at the Mayo Clinic in Rochester, Minn., from January 2000 to Nov. 4, 2005. Clinicians performed 732 “pulse generator replacements” (pacemakers, ICDs or cardiac resynchronization therapy devices) during that time period.

Of these, 570 were due to elective replacement indicators, and 162 were due to a manufacturer’s advisory or recall.

Hayes noted nine (1.24%) complications that required a subsequent device-related procedure: five infections, three hematomas and one incisional dehiscence.

According to the research abstract, all device system infections required complete removal of the system. The three patients with hematoma formation were or had been on warfarin (Coumadin, Bristol-Myers Squibb) and the mean INR for anticoagulation monitoring recorded prior to the procedure was 1.5.

All complications occurred from one to 60 days after device extraction and replacement, and researchers concluded they were all the result of a prior procedure.

“A recall-provoked replacement of pulse generators should be restricted to those situations in which device failure rate and the patient’s clinical dependence on the device (ie, tachy therapies delivered and degree of pacemaker dependence) outweigh the center’s calculated risk of the procedure,” researchers wrote in the abstract.

The Canadian experience

In a separate study presented at HRS, Paul Gould, MBBS, PhD, an electrophysiology fellow at the University of Western Ontario, observed the rate of complications from ICD replacement at 17 Canadian centers from October 2004 to December 2005.

Of the 2,915 advisories that were identified, 533 underwent device replacement. Complications occurred in 43 patients (8.1%), which included 31 cases of “major complications.” Of the “major complications,” 10 had pocket infections that required extraction. Researchers recorded two deaths, one 12 hours after extraction and a second from ongoing sepsis despite extraction and appropriate antibiotics.

“The risk of complications was much higher than we anticipated,” Gould said in a written statement. “Given the unexpectedly high complication rate, physicians need to seriously consider if device replacement in this context potentially puts the patient at risk.”

The following complications were also recorded by Gould and colleagues: 12 cases of hematoma requiring reoperation, nine cases of pocket infection requiring medical treatment, eight cases of system malfunction requiring reoperation, one case of heart failure requiring admission and two cases of significant site pain, one medically managed and one surgically managed.

In addition to physiologic complications, Gould’s study noted one major psychological morbidity.

Psychological effects

—Manish Undavia, MD

Another study by Manish Undavia, MD, an electrophysiology fellow at Mount Sinai School of Medicine in New York City, focused specifically on the psychological effects of a device recall.

Undavia and colleagues observed 61 patients who had received an ICD recall and compared them with 43 patients whose ICD was not under recall. There were no significant differences in age, gender, ethnicity, socioeconomic status, marital status, education level, religious beliefs or underlying cardiac risk factors between the two groups.

There was no significant difference in prior history of depression or anxiety between the two groups (28% in the group with ICD recalls compared with 23% in controls).

After conducting a post-advisory survey, researchers found no difference between the two groups in mean anxiety, depression and quality of life scores.

“Patients with recalled ICDs did not experience any greater psychological detriment,” Undavia told Cardiology Today. “This may be a reflection of the way physicians and patients communicated with each other, with the physicians doing a good job in reducing anxiety or concerns that patients might have.”

Undavia and colleagues did assess variables of trust in health care entities. They found that although recalls were associated with a slightly reduced rate of trust in the health care industry in general, patients were generally pleased with the way individual physicians handled the recalls.

In a substudy of patients who received Class I — more severe — or Class II — less severe — recalls, Undavia and colleagues found that patients who had Class I recalls had “slightly reduced but statistically significant” quality of life scores.

“This makes intuitive sense because patients with Class I recalls are going to have more clinic visits with potentially more serious complications,” Undavia said. – by Jeremy Moore

For more information:

• Hayes DL. Complication risk with pulse generator change: implications when reacting to a device advisory or recall. Presented at: 27th Annual Scientific Sessions of the Heart Rhythm Society; May 17-20, 2006; Boston.

• Gould P. Replacement of device advisory ICDs is associated with significant complications including death: report from the Canadian Heart Rhythm Society Device Advisory Working Group. Presented at: 27th Annual Scientific Sessions of the Heart Rhythm Society; May 17-20, 2006; Boston.

• Undavia M. Impact of implantable cardioverter defibrillator recall on patients’ anxiety, depression, and quality of life. Presented at: 27th Annual Scientific Sessions of the Heart Rhythm Society; May 17-20, 2006; Boston.