NEW YORK (Reuters Health) – Patients with an implantable converter-defibrillator (ICD) that uses fracture-prone Fidelis leads have similar survival rates as ICD patients with another type of lead, according to a report in the July 12 issue of the Journal of the American College of Cardiology.

Medtronic withdrew Fidelis leads from the market in 2007 after they were found to fail prematurely. However, it has been unclear whether all-cause mortality is increased in patients with implanted Fidelis leads, note Dr. Paul A. Friedman, with the Mayo Clinic in Rochester, Minnesota, and colleagues.

To investigate, they compared data on 1,030 patients with Fidelis ICD leads and 1,641 with Quattro leads, which are not under any advisory. The patients were followed with a mostly observational approach at three tertiary care centers for a mean duration of approximately 3 years.

“Importantly, a conservative follow-up strategy was adopted, with elective removal from service of nonfailed leads in only 53 (5.1%) of Fidelis and 15 (0.9%) of Quattro patients,” the authors comment.

During follow-up, there were 85 Fidelis failures and 23 Quattro failures, but none of these caused a death, the team reports.

Unadjusted 4-year overall survival was significantly reduced in the Fidelis group (80.7%) compared with the Quattro group (83.9%; p=0.025). However, on multivariate analysis adjusting for factors associated with mortality, the presence of a Fidelis lead was not significantly associated with mortality (hazard ratio 1.06), according to the report.

In discussing patient management, Dr. Friedman and colleagues note, “Current manufacturer recommendations for managing patients with Fidelis leads entail continued clinical follow-up with the addition of the Lead Integrity Alert downloadable algorithm. Our data support this strategy for most patients, in that mortality was not increased utilizing a fairly conservative approach.”

They continue, “This argues against prophylactic removal of a normally functioning Fidelis lead from service in a nonpacemaker-dependent patient.”

Nonetheless, the authors caution, management must be tailored to an individual patient’s risk. “Clinical predictors of lead failure include higher ejection fraction, age <50 years, and, possibly, sports/physical activity.” Therefore, they advise, prophylactic lead replacement may be reasonable in such patients.

Reference:
Impact of Implanted Recalled Sprint Fidelis Lead on Patient Mortality
J Am Coll Cardiol 2011;58:278–283.