Abstract
Introduction: Fidelis implantable cardioverter-defibrillator leads are prone to fractures that lead to adverse events. Approximately 268,000 patients have Fidelis leads worldwide and about 4900 in Japan. The lead failure rate in some reports was higher than in the Medtronic performance report. Thus, we investigated the longevity of Fidelis leads and compared it with that of Quattro leads. Methods and Results: From November 2005 to May 2011, 115 Fidelis and 95 Quattro leads were implanted and followed up at our hospital. Six lead fractures occurred in the Fidelis group at 5.4 years and no lead fracture in the Quattro group at 3.4 years. No deaths or injuries occurred as a result of lead failure, but all 6 fractures caused inappropriate shocks. The survival rate in the Fidelis group at 5.4 years was 92.0%, whereas that in the Fidelis group at 3.4 years was 96.5% and in the Quattro group at 3.4 years was 100%. Conclusions: The survival rate of Fidelis leads was similar to that of the Medtronic update. The difference in the survival rate at 3.4 years was not significant between Fidelis and Quattro leads. Given the small sample size and short observation period, it is impossible to conclude that Fidelis leads are inferior to Quattro leads at 3.4 years.
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