Extraction of defibrillator leads recalled for cable externalization and failure

Abstract

Background: The Riata implantable cardioverter-defibrillator lead was recalled by the Food and Drug Administration because of an increased rate of failure associated with cable externalization. Because of its mechanical separation, the Riata lead may be challenging to extract. We therefore examined the experience with Riata lead extractions at our institution.

Methods: All patients implanted with the Riata lead underwent detailed review of their electronic medical records and operative notes. Procedural complications were ascertained by reviewing the medical records up to 30 days after Riata extraction.

Results: From a total of 627 patients implanted with the Riata lead at our institution, 20 patients (age at time of extraction, 57 ± 11 years; 85 % men; lead dwell time, 48 ± 27 months) underwent lead extraction. Extraction was successful in 19 of 20 (95 %) patients and required the use of laser-powered sheaths in 18 (90 %) patients. Over a 30-day follow-up period, 1 of 20 (5 %) patients had a minor procedure-related complication consisting of a new pericardial effusion that did not require drainage.

Conclusions: Extraction of the Riata lead seems to be successful and safe and frequently requires the use of powered sheaths.