High recurrence of device-related adverse events following transvenous lead extraction procedure in patients with cardiac resynchronization devices

François Regoli, Maria Grazia Bongiorni, Roberto Rordorf, Matteo Santamaria, Caterine Klersy, Luca Segreti, Valentina De Regibus, Tiziano Moccetti, Giulio Conte, Maria Luce Caputo, Angelo Auricchio

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Little is known about the clinical outcome and recurring system-related adverse events (SAE) in cardiac resynchronization therapy (CRT) patients after transvenous lead extraction (TLE). Methods and results: From January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3±11.6years, 216 male, 88% in New York Heart Association class II-IV, ejection fraction 35.1±10.8%) were treated at four European institutions with TLE. Indications for TLE included systemic (18%) or local (45%) infection, system malfunction (34%), or other (3%). Demographic, clinical, TLE procedural, and follow-up data were collected retrospectively. Adverse events (AE) were considered as death from any cause, cardiovascular hospitalization, and SAE (SAE included pocket and/or systemic infection, lead malfunction, or pocket haematoma requiring revision). Complete removal was achieved for 607 out of 614 leads (98.9%) by using either manual traction (29%), mechanical (43%) or laser (28%) sheaths. Over a median follow-up of 21 (interquartile range 12-29) months, cumulative incidences of any AE and SAE were 39.8% and 21.5%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 17 patients (6.6%), and pocket haematoma requiring revision in 15 patients (5.9%). Oral anticoagulation therapy was an independent predictor of both any AE [hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.35-3.22, P

Original languageEnglish
JournalEuropean Journal of Heart Failure
DOIs
Publication statusAccepted/In press - 2016

Keywords

  • Cardiac resynchronization therapy
  • Device-related adverse events
  • Lead management
  • Transvenous lead extraction

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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