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

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