title: High recurrence of device-related adverse events following transvenous lead extraction procedure in patients with cardiac resynchronization devices.
abstract: BACKGROUND
  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).
  
  
  RESULTS
  From January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3 ± 11.6 years, 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 609 out of 614 leads (99.2%) by using either manual traction (28%), mechanical (52%) or laser (20%) sheaths. Over a median follow-up of 21 (interquartile range 12-29) months, cumulative incidences of any AE and SAE were 53.9% and 21.1%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 16 patients (6.2%), 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 = 0.001] and SAE (HR 2.38, 95% CI 1.21-4.68, P = 0.012) after TLE.
  
  
  CONCLUSIONS
  Even though TLE is safe and effective to treat CRT patients, a high burden of recurring SAE after TLE was observed at mid-term follow-up. Careful evaluation of both patient characteristics as well as implantation strategy is suggested when indicating TLE in a CRT patient, particularly in patients receiving oral anticoagulation therapy.
authors.affiliation: Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland. francois.regoli@cardiocentro.org.
authors.forename: François
authors.initials: F
authors.lastname: Regoli
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bongiorni
authors.affiliation: Department of Cardiology, IRCCS, Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rordorf
authors.affiliation: Cardiovascular Department, Catholic University of the Sacred Heart, Campobasso, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Santamaria
authors.affiliation: Service of Biometry and Statistics, IRCCS, Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Caterine
authors.initials: C
authors.lastname: Klersy
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Segreti
authors.affiliation: Department of Cardiology, IRCCS, Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: De Regibus
authors.affiliation: Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Moccetti
authors.affiliation: Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland.
authors.forename: Giulio
authors.initials: G
authors.lastname: Conte
authors.affiliation: Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland.
authors.forename: Maria Luce
authors.initials: ML
authors.lastname: Caputo
authors.affiliation: Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland.
authors.forename: Angelo
authors.initials: A
authors.lastname: Auricchio
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects* / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000009:adverse effects* / Q000401:mortality; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence
keywords: Cardiac resynchronization therapy; Device-related adverse events; Lead management; Transvenous lead extraction