François Regoli1, Maria Grazia Bongiorni2, Roberto Rordorf3, Matteo Santamaria4, Caterine Klersy5, Luca Segreti2, Valentina De Regibus3, Tiziano Moccetti6, Giulio Conte6, Maria Luce Caputo6, Angelo Auricchio6. 1. Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland. francois.regoli@cardiocentro.org. 2. Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy. 3. Department of Cardiology, IRCCS, Fondazione Policlinico San Matteo, Pavia, Italy. 4. Cardiovascular Department, Catholic University of the Sacred Heart, Campobasso, Italy. 5. Service of Biometry and Statistics, IRCCS, Fondazione Policlinico San Matteo, Pavia, Italy. 6. Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland.
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 ± 11.6 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.
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 ± 11.6 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: Vishal S Mehta; Hugh O'Brien; Mark K Elliott; Baldeep S Sidhu; Justin Gould; Anoop K Shetty; Steven Niederer; Christopher A Rinaldi Journal: Heart Rhythm O2 Date: 2021-10-30