Keywords
prospective clinical trial
lead extraction
outcomes
training
How to Cite
Abstract
Introduction: RENEDI (“Registro Nacional de Extracción de Dispositivos”) is the first intersocietary, prospective, multicenter and observational cohort study for patients undergoing transvenous lead extraction (TLE) performed in Argentina. Objectives: To provide real-world data of current practice in our country, characterize the population of patients and personnel involved and analyze, with an interdisciplinary and interinstitutional focus, the results obtained. Methods: An online database platform active from January 2018 to December 2019 was designed. Data provided by specialists was compiled, verified and reviewed by a Committee. Results: A total of 621 leads (325 patients - average age: 59 years; 71%: male) were extracted. The targeted leads included 379 (61%) pacemakers, 174 (28%) implantable cardioverterdefibrillator and 68 (11%) cardiac resynchronization therapy Devices. Two hundred and thirty-three (38%) were atrial leads, 367 (59%) ventricular leads, and 21 (3%) were in the coronary sinus. The average lead dwell time was 105.9 months. The commonest indication for removal was infection (68%). Vascular or cardiovascular surgeons were usually the primary operators (81%). The majority of interventions were performed in standard operating theatre (79%). The presence of stand by was reported in 65% of cases. Percutaneous approach (98%) was predominant. Hybrid approaches were performed in 7 patients (16 leads). A total of 158 (25%) leads were extracted using simple traction (median dwell time: 33.3 months). Additional and specified tools were used in 74% of cases. Overall complications rate were 4% (major: 0.3%; minor: 3.7%). Complete procedural success was 96.3%. Incomplete extraction was obtained in 23 leads. No deaths were reported. Conclusions: TLE is a safe and effective procedure associated with a low incidence of complications and high success rate when it is performed in well-trained hands. In our county, few specialists are dedicated to this practice. An extensive training and sufficient prior experience in performing these techniques are essential to minimize the risk of complications and obtain successful outcomes.
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