Maria Grazia Bongiorni1, Charles Kennergren2, Christian Butter3, Jean Claude Deharo4, Andrzej Kutarski5, Christopher A Rinaldi6, Simone L Romano1, Aldo P Maggioni7,8, Maryna Andarala7, Angelo Auricchio9, Karl-Heinz Kuck10, Carina Blomström-Lundqvist11. 1. Cardiology Department, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy. 2. Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, 413 45 Goteborg, Sweden. 3. Heart Center Brandenburg in Bernau , Department of Cardiology and Medical School Brandenburg, Ladeburger Str. 17m, 16321 Bernau b. Berlin, Germany. 4. Arrhythmias Unit, Department of Cardiology, La Timone University Hospital, CHU La Timone, 265 Rue Saint Pierre, 13005 Marseille, France. 5. Department of Cardiology, Medical University of Lublin, ul. Jaczewskiego 8, 20954 Lublin, Poland. 6. Cardiology Department, 6th Floor East Wing, Guy's & St Thomas' Hospitals, Westminster Bridge Rd, London, SE1 7EH, UK. 7. European Society of Cardiology, The European Heart House, Les Templiers, 2035 route des colles, CS 80179 Biot, 06903 Sophia Antipolis Cedex, France. 8. ANMCO Research Center, Via La Marmora 34, 50121 Firenze, Italy. 9. Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland. 10. Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany. 11. Department of Cardiology, Institution of Medical Science, Uppsala University, S-75185 Uppsala, Sweden.
Abstract
AIMS: The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association (EHRA) in order to identify the safety and efficacy of the current practice of TLE. METHODS AND RESULTS: European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV ≥ 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% [95% CI 1.3-2.1%] (58/3510 pts) including a mortality of 0.5% [95% CI 0.3-0.8%] (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% [95% CI 1.0-1.8%]). Complete clinical and radiological success rates were 96.7% [95% CI 96.1-97.3%] and 95.7% [95% CI 95.2-96.2%], respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% [95% CI 1.9-3.0%] vs. 4.1% [95% CI 2.7-6.0%], P = 0.0146; and 1.2% [95% CI 0.8-1.6%] vs. 2.5% [95% CI 1.5-4.1%] P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres. CONCLUSION: The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association (EHRA) in order to identify the safety and efficacy of the current practice of TLE. METHODS AND RESULTS: European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV ≥ 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% [95% CI 1.3-2.1%] (58/3510 pts) including a mortality of 0.5% [95% CI 0.3-0.8%] (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% [95% CI 1.0-1.8%]). Complete clinical and radiological success rates were 96.7% [95% CI 96.1-97.3%] and 95.7% [95% CI 95.2-96.2%], respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% [95% CI 1.9-3.0%] vs. 4.1% [95% CI 2.7-6.0%], P = 0.0146; and 1.2% [95% CI 0.8-1.6%] vs. 2.5% [95% CI 1.5-4.1%] P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres. CONCLUSION: The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres. Published on behalf of the European Society of Cardiology. All rights reserved.