Alessio Gasperetti1, Marco Schiavone2, Matteo Ziacchi3, Julia Vogler4, Alexander Breitenstein5, Mikael Laredo6, Pietro Palmisano7, Danilo Ricciardi8, Gianfranco Mitacchione9, Paolo Compagnucci10, Antonio Bisignani11, Andrea Angeletti3, Michela Casella10, Francesco Picarelli8, Thomas Fink4, Lukas Kaiser12, Samer Hakmi12, Leonardò Calò13, Carlo Pignalberi14, Luca Santini15, Carlo Lavalle16, Ennio Pisanò17, Iacopo Olivotto18, Claudio Tondo19, Antonio Curnis9, Antonio Dello Russo10, Nicolas Badenco6, Jan Steffel5, Charles J Love20, Roland Tilz4, Giovanni Forleo2, Mauro Biffi3. 1. Cardiology, Luigi Sacco University Hospital, Milan, Italy; Cardiology, Johns Hopkins Medicine, Baltimore, Maryland. Electronic address: alessio.gasperetti93@gmail.com. 2. Cardiology, Luigi Sacco University Hospital, Milan, Italy. 3. Cardiology, IRCCS, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola Hospital, University of Bologna, Bologna, Italy. 4. Department of Electrophysiology, Medical Clinic II, Herzzentrum Lubeck, Lubeck, Germany. 5. Cardiology, Zurich University Hospital, Zurich, Switzerland. 6. APHP, Hôpital Pitié Salpêtrière, Paris, France. 7. Cardiology, Ospedale di Tricase, Tricase, Italy. 8. Cardiology, Campus-Bio-Medico, Rome, Italy. 9. Cardiology, Spedali Civili Brescia, Brescia, Italy. 10. Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi," Ancona, Italy. 11. Cardiology, Ferrari Hospital, Castrovillari, Cosenza, Italy. 12. Cardiology, Asklepios Klinik Hamburg, Hamburg, Germany. 13. Cardiology, Policlinico Casilino, Rome, Italy. 14. Cardiology, Ospedale San Filippo Neri, Rome, Italy. 15. Cardiology, Ospedale G.B. Grassi, Ostia, Italy. 16. Cardiology, Policlinico Umberto I, Rome, Italy. 17. Cardiology, Vito Fazzi Hospital, Lecce, Italy. 18. Cardiomyopathy Unit, Careggi University Hospital, Florence, Italy. 19. Heart Rhythm Center, Monzino Cardiology Center, IRCCS, Milan, Italy. 20. Cardiology, Johns Hopkins Medicine, Baltimore, Maryland.
Abstract
BACKGROUND: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. OBJECTIVE: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. METHODS: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. RESULTS: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors. CONCLUSION: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
BACKGROUND: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. OBJECTIVE: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. METHODS: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. RESULTS: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors. CONCLUSION: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
Authors: Fabiola B Sozzi; Elisa Gherbesi; Andrea Faggiano; Eleonora Gnan; Alessio Maruccio; Marco Schiavone; Laura Iacuzio; Stefano Carugo Journal: Front Cardiovasc Med Date: 2022-06-20
Authors: Andreea Maria Ursaru; Antoniu Octavian Petris; Irina Iuliana Costache; Ana Nicolae; Adrian Crisan; Nicolae Dan Tesloianu Journal: J Cardiovasc Dev Dis Date: 2022-04-16
Authors: Anna Polewczyk; Wojciech Jacheć; Maciej Polewczyk; Dorota Szczęśniak-Stańczyk; Andrzej Kutarski Journal: J Clin Med Date: 2022-07-06 Impact factor: 4.964