Lucas Boersma1, Martin C Burke2, Petr Neuzil3, Pier Lambiase4, Ted Friehling5, Dominic A Theuns6, Fermin Garcia7, Nathan Carter8, Timothy Stivland8, Raul Weiss9. 1. St Antonius Ziekenhuis, Nieuwegein, The Netherlands. Electronic address: l.boersma@antoniusziekenhuis.nl. 2. Heart Rhythm Center, University of Chicago, Chicago, Illinois. 3. Homolka Hospital, Prague, Czech Republic. 4. The Heart Hospital, Institute of Cardiovascular Science, University College London, London, United Kingdom. 5. Inova Fairfax Hospital, Falls Church, Virginia. 6. Erasmus Medical Center, Rotterdam, The Netherlands. 7. Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania. 8. Boston Scientific Corporation, St. Paul, Minnesota. 9. Ohio State University, Columbus, Ohio.
Abstract
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoingTV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. OBJECTIVE: This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. METHODS: Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). RESULTS: Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. CONCLUSION: The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.
RCT Entities:
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. OBJECTIVE: This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. METHODS:Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). RESULTS: Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. CONCLUSION: The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.
Authors: Emily P Zeitler; Daniel J Friedman; Zak Loring; Kristen B Campbell; Sarah A Goldstein; Zachary K Wegermann; Jane Schutz; Nicole Smith; Eric Black-Maier; Sana M Al-Khatib; Jonathan P Piccini Journal: Heart Rhythm Date: 2019-09-24 Impact factor: 6.343
Authors: Kevin Willy; Markus Bettin; Florian Reinke; Nils Bögeholz; Christian Ellermann; Benjamin Rath; Patrick Leitz; Julia Köbe; Lars Eckardt; Gerrit Frommeyer Journal: Clin Res Cardiol Date: 2019-03-21 Impact factor: 5.460
Authors: Milena Leo; Alexander J Sharp; Andre Briosa E Gala; Michael T B Pope; Timothy R Betts Journal: J Interv Card Electrophysiol Date: 2022-07-14 Impact factor: 1.759
Authors: Maciej Dębski; Andrzej Ząbek; Krzysztof Boczar; Małgorzata Urbańczyk-Zawadzka; Jacek Lelakowski; Barbara Małecka Journal: J Arrhythm Date: 2017-12-21