TY - JOUR
T1 - The entirely subcutaneous implantable cardioverter-defibrillator
T2 - initial clinical experience in a large Dutch cohort
AU - Olde Nordkamp, Louise R. A.
AU - Dabiri Abkenari, Lara
AU - Boersma, Lucas V. A.
AU - Maass, Alexander H.
AU - de Groot, Joris R.
AU - van Oostrom, Antonie J. H. H. M.
AU - Theuns, Dominic A. M. J.
AU - Jordaens, Luc J. L. M.
AU - Wilde, Arthur A. M.
AU - Knops, Reinoud E.
N1 - Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2012/11/6
Y1 - 2012/11/6
N2 - OBJECTIVES: The purpose of the study was to evaluate the efficacy and safety of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD).BACKGROUND: A new entirely S-ICD has been introduced, that does not require lead placement in or on the heart. The authors report the largest multicenter experience to date with the S-ICD with a minimum of 1-year follow-up in the first 118 Dutch patients who were implanted with this device.METHODS: Patients were selected if they had a class I or IIa indication for primary or secondary prevention of sudden cardiac death. All consecutive patients from 4 high-volume centers in the Netherlands with an S-ICD implanted between December 2008 and April 2011 were included.RESULTS: A total of 118 patients (75% males, mean age 50 years) received the S-ICD. After 18 months of follow-up, 8 patients experienced 45 successful appropriate shocks (98% first shock conversion efficacy). No sudden deaths occurred. Fifteen patients (13%) received inappropriate shocks, mainly due to T-wave oversensing, which was mostly solved by a software upgrade and changing the sensing vector of the S-ICD. Sixteen patients (14%) experienced complications. Adverse events were more frequent in the first 15 implantations per center compared with subsequent implantations (inappropriate shocks 19% vs. 6.7%, p = 0.03; complications 17% vs. 10%, p = 0.10).CONCLUSIONS: This study demonstrates that the S-ICD is effective in terminating ventricular arrhythmias. There is, however, a considerable percentage of ICD related adverse events, which decreases as the therapy evolves and experience increases.
AB - OBJECTIVES: The purpose of the study was to evaluate the efficacy and safety of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD).BACKGROUND: A new entirely S-ICD has been introduced, that does not require lead placement in or on the heart. The authors report the largest multicenter experience to date with the S-ICD with a minimum of 1-year follow-up in the first 118 Dutch patients who were implanted with this device.METHODS: Patients were selected if they had a class I or IIa indication for primary or secondary prevention of sudden cardiac death. All consecutive patients from 4 high-volume centers in the Netherlands with an S-ICD implanted between December 2008 and April 2011 were included.RESULTS: A total of 118 patients (75% males, mean age 50 years) received the S-ICD. After 18 months of follow-up, 8 patients experienced 45 successful appropriate shocks (98% first shock conversion efficacy). No sudden deaths occurred. Fifteen patients (13%) received inappropriate shocks, mainly due to T-wave oversensing, which was mostly solved by a software upgrade and changing the sensing vector of the S-ICD. Sixteen patients (14%) experienced complications. Adverse events were more frequent in the first 15 implantations per center compared with subsequent implantations (inappropriate shocks 19% vs. 6.7%, p = 0.03; complications 17% vs. 10%, p = 0.10).CONCLUSIONS: This study demonstrates that the S-ICD is effective in terminating ventricular arrhythmias. There is, however, a considerable percentage of ICD related adverse events, which decreases as the therapy evolves and experience increases.
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Arrhythmias, Cardiac/epidemiology
KW - Child
KW - Cohort Studies
KW - Death, Sudden, Cardiac/epidemiology
KW - Defibrillators, Implantable
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Netherlands/epidemiology
KW - Retrospective Studies
KW - Subcutaneous Tissue/physiology
KW - Treatment Outcome
KW - Young Adult
U2 - https://doi.org/10.1016/j.jacc.2012.06.053
DO - https://doi.org/10.1016/j.jacc.2012.06.053
M3 - Article
C2 - 23062537
SN - 0735-1097
VL - 60
SP - 1933
EP - 1939
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 19
ER -