Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction.
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.


CONCLUSIONS
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.
St Antonius Ziekenhuis, Nieuwegein, The Netherlands. Electronic address: l.boersma@antoniusziekenhuis.nl.
Lucas
L
Boersma
Heart Rhythm Center, University of Chicago, Chicago, Illinois.
Martin C
MC
Burke
Homolka Hospital, Prague, Czech Republic.
Petr
P
Neuzil
The Heart Hospital, Institute of Cardiovascular Science, University College London, London, United Kingdom.
Pier
P
Lambiase
Inova Fairfax Hospital, Falls Church, Virginia.
Ted
T
Friehling
Erasmus Medical Center, Rotterdam, The Netherlands.
Dominic A
DA
Theuns
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Fermin
F
Garcia
Boston Scientific Corporation, St. Paul, Minnesota.
Nathan
N
Carter
Boston Scientific Corporation, St. Paul, Minnesota.
Timothy
T
Stivland
Ohio State University, Columbus, Ohio.
Raul
R
Weiss
D000328:Adult; D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000706:statistics & numerical data; D004554:Electric Countershock / Q000295:instrumentation* / Q000379:methods; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D012086:Reoperation / Q000706:statistics & numerical data; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D016019:Survival Analysis; D017180:Tachycardia, Ventricular / Q000628:therapy*; D016896:Treatment Outcome
Death; Infection; Safety; Subcutaneous ICD; sudden