Elsevier

Heart Rhythm

Volume 13, Issue 1, January 2016, Pages 157-164
Heart Rhythm

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

https://doi.org/10.1016/j.hrthm.2015.08.039Get rights and content
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open access

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.

Abbreviations

ICD
implantable cardioverter-defibrillator
NCDR
National Cardiovascular Data Registry
S-ICD
subcutaneous implantable cardioverter defibrillator
TV-ICD
transvenous implantable cardioverter defibrillator

Keywords

Death
sudden
Subcutaneous ICD
Infection
Safety

Cited by (0)

The S-ICD System IDE Clinical Investigation (S-ICD IDE study) and the EFFORTLESS S-ICD (Evaluation of Factors Impacting Clinical Outcome and Cost-Effectiveness of the S-ICD) Registry are sponsored in their entirety by Cameron Health, Inc, a subsidiary of Boston Scientific Corporation. Dr. Boersma has received consulting fees from Medtronic and Boston Scientific and speaking fees from Medtronic, Boston Scientific, and Biotronik. Dr. Burke has reported receiving consulting fees, research grants, and honoraria from Boston Scientific and research grants from Medtronic and St. Jude Medical, as well as consulting fees from and equity in AtaCor Medical. Dr. Lambiase has reported receiving speaker fees and research grants from Boston Scientific, Medtronic, St. Jude Medical, and the University College London Hospitals Biomedicine Research Centre, National Institute for Health Research. Dr. Theuns has reported receiving research grants from Biotronik and Boston Scientific and consulting fees from Boston Scientific. Nathan Carter and Tim Stivland are employees of Boston Scientific. Dr. Weiss has reported receiving consulting fees, speaking fees, and research grants from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude Medical.