Elsevier

Heart Rhythm

Volume 14, Issue 10, October 2017, Pages 1456-1463
Heart Rhythm

Focus Issue: Sudden Death
Devices
Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results

https://doi.org/10.1016/j.hrthm.2017.05.016Get rights and content
Under a Creative Commons license
open access

Background

The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to reduce short- and long-term complications associated with transvenous ICD leads. Early multicenter studies included younger patients with less left ventricular systolic dysfunction and fewer comorbidities than cohorts with traditional ICD.

Objective

The purpose of this study was to characterize patient selection and the acute performance of the S-ICD in a contemporary real-world setting.

Methods

The S-ICD Post-Approval Study is a prospective registry involving 86 US centers. Patients were enrolled if they met criteria for S-ICD implantation, passed an electrocardiogram screening test, and had a life expectancy of >1 year. Analyses of descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed.

Results

The study includes 1637 patients who underwent S-ICD implantation. The cohort included 68.6% (1123/1637) male patients, and 13.4% (220/1636) were receiving dialysis for end-stage renal disease. The mean age was 52 ± 15 years, with a mean left ventricular ejection fraction of 32.0% ± 14.6%. Electrocardiogram screening was successful for at least 1, 2, or 3 vectors in 100%, 93.8%, and 51.4% of patients, respectively. Medical imaging (65.1%, 1065/1636) and general anesthesia (64.1%, 1048/16) were used in a majority of patients, and 52.2% (855/1637) were implanted with the 2-incision technique. Induced ventricular tachycardia/ventricular tachycardia was successfully converted in 98.7% (1394/1412) of patients. The 30-day complication-free rate was 96.2%. Predictors of complications included diabetes, younger age, and higher body mass index.

Conclusion

Contemporary US patients with S-ICD have more comorbidities than do previous cohorts with S-ICD, but they are younger with more end-stage renal disease than do patients with transvenous ICD. Implantation success is high, and short-term complication rates are acceptable.

Keywords

Implantable cardioverter-defibrillator
Subcutaneous ICD
Arrhythmia
Ventricular arrhythmia
Registry
Sudden cardiac death
Heart failure

Cited by (0)

This Post-Approval Study was supported by Boston Scientific.

Dr Aasbo is a consultant to and receives honoraria from Boston Scientific and Biotronik. Dr El-Chami receives honoraria for consulting for Medtronic and Boston Scientific. Dr Knight and Dr Weiss receive honoraria for speaking and serving as a consultant for Boston Scientific, and respectively, Northwestern Memorial Hospital and Ohio State University receive fellowship support from Boston Scientific. Dr Kutalek reports honoraria for speaking and serving as a consultant for and research grants from Boston Scientific. Dr Herre reports honoraria and research grants from Medtronic, Abbott, and Boston Scientific. Mr Bass is an employee of NAMSA. Mr Husby and Mr Stivland are employees of Boston Scientific. Dr Burke is a consultant to and receives honoraria from Boston Scientific; receives research grants from Boston Scientific, Medtronic, and St. Jude Medical; and has equity in AtaCor Medical.