Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Nov 1;1(8):900-911.
doi: 10.1001/jamacardio.2016.2782.

Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States

Daniel J Friedman  1 , Craig S Parzynski  2 , Paul D Varosy  3 , Jordan M Prutkin  4 , Kristen K Patton  4 , Ali Mithani  5 , Andrea M Russo  5 , Jeptha P Curtis  2 , Sana M Al-Khatib  1
Affiliations

Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States

Daniel J Friedman et al. JAMA Cardiol. .

Abstract

Importance: Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described.

Objectives: To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation.

Design, setting, and participants: A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)-ICD and dual-chamber (DC)-ICD.

Main outcomes and measures: Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients.

Results: Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2% during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and ≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD) length of stay after S-ICD implantation was comparable to that after SC-ICD implantation (1.1 [1.5] vs 1.0 [1.2] days; P = .77) and less than after DC-ICD implantation (1.1 [1.5] vs 1.2 [1.5] days; P < .001).

Conclusions and relevance: The use of S-ICDs is rapidly increasing in the United States. Early adoption has been associated with low complication rates and high rates of successful DFT testing despite frequent use in patients with a high number of comorbidities.

PubMed Disclaimer

Conflict of interest statement

Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Friedman has received educational grants from Boston Scientific and St Jude and research grants from the American College of Cardiology’s National Cardiovascular Data Registry (NCDR) and is funded by T 32 training grant HL069749-13 from the National Institutes of Health. Dr Patton served as a site principal investigator for the S-ICD Investigational Device Exemption study, which was funded by Cameron Health, which has since been purchased by Boston Scientific. Dr Russo received research support from Boston Scientific and Medtronic and honoraria or consulting fees from Biotronik, Boston Scientific, Medtronic, and St Jude. Dr Curtis owns stock in Medtronic, receives research funding from Boston Scientific, and receives salary support from the American College of Cardiology to provide data analytic services. No other disclosures were reported.

Figures

Figure
Figure. Absolute Number of Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) Implanted per Quarter (Q) and Percentage of all ICD Admissions in Which an S-ICDW as Implanted
A supply chain disruption occurred during early 2013, corresponding to the observed drop in S-ICD implantation during 2013, Q2.
See this image and copyright information in PMC

Comment in

References

    1. Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337(22):1576–1583. - PubMed
    1. Connolly SJ, Gent M, Roberts RS, et al. Canadian Implantable Defibrillator Study (CIDS): a randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation. 2000;101(11):1297–1302. - PubMed
    1. Connolly SJ, Hallstrom AP, Cappato R, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials: AVID, CASH and CIDS studies: Antiarrhythmics vs Implantable Defibrillator study, Cardiac Arrest Study Hamburg, Canadian Implantable Defibrillator Study. Eur Heart J. 2000;21(24):2071–2078. - PubMed
    1. Kuck KH, Cappato R, Siebels J, Rüppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH) Circulation. 2000;102(7):748–754. - PubMed
    1. Bardy GH, Lee KL, Mark DB, et al. Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225–237. - PubMed

Publication types