The learning curve associated with the introduction of the subcutaneous implantable defibrillator

• Type of Material: Article
• Authors: Reinoud Knops, Academic Medical Center; Tom F. Brouwer, Academic Medical Center; Craig S. Barr, Russells Hall Hospital; Dominic A. Theuns, Erasmus Medical Center; Lucas Boersma, St Antonius Hospital; Raul Weiss, Ohio State University; Petr Neuzil, Na Homolce Hospital; Marcoen Scholten, Medisch Spectrum Twente; Pier D. Lambiase, University College London; Angel Rodrigo Leon, Emory University; Margaret Hood, Auckland City Hospital; Paul W. Jones, Boston Scientific; Nicholas Wold, Boston Scientific; Andrew A Grace, Papworth Hospital NHS Foundation Trust; Louise R. A. Olde Nordkamp Nordkamp, Academic Medical Center; Martin C. Burke, University of Chicago
• Language: English
• Date: 2016-07-01
• Publisher: Oxford University Press (OUP): Policy B - Oxford Open Option B
• Publication Version: Final Published Version
• Copyright Statement: © The Author 2015.
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1093/europace/euv299
• Title of Journal or Parent Work: EP-Europace
• ISSN: 1099-5129
• Volume: 18
• Issue: 7
• Start Page: 1010
• End Page: 1015
• Keywords: Subcutaneous implantable cardioverter-defibrillator; REGISTRY; Life Sciences & Biomedicine; CARDIOVERTER-DEFIBRILLATOR; Cardiovascular System & Cardiology; Learning curve; OUTCOMES; Complications; S-ICD; EFFICACY; Cardiac & Cardiovascular Systems; Implantable cardioverter-defibrillator; SAFETY; THERAPY; Inappropriate shock; Science & Technology
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Aims: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). Methods and results: In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 ( > 13 implants). Conclusion: There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.