The Learning Curve Associated with the Introduction of the Subcutaneous Implantable Defibrillator

Overview

Journal Europace

Publisher Oxford University Press

Specialties Cardiology & Vascular Diseases
Physiology

Date 2015 Sep 2

PMID 26324840

Citations 35

Authors

Reinoud E Knops

Tom F Brouwer

Craig S Barr

Dominic A Theuns

Lucas Boersma

Raul Weiss

Petr Neuzil

Marcoen Scholten

Pier D Lambiase

Angel R Leon

Margaret Hood

Paul W Jones

Nicholas Wold

Andrew A Grace

Louise R A Olde Nordkamp

Martin C Burke

Affiliations

Soon will be listed here.

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.

Citing Articles

Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial.

Mascheroni J, Stockburger M, Patwala A, Mont L, Rao A, Retzlaff H JAMA Netw Open. 2023; 6(8):e2322750.

PMID: 37651144 PMC: 10472192. DOI: 10.1001/jamanetworkopen.2023.22750.

Subcutaneous Implantable Cardioverter Defibrillator: A Contemporary Overview.

Guarracini F, Preda A, Bonvicini E, Coser A, Martin M, Quintarelli S Life (Basel). 2023; 13(8).

PMID: 37629509 PMC: 10455445. DOI: 10.3390/life13081652.

Real-world evidence for the use of subcutaneous implantable cardioverter-defibrillators in China: A single-center experience.

Zhang L, Li X, Liang Y, Wang J, Li M, Pan L Herz. 2023; 48(6):462-469.

PMID: 37540305 DOI: 10.1007/s00059-023-05192-4.

Successful defibrillation testing in patients undergoing elective subcutaneous implantable cardioverter-defibrillator generator replacement.

de Veld J, Pepplinkhuizen S, van der Stuijt W, Quast A, Olde Nordkamp L, Kooiman K Europace. 2023; 25(7).

PMID: 37379530 PMC: 10325005. DOI: 10.1093/europace/euad184.

Procedure, management, and outcome of subcutaneous implantable cardioverter-defibrillator extraction in clinical practice.

De Filippo P, Migliore F, Palmisano P, Nigro G, Ziacchi M, Rordorf R Europace. 2023; 25(6).

PMID: 37350404 PMC: 10288180. DOI: 10.1093/europace/euad158.

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