Cardioverter defibrillator implantation without induction of ventricular fibrillation

A single-blind, non-inferiority, randomised controlled trial (SIMPLE)

Jeff S. Healey, Stefan H. Hohnloser, Michael Glikson, Jorg Neuzner, Phillipe Mabo, Xavier Vinolas, Josef Kautzner, Gilles O'Hara, Lieselot Vanerven, Fredrik Gadler, Janice Pogue, Ursula Appl, Jim Gilkerson, Thierry Pochet, Kenneth M. Stein, B. Merkely, Susan Chrolavicius, Brandi Meeks, Csaba Foldesi, Bernard Thibault & 1 others Stuart J. Connolly

Research output: Contribution to journalArticle

107 Citations (Scopus)

Abstract

Background Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. Methods In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Findings Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65-1·14; pnon-inferiority

Original languageEnglish
Pages (from-to)785-791
Number of pages7
JournalThe Lancet
Volume385
Issue number9970
DOIs
Publication statusPublished - Feb 28 2015

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Defibrillators
Implantable Defibrillators
Ventricular Fibrillation
Shock
Single-Blind Method
Safety
Intention to Treat Analysis
Non-Randomized Controlled Trials
Ventricular Tachycardia
Random Allocation
Proportional Hazards Models
Thorax
Transplantation
Pregnancy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Cardioverter defibrillator implantation without induction of ventricular fibrillation : A single-blind, non-inferiority, randomised controlled trial (SIMPLE). / Healey, Jeff S.; Hohnloser, Stefan H.; Glikson, Michael; Neuzner, Jorg; Mabo, Phillipe; Vinolas, Xavier; Kautzner, Josef; O'Hara, Gilles; Vanerven, Lieselot; Gadler, Fredrik; Pogue, Janice; Appl, Ursula; Gilkerson, Jim; Pochet, Thierry; Stein, Kenneth M.; Merkely, B.; Chrolavicius, Susan; Meeks, Brandi; Foldesi, Csaba; Thibault, Bernard; Connolly, Stuart J.

In: The Lancet, Vol. 385, No. 9970, 28.02.2015, p. 785-791.

Research output: Contribution to journalArticle

Healey, JS, Hohnloser, SH, Glikson, M, Neuzner, J, Mabo, P, Vinolas, X, Kautzner, J, O'Hara, G, Vanerven, L, Gadler, F, Pogue, J, Appl, U, Gilkerson, J, Pochet, T, Stein, KM, Merkely, B, Chrolavicius, S, Meeks, B, Foldesi, C, Thibault, B & Connolly, SJ 2015, 'Cardioverter defibrillator implantation without induction of ventricular fibrillation: A single-blind, non-inferiority, randomised controlled trial (SIMPLE)', The Lancet, vol. 385, no. 9970, pp. 785-791. https://doi.org/10.1016/S0140-6736(14)61903-6
Healey, Jeff S. ; Hohnloser, Stefan H. ; Glikson, Michael ; Neuzner, Jorg ; Mabo, Phillipe ; Vinolas, Xavier ; Kautzner, Josef ; O'Hara, Gilles ; Vanerven, Lieselot ; Gadler, Fredrik ; Pogue, Janice ; Appl, Ursula ; Gilkerson, Jim ; Pochet, Thierry ; Stein, Kenneth M. ; Merkely, B. ; Chrolavicius, Susan ; Meeks, Brandi ; Foldesi, Csaba ; Thibault, Bernard ; Connolly, Stuart J. / Cardioverter defibrillator implantation without induction of ventricular fibrillation : A single-blind, non-inferiority, randomised controlled trial (SIMPLE). In: The Lancet. 2015 ; Vol. 385, No. 9970. pp. 785-791.
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T1 - Cardioverter defibrillator implantation without induction of ventricular fibrillation

T2 - A single-blind, non-inferiority, randomised controlled trial (SIMPLE)

AU - Healey, Jeff S.

AU - Hohnloser, Stefan H.

AU - Glikson, Michael

AU - Neuzner, Jorg

AU - Mabo, Phillipe

AU - Vinolas, Xavier

AU - Kautzner, Josef

AU - O'Hara, Gilles

AU - Vanerven, Lieselot

AU - Gadler, Fredrik

AU - Pogue, Janice

AU - Appl, Ursula

AU - Gilkerson, Jim

AU - Pochet, Thierry

AU - Stein, Kenneth M.

AU - Merkely, B.

AU - Chrolavicius, Susan

AU - Meeks, Brandi

AU - Foldesi, Csaba

AU - Thibault, Bernard

AU - Connolly, Stuart J.

PY - 2015/2/28

Y1 - 2015/2/28

N2 - Background Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. Methods In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Findings Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65-1·14; pnon-inferiority

AB - Background Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. Methods In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Findings Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65-1·14; pnon-inferiority

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