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Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation†
OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surge...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134441/ https://www.ncbi.nlm.nih.gov/pubmed/29672731 http://dx.doi.org/10.1093/ejcts/ezy165 |
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author | Nashef, Samer A M Fynn, Simon Abu-Omar, Yasir Spyt, Tomasz J Mills, Christine Everett, Colin C Fox-Rushby, Julia Singh, Jeshika Dalrymple-Hay, Malcolm Sudarshan, Catherine Codispoti, Massimiliano Braidley, Peter Wells, Francis C Sharples, Linda D |
author_facet | Nashef, Samer A M Fynn, Simon Abu-Omar, Yasir Spyt, Tomasz J Mills, Christine Everett, Colin C Fox-Rushby, Julia Singh, Jeshika Dalrymple-Hay, Malcolm Sudarshan, Catherine Codispoti, Massimiliano Braidley, Peter Wells, Francis C Sharples, Linda D |
author_sort | Nashef, Samer A M |
collection | PubMed |
description | OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and cost-effectiveness. METHODS: In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety. RESULTS: More ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20–3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76–5.96). Quality-adjusted life years were similar at 2 years (ablation − control −0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64–1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321–£5746). Cost-effectiveness was not demonstrated at 2 years. CONCLUSIONS: Adjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term. STUDY REGISTRATION: ISRCTN82731440 (project number 07/01/34). |
format | Online Article Text |
id | pubmed-6134441 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-61344412018-09-14 Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† Nashef, Samer A M Fynn, Simon Abu-Omar, Yasir Spyt, Tomasz J Mills, Christine Everett, Colin C Fox-Rushby, Julia Singh, Jeshika Dalrymple-Hay, Malcolm Sudarshan, Catherine Codispoti, Massimiliano Braidley, Peter Wells, Francis C Sharples, Linda D Eur J Cardiothorac Surg General Adult Cardiac OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and cost-effectiveness. METHODS: In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety. RESULTS: More ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20–3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76–5.96). Quality-adjusted life years were similar at 2 years (ablation − control −0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64–1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321–£5746). Cost-effectiveness was not demonstrated at 2 years. CONCLUSIONS: Adjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term. STUDY REGISTRATION: ISRCTN82731440 (project number 07/01/34). Oxford University Press 2018-10 2018-04-17 /pmc/articles/PMC6134441/ /pubmed/29672731 http://dx.doi.org/10.1093/ejcts/ezy165 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | General Adult Cardiac Nashef, Samer A M Fynn, Simon Abu-Omar, Yasir Spyt, Tomasz J Mills, Christine Everett, Colin C Fox-Rushby, Julia Singh, Jeshika Dalrymple-Hay, Malcolm Sudarshan, Catherine Codispoti, Massimiliano Braidley, Peter Wells, Francis C Sharples, Linda D Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
title | Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
title_full | Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
title_fullStr | Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
title_full_unstemmed | Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
title_short | Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
title_sort | amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation† |
topic | General Adult Cardiac |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134441/ https://www.ncbi.nlm.nih.gov/pubmed/29672731 http://dx.doi.org/10.1093/ejcts/ezy165 |
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