{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T04:44:16Z","timestamp":1789879456618,"version":"4.0.1"},"reference-count":91,"publisher":"National Institute for Health and Care Research","issue":"19","license":[{"start":{"date-parts":[[2018,4,1]],"date-time":"2018-04-01T00:00:00Z","timestamp":1522540800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["07\/01\/34"],"award-info":[{"award-number":["07\/01\/34"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>Atrial fibrillation (AF) can be treated using a maze procedure during planned cardiac surgery, but the effect on clinical patient outcomes, and the cost-effectiveness compared with surgery alone, are uncertain.<\/jats:p><\/jats:sec>Objectives<\/jats:title>To determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF.<\/jats:p><\/jats:sec>Design<\/jats:title>Multicentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial. Patients were randomised on a 1\u2009:\u20091 basis using random permuted blocks, stratified for surgeon and planned procedure.<\/jats:p><\/jats:sec>Setting<\/jats:title>Eleven acute NHS specialist cardiac surgical centres.<\/jats:p><\/jats:sec>Participants<\/jats:title>Patients aged \u2265\u200918 years, scheduled for elective or in-house urgent cardiac surgery, with a documented history (>\u20093 months) of AF.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Routine cardiac surgery with or without an adjunct maze procedure administered by an AF ablation device.<\/jats:p><\/jats:sec>Main outcome measures<\/jats:title>The primary outcomes were return to sinus rhythm (SR) at 12 months and quality-adjusted life-years (QALYs) over 2 years after randomisation. Secondary outcomes included return to SR at 2 years, overall and stroke-free survival, drug use, quality of life (QoL), cost-effectiveness and safety.<\/jats:p><\/jats:sec>Results<\/jats:title>Between 25 February 2009 and 6 March 2014, 352 patients were randomised to the control (n<\/jats:italic>\u2009=\u2009176) or experimental (n<\/jats:italic>\u2009=\u2009176) arms. The odds ratio (OR) for return to SR at 12 months was 2.06 [95% confidence interval (CI) 1.20 to 3.54;p<\/jats:italic>\u2009=\u20090.0091]. The mean difference (95% CI) in QALYs at 2 years between the two trial arms (maze\/control) was \u20130.025 (95% CI 0.129 to 0.078;p<\/jats:italic>\u2009=\u20090.6319). The OR for SR at 2 years was 3.24 (95% CI 1.76 to 5.96). The number of patients requiring anticoagulant drug use was significantly lower in the maze arm from 6 months after the procedure. There were no significant differences between the two arms in operative or overall survival, stroke-free survival, need for cardioversion or permanent pacemaker implants, New York Heart Association Functional Classification (for heart failure), EuroQol-5 Dimensions, three-level version score and Short Form questionnaire-36 items score at any time point. Sixty per cent of patients in each trial arm had a serious adverse event (p<\/jats:italic>\u2009=\u20091.000); most events were mild, but 71 patients (42.5%) in the maze arm and 84 patients (45.5%) in the control arm had moderately severe events; 31 patients (18.6%) in the maze arm and 38 patients (20.5%) in the control arm had severe events. The mean additional cost of the maze procedure was \u00a33533 (95% CI \u00a31321 to \u00a35746); the mean difference in QALYs was \u20130.022 (95% CI \u20130.1231 to 0.0791). The maze procedure was not cost-effective at \u00a330,000 per QALY over 2 years in any analysis. In a small substudy, the active left atrial ejection fraction was smaller than that of the control patients (mean difference of \u20138.03, 95% CI \u201312.43 to \u20133.62), but within the predefined clinically equivalent range.<\/jats:p><\/jats:sec>Limitations<\/jats:title>Low recruitment, early release of trial summaries and intermittent resource-use collection may have introduced bias and imprecise estimates.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Ablation can be practised safely in routine NHS cardiac surgical settings and increases return to SR rates, but not survival or QoL up to 2 years after surgery. Lower anticoagulant drug use and recovery of left atrial function support anticoagulant drug withdrawal provided that good atrial function is confirmed.<\/jats:p><\/jats:sec>Further work<\/jats:title>Continued follow-up and long-term clinical effectiveness and cost-effectiveness analysis. Comparison of ablation methods.<\/jats:p><\/jats:sec>Trial registration<\/jats:title>Current Controlled Trials ISRCTN82731440.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 22, No. 19. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta22190","type":"journal-article","created":{"date-parts":[[2018,4,27]],"date-time":"2018-04-27T09:39:37Z","timestamp":1524821977000},"page":"1-132","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["Amaze: a double-blind, multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of adding an ablation device-based maze procedure as an adjunct to routine cardiac surgery for patients with pre-existing atrial fibrillation"],"prefix":"10.3310","volume":"22","clinical-trial-number":[{"clinical-trial-number":"isrctn82731440","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0894-966X","authenticated-orcid":true,"given":"Linda","family":"Sharples","sequence":"first","affiliation":[{"name":"Department of Medical 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