Evidence map›Paper›PMID 29672731›Full record

Trial reportEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2018

Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.

Samer A M Nashef, Simon Fynn, Yasir Abu-Omar, Tomasz J Spyt, Christine Mills, Colin C Everett, Julia Fox-Rushby, Jeshika Singh, Malcolm Dalrymple-Hay, Catherine Sudarshan and 4 more

Abstract readClinical Trial, Phase IIIMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2022
    Trial
  2. Article
  3. Article
  4. A Comprehensive Review of Percutaneous and Surgical Left Atrial Appendage Occlusion.Journal of cardiovascular development and disease · 2024
    Review
  5. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Article
  6. Article
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Samer A M NashefDepartment of Surgery, Papworth Hospital, Cambridge, UK.
Simon FynnDepartment of Cardiology, Papworth Hospital, Cambridge, UK.
Yasir Abu-OmarDepartment of Surgery, Papworth Hospital, Cambridge, UK.
Tomasz J SpytDepartment of Cardiothoracic Surgery, Glenfield Hospital, Leicester, UK.
Christine MillsResearch and Development, Papworth Hospital, Cambridge, UK.
Colin C EverettClinical Trials Unit, University of Leeds, Leeds, UK.
Julia Fox-RushbyDepartment of Health Economics, Brunel University, London, UK.
Jeshika SinghDepartment of Health Economics, Brunel University, London, UK.
Malcolm Dalrymple-HayDepartment of Cardiothoracic Surgery, Plymouth Hospital, Derriford Hospital, Plymouth, UK.
Catherine SudarshanDepartment of Surgery, Papworth Hospital, Cambridge, UK.
Massimiliano CodispotiDepartment of Surgery, Papworth Hospital, Cambridge, UK.
Peter BraidleyDepartment of Cardiothoracic Surgery, Northern General Hospital, Sheffield, UK.
Francis C WellsDepartment of Surgery, Papworth Hospital, Cambridge, UK.
Linda D SharplesDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

Funding

Department of Health 07/01/34Medical Research Council MC_U105232027
6 · The paper itself

Abstract

objectivesAtrial 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.

methodsIn 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.

resultsMore 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.

conclusionsAdjunct 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).

Indexed as

Quality of LifeAgedAged, 80 and overAtrial FibrillationCardiac Surgical ProceduresCost-Benefit AnalysisDouble-Blind MethodFemaleHeart Conduction SystemHeart RateHumansMaleMiddle AgedQuality-Adjusted Life YearsTreatment Outcome

Identifiers

PMID29672731
PMCPMC6134441

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.