Dataset Information

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

ABSTRACT:

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).

SUBMITTER: Nashef SAM

PROVIDER: S-EPMC6134441 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Nashef Samer A M SAM Fynn Simon S Abu-Omar Yasir Y Spyt Tomasz J TJ Mills Christine C Everett Colin C CC Fox-Rushby Julia J Singh Jeshika J Dalrymple-Hay Malcolm M Sudarshan Catherine C Codispoti Massimiliano M Braidley Peter P Wells Francis C FC Sharples Linda D LD

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20181001 4

<h4>Objectives</h4>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.<h4>Methods</h4>In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomize ...[more]

PMID: 29672731

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Project description:Background: Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation. Aims: The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients. Methods: The HECTO-AF is a single-center, open label, randomized controlled trial. Patients admitted to the general internal medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. The primary outcome was the prevalence of newly diagnosed AF during the hospital stay. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Results: A total of 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65 ± 16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, and 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. The incidence of newly detected AF was 1.4% over a median of 6 hospitalized days. Seven patients (1.8%) were diagnosed with AF in the intervention group vs. 3 (0.7%) in the control group (p = 0.20). Conclusion: There was a trend toward a higher AF detection over a median of 6 hospitalized days in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis. Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT03197090].

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Dataset Information

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

Objectives

Methods

Results

Conclusions

Study registration

Publications

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

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