Patients With High Burden AF and Heart Failure Favor Ablation-Based Rhythm Control

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04/21/2022

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TheCardiologyAdvisor.com

Patients with high burden atrial fibrillation (AF) and heart failure (HF) tend to have more favorable outcomes with ablation-based rhythm control compared with rate control. These findings, from a multicenter, open-label trial were published in Circulation.

The Rhythm Control-Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation (RAFT-AF; ClinicalTrials.gov identifier: NCT01420393) study recruited patients from 21 centers in 4 countries between 2011 and 2018. Patients with high burden AF and HF were stratified by left ventricular ejection fraction (LVEF) and AF subtype and randomly assigned in a 1:1 ratio to receive either ablation-based rhythm control (n=214) or rate control (n=197). The primary composite outcome was all-cause mortality and HF events.

The ablation-based and rate-control cohorts comprised patients aged mean 65.9±8.6 and 67.5±8.0 years; 26.6% and 24.9% were women; 95.3% and 98.0% were White; BMI was 30.1±6.5 and 30.7±6.7; 65.4% and 72.1% had non-ischemic heart disease; 65.4% and 65.5% had persistent type 2 AF for 7 days or longer; and LVEF was 45% or less among 57.9% and 58.9%, respectively.

The primary composite outcome occurred among 23.4% of the ablation-based and 32.5% of the rate-control cohorts (hazard ratio [HR], 0.71; 95% CI, 0.49-1.03; P =.066).

For secondary outcomes, the ablation-based rhythm control treatment was favored for change in geometric mean N-terminal pro brain natriuretic peptide (NT-proBNP; least squares mean difference [LSMD], -37.9; 95% CI, -51.2 to -22.1; P <.0001), AF Effect on Quality of Life survey (AFEQT; LSMD, 6.2; 95% CI, 1.7 to 10.7; P =.0005), Minnesota Living with HF questionnaire (MLHFQ; LSMD, -5.4; 95% CI, -10.5 to -0.3; P =.0036), LVEF (LSMD, 6.9; 95% CI, 3.5 to 10.3; P =.017), and 6-minute walk distance (LSMD, 34.2; 95% CI, 9.3 to 59.1; P =.025).

Among patients with low (£45%) LVEF, the ablation-based intervention was favored for change in NT-proBNP (P <.0001), AFEQT (P =.004), MLHFQ (P =.012), LVEF (P =.019), and 6-minute walk distance (P =.024) and tended to favor the primary composite outcome (HR, 0.63; 95% CI, 0.39-1.02; P =.059).

For the cohort of patients with high LVEF, only changes to LVEF (P =.008) and NT-proBNP (P =.020) favored the ablation-based intervention. There was no evidence that the ablation intervention reduced the primary composite outcome (HR, 0.88; 95% CI, 0.48-1.61; P =.672).

This trial intended to recruit 600 patients, or 300 per study arm, but was terminated early due to low recruitment rates, so had limited power to evaluate the outcomes.

Although this study did not identify a significant difference for the composite outcome of mortality and HF events from either ablation-based rhythm control or rate-control, many of the secondary outcomes favored the ablation intervention, especially among the subset of patients with low LVEF. The study authors noted, “This study warrants additional investigation for ablation-based rhythm control for the treatment of {AF] and [HF], which may reduce mortality and [HF] events.”

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