The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial (JCEP Janluary 2026-Artile: The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial

Artile: The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial

Pdf Summary

This secondary analysis of the SHAM-PVI randomized, double-blind, sham-controlled trial investigated the relationship between atrial fibrillation (AF) burden and quality of life (QoL) in 126 patients with symptomatic paroxysmal or persistent AF. Patients were randomized to pulmonary vein isolation (PVI) by cryoballoon ablation or to a sham procedure, with continuous AF burden monitoring via implantable loop recorders. QoL was assessed using validated instruments including the Atrial Fibrillation Effect on Quality-of-Life (AFEQT), Mayo AF-Specific Symptom Inventory (MAFSI), and the 36-Item Short Form Health Survey (SF-36).<br /><br />Results showed a strong, statistically significant association between reductions in geometric mean AF burden and improvements in overall AFEQT scores, MAFSI symptom severity and frequency, and several SF-36 domains, including physical and social functioning. Symptoms significantly correlated with AF burden reductions included palpitations, dizziness, shortness of breath, tiredness, inability to exercise, and weakness, whereas chest pain, slow heart rate, and fainting did not correlate significantly. Importantly, the relationship between AF burden reduction and QoL improvement was consistent across both the PVI and sham groups, demonstrating that PVI’s benefits are not due to a placebo effect.<br /><br />This study underscores the clinical value of AF burden as a more nuanced and meaningful endpoint than the traditional binary measure of arrhythmia recurrence, advocating its use for guiding rhythm control strategies and evaluating intervention success. Continuous monitoring provided precise AF burden quantification, overcoming limitations of intermittent assessments. The findings reinforce that partial AF burden reduction—even without complete arrhythmia elimination—yields significant QoL improvements.<br /><br />Limitations include relatively short 6-month follow-up, exclusion of patients with advanced AF or severe comorbidities, and restriction to cryoablation technique. Future research should evaluate long-term outcomes and the relationship of AF burden reduction with hospitalizations and mortality. Overall, this substudy confirms that AF burden is a robust marker of treatment success and that PVI’s QoL benefits are genuine, not placebo-driven.

Keywords

atrial fibrillation

AF burden

quality of life

pulmonary vein isolation

cryoballoon ablation

implantable loop recorder

AFEQT

MAFSI

SF-36

randomized sham-controlled trial