Catheter ablation only as good as sham procedure for improving AF-related quality of life

Catheter ablation does not appear to be superior to a sham procedure in terms of improving atrial fibrillation (AF)-related quality of life, according to the PVI-SHAM-AF study.

PVI-SHAM-AF included 262 adults (median age 67 years, 51 percent female) with symptomatic paroxysmal or persistent AF. These participants were randomly assigned to undergo catheter ablation (n=173) or a sham procedure (n=89).

The primary endpoint of change in AF-related quality of life from baseline to 6 months was evaluated using the Atrial Fibrillation Effect on the Quality-of-life Questionnaire (AFEQT) summary score. The median follow-up was 184 days.

The mean AFEQT summary score increased from 61.3 points at baseline to 81.1 at 6 months in the catheter ablation group and from 59.2 to 74.9 points in the sham control group. The Hodges–Lehmann estimate of the between-group difference in change did not meet statistical significance (2.6 points, 95 percent confidence interval, −2.7 to 8.0; p=0.36).

One participant in each group died during the study, but neither case of death was considered related to the study procedure. Six participants in the catheter ablation group and four in the sham group experienced serious adverse events deemed as related or possibly related to the study procedure. One of these events was an ischaemic stroke that occurred in the sham group.