PVI-SHAM-AF Finds AF Ablation Misses Quality-of-Life Gain at 6 Months Despite 27% Recurrence
Updated
Updated · Medscape · Aug 30
PVI-SHAM-AF Finds AF Ablation Misses Quality-of-Life Gain at 6 Months Despite 27% Recurrence
3 articles · Updated · Medscape · Aug 30
Summary
262 symptomatic AF patients randomized 2:1 to ablation or sham showed no significant quality-of-life edge for ablation at 6 months, despite broad expectations that the procedure improves symptoms.
AFEQT scores rose from 61.3 to 81.1 after ablation and from 59.2 to 74.9 after sham, leaving a nonsignificant 2.6-point between-group difference with near-perfect blinding.
27% of ablation patients had AF recurrence on clinical follow-up or 7-day Holter versus 48% with sham, and AF burden was 11.6% versus 23.6%, confirming rhythm control without a matching quality-of-life benefit.
1,200 patients were screened across nine centers in Germany and Poland, but more than 900 declined participation; the sham procedure included venous sheaths, heavy sedation and cardioversion.
The result challenges a long-held rationale for pulmonary vein isolation and may intensify debate over placebo effects, cardioversion's role and the rapid growth of AF ablation.