Catheter ablation did not beat a sham procedure on quality of life at six months

Design

randomised, double-blind, sham-controlled, multicentre trial, 2:1 allocation, 9 sites

Population

262 adults with symptomatic paroxysmal or persistent atrial fibrillation, median age 67

Primary outcome

change in AFEQT summary score from baseline to 6 months

Effect

between-group difference 2.6 points (95% CI -2.7 to 8.0, p=0.36); AFEQT 61.3 to 81.1 with ablation, 59.2 to 74.9 with sham

PVI-SHAM-AF randomised 262 patients with symptomatic paroxysmal or persistent atrial fibrillation 2:1 to catheter ablation (173) or a sham procedure (89), double-blind, across nine sites in Germany and Poland. The primary endpoint was the change in AFEQT summary score at six months. Median age was 67, half were women, median follow-up 184 days.

Both groups improved substantially. AFEQT rose from 61.3 to 81.1 after ablation and from 59.2 to 74.9 after the sham. The between-group difference was 2.6 points (95% CI -2.7 to 8.0, p=0.36) - short of significance, and short of the roughly 5-point change usually taken as clinically meaningful even at the top of its interval. One death occurred in each arm, neither procedure-related. Procedure-related serious adverse events occurred in six ablation patients and four sham patients, one of which was a stroke, in the sham arm.

The guideline indication for ablation is symptom relief, and this is the first double-blind test of that indication. The finding does not say ablation does nothing; it says that at six months, most of the symptomatic benefit patients report is also produced by undergoing the procedure without the ablation. That belongs in the consent conversation. Twelve-month follow-up is ongoing, and nothing here speaks to rhythm outcomes, AF burden, stroke or heart failure endpoints, where the case for ablation rests on different trials.

• Tell patients the symptom benefit in blinded comparison was 2.6 AFEQT points, and that both arms improved a lot
• Separate the symptom indication from the rhythm and heart failure indications when counselling - they rest on different evidence
• Do not extrapolate to ablation in heart failure with reduced ejection fraction, which this trial did not study
• Record baseline symptom scores so post-procedure improvement can be judged against something
• Revisit rate control and drug therapy in the patient whose main complaint is symptoms rather than burden

Why it matters

Ablation for symptoms is a guideline recommendation that had never been tested against a sham - and against one, it did not win.

Don't overread it

This measured quality of life at six months in 262 patients; it says nothing about AF burden, stroke, or ablation in heart failure.

The statistics, in plain English

The confidence interval runs from 2.7 points worse to 8.0 points better. Because it crosses zero, the trial cannot exclude no benefit - but note also that its upper end barely reaches the threshold usually considered clinically meaningful, so even the most favourable reading of these data is a modest effect. With 262 patients the trial is not large, and a true small benefit could have been missed; what it does establish is that the very large improvement seen in unblinded practice is mostly not attributable to the ablation itself.

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