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Catheter ablation for atrial fibrillation (AF) did not significantly improve AF-related quality of life compared with a sham procedure, despite reducing AF recurrence. These were the main findings of the PVI-SHAM-AF trial presented in a Hot Line session today at ESC Congress 20261 and published simultaneously in The Lancet.
The prevalence of AF is projected to increase substantially due to the ageing population and the rise in cardiovascular risk factors. Symptomatic AF carries with it a substantial burden for the patient, including increased risk of stroke and death, and reduced quality of life. Catheter ablation involves disrupting the abnormal electrical pathways that cause the condition. Catheter ablation can be used for patients whose AF is not controlled by antiarrhythmic drugs or may be chosen as first-line therapy. More than 500,000 catheter ablations are performed each year globally.
The PVI-SHAM-AF trial was led by Professor Rolf Wachter from the University of Leipzig Medical Centre, Germany and Professor Nikolaos Dagres from the German Heart Centre at Charité–University Medical Centre Berlin, Germany. Explaining the rationale, Professor Dagres, said: “While it is well established that catheter ablation improves rhythm control and delays AF progression, we do not have conclusive evidence that catheter ablation impacts patients’ quality of life related to their AF. To rule out whether there is a ‘placebo effect’ associated with the procedure, we conducted the PVI-SHAM-AF trial specifically to investigate improvements in AF-related quality of life with catheter ablation compared with a sham procedure.”
This was a double-blind trial conducted in nine sites in Germany and Poland. In total, 262 patients with symptomatic paroxysmal or persistent AF were randomised 2:1 to undergo catheter ablation or a sham procedure. During the sham procedure, patients received conscious sedation for the same length of time and in the same setting as the standard procedure, and while vascular access was obtained, no catheter was placed.
Participants completed the AF Effect on the Quality of life Questionnaire (AFEQT) at baseline and at six months, answering questions on their quality of life specifically related to AF. The primary endpoint was the change from baseline to 6 months in AFEQT summary scores.
The researchers found that the AFEQT summary score improved in both groups but with no significant difference between them. The AFEQT summary score improved from 61.3 to 81.1 in the ablation group and from 59.2 to 74.9 in the sham group (p=0.36).
Freedom from AF after six months was substantially higher in the catheter ablation group compared with the sham group (73% vs. 52%, respectively).
There were five vascular access complications (three in the catheter ablation and two in the sham group). Serious adverse events related or possibly related to the study procedure occurred in six patients in the ablation group and four patients in the sham group.
Regarding limitations, 937 out of 1,199 patients invited to participate in the trial declined. “Willingness to accept sham allocation may have selected patients with different symptom burden, treatment expectations or preferences,” commented Professor Dagres. Some more severely symptomatic patients may have declined to participate because they preferred catheter ablation. Thus, selection bias may have played an important role in the outcome of this study.
“While patients often say that their quality of life has improved after a procedure, it appears from our trial findings that most of this improvement is not attributable to the catheter ablation, but to other factors. These could include a placebo effect, optimisation of therapies or other factors. Catheter ablation delays progression of AF but we can now use these data when we discuss what other benefits patients may expect from catheter ablation,” concluded Professor Wachter.
