Key takeaways
- Catheter ablation is extensively carried out to deal with atrial fibrillation (AF) however proof on whether or not the process improves sufferers’ high quality of life associated to AF is missing.
- Within the PVI-SHAM-AF trial, each catheter ablation and a sham intervention improved AF-related high quality of life, however the enchancment by catheter ablation was no more than by the sham intervention.
- Catheter ablation diminished AF recurrences.
- These knowledge underline that high quality of life enhancements in AF sufferers are usually not solely attributable to catheter ablation and ought to be mentioned with sufferers when catheter ablation is being thought-about.
Munich, Germany – 30 August 2026: Catheter ablation for atrial fibrillation (AF) didn’t considerably enhance AF-related high quality of life in contrast with a sham process, regardless of lowering AF recurrence. These had been the primary findings of the PVI-SHAM-AF trial introduced in a Sizzling Line session right this moment at ESC Congress 2026[1] and printed concurrently in The Lancet.
The prevalence of AF is projected to extend considerably as a result of ageing inhabitants and the rise in cardiovascular threat elements. Symptomatic AF carries with it a considerable burden for the affected person, together with elevated threat of stroke and demise, and diminished high quality of life. Catheter ablation entails disrupting the irregular electrical pathways that trigger the situation. Catheter ablation can be utilized for sufferers whose AF will not be managed by antiarrhythmic medication or could also be chosen as first-line remedy. Greater than 500,000 catheter ablations are carried out every year globally.
The PVI-SHAM-AF trial was led by Professor Rolf Wachter from the College of Leipzig Medical Centre, Germany and Professor Nikolaos Dagres from the German Coronary heart Centre at Charité–College Medical Centre Berlin, Germany. Explaining the rationale, Professor Dagres, mentioned: “Whereas it’s effectively established that catheter ablation improves rhythm management and delays AF development, we shouldn’t have conclusive proof that catheter ablation impacts sufferers’ high quality of life associated to their AF. To rule out whether or not there’s a ‘placebo impact’ related to the process, we carried out the PVI-SHAM-AF trial particularly to research enhancements in AF-related high quality of life with catheter ablation in contrast with a sham process.”
This was a double-blind trial carried out in 9 websites in Germany and Poland. In complete, 262 sufferers with symptomatic paroxysmal or persistent AF had been randomised 2:1 to endure catheter ablation or a sham process. Through the sham process, sufferers acquired aware sedation for a similar size of time and in the identical setting as the usual process, and whereas vascular entry was obtained, no catheter was positioned.
Members accomplished the AF Impact on the High quality of life Questionnaire (AFEQT) at baseline and at six months, answering questions on their high quality of life particularly associated to AF. The first endpoint was the change from baseline to six months in AFEQT abstract scores.
The researchers discovered that the AFEQT abstract rating improved in each teams however with no vital distinction between them. The AFEQT abstract rating improved from 61.3 to 81.1 within the ablation group and from 59.2 to 74.9 within the sham group (p=0.36).
Freedom from AF after six months was considerably increased within the catheter ablation group in contrast with the sham group (73% vs. 52%, respectively).
There have been 5 vascular entry problems (three within the catheter ablation and two within the sham group). Critical antagonistic occasions associated or probably associated to the research process occurred in six sufferers within the ablation group and 4 sufferers within the sham group.
Relating to limitations, 937 out of 1,199 sufferers invited to take part within the trial declined. “Willingness to simply accept sham allocation might have chosen sufferers with completely different symptom burden, remedy expectations or preferences,” commented Professor Dagres. Some extra severely symptomatic sufferers might have declined to take part as a result of they most popular catheter ablation. Thus, choice bias might have performed an vital position within the end result of this research.
“Whereas sufferers typically say that their high quality of life has improved after a process, it seems from our trial findings that almost all of this enchancment will not be attributable to the catheter ablation, however to different elements. These might embrace a placebo impact, optimisation of therapies or different elements. Catheter ablation delays development of AF however we are able to now use these knowledge once we focus on what different advantages sufferers might count on from catheter ablation,” concluded Professor Wachter.
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