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Nachrichten, Termine, Experten
Catheter ablation is a minimally invasive procedure used to treat atrial fibrillation, the world’s most common heart rhythm disorder. During the procedure, a catheter is guided through the femoral vein to the left atrium. Small areas of heart tissue are then ablated to disrupt the faulty electrical signals causing the irregular heartbeat. An international study led by Leipzig University, the Deutsches Herzzentrum der Charité (DHZC) and Leipzig Heart Center shows that although the procedure significantly reduces the recurrence of atrial fibrillation, after six months it provides no greater improvement in patients’ quality of life than a sham procedure.
The findings were presented on 30 August at the European Society of Cardiology (ESC) Congress and simultaneously published in The Lancet, one of the world’s leading medical journals.
Atrial fibrillation can cause palpitations, shortness of breath and fatigue, and increases the risk of stroke and death. As the condition becomes more common with advancing age and risk factors such as high blood pressure, doctors expect the number of cases to rise considerably in the coming years. More than 500,000 catheter ablation procedures are already performed worldwide each year.
There is firm scientific evidence that catheter ablation stabilises the heart rhythm and delays the progression of atrial fibrillation. Until now, however, it was unclear how much of the improvement in quality of life reported by patients was actually attributable to the procedure itself.
To investigate this, the researchers conducted the current study under the leadership of Professor Rolf Wachter and Professor Nikolaos Dagres. Wachter is Professor of Clinical and Interventional Cardiology at Leipzig University and Deputy Director of the Department of Cardiology at the University of Leipzig Medical Center. Dagres is Senior Consultant at the DHZC Department of Cardiology, Angiology and Intensive Care Medicine at Charité’s Mitte campus and a former consultant at Leipzig Heart Center. A large proportion of the patients were enrolled at Leipzig Heart Center. “Our data show that most of the improvement reported by patients does not appear to be attributable to catheter ablation itself, but rather to factors such as a placebo effect or adjustments to their medication,” explains the study’s principal investigator, Professor Wachter.
The co-principal investigator, Professor Nikolaos Dagres from the DHZC, adds: “Current guidelines recommend catheter ablation primarily to prevent the recurrence of atrial fibrillation and improve quality of life. However, our study shows that the effect of the ablation itself does not adequately explain the improvement in quality of life.”
The double-blind study was conducted at nine hospitals in Germany and Poland. A total of 262 patients with atrial fibrillation were randomly assigned to one of two groups: one group underwent catheter ablation, while the other underwent a sham procedure. The latter involved establishing vascular access in the same way as for the actual treatment, but no catheter was used. Neither the participants nor the team responsible for their subsequent care knew which treatment each patient had received.
At the beginning of the study and six months after the procedure, all participants completed a validated questionnaire assessing quality of life in relation to atrial fibrillation: the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT). The researchers found that in both groups, four out of five patients reported an improvement in their condition, with no statistically significant difference between the catheter ablation and sham-procedure groups. Catheter ablation was clearly superior to the sham procedure in only one respect: 73 per cent of patients who underwent catheter ablation remained free from atrial fibrillation after six months, compared with just 52 per cent in the control group.
Patrick Haag, the study’s medical coordinator and a resident physician at the Department of Rhythmology at Leipzig Heart Center, describes the implications for clinical practice: “These findings do not alter the fundamental effectiveness of catheter ablation in preventing the recurrence of atrial fibrillation. They do, however, change our expectations of what the treatment can achieve in terms of patients’ subjective well-being. We will analyse the data in greater depth to better understand which patient groups may also benefit in terms of their quality of life.” The findings now published are based on data collected at the six-month follow-up. The twelve-month follow-up is not yet complete, with the corresponding results to be published at a later date.
The study was funded through the Helios “Leipzig Cardiovascular Medicine” programme, which supports projects aimed at strengthening collaboration between Leipzig Heart Center and Leipzig University.
Translation: Matthew Rockey
Professor Rolf Wachter
Professor of Clinical and Interventional Cardiology, Leipzig University
Deputy Director of the Department of Cardiology, University of Leipzig Medical Center
Email: Rolf.Wachter@medizin.uni-leipzig.de
Phone: +49341-97-12825
Publication in The Lancet: Catheter Ablation for Symptomatic Atrial Fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled multicentre trial. DOI: https://doi.org/10.1016/S0140-6736(26)01558-8
Catheter ablation in the cardiac catheterization laboratory at University of Leipzig Medical Center ...
Source: Rolf Wachter
Copyright: Leipzig University
The principal investigators of the study (from left): Professor Rolf Wachter, University of Leipzig ...
Source: Leipzig University
Copyright: Leipzig University
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Catheter ablation in the cardiac catheterization laboratory at University of Leipzig Medical Center ...
Source: Rolf Wachter
Copyright: Leipzig University
The principal investigators of the study (from left): Professor Rolf Wachter, University of Leipzig ...
Source: Leipzig University
Copyright: Leipzig University
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