Reflections on the usefulness of today's atrial fibrillation ablation procedure endpoints and patient-reported outcomes.
Carina Blomstrom-LundqvistVictoria Svedung WettervikPublished in: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology (2022)
The improvement of Patient-reported outcomes, such as health-related quality of life, is the main indication for atrial fibrillation ablation. Despite this guideline derived indication for an AF ablation procedure the current standardized primary endpoint in AF ablation trials is still rhythm-related, and primarily a 30-second long AF episode. The review presents reflections on the non-rational arguments of using rhythm related endpoints rather than Patient-reported outcomes in AF ablation procedure trials despite the mismatch between many of the rhythm related variables and symptoms. Arguments for health-related quality of life as the most optimal primary endpoint in clinical trials are presented while atrial fibrillation burden is presented as the most optimal electrical complementary endpoint, apart from being the major variable in mechanistic trials.
Keyphrases
- atrial fibrillation
- patient reported outcomes
- catheter ablation
- left atrial
- left atrial appendage
- oral anticoagulants
- direct oral anticoagulants
- heart failure
- clinical trial
- percutaneous coronary intervention
- minimally invasive
- radiofrequency ablation
- acute coronary syndrome
- physical activity
- open label
- study protocol