Patient-Reported Outcomes After First Pulmonary Vein Isolation for ParoxYsmal Atrial Fibrillation: Cryoballoon vs. Radiofrequency (SPY-AF)


Nesti M. Lucà F. Mirizzi G. Bakytzhanuly A. Adelino R. Doundoulakis I. Tsiachris D. Mitropoulou F. Jordan A. Vanduynhoven P. Faga V. Papakonstantinou P.E. Xydonas S. Gezzi I. Rossi A. Garibaldi S. Sciarra L. Russo V. Palamà Z. De Masi De Luca G. Robles A.G. Landra F.
October 2025Multidisciplinary Digital Publishing Institute (MDPI)

Journal of Clinical Medicine
2025#14Issue 19

Background/Objectives: Patient-reported outcome after treatment is an important factor that positively correlates with the quality of care and can influence the patient’s future health choices. Both radiofrequency ablation (RFA) and cryoballoon ablation (CBA) are effective techniques for pulmonary vein isolation in patients with atrial fibrillation (AF) and have shown similar results in efficacy and safety, but they have not been thoroughly compared in terms of patient satisfaction. The aim of this study is to assess the satisfaction of paroxysmal AF patients who underwent RFA and CBA after their first procedure. Methods: Consecutive patients who underwent their first procedure of pulmonary vein isolation with RFA or CBA in eight international centres were included. A ten-point Likert scale was used for measuring patient-reported outcomes, evaluating anxiety before procedure, pain during and after ablation, motivation to repeat the procedure in future if necessary, and real and perceived procedural time. Results: A total of 483 patients were enrolled. Median age was 63 [56–69] years, and 281 (58.1%) patients were men. In total, 385 (79.7%) patients underwent RFA and 98 (20.3%) underwent CBA. RFA and CBA were equivalent in terms of the satisfaction of the patient, with the only exception being groin pain, which was lower in the CBA group (2 [0–3] vs. 3 [1–4], p = 0.002). Conscious sedation was used in 414 (86.7%) patients and general anaesthesia in 69 (14.3%) patients. The use of general anaesthesia reduced the perceived pain during and after the procedure in both techniques (p < 0.05), but it resulted in lower pre-procedural anxiety only in RFA patients compared to those under conscious sedation (4 [2–6] vs. 5 [3–7], p = 0.007). Anaesthetic management alone did not affect the willingness to repeat the procedure in RFA patients, while CBA patients under general anaesthesia were more motivated to repeat the procedure than those under conscious sedation (10 [8–10] vs. 7 [6–8], p < 0.001). The perceived procedure time was shorter than the actual time in all settings. Conclusions: Anaesthetic management seems to have a greater impact on patient-reported outcome than the technique used during ablation. Despite this, patients most motivated to repeat the procedure were those who underwent CBA under general anaesthesia.

cryoballoon ablation , pulmonary vein isolation , radiofrequency ablation paroxysmal atrial fibrillation

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Fondazione Toscana Gabriele Monasterio, Pisa, 56124, Italy
Department of Cardiology, Grande Ospedale Metropolitano (GOM) of Reggio Calabria, Bianchi Melacrino Morelli Hospital, Reggio Calabria, 89124, Italy
Corporate Fund ”University Medical Center”, Heart Center, Astana, 010000, Kazakhstan
Arrhythmia Department, Clinique Pasteur, Toulouse, 31076, France
Arrhythmia Department, Vall d’Hebron University Hospital, Barcelona, 08035, Spain
First Department of Cardiology, “Hippokration” Hospital, National and Kapodistrian University, Athens, 11527, Greece
Athens Heart Center, Athens, 15125, Greece
Arrhythmology Department, University Hospital Dubrava, Zagreb, 10000, Croatia
Department of Cardiology, Arrhythmia Clinic, ASZ Aalst, Aalst, 9300, Belgium
Department of Cardiology, Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, 08907, Spain
Cardiology Department, Evangelismos Hospital, Athens, 10676, Greece
Malattie dell’Apparato Cardiovascolare, University of L’Aquila, L’Aquila, 67100, Italy
Cardiology Unit, Department of Medical and Translationsl Sciences, University of Campania “Luigi Vanvitelli”, Monaldi Hospital, Naples, 80138, Italy
Electrophysiology Unit, Casa di Cura “Villa Verde”, Taranto, 74121, Italy
Cardiology Department, Card. G. Panico Hospital, Tricase, 73039, Italy
Cardiology Department, Ospedale “L. Bonomo”, Andria, 76123, Italy
Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, 53100, Italy

Fondazione Toscana Gabriele Monasterio
Department of Cardiology
Corporate Fund ”University Medical Center”
Arrhythmia Department
Arrhythmia Department
First Department of Cardiology
Athens Heart Center
Arrhythmology Department
Department of Cardiology
Department of Cardiology
Cardiology Department
Malattie dell’Apparato Cardiovascolare
Cardiology Unit
Electrophysiology Unit
Cardiology Department
Cardiology Department
Division of Cardiology

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