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

Abstract

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.