Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Pacing Clin Electrophysiol. 2024 May;47(5):595-602. doi: 10.1111/pace.14943. Epub 2024 Mar 25.
Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry.
Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores).
A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p = 0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p = 0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p = 0.03. Comparable results were observed in paroxysmal and persistent AF.
CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.
目前缺乏关于冷冻球囊消融术（CBA）与射频消融术（RFA）后患者报告结局（PRO）的相关数据。我们旨在通过一个大型前瞻性 PRO 注册研究，评估单纯冷冻球囊肺静脉隔离术（CRYO-PVI-ONLY）与 RFA 联合 PVI 和后间隔隔离术（RF-PVI+PWI）对生活质量和临床结局的影响。
本研究纳入了 2013 年至 2016 年在我院行房颤消融术的患者，并自动纳入前瞻性 PRO 注册研究。根据年龄、性别和房颤类型（阵发性 vs. 持续性），对 CRYO-PVI-ONLY 患者进行 1:1 匹配，以纳入 RF-PVI+PWI 患者。在基线和 1 年时，采用 PRO 调查评估生活质量和临床结局。房颤症状严重程度评分（AFSSS）用于评估生活质量。此外，我们评估了患者报告的临床改善、心律失常复发和房颤负荷（房颤频率和持续时间评分）。
共纳入 296 例患者（每组 148 例，72%为阵发性）。PRO 结果显示，整体研究人群的生活质量显著改善，且在 CRYO-PVI-ONLY 组和 RF-PVI+PWI 组之间无差异（基线时 AFSSS 中位数分别为 11.5 和 11，1 年后分别降至 2 和 4，p=0.44）。同样，报告整体生活质量和房颤相关症状改善的患者比例较高，且两组之间相似[92%（CRYO-PVI-ONLY）vs. 92.8%（RF-PVI+PWI）；p=0.88]。CRYO-PVI-ONLY 组心律失常复发率（39.7%）明显高于 RF-PVI+PWI 组（27.7%），p=0.03。阵发性和持续性房颤的结果相似。
单纯冷冻球囊肺静脉隔离术和 RFA 联合 PVI 和后间隔隔离术均能显著改善患者报告的结局，包括生活质量和房颤负荷；而 RFA 联合 PVI 和后间隔隔离术在减少复发方面更有效。
