Boehmer Andreas A, Rothe Moritz, Nussbaum Elena, Ruckes Christian, Dobre Bianca C, Kaess Bernhard M, Ehrlich Joachim R
Department of Cardiology, St. Josefs-Hospital Wiesbaden, Germany.
Interdisciplinary Center for Clinical Trials, University of Mainz, Germany.
Int J Cardiol Heart Vasc. 2023 Jul 20;47:101244. doi: 10.1016/j.ijcha.2023.101244. eCollection 2023 Aug.
Patients with obesity are at higher risk of developing atrial fibrillation (AF) and benefit from radiofrequency ablation. Potentially, cryoballoon ablation (CBA) may be equally effective and safe in such patients.
We conducted a prospective, single-center study to investigate whether CBA for pulmonary vein isolation is as effective and safe in obese patients as it is in non-obese controls. Primary efficacy endpoint was recurrence of AF, atrial flutter or atrial tachycardia after a 90-day blanking period. Safety endpoints were death, stroke or procedure-associated complications. Conduction of a subgroup analysis regarding the impact of additional diabetes was predefined in case the primary efficacy endpoint was met. The study was event driven and powered for noninferiority.
A total of 949 patients underwent CBA (251 obese with mean body-mass-index 33.5 ± 3 kg/m and 698 non-obese with mean body-mass-index 25.3 ± 3 kg/m) during a 5-year recruitment period. Median follow-up was 15 months. The primary efficacy endpoint occurred in 78/251 obese and 247/698 non-obese patients (12-months Kaplan-Meier event-rate estimates, hazard ratio 0.79; 95% confidence interval [CI], 0.58 to 1.07; log-rank = 0.0002 for noninferiority). No differences were observed in safety end point occurrence ( = 0.78). The occurrence of primary efficacy end point was found to be unaffected by the presence of diabetes in the prespecified subgroup analysis (log-rank = 0.57).
CBA is effective and safe in obese and DM patients. Weighing the high cardiovascular risk of obese patients against a reduction of cardiovascular events by early rhythm control, CBA should be offered to this patient population.
肥胖患者发生心房颤动（AF）的风险较高，且可从射频消融术中获益。冷冻球囊消融术（CBA）在这类患者中可能同样有效且安全。
我们开展了一项前瞻性单中心研究，以调查针对肥胖患者进行肺静脉隔离的CBA是否与非肥胖对照患者一样有效且安全。主要疗效终点为90天空白期后AF、心房扑动或房性心动过速的复发情况。安全终点为死亡、中风或与手术相关的并发症。若达到主要疗效终点，则预先设定对合并糖尿病的影响进行亚组分析。该研究以事件为驱动，且具有非劣效性检验效能。
在5年的招募期内，共有949例患者接受了CBA（251例肥胖患者，平均体重指数为33.5±3kg/m²，698例非肥胖患者，平均体重指数为25.3±3kg/m²）。中位随访时间为15个月。主要疗效终点发生在78/251例肥胖患者和247/698例非肥胖患者中（12个月的Kaplan-Meier事件发生率估计值，风险比为0.79；95%置信区间[CI]为0.58至1.07；非劣效性检验的对数秩检验P=0.0002）。在安全终点的发生情况方面未观察到差异（P=0.78）。在预先设定的亚组分析中，发现主要疗效终点的发生不受糖尿病存在与否的影响（对数秩检验P=0.57）。
CBA在肥胖和糖尿病患者中有效且安全。鉴于肥胖患者心血管风险较高且早期节律控制可减少心血管事件，应向该患者群体提供CBA。
