METHODS: Consecutive patients with cryptogenic stroke who underwent PFO closure were prospectively enrolled at a single center from September 2019 to April 2023. Patients were categorized into simple and complex groups based on PFO morphology. Composite events were compared between the two groups during a median follow-up of 24 months, including all-cause mortality, recurrent stroke, residual moderate or severe shunt, and symptomatic atrial fibrillation.
RESULTS: A total of 247 patients were enrolled, with a mean age of 41.9 ± 13.0 years and 45.3% males. Ninety-one (36.8%) patients had complex PFO. These individuals were older (45.4 ± 12.5 years vs. 39.9 ± 12.9 years; P = 0.001), more males (56.0% vs. 39.1%; P = 0.010), had longer procedure times (54 ± 32 min vs 46 ± 29 min; P = 0.044), and had a higher rate of using delivery sheath-assisted crossing of the PFO (22.0% vs 12.8%; P = 0.040) than those with simple PFO. The estimated event rates were 27.9% and 11.3% (P = 0.006) in the complex and simple PFO groups, respectively (12.9 events and 5.2 events per 100 person-years; P = 0.001). After adjusting for age, sex, hypertension, diabetes, smoking, device type, and left atrial diameters, complex PFO remained independently associated with composite events (HR 2.10, 95%CI 1.06-4.17, P = 0.034).
CONCLUSIONS: Patients with complex PFO may suffer from a higher risk of adverse events following transcatheter PFO closure.
方法:从2019年9月至2023年4月,在单个中心前瞻性地招募了连续接受PFO封堵术的隐源性卒中患者。根据PFO形态将患者分为简单组和复杂组。在24个月的中位随访期间,比较两组之间的复合事件。包括全因死亡率,复发性中风,残余中度或重度分流,和有症状的心房颤动。
结果:共纳入247例患者,平均年龄41.9±13.0岁,男性占45.3%。91例(36.8%)患者出现复杂PFO。这些人年龄较大(45.4±12.5岁与39.9±12.9年;P=0.001),更多男性(56.0%vs.39.1%;P=0.010),手术时间较长(54±32分钟vs46±29分钟;P=0.044),与单纯PFO相比,使用鞘管辅助穿插PFO的比率更高(22.0%vs12.8%;P=0.040)。复杂和简单PFO组的估计事件发生率分别为27.9%和11.3%(P=0.006)。分别为12.9个事件和5.2个事件/100人年;P=0.001。在调整了年龄之后,性别,高血压,糖尿病,吸烟,设备类型,和左心房直径,复杂PFO与复合事件独立相关(HR2.10,95CI1.06-4.17,P=0.034)。
结论:患有复杂PFO的患者在经导管PFO封堵后可能遭受更高的不良事件风险。