Abstract：
BACKGROUND: Anatomic variations of the patent foramen ovale (PFO) are commonly observed, yet limited research has investigated their impact on clinical outcomes following transcatheter closure. We aimed to explore the association between PFO morphology and clinical outcomes.
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.
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.
摘要：
背景：通常观察到卵圆孔未闭（PFO）的解剖变异，但有限的研究调查了它们对经导管封堵术后临床结局的影响.我们旨在探讨PFO形态与临床结局之间的关系。
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。
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。
