经导管瓣周漏封堵术后临床成功的预测因素：一项国际前瞻性多中心注册研究。
Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry.
机构信息
Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Faculté de médecine Paris-Saclay, Université Paris-Saclay, France (S.H., D.B., M.K., B.G.).
Medical University of Silesia, Katowice, Poland (G.S.).
出版信息
Circ Cardiovasc Interv. 2022 Oct;15(10):e012193. doi: 10.1161/CIRCINTERVENTIONS.122.012193. Epub 2022 Oct 18.
BACKGROUND
Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure.
METHODS
Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death.
RESULTS
We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (=0.371); and clinical success rates of 70.3% and 88.0%, respectively (=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; 0.002; 3.6 [1.1-11.1]; =0.036; and 3.7 [1.2-11.9]; =0.025; respectively).
CONCLUSIONS
Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifiers: NCT05089136.
背景
经导管闭合症状性人工瓣周漏（PVL）是可行的，但目前尚无确凿证据表明其具有一致的疗效。我们旨在确定经导管 PVL 闭合后临床成功的预测因素。
方法
2017 年至 2019 年，连续有 216 例症状性患者被纳入 24 个欧洲中心的前瞻性登记研究（FFPP），这些患者因症状性人工瓣周漏接受经导管 PVL 闭合治疗。1 个月内无以下任何情况为临床成功：心力衰竭再入院、输血、开胸瓣膜手术和死亡。
结果
我们纳入了 216 例症状性患者，他们共接受了 238 次经皮 PVL 二尖瓣（64.3%）、主动脉瓣（34.0%）或三尖瓣（1.7%）瓣闭合术。分别有 48.9%、7.8%和 43.3%的患者出现心力衰竭、溶血性贫血或两者兼有。在 69.6%、26.6%和 3.8%的患者中，同一手术中处理了 1 个、2 个和 3 个漏口。在 18.6%、52.4%和 28.1%的病例中，漏口分别为针尖样或累及瓣环的 1/8 或 1/4。最常使用的装置是 Vascular Plug 3、心室间隔缺损封堵器、Vascular Plug 2 和瓣周漏装置（分别占 45.0%、16.6%、14.2%和 13.6%）。分别有 85.0%的二尖瓣和 91.4%的主动脉瓣手术获得了成功的装置（漏口减少至≤2 级）（=0.164）；围手术期主要不良事件发生率分别为 3.3%和 1.2%（=0.371）；临床成功率分别为 70.3%和 88.0%（=0.004）。多变量分析显示，技术失败、机械瓣和溶血性贫血与临床治疗失败独立相关（比值比[95%置信区间]，7.7[2.0-25.0]；=0.002；3.6[1.1-11.1]；=0.036；3.7[1.2-11.9]；=0.025）。
结论
在症状性患者中，经导管 PVL 闭合术是有效且安全的，但在患有溶血性贫血和/或机械瓣的患者中，临床成功率较低。
注册
临床试验
gov；唯一标识符：NCT05089136。
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