■经导管二尖瓣瓣膜置换术为生物瓣膜衰竭的高危患者提供了一种侵入性较小的替代方案。中等风险患者的经验有限。我们旨在评估PARTNER3二尖瓣瓣膜研究的1年结局。
■这个前景,单臂,多中心研究纳入有症状的二尖瓣生物假体失效患者,表现出大于或等于中度狭窄和反流,胸外科医师协会评分≥3%和<8%。通过经中隔方法使用了可球囊扩张的经导管心脏瓣膜(SAPIEN3,EdwardsLifesciences)。主要终点是1年时全因死亡率和卒中的复合。
■从2018年到2021年,共有来自12个部位的50名患者接受了二尖瓣瓣膜术。平均年龄为70.1±9.7岁,胸外科医师协会平均评分为4.1%±1.6%,54%是女性。1年内无主要终点事件(死亡率或卒中),没有左心室流出道梗阻,心内膜炎,或二尖瓣再介入。6名患者(12%)需要再次住院,包括心力衰竭(n=2),轻微的手术副作用(n=2),和瓣膜血栓形成(n=2;两者均通过抗凝解决)。额外的瓣膜血栓形成与无明显临床后遗症有关。从基线到1年,所有有数据的受试者均无/微量或轻度(1级+)二尖瓣反流,纽约心脏协会的级别有87.2%(41/47)的患者改善.
■在中危患者中,经房间隔入路采用球囊扩张瓣膜的二尖瓣瓣膜与改善症状和生活质量有关。足够的经导管瓣膜性能,随访1年无死亡或卒中。
■URL:https://www。clinicaltrials.gov;唯一标识符:NCT03193801.
UNASSIGNED: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study.
UNASSIGNED: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year.
UNASSIGNED: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients.
UNASSIGNED: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up.
UNASSIGNED: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.