One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients.

IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
S Chris Malaisrie, Mayra Guerrero, Charles Davidson, Mathew Williams, Fábio Sândoli de Brito, Alexandre Abizaid, Pinak Shah, Tsuyoshi Kaneko, Karl Poon, Justin Levisay, Xiao Yu, Philippe Pibarot, Rebecca T Hahn, Philipp Blanke, Martin B Leon, Michael J Mack, Alan Zajarias
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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.

中度手术风险患者经隔膜二尖瓣内置瓣膜的一年疗效。
背景:经导管二尖瓣瓣内置换术为生物人工瓣膜功能衰竭的高危患者提供了一种创伤较小的替代方法。中危患者的经验有限。我们旨在评估 PARTNER 3 二尖瓣瓣内成形术研究的 1 年疗效:这项前瞻性、单臂、多中心研究招募了二尖瓣生物瓣膜功能衰竭、二尖瓣狭窄和反流大于或等于中度、胸外科医师协会评分≥3%的无症状患者:2018年至2021年,共有来自12个地点的50名患者接受了二尖瓣置入术。平均年龄为(70.1±9.7)岁,胸外科医师学会平均评分为(4.1%±1.6%),54%为女性。一年内未发生主要终点事件(死亡或中风),未报告左心室流出道梗阻、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(2人)、轻微的手术副作用(2人)和瓣膜血栓(2人;抗凝治疗后均缓解)。另外一次瓣膜血栓形成没有引起明显的临床后遗症。从基线到1年,所有有可用数据的受试者均无/微量或轻度(1+级)二尖瓣反流,87.2%(41/47)的患者纽约心脏协会分级有所改善:结论:在中危患者中通过经皮途径植入球囊扩张瓣膜的二尖瓣瓣中瓣与症状和生活质量的改善、充分的经导管瓣膜性能以及随访1年无死亡或中风有关:URL:https://www.clinicaltrials.gov;唯一标识符:NCT03193801。
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来源期刊
Circulation: Cardiovascular Interventions
Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
1.80%
发文量
221
审稿时长
6-12 weeks
期刊介绍: Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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