用于功能性三尖瓣反流的Cardioband三尖瓣系统的早期可行性研究：30天结果
Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.
作者信息
Davidson Charles J, Lim D Scott, Smith Robert L, Kodali Susheel K, Kipperman Robert M, Eleid Mackram F, Reisman Mark, Whisenant Brian, Puthumana Jyothy, Abramson Sandra, Fowler Dale, Grayburn Paul, Hahn Rebecca T, Koulogiannis Konstantinos, Pislaru Sorin V, Zwink Todd, Minder Michael, Dahou Abdellaziz, Deo Shekhar H, Vandrangi Prashanthi, Deuschl Florian, Feldman Ted E, Gray William A
机构信息
Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Department of Medicine, University of Virginia Health System Hospital, Charlottesville, Virginia, USA.
出版信息
JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.
OBJECTIVES
The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR).
BACKGROUND
Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited.
METHODS
In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee.
RESULTS
The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001).
CONCLUSIONS
In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).
目的
本研究首次报告了美国第一项使用Cardioband三尖瓣重建系统治疗功能性三尖瓣反流（TR）的30天结果。
背景
TR严重程度增加与发病率和死亡率逐渐升高相关；然而，孤立性严重疾病的治疗选择有限。
方法
在这项单臂、多中心、前瞻性、经美国食品药品监督管理局批准的早期可行性研究（EFS）中，纳入了30例有严重或更严重症状性功能性TR的患者，这些患者被当地心脏团队和多学科筛查委员会认定为适合使用Cardioband三尖瓣系统进行经导管三尖瓣修复的候选人。
结果
患者平均年龄为77岁，80%为女性，97%患有心房颤动，70%处于纽约心脏协会功能分级III至IV级，平均左心室射血分数为58%，27%有严重TR，20%有大量TR，53%有重度TR。器械成功率为93%，所有患者在30天时均存活。在基线和30天之间，三尖瓣隔侧环直径减少了13%（p<0.001），85%的患者TR降低≥1级，44%的患者TR≤中度，75%处于纽约心脏协会功能分级I至II级（p<0.00），堪萨斯城心肌病问卷总分总体提高了16分（p<0.001）。
结论
在有严重症状性功能性TR的患者中，这是美国第一项使用Cardioband三尖瓣系统进行直接经导管环缩的研究。这项早期可行性研究证明了高手术可行性且30天无死亡率。功能性TR显著降低，功能状态和生活质量有临床显著改善。（爱德华兹Cardioband三尖瓣重建系统早期可行性研究；NCT03382457）
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