经导管二尖瓣修复术治疗中重度二尖瓣反流合并心力衰竭。
Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation.
机构信息
From the Department of Cardiology of German Heart Center Charité and the Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin (S.D.A., M.D., W.H.), the Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, the Berlin Institute of Health, and DZHK Partner Site Berlin (U.L.), Deutsches Herzzentrum der Charité, the Department of Cardiology, Angiology, and Intensive Care Medicine, Campus Charité Mitte, the Center for Cardiovascular Telemedicine, and DZHK Partner Site Berlin, Charité Universitätsmedizin (F.K.), Berlin, the Departments of Cardiology and Pneumology (S.D.A., M.D., G.H., W.S.) and Medical Statistics (T.F., M.P.) and the Clinical Trial Unit (J.H.), University Medical Center Göttingen, and the Heart Center, Department of Cardiology (W.S.), Georg August University of Göttingen, DZHK Partner Site Göttingen, Göttingen, the Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz (R.S.B., M. Geyer, T.F.R.), Mainz, the Department of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, and Cardiovascular Research Institute Düsseldorf, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf (M. Kelm), the Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck (K.-H.K.), the West German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, University Duisburg-Essen, Essen (T.R.), the Heart and Vascular Center, Bad Bevensen (U.S.), the Department of Internal Medicine I, Cardiology, University Hospital Jena, Jena (P.C.S.), the Institute for Cardiovascular Regeneration, Goethe University Frankfurt, and DZHK Partner Site Rhein-Main, Frankfurt am Main (A.Z.), the Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, and DZHK Partner Site Hamburg-Kiel-Lübeck, Hamburg (M. Karakas), the Department of Cardiology, Rostock University Medical Center, Rostock (A.Ö.), the Department of Medicine, Heart and Vascular Center, Division of Cardiology and Vascular Medicine, Johanniter Hospital Stendal, Stendal (M. Gross), the Mid-German Heart Center, Department of Cardiology, Angiology, and Intensive Care Medicine, University Hospital Halle, Halle (J.T.) - all in Germany; the Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.); Baylor Scott and White Research Institute, Dallas (J.B., M.S.K.), Baylor Scott and White the Heart Hospital Plano, Plano (M.S.K.), and the Department of Medicine, Baylor College of Medicine, Temple (M.S.K.) - all in Texas; the Department of Translational Medicine, University of Ferrara, Ferrara (R.F.), the Cardiac Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan (O.A.), ANMCO Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Heart Care Foundation, Florence (A.P.M.), and the Institute of Cardiology, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, and the Department of Medical and Surgical Specialties, Radiologic Sciences and Public Health, University of Brescia, Brescia (M.M., M.A.) - all in Italy; the Division of Cardiovascular Medicine, Ohio State University, Columbus (W.T.A.); the Department of Cardiology, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano (A.A.), and the Center for Translational and Experimental Cardiology, Department of Cardiology, University Hospital Zurich, University of Zurich, Zurich (F.R.) - both in Switzerland; the Heart Institute, Hospital Universitari Germans Trias i Pujol, Barcelona (A.B.-G., E.S.-V.), and the Department of Cardiology, Hospital Universitario Ramón y Cajal, and Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid (J.L.Z.) - all in Spain; the School of Cardiovascular and Metabolic Health, University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow, United Kingdom (J.G.F.C., M.C.P.); the Department of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens (G.F.), and the Department of Transcatheter Heart Valves, Hygeia Hospital (K.S., M.C., P.K., K.P.), Athens, and the Department of Cardiology, St. Luke's Hospital (N.M., E.K.T.), and the European Interbalkan Medical Center (V.N., I.N., K.P.), Thessaloniki - all in Greece; the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen (F.G.); Unité Formation et Recherche Médecine, Université de Paris-Cité, site Bichat, Laboratoire de Recherche Vasculaire Translationnelle, INSERM, Groupe Hospitalier Bichat, Paris (A.V.); the Division of Cardiology, General Hospital Murska Sobota, Murska Sobota, and the Faculty of Medicine, University of Ljubljana, Ljubljana - both in Slovenia (M.L.); the Division of Cardiology and Structural Heart Diseases (G.S., W.W.) and the Department of Cardiology, Congenital Heart Diseases, and Electrotherapy (Z.K.), Medical University of Silesia, Katowice, the Institute of Heart Diseases, Medical University and University Hospital, Wrocław (K.R., P.P.), and the Department of Interventional Cardiology, Department of Radiology and Diagnostic Imaging, John Paul II Hospital, Krakow (Ł.W.) - all in Poland; and Centro Academico de Medicina de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.).
出版信息
N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31.
BACKGROUND
Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain.
METHODS
We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status).
RESULTS
A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%).
CONCLUSIONS
Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).
背景
经导管二尖瓣修复术是否能改善心力衰竭伴功能性二尖瓣反流患者的结局尚不确定。
方法
我们在 9 个国家的 30 个地点开展了一项随机对照试验，纳入了心力衰竭伴中度至重度功能性二尖瓣反流的患者。患者以 1:1 的比例随机分配至经导管二尖瓣修复术联合指南推荐的药物治疗（器械组）或单纯药物治疗（对照组）。主要终点为 24 个月时因心力衰竭或心血管死亡首次或再次住院的复合发生率；24 个月时心力衰竭首次或再次住院的发生率；以及自基线至 12 个月时堪萨斯城心肌病问卷整体评分（KCCQ-OS；评分范围为 0 至 100，分数越高表示健康状况越好）的变化。
结果
共有 505 例患者接受了随机分组：250 例患者分入器械组，255 例患者分入对照组。24 个月时，器械组因心力衰竭或心血管死亡首次或再次住院的发生率为每 100 患者-年 37.0 例，对照组为每 100 患者-年 58.9 例（发生率比，0.64；95%置信区间[CI]，0.48 至 0.85；P=0.002）。器械组因心力衰竭首次或再次住院的发生率为每 100 患者-年 26.9 例，对照组为每 100 患者-年 46.6 例（发生率比，0.59；95%CI，0.42 至 0.82；P=0.002）。器械组 KCCQ-OS 评分平均增加（±SD）21.6±26.9 分，对照组增加 8.0±24.5 分（平均差值，10.9 分；95%CI，6.8 至 15.0；P<0.001）。器械相关安全性事件发生于 4 例患者（1.6%）。
结论
在接受药物治疗的伴中度至重度功能性二尖瓣反流的心力衰竭患者中，与单纯药物治疗相比，经导管二尖瓣修复术可降低 24 个月时因心力衰竭或心血管死亡首次或再次住院的发生率和心力衰竭首次或再次住院的发生率，并改善 12 个月时的健康状况。（由 Abbott Laboratories 资助；RESHAPE-HF2 临床试验.gov 编号，NCT02444338。）
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