Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation

被引：19

作者：

Baldus, Stephan ^{[1
]}

Doenst, Torsten ^{[4
]}

Pfister, Roman ^{[1
]}

Gummert, Jan ^{[6
]}

Kessler, Mirjam ^{[8
]}

Boekstegers, Peter ^{[9
]}

Lubos, Edith ^{[11
,12
]}

Schroeder, Jorg ^{[14
]}

Thiele, Holger ^{[16
,17
]}

Walther, Thomas ^{[3
,18
,19
]}

Kelm, Malte ^{[20
,21
]}

Hausleiter, Jorg ^{[22
]}

Eitel, Ingo ^{[24
,25
]}

Fischer-Rasokat, Ulrich ^{[26
]}

Bufe, Alexander ^{[10
]}

Schmeisser, Alexander ^{[27
]}

Ince, Huseyin ^{[28
]}

Lurz, Philipp ^{[29
,30
]}

von Bardeleben, Ralph Stephan ^{[29
]}

Hagl, Christian ^{[23
]}

Noack, Thilo ^{[15
]}

Reith, Sebastian ^{[31
]}

Beucher, Harald ^{[32
]}

Reichenspurner, Hermann ^{[13
]}

Rottbauer, Wolfgang ^{[8
]}

Schulze, P. Christian ^{[5
]}

Mueller, Wiebke ^{[2
]}

Frank, Julia ^{[2
]}

Hellmich, Martin ^{[2
]}

Wahlers, Thorsten

Rudolph, Volker ^{[7
]}

机构：

[1] Univ Cologne, Dept Internal Med 3, Fac Med, Cologne, Germany

[2] Univ Cologne, Inst Med Stat & Computat Biol, Fac Med, Cologne, Germany

[3] Univ Cologne, Cardiothorac Surg, Fac Med, Cologne, Germany

[4] Friedrich Schiller Univ Jena, Jena Univ Hosp, Dept Cardiothorac Surg, Jena, Germany

[5] Friedrich Schiller Univ Jena, Jena Univ Hosp, Dept Cardiol, Jena, Germany

[6] Ruhr Univ Bochum, Med Fac OWL, Thorac & Cardiovasc Surg, Heart & Diabet Ctr NRW,Univ Hosp, Bad Oeynhausen, Germany

[7] Ruhr Univ Bochum, Med Fac OWL, Gen & Intervent Cardiol Angiol, Heart & Diabet Ctr NRW,Univ Hosp, Bad Oeynhausen, Germany

[8] Ulm Univ, Heart Ctr, Dept Cardiol, Ulm, Germany

[9] Univ Witten Herdecke, Sch Med, Fac Hlth, Witten, Germany

[10] Univ Witten Herdecke, Helios Klinikum Krefeld, Witten, Germany

[11] Marien Hosp, Cochem, Germany

[12] Univ Hosp Eppendorf, Dept Cardiol, Hamburg, Germany

[13] Univ Med Ctr Hamburg Eppendorf, Dept Cardiothorac Surg, Univ Heart & Vasc Ctr Hamburg, Hamburg, Germany

[14] Rhein Westfal TH Aachen, Univ Hosp Aachen, Dept Internal Med 1, Aachen, Germany

[15] Univ Leipzig, Cardiac Surg, Leipzig, Germany

[16] Univ Leipzig, Heart Ctr Leipzig, Leipzig, Germany

[17] Leipzig Heart Sci, Leipzig, Germany

[18] Univ Hosp Frankfurt, Dept Cardiovasc Surg, Frankfurt, Germany

[19] Goethe Univ Frankfurt, Frankfurt, Germany

[20] Univ Hosp Dusseldorf, Dusseldorf, Germany

[21] CARID Cardiovasc Res Inst Dusseldorf, Dusseldorf, Germany

[22] Ludwig Maximilian Univ Munich, Med Clin & Polyclin, Munich, Germany

[23] Ludwig Maximilian Univ Munich, Dept Cardiac Surg, Munich, Germany

[24] Univ Heart Ctr Lubeck, Med Clin 2, Lubeck, Germany

[25] German Ctr Cardiovasc Res DZHK, Lubeck, Germany

[26] Kerckhoff Heart Ctr, Dept Cardiol, Bad Nauheim, Germany

[27] Otto von Guericke Univ, Magdeburg, Germany

[28] Univ Med Ctr, Dept Cardiol, Rostock, Germany

[29] Univ Med Ctr Mainz, Dept Cardiol, Mainz, Germany

[30] German Ctr Cardiovasc Res DZHK, Partner Site Rhine Main, Mainz, Germany

[31] St Franziskus Hosp, Munster, Germany

[32] Helios Klinikum Siegburg, Dept Cardiol, Siegburg, Germany

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2024年 / 391卷 / 19期

关键词：

OUTCOMES;

D O I：

10.1056/NEJMoa2408739

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population. METHODS In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure. RESULTS A total of 210 patients underwent randomization. The mean (+/- SD) age of the patients was 70.5 +/- 7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0 +/- 11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001). CONCLUSIONS Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year.

引用

页码：1787 / 1798

页数：12

共 50 条

[21] Mitral valve repair versus replacement in simultaneous aortic and mitral valve surgery
Urban, Marian
Pirk, Jan
Szarszoi, Ondrej
Skalsky, Ivo
Maly, Jiri
Netuka, Ivan
[J]. EXPERIMENTAL & CLINICAL CARDIOLOGY, 2013, 18 (01) : 22 - 26
[22] Feasibility of the transcatheter mitral valve repair for patients with severe mitral regurgitation and endangered heart failure
Lee, Ching-Wei
Huang, Wei-Ming
Tsai, Yi-Lin
Lu, Dai-Yin
Sung, Shih-Hsien
Yu, Wen-Chung
Guo, Chao-Yu
Chen, Chen-Huan
[J]. JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION, 2021, 120 (01) : 452 - 459
[23] Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation With Complex Mitral Valve Anatomy
Joseph, Megan S.
Bach, David S.
[J]. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2023, 81 (05) : 443 - 445
[24] Transcatheter mitral valve intervention: an emerging treatment for mitral regurgitation
Markham, Ryan
Kyranis, Stephen
Aroney, Nicholas
Lau, Katherine
Poon, Karl
Scalia, Gregory
Walters, Darren
[J]. INTERNAL MEDICINE JOURNAL, 2018, 48 (04) : 382 - 390
[25] Percutaneous Mitral-Valve Intervention for Secondary Mitral Regurgitation: Data From Real-Life
Kaddoura, Rasha
Al-Badriyeh, Daoud
Abushanab, Dina
Al-Hijji, Mohammed
[J]. CURRENT PROBLEMS IN CARDIOLOGY, 2023, 48 (10)
[26] Reoperative Mitral Surgery Versus Transcatheter Mitral Valve Replacement: A Systematic Review
Sengupta, Aditya
Yazdchi, Farhang
Alexis, Sophia L.
Percy, Edward
Premkumar, Akash
Hirji, Sameer
Bapat, Vinayak N.
Bhatt, Deepak L.
Kaneko, Tsuyoshi
Tang, Gilbert H. L.
[J]. JOURNAL OF THE AMERICAN HEART ASSOCIATION, 2021, 10 (06):
[27] Percutaneous mitral valve repair for secondary mitral valve regurgitation: A systematic review and meta-analysis
Kumar, Ashish
Al-khafaji, Jaafar
Shariff, Mariam
Vaz, Igor Pedreira
Adalja, Devina
Doshi, Rajkumar
[J]. EUROPEAN JOURNAL OF INTERNAL MEDICINE, 2020, 78 : 107 - 112
[28] Successful Surgical Repair of the Parachute Mitral Valve with Mitral Valve Regurgitation
Shiraishi, Manabu
Yamaguchi, Atsushi
Adachi, Hideo
[J]. ANNALS OF THORACIC AND CARDIOVASCULAR SURGERY, 2012, 18 (06) : 569 - 572
[29] Mitral Regurgitation and Coronary Artery Bypass Surgery : Comparison of Mitral Valve Repair and Replacement
Ljubacev, A.
Medved, I.
Ostric, M.
Zuvic-Butorac, M.
Sokolic, J.
[J]. ACTA CHIRURGICA BELGICA, 2013, 113 (03) : 187 - 191
[30] First-in-human Results of the Novel Transcatheter Mitral Valve Repair System for Severe Mitral Regurgitation
Lu, Zhi-Nan
Ke, Yutong
Bian, Yingnan
He, Jing
Wu, Wenhui
Liu, Xinmin
Li, Yang
Liu, Ran
Luo, Taiyang
Guo, Xunan
Song, Guangyuan
[J]. CARDIOLOGY DISCOVERY, 2024, 4 (02): : 148 - 159

← 1 2 3 4 5 →