Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation

被引：23

作者：

Anker, Stefan D. ^{[1
,2
,6
,7
]}

Friede, Tim ^{[8
]}

von Bardeleben, Ralph-Stephan ^{[12
]}

Butler, Javed ^{[27
,28
]}

Khan, Muhammad-Shahzeb ^{[28
,29
,30
]}

Diek, Monika ^{[1
,2
,6
,7
]}

Heinrich, Jutta ^{[9
]}

Geyer, Martin ^{[12
]}

Placzek, Marius ^{[8
]}

Ferrari, Roberto ^{[31
]}

Abraham, William T. ^{[36
]}

Alfieri, Ottavio ^{[32
]}

Auricchio, Angelo ^{[37
]}

Bayes-Genis, Antoni ^{[39
]}

Cleland, John G. F. ^{[42
]}

Filippatos, Gerasimos ^{[43
]}

Gustafsson, Finn ^{[47
]}

Haverkamp, Wilhelm ^{[1
,2
]}

Kelm, Malte ^{[13
,14
,15
]}

Kuck, Karl-Heinz ^{[16
]}

Landmesser, Ulf ^{[3
,4
]}

Maggioni, Aldo P. ^{[33
]}

Metra, Marco ^{[34
,35
]}

Ninios, Vlasis ^{[46
]}

Petrie, Mark C. ^{[42
]}

Rassaf, Tienush ^{[17
]}

Ruschitzka, Frank ^{[38
]}

Schafer, Ulrich ^{[18
]}

Schulze, P. Christian ^{[19
]}

Spargias, Konstantinos ^{[44
]}

Vahanian, Alec ^{[48
]}

Zamorano, Jose Luis ^{[40
,41
]}

Zeiher, Andreas ^{[20
,21
]}

Karakas, Mahir ^{[22
,23
]}

Koehler, Friedrich ^{[5
]}

Lainscak, Mitja ^{[49
,50
]}

Oner, Alper ^{[24
]}

Mezilis, Nikolaos ^{[45
]}

Theofilogiannakos, Efstratios K. ^{[45
]}

Ninios, Ilias ^{[46
]}

Chrissoheris, Michael ^{[44
]}

Kourkoveli, Panagiota ^{[44
]}

Papadopoulos, Konstantinos ^{[44
,46
]}

Smolka, Grzegorz ^{[51
]}

Wojakowski, Wojciech ^{[51
]}

Reczuch, Krzysztof ^{[53
]}

Pinto, Fausto J. ^{[55
]}

Wiewiorka, Lukasz ^{[54
]}

Kalarus, Zbigniew ^{[52
]}

Adamo, Marianna ^{[34
,35
]}

机构：

[1] German Heart Ctr Charite, Dept Cardiol, Berlin, Germany

[2] Charite, German Ctr Cardiovasc Res DZHK, Ctr Regenerat Therapies, Inst Hlth, Partner Site Berlin, Berlin, Germany

[3] Berlin Inst Hlth, Deutsch Herzzentrum Charite, Dept Cardiol Angiol & Intens Care Med, Campus Benjamin Franklin, Berlin, Germany

[4] DZHK Partner Site Berlin, Berlin, Germany

[5] Charite, Dept Cardiol Angiol & Intens Care Med, Campus Charite Mitte, Ctr CardiovascTelemed, Berlin, Germany

[6] Georg August Univ Gottingen, Dept Cardiol, DZHK Partner Site Gottingen, Gottingen, Germany

[7] Georg August Univ Gottingen, Dept Pneumol, DZHK Partner Site Gottingen, Gottingen, Germany

[8] Georg August Univ Gottingen, Dept Med Stat, DZHK Partner Site Gottingen, Gottingen, Germany

[9] Georg August Univ Gottingen, Clin Trial Unit, DZHK Partner Site Gottingen, Gottingen, Germany

[10] Georg August Univ Gottingen, Univ Med Ctr Gottingen, DZHK Partner Site Gottingen, Gottingen, Germany

[11] Georg August Univ Gottingen, Ctr Heart, Dept Cardiol, DZHK Partner Site Gottingen, Gottingen, Germany

[12] Johannes Gutenberg Univ Mainz, Univ Med Ctr, Dept Cardiol, Mainz, Germany

[13] Heinrich Heine Univ Dusseldorf, Med Fac, Univ Hosp Dusseldorf, Dept Cardiol Pulmonol & Vasc Med, Dusseldorf, Germany

[14] Heinrich Heine Univ Dusseldorf, Fac Med, Cardiovasc Res Inst Dusseldorf, Dusseldorf, Germany

[15] Heinrich Heine Univ Dusseldorf, Fac Med, Univ Hosp Dusseldorf, Dusseldorf, Germany

[16] Univ Hosp Schleswig Holstein, Univ Heart Ctr Lubeck, Dept Rhythmol, Lubeck, Germany

[17] Univ Duisburg Essen, Univ Hosp Essen, Dept Cardiol & Vasc Med, West German Heart & Vasc Ctr, Essen, Germany

[18] Heart & Vasc Ctr, Bad Bevensen, Germany

[19] Univ Hosp Jena, Cardiol, Dept Internal Med 1, Jena, Germany

[20] Goethe Univ Frankfurt, Inst Cardiovasc Regenerat, Frankfurt, Germany

[21] DZHK Partner Site Rhein Main, Frankfurt, Germany

[22] Univ Med Ctr Hamburg Eppendorf, Dept Intens Care Med, Hamburg, Germany

[23] DZHK Partner Site Hamburg Kiel Lubeck, Hamburg, Germany

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

[25] Johanniter Hosp Stendal, Dept Med, Heart & Vasc Ctr, Div Cardiol & Vasc Med, Stendal, Germany

[26] Univ Hosp Halle, Mid German Heart Ctr, Dept Cardiol Angiol & Intens Care Med, Halle, Germany

[27] Univ Mississippi, Med Ctr, Dept Med, Jackson, MS 39216 USA

[28] Baylor Scott & White Res Inst, Dallas, TX USA

[29] Baylor Scott & White Heart Hosp Plano, Plano, TX USA

[30] Baylor Coll Med, Dept Med, Temple, TX USA

[31] Univ Ferrara, Dept Translat Med, Ferrara, Italy

[32] IRCCS San Raffaele Sci Inst, Cardiac Surg Unit, Milan, Italy

[33] Heart Care Fdn, ANMCO Assoc Nazl Med Cardiol Osped Res Ctr, Florence, Italy

[34] Azienda Socio Sanitaria Terr Spedali Civili Bresc, Inst Cardiol, Brescia, Italy

[35] Univ Brescia, Dept Med & Surg Specialties, Radiol Sci & Publ Hlth, Brescia, Italy

[36] Ohio State Univ, Div Cardiovasc Med, Columbus, OH 43210 USA

[37] Ente Osped Cantonale, Cardioctr Ticino Inst, Dept Cardiol, Lugano, Switzerland

[38] Univ Zurich, Univ Hosp Zurich, Dept Cardiol, Ctr Translat & Expt Cardiol, Zurich, Switzerland

[39] Hosp Badalona Germans Trias & Pujol, Inst Heart, Barcelona, Spain

[40] Hosp Univ Ramon y Cajal, Dept Cardiol, Madrid, Spain

[41] Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Cardiovasc, Madrid, Spain

[42] Univ Glasgow, Sch Cardiovasc & Metab Hlth, British Heart Fdn, Glasgow Cardiovasc Res Ctr, Glasgow, Lanark, Scotland

[43] Natl & Kapodistrian Univ Athens, Sch Med, Attikon Univ Hosp, Dept Cardiol, Athens, Greece

[44] Hygeia Hosp, Dept Transcatheter Heart Valves, Athens, Greece

[45] St Lukes Hosp, Dept Cardiol, Thessaloniki, Greece

[46] European Interbalkan Med Ctr, Thessaloniki, Greece

[47] Copenhagen Univ Hosp, Rigshosp, Dept Cardiol, Copenhagen, Denmark

[48] Univ Paris Cite, Unite Format & Rech Med, Lab Rech Vasc Translat, Grp Hosp Bichat,INSERM, Site Bichat, Paris, France

[49] Gen Hosp Murska Sobota, Div Cardiol, Murska Sobota, Slovenia

[50] Univ Ljubljana, Fac Med, Ljubljana, Slovenia

来源：

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

关键词：

PERCUTANEOUS REPAIR; LESSONS;

D O I：

10.1056/NEJMoa2314328

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1799 / 1809

页数：11

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