TY - JOUR
T1 - Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation
T2 - A Global Feasibility Trial
AU - Muller, David W.M.
AU - Farivar, Robert Saeid
AU - Jansz, Paul
AU - Bae, Richard
AU - Walters, Darren
AU - Clarke, Andrew
AU - Grayburn, Paul A.
AU - Stoler, Robert C.
AU - Dahle, Gry
AU - Rein, Kjell Arne
AU - Shaw, Marty
AU - Scalia, Gregory M.
AU - Guerrero, Mayra
AU - Pearson, Paul
AU - Kapadia, Samir
AU - Gillinov, Marc
AU - Pichard, Augusto
AU - Corso, Paul
AU - Popma, Jeffrey
AU - Chuang, Michael
AU - Blanke, Philippe
AU - Leipsic, Jonathon
AU - Sorajja, Paul
AU - Conellan, Mark
AU - Spina, Roberto
AU - Pedersen, Wesley
AU - Sun, Benjamin
AU - Scalia, Gregory
AU - Grayburn, Paul
AU - Stoler, Robert
AU - Hebeler, Robert
AU - Fiane, Arnt
AU - Feldman, Ted
AU - Salinger, Michael
AU - Smart, Steven
AU - Mick, Stephanie
AU - Krishnaswamy, Amar
AU - Carroll, John
AU - George, Isaac
AU - Missov, Emil
AU - Kiser, Andrew
N1 - Publisher Copyright:
© 2017 American College of Cardiology Foundation
PY - 2017/1/31
Y1 - 2017/1/31
N2 - Background Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. Objectives This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. Methods Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. Results Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. Conclusions TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery.
AB - Background Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. Objectives This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. Methods Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. Results Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. Conclusions TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery.
KW - heart failure
KW - mitral prosthesis
KW - mitral regurgitation
KW - mitral valve implantation
KW - transcatheter
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U2 - 10.1016/j.jacc.2016.10.068
DO - 10.1016/j.jacc.2016.10.068
M3 - Article
C2 - 28040318
AN - SCOPUS:85009343073
SN - 0735-1097
VL - 69
SP - 381
EP - 391
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 4
ER -