Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison
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Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation : A Propensity Score-Matched Comparison. / Ludwig, Sebastian; Conradi, Lenard; Cohen, David J.; Coisne, Augustin; Scotti, Andrea; Abraham, William T.; Ben Ali, Walid; Zhou, Zhipeng; Li, Yanru; Kar, Saibal; Duncan, Alison; Scott Lim, D.; Adamo, Marianna; Redfors, Björn; Muller, David W.M.; Webb, John G.; Petronio, Anna S.; Ruge, Hendrik; Nickenig, Georg; Sondergaard, Lars; Adam, Matti; Regazzoli, Damiano; Garatti, Andrea; Schmidt, Tobias; Andreas, Martin; Dahle, Gry; Walther, Thomas; Kempfert, Joerg; Tang, Gilbert H.L.; Redwood, Simon; Taramasso, Maurizio; Praz, Fabien; Fam, Neil; Dumonteil, Nicolas; Obadia, Jean François; Von Bardeleben, Ralph Stephan; Rudolph, Tanja K.; Reardon, Michael J.; Metra, Marco; Denti, Paolo; Mack, Michael J.; Hausleiter, Jörg; Asch, Federico M.; Latib, Azeem; Lindenfeld, Joann; Modine, Thomas; Stone, Gregg W.; Granada, Juan F.
I: Circulation: Cardiovascular Interventions, Bind 16, Nr. 6, E013045, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation
T2 - A Propensity Score-Matched Comparison
AU - Ludwig, Sebastian
AU - Conradi, Lenard
AU - Cohen, David J.
AU - Coisne, Augustin
AU - Scotti, Andrea
AU - Abraham, William T.
AU - Ben Ali, Walid
AU - Zhou, Zhipeng
AU - Li, Yanru
AU - Kar, Saibal
AU - Duncan, Alison
AU - Scott Lim, D.
AU - Adamo, Marianna
AU - Redfors, Björn
AU - Muller, David W.M.
AU - Webb, John G.
AU - Petronio, Anna S.
AU - Ruge, Hendrik
AU - Nickenig, Georg
AU - Sondergaard, Lars
AU - Adam, Matti
AU - Regazzoli, Damiano
AU - Garatti, Andrea
AU - Schmidt, Tobias
AU - Andreas, Martin
AU - Dahle, Gry
AU - Walther, Thomas
AU - Kempfert, Joerg
AU - Tang, Gilbert H.L.
AU - Redwood, Simon
AU - Taramasso, Maurizio
AU - Praz, Fabien
AU - Fam, Neil
AU - Dumonteil, Nicolas
AU - Obadia, Jean François
AU - Von Bardeleben, Ralph Stephan
AU - Rudolph, Tanja K.
AU - Reardon, Michael J.
AU - Metra, Marco
AU - Denti, Paolo
AU - Mack, Michael J.
AU - Hausleiter, Jörg
AU - Asch, Federico M.
AU - Latib, Azeem
AU - Lindenfeld, Joann
AU - Modine, Thomas
AU - Stone, Gregg W.
AU - Granada, Juan F.
N1 - Publisher Copyright: © 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023
Y1 - 2023
N2 - Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT).
AB - Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT).
KW - bioprosthesis
KW - heart failure
KW - heart valve disease
KW - mitral valve
KW - mitral valve insufficiency
KW - propensity score
U2 - 10.1161/CIRCINTERVENTIONS.123.013045
DO - 10.1161/CIRCINTERVENTIONS.123.013045
M3 - Journal article
C2 - 37194288
AN - SCOPUS:85163415888
VL - 16
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
SN - 1941-7640
IS - 6
M1 - E013045
ER -
ID: 362897543