Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison

Sebastian Ludwig; Lenard Conradi; David J. Cohen; Augustin Coisne; Andrea Scotti; William T. Abraham; Walid Ben Ali; Zhipeng Zhou; Yanru Li; Saibal Kar; Alison Duncan; D. Scott Lim; Marianna Adamo; Björn Redfors; David W.M. Muller; John G. Webb; Anna S. Petronio; Hendrik Ruge; Georg Nickenig; Lars Sondergaard; Matti Adam; Damiano Regazzoli; Andrea Garatti; Tobias Schmidt; Martin Andreas; Gry Dahle; Thomas Walther; Joerg Kempfert; Gilbert H.L. Tang; Simon Redwood; Maurizio Taramasso; Fabien Praz; Neil Fam; Nicolas Dumonteil; Jean François Obadia; Ralph Stephan Von Bardeleben; Tanja K. Rudolph; Michael J. Reardon; Marco Metra; Paolo Denti; Michael J. Mack; Jörg Hausleiter; Federico M. Asch; Azeem Latib; Joann Lindenfeld; Thomas Modine; Gregg W. Stone; Juan F. Granada

doi:10.1161/CIRCINTERVENTIONS.123.013045

Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison

Sebastian Ludwig, Lenard Conradi, David J. Cohen, Augustin Coisne, Andrea Scotti, William T. Abraham, Walid Ben Ali, Zhipeng Zhou, Yanru Li, Saibal Kar, Alison Duncan, D. Scott Lim, Marianna Adamo, Björn Redfors, David W.M. Muller, John G. Webb, Anna S. Petronio, Hendrik Ruge, Georg Nickenig, Lars SondergaardMatti Adam, Damiano Regazzoli, Andrea Garatti, Tobias Schmidt, Martin Andreas, Gry Dahle, Thomas Walther, Joerg Kempfert, Gilbert H.L. Tang, Simon Redwood, Maurizio Taramasso, Fabien Praz, Neil Fam, Nicolas Dumonteil, Jean François Obadia, Ralph Stephan Von Bardeleben, Tanja K. Rudolph, Michael J. Reardon, Marco Metra, Paolo Denti, Michael J. Mack, Jörg Hausleiter, Federico M. Asch, Azeem Latib, Joann Lindenfeld, Thomas Modine, Gregg W. Stone, Juan F. Granada

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

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).

Original language	English (US)
Pages (from-to)	E013045
Journal	Circulation: Cardiovascular Interventions
Volume	16
Issue number	6
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.123.013045
State	Published - Jun 1 2023

Keywords

bioprosthesis
heart failure
heart valve disease
mitral valve
mitral valve insufficiency
propensity score
Mitral Valve Insufficiency/diagnostic imaging
Heart Valve Prosthesis Implantation
Humans
Mitral Valve/diagnostic imaging
Male
Treatment Outcome
Heart Failure/etiology
Propensity Score
Cardiac Catheterization/adverse effects
Female

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1161/CIRCINTERVENTIONS.123.013045

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Ludwig, S., Conradi, L., Cohen, D. J., Coisne, A., Scotti, A., Abraham, W. T., Ben Ali, W., Zhou, Z., Li, Y., Kar, S., Duncan, A., Scott Lim, D., Adamo, M., Redfors, B., Muller, D. W. M., Webb, J. G., Petronio, A. S., Ruge, H., Nickenig, G., ... Granada, J. F. (2023). Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison. Circulation: Cardiovascular Interventions, 16(6), E013045. https://doi.org/10.1161/CIRCINTERVENTIONS.123.013045

Ludwig, S, Conradi, L, Cohen, DJ, Coisne, A, Scotti, A, Abraham, WT, Ben Ali, W, Zhou, Z, Li, Y, Kar, S, Duncan, A, Scott Lim, D, Adamo, M, Redfors, B, Muller, DWM, Webb, JG, Petronio, AS, Ruge, H, Nickenig, G, Sondergaard, L, Adam, M, Regazzoli, D, Garatti, A, Schmidt, T, Andreas, M, Dahle, G, Walther, T, Kempfert, J, Tang, GHL, Redwood, S, Taramasso, M, Praz, F, Fam, N, Dumonteil, N, Obadia, JF, Von Bardeleben, RS, Rudolph, TK, Reardon, MJ, Metra, M, Denti, P, Mack, MJ, Hausleiter, J, Asch, FM, Latib, A, Lindenfeld, J, Modine, T, Stone, GW & Granada, JF 2023, 'Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison', Circulation: Cardiovascular Interventions, vol. 16, no. 6, pp. E013045. https://doi.org/10.1161/CIRCINTERVENTIONS.123.013045

@article{6d18d019ed0e4c2d9b3e5f10e2ac95f7,

title = "Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison",

abstract = "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).",

keywords = "bioprosthesis, heart failure, heart valve disease, mitral valve, mitral valve insufficiency, propensity score, Mitral Valve Insufficiency/diagnostic imaging, Heart Valve Prosthesis Implantation, Humans, Mitral Valve/diagnostic imaging, Male, Treatment Outcome, Heart Failure/etiology, Propensity Score, Cardiac Catheterization/adverse effects, Female",

author = "Sebastian Ludwig and Lenard Conradi and Cohen, {David J.} and Augustin Coisne and Andrea Scotti and Abraham, {William T.} and {Ben Ali}, Walid and Zhipeng Zhou and Yanru Li and Saibal Kar and Alison Duncan and {Scott Lim}, D. and Marianna Adamo and Bj{\"o}rn Redfors and Muller, {David W.M.} and Webb, {John G.} and Petronio, {Anna S.} and Hendrik Ruge and Georg Nickenig and Lars Sondergaard and Matti Adam and Damiano Regazzoli and Andrea Garatti and Tobias Schmidt and Martin Andreas and Gry Dahle and Thomas Walther and Joerg Kempfert and Tang, {Gilbert H.L.} and Simon Redwood and Maurizio Taramasso and Fabien Praz and Neil Fam and Nicolas Dumonteil and Obadia, {Jean Fran{\c c}ois} and {Von Bardeleben}, {Ralph Stephan} and Rudolph, {Tanja K.} and Reardon, {Michael J.} and Marco Metra and Paolo Denti and Mack, {Michael J.} and J{\"o}rg Hausleiter and Asch, {Federico M.} and Azeem Latib and Joann Lindenfeld and Thomas Modine and Stone, {Gregg W.} and Granada, {Juan F.}",

year = "2023",

month = jun,

day = "1",

doi = "10.1161/CIRCINTERVENTIONS.123.013045",

language = "English (US)",

volume = "16",

pages = "E013045",

journal = "Circulation: Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins",

number = "6",

}

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.

PY - 2023/6/1

Y1 - 2023/6/1

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

KW - Mitral Valve Insufficiency/diagnostic imaging

KW - Heart Valve Prosthesis Implantation

KW - Humans

KW - Mitral Valve/diagnostic imaging

KW - Male

KW - Treatment Outcome

KW - Heart Failure/etiology

KW - Propensity Score

KW - Cardiac Catheterization/adverse effects

KW - Female

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U2 - 10.1161/CIRCINTERVENTIONS.123.013045

DO - 10.1161/CIRCINTERVENTIONS.123.013045

M3 - Article

C2 - 37194288

AN - SCOPUS:85163415888

SN - 1941-7640

VL - 16

SP - E013045

JO - Circulation: Cardiovascular Interventions

JF - Circulation: Cardiovascular Interventions

IS - 6

ER -

Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison

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