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 Sonia Petronio; Hendrik Ruge; Georg Nickenig; Lars Sondergaard; Matti Adam; Damiano Regazzoli; Andrea Garatti; Tobias Schmidt; Martin Andreas; Gry Dahle; Thomas Walther; Joerg Kempfert; Gilbert Hl Tang; Simon R Redwood; Maurizio Taramasso; Fabien Praz; Neil P Fam; Nicolas Dumonteil; Jean-François Obadia; Ralph Stephan von Bardeleben; Tanja Katharina 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; CHOICE-MI and the COAPT Trial Investigators

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 Sonia Petronio, Hendrik Ruge, Georg Nickenig, Lars SondergaardMatti Adam, Damiano Regazzoli, Andrea Garatti, Tobias Schmidt, Martin Andreas, Gry Dahle, Thomas Walther, Joerg Kempfert, Gilbert Hl Tang, Simon R Redwood, Maurizio Taramasso, Fabien Praz, Neil P Fam, Nicolas Dumonteil, Jean-François Obadia, Ralph Stephan von Bardeleben, Tanja Katharina 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^*, CHOICE-MI and the COAPT Trial Investigators

^*Corresponding author for this work

Department of Cardiology

17 Citations (Scopus)

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
Journal	Circulation. Cardiovascular interventions
Volume	16
Issue number	6
Pages (from-to)	e013045
ISSN	1941-7640
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.123.013045
Publication status	Published - Jun 2023

Keywords

bioprosthesis
heart failure
heart valve disease
mitral valve
mitral valve insufficiency
propensity score

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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., Lim, D. S., Adamo, M., Redfors, B., Muller, D. W. M., Webb, J. G., Petronio, A. S., Ruge, H., Nickenig, G., ... CHOICE-MI and the COAPT Trial Investigators (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, Lim, DS, 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, GH, Redwood, SR, Taramasso, M, Praz, F, Fam, NP, Dumonteil, N, Obadia, J-F, 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 & CHOICE-MI and the COAPT Trial Investigators 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{f4f7eec49d03471da140b1b2a0c1968c,

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",

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 Lim, \{D Scott\} and Marianna Adamo and Bj{\"o}rn Redfors and Muller, \{David W M\} and Webb, \{John G\} and Petronio, \{Anna Sonia\} 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 Hl\} and Redwood, \{Simon R\} and Maurizio Taramasso and Fabien Praz and Fam, \{Neil P\} and Nicolas Dumonteil and Jean-Fran{\c c}ois Obadia and \{von Bardeleben\}, \{Ralph Stephan\} and Rudolph, \{Tanja Katharina\} 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\} and \{CHOICE-MI and the COAPT Trial Investigators\}",

year = "2023",

month = jun,

doi = "10.1161/CIRCINTERVENTIONS.123.013045",

language = "English",

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 - Lim, D Scott

AU - Adamo, Marianna

AU - Redfors, Björn

AU - Muller, David W M

AU - Webb, John G

AU - Petronio, Anna Sonia

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 Hl

AU - Redwood, Simon R

AU - Taramasso, Maurizio

AU - Praz, Fabien

AU - Fam, Neil P

AU - Dumonteil, Nicolas

AU - Obadia, Jean-François

AU - von Bardeleben, Ralph Stephan

AU - Rudolph, Tanja Katharina

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

AU - CHOICE-MI and the COAPT Trial Investigators

PY - 2023/6

Y1 - 2023/6

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

UR - https://www.scopus.com/pages/publications/85163415888

U2 - 10.1161/CIRCINTERVENTIONS.123.013045

DO - 10.1161/CIRCINTERVENTIONS.123.013045

M3 - Journal article

C2 - 37194288

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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