5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results

Mayra E. Guerrero; Mackram F. Eleid; Dee Dee Wang; Amit Pursnani; Susheel K. Kodali; Isaac George; Igor Palacios; Hyde Russell; Raj R. Makkar; Saibal Kar; Lowell F. Satler; Vivek Rajagopal; George Dangas; Gilbert H.L. Tang; James M. McCabe; Brian K. Whisenant; Kenith Fang; Prakash Balan; Richard Smalling; Tatiana Kaptzan; Bradley Lewis; Pamela S. Douglas; Rebecca T. Hahn; Jeremy Thaden; Jae K. Oh; Martin Leon; William O'Neill; Charanjit Rihal

doi:10.1016/j.jcin.2023.06.041

5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results

Mayra E. Guerrero, Mackram F. Eleid, Dee Dee Wang, Amit Pursnani, Susheel K. Kodali, Isaac George, Igor Palacios, Hyde Russell, Raj R. Makkar, Saibal Kar, Lowell F. Satler, Vivek Rajagopal, George Dangas, Gilbert H.L. Tang, James M. McCabe, Brian K. Whisenant, Kenith Fang, Prakash Balan, Richard Smalling, Tatiana KaptzanBradley Lewis, Pamela S. Douglas, Rebecca T. Hahn, Jeremy Thaden, Jae K. Oh, Martin Leon, William O'Neill, Charanjit Rihal

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

18 Scopus citations

Abstract

Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve–in–mitral annular calcification (ViMAC). Objectives: The aim of this study was to evaluate 5-year outcomes among these patients. Methods: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. Results: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. Conclusions: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

Original language	English
Pages (from-to)	2211-2227
Number of pages	17
Journal	JACC: Cardiovascular Interventions
Volume	16
Issue number	18
DOIs	https://doi.org/10.1016/j.jcin.2023.06.041
State	Published - 25 Sep 2023

Keywords

mitral annular calcification
mitral regurgitation
mitral stenosis
mitral valve-in-valve
transcatheter mitral valve replacement

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10.1016/j.jcin.2023.06.041

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Guerrero, M. E., Eleid, M. F., Wang, D. D., Pursnani, A., Kodali, S. K., George, I., Palacios, I., Russell, H., Makkar, R. R., Kar, S., Satler, L. F., Rajagopal, V., Dangas, G., Tang, G. H. L., McCabe, J. M., Whisenant, B. K., Fang, K., Balan, P., Smalling, R., ... Rihal, C. (2023). 5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results. JACC: Cardiovascular Interventions, 16(18), 2211-2227. https://doi.org/10.1016/j.jcin.2023.06.041

@article{20b580aec13e4492b3ceed9cd62fb68b,

title = "5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results",

abstract = "Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve–in–mitral annular calcification (ViMAC). Objectives: The aim of this study was to evaluate 5-year outcomes among these patients. Methods: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. Results: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. Conclusions: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.",

keywords = "mitral annular calcification, mitral regurgitation, mitral stenosis, mitral valve-in-valve, transcatheter mitral valve replacement",

author = "Guerrero, {Mayra E.} and Eleid, {Mackram F.} and Wang, {Dee Dee} and Amit Pursnani and Kodali, {Susheel K.} and Isaac George and Igor Palacios and Hyde Russell and Makkar, {Raj R.} and Saibal Kar and Satler, {Lowell F.} and Vivek Rajagopal and George Dangas and Tang, {Gilbert H.L.} and McCabe, {James M.} and Whisenant, {Brian K.} and Kenith Fang and Prakash Balan and Richard Smalling and Tatiana Kaptzan and Bradley Lewis and Douglas, {Pamela S.} and Hahn, {Rebecca T.} and Jeremy Thaden and Oh, {Jae K.} and Martin Leon and William O'Neill and Charanjit Rihal",

note = "Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = sep,

day = "25",

doi = "10.1016/j.jcin.2023.06.041",

language = "English",

volume = "16",

pages = "2211--2227",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "18",

}

Guerrero, ME, Eleid, MF, Wang, DD, Pursnani, A, Kodali, SK, George, I, Palacios, I, Russell, H, Makkar, RR, Kar, S, Satler, LF, Rajagopal, V, Dangas, G , Tang, GHL, McCabe, JM, Whisenant, BK, Fang, K, Balan, P, Smalling, R, Kaptzan, T, Lewis, B, Douglas, PS, Hahn, RT, Thaden, J, Oh, JK, Leon, M, O'Neill, W & Rihal, C 2023, '5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results', JACC: Cardiovascular Interventions, vol. 16, no. 18, pp. 2211-2227. https://doi.org/10.1016/j.jcin.2023.06.041

TY - JOUR

T1 - 5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes

T2 - MITRAL Trial Final Results

AU - Guerrero, Mayra E.

AU - Eleid, Mackram F.

AU - Wang, Dee Dee

AU - Pursnani, Amit

AU - Kodali, Susheel K.

AU - George, Isaac

AU - Palacios, Igor

AU - Russell, Hyde

AU - Makkar, Raj R.

AU - Kar, Saibal

AU - Satler, Lowell F.

AU - Rajagopal, Vivek

AU - Dangas, George

AU - Tang, Gilbert H.L.

AU - McCabe, James M.

AU - Whisenant, Brian K.

AU - Fang, Kenith

AU - Balan, Prakash

AU - Smalling, Richard

AU - Kaptzan, Tatiana

AU - Lewis, Bradley

AU - Douglas, Pamela S.

AU - Hahn, Rebecca T.

AU - Thaden, Jeremy

AU - Oh, Jae K.

AU - Leon, Martin

AU - O'Neill, William

AU - Rihal, Charanjit

PY - 2023/9/25

Y1 - 2023/9/25

N2 - Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve–in–mitral annular calcification (ViMAC). Objectives: The aim of this study was to evaluate 5-year outcomes among these patients. Methods: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. Results: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. Conclusions: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

AB - Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve–in–mitral annular calcification (ViMAC). Objectives: The aim of this study was to evaluate 5-year outcomes among these patients. Methods: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. Results: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. Conclusions: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

KW - mitral annular calcification

KW - mitral regurgitation

KW - mitral stenosis

KW - mitral valve-in-valve

KW - transcatheter mitral valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85171200829&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2023.06.041

DO - 10.1016/j.jcin.2023.06.041

M3 - Article

AN - SCOPUS:85171200829

SN - 1936-8798

VL - 16

SP - 2211

EP - 2227

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 18

ER -

5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results

Abstract

Keywords

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