Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes

Mayra Guerrero; Amit Pursnani; Akhil Narang; Michael Salinger; Dee Dee Wang; Mackram Eleid; Susheel K. Kodali; Isaac George; Lowell Satler; Ron Waksman; Christopher U. Meduri; Vivek Rajagopal; Ignacio Inglessis; Igor Palacios; Mark Reisman; Marvin H. Eng; Hyde M. Russell; Ashish Pershad; Kenith Fang; Saibal Kar; Rajj Makkar; Jorge Saucedo; Paul Pearson; Ujala Bokhary; Tatiana Kaptzan; Brad Lewis; Carl Tommaso; Philip Krause; Jeremy Thaden; Jae Oh; Roberto M. Lang; Rebecca T. Hahn; Martin B. Leon; William W. O'Neill; Ted Feldman; Charanjit Rihal

doi:10.1016/j.jcin.2021.02.027

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes

Mayra Guerrero^*, Amit Pursnani, Akhil Narang, Michael Salinger, Dee Dee Wang, Mackram Eleid, Susheel K. Kodali, Isaac George, Lowell Satler, Ron Waksman, Christopher U. Meduri, Vivek Rajagopal, Ignacio Inglessis, Igor Palacios, Mark Reisman, Marvin H. Eng, Hyde M. Russell, Ashish Pershad, Kenith Fang, Saibal KarRajj Makkar, Jorge Saucedo, Paul Pearson, Ujala Bokhary, Tatiana Kaptzan, Brad Lewis, Carl Tommaso, Philip Krause, Jeremy Thaden, Jae Oh, Roberto M. Lang, Rebecca T. Hahn, Martin B. Leon, William W. O'Neill, Ted Feldman, Charanjit Rihal

^*Corresponding author for this work

Medicine, Cardiology Division

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

48 Scopus citations

Abstract

Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). Results: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

Original language	English (US)
Pages (from-to)	859-872
Number of pages	14
Journal	JACC: Cardiovascular Interventions
Volume	14
Issue number	8
DOIs	https://doi.org/10.1016/j.jcin.2021.02.027
State	Published - Apr 26 2021

Funding

Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences and Boston Scientific; has received research grant support from Boston Scientific assigned to her employer, Henry Ford Health; and holds equity in Encompass Technologies. Dr. Kodali has served as a consultant for Admedus, Meril Lifesciences, Abbott Vascular, JenaValve, and Claret Medical; and has ownership interest in Dura Biotech, Thubrikar Aortic Valve, Micro Interventional Devices, and Supira Medical. Dr. George has served as consultant for Cardiomech, VDyne, MitreMedical, and Neptune Medical. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and has served on the advisory board for Boston Scientific. Dr. Reisman has served as consultant for Edwards Lifesciences. Dr. Hahn has received speaker fees from Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. O’Neill has served as a consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. Dr. Feldman is an employee of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Keywords

mitral valve-in-valve
surgical mitral valve replacement
transcatheter mitral valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jcin.2021.02.027

Cite this

Guerrero, M., Pursnani, A., Narang, A., Salinger, M., Wang, D. D., Eleid, M., Kodali, S. K., George, I., Satler, L., Waksman, R., Meduri, C. U., Rajagopal, V., Inglessis, I., Palacios, I., Reisman, M., Eng, M. H., Russell, H. M., Pershad, A., Fang, K., ... Rihal, C. (2021). Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes. JACC: Cardiovascular Interventions, 14(8), 859-872. https://doi.org/10.1016/j.jcin.2021.02.027

@article{effb45677f12490fbc0e9c9ea6b7d530,

title = "Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes",

abstract = "Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). Results: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.",

keywords = "mitral valve-in-valve, surgical mitral valve replacement, transcatheter mitral valve replacement",

author = "Mayra Guerrero and Amit Pursnani and Akhil Narang and Michael Salinger and Wang, {Dee Dee} and Mackram Eleid and Kodali, {Susheel K.} and Isaac George and Lowell Satler and Ron Waksman and Meduri, {Christopher U.} and Vivek Rajagopal and Ignacio Inglessis and Igor Palacios and Mark Reisman and Eng, {Marvin H.} and Russell, {Hyde M.} and Ashish Pershad and Kenith Fang and Saibal Kar and Rajj Makkar and Jorge Saucedo and Paul Pearson and Ujala Bokhary and Tatiana Kaptzan and Brad Lewis and Carl Tommaso and Philip Krause and Jeremy Thaden and Jae Oh and Lang, {Roberto M.} and Hahn, {Rebecca T.} and Leon, {Martin B.} and O'Neill, {William W.} and Ted Feldman and Charanjit Rihal",

note = "Publisher Copyright: {\textcopyright} 2021 American College of Cardiology Foundation",

year = "2021",

month = apr,

day = "26",

doi = "10.1016/j.jcin.2021.02.027",

language = "English (US)",

volume = "14",

pages = "859--872",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "8",

}

Guerrero, M, Pursnani, A, Narang, A, Salinger, M, Wang, DD, Eleid, M, Kodali, SK, George, I, Satler, L, Waksman, R, Meduri, CU, Rajagopal, V, Inglessis, I, Palacios, I, Reisman, M, Eng, MH, Russell, HM, Pershad, A, Fang, K, Kar, S, Makkar, R, Saucedo, J, Pearson, P, Bokhary, U, Kaptzan, T, Lewis, B, Tommaso, C, Krause, P, Thaden, J, Oh, J, Lang, RM, Hahn, RT, Leon, MB, O'Neill, WW, Feldman, T & Rihal, C 2021, 'Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes', JACC: Cardiovascular Interventions, vol. 14, no. 8, pp. 859-872. https://doi.org/10.1016/j.jcin.2021.02.027

TY - JOUR

T1 - Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses

T2 - MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes

AU - Guerrero, Mayra

AU - Pursnani, Amit

AU - Narang, Akhil

AU - Salinger, Michael

AU - Wang, Dee Dee

AU - Eleid, Mackram

AU - Kodali, Susheel K.

AU - George, Isaac

AU - Satler, Lowell

AU - Waksman, Ron

AU - Meduri, Christopher U.

AU - Rajagopal, Vivek

AU - Inglessis, Ignacio

AU - Palacios, Igor

AU - Reisman, Mark

AU - Eng, Marvin H.

AU - Russell, Hyde M.

AU - Pershad, Ashish

AU - Fang, Kenith

AU - Kar, Saibal

AU - Makkar, Rajj

AU - Saucedo, Jorge

AU - Pearson, Paul

AU - Bokhary, Ujala

AU - Kaptzan, Tatiana

AU - Lewis, Brad

AU - Tommaso, Carl

AU - Krause, Philip

AU - Thaden, Jeremy

AU - Oh, Jae

AU - Lang, Roberto M.

AU - Hahn, Rebecca T.

AU - Leon, Martin B.

AU - O'Neill, William W.

AU - Feldman, Ted

AU - Rihal, Charanjit

PY - 2021/4/26

Y1 - 2021/4/26

N2 - Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). Results: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

AB - Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). Results: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

KW - mitral valve-in-valve

KW - surgical mitral valve replacement

KW - transcatheter mitral valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85103927122&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85103927122&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2021.02.027

DO - 10.1016/j.jcin.2021.02.027

M3 - Article

C2 - 33888231

AN - SCOPUS:85103927122

SN - 1936-8798

VL - 14

SP - 859

EP - 872

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 8

ER -

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes

Abstract

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this