Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVEREST II study

Donald D. Glower; Saibal Kar; Alfredo Trento; D. Scott Lim; Tanvir Bajwa; Ramon Quesada; Patrick L. Whitlow; Michael J. Rinaldi; Paul Grayburn; Michael J. Mack; Laura Mauri; Patrick M McCarthy; Ted Feldman

doi:10.1016/j.jacc.2013.12.062

Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVEREST II study

Donald D. Glower^*, Saibal Kar, Alfredo Trento, D. Scott Lim, Tanvir Bajwa, Ramon Quesada, Patrick L. Whitlow, Michael J. Rinaldi, Paul Grayburn, Michael J. Mack, Laura Mauri, Patrick M McCarthy, Ted Feldman

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

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

368 Scopus citations

Abstract

Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

Original language	English (US)
Pages (from-to)	172-181
Number of pages	10
Journal	Journal of the American College of Cardiology
Volume	64
Issue number	2
DOIs	https://doi.org/10.1016/j.jacc.2013.12.062
State	Published - Jul 15 2014

Funding

Dr. Kar has received honoraria and institutional research support from Abbott. Dr. Lim is a consultant for and has received research grants from Abbott Vascular . Dr. Whitlow’s institution has received research support for participating in the EVEREST trials from Abbott. Dr. Rinaldi is a consultant for Abbott. Dr. Grayburn has received grants from Abbott , Medtronic , Baxter , ValTech Cardio , and Guided Delivery Systems ; and has received consulting fees and/or honoraria from Abbott, Tendyne, and Bracco Diagnostics. Dr. Mauri’s institution has received research grants from Abbott , Boston Scientific , Cordis , Medtronic , Eli Lilly , Daiichi-Sankyo , Bristol-Myers Squibb , and Sanofi-Aventis . Dr. McCarthy is a consultant to Abbott and Edwards Lifesciences; and receives royalties from Edwards Lifesciences. Dr. Feldman is a consultant for and has received honoraria and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.

Keywords

high surgical risk
mitral valve insufficiency
percutaneous

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2013.12.062

Cite this

Glower, D. D., Kar, S., Trento, A., Lim, D. S., Bajwa, T., Quesada, R., Whitlow, P. L., Rinaldi, M. J., Grayburn, P., Mack, M. J., Mauri, L., McCarthy, P. M., & Feldman, T. (2014). Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVEREST II study. Journal of the American College of Cardiology, 64(2), 172-181. https://doi.org/10.1016/j.jacc.2013.12.062

@article{a9d812e3ea32468d804a5ff04d35e12a,

title = "Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVEREST II study",

abstract = "Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).",

keywords = "high surgical risk, mitral valve insufficiency, percutaneous",

author = "Glower, {Donald D.} and Saibal Kar and Alfredo Trento and Lim, {D. Scott} and Tanvir Bajwa and Ramon Quesada and Whitlow, {Patrick L.} and Rinaldi, {Michael J.} and Paul Grayburn and Mack, {Michael J.} and Laura Mauri and McCarthy, {Patrick M} and Ted Feldman",

note = "Funding Information: Dr. Kar has received honoraria and institutional research support from Abbott. Dr. Lim is a consultant for and has received research grants from Abbott Vascular . Dr. Whitlow{\textquoteright}s institution has received research support for participating in the EVEREST trials from Abbott. Dr. Rinaldi is a consultant for Abbott. Dr. Grayburn has received grants from Abbott , Medtronic , Baxter , ValTech Cardio , and Guided Delivery Systems ; and has received consulting fees and/or honoraria from Abbott, Tendyne, and Bracco Diagnostics. Dr. Mauri{\textquoteright}s institution has received research grants from Abbott , Boston Scientific , Cordis , Medtronic , Eli Lilly , Daiichi-Sankyo , Bristol-Myers Squibb , and Sanofi-Aventis . Dr. McCarthy is a consultant to Abbott and Edwards Lifesciences; and receives royalties from Edwards Lifesciences. Dr. Feldman is a consultant for and has received honoraria and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore. All other authors have reported they have no relationships relevant to the contents of this paper to disclose. ",

year = "2014",

month = jul,

day = "15",

doi = "10.1016/j.jacc.2013.12.062",

language = "English (US)",

volume = "64",

pages = "172--181",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "2",

}

Glower, DD, Kar, S, Trento, A, Lim, DS, Bajwa, T, Quesada, R, Whitlow, PL, Rinaldi, MJ, Grayburn, P, Mack, MJ, Mauri, L, McCarthy, PM & Feldman, T 2014, 'Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVEREST II study', Journal of the American College of Cardiology, vol. 64, no. 2, pp. 172-181. https://doi.org/10.1016/j.jacc.2013.12.062

TY - JOUR

T1 - Percutaneous mitral valve repair for mitral regurgitation in high-risk patients

T2 - Results of the EVEREST II study

AU - Glower, Donald D.

AU - Kar, Saibal

AU - Trento, Alfredo

AU - Lim, D. Scott

AU - Bajwa, Tanvir

AU - Quesada, Ramon

AU - Whitlow, Patrick L.

AU - Rinaldi, Michael J.

AU - Grayburn, Paul

AU - Mack, Michael J.

AU - Mauri, Laura

AU - McCarthy, Patrick M

AU - Feldman, Ted

N1 - Funding Information: Dr. Kar has received honoraria and institutional research support from Abbott. Dr. Lim is a consultant for and has received research grants from Abbott Vascular . Dr. Whitlow’s institution has received research support for participating in the EVEREST trials from Abbott. Dr. Rinaldi is a consultant for Abbott. Dr. Grayburn has received grants from Abbott , Medtronic , Baxter , ValTech Cardio , and Guided Delivery Systems ; and has received consulting fees and/or honoraria from Abbott, Tendyne, and Bracco Diagnostics. Dr. Mauri’s institution has received research grants from Abbott , Boston Scientific , Cordis , Medtronic , Eli Lilly , Daiichi-Sankyo , Bristol-Myers Squibb , and Sanofi-Aventis . Dr. McCarthy is a consultant to Abbott and Edwards Lifesciences; and receives royalties from Edwards Lifesciences. Dr. Feldman is a consultant for and has received honoraria and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.

PY - 2014/7/15

Y1 - 2014/7/15

N2 - Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

AB - Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

KW - high surgical risk

KW - mitral valve insufficiency

KW - percutaneous

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Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVEREST II study

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