Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients

Saibal Kar, Ted Feldman, Atif Qasim, Alfredo Trento, Samir Kapadia, Wesley Pedersen, D. Scott Lim, Robert Kipperman, Richard W. Smalling, Tanvir Bajwa, Howard C. Hermann, James B. Hermiller, John M. Lasala, Mark Reisman, Donald Glower, Laura Mauri, Patrick Whitlow

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Objectives: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Methods: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. Results: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. Conclusions: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. Trial registration number: NCT01940120.

Original languageEnglish (US)
JournalHeart
DOIs
StateAccepted/In press - Jan 1 2018

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Mitral Valve Insufficiency
Mitral Valve
Mitral Valve Stenosis
Stroke Volume
Mortality
Comorbidity
Dilatation
Safety
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Kar, S., Feldman, T., Qasim, A., Trento, A., Kapadia, S., Pedersen, W., ... Whitlow, P. (Accepted/In press). Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. https://doi.org/10.1136/heartjnl-2017-312605
Kar, Saibal ; Feldman, Ted ; Qasim, Atif ; Trento, Alfredo ; Kapadia, Samir ; Pedersen, Wesley ; Lim, D. Scott ; Kipperman, Robert ; Smalling, Richard W. ; Bajwa, Tanvir ; Hermann, Howard C. ; Hermiller, James B. ; Lasala, John M. ; Reisman, Mark ; Glower, Donald ; Mauri, Laura ; Whitlow, Patrick. / Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. In: Heart. 2018.
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title = "Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients",
abstract = "Objectives: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Methods: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12{\%} or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. Results: At 5 years, clinical follow-up was achieved in 90{\%} of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6{\%}) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75{\%} of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95{\%} CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95{\%} CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. Conclusions: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. Trial registration number: NCT01940120.",
author = "Saibal Kar and Ted Feldman and Atif Qasim and Alfredo Trento and Samir Kapadia and Wesley Pedersen and Lim, {D. Scott} and Robert Kipperman and Smalling, {Richard W.} and Tanvir Bajwa and Hermann, {Howard C.} and Hermiller, {James B.} and Lasala, {John M.} and Mark Reisman and Donald Glower and Laura Mauri and Patrick Whitlow",
year = "2018",
month = "1",
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doi = "10.1136/heartjnl-2017-312605",
language = "English (US)",
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Kar, S, Feldman, T, Qasim, A, Trento, A, Kapadia, S, Pedersen, W, Lim, DS, Kipperman, R, Smalling, RW, Bajwa, T, Hermann, HC, Hermiller, JB, Lasala, JM, Reisman, M, Glower, D, Mauri, L & Whitlow, P 2018, 'Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients', Heart. https://doi.org/10.1136/heartjnl-2017-312605

Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. / Kar, Saibal; Feldman, Ted; Qasim, Atif; Trento, Alfredo; Kapadia, Samir; Pedersen, Wesley; Lim, D. Scott; Kipperman, Robert; Smalling, Richard W.; Bajwa, Tanvir; Hermann, Howard C.; Hermiller, James B.; Lasala, John M.; Reisman, Mark; Glower, Donald; Mauri, Laura; Whitlow, Patrick.

In: Heart, 01.01.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients

AU - Kar, Saibal

AU - Feldman, Ted

AU - Qasim, Atif

AU - Trento, Alfredo

AU - Kapadia, Samir

AU - Pedersen, Wesley

AU - Lim, D. Scott

AU - Kipperman, Robert

AU - Smalling, Richard W.

AU - Bajwa, Tanvir

AU - Hermann, Howard C.

AU - Hermiller, James B.

AU - Lasala, John M.

AU - Reisman, Mark

AU - Glower, Donald

AU - Mauri, Laura

AU - Whitlow, Patrick

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objectives: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Methods: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. Results: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. Conclusions: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. Trial registration number: NCT01940120.

AB - Objectives: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Methods: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. Results: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. Conclusions: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. Trial registration number: NCT01940120.

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U2 - 10.1136/heartjnl-2017-312605

DO - 10.1136/heartjnl-2017-312605

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JO - Heart

JF - Heart

SN - 1355-6037

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