One-Year Outcomes after MitraClip for Functional Mitral Regurgitation

Gorav Ailawadi, D. Scott Lim, Michael J. Mack, Alfredo Trento, Saibal Kar, Paul A. Grayburn, Donald D. Glower, Andrew Wang, Elyse Foster, Atif Qasim, Neil J. Weissman, Jeffrey Ellis, Lori Crosson, Frank Fan, Irving L. Kron, Paul J. Pearson, Ted Feldman

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). Methods: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. Results: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients (P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% (P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure (P<0.0001). Conclusions: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

Original languageEnglish (US)
Pages (from-to)37-47
Number of pages11
JournalCirculation
Volume139
Issue number1
DOIs
StatePublished - Jan 2 2019
Externally publishedYes

Fingerprint

Mitral Valve Insufficiency
Mitral Valve
Registries
Ventricular Remodeling
Mortality
Kaplan-Meier Estimate
Stroke Volume
Multicenter Studies
Heart Ventricles
Renal Insufficiency
Dilatation
Hospitalization
Randomized Controlled Trials
Heart Failure
Stroke
Clinical Trials
Safety

Keywords

  • heart valves
  • mitral valve annuloplasty
  • mitral valve insufficiency

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Ailawadi, G., Lim, D. S., Mack, M. J., Trento, A., Kar, S., Grayburn, P. A., ... Feldman, T. (2019). One-Year Outcomes after MitraClip for Functional Mitral Regurgitation. Circulation, 139(1), 37-47. https://doi.org/10.1161/CIRCULATIONAHA.117.031733

One-Year Outcomes after MitraClip for Functional Mitral Regurgitation. / Ailawadi, Gorav; Lim, D. Scott; Mack, Michael J.; Trento, Alfredo; Kar, Saibal; Grayburn, Paul A.; Glower, Donald D.; Wang, Andrew; Foster, Elyse; Qasim, Atif; Weissman, Neil J.; Ellis, Jeffrey; Crosson, Lori; Fan, Frank; Kron, Irving L.; Pearson, Paul J.; Feldman, Ted.

In: Circulation, Vol. 139, No. 1, 02.01.2019, p. 37-47.

Research output: Contribution to journalArticle

Ailawadi, G, Lim, DS, Mack, MJ, Trento, A, Kar, S, Grayburn, PA, Glower, DD, Wang, A, Foster, E, Qasim, A, Weissman, NJ, Ellis, J, Crosson, L, Fan, F, Kron, IL, Pearson, PJ & Feldman, T 2019, 'One-Year Outcomes after MitraClip for Functional Mitral Regurgitation', Circulation, vol. 139, no. 1, pp. 37-47. https://doi.org/10.1161/CIRCULATIONAHA.117.031733
Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA et al. One-Year Outcomes after MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. https://doi.org/10.1161/CIRCULATIONAHA.117.031733
Ailawadi, Gorav ; Lim, D. Scott ; Mack, Michael J. ; Trento, Alfredo ; Kar, Saibal ; Grayburn, Paul A. ; Glower, Donald D. ; Wang, Andrew ; Foster, Elyse ; Qasim, Atif ; Weissman, Neil J. ; Ellis, Jeffrey ; Crosson, Lori ; Fan, Frank ; Kron, Irving L. ; Pearson, Paul J. ; Feldman, Ted. / One-Year Outcomes after MitraClip for Functional Mitral Regurgitation. In: Circulation. 2019 ; Vol. 139, No. 1. pp. 37-47.
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abstract = "Background: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). Methods: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12{\%} or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. Results: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9{\%}) with SMR underwent the MitraClip procedure. At baseline, 80.5{\%} of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6{\%}), stroke (2.3{\%}), and renal failure (1.5{\%}). At discharge, 88.8{\%} had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8{\%}. The majority of surviving patients (84.7{\%}) remained with MR ≤2+ and New York Heart Association class I/II (83.0{\%}). Kaplan-Meier survival at 1 year was 74.1{\%} in HR patients and 86.4{\%} in non-HR patients (P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0{\%} versus 87.0{\%}) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1{\%} versus 91.8{\%} (P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure (P<0.0001). Conclusions: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.",
keywords = "heart valves, mitral valve annuloplasty, mitral valve insufficiency",
author = "Gorav Ailawadi and Lim, {D. Scott} and Mack, {Michael J.} and Alfredo Trento and Saibal Kar and Grayburn, {Paul A.} and Glower, {Donald D.} and Andrew Wang and Elyse Foster and Atif Qasim and Weissman, {Neil J.} and Jeffrey Ellis and Lori Crosson and Frank Fan and Kron, {Irving L.} and Pearson, {Paul J.} and Ted Feldman",
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TY - JOUR

T1 - One-Year Outcomes after MitraClip for Functional Mitral Regurgitation

AU - Ailawadi, Gorav

AU - Lim, D. Scott

AU - Mack, Michael J.

AU - Trento, Alfredo

AU - Kar, Saibal

AU - Grayburn, Paul A.

AU - Glower, Donald D.

AU - Wang, Andrew

AU - Foster, Elyse

AU - Qasim, Atif

AU - Weissman, Neil J.

AU - Ellis, Jeffrey

AU - Crosson, Lori

AU - Fan, Frank

AU - Kron, Irving L.

AU - Pearson, Paul J.

AU - Feldman, Ted

PY - 2019/1/2

Y1 - 2019/1/2

N2 - Background: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). Methods: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. Results: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients (P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% (P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure (P<0.0001). Conclusions: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

AB - Background: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). Methods: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. Results: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients (P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% (P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure (P<0.0001). Conclusions: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

KW - heart valves

KW - mitral valve annuloplasty

KW - mitral valve insufficiency

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