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One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.

Publication ,  Journal Article
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 ...
Published in: Circulation
January 2, 2019

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.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

January 2, 2019

Volume

139

Issue

1

Start / End Page

37 / 47

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Severity of Illness Index
  • Risk Factors
  • Risk Assessment
  • Registries
  • Recovery of Function
  • Prosthesis Design
  • Prospective Studies
  • Postoperative Complications
 

Citation

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Ailawadi, G., Lim, D. S., Mack, M. J., Trento, A., Kar, S., Grayburn, P. A., … EVEREST II Investigators, . (2019). One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation, 139(1), 37–47. https://doi.org/10.1161/CIRCULATIONAHA.117.031733
Ailawadi, Gorav, D Scott Lim, Michael J. Mack, Alfredo Trento, Saibal Kar, Paul A. Grayburn, Donald D. Glower, et al. “One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.Circulation 139, no. 1 (January 2, 2019): 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.
Ailawadi, Gorav, et al. “One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.Circulation, vol. 139, no. 1, Jan. 2019, pp. 37–47. Pubmed, doi:10.1161/CIRCULATIONAHA.117.031733.
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, EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37–47.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

January 2, 2019

Volume

139

Issue

1

Start / End Page

37 / 47

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Severity of Illness Index
  • Risk Factors
  • Risk Assessment
  • Registries
  • Recovery of Function
  • Prosthesis Design
  • Prospective Studies
  • Postoperative Complications