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Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

Publication ,  Journal Article
Whitlow, PL; Feldman, T; Pedersen, WR; Lim, DS; Kipperman, R; Smalling, R; Bajwa, T; Herrmann, HC; Lasala, J; Maddux, JT; Tuzcu, M; Kapadia, S ...
Published in: J Am Coll Cardiol
January 10, 2012

OBJECTIVES: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. METHODS: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. RESULTS: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). CONCLUSIONS: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

January 10, 2012

Volume

59

Issue

2

Start / End Page

130 / 139

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Retrospective Studies
  • Postoperative Complications
  • Mitral Valve Insufficiency
  • Mitral Valve
  • Male
  • Humans
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis
 

Citation

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Whitlow, P. L., Feldman, T., Pedersen, W. R., Lim, D. S., Kipperman, R., Smalling, R., … EVEREST II Investigators, . (2012). Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol, 59(2), 130–139. https://doi.org/10.1016/j.jacc.2011.08.067
Whitlow, Patrick L., Ted Feldman, Wes R. Pedersen, D Scott Lim, Robert Kipperman, Richard Smalling, Tanvir Bajwa, et al. “Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.J Am Coll Cardiol 59, no. 2 (January 10, 2012): 130–39. https://doi.org/10.1016/j.jacc.2011.08.067.
Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, et al. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130–9.
Whitlow, Patrick L., et al. “Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.J Am Coll Cardiol, vol. 59, no. 2, Jan. 2012, pp. 130–39. Pubmed, doi:10.1016/j.jacc.2011.08.067.
Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S, EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130–139.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

January 10, 2012

Volume

59

Issue

2

Start / End Page

130 / 139

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Retrospective Studies
  • Postoperative Complications
  • Mitral Valve Insufficiency
  • Mitral Valve
  • Male
  • Humans
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis