Mitral Valve Repair or Replacement for Severe Ischemic Mitral Regurgitation - CTSN: MV Repair vs. Replacement

Nov 09, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health; Canadian Institutes of Health Research
Date Presented:
11/09/2015
Date Published:
11/09/2015
Original Posted Date:
11/09/2015
References

Description:

The goal of the trial was to compare mitral valve repair compared with mitral valve replacement among patients with severe ischemic (functional) mitral regurgitation.

Contribution to the Literature: While this trial showed no difference in 2-year mortality, moderate to severe mitral regurgitation was markedly increased with mitral valve repair.

Study Design

  • Randomized
  • Parallel

Patients with severe ischemic (functional) mitral regurgitation were randomized to mitral valve repair with mitral annuloplasty (n = 126) versus mitral valve replacement with chordal sparing (n = 125).

Mitral valve repair was performed with a rigid or semi-rigid mitral annuloplasty ring.

Mitral valve replacement included preservation of the subvalvular complex by the chordal sparing technique. The choice of a bioprosthetic vs. mechanical valve was left to surgeon discretion; however, a bioprosthetic valve was most commonly used.

  • Total number of enrollees: 251
  • Duration of follow-up: 2 years
  • Mean patient age: 69 years
  • Percentage female: 39%
  • Percentage diabetics: 38%
  • Approximately 75% of patients underwent concomitant coronary artery bypass grafting

Inclusion criteria:

  • Patients undergoing open heart surgery for treatment of severe ischemic (functional) mitral regurgitation with or without coronary artery bypass grafting

Principal Findings:

The primary outcome, mean left ventricular end-systolic volume index (LVESVI) at 1 year, was 55 ± 25 ml/m2 in the repair group vs. 61 ± 32 ml/m2 in the replacement group (mean change from baseline, −6.6 and −6.8 ml per square meter, respectively)

Secondary outcomes:

  • Mortality at 2 years: 19% in the repair group vs. 23% in the replacement group (p = 0.42)
  • Moderate or severe mitral regurgitation at 2 years: 59% in the repair group vs. 3.8% in the replacement group (p < 0.001)
  • Serious adverse event related to heart failure: 24% in the repair group vs. 15% in the replacement group (p = 0.05)
  • Readmission for a cardiovascular event: 48% in the repair group vs. 32% in the replacement group (p = 0.01)
  • LVESVI at 2 years: 53 cc/m2 in the repair group vs. 61 cc/m2 in the replacement group
  • LV ejection fraction at 2 years: 43% in the repair group vs. 38% in the replacement group

Interpretation:

Among individuals with severe ischemic (functional) mitral regurgitation, mitral valve repair with mitral annuloplasty vs. mitral valve replacement was associated with similar mortality and LV geometry/function at 2 years. However, patients who underwent mitral valve repair had a marked increase in moderate or severe mitral regurgitation and serious adverse events related to heart failure at 2 years vs. mitral valve replacement.

This trial has important implications since mitral valve repair is a less morbid procedure than mitral valve replacement; however, it results in less durable mitral valve function. Future research may help to understand the mechanisms responsible for progressive mitral regurgitation after mitral annuloplasty. These results do not apply to patients with primary (degenerative mitral regurgitation).

References:

Goldstein D, Moskowitz AJ, Gelijns AC, et al., on behalf of the CTSN. Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation. N Engl J Med 2015;Nov 9:[Epub ahead of print].

Acker MA, Parides MK, Perrault LP, et al., on behalf of the CTSN. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med 2014;370:23-32.

Presented by Dr. Daniel Goldstein at the American Heart Association Scientific Sessions, Orlando, FL, November 9, 2015.

Keywords: Cardiac Surgical Procedures, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Mitral Valve Annuloplasty, Mitral Valve Insufficiency, Secondary Prevention, Stroke Volume, AHA Annual Scientific Sessions


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