Clinical Trial: Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Early Surgery Versus Conventional Treatment for Asymptomatic Patients With Severe Degenerative Mitral Regurgitation: A Propensity Analysis

Brief Summary: The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and effective in the other prospective study. The consensus guidelines for the performance of early surgery in asymptomatic patients with severe MR are different, reflecting controversy. Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to identify high-risk patients in whom early surgery may be warranted. Thus, the investigators try to compare long-term outcomes of early surgery with those of a conventional-treatment strategy in a large prospective cohort of asymptomatic patients with severe degenerative MR using a propensity analysis, and to identify high-risk subgroups to whom early surgery is more beneficial.

Detailed Summary:

Surgery is the only definitive therapy for severe mitral regurgitation (MR) and the guidelines recommend surgery for management of MR to symptomatic patients or asymptomatic patients with left ventricular (LV) dysfunction. However, the timing of surgical intervention in asymptomatic patients with severe MR remains unclear due to the lack of randomized clinical trials comparing early surgery versus watchful waiting. The benefit of early surgery has been suggested in prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and effective in the other prospective study. The consensus guidelines for the performance of early surgery in asymptomatic patients with severe MR are different, reflecting controversy. The 2006 American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend early surgery for asymptomatic patients if the success rate of mitral valve repair is expected to exceed 90%, but the 2007 European Society of Cardiology (ESC) guidelines recommend watchful waiting for such patients.

Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to identify high-risk patients in whom early surgery may be warranted. Older patients and those with a larger effective regurgitant orifice (ERO) showed increased mortality under medical management, but it is controversial whether early surgery would improve clinical outcome of such patients, because the performance of surgery in high-risk patients might be associated with increased operative risk. Although randomized trials are required to establish indications for early surgery, ethical and financial constraints do not allow us to conduct a randomized trial and the investigators choose to perform a propensity analysis in a large prospective cohort of patients. The investigators try to compare long-term outcomes of early surgery with those of
Sponsor: Asan Medical Center

Current Primary Outcome: Cardiac mortality [ Time Frame: Up to 10 years ]

Cardiac mortality is defined as operative mortality, sudden cardiac death, death from complications of myocardial infarction, heart failure, complications of cardiac intervention or other cardiac disease. Operative mortality is defined as death within 30 days of mitral valve surgery.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Repeat mitral valve surgery [ Time Frame: Up to 10 years ]
  • Hospitalization due to congestive heart failure [ Time Frame: Up to 10 years ]
    A congestive heart failure hospitalization is defined as an unplanned, urgent admission for the management of congestive heart failure . A patient admitted for congestive heart failure have to show resting dyspnea and radiological signs of pulmonary edema and require intravenous diuretics.
  • A composite of cardiac events [ Time Frame: Up to 10 years ]
    A composite of cardiac mortality, repeat MV surgery and hospitalization due to congestive heart failure during follow-up.


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: October 8, 2012
Date Started: December 2007
Date Completion: March 2018
Last Updated: July 11, 2016
Last Verified: July 2016