Long Term Follow Up for CTSN Mitral Valve Repair Studies

Long-Term Follow-Up For Participants Of: Evaluation Of Outcomes Following Mitral Valve Repair/Replacement In SMR and Surgical Interventions For MMR Trials

This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Mitral Valve Insufficiency
• Intervention / Treatment: Other: MV Repair; Other: MV Replacement; Other: CABG

Detailed Description

This study is a continuation of two CTSN randomized trials --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- for the purpose of assessing the long-term outcomes of the index surgical therapies. Key clinical outcomes will be collected utilizing electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases. Extended follow-up data will be obtained on up to 199 SMR and 270 MMR trial participants, who were alive at their 2-year follow-up evaluation. Patients will be followed for a minimum of 5 years and up to 10 years after randomization (the time of index surgical procedure). This follow-up data collection will be conducted by the Cardiothoracic Surgical Trials Network (CTSN) primarily utilizing the minimal PHI necessary to link data obtained from the MMR and SMR trials to other healthcare- and/or vital status-related databases.

Because the design of surgical trials for ischemic mitral regurgitation that would use mortality as a primary endpoint requires the enrollment of thousands of patients, the selected primary endpoint for the CTSN SMR and MMR trials was an echocardiographic measure of left ventricular remodeling. Secondary endpoints included, among others, survival, adverse events, readmissions and costs over a 2-year period. The SMR trial showed no difference in left ventricular reverse remodeling, but the rate of moderate or severe mitral regurgitation recurrence was significantly higher with mitral valve repair, resulting in more heart failure-related adverse events and cardiovascular admissions. Longer-term follow-up will be critical to assess whether this observed trend amongst SMR patients will continue and whether a survival difference will manifest over time. In moderate ischemic mitral regurgitation, mitral valve repair provided a more durable correction of mitral regurgitation than coronary artery bypass grafting (CABG) alone, but repair did not improve survival or reduce overall adverse events or readmissions, and was associated with an early hazard of neurological and supraventricular arrhythmic events. Longer-term follow-up of MMR patients will provide insights into whether the higher degree of recurrent mitral regurgitation with CABG alone will be associated with differences in adverse events, readmissions and survival. Additionally, the benefits of alternative surgical treatments for ischemic mitral regurgitation, which have differential upfront risks and costs, will likely extend beyond 2 years. Cost-effectiveness analysis will delineate the long-term cost-benefit trade-offs between mitral valve repair versus replacement for SMR, and of CABG with repair versus CABG alone for MMR, which should inform surgical decision making, and examine how differences in life expectancy and risk profiles of different patient groups affect cost-effectiveness over time. This extended follow-up should provide important clinical and health policy insights.

• Study Type: Observational
• Enrollment (Actual): 368

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
  • Alberta
    • Edmonton, Alberta, Canada, t6g2b7
      • University of Alberta Hospital
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Science Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • Saint Michael's Hospital
    • Toronto, Ontario, Canada, M5B 1W8
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H2W 1T8
      • Centre Hospitalier de l'Universite de Montreal
    • Montreal, Quebec, Canada
      • Hopital du Sacre-Coeur de Montreal
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Einstein Heart Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Greenville, North Carolina, United States, 27834
      • East Carolina Heart Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Research Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health Systems
    • Falls Church, Virginia, United States, 22042
      • Inova Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention

Description

Inclusion Criteria:

• Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention

Exclusion Criteria:

• Patients participating in the MMR and SMR trials who withdrew consent prior to the 2-year follow-up evaluation

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SMR MV Repair; This group of patients had been randomized in the SMR study to mitral valve repair with annuloplasty ring.	Other: MV Repair; Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.; Other Names: Mitral Valve Repair
MV Replacement; This group of patients had been randomized in the SMR study to mitral valve replacement.	Other: MV Replacement; Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.; Other Names: Mitral Valve Replacement
MMR MV Repair; This group of patients had been randomized in the MMR study to mitral valve repair with annuloplasty ring.	Other: MV Repair; Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.; Other Names: Mitral Valve Repair
CABG; This group of patients had been randomized in the MMR study to receive CABG	Other: CABG; Participants underwent coronary artery bypass grafting; Other Names: Coronary Artery Bypass Grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	All-cause mortality will be assessed.	up to 10 years post-surgery (at the time of registry data transfer)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeat Cardiac Interventions for MR	Repeat cardiac interventions for MR in particular will be determined for the duration of follow-up and will be analyzed using a time-to-event analysis.	up to 10 years post-surgery (at the time of registry data transfer)
Hospital Costs	Hospital costs will be calculated for the duration of follow-up utilizing the minimum PHI necessary to link the CTSN databases to other databases (e.g., Vizient, CMS Medicare, and Canadian Province databases). Cost data will be extracted from the Vizient operational database system for member sites or national payer or state-wide databases. Dates of charges and revenue codes will be used to match the cost data with data on readmissions. We will estimate costs including center-specific ratios of cost to charges. These ratios will be based on the annual Medicare costs reports submitted annually by participating study sites to Medicare. These data will be used to impute data for patients treated at hospitals, which are non-Vizient members.	up to 10 years post-surgery (at the time of registry data transfer)
Cost Effectiveness	Cost Effectiveness using Incremental Cost Effectiveness Ratio and Net Health Benefit parameters. The primary objective of the cost-effectiveness analysis (CEA) is to estimate the incremental cost-effectiveness ratio (ICER) of the intervention under investigation as compared to the study-defined alternative. This ratio measures the ratio of the difference in costs and outcomes between the two study arms for each trial, with outcomes measured as life-years. We will also compute net health benefits (NHB) as an alternative way of looking at cost-effectiveness. This parameter compares the incremental effectiveness of an intervention with the minimum health effect that society would demand in return for the investment; i.e., with the health produced by investing at the societal ceiling cost-effectiveness ratio.	up to 10 years post-surgery (at the time of registry data transfer)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Canadian Institutes of Health Research (CIHR)
• Investigators: Study Chair: Richard Weisel, MD, Toronto General Hospital; Principal Investigator: Annetine C Gelijns, PhD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Mitral Valve Disease; Ischemic Mitral Regurgitation; Moderate Mitral Regurgitation; Severe Mitral Regurgitation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Mitral Valve Insufficiency
• Other Study ID Numbers: GCO 08-1078-00012; U01HL088942 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No