Long Term Follow Up for CTSN Mitral Valve Repair Studies

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03066050

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Canadian Institutes of Health Research (CIHR) (Other)

368

Enrollment

Locations

71.9

Anticipated Duration (Months)

15.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Insufficiency Coronary Artery Disease	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 Design

Study Type:

Observational

Actual Enrollment :

368 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

May 3, 2017

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Survival [up to 10 years post-surgery (at the time of registry data transfer)]
All-cause mortality will be assessed.

Secondary Outcome Measures

Repeat Cardiac Interventions for MR [up to 10 years post-surgery (at the time of registry data transfer)]
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.
Hospital Costs [up to 10 years post-surgery (at the time of registry data transfer)]
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.
Cost Effectiveness [up to 10 years post-surgery (at the time of registry data transfer)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	Emory University	Atlanta	Georgia	United States	30308
3	University of Maryland	Baltimore	Maryland	United States	21201
4	Suburban Hospital	Bethesda	Maryland	United States	20814
5	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
6	Montefiore Einstein Heart Center	Bronx	New York	United States	10467
7	Columbia University Medical Center	New York	New York	United States	10032
8	Mission Hospital	Asheville	North Carolina	United States	28801
9	Duke University	Durham	North Carolina	United States	27710
10	East Carolina Heart Institute	Greenville	North Carolina	United States	27834
11	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
12	Ohio State University	Columbus	Ohio	United States	43210
13	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
14	Baylor Research Institute	Plano	Texas	United States	75093
15	University of Virginia Health Systems	Charlottesville	Virginia	United States	22908
16	Inova Heart and Vascular Institute	Falls Church	Virginia	United States	22042
17	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G2B7
18	Sunnybrook Health Science Centre	Toronto	Ontario	Canada	M4N 3M5
19	Saint Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
20	Toronto General Hospital	Toronto	Ontario	Canada	M5B 1W8
21	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
22	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec	Canada	H2W 1T8
23	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec	Canada
24	Institut Universitaire de Cardiologie de Quebec (Hopital Laval)	Quebec		Canada	G1V 4G5