Improving Mitral Repair for Functional Mitral Regurgitation

Not Applicable

Completed

• Conditions: Cardiomyopathy; Congestive Heart Failure; Valvular Heart Disease; Heart Disease; Cardiovascular Diseases; Coronary Artery Disease; Mitral Valve Disease
• Interventions: Procedure: Undersizing Mitral Annuloplasty; Procedure: Papillary Muscle Approximation

• Registration Number: NCT03366649
• Lead Sponsor: Emory University

Brief Summary

The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.

The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though widely adopted, durability of the repair is less, as 58% of the patients present with recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA failure, but research indicates that some geometric indices might be strong predictors. The investigators are interested in testing the hypothesis that, elevated lateral inter-papillary muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the first part of this study, the study team will measure lateral IPMS before surgery, and relate to post-surgery FMR severity at discharge/30 days, 6 months and 12 months.

A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is expected to improve the durability of UMA. In the second part of this study, the investigators will perform PMA and UMA together and determine if FMR severity is reduced at discharge/30 days, 6 months and 12 months.

Detailed Description

Functional mitral regurgitation (FMR) is a common heart valve lesion that is observed in patients suffering for cardiomyopathies. Timely surgical repair of FMR can reduce volume overload and potentially improve cardiac function. Durable surgical techniques for FMR repair are lacking. Undersizing mitral annuloplasty (UMA) is the current technique of choice, but its durability is quite poor. Thirty five percent of the repairs fail within one year and 58% fail within 2 years.

One of the probable mechanisms causing UMA failure is elevated lateral inter-papillary muscle separation (IPMS). The study investigators are interested in understanding if the extent of lateral IPMS has a direct impact on the failure rates of UMA at 1 year post surgery. Secondly, the investigators are interested in determining if patients with elevated lateral IPMS benefit from papillary muscle approximation (PMA) along with UMA.

The investigators are interested in determining the best way to correct functional mitral regurgitation, as there is currently not one technique that is established to better than the other. The most common repair technique is called undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Another more recent technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. In this research study, the study team is investigating whether they can identify those patients who will benefit from one repair over another.

The primary objective of this protocol is to investigate if pre-operative IPMS is predictive of FMR severity at 12 months after UMA to repair FMR. Furthermore, whether a cut-off value of pre-operative inter-papillary muscle separation can be established to predict patients who might have failure of UMA.

The secondary objective of this protocol is to investigate if adding PMA to UMA is an effective technique in reducing recurrence of FMR at 12 months post-procedure.

Study Timeline

• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-08
• Study Start: 2018-03-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Mitral regurgitation of moderate or greater severity, as defined by the guidelines of the American Society of Echocardiography (via a transthoracic echo)
• Cardiomyopathy of ischemic or non-ischemic origins, with or without the need for coronary revascularization
• Concomitant right-sided valve repair or replacement (i.e. patients requiring concomitant tricuspid procedures)
• Able to sign informed consent and release of medical information forms

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Exclusion Criteria

• Any evidence of structural (chordal or leaflet) mitral lesions
• Prior mitral valve repair
• Contraindication for cardiopulmonary bypass
• Clinical signs of cardiogenic shock at the time of randomization
• ST-segment elevation myocardial infarction within 14 days before inclusion in this study
• Congenital heart disease, except patent foramen ovale (PFO) or atrial septal defect (ASD)
• Chronic renal insufficiency defined by creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
• Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
• Pregnancy at the time of randomization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UMA + PMA (Group 2)	Undersizing Mitral Annuloplasty	Participants in the UMA + PMA group will receive an undersizing mitral annuloplasty (UMA) with papillary muscle approximation (PMA).
UMA (Group 1)	Undersizing Mitral Annuloplasty	Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA).
UMA + PMA (Group 2)	Papillary Muscle Approximation	Participants in the UMA + PMA group will receive an undersizing mitral annuloplasty (UMA) with papillary muscle approximation (PMA).

Primary Outcome Measures

Name	Time	Method
Change in FMR Severity	Pre-Intervention, Post-Intervention (30 Days), Post-Intervention (6 Months), Post-Intervention (12 Months)	Severity of mitral regurgitation measured using cardiac echocardiography and/or MRI (per physician's discretion).

Secondary Outcome Measures

Name	Time	Method
Change in Minnesota Living with Heart Failure (MLHF) Questionnaire Score	Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)	The Minnesota Living with Heart Failure Questionnaire is a 21-item questionnaire that asks participants to describe how much their heart failure has affected life during the past month (4 weeks). Participants are asked if their heart failure prevented them from living as they want when completing daily tasks. Responses are rated on a scale from 0 to 5; 0 represents "no", 1 represents "very little" and 5 represents "very much" on a continuum. The MLHF score is obtained by summing the subjects responses. A minimum score is 0 indicating no affect to life and a maximum score is 105 indicating the greatest affect to life.
All Cause Readmission Rate	Post Surgery (Up to 30 Days)	Readmission rate will be calculated for any cause within the first 30 days following surgery throughout the duration of the study.
Number of Major Adverse Cardiac Events (MACE)	Up to 12 months post -intervention	MACE is defined as a composite of clinical events comprised of the following: * Death; * Stroke; * Worsening heart failure (+1 New York Heart Association (NYHA) class); * Congestive heart failure (CHF) hospitalization; * Mitral valve re-intervention
Mortality Rate	Post-Intervention (Up to 20 Days), Post-Intervention (Month 6), Post-Intervention (Month 12)	The number of participants who are deceased will be collected throughout the study at discharge and planned follow up visits.
Change in Functional Status assessed by 6-Minute Walk Test (6MWT)	Baseline, Post-intervention (Month 6), Post-Intervention (Month 12)	Functional status will be measured by a 6-minute walk test, which assesses the distance walked (in feet) on a flat, hard surface in a period of 6 minutes (the 6MWD). The test is used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease. Optimal reference equations from healthy population-based samples using standardized 6MWT methods are not yet available. A low 6MWD is nonspecific and nondiagnostic. When the 6MWD is reduced, a thorough search for the cause of the impairment is warranted.
Change in Quality-of-Life Scale Score	Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)	Participants will be asked to measure their perceived quality of life on a scale from 0 to 100 where 0 indicates "worst imaginable health state" and 100 indicates "best imaginable health state".
Change in Left Ventricular Mass	Baseline, Post-Intervention (Month 12)	Change in left ventricular mass at 12 months post intervention compared to baseline as measured by cardiac MRI.
Heart Failure Readmission Rate	Post Surgery (Up to 30 Days)	Readmission rate will be calculated for heart failure after 30 days following surgery throughout the duration of the study. Classification of readmission as heart failure related requires at least 2 out of the following signs and symptoms of acute decompensated heart failure: * Dyspnea felt related to HF; * Treatment with intravenous diuretic, vasodilator or inotropic therapy; * X ray evidence of pulmonary edema or pulmonary vascular congestion; * Rales on physical exam; * Pulmonary capillary wedge pressure (PCWP) or LVEDP \> 18mm Hg
Change in Left Ventricular Volume	Baseline, Post-Intervention (Month 12)	Change in left ventricular volume at 12 months post intervention compared to baseline as measured by cardiac MRI

Trial Locations

Locations (3)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory St. Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States