MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery (MRI-MVS)

Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study

Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.

Study Overview

• Status: Unknown
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Procedure: Mitral valve surgery

Detailed Description

Mitral regurgitation is a common disease which can lead to heart failure and death if left untreated. The only known therapy for mitral regurgitation is correction of the mitral valve, most commonly performed by surgical repair or replacement. According the STS database, there were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for replacement. This data does not take into account long-term mortality and morbidity from re-operation and life-long anti-coagulation as well as changes in quality of life.

The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Susan Miller, RN; Phone Number: 9739715597; Email: susan.miller@atlantichealth.org
• Study Contact Backup: Name: Seth Uretsky, MD; Phone Number: 9739715597; Email: seth.uretsky@atlantichealth.org

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Morristown Medical Center
      • Contact: Seth Uretsky, MD; Phone Number: 973-971-5597; Email: seth.uretsky@atlantichealth.org
      • Contact: Susan Miller, RN; Phone Number: 9739715597; Email: susan.miller@atlantichealth.org

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for mitral regurgitation.

Description

Inclusion Criteria:

• Age 18 years and older.
• Able to give informed consent.
• Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days.
• Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease.

Exclusion Criteria:

• Secondary mitral regurgitation.
• Have a device which is not compatible with MRI
• Claustrophobia preventing MRI.
• Concomitant CABG, other valve surgery, or other cardiac surgery.
• Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mitral Valve Surgery; Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency.	Procedure: Mitral valve surgery; ACC/AHA guideline directed mitral valve repair or replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.	Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.	2 years
Repair vs Replacement	Assess if the likelihood of mitral valve repair vs. replacement is associated with mitral regurgitant severity as quantified by MRI.	4 months
Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.	Cross sectional data regarding severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery	0 days
Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.	Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.	4 months

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: MRI; Mitral Regurgitation; Mitral valve Surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 967510-2

Plan for Individual participant data (IPD)

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