Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation

Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case.

When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team.

To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients.

The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.

Study Overview

• Status: Completed
• Conditions: Aortic Regurgitation; Functional Mitral Regurgitation
• Intervention / Treatment: Procedure: Aortic valve replacement; Procedure: Mitral valve annuloplasty

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Irccs Ospedale San Raffaele

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

Patients affected by severe AR and moderate MR. The patients are divided in 2 groups: in the Study group, patients underwent isolated aortic valve surgery, while in the Control group, mitral valve surgery was also added.

Description

Inclusion Criteria:

• Adult patients;
• Patients with severe aortic regurgitation (AR) AND moderate mitral regurgitation (MR).
• Patients underwent isolated aortic valve surgery (Study Group) or concomitant mitral valve surgery (Control Group) and
• Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from January 2004 to January 2019

Exclusion Criteria:

• Patient with more than moderate MR

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aortic valve surgery only	Procedure: Aortic valve replacement; An aortic valve prosthesis is surgically implanted to treat AR
Aortic valve + mitral valve surgery	Procedure: Aortic valve replacement; An aortic valve prosthesis is surgically implanted to treat AR; Procedure: Mitral valve annuloplasty; Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality for cardiac causes	Through study completion, an average of 7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
All causes mortality	Through study completion, an average of 7 years
Severe AR recurrency	Through study completion, an average of 7 years
Reintervention for severe AR recurrency	Through study completion, an average of 7 years
Reintervention for severe MR	Through study completion, an average of 7 years

Collaborators and Investigators

• Sponsor: Michele De Bonis

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Mitral Valve Insufficiency; Aortic Valve Insufficiency
• Other Study ID Numbers: MOSMIR-SAR

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