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

Completed

• Conditions: Functional Mitral Regurgitation; Aortic Regurgitation
• Interventions: Procedure: Aortic valve replacement; Procedure: Mitral valve annuloplasty

• Registration Number: NCT05774808
• Lead Sponsor: Michele De Bonis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Study First Submitted: 2023-01-30
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic valve surgery only	Aortic valve replacement	-
Aortic valve + mitral valve surgery	Mitral valve annuloplasty	-
Aortic valve + mitral valve surgery	Aortic valve replacement	-

Primary Outcome Measures

Name	Time	Method
Mortality for cardiac causes	Through study completion, an average of 7 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy