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

NCT ID: NCT05774808

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2022-02-23

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.

Conditions

Aortic Regurgitation; Functional Mitral Regurgitation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Aortic valve surgery only

Aortic valve replacement

Intervention Type: PROCEDURE

An aortic valve prosthesis is surgically implanted to treat AR

Aortic valve + mitral valve surgery

Aortic valve replacement

Intervention Type: PROCEDURE

An aortic valve prosthesis is surgically implanted to treat AR

Mitral valve annuloplasty

Intervention Type: PROCEDURE

Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR

Interventions

Aortic valve replacement

An aortic valve prosthesis is surgically implanted to treat AR

Intervention Type: PROCEDURE

Mitral valve annuloplasty

Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michele De Bonis

OTHER

Sponsor Role: lead

Responsible Party

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

MOSMIR-SAR

Identifier Type: -

Identifier Source: org_study_id