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

NCT05774808 | Completed

• 1 other identifier: MOSMIR-SAR
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mortality for cardiac causes

  Through study completion, an average of 7 years

Secondary Outcomes (4)

• 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

Study Arms (2)

Aortic valve surgery only

Procedure: Aortic valve replacement

Aortic valve + mitral valve surgery

Procedure: Aortic valve replacement; Procedure: Mitral valve annuloplasty

Interventions

Aortic valve replacement PROCEDURE

An aortic valve prosthesis is surgically implanted to treat AR

Aortic valve + mitral valve surgery; Aortic valve surgery only

Mitral valve annuloplasty PROCEDURE

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

Aortic valve + mitral valve surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient with more than moderate MR

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement; Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Cardiac Valve Annuloplasty

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 20, 2023
• Study Start: February 2, 2022
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)