LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery

NCT ID: NCT05774795

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2021-03-31

Brief Summary

Multivalvular heart disease is a highly prevalent clinical condition that comprises 14.6% of the patients undergoing valvular surgery. Specifically, aortic valve regurgitation (AR) can be present in a considerable proportion of patients undergoing mitral valve (MV) surgery. In the Society of Thoracic Surgeons database, con- comitant aortic and mitral surgery accounted for 57.8% of the total multivalvular procedures with an unadjusted mortality rate of 10.7%.

When both the aortic and MVs exhibit severe disease, con- comitant valve surgery is well-accepted by the surgical commu- nity and supported by current guidelines. On the other hand, when the aortic valve (AV) shows only moderate regurgita- tion, which would not be surgically treated if singly present, the appropriate management of the AV pathology at the time of MV surgery is still under debate.

The American College of Cardiology guidelines state that aortic valve replacement (AVR) is reasonable (class IIa) in patients with moderate AR (stage B) while undergoing surgery on the ascend- ing aorta, a coronary artery bypass graft or MV surgery (level of evidence: C). Conversely, the latest European Society of Cardiology guidelines on valvular heart disease define as con- troversial the decision to treat the AV in patients with moderate AR who undergo MV surgery, considering the slow progression of this disease. In this group of patients, they advocate a heart team approach that will take into account the aetiology of AR, the life expectancy of the patient, the operative risk and other clinical factors.

This disagreement may lead to uncertainty about how patients with less than severe AR should be managed during MV surgery, especially considering the burden of double-valve surgical procedures.

The goal of this study is to evaluate the immediate and long- term outcomes, including the need for a new procedure on the AV, in patients with moderate AR at the time of MV surgery.

Conditions

Aortic Regurgitation; Mitral Regurgitation

Study Design

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

Study Groups

Mitral valve surgery only

Mitral valve surgery

Intervention Type: PROCEDURE

Mitral valve repair or replacement to treat mitral regurgitation

Mitral valve surgery + Aortic valve surgery

Mitral valve surgery

Intervention Type: PROCEDURE

Mitral valve repair or replacement to treat mitral regurgitation

Aortic valve surgery

Intervention Type: PROCEDURE

Aortic valve replacement to treat aortic regurgitation

Interventions

Mitral valve surgery

Mitral valve repair or replacement to treat mitral regurgitation

Intervention Type: PROCEDURE

Aortic valve surgery

Aortic valve replacement to treat aortic regurgitation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

General criteria for both groups

• Adult patients;
• Patients undergoing mitral valve surgery, with moderate-grade AR, as assessed by preoperative echocardiography;

Specific criteria Group 1 (study group) - Patients who have not undergone aortic valve surgery in conjunction with mitral valve surgery

Specific criteria Group 2 (control group)

• Patients undergoing aortic valve surgery in conjunction with mitral valve surgery

Exclusion Criteria

• Patients who have not undergone mitral surgery
• Patients undergoing multivalvular surgery other than mitro-aortic surgery

• 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 the Advanced and Research Therapies

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

LOTMAR

Identifier Type: -

Identifier Source: org_study_id