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

NCT05774795 | Completed

• 1 other identifier: LOTMAR
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  through study completion, an average of 12 years

Study Arms (2)

Mitral valve surgery only

Procedure: Mitral valve surgery

Mitral valve surgery + Aortic valve surgery

Procedure: Mitral valve surgery; Procedure: Aortic valve surgery

Interventions

Mitral valve surgery PROCEDURE

Mitral valve repair or replacement to treat mitral regurgitation

Mitral valve surgery + Aortic valve surgery; Mitral valve surgery only

Aortic valve surgery PROCEDURE

Aortic valve replacement to treat aortic regurgitation

Mitral valve surgery + Aortic 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 needing a mitral valve surgery and affected by moderate aortic regurgitation. In one group, also aortic valve surgery is performed, in the other, only surgery on the mitral valve is performed

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

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

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 the Advanced and Research Therapies

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 20, 2023
• Study Start: March 24, 2021
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)