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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774795
• Other study ID #: LOTMAR
• Status: Completed
• Start date: March 24, 2021
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• Mitral valve surgery
Mitral valve repair or replacement to treat mitral regurgitation
• Aortic valve surgery
Aortic valve replacement to treat aortic regurgitation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		through study completion, an average of 12 years