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Clinical Trials/NCT05774795
NCT05774795
Completed
Not Applicable

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

Michele De Bonis1 site in 1 country183 target enrollmentMarch 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Regurgitation
Sponsor
Michele De Bonis
Enrollment
183
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2021
End Date
March 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of the Advanced and Research Therapies

Ospedale San Raffaele

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

Outcomes

Primary Outcomes

Mortality

Time Frame: through study completion, an average of 12 years

Study Sites (1)

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