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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Regurgitation, Functional Mitral Regurgitation

Intervention / Treatment
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* Procedure: Aortic valve replacement
* Procedure: Mitral valve annuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patient with more than moderate MR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic valve surgery only<br> | Procedure: Aortic valve replacement<br>* An aortic valve prosthesis is surgically implanted to treat AR<br>|
| Aortic valve + mitral valve surgery<br> | Procedure: Aortic valve replacement<br>* An aortic valve prosthesis is surgically implanted to treat AR<br>Procedure: Mitral valve annuloplasty<br>* Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality for cardiac causes |  | Through study completion, an average of 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |