Clinical trial NCT05774808: Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
Official title: Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Regurgitation
Functional Mitral Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by severe AR and moderate MR. The patients are divided in 2 groups: in the Study group, patients underwent isolated aortic valve surgery, while in the Control group, mitral valve surgery was also added.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality for cardiac causes
timeFrame: Through study completion, an average of 7 years
Secondary outcomes:
measure: All causes mortality
timeFrame: Through study completion, an average of 7 years
measure: Severe AR recurrency
timeFrame: Through study completion, an average of 7 years
measure: Reintervention for severe AR recurrency
timeFrame: Through study completion, an average of 7 years
measure: Reintervention for severe MR
timeFrame: Through study completion, an average of 7 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: