Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

NCT05836480 | Completed

• 1 other identifier: SUB-MVR
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease. Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+). The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Mortality

  through study completion, a minimum of 6 years

Study Arms (2)

Suboptimal repair

Patients discharged with a residual mitral regurgitation of at least moderate (2+)degree

Procedure: mitral valve repair

Optimal repair

Patients discharged with a residual mitral regurgitation of mild (1+) or less degree (trace or 0)

Procedure: mitral valve repair

Interventions

mitral valve repair PROCEDURE

conservative surgery to treat mitral regurgitation. A mitral valve plasty is performed according to the most appropriate technique

Optimal repair; Suboptimal repair

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 who underwent surgical mitral valve repair. Patients of study (Suboptimal) group were discharged with a 2+ or more residual mitral regurgitation, patients in control group (Optimal) were discharged with a 1+ or less residual mitral regurgitation

You may qualify if:

• Study group:
• presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
• presence of moderate residual mitral regurgitation at discharge.
• Control group:
• presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
• presence of residual mitral regurgitation of at least mild grade at discharge.

You may not qualify if:

• none

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

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 Advance and Research Therapies

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: May 1, 2023
• Study Start: October 5, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)