Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

Completed

• Conditions: Degenerative Mitral Valve Disease
• Interventions: Procedure: Mitral valve replacement; Procedure: Mitral valve repair (PLM)

• Registration Number: NCT05839782
• Lead Sponsor: Michele De Bonis

Brief Summary

The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.

However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.

Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Study First Submitted: 2023-01-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• adult patients
• failure of previous mitral valve repair which needed a new surgical treatment
• group Re-PLM: patients reoperated with a new mitral valve repair
• group Re-SVM: patients reoperated with a mitral valve replacement

Exclusion Criteria

• urgent/emergent procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Re-SVM	Mitral valve replacement	Patient in which a mitral valve replacement is performed to treat failed mitral valve repair
Re-PLM	Mitral valve repair (PLM)	Patient in which a new mitral valve repair is performed to treat failed mitral valve repair

Primary Outcome Measures

Name	Time	Method
Survival after reintervention	through study completion, a minimum of 2 years	Time of survival after reintervention for failed mitral valve repair

Secondary Outcome Measures

Name	Time	Method
Risk factors for reintervention	through study completion, a minimum of 2 years	Identification of predictors of reintervention after mitral valve repair

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele - Cardiac Surgery Department; 🇮🇹 Milan, Italy