Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?

Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken.

The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Procedure: Mitral valve annuloplasty

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for functional mitral regurgitation with annuloplasty. Study group will comprehend patients with atrial functional mitral regurgitation, the control group will be of patients with non-atrial functional mitral regurgitation

Description

Atrial MR group Inclusion criteria

• Adult patients, underwent mitral annuloplasty for atrial functional mitral Anatomical criteria
• Annular dilatation with anterior-posterior diameter (AP) in systole >35mm
• Ratio of AP diameter in systole to anterior leaflet length in diastole >1.3
• Normal leaflets anatomy
• Mild fibrosis may be present
• A small cleft may be present as a result of annular dilatation Functional criteria
• Normal leaflet mobility (Carpentier type I)
• Coaptation depth <10mm
• Absence of ventricular tethering
• Centrality of the regurgitant jet Atrial and ventricular characteristics
• Left atrium diameter > 40 mm
• Normal systolic function of the left ventricle
• Mild left ventricular systolic dysfunction Mild LV (tachycardia induced) with EF >45%
• Absence of regional abnormalities in left ventricular wall motion Clinical criteria
• Persistent, long-standing persistent, or permanent atrial fibrillation

Exclusion criteria

• Degenerative MR including congenital clefts
• LVEF < 45%
• Ventricular tethering
• Coaptation depth >10 mm
• Regional abnormalities in left ventricular wall motion
• Sinus rhythm
• Presence of coronary artery disease
• Absence of annular dilatation

Non-atrial MR group Inclusion criteria

• Adult patients underwent cardiac surgery for non-atrial functional mitral regurgitation in the setting of an idiopathic or ischemic cardiomyopathy

Exclusion criteria

• FE<40%
• Concomitant coronary artery bypass graft
• Age <65 years and >75years
• Treated with annuloplasty + edge-to-edge surgery
• Sinus rhythm

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Function Atrial MR	Procedure: Mitral valve annuloplasty; implantation of a prosthetic ring to treat mitral valve regurgitation
Functiona Non-atrial MR	Procedure: Mitral valve annuloplasty; implantation of a prosthetic ring to treat mitral valve regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 days

Collaborators and Investigators

• Sponsor: Michele De Bonis

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MAT-SAFMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No