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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2020-12-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Mitral Regurgitation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Function Atrial MR

Mitral valve annuloplasty

Intervention Type PROCEDURE

implantation of a prosthetic ring to treat mitral valve regurgitation

Functiona Non-atrial MR

Mitral valve annuloplasty

Intervention Type PROCEDURE

implantation of a prosthetic ring to treat mitral valve regurgitation

Interventions

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Mitral valve annuloplasty

implantation of a prosthetic ring to treat mitral valve regurgitation

Intervention Type PROCEDURE

Eligibility Criteria

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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

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

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No