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

M

Michele De Bonis

Status

Completed

Conditions

Mitral Regurgitation

Treatments

Procedure: Mitral valve annuloplasty

Study type

Observational

Funder types

Other

Identifiers

NCT05836376
MAT-SAFMR

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

55 participants in 2 patient groups

Function Atrial MR
Treatment:
Procedure: Mitral valve annuloplasty
Functiona Non-atrial MR
Treatment:
Procedure: Mitral valve annuloplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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