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December 8, 2022

Standardized subannular repair in type IIIb mitral regurgitation: 1-year results from REFORM-MR Registry
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Standardized subannular repair in type IIIb mitral regurgitation: 1-year results from REFORM-MR Registry

Girdauskas E, Pausch J, Eden M, Krane […]

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Standardized subannular repair in type IIIb mitral regurgitation: 1-year results from REFORM-MR Registry

Girdauskas E, Pausch J, Eden M, Krane M, Borger M, Walther T, Kuntze T and Falk V.

Presented at 36th European Association for Cardio-Thoracic Surgery Annual Meeting, 2022.

Key points:

  • Annuloplasty combined with papillary muscle repositioning to treat type IIIb mitral regurgitation (MR) had acceptable perioperative and 1-year efficacy and safety outcomes.

Background information

  • Treating type IIIb MR with annuloplasty alone is associated with a high recurrence rate.
  • Combining annuloplasty with subannular repair by papillary muscle repositioning may increase the stability of mitral valve repair in this patient population.

Aims

  • To evaluate the safety and efficacy of standardised subannular repair.

Type of study

  • A prospective, single-arm, multicentre registry study.

Endpoints

  • The primary endpoint was freedom from MR >2+ after 2 years.1
  • Secondary endpoints included survival, major adverse cardiac and cerebrovascular events and reinterventions.

Methods

  • The study included patients with secondary MR, left ventricular ejection fraction (LVEF) ≤50%, left ventricular end-diastolic diameter (LVEDD) ≥55 mm and tenting of the proximal or anterior mitral leaflets >10 mm.
  • Patients underwent annuloplasty (with Carpentier- McCarthy-Adams IMR ETlogix) together with bilateral papillary muscle repositioning.
  • Endpoint assessment was performed in echocardiography and magnetic resonance imaging CoreLabs.

Results

Patients

  • The study included 94 patients from six centres (Table 1).

Table 1. Baseline characteristics.

Perioperative outcomes

  • The mean cardiopulmonary bypass time was 158 ± 40 min.
  • Five patients (5%) developed low cardiac output syndrome and two patients (2%) experienced stroke.
  • One patient died during the hospital stay (1.4%).
  • At discharge, 43 patients (49%) were free of MR, and 35 (40%) had mild and 9 (10%) moderate residual MR.

Echocardiographic results

  • At 1-year, 95.8% of patients were free of MR >2+ (Kaplan-Meir analysis).
  • There was improved left ventricular (LV) geometry (remodeling) and reduced tenting parameters at 1-year.

Survival

  • The survival rate at 1-year was 95.5%.

Conclusion

Standardised subannular repair by papillary muscle repositioning showed acceptable perioperative and 1-year efficacy and safety outcomes in patients with functional MR, including a low MR >2 recurrence rate.

Improved LV remodeling and tenting parameters were also evident 12 months after surgery. A 2-year follow-up of the study population is currently underway.

References:

  1. NCT03470155. Available at: https://clinicaltrials.gov/ct2/show/ NCT03470155. [Accessed September 2022].

This document is a summary of the Girdauskas E et al. presentation, as presented at the EACTS congress and covers key information including aim, type of study, methods, results and conclusions.

The full publication is available at:

https://bit.ly/girdauskas2022

Abbreviations:

Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

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