Table 2 REFORM-MR registry objectives

Primary objective

Freedom from recurrent FMR (> Grade 2) in patients with type IIIb FMR with reduced systolic ventricle function at 2-years follow-up after subannular repair by realignment of papillary muscles combined with annuloplasty

Secondary objectives

Assessment of common tenting parameters (tenting height, coaptation length, tenting area, posterior mitral leaflet and anterior mitral leaflet angles) via detailed echocardiographic examination and their correlation with the following clinical outcomes 6 months, 1 year, and 2 years after subannular repair combined with annuloplasty:

  Adverse cardiac events (MACCE)

  Mitral valve re-intervention

  Device therapy in advanced heart failure (Left ventricular assist device/Heart transplantation)

  Cardiac mortality

Re-hospitalization due to heart failure

QoL assessment of patients with FMR before and after subannular repair using SF-12 Health Survey

Development of surgical strategies to improve long-term outcomes in patients with high-grade LV dilatation, including:

  Recurrent heart failure

  Long-term survival

  Ventricular function