Frequently associated with hospitalization for cardiac failure and mortality, secondary mitral valve regurgitation (MR) is the most common cause of mitral insufficiency.
Current guideline recommendation is surgery. However, some studies have shown edge-to-edge repair (TEER) is effective for patients with favorable anatomy and high surgical risk.
The MATTTERHORN, a randomized multicenter clinical trial, included 208 patients allocated 1:1 to TEER or surgery (repair or replacement).
For study inclusion, significant mitral insufficiency was defined as effective regurgitant orifice area ≥20 mm², contracted vein >8 mm, regurgitant volume ≥30 ml, ≥50% ejection fraction and at least 2 hospitalizations for DF within prior 12 months.
Primary efficacy end point was a combination of all cause death, hospitalization for CF, reintervention, new ventricular assist device implantation, or stroke, at 12 months.
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Baseline characteristics were similar: mean age 70, 39% women, 26% diabetic, 83% hypertensive, 44% CAD, 3.4% CABG, 51% atrial fibrillation, 6% stroke and 35% kidney function deterioration. STS score was 2% and EuroSCORE 3%.
Most patients were in functional class III-IV. 96% presented mitral valve insufficiency grade 3+ or higher, with 22 mm² effective regurgitant area and 43% ejection fraction.
There were no differences between TEER and surgery at one year.
At 12 month followup, there were no significant differences as regards success between TEER and surgery. Efficacy end point resulted non-inferior with TEER vs surgery (16.7% vs. 22.5%; estimated mean difference, −6 perceptual points, CI 95%, −17 to 6; P<0.001 for non-inferiority). There were no differences in all-cause mortality, hospitalization for cardiac failure, reintervention, ventricular assist device implantation or stroke.
Both groups showed improved functional class, 6-minute walk test and maintained MR reduction at one year followup.
Conclusion
In patients with cardiac failure and secondary mitral valve regurgitation, TEER resulted non-inferior vs mitral valve surgery as regards the composite of death, rehospitalization for CF, stroke, reintervention or ventricular assist device implantation at one year.
Original Title: Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation. For the MATTERHORN Investigators.
Reference: Stephan Baldus, et al. NEJM 2024 DOI: 10.1056/NEJMoa2408739.
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