Mitral Transcatheter Edge-to-Edge Repair in INTERMACS 3-4 Profile Patients with Severe Mitral Regurgitation.

Abstract

Background: Heart transplantation and left ventricular assist device (LVAD) implementation are effective treatments for advanced heart failure (HF), although their use is limited by organ availability and the high incidence of adverse events. The efficacy of mitral transcatheter edge-to-edge repair (TEER) as a bridge to transplantation or as a destination therapy in advanced HF is still debated.

Methods: A total of 63 patients with INTERMACS class 3 or 4 with contraindications for LVAD and severe functional mitral regurgitation (FMR) were evaluated for TEER implantation eligibility. The primary endpoint was a composite of death, urgent heart transplantation and LVAD implantation at 12 months.

Results: A total of 36 patients underwent TEER, while 27 patients received optimal medical therapy (MT) alone. In the intervention group, 35 patients (97%) were discharged alive. In the MT group, two in-hospital deaths occurred, two patients underwent urgent heart transplantation, and three patients were discharged on inotropes. At the 12-month follow-up, the incidence of the primary endpoint occurring was lower in the TEER group (25% vs. 70%, HR 0.25, 95% CI 0.11-0.60, p < 0.01) and the tolerance to neurohormonal therapy was higher (53% vs. 30%, p = 0.03).

Conclusions: In advanced HF patients with INTERMACS profile 3 or 4 and severe FMR, TEER on top of optimal MT was associated with a lower incidence of death, urgent heart transplantation or LVAD implantation at 12 months compared to optimal MT alone.