Futility and event-free survival predictors of mitral valve edge-to-edge repair in patients with advanced heart failure evaluated for heart transplantation
F di Cosmo, L Barreiro Mesa, M Ruiz Ortiz, M Pan Alvarez Ossorio, F Angelini, S Frea, G M De Ferrari, D Mesa Rubio, J D Martin Diaz, M Cabello Terron, E Enrile Sanchez, M Delgado Ortega, F Esteban Martinez, A Rodriguez Almodovar, N V Yacoub BricenoAbstract
Background
Mitral valve transcatheter edge-to-edge repair (M-TEER) has emerged as a therapeutic option for patients within funcional mitral regurgitation (FMR) and Advanced heart failure (AdHF) as a potential bridge therapy to heart transplantation (HTx), but mortality remains high, highlighting the need to better define which patients may truly benefit from this therapy.
Purpose
To analyse futility and to identify predictors of futility following M-TEER in patients with AdHF and significant FMR, evaluated for HTx listing.
Methods
A retrospective analysis was conducted using data obtained from a prospective, multicenter, observational registry of all patients treated with M-TEER in two tertiary european hospitals. Futility was defined as all-cause mortality, urgent HTx or left ventricular assist device (LVAD) implantation within 12 months, or failure to reduce heart failure (HF) hospitalization rate. The primary endpoint was the rate and predictors of futility. Secundary endpoints included survival free from the composite of all-cause mortality, HTx or LVAD implantation, first rehospitalization for HF, predictors of the combined endpoint, and changes in HF hospitalization rate after the procedure.
Results
A total of 100 patients (median age 61- IQR 54-66 years-, 84% male) were included. At least one criterium of futility was observed in 30 patients (30%) within the first year (5 LVAD implantations, 9 urgent HTx, 19 deaths). 99% of the patients had technical success with moderate or less mitral regurgitacion (MR) in 87% at discharge. The results in univariate analysis are in Table; in multivariate analysis, the anteroposterior mitral annulus diameter was the only independent predictor of futility (OR 0.89, 95% CI 0.80-0.98; p=0.023), with a cut-off value of 36.5 mm (Figure), AUC 0.70(95%CI 0.57-0.83), p=0.007. Survival free from the combined endpoint was 51%, 34% and 26% at 1, 3 and 5 years, respectively (Figure). Independent predictors of the composite event were INTERMACS class 1–4, alanine aminotransferase, NT-proBNP, and lower left ventricular ejection fraction. MR ≤2+ was achieved in 63% of patients, with symptomatic improvement (NYHA III–IV) in 56% at last follow-up. Hospitalization rates decreased from 176 to 20 per 100 patient-years after M-TEER (rate ratio 0.11, 95% CI 0.09–0.15; p <0.005).
Conclusions
In a cohort of AdHF patients with FMR evaluated for HTx, nearly one third of patients presented futility following M-TEER and a smaller mitral annulus was identified as an independent predictor of futility. M-TEER appears to be safe and effective, significantly reducing symptoms and HF hospitalizations. However, patient selection remains crucial.Table 1 MTEERFor image description, please refer to the figure legend and surrounding text.Figure 1 Futility MTEERFor image description, please refer to the figure legend and surrounding text.