AIMS: Current guidelines consider severe systolic left ventricular dysfunction [ejection fraction (EF) ≤20 %; left ventricular dysfunction (LVD)] a contraindication for transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the efficacy and safety of TAVI in this extreme risk subset of patients. METHODS AND RESULTS: The study population (253 patients) was divided into two groups; the LVD group [21 patients with left ventricular ejection fraction (LVEF) ≤20 %] and the control group (232 patients with LVEF >20 %). TAVI was generally performed transfemorally under analgosedation without mechanical circulatory support. Clinical and hemodynamic variables, as well as procedural and follow-up outcomes, were compared, and all events were defined according to the Valve Academic Research Consortium criteria for event definition. Mean EF in the LVD group was 18.3 ± 2.9 % compared to 50.9 ± 11.3 % in the control group. Patients in the LVD group were younger, more commonly males, had higher logistic EuroSCORE and lower mean aortic pressure gradients. Immediate procedural mortality was low and similar in both groups (0 vs. 2.2 % in the LVD and control group, respectively, p = 0.49). At 30 days, post-procedural vascular and bleeding complications as well as strokes were similar, but all-cause mortality was higher in the LVD group (14.3 vs. 3.4 %, p = 0.05). In the survivors of the LVD group, New York Heart Association functional class and LVEF significantly improved at 30 days and 6 months. Survival at 1 and 2 years was 70.2 vs. 86.0 % and 56.1 vs. 78.3 % in the LVD and control group, respectively (log-rank p = 0.03). CONCLUSIONS: TAVI without mechanical circulatory support appears feasible, safe and effective in patients with severe aortic stenosis and severe LVD, but short- and long-term mortality remain high. TAVI should be considered a viable treatment option in this subset of extremely compromised patients.
AIMS: Current guidelines consider severe systolic left ventricular dysfunction [ejection fraction (EF) ≤20 %; left ventricular dysfunction (LVD)] a contraindication for transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the efficacy and safety of TAVI in this extreme risk subset of patients. METHODS AND RESULTS: The study population (253 patients) was divided into two groups; the LVD group [21 patients with left ventricular ejection fraction (LVEF) ≤20 %] and the control group (232 patients with LVEF >20 %). TAVI was generally performed transfemorally under analgosedation without mechanical circulatory support. Clinical and hemodynamic variables, as well as procedural and follow-up outcomes, were compared, and all events were defined according to the Valve Academic Research Consortium criteria for event definition. Mean EF in the LVD group was 18.3 ± 2.9 % compared to 50.9 ± 11.3 % in the control group. Patients in the LVD group were younger, more commonly males, had higher logistic EuroSCORE and lower mean aortic pressure gradients. Immediate procedural mortality was low and similar in both groups (0 vs. 2.2 % in the LVD and control group, respectively, p = 0.49). At 30 days, post-procedural vascular and bleeding complications as well as strokes were similar, but all-cause mortality was higher in the LVD group (14.3 vs. 3.4 %, p = 0.05). In the survivors of the LVD group, New York Heart Association functional class and LVEF significantly improved at 30 days and 6 months. Survival at 1 and 2 years was 70.2 vs. 86.0 % and 56.1 vs. 78.3 % in the LVD and control group, respectively (log-rank p = 0.03). CONCLUSIONS: TAVI without mechanical circulatory support appears feasible, safe and effective in patients with severe aortic stenosis and severe LVD, but short- and long-term mortality remain high. TAVI should be considered a viable treatment option in this subset of extremely compromised patients.
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