BACKGROUND The multicenter, prospective, single-arm, observational Evolut R FORWARD Study assessed 1038 patients with symptomatic aortic stenosis at increased surgical risk in a routine hospital setting. The 30-day mortality rate was 1.9% and disabling stroke was 1.8%. In anticipation of current trials evaluating TAVR in patients at lower surgical risk, we performed a post-hoc analysis in patients with an STS predicted risk of mortality <3.0%. METHODS Patients were implanted with the self-expanding Evolut R transcatheter valve system (Medtronic, Minneapolis, MN) in routine practice at 53 centers on 4 continents after Heart Team assessment for eligibility. An independent Clinical Events Committee adjudicated safety endpoints to 30 days based on VARC-2 definitions. An independent echocardiographic core laboratory centrally analysed valve hemodynamics and the incidence of prosthetic valve regurgitation. RESULTS An STS <3% (mean 2.2+/-0.5%) was present in 257 patients. Baseline data included; mean age 77.9 +/- 6.9 years, 53.7% women, 19.1% diabetes, 15.0% COPD, 7.8% prior CABG, 26.8% PCI, 10.6% MI, 26.3% AF. 98.0% had >= NYHA class II symptoms, 15.4% required assisted living and 28.6% were deemed frail. Conscious sedation was used in 52.1% of patients and iliofemoral access used in 99.2%. An Enveo R InLine sheath was used in 86.9% of patients. 1 valve was implanted in the proper anatomical position in all patients. At discharge, the mean AV gradient was 8.7+/-4.5 mmHg and EOA was 1.9+/-0.6 cm2. 30-Day outcomes are in the Table CONCLUSION Low-risk patients based on STS score had similar safety and efficacy results as previously shown for the entire FORWARD Study cohort. (Table Presented).
Grube, E., Van Mieghem, N., Modine, T., Bleiziffer, S., Werner, N., & Windecker, S. (2017). TCT-771 30-Day Outcomes in Patients with a Society of Thoracic Surgeons Predicted Risk of Mortality <3% from the Evolut R FORWARD Study. Journal of the American College of Cardiology, 70(18), B262. https://doi.org/10.1016/j.jacc.2017.09.657