TCT-771 30-Day Outcomes in Patients with a Society of Thoracic Surgeons Predicted Risk of Mortality <3% from the Evolut R FORWARD Study

  • Grube E
  • Van Mieghem N
  • Modine T
  • et al.
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Abstract

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).

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APA

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

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