OR3-6 | Early Outcomes from the Optimize PRO TAVR Care Pathway Evolut FX System Addendum Study

The Optimize PRO study interim analysis reported favorable outcomes using a TAVR "optimized" care pathway and cusp overlap technique (COT) resulting in low permanent pacemaker implantation rates and no moderate or severe aortic regurgitation (AR) at 30 days with reproducible outcomes across sites and operators [1]. The next generation supra-annular, self-expanding Evolut FX TAV system has been designed to improve deliverability, trackability, and deployment accuracy. An Optimize PRO Addendum collected data for patients with the new Evolut FX TAV system. Optimize PRO FX Addendum is a post-market, multi-center, prospective, non-randomized study conducted in the United States. Inclusion and exclusion criteria are identical to the Optimize PRO study, which includes patients with severe, symptomatic native aortic valve stenosis (NYHA Class ≥ II) with suitable anatomy for transfemoral TAVR. Exclusion criteria include bicuspid anatomy, previous aortic valve replacement, existing permanent pacemaker, and LVEF < 35%. Valve deployment was performed with COT and the standard procedures of the "optimized" TAVR care pathway protocol requirements. Clinical assessments were performed at baseline, discharge and 30 days, and follow-up is planned for 1 year post-procedure. A CT to assess commissural alignment and implantation depth was collected post-procedure through the 30-day follow-up visit. The primary endpoint is a composite of all-cause mortality or all stroke at 30 days. Secondary endpoints include the rate of pacemaker implant at 30 days, percent of patients with a non-coronary cusp depth of implant between 1.0-5.0 mm, percent of patients with ≥ moderate AR at discharge, and median days from index procedure to discharge. Thirty day outcomes will be reported for 151 treated patients enrolled in 11 sites for the first time at SCAI 2024. Thirty-day valve performance and procedural outcomes in patients undergoing TAVR with the new Evolut FX TAV system with an "optimized" pre- and post- procedural pathway will be reported for the first time.