30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study

Primary results from the Optimize PRO study reported transcatheter aortic valve replacement (TAVR) with cusp overlap technique (COT) resulting in low 30-day permanent pacemaker implantation (PPI) rates and no ≥moderate aortic regurgitation (AR). To evaluate outcomes after Evolut FX implantation using the COT and postprocedural computed tomography (CT). The Optimize PRO FX Addendum study is a post-market, prospective, multicenter non-randomized study. Patients with severe aortic stenosis underwent TAVR with Evolut FX using COT protocol. Postprocedurally, we evaluated COT adherence to identify key steps, and compared CT-assessed TAV orientation with fluoroscopically-guided commissural alignment. There were 151 patients implanted with Evolut FX from September 2022 to October 2023. Median duration of follow was 371 (Q1-Q3: 352-388) days. Compliance with the refined COT was 86.0%. Median length of stay was 1 day. The primary endpoint of all-cause mortality or all stroke was 2.7% (95% CI: 1.0-6.9%) at 30 days and 7.5% (95% CI 4.2-13.1%) at 1 year. New PPI rate was 6.7% (95% CI 3.7-12.1%) at 30 days and 8.8% (95% CI 5.2-14.6%) at 1 year. One patient had moderate AR and none had severe AR at 1 year. Commissural alignment was 91.5% (107/117) when assessed by marker positioning on fluoroscopy and 86.9% (113/130) when assessed by CT, indicating good agreement. CT indicated no severe coronary misalignment in >92% of patients. Evolut FX with a refined COT was associated with low PPI rates and no severe AR at 1 year. Postprocedural CT demonstrated consistent commissural and coronary alignment.