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

Primary results from the Optimize PRO study demonstrated that transcatheter aortic valve replacement (TAVR) with the cusp overlap technique (COT) resulted in low 30-day permanent pacemaker implantation (PPI) rates and no moderate or greater aortic regurgitation (AR).

The aim of this study was to evaluate outcomes after Evolut FX implantation using the COT and postprocedural computed tomography (CT).

The Optimize PRO FX Addendum study is a postmarket, prospective, multicenter, nonrandomized study. Patients with severe aortic stenosis underwent TAVR with the Evolut FX using the COT protocol. Postprocedurally, COT adherence was evaluated to identify key steps, and CT-assessed transcatheter aortic valve orientation was compared with fluoroscopically guided commissural alignment.

A total of 151 patients received the Evolut FX device from September 2022 to October 2023. The median duration of follow-up was 371 days (Q1-Q3: 352-388 days). Compliance with the refined COT was 86.0%. The median length of stay was 1 day. The rate of 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. The 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. The rate of commissural alignment was 91.5% (107 of 117) when assessed by marker positioning on fluoroscopy and 86.9% (113 of 130) when assessed using CT, indicating good agreement. CT indicated no severe coronary misalignment in >92% of patients.

Implantation of the Evolut FX device 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.