Global Results From the Optimize PRO Study: Standardized TAVR Technique and Care Pathway

Background

The safety and efficacy of utilizing standardized implant protocols and care pathways are limited in large global prospective studies of transcatheter aortic valve replacement (TAVR), and institutional variability remains. This analysis aims to report 30-day outcomes from the global Optimize PRO study evaluating valve performance and procedural outcomes using an “optimized” TAVR care pathway and the cusp overlap technique (COT) in patients receiving Evolut PRO/PRO+ valves.

Methods

The Optimize PRO study is a multicenter, postmarket, prospective study conducted in 50 centers in the United States, Canada, Europe, the Middle East, and Australia. Patients with symptomatic severe aortic stenosis and no preexisting pacemakers underwent TAVR with standardized optimized preprocedure, periprocedure, and postprocedure pathways.

Results

There were 653 patients with attempted TAVR implants, a mean age of 79.1 ± 6.5 years, and a mean Society of Thoracic Surgeons predictive risk of mortality of 3.2% ± 2.5%. The primary 30-day end point of all-cause mortality or all stroke was 5.1%, all-cause mortality 0.8%, and disabling stroke 1.7%. The new 30-day permanent pacemaker implantation rate was 6.4% with 4-step COT compliance and 11.1% overall. At discharge, there were no instances of moderate or severe aortic regurgitation, and 76.2% of patients had none/trace aortic regurgitation. The median length of stay was 2 days.

Conclusions

The Optimize PRO study demonstrated low rates of new permanent pacemaker implantation and no moderate to severe aortic regurgitation after TAVR with Evolut PRO/PRO+ using COT and perioperative protocols in a global cohort of severe aortic stenosis patients. Best practices resulted in consistent implantation depth and low complication rates.