An Optimized TAVR care pathway using Evolut PRO and PRO+: Early results from the Optimize PRO study
Presenter
Kendra J. Grubb, M.D., Emory University, Atlanta, GA
Kendra J. Grubb, M.D., Emory University, Atlanta, GA, Hemal Gada, M.D., FSCAI, UPMC Pinnacle, Mechanicsburg, PA, Josep Rodes-Cabau, M.D., Quebec Heart Institute at Laval Hospital, Quebec, FL, Suneet Mittal, M.D., Valley Health System, New York, NY, Tamim M. Nazif, M.D., FSCAI, NewYork-Presbyterian Columbia University Irving Medical Center, New York, NY, Shuzhen Li, PhD, Medtronic, Minneapolis, MN and Steven J. Yakubov, M.D., MSCAI, OhioHealth Heart & Vascular Physicians, Columbus, OH
Keywords: Structural Heart Disease (SHD) and TAVI/TAVR/Aortic Valve
Background: Improved TAVR procedural success and lower complication rates have been achieved with each iteration of the self-expanding Evolut transcatheter heart valve (Evolut R, Evolut PRO, Evolut PRO+). However, these findings are variable and may be due to lack of uniform protocols for implantation and post-implant management, which have both been associated with lower rates of conduction disturbance (CD) and new permanent pacemaker implantation (PPI). The purpose of the Optimize PRO study is to determine if use of the cusp overlap deployment technique with the Evolut PRO and PRO+ valves followed by an optimized TAVR clinical care pathway will reduce CD, need for PPI, and expedite discharge without increasing safety risks.
Methods: Optimize PRO is a nonrandomized, prospective, post-market study conducted at 46 sites in the US and Canada with maximum enrollment of 400 patients. Patients must have severe symptomatic aortic stenosis (NYHA Class ≥II), and suitable anatomy for the Evolut PRO or PRO+ device. Exclusion criteria are LVEF<35% and prior aortic valve replacement or permanent pacemaker. Sites will deploy the device using the cusp overlap technique and follow a standardized TAVR care pathway, including an early discharge plan and a CD management algorithm. Echocardiograms, assessed by a core laboratory, will be collected at screening, discharge and 12 months post-procedure. Clinical follow-up at 30 days and 12 months will include 12-lead ECG and pacemaker interrogation if applicable. The primary endpoint is all-cause mortality or all-stroke at 30 days. Secondary endpoints include length of stay, percent of patients with ≥ moderate aortic regurgitation at discharge, and 30-day PPI rate.
Results: Results from a prespecified interim analysis of 100 patients with 30-day follow-up will be presented.
Conclusions: The Optimize PRO study seeks to optimize TAVR outcomes through implementation of a pre-specified TAVR implantation technique and optimized TAVR clinical care pathway. This study will assess whether the cusp overlap implantation technique and TAVR care pathway can consistently reduce CD rates and guide early discharge across sites and operators.