Survey Captures Physicians’ Real-World Experience With Medtronic’s Evolut FX TAVR System

May 19, 2022—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that results from the Evolut FX transcatheter aortic valve replacement (TAVR) clinical survey reported improved deliverability, tracking, and deployment of a next-generation device compared to its predecessor. The survey was comprised of feedback from physicians across the United States.

The findings were presented as late-breaking clinical research at the SCAI 2023 Scientific Sessions held May 18-20 in Phoenix, Arizona.

According to SCAI, physician feedback on the next-generation Evolut FX TAVR system (Medtronic) was obtained from 539 physician who were administered surveys (or from 539 Evolut FX implantations) with a broad range of implant experience and volume at 69 centers in the United States from June 24 to September 11, 2022. Survey results compared procedures with Evolut FX to the physicians’ earlier experiences with Medtronic’s Evolut Pro+ system using descriptive statistics.

As summarized by SCAI, Evolut FX valves (23 mm, 7%; 26 mm, 30%; 29 mm, 45%; 34 mm, 19%) were implanted via transfemoral (TF) access in 97% of cases. The cusp-overlap technique was used in 89% (457/516) of cases. Commissural alignment was achieved in 96% (447/465) of TF cases using the cusp-overlap view. During initial deployment, no noticeable ventricular movement of the Evolut FX device was reported in 79% (398/506) of cases and 79% (413/526) of operators rated the FX as having a more predictable deployment.

“Commissural alignment during TAVR procedures is key to improving coronary access, blood flow and valve performance,” commented lead author of the analysis Tanvir Bajwa, MD, in the SCAI press release. “These real-world physician insights underscore the procedural benefits of improved deliverability with a more predictable deployment.”

Dr. Bajwa is an interventional cardiologist and Medical Director of the Structural Heart Program at Aurora St. Luke’s Medical Center and Aurora Medical Center-Oshkosh, in Milwaukee, Wisconsin. The authors noted they intend to study how the device enhancements impact patient outcomes in future clinical trials, stated SCAI.