The study reports improving the deliverability, traceability and deployment of the next generation Evolut FX TAVR system


Results from the Evolut FX TAVR (Transcatheter Aortic Valve Replacement) clinical survey were presented today as a recent clinical paper at the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 Scientific Sessions. The survey, which consists of feedback from physicians across the United States, reported improved deliverability, traceability, and deployment of the next-generation device compared to its predecessor.

Aortic stenosis (AS) is one of the most common diseases of the heart valves and can lead to heart failure. Once the symptoms of ankylosing spondylitis begin, the average patient survival can be up to two years without treatment. TAVR is a minimally invasive procedure for treating patients with severe symptoms of AS that has been shown to improve patient survival.

Physician feedback on the next generation Evolut FX TAVR System (Medtronic) was obtained from June 24 to September 11, 2022, at 69 US centers from 539 physician-run surveys (or from 539 Evolut FX implants) with a wide range of implant experience. And how much. Survey results compared Evolut FX to clinicians’ previous experiences with the Evolut PRO+ System using descriptive statistics.

Commissural alignment during TAVR procedures is key to improving coronary artery access, blood flow, and valve performance. These real-world clinician insights confirm the procedural benefits of improved deliverability with more predictable deployment.”

Tanvir Bajwa, MD, FACC, FSCAI and interventional cardiologist and medical director of the Structural Heart Program at Aurora St. Luke Medical Center and Aurora Medical Center-Oshkosh, in Milwaukee, Wisconsin, and lead author of the analysis

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 overlapping technique (COT) was used in 89% (457/516) of the cases. Central alignment was achieved in 96% (447/465) of the TF cases using overlapping overlap width. During initial deployment, no noticeable ventricular movement was reported for the Evolut FX in 79% (398/506) of cases and 79% (413/526) of operators rated FX as more predictable diffuse.

The authors note that they intend to study how device improvements may affect patient outcomes in future clinical trials.


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