Survey: Next-generation TAVR system improves resistance, tracking, ease of alignment
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Key takeaways:
- Surveyed operators reported improved resistance and ease of tracking with the next-generation TAVR system.
- Deployment symmetry and commissural alignment were also reportedly improved vs. the prior system.
Findings from a survey of operators who used a next-generation transcatheter aortic valve replacement system indicated improved deployment and commissural alignment vs. the device’s predecessor system, a speaker reported.
The results of the next-generation self-expanding TAVR system (Evolut FX, Medtronic) limited market release clinical survey were presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
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“Supra-annular TAVR is becoming very popular. With more devices coming, there are nuances and improvement in these devices,” Tanvir K. Bajwa, MD, FACC, FSCAI, interventional cardiologist and medical director of the Structural Heart Program at Aurora St. Luke’s Medical Center and Aurora Medical Center-Oshkosh in Milwaukee, said during a presentation. “We tested the performance and use of the Evolut FX system, which is a new Medtronic TAVR system.” Operators were asked to compare the new system to its predecessor (Evolut Pro+, Medtronic).
In a previous first-in-human multicenter study, the TAVR system was tested in 168 adults with symptomatic aortic stenosis or prosthetic aortic valve degeneration (mean age, 81 years; 54% women).
As Healio previously reported, the next-generation TAVR system demonstrated improved commissural alignment and target implant depth compared with Evolut Pro+.
Differences between the new system and its predecessor include the feature of radiopaque markers to help operators visualize depth and valve leaflet location during implantation; a single spine wire designed for improved flexibility; a stability layer designed to improve deployment predictability; and a tip designed for more dilator-like vessel access.
In August 2021, the updated TAVR system was approved by the FDA for the treatment of severe aortic stenosis in patients at high or extreme surgical risk.
The present study includes the updated results from a clinical survey following the limited market release of the TAVR system. Feedback was aggregated from June 24 to Sept. 11, 2022, from 539 U.S. physicians at 69 centers.
Overall, 88.6% of respondents reported using the cusp overlap technique and 96.1% reported achieving commissural alignment.
Regarding ease of insertion, 83% of respondents reported less resistance with the next-generation system compared with the previous generation, whereas 16.9% reported similar resistance. Improved ease of tracking though vasculature was reported by 84.7% of respondents, whereas similar tracking was reported by 15.3%, according to the presentation.
Among the respondents, 77.3% reported that positioning after deployment was the same compared with before deployment, whereas 21.2% reported some movement.
“From the survey of about 560 people, the Evolut FX design improvement translated to documented improvements in device deliverability, deployment symmetry and stability and documented commissural alignment as assessed by experience self-explaining and balloon-expandable operators; hence, giving us the opportunity to have a better access for the coronary arteries in the future,” Bajwa said during the presentation. “Characterization of clinical outcomes in patients treated with Evolut FX is ongoing throughout the continuing registry.”
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Bajwa TK, et al. Late-Breaking Presentation VIII. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 18-20, 2023; Phoenix.
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