Next-gen self-expanding valve improves alignment, implant depth in TAVR
In a real-world setting, a next-generation self-expanding transcatheter aortic valve replacement system showed improved commissural alignment and target implant depth compared with a prior system, researchers reported at PCR London Valves.
TAVR with the supra-annular, self-expanding Evolut system (Medtronic) has improved the rate of paravalvular leak and pacemaker implants, Gilbert H.L. Tang, MD, MSc, MBA, surgical director for the Structural Heart Program and professor of cardiovascular surgery at Icahn School of Medicine at Mount Sinai, said during a presentation. However, the current Evolut Pro+ system is limited by its final implant depth, which is often different from its prerelease position, resulting in asymmetric deployment, Tang said.
The next-generation Evolut FX system is intended to improve commissural alignment while addressing these issues, Tang said.
“We are reporting on the first, initial experiences with this system, particularly because there are a number of new designs over the Evolut Pro+ platform,” Tang told Healio. “The previous Pro+ had two spines in the delivery system; now, they have simplified to one spine, enabling better trackability, which is especially useful for those with challenging anatomy. Additionally, they modified the nose cone design for femoral artery insertion, so insertion should be easier and minimize vascular complications.”
In a first-in-human, six-center study, Tang and colleagues analyzed data from 168 adults with symptomatic aortic stenosis (89%) or prosthetic aortic valve degeneration (11%) who underwent TAVR with the Evolut FX system. The mean age of participants was 81 years; 53.6% were women; half of participants had CAD; the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.23%. Among the cohort, 32.7% were at high or extreme risk for surgery, 28.6% were intermediate risk and 38.7% were low risk. Researchers assessed procedural, in-hospital and 3-day clinical and echocardiographic outcomes using Valve Academic Research Consortium 3 criteria.
Researchers found that commissural alignment was achieved in 95.8% of cases. Trackability also improved, with more symmetric deployment despite using a 19% Lunderquist wire, Tang said.
“It was reassuring to see commissural alignment improved from 80% in our [center’s] experience to 95.8% with the FX system,” Tang said. “I would add a footnote: These are not perfectly aligned; the system is not designed for this purpose. A minority of patients had mild misalignment, but even then, the coronary access should not matter.”
At 30 days, 92.9% of patients were discharged home. Two patients died, three experienced stroke and two experienced major vascular complications, with 15% receiving permanent pacemakers. Researchers observed only 13.1% of participants experiencing mild paravalvular leak; there were no moderate or severe paravalvular leaks observed. Hemodynamic performance was similar to the earlier-generation CoreValve and Evolut devices, Tang said.
Tang said further studies with the Evolut FX system are needed to confirm the findings.
“The Evolut FX platform is a significant improvement over the Evolut Pro+ platform in terms of achieving commissural alignment, a more symmetric implant and a more stable implant to facilitate coronary access in future aortic valve reintervention,” Tang told Healio. “This will be very important in patients who are younger with longer life expectancy, who are now undergoing TAVR with increased frequency.”
Reference:
- Medtronic. news.medtronic.com/Medtronics-Next-Gen-Evolut-TM-FX-TAVR-System-Shows-Significant-Improvement-in-Commissure-Alignment-in-Real-World-Setting. Published Nov. 29, 2022. Accessed Nov. 30, 2022.
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Tang G, et al. Top Late-Breaking Trials. Presented at: PCR London Valves; Nov. 27-29, 2022; London.