MiRus, LLC. reported that Pradeep K. Yadav MD, Director of Structural Interventions, Piedmont Heart Institute, Atlanta presented the initial experience with the MiRus Siegel™ 8-Fr aortic transcatheter heart valve (THV) at the New York Valves conference.
Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet. Three patients had peripheral arterial disease with vascular access < 5.5 mm. There was no mortality or stroke at 30 days and no patients required a permanent pacemaker (PPM) or suffered vascular complications. At 30 days, the mean echo gradient was 6.7 mmHg; four of the five patients had no peri-valvular leak (PVL) and one bicuspid patient had trace PVL.
“The ease of use and hemodynamics were impressive” commented Pradeep K. Yadav, MD. “On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning. The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love. Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability.”
The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon.
The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil.
“This initial data is striking and potentially heralds a new age for TAVR,” stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. “The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible. From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients. We are truly on the precipice of surgical-like outcomes with the Siegel THV!!”