A study suggests that features of the Laguna Tech Alpha and Zeta aortic valve replacement systems contribute to a successful implantation in patients with all types of aortic valve disease, even without calcium. Findings presented at Cardiovascular Research Technologies (CRT) 2024 in Washington, D.C., point to the “cutting-edge design and technology” that broadens the profile of eligible patients as key to a successful approach in treating aortic regurgitation (AR). The early feasibility study also highlights the simplicity of placing Alpha and Zeta’s self-expanding arm anchors that contribute to their ability to treat non-calcific AR and calcified stenosis. “[We] demonstrated the successful use of Laguna Tech Alpha and Zeta valve and delivery systems,” said Scott Lim, MD, a consultant for Laguna Tech and professor of medicine and pediatrics at the University of Virginia in Charlottesville. “Results [were obtained] with no paravalvular leak (PVL)/AR, large aortic valve area (AVA), and commissural alignment. “The next clinical phase will further evaluate systems with a US EFS/EU study targeted for Q3 2024,” Lim added during Sunday’s Late-Breaking Early Feasibility Study Clinical Trials session. Main findings In the five patients receiving the Alpha self-expanding valve (SEV), four had the valve deployed without complication, with no residual aortic stenosis (AS) or AR at last follow-up (between 1 and 12 months). However, one patient had valve embolization due to inadvertent discontinuation of rapid pacing and resultant conversation to surgery. Of those receiving the Zeta BEV, all seven had the valve deployed in the correct position, with a consistent landing height by fluoroscopy. One death occurred before30 days due to aortic dissection (bicuspid aortic valve with pre-existing eccentric aortic aneurysm), and the remaining six had no residual AS/AR at last follow-up. The follow-up computed tomography (CT)O scan demonstrated commissural alignment with surviving patients categorized as New York Heart Association Class I. Follow-up echocardiography demonstrated normal valve function. Alpha and Zeta details Discussing further details about the Zeta Aortic Valve System, Lim said the device was designed to restore heart function by placing leaflet-capture arms in the aortic cusps and placement of the valve within the annulus. The valve is then balloon expanded into the annulus to form a new functioning valve, and it seals by wrapping the native leaflets around the Zeta frame to prevent paravalvular leak. Similarly , the Alpha Aortic Valve works by placing support arms in the aortic cusps and placement of the valve within the annulus. “The valve self-expands into the annulus to form a new functioning valve and seals at the annulus to prevent paravalvular leak,” Lim added. Methodology Patients were screened at three sites (Tbilisi, Georgia; Santo Domingo, Dominican Republic; and Santiago, Chile) for severe, symptomatic aortic valve disease at high/prohibitive surgical risk. CT was performed for both aortic valve complex anatomy and arterial access. All patients had transesophageal echocardiography (TEE) at baseline and at follow-up. Both the Alpha and Zeta valves incorporated leaflet retention arms, a delivery capsule and delivery system capable of both articulation and commissural alignment. Valve leaflets were of dry-tissue technology, and sizes included 23 mm, 26 mm, 29 mm and 32 mm. Initial cases utilized both fluoroscopy and TEE to guide the valve placement, ensuring both proper anchoring on the native leaflets as well as commissural alignment, but with greater experience, valves were able to be placed more efficiently by fluoroscopy alone. In total, 12 procedures were carried out, in which five patients received the Alpha SEV. Out of the five cases, two had baseline severe AR, two having severe AS, and one had mixed disease. Seven of the cases used the Zeta BEV, with four having baseline severe AR, two having severe AS, and one having mixed disease. Photo Credit: Jason Wermers/CRTonline.org Photo Caption: Scott Lim, MD, presents early feasibility study results of the Laguna Tech transcatheter heart valves Sunday at CRT 2024 in Washington, D.C.