Transcatheter valve with a hollow balloon for aortic valve insufficiency

Abstract

During the past decade transcatheter aortic valve implantation (TAVI) has revolutionized our approach to heart valve disease. Although largely applied to patients with calcific aortic valve stenosis, there is an unmet clinical need to also treat patients with aortic valve insufficiency in patients with non-calcific aortic valve disorders. The following Techno-College tutorial demonstrates our pre-clinical experience with a novel non-occlusive, self-homing TAVI system, developed with Strait Access Technologies, that we hope will improve outcomes for treatment of non-calcific aortic valve insufficiency.

The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets

“…Clearly, TAVR suitable for pure, non-calcific AR in younger patients would therefore not only be for a fringe-indication but of relevance for a dominant pathology in MICs (9,10,15,31). Recent publications on the use of TAVR for RHD can be regarded as important harbingers of this development (14)(15)(16)(17)31) particularly since TAVR was shown to have a profound, durable impact on heart remodeling in patients with severe AR. Within the first 3 days, a significant decrease in LV end-diastolic pressure, a significant reduction in LV size and mass index (54) and a sharp reduction in systolic pulmonary arterial pressure were seen (55), confirming that in patients undergoing valve replacement for severe AR, cardiac function often recovers faster than in AS.…”

“…This is still reflected in contemporary TAVR designs whose simple mesh structures are sufficient to anchor the stents in the rigid calcific deposits of AS. However, given the huge global burden of rheumatic heart disease (RHD) in emerging economies (8)(9)(10) with its predominance of AR (9)(10)(11)(12)(13) and the growing number of patients with pure AR in industrialized countries, it seems timely to extend transcatheter procedures to patients with non-calcified regurgitant aortic valves (14)(15)(16)(17).…”

Preclinical evaluation of a transcatheter aortic valve replacement system for patients with rheumatic heart disease

“…Preoperatively, animals were screened with transthoracic echocardiography (Vivid I BT09; General Electric, Horten, Norway) to pre-assess aortic dimensions. Group 1 (n=5) underwent a transapical insertion of a SAT pericardial TAVI valve (size 23 mm) in the orthotopic position 16 and Group 2 (n=5) underwent a surgical AVR (sAVR). In brief, the SAT-TAVI deployment system is transapically inserted and advanced into the ascending aorta under fluoroscopic and echo control allowing the confirmation of root dimensions (Table 1, Table 2).…”

Next-generation tissue-engineered heart valves with repair, remodelling and regeneration capacity

“…In the future, polymeric heart valves may be combined with minimally invasive transcatheter procedures, to provide a cost-efficient solution for the treatment of rheumatic valvular disease in emerging countries 57 . In this context, Strait Access Technologies developed a TAVR strategy for low resource countries that uses a supra-annular anchoring technique to provide correct valve positioning via tactile feedback and without the need for fluoroscopic imaging 57,65 . However, significant challenges still remain for polymeric valves: firstly, researchers need to balance durability and biocompatibility of the material to ensure long-term in-vivo performance and improved valve longevity compared to bioprostheses; secondly, variability between different polymer batch synthesis and/or processing should be limited do not impact valve reproducibility; and, finally, polymer wear should be prevented at any time to limit the risk of tear and failure.…”