Does transcatheter aortic valve replacement with dedicated devices improve procedural success and clinical outcomes in patients with severe native aortic regurgitation who are poor surgical candidates?
Dedicated TAVR devices for severe aortic regurgitation show promise in overcoming the anatomical challenges and poor outcomes associated with off-label use of current generation transcatheter heart valves.
Untreated clinically significant aortic regurgitation (AR) is frequently seen in the general population and is associated with worse outcomes, including higher mortality. Surgical aortic valve replacement is currently the treatment of choice for severe AR. However, a significant proportion of these patients are not good surgical candidates due to advanced age, frailty, and underlying comorbidities, prompting the need for transcatheter options. Current guidelines do not recommend transcatheter aortic valve replacement (TAVR) for severe AR with commercially available transcatheter heart valves (THVs). Off-label use of commercial TAVR devices has been associated with lower procedural success, increased complications, mainly valve embolization and residual AR, and poor clinical outcomes. The suboptimal results of TAVR with the current generation THVs are attributed to anatomical factors such as a lack of annular calcium, a large aortic annulus, and a dilated aortic root, posing challenges for device anchoring. TAVR with dedicated devices for AR, such as the JenaValve and the J-Valve, is rapidly evolving, with preliminary evidence suggesting higher procedural success rates and improved clinical outcomes during short-term follow-up. There is a significant unmet need for the development of transcatheter therapies with dedicated THVs for severe AR, and both the JenaValve and J-Valve systems are undergoing rigorous clinical trial testing before regulatory approval in the United States.
Guddeti et al. (Tue,) studied this question.