Off-the-shelf tissue engineered heart valves for in situ regeneration: current state, challenges and future directions.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is continuously evolving and is expected to surpass surgical valve implantation in the near future. Combining durable valve substitutes with minimally invasive implantation techniques might increase the clinical relevance of this therapeutic option for younger patient populations. Tissue engineering offers the possibility to create tissue engineered heart valves (TEHVs) with regenerative and self-repair capacities which may overcome the pitfalls of current TAVR prostheses. Areas covered: This review focuses on off-the-shelf TEHVs which rely on a clinically-relevant in situ tissue engineering approach and which have already advanced into preclinical or first-in-human investigation. Expert commentary: Among the off-the-shelf in situ TEHVs reported in literature, the vast majority covers pulmonary valve substitutes, and only few are combined with transcatheter implantation technologies. Hence, further innovations should include the development of transcatheter tissue engineered aortic valve substitutes, which would considerably increase the clinical relevance of such prostheses.