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Abstract
Valvular heart disease represents a leading cause of mortality worldwide. Transcatheter heart valve replacement techniques have been recently introduced into the clinical routine expanding the treatment options for affected patients. However, despite this technical progress toward minimally invasive, transcatheter strategies, the available heart valve prostheses for these techniques are bioprosthetic and associated with progressive degeneration. To overcome such limitations, the concept of heart valve tissue engineering has been repeatedly suggested for future therapy concepts. Ideally, a clinically relevant heart valve tissue engineering concept would combine minimally invasive strategies for both, living autologous valve generation as well as valve implantation. Therefore, merging transcatheter techniques with living tissue engineered heart valves into a trascatheter tissue engineered heart valve concept could significantly improve current treatment options for patients suffering from valvular heart disease. This report provides an overview on transcatheter tissue engineered heart valves and summarizes available pre-clinical data.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Key issues
Valvular heart disease represents a leading cause of mortality worldwide.
Transcatheter heart valve replacement techniques have been recently introduced into the clinical routine currently focusing on the treatment of elderly high-risk patients.
Despite this technical progress toward minimally invasive, transcatheter strategies, the currently implanted prostheses for transcatheter approaches are of biological origin, which implies that all disadvantages apply including continuous calcification.
Heart valve tissue engineering has been repeatedly suggested to have the potential to overcome these current limitations and to significantly improve future therapy concepts.
By generating living heart valve prostheses, the risk for continuous degeneration could be minimized, while such prostheses would offer the significant advantages of growth potential, remodeling and regeneration capacity.
A clinically relevant heart valve tissue engineering concept would combine minimally invasive strategies for both, living valve generation as well as valve implantation.
Current data clearly indicate the principal feasibility to merge transcatheter strategies and heart valve tissue engineering into a translational therapy concept of high clinical relevance.
On the route into clinics several aspects need to be addressed to ensure a safe and broad clinical translation. These include the demonstration of long-term safety, the definition of safety and quality guidelines for tissue engineered heart valve, a meticulous understanding of the underlying remodeling mechanisms and the use of independent predictor and imaging tools to monitor tissue engineered heart valve in order to avoid potential failure.
While most tissue engineering concepts require demanding technical, logistical and financial efforts, more simplicity is needed to facilitate the broad translation into clinics. Therefore, concepts such as the in situ, bone marrow cell-based single-step strategies or off-the-shelf technologies may greatly simplify previous strategies toward clinical application.
Additional effort is needed to further adapt the stent-design and delivery systems for tissue engineering applications.