For Patients

Young patients with severe aortic valve disease today are facing a real dilemma. Once the indication for aortic valve replacement has been confirmed by their physician, they have to choose either a mechanical valve replacement option, which directly affects their quality of life as strict life-long blood anticoagulation is needed to avoid cerebral thromboembolism. These “blood thinners” have an inherent risk for severe bleeding episodes, which needs to be considered in both professional and leisure activities.

The majority of patients nowadays try to avoid anticoagulation for these reasons. Young patients who do not want mechanical prostheses can opt for a biological prosthesis, e.g. a pericardial xenogenic heart valve, which unfortunately does not provide satisfactory durability in young patients, and rapid valve degeneration can occur within months. These patients further have the option for the so-called Ross procedure which is an extensive operative procedure where the diseased aortic valve is replaced by the patient`s pulmonary valve as an autograft. The pulmonary valve itself has to be consecutively replaced by a heart valve prosthesis leading to a “two-valve” diseased heart, as almost all autografts are impaired by progressive dilatation and the pulmonary valve prosthesis, often a conventional cryopreserved homograft, degenerates in the same way as all biological valves, thereby leading to frequent reoperations. Reoperations have a substantial higher mortality due to postoperative adhesions.*

The lack of a reasonable aortic valve prosthesis for young patients has driven research in tissue engineering concepts. The basis for current tissue-engineering concepts are either artificial polymeric or biological scaffolds, which may derive from human tissue donation or animals. Total artificial tissue-engineered heart valve concepts would solve many unmet clinical demands such as permanent availability of different sizes and lengths. These concepts have shown good results in the technical implementation of valved polymeric conduit production and have successfully been used for in vitro and in vivo seeding of different (stem) cell lines.

However, long-term animal models have not delivered satisfactory results so far due to the lack of mechanical stability of the total artificial matrices, leading to early failure of valvular function. Tissue-engineered biological scaffolds of porcine origin have failed dramatically in a number of paediatric patients, resulting in cautious scepticism regarding xenogenic matrices.

In contrast, the decellularised allogenic matrices based on fresh homografts, which form the basis for ARISE, have provided initial auspicious clinical results which warrant further prospective clinical research.

A film on the decellularized heart valves with sound bites from patients and the treating physicians can be found at ARISE-Videos.