The Fraunhofer FEP has developed a process, called SULEEI, which makes it possible to sterilize and preserve decellularized pericardial tissue by means of photo-initiated ultraviolet crosslinking with low-energy electron irradiation. The complex procedure is under evaluation in cooperation with the department of cardiac surgery belonging to the heart center of the university hospital as part of the Technische Universität Dresden.
Calcifications and inflammatory processes affect the performance of heart valves and may cause high grade stenosis which finally results in a weakened heart muscle.
Treatment of decellularized pericardial tissue
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As a consequence, the patient develops a heart failure and suffers by symptoms as abnormal fatigue, breathing difficulties, disability, chest pain and even acute unconsciousness. Both, the early diagnosis and a timely therapy may prevent serious harm and above all the patient's death.
The only treatment option available for high-grade stenosis is replacing the heart valve by cardiac surgery. There is no drug-based therapy for resolving valve changes as yet. Replacing a heart valve instantly reduces the level of resistance affecting it, leading to a rapid improvement in both heart function and the patient's symptoms. As a result, the patient can ultimately return to a normal quality of life and life expectancy.
The primary options available when selecting a replacement heart valve are a mechanical (synthetic) one or a biological one. The patient’s age, plus factors including life expectancy, lifestyle, and any secondary illnesses, all have to be taken into account when selecting a prosthesis.
The process of manufacturing mechanical prostheses is based on inert composite materials using titanium. The main advantages associated with this type of implant are its longevity and lack of substantial wear and tear, meaning that the patient normally does not have to undergo more than one operation. As blood clots can be formed onto the valve contact surfaces, however, patients are required to take blood-thinning medication throughout the remainder of their lives, putting them at increased risk of hemorrhage.
In recent years, biological prostheses have become an increasingly popular alternative. Primarily made from bovine pericardial tissue (referring to the sac surrounding the heart) or porcine heart valves, what makes them especially appealing is the fact that they are not composed of thrombogenic materials, so there is no need for the patient to be put on a permanent course of blood-thinning medication.
However, biological prostheses suffer from a shorter functional life: After 10 to 15 years, 30 to 40 percent of all patients experience a similar level of degenerative change as they would have with the native valve showing an equivalent level of stenosis. As a consequence, the patients ends up reporting the same symptoms as they had before the operation and another valve replacement procedure is required.
Working in cooperation with the Cardiac Surgery Department, the Medical and Biotechnological Applications business unit at Fraunhofer FEP has developed a new treatment procedure known as SULEEI: sterilization (S) and preservation of decellularized pericardial tissue via photo-initiated ultraviolet (U) crosslinking with low-energy electron irradiation (LEEI). Researchers at the Heart Center Dresden (part of the Faculty of Medicine CGC at the university) are exploring the pathogenesis of aortic valve stenosis, which in most cases is accompanied by a form of tissue calcification known as sclerosis.
Simona Walker, a PhD student at Fraunhofer FEP, explains the innovation: "The SULEEI procedure is a unique combination of two mechanisms. It is a multi-component procedure that starts by crosslinking the decellularized biological tissue using a vitamin B2 assisted UV treatment. The hereby achieved effect can be enhanced by the subsequent applied treatment, which involves low-energy electrons.
These electrons produce numerous effects. The aim is to achieve a similar crosslinking degree in comparison to the conventional glutaraldehyde treatment. In conclusion, through the use of non-toxic substances the biocompatibility is increased. Applying the SULEEI process eliminates the need for any subsequent sterilization."
MEDICA-tradefair.com; Source: Fraunhofer Institute for Organic Electronics, Electron Beam and Plasma Technology FEP