Clinical study on lifelong aortic heart valve replacements - EU awards EUR 5 million to ARISE project

March 2015 saw the Kick-off Meeting of the EU-funded clinical study 'Aortic Valve Replacement using Individualised Regenerative allografts: Bridging the Therapeutic Gap', which took place at the EACTS house in Windsor (UK) - European Association For Cardio-Thoracic Surgery. The project will be funded with EUR 5 million over the next four years and is coordinated by the Hannover Medical School in Germany.

In the surroundings of the EACTS house the project partners have set the first signals to assess a new kind of aortic valve replacement which can overcome the typical problems of biological graft rejection and is significantly more durable than currently available alternatives. In addition to the Hannover Medical School, the consortium includes five other leading European heart centers (Leids Universitair Medisch Centrum – The Netherlands, Royal Brompton & Harefield – United Kingdom, Universitair Ziekenhuis Leuven – Belgium, Azienda Ospedaliera Universita Padova /Universita Degli Studi di Padova – Italy, l’Institut d’Investigacions Biomèdiques August Pi i Sunyer - Spain). The clinical centers will enrol a total of 120 patients. During the project life time they will be supported by the Center for Ethics and Law in Life Sciences located at the Leibniz University of Hannover dealing with ethical issues of this new intervention.

The ARISE project will transfer the principle of decellularized heart valves, which has been tested for pulmonary valves in the ESPOIR study since 2012, to aortic valve replacement. 'We first applied this approach in the pulmonary position, as the pressure on the aortic valve, the pathway through which the heart pumps blood from the left ventricle into the aorta, is three times higher than in the right ventricle. In addition, the coronary arteries originate directly behind the aortic valve which makes the implantation of an aortic valve anatomically much more complicated than pulmonary valves,' explained Professor Axel Haverich, head of Cardiac, Thoracic, Transplantation and Vascular Surgery at the Hannover Medical School and coordinator of the ARISE study.

Decellularized 'homografts' are human donor heart valves which have been stripped completely of all cells, leaving only a collagen matrix structure. The process of decellularization is undertaken in a special laboratory at corlife oHG, an innovative German spin-off. The advantage is that these heart valves last a lifetime, are not rejected and have the potential to grow in pediatric and adolescent patients.

The standard procedure for valve replacement involves the implantation of mechanical valves or biological heart valves of animal origin. However, both options have significant drawbacks. Mechanical valves require a lifelong regimen of blood thinners and animal valves degenerate after about eight to ten years, requiring additional surgery, which leads to an increased risk for patients with each reoperation. Patient recruitment to the study is carried out in collaboration with an independent, international ethics committee which involves European patient organizations. Enrolment to the study is expected to begin in autumn 2015.

The project website will be available soon at http://www.arise-clinicalstudy.eu/ including a video on the decellularized heart valves with sound bites from patients and the treating physicians.

For more information, please contact Dr. Samir Sarikouch, Tel. [phone], Email: sarikouch.samir mh-hannover.de.

Countries

Belgium, Germany, Spain, Italy, Netherlands, United Kingdom