Press Release

Wednesday, 11 March 2015

Holding up under pressure: the MHH heads clinical study on lifelong aortic heart valve replacements EU awards 5 million Euro to the 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 is to receive 5 million Euro in funding over the next four years. Under the lead of Hannover Medical School (MHH), the project will 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 MHH, the consortium includes five other leading European heart centers and will enrol a total of 120 patients.

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 (HTTG) at the MHH 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, an innovative MHH 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. According to ARISE’s coordinating investigator and Head of Clinical Trials at the HTTG, Dr. Samir Sarikouch, "This treatment option is particularly suitable for young women who later want to start a family.  A major advantage is that no blood thinners are required after the procedure, as these are associated with significant risks such as thrombosis, embolism, congenital malformations and severe bleeding in case of injury or during birth”.

Each year, 65,000 aortic valve replacement procedures are carried out in Europe to treat acquired or congenital heart valve diseases.  Over the past four years, MHH surgeons have implanted decellularized aortic valves in 50 patients. One of these patients was Signe Lenz Somdalen, who is a perfect testimony to the advantages of this novel form of valve replacement: “In 2013, I underwent surgery to receive a decellularized aortic valve. Without this procedure, I would never have been able to have a second child".

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.

For more information, please contact Dr. Samir Sarikouch, Tel. +49 (511) 532-5567, Email: sarikouch.samir(at)

For TV journalists: a film on the decellularized heart valves with sound bites from patients and the treating physicians can be found at ESPOIR-Videos. All image rights belong to the MHH. If you would like to use any of the pictures, please contact the MHH Press Office, Tel. +49 (511) 532-6772.