Press Release

Tuesday, 21 April 2015

First ESPOIR decellularized homografts implanted at “KiSpi” and “GOSH”

Two of the largest paediatric hospitals in Europe, Kinderspital Zürich (UZH) and Great Ormond Street Hospital (GOSH) in London, have successfully implanted decellularized homografts for pulmonary valve replacement within the ESPOIR EU-wide clinical trial in early April 2015.

Prof. Michael Hübler and his team at the Kinderspital Zürich used an ESPOIR PV valve for pulmonary valve substitution in a 14 year old patient during a so-called Ross operation, a complex operation where the patient’s pulmonary valve is used to replace a defective aortic valve with the subsequent reconstruction of the right ventricular outflow tract using a valve prosthesis. Prof. Hübler described the handling of the decellularized graft as “remarkable”. The young patient was able to leave the intensive care unit the day after the operation and was discharged one week after with excellent postoperative results.

At Great Ormond Street Hospital in London, an ESPOIR PV valve was implanted by Dr. Victor Tsang and co-workers to replace a pulmonary valve in a 10 year old patient following a repair procedure for Tetralogy of Fallot. This re-do operation was required due to progressing right ventricular dilatation resulting from pulmonary valve incompetence and the patient’s own pulmonary valve was then replaced by the ESPOIR valve.

The ESPOIR PV valves are donated human valves which have been decellularized in a specialized procedure at corlife OHG in Hannover, an innovative bio-tech company active in the area of Tissue Engineering.  Human heart valves were provided within this European study by the German Society for Tissue Transplantation (DGFG), a not-for-profit organisation responsible for the allocation of donated human tissue within Germany.

Prof. Haverich, coordinator of the European Commission funded ESPOIR project said “This is a big step forward for this important trial.  We also expect the University of Padua and Leiden University to include their first patients soon, which would mean that all participating centres are within the clinical phase of the trial!” The ESPOIR project will evaluate decellularized homograft valves for pulmonary valve replacement in comparison to current valve substitutes within a large prospective multicentre trial carried out at leading European Centres for Congenital Cardiothoracic Surgery. Safety and efficacy aspects, such as re-operation and re-intervention rates, hemodynamic performance, growth potential and long term durability, will be assessed within the study.