Banking and Distribution of Cryopreserved Heart Valves and Large Arteries
The Heart Valve Bank European Homograft Bank (EHB) was set up in 1989 as a non-profit organization in order to respond to the growing request of cardiac surgeons for quality controlled Cryopreserved heart valve allografts (aortic, pulmonary, mitral).
Since 1991, EHB also prepares and distributes large arteries, namely ascending and descending aorta, aortic arch, aortic bifurcation, superficial femoral arteries, as well as the non-valved pulmonary bifurcation.
On May 11, 2015 EHB was taken over by the St-Jean Clinic asbl, as its integrated service and is located at the Méridien Site on Rue du Méridien 100, 1210 Brussels.
EHB is an authorized Cardio-vascular Tissue Bank in accordance with the European recommendations and Belgian legislation on Tissue Banking from 19 December 2008[FAGG/AFMPS nr. 14-0002 (heart valves) and 14-0003 (blood vessels); PEI authorization nr. PEI.B.04076.01.1 (heart valves) and PEI.B.04099.01.1 (vessels)].
EHB activity is based on the cooperation of a large international network of procurement and implantation centres. Namely, the human body material source is recovered by the organ transplant teams or collaborating tissue banks and sent to EHB for processing and preparation of allografts, their quality control, cryopreservation and storage. On basis of the demands of the implanting surgeons from those (and other centres) EHB selects, allocates and distributes the appropriate allografts for their patients, on basis of the medical indication, state of emergency of the patient and the availability of the allografts.
During 25 years of its activity EHB has distributed about 9.000 allografts (about 6.000 valves and about 3.000 arterial allografts) mainly in Belgian, French, Swiss and German implanting centres, but also in other destinations, such as Croatia, Great Britain, Greece Korea, Luxemburg, Netherlands, New Zealand, Saudi Arabia, Slovenia, Serbia, Turkey, etc. For over 25 years, thousands of patients worldwide have benefited from the allografts delivered by EHB.
The main objectives of EHB are:
- Supply of cardiac and vascular surgeons with appropriate valve and vascular allograft,
- Scientific collaboration activity in the field of transplantation of human tissues and cells,
- International and inter-tissue bank collaboration,
- Coordination of donor selection and tissue recovery for the preparation of cardio-vascular allografts of the international network of the hospitals,
- Training and teaching of the tissue banking professionals in the field of the cardiovascular tissue transplantation.
Protocol of Cardiovascular Tissue Banking
According to the requirements of the EU Directives, to the Belgian legislation and standards, and to the recommendations of the EATB, the Manager of Human Body Material is responsibility for the entire process of obtainment, tissue processing, storage and distribution of allografts.
Processing and quality control of the allografts
Preparation
Dissection of the aortic and pulmonary roots, mitral valves and/or arteries as well as all steps of the processing are performed by appropriately trained medical and paramedical staff inside a vertical laminar flow clean-room Class A, background Class B/C. After macroscopic examination, competence testing and measurements, the tissues are decontaminated in a low temperature, low concentrated antibiotic cocktail during 40-48 hours.
Cryopreservation
Following decontamination, the tissues are cryopreserved using the dimethyl-sulfoxide (DMSO) as cryoprotecting solution. The pouches with the tissues are frozen in liquid nitrogen vapors according to a specific computer monitored program.
Quality control involves
- Microbiology (before and after decontamination) :
- Aerobic and anaerobic bacteria
- Mycoses and yeasts
- Mycobacterium Tuberculosis (by indication)
- Serology : Screening of the donor for transmissible diseases
- Hepatitis B & C, AIDS, HTLV, Syphilis
- Q- Fever (by indication), Coxsackie viruses (by indication)
- Histology : Pieces of the cardiac muscle (myocardium), aortic and mitral wall and mitral valve (hearts) and pieces of the arterial tissue are systematically tested histologically for exclusion of any infection or malignancy, as well as to detect any malformation of the valve/vascular tissue.
Curve of cryopreservation
Each tissue must have the registered cryopreservation curve, as to be able to document the requested quality.
Final validation
The manager of human body material (Medical Doctor), after having obtained all necessary tests, controls them for conformity with the regulation and quality requirements and validates the allografts for clinical application.
Location
Site Méridien - Level 6
Phone: 02/225.94.51
Fax: 02/225.94.52
E-mail: ehb@clstjean.be
Opening hours of the secretariat
8h00-18h00 (from Monday to Friday). EHB is available by telephone 24 hours a day and 7 days a week. A duty system is arranged between its administrative and medical/paramedical staff members (Tel: +32 475/51.99.32).
Team
Documents to download
The EHB protocols are based on the following regulatory and legal refrences :
- Directive 2004/23CE of the European Parliament and Commission concerning the establishment of the standards of the quality and security for the donation, achievement, control, processing, preservation and storage of the human tissues and cells
- Directive 2006/17/CE from the Commission containing the application of the Directive 2004/23/CE from the European Parliament and Commission, concerning certain technical requirements related to donation, procurement and control of the tissues and cells of human origin
- Directive 2006/86/CE from the Commission, containing application of the Directive 2004/23/CE from the European Parliament and Commission from March 31st 2004, concerning the technical requirements of traceability and notification of the reactions and side-effects and certain technical requirements related to the processing, preservation, storage and distribution of the human tissues and cells
- Belgian Law concerning the achievement and use of the human body material intended for human medical application or for scientific research (December 19, 2008)
- Royal Decree of September 28, 2009 fixing the quality on security conditions that must be fulfilled by the Tissue Banks, the Intermediate structures and the Production Institutions for donation, procurement, preparing, testing, storage and distribution of substances of human origin
- Belgian Standards for cardiovascular allografts (2007, reviewed in 2013)
Main Procurement and/or Implantation Centers
Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Cardiovasculaire Heelkunde
Moorselbaan 164
B-9300 Aalst
Universitair Ziekenhuis Antwerpen
Cardiale Heelkunde
Wilrijkstraat 10
B-2650 Edegem
Hôpital Erasme
Chirurgie Cardiaque
Route de Lennik, 808
B-1070 Bruxelles
Cliniques Universitaires Saint-Luc
Chirurgie cardiovasculaire
Avenue Hippocrate 10
B-1200 Bruxelles
Hôpital Universitaire Brugmann/HUDERF
Chirurgie Cardiaque
Place Van Gehuchten
B-1120 Bruxelles
Universitaire Ziekenhuis Brussel (VUB)
Cardiale Heelkunde
Laarbeeklaan 101
B-1090 Bruxelles
Universitair Ziekenhuis Gent
Cardiale Heelkunde
De Pintelaan 185
B-9000 Gent
Universitair Ziekenhuis Gasthuisberg, LSGT, KULeuven
Cardiale Heelkunde
Herestraat 49
B-3000 Leuven
CHU Liège
Chirurgie Cardiovasculaire
Domaine Universitaire du Sart Tilman
B-4000 Liège
Z.O.L. - St. Jan
Schiepse Bos 6
B-3600 Genk
CHR de Citadelle
Chirurgie Vasculaire
Boulevard du 12ème de ligne
B-4000 Liège
U.Z. Leuven, LSGT, KU Leuven
Vaatheelkunde
Herestraat 49
B-3000 Leuven
Clinique Notre-Dame
Chirurgie Vasculaire
Rue Basse Hermalle 4
B-4530 Oueye-Hermalles/Argenteau
HUDERF (Hôpital Universitaire des Enfants Reine Fabiola)
Chirurgie Cardiaque
Avenue J.J. Crocq 15
B-1120 Bruxelles
Clinique St.Joseph
Chirurgie Vasculaire
Rue de Hesbaye 75
B-4000 Liège
Heilig Hart Ziekenhuis
Cardiale Heelkunde
Wilgenstraat
B-8800 Roeselare
Clinique Saint-Jean
Chirurgie Cardiaque et Vasculaire
Boulevard du Jardin Botanique 32
B-1000 Bruxelles
France
Centre Hospitalier Universitaire Nord Amiens
Département d'Anesthésiologie - Réanimation Chirurgicale "A"
F-80054 Amiens Cedex 1
Centre Hospitalier Régional Universitaire de Nantes
Chirurgie Cardiovasculaire
Hôpital Laënnec
Boulevard Jacques Monod
F-44035 Nantes Cedex
Centre Hospitalier Régional, Hôpital Cardiologique de Lille
Chirurgie cardiovasculaire et cardiaque
Boulevard du Prof. J. Leclercq
F-59037 Lille Cedex
Hôpital Civil de Strasbourg
Chirurgie Cardiovasculaire
Place de l'Hôpital 1
F- 67091 Strasbourg Cedex
CH de Mulhouse
87, Avenue Altkirch
F-68100 Mulhouse
Germany
Universitätsklinikum Giessen
Herz- & Gefässchirurgie
Klinikstrasse 29
D-35392 Giessen
Kinderherzzentrum Giessen
Feulgenstr. 12
D-35390 Giessen
Klinikum Krefeld
Klinik für Herz- und Thoraxchirurgie
utherplatz 40
D- 47805 Krefeld
RWTH Aachen
Thorax-, Herz-, & Gefässchirurgie
Paulstrasse 30
D-52017 Aachen
Klinik der Universität zu Köln
Kerpenerstr. 62
D-50924 Koln
Herzzentrum Bodensee GmbH
UK Heidelberg
Switzerland
Hôpital Cantonal Universitaire de Genève
Chirurgie Cardiovasculaire
Rue Micheli-du-Crest 24
CH-1211 Genève 4
Centre Hospitalier Universitaire Vaudois, Lausanne
Chirurgie Cardiovasculaire
Rue Bugnon
CH-1011 Lausanne
Kinderspital Zürich
Klinik für Herz- & Gefässchirurgie
Rämistrasse 100
CH-8091 Zürich
Kantonsspital St. Gallen
Klinik für Chirurgie
CH- St. Gallen
UniversitätsSpital Zürich
Rämistrasse 100
CH-8091 Zürich
Stadtspital Triemli
Birmensdorferstrasse 497
CH-8063 Zürich
University Hospital Bern
Switzerland Clinic for Cardiovascular Surgery
CH-3010 Bern
Cardiocentro Ticino
Cardiochirurgia Fondazione
Via Tesserete 48
CH-6900 Lugano
Hôpital de Sion CHCVs
Avenue du Grand-Champsec 80
CH-1950 Sion
Associated Laboratories
CEBIODI, Laboratoire Clinique Saint-Jean
Laboratoire de séro-virologie
(Laboratoire de Référence SIDA)
Hôpital Erasme
B-1070 Bruxelles
Service Francophone du Sang, Laboratoire d’Analyses Biologiques
Rue du Fond du Maréchale 8/1
5020 Suarlée
LCA Laboratoires de Contrôle et d'Analyse S.A.
Z.1 Researchpark 110
1731 Zellik
Département d'Anatomie Pathologique
UCL St. Luc
Avenue Hippocrate 10
B-1120 Bruxelles
Financial Aspects of Homograft Delivery
The prizes of the allografts (heart valves/arterial allografts) are fixed by the Ministerial Decree of 14 october 2009, fixing the prizes of the human body material).
Each year, on 1st of January the prizes are reviewed in basis of the Belgian national Health index.
Members of the Advisory Board
| Dr. Michel HURNI, President | Chirurgie Cardiovasculaire Rue Bugnon CH-1011 Lausanne |
| Prof. emer. Willem DAENEN | Populierenlaan 6 B-3210 Linden |
| Dr. Hélène DEMANET | Chirurgie Cardiaque, HUDERFF Avenue Jean Joseph Crocq 15, B-1020 Bruxelles |
| Prof. Katrien FRANCOIS | Cardiale Heelkunde UZ Gent Depintelaan 185 B-9000 Gent |
| Prof. Inge FOURNEAU | Vasculaire Heelkunde Herestraat 49 B-3000 Leuven |
| Prof. André VINCENTELLI | Chirurgie cardiaque Boulevard du Prof. J. Leclercq F-59037 Lille Cedex |
| Prof. Jean RUBAY | Chirurgie Cardiovasculaire Avenue Hippocrate 10 B-1200 Bruxelles |
| Prof. Robert VERHELST | Chirurgie Cardiovasculaire Avenue Hippocrate 10 B-1200 Bruxelles |
| Prof. Xaver- Franz SCHMID | Klinikum Krefeld Lutherpl. 40, D- 47805 Krefeld |
| Prof. Hendrik VAN DAMME | Chirurgie Cardiovasculaire Domaine Universitaire du Sart Tilman B-4000 Liège |
| Dr. Benoit HERMANS | Clinique Saint-Jean Bld. J. Botanique 32 B-1000 Bruxelles |