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The Chair's report for the periode 2010-2011

Scandiatransplant 02.05.2011

 

The Chairman’s report for the period 16.5.2010-24.5.2011 to the meeting of the Council of Representatives 25.5.2011, Copenhagen.

I was elected Chairman of the Scandiatransplant Board by the Council of Representatives in 19.05.2010, in Helsinki. I have retired 1 month earlier from my position as the head of the Clinic of Transplantation and Liver Surgery in Helsinki. I have served in the Board on Scandiatransplant for 6 years in the1990-ies, and as the Chairman in 1992 when the new Scandiatransplant Association was established.

The core issues of  the Scandiatransplant activities and the different groups have run pretty much as planned. However, the activities on the European front in the backwater of the new EU Directive on quality and safety of organs intended for transplantation have been a rather busy business during the past 12 months.

The Board:

 

  • Krister Höckerstedt, Finland - chair
  • Kaj Anker Jörgensen, Denmark
  • HJelena Isoniemi, Finland
  • Michael Olausson, Sweden
  • Per Pfeffer, Norway
  • Margrét Birna Andrésdóttir, Iceland


Center changes:
In the Nordic countries the total number of transplant hospitals has been reduced from 11 to 10. In Denmark the kidney transplant activity has ended a the Herlev hospital, thus the transplant hospitals thus reduced from 4 to 3: Copenhagen, Aarhus, Odense.

Other changes
Sweden:

  • The Heart centers were reduced from 3 to 2: Gothenburg and Lund.
  • The Liver centers were earlier reduced from 3 to 2: Stockholm and Gothenburg

Finland:

  • In Helsinki the Transplantation and Liver Surgery clinic including the adult liver and kidney transplantations have moved from the Surgical Hospital to the Meilahti campus. Now all transplantation clinics are on the same campus.

Norway:

  • Rikshospitalet, where all transplantations are performed has a new name: Rikshospitalet, Oslo University Hospital.


Activities
Activities in the Nordic countries registered by the Sctp office are presented in detail by MD Niels Grunnet (www.scandiatransplant.org).

The following observations may be taken out:

-  The number of DCD (388) decreased slightly form the record year 2009.
-  The total number of transplantations (1673) have slightly decreased since 2009.

-  The total nr of patients entering the waiting list was 1427, the lowest in 12 years. The kidney transplant waiting
list has now been reduced in the last 4 years. These results may partly  be explained due to an increased activity
in living donor KTX

- The organ exchange was still highest for the thoracic organs and the liver. However, the exchange of kidneys
increased for the third consequtive year.

-  Pancreas transplantation (2) started in Finland in two adults. Both were combined with KTX.

Activities of the Scandiatransplant groups

All Sctp groups have held their regular meetings.
NLTG organised a 25 year Anniversary Symposium in Copenhagen in November with presentations and participants from all 5 centers. Sir Roy Calne as a guest of honour gave an invited lecture on the historical perspective of transplantation.

- The NTSG group has renewed the guidelines for exchange and rotation rules regarding the lungs and the hearts
from deceased donors
- The NPRT group has been reorganised
- The Tissue Typers group suggest new STAMP exchange rules
- The NKG presents a change to the exchange rules

Other activities
Finland has received a new law on organ donation and transplantation in August 2010. Presumed consent was included in organ donation from deceased donors. Attention was taken to minimize expenses for living donors (day pay).
As suggested at the 2010 meeting of the Council of Representatives, the Board has decided to initiate a new
Scandiatransplant Research Grant:

  • To support initiation of inter-Nordic research projects in relation to Scandiatransplant.
  • 20.000 Euros are granted to initiate novel inter-Nordic research projects where at least two Scandinavian countries are participating.
  • The funding can only be granted to a specific project once.
  • The Scandiatransplant Board will evaluate written applications once a year.
  • The first application dead-line was 10.03.2011
  • The Board will select the best research project at the Board meeting 24.05.2011.


The History of Scandiatransplant
Another suggestion at the 2010 meeting of the Council of Representatives was to write the History of Scandiatransplant. Arnt Jakobsen has declared that he is willing to initiate the project in 2011. The start will include visits to the different transplant hospitals and institutions for the collection of data.
UEMS Transplant Division has since 2008 performed exams for transplant surgeons in organ donation, kidney, liver and pancreas transplantation. 130 surgeons have passed the exams, a few of them from the Nordic countries.

The first UEMS transplant center audits were performed in 2010. The Oslo transplant center has been audited by a group from the UEMS Transplant Division and received “Accreditation for training in liver, kidney and pancreas transplantation” with very high gradings.
Per Pfeffer, head of the Transplant committee in the Council of Europe, informed that there is now also standards in the Council of Europe for examination of transplant surgeons, transplant coordinators and transplant nephrologists.

The meeting with Sctp Board and the Nordic National Health Authority representatives was held in Sept 21.2010. Info on the Sctp homepage.

The National representatives were:

  • Jorunn Svendsen, (Helsedirektoratet) Norwegian Directorate for Health, Oslo
  • Per Fauchald, (Helsedirektoratet), Norwegian Directorate for Health, Oslo
  • Raija Asola, Ministry of Social Affairs and Health, Health Department, Finland
  • Charlotte Möller, The National Council for Organ and Tissue Donation
  • Bjørn Ursin Knudsen, Sundhedsstyrelsen (Health Authority), Copenhagen
  • Lone Bøgh, The Danish Centre for Organ Donation, Aarhus, Denmark


Information on Sctp was given and the EU-directive and EFRETOS were discussed.
The Danish Center for Organ Donation has created an online database which from the April 2010 shall contain information on all deaths in ICUs both of brain death and heart death to try to find out potential actual and realized organ donors. On all intensive care units a doctor and a nurse have been given the function as a contact person being responsible for all activities in relation to organ donation.

Newsletters
Three Scandiatransplant newsletters have been produced in 2010 by Frank Pedersen and Ilse Duus Weinreich. Niels Grunnet and Susanne Sönder have present news from the office and Bo Hedemark Pedersen has kept us up-to-date on the latest developments of the IT-programs.

All meeting protocols are displayed on our homepage.
Specific issues discussed in the different Sctp groups are reported.
Change of exchange rules have been promptly reported.
Quality control has been performed by producing an “Organ exchange compliance log” in the Sctp homepage. Compliance to Sctp rules has been evaluated in kidney exchange. Every center may check their own performance.
NKG as one of the youngest groups has been presented in more detail.

European Union
In EU the “Directive 2010/45/EU of the European Parliament of the Council of 7 July on Standards of quality and safety of human organs intended for transplantation was approved in July 2010. (EC presentation).

The main chapters in the Directive are:

  • The quality and safety of organs
  • Donor and recipient protection and donor selection and evaluation.
  • Obligations of competent authorities and exchange of information.
  • Organ exchange with third countries and European exchange organisations.
  • Article 31. Member states shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 27 August 2012. They shall forthwith inform the Commission thereof.


The Directive includes an Annex PART A Minimum data set with a list of data for organ and donor characterisation to be collected for each organ donation, and PART B Complementary data set with a characterisation of grouped data, which in addition may be collected based on the decision of the medical team.

The Directive contains an Action Plan with 10 articles on security and traceability in organ donation and transplantation.

To fulfil the issues of this Directive each Nordic member state (plus Norway and Iceland) should a) adjust the law and appropriate regulations accordingly and b) select the appropriate data to be collected, c) produce a national register on suitable variables for each member state before 27th of August, 2012. It should again be noted that the Action Plan is a recommendation – not mandatory.

The EU Directive Action plan has been discussed in 4 meetings in Brussels. They have usually been chaired by Stefaan van der Spiegel and once by Antti Maunu (Finland), the Deputy head of Unit Health Law and International at the Commission. The very active secretaries Anna Pavlou and Olga Salomon will leave in May 2011.

Participants have been the Competent authorities and transplantation experts of the 27 Member States as well as Scandiatransplant, Eurotransplant, ONT and WHO (c. 50 persons). The Nordic countries have all participated. Earlier EU-projects on Organ Donation were presented, and also programs in new EU-states, like Slovenia. Results from a survey on the number of organ donors and transplantations of the Member States have been shown (Indicators results).
Questionnaires on Indicators of organ donation have been sent out.

(Indicators exercise).

Living donor programs and plans have been presented by Arnt Jakobsen and Charlotte Möller (EU and why LD).

My impression at this stage is that these meetings have been very loosely organised and the most important parts of the Directive are still to be discussed: The Annex A: Minimum data set with a list of data for organ and donor characterisation and B: Complimentary data set. The next EU-meeting is in September.

European Framework for the Evaluation of Organ Transplants  (EFRETOS)
The EFRETOS is a EU-funded (1.4 mill. €) project for 2008-2011. The aim is to describe the optimal content of a registry of registries, based on the existing transplant registries in Europe. The goal is to create a pan-European Registry on organ donation, transplantation and transplantation follow-up (Executive summary).

Partners of the EFRETOS Consortium are the main OEOs of Europe:

  • ABM Agence de la Biomédecine (France)
  • CNT Instituto Superiore de Sanità  (Italy)
  • Czech Transplant Society (Czech Republic)
  • DSO Deutsche Stiftung Organtransplantation (Germany)
  • ESOT European Society for Organ Transplantation
  • ET Eurotransplant International Foundation (The Netherlands)
  • HNTO Hellenic National Transplant Organization (Greece)
  • NHSBT NHS Blood and Transplant (UK)
  • NTS De Nederlandse Transplantatie Stichting (The Netherlands)
  • Poltransplant (Poland)
  • SKT Scandiatransplant (Denmark)

EFRETOS is lead by Eurotransplant and chaired by its head Arie Oosterlee.

More than 50 experts have been working in 6 working parties to produce 15 different documents (deliverables) on the content of a future Registry of Registries. The main contents have been Data dictionary, Quality assurance, Safety and organ vigilance, Non-standard risk donors, Specification of variables for the donor, organs and transplantation, IT-communications and Governance.
On of the main reports is the data dictionary deliverable 7 concerning which data should be included in the register for registries (Deliverables 7). EFRETOS wants specific data to be mandatory (Tier 1).

Frank Pedersen has checked the availability of data in the present Scandiatransplant system (see previous Box). Those with green colour are part of the Scandiatransplant present registration and can be drawn out, those with red colour are not available at the time being, those with yellow colour have a question mark.

The Sctp Board has stated that

  • the EU Directive is a document for member states and not in itself for an interest organisation as the Scandiatransplant Association.
  • A pan-European Registry including the Scandiatransplant registry data from the Nordic countries is a central issue for us. The Sctp Board has been reluctant to suggest adoption of this European registry as such for the Nordic states. This opinion has also been given by the NLTG, KTG and the Coordinators’ group, for which I have presented the EFRETOS project.

The Sctp Board has sent a letter to the EFRETOS to present these opinions and also to pose 7 questions on the Governance of this project. As an answer to this, an extra EFRETOS-meeting was held in April 26. The final results will be sent to the Council of Representatives.

EFRETOS will be discussed at the meeting of Council of Representatives, May 25.

Anyway, the possible implication of EFRETOS in the Nordic countries is decided by the Member States with the national experts on transplantation and the Competent authorities (Socialstyrelsen/ Ministry of Health/Helsedepartementet/ Sundhetsministeriet/ Sundhedsstyrelsen/).

Scandiatransplant and Estonia
Estonia has in many years showed an interest in collaboration with Scandiatransplant. Estonia has developed a functional transplantation programme starting 1968. The nr of transplants performed are: 861 kidneys, 15 livers (since 1999) and 1 lung (2010). All transplantations are performed in Tartu. In 2009 Estonia had deceased organ donors 25.4  p.m.p. The largest donor hospital is in Tallinn. With a twinning agreement with Eurotransplant 10 lungs have been sent  to Vienna.

In April 2010 the Tartu Univeristy Hospital director Urmas Siguur sent Sctp a letter exploring future collaboration with Sctp. The former Sctp chairman Arnt Jakobsen has replied that non-Nordic countries cannot be members of Sctp, but perhaps a collaboration like the twinning system might be a workable solution between Estonia and Scandiatransplant.
In January 2011 Virge Pall, Director, Tartu University Hospital. He informed that a new Transplantation Center at Tartu University has been founded. The Tartu director proposes collaboration possibilities with Scandiatransplant.
Several Sctp Board members have visited Estonia during the years. Many Estonian transplant surgeons have been trained in Helsinki and I have initiated and fostered the liver program.
The new Sctp Board has discussed this in 2/2011. Based on the fact that Sctp has collaboration with all official Organ Exchange Organisations in Europe it is suggested that similar collaboration may start with an OEO in Estonia if the following conditions are met:

  • The Transplantation Centre at Tartu University Hospital represents the OEO of Estonia
  • Formal accreditation of activities related to transplantation of this Centre and the donor hospitals in Estonia is shown.

During my first year as Scandiatransplant (Sctp) chairman I have attended 21 meetings:

- Sctp Board (3)
- Sctp & and The Nordic Competent authorities (1)
- Sctp office & Aarhus University Hospital directors (2)
- Sctp Liver, Kidney and Coordinator’s group meetings (3)
- EU-meetings in Brussels (5 including 1 teleconference)
- EFRETOS meetings at Schiphol airport
- Amsterdam or Brussels (7, including 1 teleconference).

Krister Höckerstedt
Chair, Board of Scandiatransplant