Single centre 12 year experience with durable mechanical circulatory support: comparison with the EUROMACS registry.

OBJECTIVES: Mechanical circulatory support is an established therapy in end-stage heart failure. The EUROMACS registry was created to promote research in these patients. The aim of this report was to present our 12 year experience with the durable mechanical circulatory support devices and compare it with the EUROMACS registry. METHODS: Data from the entire EUROMACS registry from January 2011 to April 2019 were included (4704 implantations in 4410 patients). During the 12 years of our experience, until April 2019,125 mechanical support devices were implanted, in 122 patients. We compare patients´ characteristics, operative data and results with the EUROMACS registry and we report the major complications during the observational period. RESULTS: Primary end-point (death) occurred in 40 (32.8 %) patients in our cohort during the follow-up period, representing the survival rate 75 %, 68 %, and 58 % for 6, 12, 24 months respectively, which compares favourably with the data, reported by the EUROMACS registry, the survival 66 % and 53 % after 1 and 2 years respectively. Cerebrovascular accident occurred in 7 %, a bleeding event in 32 %, significant infection (driveline) in 78 % and a device malfunction in 13 % of the patients. Forty- three patients underwent a heart transplant with hospital and long-term mortality of 11.6 % and 14 % respectively. CONCLUSION: Mechanical circulatory support is a valuable therapeutic option with excellent survival rates, nevertheless it is associated with clinically significant complications rates. The direct comparison between our cohort and the EUROMACS registry showed that early implantation strategy and mini invasive approach may improve survival rates and decrease postoperative complications (Tab. 3, Fig. 3, Ref. 16).

The future of heart valve banking and of homografts: perspective from the Deutsches Herzzentrum Berlin.

Ever since the early days of homograft implantation in 1956, and the introduction into clinical practice by Ross and Barrat Boyes, homograft heart valves have proven to have many advantages. Its disadvantages became evident during long-term follow up. Factors, such as donor and recipient morbidity, tissue banking techniques, and the often complex surgical technique required to implant, are of great influence on the long term results. Because of European Directives, legally binding quality assurance regulations have been introduced in homograft banks. However, still not all processing methods have been scientifically sub-structured on their effects on the final product and its durability. The donor shortage has stimulated researchers and industries to develop and improve mechanical and biological valve substitutes such as the stentless bioprostheses. In general, candidates for homograft valve implantation include patients with: endocarditis, congenital defects and women who wish to become pregnant. For each category of patients different implantation techniques are required. The results of homograft banking and homograft transplantation in the German Heart Institute Berlin are satisfactory. Freedom of re-infection rate after homograft implantation is 91.9% +/- 3.6% after 15 years. Current developments show an increased interest in tissue engineered as well as in de- and re-cellularization of heart valve homografts. The advantages and disadvantages of the several processing techniques have not yet been proven in long term clinical results. For homograft bankers these developments pose as a challenge to join forces and to initiate cooperate projects aimed at scientific and organizational development.

Cardiovascular tissue banking in Europe.

INTRODUCTION: In the past 50 years, human cardiovascular tissue allografts, also called homografts, have been implanted into patients with different valvular diseases. The use of these allografts and  the number of cardiovascular tissue banks and their respective techniques increased. We conducted a survey to establish the quantity of allografts processed, and issued by, European tissue banks. The survey also included the collection of other relevant statistics. METHODS: In 2011, the Foundation of European Tissue Banks collected data from 19 different cardiovascular tissue banks in 11 European countries. RESULTS: From  2007 to 2010 the  data show a decrease in the number of hearts received, from 1700 to 1640 in 18 tissue banks; the average number of hearts received for cardiovascular tissue processing decreased from 113 to 91. The number of heart valves issued for transplantation increased from 1272 in 2007 to 1486 in 2010. The average rate of discard because of microbiological contamination was 20.7%, while 4.2% of the grafts were not used because of positive serology. Half of the tissue banks issued arterial grafts, while 3 banks also issued veins and pericardium. An overview of decontamination methods shows considerable methodological differencesbetween 17 cardiovascular tissue banks. CONCLUSIONS: From the experience in Europe, it can be concluded that cardiovascular tissue banks have an established place in the domain of cardiovascular surgery. The statistics show fluctuating data concerning the demand for human cardiovascular allografts and methodological questions. There is room for growth and improvement with respect to validation of decontamination methods.

European quality system for tissue banking.

AIM: The aims of this project were to analyze the factors that influence quality and safety of tissues for transplantation and to develop the method to ensure standards of quality and safety in relation to tissue banking as demanded by European Directive 2004/23/EC and its technical annexes. It is organized in 4 Working Groups, the objectives of each one being focused in a specific area. STANDARDS: The Guide of Recommendations for Tissue Banking is structured into 4 parts: (1) quality systems that apply to tissue banking and general quality system requirements, (2) regulatory framework in Europe, (3) standards available, and (4) recommendations of the fundamental quality and safety keypoints. REGISTRY: This Working Group handled design of a multinational musculoskeletal tissue registry prototype. TRAINING: This Working Group handled design and validation of a specialized training model structured into online and face-to-face courses. The model was improved with suggestions from students, and 100% certification was obtained. AUDIT: The Guide for Auditing Tissue Establishments provides guidance for auditors, a self-assessment questionnaire, and an audit report form. The effectiveness and sustainability of the outputs were assessed. Both guides are useful for experienced tissue establishments and auditors and also for professionals that are starting in the field. The registry prototype proves it is possible to exchange tissues between establishments throughout Europe. The training model has been effective in educating staff and means having professionals with excellent expertise. Member states could adapt/adopt it. The guides should be updated periodically and perhaps a European organization should take responsibility for this and even create a body of auditors.

Shortage in the face of plenty: improving the allocation of corneas for transplantation.

BACKGROUND: As there are plenty of potential corneal donors, theoretically there should be no shortage of corneal grafts. Practically, however, shortages have been a problem, especially with HLA-matched corneas, which are increasingly requested. This increase requires evaluation and proper adaptation to meet all requests in the future. METHODS: BIS' allocation data for corneal transplants were analyzed for the years 1998 through 2001. RESULTS: Allocation of matched corneas almost doubled in 2000. The waiting list for matched grafts could be reduced by one third. CONCLUSIONS: A steep increase in demand for matched grafts could be noted by the year 2000. This signifies that the results of positive matching studies have ultimately been taken notice of by the ophthalmic surgeons with consequent adaptation of their graft orders. BIS has mostly been able to cope with these rapidly changing and increasing demands, but more efforts are continuously needed to supply those typed and matched corneas within short time. Our next step will be to offer HLA-DR matching routinely in addition to the current HLA-A/-B matching. We are looking forward with great interest to the introduction of even more specified matching algorithms in the not too far distant future, and are prepared to meet all the requirements which might be associated with such challenges.

Tissue banking programmes in Europe.

In Europe, organ centres such as Bio Implant Services (BIS) in cooperation with Eurotransplant, play an intermediary role from donation of tissue and organs to allocation and transplantation. They take responsibility for donor medical/safety screening and organize procurement. Tissue banks are autonomous and are responsible for tissue processing and preservation. Allocation of scarce tissues is performed according to rules set by committees of renowned experts in the field. Most frequently donated types of tissues are corneas, heart valves, bone and soft tissue and skin. In this article, optimal serological screening of the donor, and the banking of these tissues in Europe is reviewed in relation to clinical need and volume of transplantable tissues available, number of banks and their organisational level, methods of explantation, processing and preservation, quality standards and new developments.