No of new patient per Million معدل الحدوث (لكل مليون نسمة ) عدد مرضى الجُدد (2007م) عدد السكان (2006م) المنطقة 1435443.810.102الجنوبية 1429706.819.111الوسطى 1344663.470.525الشرقية 13110017.625.261الغربية 1212361.953.850الشمالية 1363217723.678.849المجموع
Transplant global history Research for transplant: one hundred years ago –Alexis Carrel (Nobel Prize 1912) WW II, kidney transplants between identical twins immunosuppression –living donors First heart transplant (1967) –“Definition” of brain death –Growing no organs from deceased donors (DD) –Supply never meets the need (waiting lists) Transplantation becomes global practice 1980s: organ trafficking and Tourism.
Deceased donors Donor has been declared dead by two physicians independent of the transplant team Usually occurs only in cases of neurologically determined death Live donors to donate one or part of an organ to someone on a transplant waiting list. DONATION
Yearly Number of kidney transplant per million population per year - USA - 52 Predominantly Deceased Donors Europe -27 Predominantly Deceased Donors Asia - 3 Predominantly Living Donors WORLD STATUS OF RENAL TRANSPLANTS
The deceased donors per million population per year USA - 20.7 Europe - 15.9 Asia - 1.1 South America - 2.6 DECEASED DONOR RATES
Incidence of End Stage Organ failure Community and professional Mind-set to Brain Death and Donation Legal aspect Trained Donor Coordinators COMMON PROBLEMS IN DD TRANSPLANT
Public awarness Reporting of Brain Death Hospitals Donation system. Religion, Society and Organ Donation COMMON PROBLEMS IN DD
System Funding for Donor program Hospitals work to identify & maintain “Brain Dead” donors Community Awareness of “Brain- Death” Concept For cadaveric donation, ‘ Society acceptance remains a crucial in a transplant program’ PROBLEMS WITH DD Transplant
Transport of organs – between cities Adequate No. of Intensivists in ICUs Well qualified Surgeons to undertake Retrieval & TX HLA Tissue typing and Cross-match Trained transplant Co-coordinators Trained transplant Co-coordinators Support Organization to SCOT Hospitals Donation System
... و مَنَ اَحياها فَكَاَ نما اَحيَا الناسَ جميعاً... And he who saves a man’s life shall be considered as one who has saved the life of mankind as a whole
Issues Issues A. Living donors A. Autonomy vs. nonmaleficence B. Risks to Donor ( “benefit”) B. Deceased donors A. Brain death (accuracy; conflict of interests) B. Consent? C. Waiting lists A. Allocation (medical vs. social) B. “Shortage” D. Commercialism A. Autonomy vs. desperate “donors” ) B. Transplant tourism ( “ deal” including donor, at “bargain” )
Japan - 12,974 Taiwan - 7000 Saudi Arabia - 4248 Korea - 4000 Pakistan - 1650 Hong Kong - 1018 Singapore - 666 Bangladesh - 125 Waiting Time Taiwan – 1.9 yrs Korea – 2.2 yrs Hong Kong – 4.3 yrs Singapore– 5.8 yrs No Waiting list in Iran for Kidney Tx. KIDNEY TX WAITING LIST IN ASIA (2002)
Waiting List #’s# of donors per population Australia 1,76410 per 1,000,000 Canada 3,99013.5 per 1,000,000 United States 75,00034.3 per 1,000,000 KIDNEY TX WAITING LIST IN THE WORLD (2002)
Five organ trafficking hotpots identified by the WHO CHINA PAKISTAN EGYPT COLOMBIA PHILIPPINES 2007 Sources: Reuters, World Health Organization
Clinical Outcomes for Saudi Patients Receiving Deceased Donor Liver Transplantation in China 2 King Faisal Specialist Hospital & Research Center – Saudi Arabia
consequent increase in the number of patients seeking transplant abroad especially in China. Attracting factors in China: easy accessibility. relatively low cost, relatively short waiting time. lax transplantation indications.
Despite these attractive factors, the main growing concern with this choice is the uncertainty regarding the outcome …… Despite these attractive factors, the main growing concern with this choice is the uncertainty regarding the outcome ……
Seventy-four adult patients (60 males & 14 females). Mean age: 54.7 years. Nationality: Nationality: Forty-six Saudi nationals; 28 Egyptians. Average MELD score: 17. In 5 patients (6.8%) MELD score > 25. Indications for liver transplantation: hepatitis C related decompensated cirrhosis (n=29). hepatocellular carcinoma (n=24). hepatitis B (n=14). cryptogenic cirrhosis (n=6). primary biliary cirrhosis (n=1). Median period between contacting centre & travel: 4 weeks (2-16w). RESULTS
41 patients (55%) had been denied live transplantation in KSA or in Egypt. Reasons for rejection of transplantation: unsuitable medical condition due to multiple co-morbidities (n=23), age >65 (n=13), advanced hepatocellular carcinoma (n=5). three patients: tumor size > Milan and UCSF criteria; one: invasion of the right branch of the portal vein; one: invasion of the main portal vein.
Reports from China ● In-China waiting period: ● In-China waiting period: 5-20 days (median14 days). Donors’ data: ● Donors’ data: Only the age of the donor (range 20-35 years, median 25 years) & the cause of death (severe brain injury in all cases) were provided. Operative details: ● Operative details: missing or incomplete. ● Early post-operative morbidity: ● Early post-operative morbidity: Complications were rarely described in detail. ● Mortality: ● Mortality: Two patients died in China, due to unknown cause.
Follow up after return from China ● Follow up care for a median of 13 months (2-60 months).
Diffuse biliary stricture: Diffuse biliary stricture: 14 (18.9%) Six died. The rest required repeated interventions (ERCP, PTC). Two required surgery and one required retransplantation. Anastomotic stricture: Anastomotic stricture: 6 (8.1%) Bileleakage: Bile leakage: 4 (5.4%) Biliary Complications
Mortality ● Two patients died in China very early after surgery. ● Sixteen died during follow up: biliary complications resulting in either sepsis or poor graft function (10 patients). recurrent metastatic HCC (3 patients). poor graft function due to portal vein thrombosis (1 patient). GVHD (1 patient). fibrosing cholestatic hepatitis (1 patient).
Age above sixty-five: revise Age above sixty-five: revise Eight died in the first year post-transplant, Two had portal vein thrombosis, one had biliary stricture, five required repeated admissions to the hospital during the first year, and three suffered from severe infections. 1)Rejected due to advanced HCC Four died in the 1 st year post transplant, three of whom suffered from brain or lung metastasis. One died after two months of severe pneumonia and sepsis. Outcome of patients rejected for Tx in KSA
Incidence of Complications China KFSH & RC P-value Biliary complications20 (27%)13(10.8%)<0.01 Vascular complications 3 (4.1%)5(4.2%)>0.05 Sepsis7 (9.5%)1(1.0%)<0.01 Acquired HBV infection 4 (5.4%)0 (0)<0.05 Metastasis3(4.0%)0 (0)<0.05 Requirement for surgery 16 (21.6%)12 (10%)<0.05
Medical Care Postoperative interventions. Frequent hospital admissions. Frequent Visits to day medical unit. Frequent Visits to the ER. Frequent Laboratory investigations. Burden on the Hospital resources.
The results in this study may not represent the actual survival data of the Chinese centers. Indeed, the presented data from China are only of the patients who are followed up in our center, and do not include those who may have had early death or complications, those who are followed elsewhere, and all other non-Saudi & non-Egyptian patients not known to us.
Renal Transplant – Favorable Outcomes Sever MS et al 1997 540 Saudi patients transplanted in India 96% graft survival 89% patient survival Similar results to those transplanted in Saudi Arabia Pediatr Nephrol. 2006 Morad et al 2000 515 Malaysian patients transplanted in China or India >90% graft and patient survival » Transplant Proc. 2000 Nov
Renal Transplant - Inferior Outcomes Kennedy et al 2005 16 Australian patients 66% graft survival 85% patient survival Sever et al 2001 Turkish patients 84% graft survival patient survival similar to locally transplanted patients
Compared to Canadian Transplants…. Inferior graft survival at 3 years 98% biologically related donors 86% emotionally related donors 62% transplanted abroad Patient survival at 3 years 100% for those transplanted in Canada 82% for transplant tourists
Iran facts: One, and five survival rate is reported to be 92.8%, 83.7% respectively. Iran is the only country with no waiting list for kidney transplant and patients can receive the necessary organ in less than 2 months.
Transplant outcomes Outcomes of United States Residents who Undergo Kidney Transplantation Overseas: Canales et al, Transplant Tourism 10 kidney transplant patients (Sept 02 – July 06) Transplanted in Pakistan (8), China (1), Iran (1) Mean age: 36.8 years Follow-up period: 0.4-3.7 years (mean 2.0) 6 serious post op (in 3 months) infections in 4 patients 1 death 1 graft failure due to acute rejection Graft survival and function – generally good High incidence of post transplant infection Inadequate communication of information – immunosuppressive regimens and perioperative information
Kidney Transplants - India 150,000 Indians need transplants annually Only 3,500 actually performed Sale of organs illegal - Criminal act for foreigners to go to India to obtain transplants
Stem Cell Transplants - China Parkinsons: Human retinal epithelial cells from adults No immunosuppression required Cells injected stereotactically into putamen Daily cocktail of drugs to ‘fertilize the area’ Stem cell activation and proliferation treatment (to enhance the body’s own neural stem cells) ~20 patients treated No published RCTs
Stem Cell Transplants - China Stroke ‘self stem cell activation and proliferation’ 50 patients treated Minor to significant improvements Cerebral plasy, Degenerative neurologic disorders, Epilepsy, Brain infections Neural (fetal) stem cells Bone marrow stem cells (autologous) Both types of cells delivered by lumbar puncture – cells are said to flow through the CSF into the brain
Ethical issues – transplant tourism Source of transplanted organs Potential for coerced organ ‘donation’ Involuntary donations – executed prisoners, kidnapping ?? Transplant flow…. South to north Female to male Inter ethnic Poor to financially secure Association with organized crime India, Brazil and other areas
WHO World Health Organization 1987: concern over commercial trade (WHA) reports about brokers Benefits??? 1989: Initiative for standards needed (WHA) International interest 1991: WHO Principles (WHA) 2004: Assemble more data (WHA) 2003: worldwide discussion on transplantation (Madrid) 2004-2006: meetings on cells, tissues, organs 2006: comprehensive awareness on Transplantation 2007: overall Observations (Spanish Ministry of Health) 2007: Second worldwide conference (Geneva)
WHO 1991: Principles International standards Deceased donors preferred Related donors preferred No commercial transactions in human body,prohibition on advertising. Fair access to donated organs ( economic) 2008: In revising Principles? Preference for deceased tempered by practice changes wider door for unrelated Commercial ban maintained, “incentives” acceptable? (real vs. subtle) Actions translucent & scrutinize; confidentiality secured. Quality for donors & Tx recipient.
Policies 50+ countries adopted laws giving effect to norms in 1991 Guiding Principles China: law adopted in 2006 sets standards license of transplant facilities (many closed) Bans profitable dealings. Establish criterions for deceased donor and allocation of organs End using organs from executed prisoners Pakistan: law adopted in 2007 ban “transplant tourism”
Organ Shortage is a Crisis In the gulf we need to Network and start thinking of sharing resources, expertise and organs Set up Collaborative project Use Media for advertising Get Islamic scholars to contribute on Organ promotion. Set up regional Transplant coordinators Forums Cadaver Transplant - Conclusion
Our data clearly show that Saudi patients who received transplants in China exhibited high mortality and morbidity rates. This result could be attributed to poor selection criteria, long warm ischemia time, and a question of suboptimal post-transplant care. Patients and clinicians need be aware of the outcome and its implications. Furthermore, patients should be enlightened about these risks as well. CHINA CONCLUSION
In Gulf countries we need successful donor programs that look at all the options On a straightforward steps and changes we can make all the distinction for our patients DD Transplant - Conclusion
Bottom line Transplant tourism is a reality… and a growth is expected Both risks and benefits exist Difficult to determine the extent of risks Quality of care is variable Gulf countries be aware Many ethical issues