Transplantation Tourism Mohammed Alsaghier, MBBS MultiOrgan Transplant Surgeon King Fahed Specialist...
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Transcript of Transplantation Tourism Mohammed Alsaghier, MBBS MultiOrgan Transplant Surgeon King Fahed Specialist...
Transplantation TourismTransplantation Tourism
Mohammed Alsaghier, MBBSMultiOrgan Transplant Surgeon King Fahed Specialist Hospital
Damamm , Saudi Arabia
Outline of PresentationOutline of Presentation
• Background
• Challenges for transplant on Saudi Arabia
• Transplant Tourism
• China
• Conclusions
Issues with Transplant Tourism
• Clinical / Medical
• Financial
• Ethical
• Legal
Introduction
No of Dialysis units on Saudi No of Dialysis units on Saudi ArabiaArabia
1971-20071971-2007
1993-20071993-2007 No of PatientsNo of Patients
20072007Age distribution byAge distribution by
The future patientsThe future patientsمم1995-20151995-2015
No of new patient per MillionNo of new patient per Million
الحدوث معدلمليون) لكل
نسمة (
دد الُج� مرضى عددم(2007)
السكان عددم(2006)
المنطقة
الُجنوبية1435443.810.102
الوسطى1429706.819.111
الشرقية1344663.470.525
الغربية13110017.625.261
الشمالية1212361.953.850
المُجموع1363217723.678.849
Transplant global historyTransplant 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 DONATIONDECEASED DONATION
Deceased donorsDeceased donors
• Donor has been declared dead by two physicians independent of the transplant team
• Usually occurs only in cases of neurologically determined death
Live donorsLive donors
• to donate one or part of an organ to someone on a transplant waiting list.
DONATIONDONATION
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 WORLD STATUS OF RENAL TRANSPLANTSTRANSPLANTS
The deceased donors per million population per year
USA - 20.7 Europe - 15.9 Asia - 1.1 South America - 2.6
DECEASED DONOR RATESDECEASED DONOR RATES
1986-20071986-2007
1986-20071986-2007
The successful Donation from DDThe successful Donation from DD1986-20071986-2007
DD Reported 2008DD Reported 2008
االستئصال
الحاالت العائلهاالقرارالمثبته
الحاالت المبلغة
مستشفى
910252634RMC
االيمان78141023
االمير 79121317سلمان
الحرس 55131316الوطني
الُجامعة336711
العسكري00457
00235KFMC
الملك 00223فيصل
المملكة 789020825738969
الدول 1517282931األخرى
Reason for Donation Rejectionم1986-2007
• 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 COMMON PROBLEMS IN DD TRANSPLANTTRANSPLANT
• Public awarness
• Reporting of Brain Death
• Hospitals Donation system .
• Religion , Society and Organ Donation
COMMON PROBLEMS IN DDCOMMON 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’Society acceptance remains a crucial in a transplant program’
PROBLEMS WITH DD TransplantPROBLEMS WITH DD Transplant
Transport of organs –between cities
Transport of organs –between cities
Adequate No. of Intensivists in ICUs
Adequate No. of Intensivists in ICUs
Well qualified Surgeons to undertake Retrieval & TX
Well qualified Surgeons to undertake Retrieval & TX
HLA Tissue typing and Cross-matchHLA Tissue typing and Cross-match
Trained transplant
Co-coordinators
Trained transplant
Co-coordinators
Support Organization to SCOT
Support Organization to SCOT
Hospitals Donation SystemHospitals Donation System
ا;حي;ا... نما ك;ا; ف; ا;حياها م;َن; وجميعا? ... الناس;
And he who saves a man’s life shall be considered as one who has saved the life of mankind as a
whole
Transplantation TourismTransplantation Tourism
IssuesIssuesA. Living donors
A. Autonomy vs. nonmaleficence B. Risks to Donor ( “benefit”)
B. Deceased donorsA. Brain death (accuracy; conflict of interests)B. Consent?
C. Waiting listsA. Allocation (medical vs. social)B. “Shortage”
D. CommercialismA. 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 No Waiting list in Iran for
Kidney Tx.Kidney Tx.
KIDNEY TX WAITING LIST IN ASIA (2002)KIDNEY TX WAITING LIST IN ASIA (2002)
Waiting List #’s# of donors per population
AustraliaAustralia1,76410 per 1,000,000
CanadaCanada3,99013.5 per 1,000,000
United United StatesStates
75,00034.3 per 1,000,000
KIDNEY TX WAITING LIST IN THE KIDNEY TX WAITING LIST IN THE WORLD (2002)WORLD (2002)
Five organ trafficking hotpots identified by Five organ trafficking hotpots identified by the WHOthe WHO
CHINAPAKISTAN
EGYPTCOLOMBIA
PHILIPPINES
2007Sources: Reuters, World Health Organization
Clinical Outcomes for Saudi Patients Clinical Outcomes for Saudi Patients Receiving Deceased Donor Liver Receiving Deceased Donor Liver
Transplantation in ChinaTransplantation in China
2King 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 Despite these attractive factors, the main growing concern with this choice is the growing concern with this choice is the
uncertaintyuncertainty regarding the outcomeregarding 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: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: Median period between contacting centre & travel:
• 4 weeks (2-16w).
RESULTSRESULTS
• 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 ChinaReports 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 ChinaFollow up after return from China
● Follow up care for a median of 13 months (2-60 months).
ComplicationsComplications
Biliary complicationsBiliary complications
• 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%)
• BileBile leakage:leakage: 4 (5.4%)
Biliary ComplicationsBiliary Complications
MortalityMortality
● Two patients died in China very early after surgery.
● Sixteen died during follow up: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: Age above sixty-five: reviserevise• 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)1) Rejected due to advanced HCCRejected due to advanced HCC • Four died in the 1st 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 Outcome of patients rejected for Tx in KSAin KSA
Comparison of Outcome with patients at Comparison of Outcome with patients at KFSHKFSH
China
)n=74(
KFSH & RC
)n=120(
P-value
Age54.7 )10.0( 42.1)14.4( <0.01
MELD score 17 )13- 23( 19)15-26( >0.01
HCC > Milan criteria
5 )6.76%( 0)0( <0.001
Patient Survival ratePatient Survival rateSurvival Functions
Survival ( Days )
Country
Saudi ArabiaChina
1.00 - Censored
2.00 - Censored
Cu
m S
urvi
val
0 500 1000 1500 2000
1.0
0.8
0.6
0.4
0.2
0.0
Graft Survival rateGraft Survival rate
1 - Censored2 - Censored
1.0
0.8
0.6
0.4
0.2
0.0
Cu
m S
urvi
val
Survival Functions
0 500 1000 1500 20000 500 1000 1500 2000
Survival ( Days )
12
Country
Incidence of ComplicationsIncidence of Complications
ChinaChinaKFSH & RCKFSH & RCP-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 CareMedical 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 OutcomesRenal 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 OutcomesRenal 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 TransplantsCompared 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 factsIran 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 outcomesTransplant 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 - IndiaKidney 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
SurgeryUSA USDIndia USD
BMTx400,00030,000
Liver Tx500,00040,000
CABG50,0005,000
Neuro-surgery29,0008,000
Knee surgery16,0004,500
Stem Cell Transplants - ChinaStem 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 - ChinaStem 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 tourismEthical 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
WHOWHO• 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)
WHOWHO• 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 CrisisIn 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 - ConclusionCadaver 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 CONCLUSIONCHINA 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 - ConclusionDD Transplant - Conclusion
Bottom lineBottom 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
THANK YOUTHANK YOU