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The Swiss Transplant Cohort Study1.5.2008 – 30.6.2013
PD Dr Michael T Koller National Epidemiologist &
Head of the data center of the STCS
On behalf of all members of the [email protected]
www.stcs.ch
2
We write the medical history that others read.4)
4) Not long ago, the University Hospital of Zurich transplanted to two patients simultanously a double lung by segmentation of the donor lung . The girl and the jung men, who suffered from birth of CF got a new life – and medicine a new chapter of history.
3
An example of STCS collaboration
• E-Mail the ad to … [email protected]
• What was exactly done in Zürich?
• How was the outcome in the recipients?
• Response time from Zürich: 45’ !!
USZ: segmentation of the donor lung …
Donor: 33y old male† ICH
R1: 19 y young male (80001753). Double lung.
R2: 14 y young female(80001757). Double lung.
16.12.2010
15.12.2010
5
Recipient 80001757 & 80001753: longitudinal follow-up
ID: M
OTTID: A
spergillus
Pleural effusion
No events
Recipient 80001757 & 80001753:The STCS psychosocial questionaire: «Patient, how is your life?» The 14 years old female Visit The 19 years old man
No PSQ: child. BL
FUP 6
FUP 12
FUP 24
FUP 36
PSQ 0: not available
PSQ 1: student, never misses a dose of IS; sleep quality of 10/10!; No smoking; No problems to perform usual activities; No pain or discomfort.Most of the time cheerful; Single;
PSQ 2: no change
PSQ 3 (V2): phys activity 2/week 60 min, easy; QoL: 86/100 VAS. Team trust: 10/10. Full adherent to medication.
PSQ 4(V2): phys activity 3/week 45 min, very hard!! QoL: 91/100 VAS; Team trust: 10/10. No smoking. Full adherent to drugs. Still single.
10
STCS post-LTX overall patient survival
Freeman Hospital, Newcastle , adult CF only,
1994 - 2004
US: Columbia University Medical Center (CUMC),
2001-2008, n=274
UNOS Data from 15`642 adult lung TPX recipients between 1987 and 2009
and in US 61 centers
ISHLT Registry (worlwide, US, Europe). 2004-2010,
n=17’715
40%
12%
25%
11
0 1 2 3 4 5 6 7 8 9 10 11 12 13 140
20
40
60
80
100
2004-6/2010 (N=17,715)
Years
Surv
ival
(%)
N at risk = 1,055
Post-LTX overall patient survival: STCS vs ISHLT
12
Lessons from international benchmarking
• Compared to the others: we perform well!
• But: 40% of all LTX recipients are dead by 5 years
Post-HTX overall patient survival
CTS Registry (Europe). 1985-2011, n=28’828
Only first TPX
ISHLT Registry (worlwide, US, Europe). 1982-2011,
n=103’299
UNOS Data, 8029 HTX recipients between
2001 and 2009 and in US 61 centers
25%22%
18%
17
Lessons from national HTX benchmarking
Center-specific differences in post-HTX survival disappeared with time…
1. The increase of the sample size (n=85 n=169) reduced differences due to random variation
2. The discussion of center-specific data lead to critical review of case fatalities with impact on patient care
21
Post-RTX incidence of graft-failure by donor-typeAB0 compatible / AB0 incompatible
4 «simultaneous» failures of AB0 incompatible allografts failure rate stable at ~ 5%- ACR vascular + TMA- ACR vascular + ATN- ACR vascular + «ARF»- AHR
Center AB0 not c
USZ 26
USB 38
CHUV 0
BE 8
HUG 16
SG 3
Total 91
RTX recipients from living vs deceased donationBaseline characteristics
RTX recipientsdeceased donation
RTX recipientsliving donation
Number of patients 769 552Recipient age (in yrs), median 56.1 50.5 - IQR (44.8, 63.7) (37.2, 60.2)Pediatric, n (%) 37 (4.8%) 22 (4%)Male gender, n (%) 491 (63.8%) 367 (66.5%)
Donor age (in yrs), median 55 53 - IQR (41, 63) (45, 61)
HLA A compatible*, n (%) 107 (14.1%) 78 (14.3%)HLA B compatible*, n (%) 42 (5.5%) 55 (10.1%)HLA DR compatible*, n (%) 98 (12.9%) 79 (14.5%)Class I DSA pos 109 (44.1%) 53 (35.1%)Class II DSA pos 86 (41%) 47 (36.2%)DGF, n (%) 122 (15.9%) 8 (1%)PNF, n (%) 8 (1.4%) 0 (0%)
Current smoker, n (%) 110 (14.3%) 59 (10.7%)Higher education, n (%) 119 (15.5%) 169 (30.6%)No work capacity (0%), n (%) 318 (41.4%) 184 (33.3%)
* N
umbe
r of m
ism
atch
es =
0
29
Graft-failure in double TPX
Kidney Liver Pancreas Total
Kidney - Liver 1 1 0 2
Kidney – Pancreas(n=57)
0 0 10 10
Pancreas - Small bowel 0 0 1 1
Total 1 1 11 13
31
Patient recruitment by organTotal Re-
TPX(%)
Second TPX
(%)
Kidney 1321 15.3 1.9
Liver 481 3.7 1.5Lung 234 3.0 1.3
Heart 169 0.6 0.0Kidney -
Pancreas57 0.0 7.0
…. … … …
32
Number of patients
Patients (%)
Total number 2358 100.0Pediatric patients 123 5.4
Single Tpx at enrolment 2241 95.0Double Tpx at enrolment 114 4.8
Triple Tpx at enrolment 3 0.1
1st Tpx at enrolment 2057 87.2Re-Tpx at enrolment 237 10.1
2nd Tpx at enrolment 64 2.7
33
Patients follow-up
Follow-upMedian follow-up duration (years) 2.7
IQR (years) 1.4 - 4.08Patient with longest follow-up (years) 5.6
Number of deaths 261Patients with (at least one) graft failure 154
Patients lost to follow-up* 14
36
AchievementsScientific committee: completed / published projects
1: Bucheli E, Kralidis G, Boggian K, Cusini A, Garzoni C, Manuel O, Meylan PR, Mueller NJ, Khanna N, van Delden C, Berger C, Koller MT, Weisser M; The Swiss Transplant Cohort Study. Impact of enterococcal colonization and infection in solid organ transplantation recipients from the Swiss Transplant Cohort Study.Transpl Infect Dis. 2013 Dec 16.
2: De Geest S, Burkhalter H, Berben L, Bogert LJ, Denhaerynck K, Glass TR, Goetzmann L, Kirsch M, Kiss A, Koller MT, Piot-Ziegler C, Schmidt-Trucksäss A; Psychosocial Interest Group, Swiss Transplant Cohort Study. The Swiss Transplant Cohort Study's framework for assessing lifelong psychosocial factors in solid-organ transplants. Prog Transplant. 2013 Sep;23(3):235-46.
3: Burkhalter H, Wirz-Justice A, Cajochen C, Weaver T, Steiger J, Fehr T, Venzin RM, De Geest S. Validation of a single item to assess daytime sleepiness for the Swiss Transplant Cohort Study. Prog Transplant. 2013 Sep;23(3):220-8.
4: Manuel O, Kralidis G, Mueller NJ, Hirsch HH, Garzoni C, van Delden C, Berger C, Boggian K, Cusini A, Koller MT, Weisser M, Pascual M, Meylan PR; Swiss Transplant Cohort Study. Impact of antiviral preventive strategies on the incidence and outcomes of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2013 Sep;13(9):2402-10.
5: Koller MT, van Delden C, Müller NJ, Baumann P, Lovis C, Marti HP, Fehr T,Binet I, De Geest S, Bucher HC, Meylan P, Pascual M, Steiger J. Design and methodology of the Swiss Transplant Cohort Study (STCS): a comprehensive prospective nationwide long-term follow-up cohort. Eur J Epidemiol. 2013Apr;28(4):347-55.
6: Berger C, Boggian K, Cusini A, van Delden C, Garzoni C, Hirsch HH, Khanna N,Koller M, Manuel O, Meylan P, Nadal D, Weisser M, Mueller NJ; Transplant Infectious Diseases Working Group, Swiss Transplant Cohort Study. Relevance of cohort studies for the study of transplant infectious diseases. Curr Opin OrganTransplant. 2012 Dec;17(6):581-5.
37
Evolution of scientific projects applications
2009 2010 2011 2012 2013 2014 20150
2
4
6
8
10
12
14
16
18
20
approvedexpected
38
International collaborations
Collaboration / Partner Topic
A. Humar, Edmonton (Toronto) CMV pathogenesis
Giral/Foucher, DIVAT cohort, France Long-term evolution after kidney transplantation
German Center for Infection Research, Munich, Germany
Sharing of infrastructural experienceComprehensive ID outcome collection
SysClad (EU project), France Systems prediction of Chronic Lung Allograft Dysfunction
J Wilson McManus, PROOF, Canada‐ Biomarkers in Transplantation
Aguado, Resitra cohort, Spain European analysis of rare Infectious Diseases endpoints (Aspergillosis)
39
Achievements
• Recent SNSF Re-funding … the 3rd period!• Active working groups: LDM, PSIG, ID, Genetic,
Lab• Comprehensive reporting on TPX outcomes• Operating data center providing project support
and data upates
40
Challenges• IT IS INCREASING!
Patients, Transplantations, Organs, Follow-up, Events, Samples, Projects, Disk volume, Staff, Meetings, Data requests, official/political requests …
• Increase the scientific output• Perform sophisticated national and international
center benchmarking• Don’t stop to let that system grow!
Heart3
Liver(incl. small
bowel)3
Kidney6
Pancreasislet
2
Stem cellAlogeneiic 3
ID2
Lung2
Scientific Committee
Data center
Executive Office(MP, CVD + JS)
Coordination
Board of Representatives• 1 per center (6, with one vote each)• Representation Ticino (1) to be discussed• Stem cell (1)• Pediatrics (1)• Swisstransplant (1)• Executive office (3, 1 vote)• IT and Epidemiology (no vote)
Pediatrics1
Swisstransplant1
Immunology2
IT1
Epidemiologyincl. data management center
1
Executive office3
(1 vote)
Psychosocial group2
Working groups• Lab group (PM)• Psycho social group (SDG)• ID group (CVD)• Local data managers group (EB)• Pediatric group (DN)• Stem cell group (JP)
Head: MK
Central Data Mana-gement (JR,MW)
Epidemio-logy (MK)
Bio-Statistician (SS)
IT
Head: CL
(PB)
48
Recipients 80001757 & 80001753 The 14 years old female Visit The 19 years old man
Donor: 33 y, male, † ICHTPX: 16.12.2010, double lung!
BL Donor: 33 y, male, † ICHTPX: 15.12.2010, double lung!
2 RT infections: - Mycobacterium other than tuberculosis (MOTT)- Aspergillus fumigatus
Complications: Pleural effusion
No PSQ: child.
FUP No infections! No complications!
PSQ 1: student, never misses a dose of IS, sleep quality of 10/10!; No smoking; No problems to perform usual activities; Most of the time cheerful; Single;
PSQ 3 (V2!): phys activity 2/week 60 min, easy; QoL: 86/100 VAS. Team trust: 10/10. Full adherent to drugs.
PSQ 4: phys activity 3/week 45 min, very hard!! QoL: 91/100 VAS; Team trust: 10/10. No smoking. Full adherent to drugs. Still single.