ISSN 2712-472X DONORSKA IN TRANSPLANTACIJSKA DEJAVNOST V SLOVENIJI DONATION AND TRANSPLANTATION ACTIVITY IN SLOVENIA DAJ ŽIVLJENJU PRILOŽNOST GIVE LIFE A CHANCE 2020 GIVE DAJ Life a chance Življenju priložnost Donorska in transplantacijska dejavnost Donation and transplantation activity v Sloveniji v letu 2020 in Slovenia in 2020 Daj življenju priložnost - Donorska in transplantacijska dejavnost v Sloveniji v letu 2020 Urednici: Danica Avsec, Barbara Uštar Avtorji: Danica Avsec, Barbara Uštar, Jana Šimenc, Andrej Gadžijev, Gorazd Cebulc, Jože Jakovac Lektorica: Nives Mahne Cehovin Oblikovanje in prelom: Vesna Žerjal Tisk: Cicero Begunje, d.o.o. Kraj in leto izida: Ljubljana, 2021 Založba: Zavod RS za presaditve organov in tkiv Slovenija-transplant Avtorske pravice: Zavod RS za presaditve organov in tkiv Slovenija-transplant Naklada: 200 izvodov Publikacija je bila izdana s pomocjo javnih sredstev iz proracuna Zavoda RS za presaditve organov in tkiv Slovenija-transplant. Publikacija je brezplacna. ISSN 2712-472X Give life a chance – Donation and transplantation activity in Slovenia in 2020 Editors: Danica Avsec, Barbara Uštar Authors: Danica Avsec, Barbara Uštar, Jana Šimenc, Andrej Gadžijev, Gorazd Cebulc, Jože Jakovac Translation: Nives Mahne Cehovin Language editing and proofreading: Murray James Bales Layout and design: Vesna Žerjal Printed by: Cicero Begunje, d.o.o. Slovenia: Ljubljana 2021 Original title: Daj življenju priložnost - Donorska in transplantacijska dejavnost v Sloveniji v letu 2020 Publisher: Institute for Transplantation of Organs and Tissues of the Republic of Slovenia Slovenija-transplant Copyright: Institute for Transplantation of Organs and Tissues of the Republic of Slovenia Slovenija-transplant Printed in 200 copies This publication is funded from public funds – budget of Institute for Transplantation of Organs and Tissues of the Republic of Slovenia Slovenija-transplant. This publication is free of charge. Uvodne besede V letni publikaciji Daj življenju priložnost predstavljamo statisticne podatke in izbrane presežke v donorski in transplantacijski dejavnosti v 2020.Lansko leto smo obeleževali pomembno 20.obletnico uspešnega sodelova­nja Slovenije z Eurotransplantom. Že leta 2000 smo izpolnili zahtevne prikljucitvene pogoje in se pridružili sku­pini najnaprednejših srednjeevropskih držav s podrocja donorske in transplantacijske dejavnosti. S clanstvom smo obcutno izboljšali izide zdravljenja za naše bolnike in spodbudili razvoj dejavnosti na nacionalni ravni. Sre­dišcni slavnostni simpozij smo januarja v sodelovanju z UKC Ljubljana uspeli izpeljati še v živo. Poleg praznovanja obletnice pa je leto2020 zaznamovalo delo v oteženih razmerah zaradi epidemije covid-19. Zelo smo zadovoljni, da smo kljub krizni situaciji ohranili zagon v donorskem programu. Potrebno je bilo ne­nehno spodbujanje in trud sodelavcev in sodelavk, redna in dobra medosebna komunikacija ter prilagajanje preventivnim protokolom v mednarodnem obmocju držav Eurotransplanta. Ves cas nas je vodilo zavedanje, da epidemija ne sme zaustaviti dejavnosti, da pridobljeni organi ne smejo v unicenje, in da je bolnikom na cakalnih seznamih treba zagotoviti zdravljenje s presaditvijo. Leto smo kljub vsem težavam v zdravstvu in oviram zakljucili z višjim številom umrlih darovalcev in transplan­tacij kot v letu 2019. S tem se tudi na mednarodni ravni uvršcamo med najboljše države s podrocja. Ponovno smo dokazali kakovosten pristop, predanost delu in dobro povezanost vseh strokovnjakov v nacionalni tran­splantacijski mreži. Iskreno se zahvaljujemo tudi vsem svojcem umrlih, ki so v custveno zahtevnih situacijah ohranili humanost, cut za socloveka in podali soglasje za darovanje. Prim. Danica Avsec, dr. med., svetnica, direktorica zavoda Slovenija-transplant in odgovorna zdravnica za donorsko dejavnost Kazalo 3 Uvodne besede 6 Slovarcek temeljnjih izrazov 8 Zavod Slovenija-transplant 10 Presežki in zaznamki leta 2020 12 20 let uspešnega sodelovanja Slovenije z Eurotransplantom 14 Kljucne številke leta 2020 17 CVRSTI ORGANI 18 Nacionalni cakalni seznam za presaditve organov 23 Število umrlih darovalcev 30 Register opredeljenih oseb glede darovanja organov in tkiv po smrti 32 Odstotki privolitev za darovanje pri pogovoru s svojci 34 Delovanje donorskih centrov 44 Pridobljeni cvrsti organi za namen zdravljenja 47 Presajeni cvrsti organi 56 Rezultati slovenskih programov za presaditve organov 61 TKIVA IN CELICE 62 Presaditve krvotvornih maticnih celic 64 Program pridobivanja in presaditve roženic 66 Ostala tkiva in celice 70 Neželeni dogodki in reakcije 72 OBJAVE IN PREDAVANJA NA KONFERENCAH 74 VIRI Table of contents 77 Introductory words 78 The Slovenija-transplant Institute 80 Achievements and highlights of 2020 84 20 years of Slovenia’s successful cooperation with Eurotransplant 86 Key statistics for 2020 89 SOLID ORGANS 90 National waiting list for organ transplantation 95 Number of deceased donors 102 Register for donation declarations 104 Percentage of consent for donation 106 Operations of the donor centres 116 Procured solid organs for the purpose of medical treatment 119 Transplanted solid organs 128 The results of Slovenian organ transplant programmes 133 TISSUES AND CELLS 134 Transplantation of haematopoietic stem cells 136 Cornea procurement and transplantation programme 138 Other tissues and cells Adverse events and reactions 142 144 PUBLICATIONS AND CONFERENCES 146 REFERENCES Slovarcek temeljnih izrazov BOLNIŠNICNA KRVNA BANKA: enota, ki v bolnišnici shranju­je in razdeljuje kri ter krvne komponente in opravlja pred­transfuzijsko testiranje ter bolnišnicne transfuzijske dejav­nosti. Za zbiranje krvi torej ni pooblašcena. BOLNIŠNICNI TRANSPLANTACIJSKI KOORDINATOR: zakon dolo-ca nacin imenovanja, naloge bolnišnicnih koordinatorjev in pravilnik o koordinatorjih. Naloge bolnišnicnih transplanta­cijskih koordinatorjev so: organizacija in koordinacija dela na vseh podrocjih transplantacijske dejavnosti v bolnišni­ci, od odkrivanja možnih mrtvih darovalcev do organizaci­je in koordinacije odvzemov v bolnišnici ter pospeševanje programa pridobivanja organov in tkiv za presaditev. Delo opravljajo zdravniki specialisti, ki so pridobili dodatna zna­nja o vseh podrocjih transplantacijske dejavnosti v bolnišni­ci oz. donorskem centru. CENTRALNI TRANSPLANTACIJSKI KOORDINATOR: zdravnik z do-datnimi znanji, ki organizira in koordinira transplantacijsko dejavnost od zaznave možnega darovalca do odvzema. Centralni transplantacijski koordinatorji so v pripravljenosti 24 ur na dan vse dni na leto. CAKALNI SEZNAM (PREJEMNIKOV): zbirka podatkov zapored-no vpisanih pacientov, ki cakajo na presaditev z namenom zdravljenja. Indikacije za presaditev so za vsak organ/tkivo/ celico specificne. DAROVALEC: oseba, ki daruje del telesa za namen zdravlje­nja, ne glede na to, ali do darovanje pride za casa življenja ali po njeni/njegovi smrti. DAROVANJE: darovanje dela telesa, namenjenega za zdrav­ ljenje s presaditvijo. DEJANSKI UMRLI DAROVALEC: aktiven darovalec, od katere­ga je bil presajen vsaj en organ. DODELJEVANJE: postopek, po katerem se izbere najustreznej­ šega prejemnika. DONORSKA BOLNIŠNICA ALI CENTER: javnozdravstveni zavod ali enota tega zavoda, ki izvaja dejavnost pridobivanja de­lov telesa za namen zdravljenja s presaditvijo. HUD NEŽELEN DOGODEK: kateri koli neželen ali nepredviden dogodek v zvezi s katero koli stopnjo postopka darovanja do presaditve, ki lahko povzroci prenos nalezljive bolezni, smrt, ogrozi življenje, povzroci invalidnost ali nezmožnost za delo,katerega posledica je hospitalizacija ali obolevnost,ali ki podaljša hospitalizacijo ali obolevnost. HUDA NEŽELENA REAKCIJA: nenameren odziv, vkljucno s po­javom prenosljive bolezni, pri živem darovalcu ali prejemni­ku, ki bi lahko bil povezan s katero koli stopnjo postopka od darovanja do presaditve, ki je smrten, smrtno nevaren, ki povzroca invalidnost ali nezmožnost za delo, ali katerega posledica je hospitalizacija ali obolevnost ali ki podaljša ho-spitalizacijo ali obolevnost. INTENZIVNO ZDRAVLJENJE/INTENZIVNA NEGA: zdravljenje, ki zahteva hitro odzivno diagnostiko, terapijo, nego in stalni nadzor življenjskih funkcij bolnika ponavadi v enoti za inten­zivno zdravljenje. MOŽEN UMRLI/MRTVI DAROVALEC: oseba, katere klinicno sta­nje kaže na verjetnost, da izpolnjuje merila za možgansko smrt. NACIONALNA IDENTIFIKACIJSKA ŠTEVILKA DAROVALCA OZI­ROMA PREJEMNIKA: identifikacijska oznaka, ki jo v skladu z nacionalnim sistemom identifikacije darovalcu ali prejemniku dodeli Slovenija-transplant in služi kot povezovalni znak, prek katerega se sledi darovalcu in prejemniku organa, zlasti pri iz­ menjavi podatkov med donorskimi centri, transplantacijski- mi centri in drugimi državami clanicami Evropske unije. PRIMEREN UMRLI/MRTVI DAROVALEC: medicinsko ustrezna oseba, pri kateri je bila ugotovljena smrt na podlagi nevrolo­ ških meril, glede na relevantno zakonodajo. SLEDLJIVOST: možnost, da se najde in identificira organ v vseh fazah preskrbe z organi ali unicenja, vkljucno z mož­nostjo, da se identificirata darovalec in donorski center, po­išcejo prejemniki pri transplantacijskem centru ter identifici­ rajo vsi pomembni neosebni podatki v zvezi s proizvodi in materiali v stiku z organom. STOPNJA ODKLONITVE: odstotek odklonitev svojcev oz. oseb, ki so blizu umrlemu, za darovanje po smrti. STOPNJA ZAVRNITEV: odstotek zavrnitev presadka pri preje­ mniku. TRANSPLANTACIJSKA DEJAVNOST: zdravstvena dejavnost, ki vkljucuje postopke darovanja, pridobivanja, testiranja in ra­zdeljevanja organov ter darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja tkiv in celic za potrebe zdravljenja s presaditvijo. TRANSPLANTACIJSKI CENTER: javnozdravstveni zavod ali eno­ta tega zavoda, ki izvaja dejavnost zdravljenja s presaditvi­ jo organov. TRANSFUZIJSKI CENTER: organizacijska enota, ki je v bolniš­nici odgovorna za zbiranje krvi, testiranje, predelavo zbra­ne krvi v krvne komponente in njihovo shranjevanje. Izvaja predtransfuzijsko testiranje in bolnišnicne transfuzijske de­javnosti ter bolnišnice in druge porabnike oskrbuje s krvjo in krvnimi komponentami. TRANSFUZIJSKI ZAVOD OZIROMA ZAVOD RS ZA TRANSFUZIJSKO MEDICINO V LJUBLJANI: na državni ravni odgovoren za stro­kovno raven preskrbe s krvjo in krvnimi pripravki ter pove­ zovanje transfuzijske medicine z bolnišnicno dejavnostjo. Zavod usklajuje vse dejavnosti v zvezi z izbiro krvodajalcev, zbiranjem,testiranjem,predelavo, hrambo in razdeljevanjem krvi ter krvnih pripravkov,klinicno rabo krvi in nadzoromnad težkimi neželenimi dogodki oziroma reakcijami v zvezi s transfuzijo krvi. Zavod RS za transfuzijsko medicino na dr­žavni ravni usklajuje in povezuje mrežo bolnišnicnih transfu­zijskih oddelkov in bolnišnicnih krvnih bank, vodi enoten in-formacijski sistem, strokovno izobraževanje in razvojno-ra­ziskovalno dejavnost ter sodeluje z mednarodnimi organi­zacijami, zvezami in sorodnimi zavodi v drugih državah. Zavod Slovenija-transplant Javni zavod Republike Slovenije za presaditve organov in tkiv Slovenija-transplant je od leta 2002 osrednja nacionalna strokovna ustanova, ki povezuje, koordinira, pospešuje ter nadzira donorsko in transplantacijsko dejavnost v Sloveniji. V zavodu Slovenija-transplant je centralna koordina­cijska pisarna nacionalne transplantacijske mreže, ki je bila ustanovljena leta 1998. Nacionalno mrežo sestavlja enajst donorskih bolnišnic po Sloveniji, Center za transplantacijsko dejavnost v UKC Ljubljana in Center za tipizacijo tkiv, ki deluje v sklopu Zavoda RS za transfuzijsko medicino. Nacionalna mreža omogoca delovanje donorskega in prejemniškega programa ter zagotavlja, da imajo dostop do zdravljenja s presaditvijo vsi, ki ga potrebujejo. Mreža deluje nepretrgoma, zato so strokovne ekipe v pripravljenosti 24 ur na dan, vse dni v letu. Od leta 2000 je Slovenija vkljucena v neprofitno organizacijo za izmenjavo organov in tkiv Eurotransplant. Z izpolnjevanjem zahtevnih vstopnih pogojev se je prva iz regije prikljucila veliki skupini petih uspešnih držav na podrocju zdravljenja s presaditvijo, t. j. Nemciji, Avstriji, Belgiji, Luksemburgu in Nizozemski. Od leta 2002 je Slovenija-transplant nosilec pogodbe z Eurotran­splantom. Eurotransplant danes združuje 8 držav in prek 137 milijonov prebivalcev, sedež ima v Leidnu na Nizozemskem. Clanstvo je pomembno za naše bolnike, saj so se s prikljucitvijo bi-stveno izboljšale možnosti preživetja in izidi zdravljenja s presaditvijo, predvsem v visoko urgen­tnih, življenjsko ogrožajocih stanjih, kot sta akutna odpoved delovanja srca in jeter, ter v drugih posebnih primerih (npr. otroci, hipersenzibilizirani bolniki). S sodelovanjem so se tudi obcutno zmanjšali cakalni seznami, nacionalni transplantacijski programi so se razmahnili, izvajati smo zaceli kombinirane presaditve. Predvsem pa smo lahko omogocili optimalnejšo tkivno skladnost med darovalcem in prejemnikom. Nekateri bolniki zaradi tkivne neskladnosti ustreznega organa v Sloveniji sploh ne bi docakali. V letu 2020 smo obeleževali pomembno 20. obletnico uspešnega sodelovanja z Eurotransplantom. ZAVOD SLOVENIJA-TRANSPLANT Zavod Slovenija-transplant se od ustanovitve naprej nenehno razvija v skladu s priporocenimi mednarodnimi smernicami. Stremimo k ustvarjanju izobražene in motivirane strokovne javnosti ter z vecplastnim komuniciranjem vztrajno povecujemo zaupanje v transplantacijsko medicino med splošno javnostjo. Preko clanstev v mednarodnih strokovnih odborih in s sodelovanjem v evropskih projektih smo tesno vpeti v mednarodno okolje, tudi kot aktivni soustvarjalci strategij, razvoja in izobraževanja strokovnjakov v donorski in transplantacijski dejavnosti na mednarodnem podrocju. Ostajamo mednarodno prepoznan in zgleden primer za varen in ucinkovit nacin orga­nizacije in vodenja nacionalnega donorskega programa. Pri urejanju in vodenju podrocja pridobivanja in uporabe delov cloveškega telesa za namen zdra­vljenja v Slovenija-transplantu dosledno upoštevamo zakonodajo, evropske direktive in sprejete mednarodne konvencije. Prav tako skrbimo za ustrezno posodabljanje nacionalne zakonodaje in strokovnih protokolov. Ob uvajanju sprememb vkljucujemo predloge in odlocitve zdravstvene stroke, kriticne družbene premisleke ter nacela medicinske etike in deontologije. Kljucne smernice delovanja zavoda so: samozadostnost I enakost in varnost za bolnike I opti­malna ucinkovitost I kakovost I sledljivost I profesionalnost I nekomercialnost I transparentnost I prostovoljno darovanje I preprecevanje zlorab. Slovenija-transplant od ustanovitve vodi prim. Danica Avsec, dr. med, svetnica in odgovorna zdravnica za donorsko dejavnost. Zavod deluje pod okriljem Ministrstva RS za zdravje. V letu 2020 je bilo v organizaciji devet redno zaposlenih, v donorskem programu pa je sodelovalo 90 pogodbenih sodelavcev. www.slovenija-transplant.si @SloTransplant Presežki in zaznamki leta 2020 Uspešno soocanje z izzivi ob epidemiji covid-19 Število umrlih darovalcev in transplantacij organov je bilo v primerjavi z letom 2019 višje. Kljub omejitvam v mednarodnem prometu, logistiki in razlicnih epidemioloških ukrepih v državah, smo z dodatnimi napori nepretrgoma zagotavljali sodelovanje in izmenjavo organov in tkiv z državami v Eurotransplantu. Odlicno sodelovanje z mediji Objavili smo vec kot 40 poglobljenihcasopisnihintervjujev insevec kot 180-krat pojavili v medijih. V sodelovanju z RTV Slovenija smo pripravili 12-minutno dokumentarno televizijsko oddajo. Visoka stopnja soglasja za darovanje Opravili smo 70 pojasnilnih pogovorov s svojci umrlih glede darovanja organov. Velika vecina (76 %) je podala soglasje, kar kaže na visoko zaupanje javnosti v našo dejavnost. Premikanje strokovnih mejnikov v nacionalnem programu za presaditev pljuc v UKC Ljubljana V UKC Ljubljana so opravili prvo presaditev pljuc pri pediatricni bolnici, 34-letniku pa presadili pljuca, ki so mu dokoncno odpovedala zaradi zapletov po covidu-19. Gre za vrhunski strokoven uspeh tudi v mednarodnem okolju. 50 let od prve presaditve ledvice Od prve presaditve organa - ledvice živega darovalca - v Sloveniji, pa tudi na podrocju nekdanje Jugoslavije, je minilo natanko 50 let. Kontinuirani uspehi v nacionalnem programu za presaditev srca v UKC Ljubljana Slovenija se po številu presaditev src na milijon prebivalcev že vrsto letuvršca v sam svetovni vrh. Nova informativna zgibanka o darovanju organov in tkiv Zasnovali in natisnili smo nove informativne zgibanke z osnovnimi informacijami in pojasnili glede darovanja organov in tkiv. Vsebina je zanimiva in uporabna za splošno javnost, za zdravstveno osebje na primarni ravni in za medije. 13.000 izvodov zgibank smo razširili v zdravstvene domove po Sloveniji. Slavnostni simpozij ob 20. obletnici uspešnega sodelovanja z Eurotransplantom Januarja smo s slavnostnim simpozijem v sodelovanju z UKC Ljubljana obeležili 20. obletnico odlicnega sodelovanja z Eurotransplantom. Podpis nove pogodbe o sodelovanju z UKC Ljubljana Po 17. letih smo z UKC Ljubljana podpisali novo pogodbo o sodelovanju na podrocju donorske in transplantacijske dejavnosti. Pogodba prinaša novosti predvsem z jasno definicijo in razdelitvijo nalog med vsemi deležniki v donorskem in transplantacijskem programu, na novo pa je definirana tudi vloga bolnišnicnega transplantacijskega koordinatorja v UKC Ljubljana in razdelitev stroškov med UKC Ljubljana in Slovenija-transplantom. Nižje število opredelitev V nacionalni register opredeljenih oseb glede posmrtnega darovanja se je kljub možnosti opre­delitve po elektronski poti vpisalo 40 % manj oseb kot v letu 2019. 20 let uspešnega sodelovanja Slovenije z Eurotransplantom V letu 2020 smo obeleževali pomembno 20-letnico uspešnega sodelovanja Slovenije z Eurotran­splantom (ET), mednarodno neprofitno organizacijo za izmenjavo organov in tkiv. Slovenija je bila prva država iz regije JV Evrope, ki je že leta 2000 izpolnila zahtevne pogoje in bila sprejeta v ET. S tem se je prikljucila veliki skupini petih uspešnih in naprednejših držav s podrocja zdravljenja s presaditvijo (Nemciji, Avstriji, Belgiji, Nizozemski, Luksemburgu). Organizacija danes združuje osem držav, ki imajo skupaj prek 137 milijonov prebivalcev. Dolžnost vsake države in zdravstvenega sistema je, da bolnikom zagotovi dostop do kakovostnega zdravljenja s presaditvijo ter vzpostavi transparenten in varen sistem darovanja organov in tkiv z upoštevanjem eticnih principov. V Sloveniji je bila nacionalna transplantacijska mreža ustanovljena leta 1998, a žal nekateri bolniki zaradi tkivne neskladnosti v Sloveniji ustreznega organa in zdra­vljenja niso docakali. S clanstvom v ET pa smo uspeli zagotoviti veliko boljšo dostopnost in izide zdravljenja s presaditvijo za naše bolnike, predvsem v visoko urgentnih, visoko senzibiliziranih in življenjsko ogrožajocih stanjih, kot sta akutna odpoved delovanja srca, jeter in pljuc. Sodelovanje v mednarodni mreži je namrec omogocilo optimalnejšo tkivno skladnost med darovalci in prejemniki ledvic (v obdobju pred ET, med 1970 do 1998, je bila tkivna skladnost HLAdosežena le v 20-35 %). S clanstvom v ET smo v Sloveniji pridobili priložnost za obcutno izboljšanje nacionalnega donor-skega programa. Optimizirali smo prejemniške programe za zdravljenje s presaditvijo src, ledvic in jeter ter zaceli izvajati kombinirane presaditve. Zgovoren je podatek, da je bilo po prikljucitvi število presaditev od umrlih darovalcev za 2,8 krat višje, presaditve od živih darovalcev pa soizvajali le še sporadicno. Število umrlih darovalcev se je obcutno povecalo, zagotovili smo tudi manjše izgube oz. možnost, da se v vecji množici ljudi za vsak pridobljen organ poišce medicin­sko ustreznega in skladnega prejemnika (decembra 2020 je bilo na skupnem cakalnem seznamu za presaditev organa 14.090 bolnikov). 20 LET USPEŠNEGA SODELOVANJA SLOVENIJE Z EVROTRANSPLANTOM Poleg bolnikov smo številne prednosti pridobili tudi izvajalci dejavnosti, saj nenehna izmenjava znanja in izkušenj med državami clanicami prispeva k razvoju dejavnosti na nacionalni in med-narodni ravni. Sodelovanje je navsezadnje tudi imenitna priložnost za uveljavljanje in prilagajanje standardom velikih držav s tradicijo urejenosti in velikim potencialom za napredek. Strokovne odlocitve in usmeritve ET nastajajo v procesu soodlocanja s strokovnjaki vseh držav clanic in preverjanju skladnosti s posameznimi nacionalnimi zakonodajami. Poleg strokovnjakov iz UKC Ljubljana to nalogo že vsa leta opravlja zavod Slovenija-transplant, ki je pooblašcena nacionalna organizacija za koordinacijo donorske medicine, zagotavljanje kakovosti, varnosti in skladnosti vseh postopkov z najnovejšimi dosežki v medicini, zakonodajo in eticnimi vidiki. Pomembno 20-letnico sodelovanja in uveljavljene prisotnosti v srednjeevropskem prostoru smo obeležili s slavnostnim dogodkom, ki je (še v živo) potekal 17. januarja 2020 v UKC Ljubljana. Na odlicno obiskanem simpoziju smo prikazali povezanost, visoko strokovnost, entuziazem, komple­ksnost in uspehe v donorski in transplantacijski dejavnosti pri nas. Predavatelji so predstavili ce­ lotno verigo postopkov, od ocenjevanja darovalcev,ugotavljanja tkivne skladnosti, organiziranosti in kakovosti donorskega programa, izobraževanja zdravstvenega osebja, informiranja javnosti, do uspehov in inovativnih tehnik v izvajanju posameznih programov presaditve organov. Posebej navdušujoci so rezultati in uspehi v programu presaditve pljuc, src in ledvic. Dogodek je bil navsezadnje priložnost za praznovanje skladnosti v delovanju v nacionalni do-norski mreži med Slovenija-transplantom, UKC Ljubljana in vsemi donorskimi bolnišnicami po Sloveniji. Le s skupnim in celovitim pristopom lahko tudi v prihodnje zagotavljamo kakovostno in varno zdravljenje s presaditvijo. Kljucne številke leta 2020 47 LEDVICE SRCE JETRA PLJUCA T. SLINAVKA ROŽENICE 6817 3413 4 92 PLJUCA JETRA 7 ZA NUJNO 17 Cvrsti organi NACIONALNI CAKALNI SEZNAM ZA PRESADITVE ORGANOV Cakalni seznam je seznam bolnikov, ki cakajo na del cloveškega telesa za presaditev z name-nom zdravljenja. Indikacije za presaditev so za vsak organ/tkivo/celico specificne. Vsi bolniki v Republiki Sloveniji imajo enake možnosti za uvrstitev na cakalni seznam prejemnikov in zago­tovljen enak dostop do presaditve delov cloveškega telesa. Konec leta 2020 so na presaditevcakali 204 bolniki. Število cakajocih se je v primerjavi z letom 2019 zmanjšalo, predvsem zaradi epidemiološke situacije s covid-19, ko so zdravniki obravnavali manj potencialnih kandidatov za uvrstitev na cakalni seznam, zlasti za presaditev ledvice. Povprecna cakalna doba je za vse organe v primerjavi z ostalimi državami relativno kratka. Slovenski bolniki cakajo na presaditev srca, jeter ali ledvice v povprecju manj kot leto dni. Za tocnejše podatke o povprecnih cakalnih dobah za posamezen organ glej poglavje Rezultati slovenskih programov za presaditve organov. V letu 2020 je bilo v Sloveniji na cakalni seznam na novo uvršcenih 93 bolnikov, od tega 27 za ledvico, 29 za srce, 8 za pljuca, 28 za jetra in 1 za ledvico v kombinaciji s trebušno slinavko. Stanje na nacionalnem cakalnem seznamu na dan 31. 12. 2020 (vsi cakajoci) Ledvica Srce Pljuca Jetra* Trebušna slinavka** 115 53 5 32 4 SKUPAJ 204 bolniki *Od tega 2 skupaj z ledvico **Od tega 3 skupaj z ledvico Vir: http://statistics.eurotransplant.org/ Nacionalni cakalni seznam v obdobju 2011-2020 (stanje na dan 31. 12., vsi cakajoci) Leto Ledvica Srce Pljuca* Jetra Trebušna slinavka SKUPAJ 2011 120 46 17 183 2012 113 38 18 2 169 2013 114 39 19 1 171 2014 136 31 21 11 188 2015 110 52 29 11 190 2016 95 58 28 7 181 2017 112 56 35 8 203 2018 135 65 35 6 234 2019 138 55 35 5 227 2020 115 53 5 32 4 204 Vir: http://statistics.eurotransplant.org/ *Do leta 2020 so bili slovenski pacienti, ki so cakali na presaditev pljuc, uvršceni na avstrijski cakalni seznami. Delež bolnikov na nacionalnem cakalnem seznamu po posameznem organu v letu 2020 LEGENDA Pljuca(5) Srce (53) Ledvica (115) Jetra (32) Trebušna slinavka (4) 53 Gibanje števila bolnikov na cakalni listi po organih in skupaj 2011-2020 140 130 120 110 100 90 80 70 60 50 40 30 20 10 Število bolnikov, umrlih med cakanjem na presaditev organa 2011-2020 Leto Ledvica Ledvica skupaj s trebušno slinavko Srce Pljuca Jetra SKUPAJ 2011 6 8 3 17 2012 2 8 7 17 2013 2 5 5 12 2014 4 5 2 11 2015 1 1 3 5 10 2016 3 7 3 13 2017 1 6 6 13 2018 1 2 6 5 14 2019 1 6 5 12 2020 1 2 1 4 Vir: http://statistics.eurotransplant.org/ Gibanje števila bolnikov, umrlih med cakanjem na presaditev organa 2011-2020 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Vir: http://statistics.eurotransplant.org/ LEGENDA Ledvica in trebušna slinavka Ledvica Jetra Srce * Gibanje števila bolnikov ŠTEVILO UMRLIH DAROVALCEV V letu 2020 smo v slovenskih donorskih bolnišnicah pridobili 47 aktivnih umrlih darovalcev, ki so bili medicinsko ustrezni in za katere smo pridobili privolitev svojcev. Uvodoma so prikazani podatki o številu aktivnih umrlih darovalcev v Sloveniji v primerjavi z ostalimi državami sveta. V nadalje­vanju so prikazani podatki o številu dejanskih umrlih darovalcev, kar pomeni, da je bil od vsakega darovalca presajen vsaj en organ. V primerjavi z ostalimi državami clanicami Eurotransplanta se Slovenija po številu dejanskih umrlih darovalcev na milijon prebivalcev v letu 2020 ponovno, kot že nekaj let zapored, uvršca na cetrto mesto. Število aktivnih umrlih darovalcev (MD) na milijon prebivalcev (NMP) v Sloveniji v letu 2020 v primerjavi z ostalimi državami sveta Država Število MD/NMP2020 1. ZDA 38,35 2. Španija 37,4 3. Portugalska* 33,8 4. Ceška 27,14 5. Belorusija* 26,2 6. Malta* 25 7. Združeno kraljestvo* 24,88 8. Estonija 24,83 9. Avstrija 23,9 10. Hrvaška 23,7 Država Število MD/NMP2020 11. Francija** 22,4 12. Slovenija 22,25 13. Finska** 21,9 14. *Kanada** 21,87 15. Belgija** 21,12 16. Italija** 20,5 17. Danska** 20,4 18. Urugvaj 19,2 19. Norveška** 18,8 20. Avstralija** 18,53 Država Število MD/NMP2020 21. Švica* 18,4 22. Slovaška* 17,96 23. Litva 17,5 24. Švedska** 16,8 25. Nizozemska** 16,67 26. Brazilija** 15,5 27. Nova Zelandija* 15 28. Iran* 14,34 29. Irska 12,8 30. Kuba* 12 *Podatki za leto 2019 ** Število dejanskih darovalcev *Podatki za leto 2019 ** Število dejanskih darovalcev Država Število MD/NMP2020 31. Madžarska** 11,3 32. Islandija** 10,9 33. Nemcija** 10,77 34. Cile* 10,4 35. Poljska 10,27 36. Latvija* 9,9 37. Argentina 9,78 Država Število MD/NMP2020 38. Izrael 9,2 39. Južna koreja* 8,68 40. Kolumbija* 8,4 41. Ekvador* 7,78 42. Turcija* 7,54 43. Ciper* 6,86 44. Kostarika* 6,66 Država Število MD/NMP2020 45. Grcija* 5,5 46. Rusija* 5,14 47. Luksemburg** 5 48. Mehika* 4,45 49. Romunija* 4,39 50. Panama* 4,29 51. Kitajska* 4,16 Graf števila aktivnih umrlih darovalcev (MD) na milijon prebivalcev (NMP) MD/NMP 50 40 30 20 10 0 ZDA ŠPA POR CEŠ BLR MAL ZK EST AUS HRV FRA SLO FIN KAN BEL ITA DAN URG NOR AVS ŠVI SLOV LIT ŠVE NIZ BRA N.ZE IRA IRS KUB MAD ISL NEM CIL POL LAT Država Število MD/NMP2020 Država Število MD/NMP2020 Država Število MD/NMP2020 52. Moldavija* 4,1 59. Severna Makedonija* 1,43 66. Nikaragua* 0,32 53. Bolgarija 4 60. ZAE* 1 67. Filipini 0,05 54. Hong Kong* 3,86 61. Japonska* 0,99 55. Kuvajt 3,5 62. Trinidad in Tobago* 0,72 56. Katar* 2,96 63. Malezija* 0,53 57. Peru* 2,28 64. Indija* 0,52 58. Saudijska Arabija 1,9 65. Dominikanska repub. 0,4 *Podatki za leto 2019 ** Število dejanskih darovalcev IRODaT (International Registry in Organ Donation and Transplantation), www.irodat.org, MD/NMP 50 40 30 20 10 0 9,7837 9,238 8,688,439 40 7,7841 7,5442 6,8643 6,6644 5,545 5,1446 547 4,4548 4,3949 4,2950 4,1651 4,152 453 3,8654 3,5 55 2,96 56 2,2857 58 1,9 59 1,43 60 1 61 0,99 62 0,72 63 0,53 0,05 64 65 66 67 0,520,40,32 ARG IZR J.KO KOL EKV TUR CIP KOS GRC RUS LUX MEH ROM PAN KIT MOL BOL H.K. KUV KAT PER S.AR. S.MK ZAE JAP T&T MAL IND D.RE. NIK FIL Število dejanskih umrlih darovalcev (MD) na milijon prebivalcev (NMP) v Sloveniji v letu 2020 in v primerjavi z državami Eurotransplanta. Država Slovenija (SLO) Eurotransplant (ET) Število MD 39 1.837 MD/NMP 18,5 13,2 Število dejanskih umrlih darovalcev na milijon prebivalcev (MD/NMP) ter primerjava z državami clanicami Eurotransplanta v letu 2020 Država ET Število MD/NMP 2020 1. Hrvaška (HR) 23,9 2. Belgija (BE) 21,2 3. Avstrija (AT) 21,1 4. Slovenija (SLO) 18,5 5. Nizozemska (NL) 14,4 6. Madžarska (HU) 11,0 7. Nemcija (DE) 10,7 8. Luksemburg (LU) 4,8 Vir: http://statistics.eurotransplant.org/ Število dejanskih umrlih darovalcev (MD) ter število umrlih darovalcev na milijon prebivalcev (MD/NMP) Sloveniji v letih od 1998 do 2020 Leto Število MD Število MD/NMP 1998 27 13,6 1999 26 13,1 2000 22 11,1 2001 23 11,6 2002 35 17,6 2003 28 14 2004 36 18 2005 21 10,5 2006 30 15 2007 22 10,9 2008 36 17,8 2009 33 16,2 2010 40 19,5 Leto Število MD Število MD/NMP 2011 31 15,1 2012 46 22,4 2013 45 21,9 2014 43 20,9 2015 53 25,7 2016 41 19,9 2017 39 18,9 2018 40 19,4 2019 38 18,3 2020 39 18,5 SKUPAJ 794 17,0 Vir: http://statistics.eurotransplant.org/ Število dejanskih umrlih darovalcev (MD) in število dejanskih umrlih darovalcev na milijon prebivalcev (MD/NMP) v Sloveniji v letih od 1998 do 2020 30 25 20 15 10 5 0 Klasifikacija umrlih darovalcev organov MOREBITEN UMRLI DAROVALEC ORGANOV Bolnik s hudo poškodbo možganov ALI bolnik z zaustavitvijo krvnega obtoka IN ocitno medicinsko primeren za darovanje organov Darovanje po smrti zaradi zaustavitve krvnega obtoka (DSK) Lececi zdravnik prepozna/opozori na možnega darovalca Darovanje po možganski smrti (DMS) MOŽEN DAROVALEC (DSK) a. Oseba, pri kateri se je zaustavilo delovanje krvnega obtoka in dihanje, postopki oživljanja se ne uporabijo oz. se ne nadaljujejo. ALI b. Oseba, pri kateri je mogoce predvideti, da se bo v dolocenem casovnem okviru zaustavilo delovanje krvnega obtoka in dihanje, kar bo omogocilo pridobitev organov. Razlogi, zakaj možen darovalec ne postane dejanski darovalec SISTEM DELA - Zdravstveno osebje ni prepoznalo /opozorilo na možnega mrtvega darovalca ali primernega darovalca, - Možganska smrt ni potrjena (npr. ne izpolnjuje meril) oz. posto­pek ugotavljanja MS ni zakljucen (npr. ker ni na voljo ustreznih diagnosticnih naprav oz. osebja, ki bi opravilo potrditveni test), - Smrt zaradi zaustavitve krvnega obtoka ni pravocasno potrjena, - Logisticne težave (npr. ekipa za odvzem organov ni na voljo), - Ni ustreznega prejemnika (npr. pri otroku, krvna skupina, pozitivna serologija). DAROVALEC/ORGAN - Medicinsko neustrezen (npr. pozitivna serologija, tumor), - Hemodinamska nestabilnost /nepredvidena zaustavitev srca, -Anatomske, histološke in/ali funkcionalne nepravilnosti organov, - Organi poškodovani med postopkom pridobivanja, - Nezadostna perfuzija organov ali krvni strdek. PRIVOLITEV - Umrli je za casa življenja izrazil voljo, da ne želi biti darovalec, - Zavrnitev svojcev umrlega, - Zavrnitev mrliškega oglednika ali preiskovalnega sodnika zaradi forenzicnih razlogov. MOŽEN DAROVALEC (DMS) Oseba, katere klinicno stanje kaže na verjetnost, da izpolnjuje merila za možgansko smrt. PRIMEREN DAROVALEC (DSK) Medicinsko ustrezna oseba, pri kateri je bila ugotovljena smrt na podlagi nepovratne prekinitve delovanja krvnega obtoka in dihanja, glede na relevantno zakonodajo, v casovnem okviru, ki omogoca pridobitev organov. PRIMEREN DAROVALEC (DMS) Medicinsko ustrezna oseba, pri kateri je bila ugotovljena smrt na podlagi nevroloških meril, glede na relevantno zakonodajo. AKTIVEN DAROVALEC (DSK) Primeren darovalec, za katerega imamo privolitev a. Narejen je bil operacijski rez z namenom prido­bitve organov za namen presaditve. ALI b. Pridobljen je bil vsaj en organ za namen presaditve. AKTIVEN DAROVALEC (DMS) Primeren darovalec, za katerega imamo privolitev a. Narejen je bil operacijski rez z namenom pridobitve organov za namen presaditve. ALI b. Pridobljen je bil vsaj en organ za namen presaditve. DEJANSKI DAROVALEC (DSK) Aktiven darovalec, od katerega je bil presajen vsaj en organ. DEJANSKI DAROVALEC (DMS) Aktiven darovalec, od katerega je bil presajen vsaj en organ. Upoštevati je potrebno »pravilo umrlega darovalca«. Bolnik lahko postane darovalec šele po smrti, pridobitev organov ne sme povzrociti smrti darovalca. Povzeto po Madridski resoluciji o darovanju organov in transplantaciji REGISTER OPREDELJENIH OSEB GLEDE DAROVANJA ORGANOV IN TKIV PO SMRTI Vsak slovenski državljan ima v casu življenja pravico in možnost, da se opredeli glede darovanja organov in tkiv. Odlocitev formalno potrdimo z vpisom v nacionalni register opredeljenih oseb, ki je bil vzpostavljen leta 2004. Izjavo o opredelitvi glede darovanja lahko podpišemo osebno na števil­nih pooblašcenih mestih v vec krajih po Sloveniji (natancen seznam je objavljen na www.slovenija--transplant.si) ali elektronsko z digitalnim podpisom preko portala eUprava (https://e-uprava.gov. si/). Od junija 2017 je poleg opredelitve ZA darovanje mogoca tudi opredelitev PROTI darovanju. V letu 2020 se je v nacionalni register opredeljenih oseb glede posmrtnega darovanja zaradi epi­demije covid-19 kljub možnosti opredelitve po elektronski poti, vpisalo 40 % manj oseb kot prejšnja leta. Zbrali smo 752 opredelitev (746 ZA in 6 PROTI). V nacionalnem registru opredeljenih oseb glede darovanja organov po smrti je bilo 31. 12. 2020 skupaj vpisanih 10.618 oseb (od tega 10.598 za in 20 proti). Elektronski nacin vpisa je od vzpostavitve tega nacina v novembru 2018 uporabilo 1785 oseb. Letno se na ta nacin opredeli okoli 40 % vseh opredeljenih, v letu 2020 pa je zaradi zmanjšane dostopnosti pooblašcenih mest za osebno opredelitev to možnost uporabilo 61 % vseh opredeljenih. Število vpisanih v registru opredeljenih oseb glede darovanja organov in tkiv po letih v obdobju od 2004 do 2020 Vir: arhiv Slovenija-transplanta Leto Št. vpisanih 2004 91 2005 228 2006 308 2007 386 2008 460 2009 513 Leto Št. vpisanih 2010 382 2011 381 2012 312 2013 300 2014 739 2015 632 Leto Št. vpisanih 2016 594 2017 1.523 2018 1.763 2019 1.254 2020 752 SKUPAJ 10.618 Število vpisanih v registru opredeljenih oseb glede darovanja organov in tkiv po letih v obdobju 2004–2020 1800 1650 1500 1350 1200 1050 900 750 600 450 300 150 0 ODSTOTKI PRIVOLITEV ZA DAROVANJE PRI POGOVORU S SVOJCI Pogovor s svojci oz. bližnjimi osebami možnega mrtvega darovalca glede darovanja se opravi v vseh primerih, ko je možno izpeljati postopke za darovanje organov za presaditev in odvzem od umrle osebe. Transplantacijski koordinator šele po potrditvi smrti ter vpisu casa smrti preveri v registru, ali je bil umrli opredeljen kot darovalec po smrti. Kljub znani opredelitvi centralni koordi­nator za transplantacijo vedno opravi pogovor o darovanju s svojci umrlega. V pogovoru poskuša izvedeti, kakšno je bilo stališce umrlega glede posmrtnega darovanja in v primeru privolitve v nadaljevanju pogovora pridobi dodatne zdravstvene podatke, ki so pomembni za darovanje. Ce volja umrlega ni znana, se na koncu glede darovanja odlocijo svojci. Vsi postopki so izvedeni z visoko stopnjo tankocutnosti, razumevanja izjemno težkih custvenih okolišcin ter v skladu z za­konodajnimi dolocbami in medicinsko doktrino. V letu 2020 je darovanje odklonilo 24 % svojcev. Ker je smrt bližnjega za vsakogar izmed nas težka izkušnja, Slovenija-transplant svojcem da­rovalcev nudi možnost posvetovanja ob žalovanju s strokovno usposobljenimi in izkušenimi strokovnjaki. Odstotki privolitev za darovanje v obdobju od 1998 do 2020 Vir: arhiv Slovenija-transplanta Leto % 1998 79 1999 70 2000 63 2001 64 Leto % 2002 78 2003 77 2004 70 2005 81 Leto % 2006 80 2007 85 2008 80 2009 85 Leto % 2010 80 2011 86 2012 69 2013 69 Leto % 2014 80 2015 81 2016 76 2017 83 Leto % 2018 66 2019 77 2020 76 Odstotki privolitev za darovanje v obdobju od 1998 do 2020 90 80 70 60 DELOVANJE DONORSKIH CENTROV V slovenski donorski program je vkljucenih enajst donorskih bolnišnic oz. centrov: UKC Ljubljana in UKC Maribor ter splošne bolnišnice v Celju, Murski Soboti, Novi Gorici, Izoli, na Ptuju, v Novem mestu, Slovenj Gradcu, na Jesenicah in v Brežicah. V donorskem centru izvajajo naslednje dejavnosti: • odkrivajo možne mrtve darovalce, • izvajajo diagnostiko možganske smrti, • ugotavljajo primernost organov in tkiv za odvzem in presaditev, • seznanjajo pokojnikove bližnje z možnostjo darovanja in pridobijo soglasje svojcev, • ohranjajo delovanje organov mrtvih darovalcev – v intenzivni terapiji in med odvzemom organov, • sodelujejo pri odvzemih organov in tkiv, ki jih izvajajo slovenske in tuje kirurške ekipe. Najvec darovalcev v Sloveniji pridobijo v UKC Ljubljana, kjer imajo najvecje število postelj v enotah intenzivne terapije in so v letu 2020 pridobili 22 dejanskih umrlih darovalcev. Rezultati so dobri tudi v UKC Maribor, kjer so v letu 2020 pridobili 7 dejanskih umrlih darovalcev in v SB Celje s 5 pridobljenimi dejanskimi umrlimi darovalci. Po enega darovalca so pridobili še v SB Izola, SB Nova Gorica, SB Murska Sobota, SB Jesenice in v SB Ptuj. Število in delež dejanskih umrlih darovalcev v posameznih donorskih centrih (DC) v letu 2020 Donorski center Število MD Delež v % UKC Ljubljana skupaj 22 56 Od tega ONIT* 10 Od tega CIT** 9 Od tega KOIIM*** 3 UKC Maribor 7 18 SB Celje 5 13 SB Jesenice 1 2,6 SB Nova Gorica 1 2,6 SB Izola 1 2,6 SB Murska Sobota 1 2,6 SB Ptuj 1 2,6 SKUPAJ 39 100 * ONIT – oddelek nevrološke intenzivne terapije, ** CIT – centralna intenzivna terapija, *** KOIIM – klinicni oddelek interne intenzivne medicine. SB Izola Vir: arhiv Slovenija-transplanta SB Murska sobota SB Ptuj CVRSTI ORGANI SLAVNOSTNI SIMPOZIJ OB 20. OBLETNICI USPEŠNEGA SODELOVANJA Z EUROTRANSPLANTOM, UKC LJUBLJANA, JANUAR 2020 FOTO: ANDREJ ZORE Število dejanskih umrlih darovalcev po donorskih centrih od 1998 do 2020 Vir: arhiv Slovenija-transplanta Leto UKC LJ UKC MB SB CE SB MS SB NG SB Izola SB Ptuj SB JE SB NM SB SG SB Brežice 1998-2009 176 95 22 7 10 9 7 6 3 4 2010 26 8 2 2 1 1 2011 21 6 2 1 1 2012 22 8 9 3 1 2 1 2013 21 8 7 5 3 1 2014 31 4 3 1 1 2 1 2015 25 11 10 2 1 1 1 1 1 2016 28 2 7 1 2 1 2017 22 7 4 2 1 1 2 2018 18 13 4 2 1 1 1 2019 15 8 6 3 1 3 1 1 2020 22 7 5 1 1 1 1 1 SKUPAJ 427 177 81 24 25 17 14 14 7 6 2 Število dejanskih umrlih darovalcev po donorskih centrih od 1998 do 2020 LEGENDA UKC Ljubljana UKC Maribor SB Celje SB Murska Sobota SB Izola SB Jesenice SB Nova Gorica SB Ptuj SB Novo mesto SB Slovenj Gradec SB Brežice 1998 - 2009 2012 2013 2016 2017 2018 2019 2020 Potencial in realizacija v donorskih bolnišnicah (zakljucena analiza za leto 2020) Potencial za darovanje za posamezno donorsko bolnišnico se izraža kot odstotek možgansko umrlih od vseh umrlih na oddelku za intenzivno zdravljenje (OIZ). Pove nam, pri koliko umrlih je bila do konca izpeljana diagnostika možganske smrti. Potencial je v neposredni povezavi z odkri­vanjem primernih darovalcev na OIZ. Realizacija v procesu darovanja nam pove, koliko primernih darovalcev (dokazana možganska smrt) je postalo aktivnih darovalcev. Izraža se kot odstotek aktivnih darovalcev od vseh dokazanih možgansko umrlih na OIZ. Vir: arhiv Slovenija-transplanta Donorska bolnišnica Vse smrti v OIZ MD PD *Potencial (%) Dosegljivi (%) AD Realizacija (%) **Dosegljiva (%) UKC Ljubljana 407 61 45 11.1 13.7 24 53 65 UKC Maribor 236 25 11 4.7 13.7 7 64 65 SB Novo mesto 99 3 / / 8.3 / / 55 SB Celje 180 18 12 6.7 8.3 7 58 55 SB Nova Gorica 72 7 1 1.3 8.3 1 100 55 SB Ptuj 48 3 2 4.2 8.3 1 50 55 SB Murska Sobota 96 7 5 5.2 8.3 3 80 55 SB Izola 76 3 1 1.3 8.3 1 100 55 SB Slovenj gradec 78 / / / 8.3 / / 55 SB Jesenice 48 2 2 4.2 8.3 2 100 55 SB Brežice 29 2 1 3.4 8.3 1 100 55 OIZ – oddelek za intenzivno zdravljenje, MD – možni darovalec, PD – primerni darovalec (dokazana možganska smrt), AD – aktivni darovalec (privolitev svojcev, odvzem organov), Potencial - % možgansko umrlih od vseh umrlih na OIZ = % PD/vse smrti na OIZ. Realizacija - % aktivnih darovalcev od vsem možgansko umrlih = % AD/PD *Potencial za donorsko bolnišnico je pricakovano višji za bolnišnice, ki imajo svojo nevrokirurško enoto in lahko dosežejo potencial tudi do 13,7 % (dosegljivi potencial). Dokaj blizu svojemu po­tencialu je bil UKC Ljubljana, medtem ko je UKC Maribor v letu 2020 za svojim potencialom pre­cej zaostal. Vzrok za to je epidemija covid-19, ki je v letu 2020 izraziteje prizadela vse OIZ iz UKC Maribor. Za bolnišnice brez lastne nevrokirurške enote pa je dosegljivi potencial za darovanje do 8,3 %. Tej številki se je leta 2020 najbolj približala SB Celje, relativno blizu je bila še SB Murska Sobota. Vecina donorskih bolnišnic je v letu 2020 zaostajala za dosegljivimi vrednostmi, kar kaže na to, da lahko še dodatno izboljšamo odkrivanje primernih darovalcev. So pa vse manjše bolni­šnice mocno cutile posledice epidemije, saj so se številni OIZ spremenili v oddelke intenzivnega zdravljenja bolnikov s covid-19. **Realizacija je odvisna predvsem od odstotka absolutnih medicinskih kontraindikacij in zavrnitev darovanja s strani svojcev v obravnavanem casovnem obdobju. **Dosegljiva realizacija upošteva do 20 % absolutnih medicinskih kontraindikacij in do 10-odstotno stopnjo odklonitve darovanja s strani svojcev, loci tudi med donorsko bolnišnico z nevrokirurško enoto ali brez nje (razlika 10 %), ostale ovire v donorskem procesu pa skupno predstavljajo do 5 %. Tako je izracunana dosegljiva realizacija za bolnišnice z nevrokirurško enoto 65 %, za tiste brez nevrokirurške enote pa 55 %. V letu 2020 so dosegljivo realizacijo presegli v SB Murska Sobota in SB Celje, blizu je bil tudi UKC Maribor. Pri nizkih vrednostih potenciala zasledimo tudi odstopanja, kot npr. v SB Izola, SB Nova Gorica in SB Brežice, kjer so dosegli 100-odstotno realizacijo pri edinem primeru, pri cimer ni bilo medicinskih kontraindikacij za darovanje, prav tako pa so svojci v darovanje privolili. V takih primerih je verjetno dvoletna bilanca natancnejša in v skladu s pricakovanimi rezultati. Pri bolnišnicah, v katerih leta 2020 ni bilo dokazanih možganskih smrti in ni bilo aktivnih darovalcev, sta potencial in realizacija prav tako 0 % oziroma nemerljiva (/). CVRSTI ORGANI Seznam odgovornih oseb (t. i. bolnišnicnih transplantacijskih koordinatorjev), ki skrbijo za razvoj, potek ter delovanje donorskega programa v posameznih donorskih centrih za leto 2020 Donorski center Odgovorne osebe UKC Ljubljana prim. asist. mag. Rade Stanic, dr. med. UKC Maribor Tanja Kuprivec, dr. med. SB Brežice Nataša Pirc, dr. med. SB Celje Barbara Hudournik, dr. med. SB Izola Damjan Polh, dr. med. SB Jesenice Andraž Nastran, dr. med. SB Murska Sobota prim. Daniel Grabar, dr. med. SB Nova gorica Edyta Cerkini, dr. med. SB Novo mesto Matej Godnic, dr. med. SB Ptuj prim. Majda Šarman, dr. med. (do 29. 2.) / Mateja Prevolšek, dr. med. (od 1. 3. 2020) SB Slovenj Gradec Rok Popic, dr. med. 8. INTENZIVNI TECAJ S PODROCJA PRIDOBIVANJA IN PRESADITVE ORGANOV TPM, LOGARSKA DOLINA, JANUAR 2020 FOTO: JANA ŠIMENC PRIDOBLJENI CVRSTI ORGANI ZA NAMEN ZDRAVLJENJA Število pridobljenih organov je odvisno od števila pridobljenih umrlih darovalcev, pa tudi od starosti in medicinskih kontraindikacij. V letu 2020 je bilo število pridobljenih organov umrlih darovalcev kljub epidemiji covid-19 višje od preteklega leta. V nadaljevanju so prikazani podatki za leto 2020 in primerjava s preteklimi leti. Število pridobljenih organov slovenskih umrlih darovalcev v letu 2020 Ledvica Srce Jetra Pljuca (obe pljucni krili) Trebušna slinavka SKUPAJ 68 17 34 13 4 136 Vir: arhiv Slovenija-transplanta LEGENDA Ledvica Srce Jetra Pljuca Trebušna slinavka Pridobljeni organi slovenskih umrlih darovalcev od leta 2000 do 2020 Leto Ledvica Srce Jetra Pljuca (obe krili) Trebušna slinavka SKUPAJ 2000-2009 559 149 217 70,5 76 1.071,5 2010 80 20 37 13 8 158 2011 58 14 24 4 5 105 2012 89 25 39 8 5 166 2013 86 26 39 19 8 178 2014 80 16 38 11 2 147 2015 92 20 46 6 6 170 2016 68 13 39 13,5 2 135,5 2017 68 19 40 15 4 146 2018 79 17 34 9 3 142 2019 75 15 31 11 / 132 2020 68 17 34 13 4 136 SKUPAJ 1.402 351 618 193 123 2.687 Vir: arhiv Slovenija-transplanta Pridobljeni organi slovenskih umrlih darovalcev od 2010 do 2020 1.615 pridobljenih organov umrlih darovalcev v SLO od 2010 do 2020 100 90 80 70 60 50 40 30 20 10 0 LEGENDA Ledvica Srce Jetra Pljuca Trebušna slinavka PRESAJENI CVRSTI ORGANI V Sloveniji imamo en transplantacijski center, to je Univerzitetni klinicni center v Ljubljani, kjer se izvajajo programi za presaditve cvrstih organov. Sistem razporejanja organov zagotavlja enako dostopnost do terapije s presaditvijo organov vsem državljanom Slovenije. Naloge transplantacijskega centra so: • priprava prejemnikov za uvrstitev na cakalni seznam, • presaditev organov, • vodenje bolnikov po presaditvi. Transplantacijski center od leta 2014 vodi kardiovaskularni kirurg dr. Ivan Kneževic, dr. med. V letu 2020 je bilo opravljenih 114 presaditev organov, 113 je bilo pridobljenih od umrlih daroval­ cev in en organ od živega darovalca. Najvec je bilo presajenih ledvic, po številu vseh presajenih organov od umrlih darovalcev na milijon prebivalcev smo nekoliko nad povprecjem držav Euro-transplanta. Pomembno višje pa je število presaditev src na milijon prebivalcev, kjer smo zadnjih nekaj let v samem svetovnem vrhu. Slovenski program za presaditev pljuc se je v letu 2020 je popolnoma osamosvojil in v UKC Lju­bljana so opravili šestnajst presaditev pljuc za slovenske bolnike. Slovenski strokovnjaki so v letu 2020 opravili prvo presaditev pljuc pri pediatricni bolnici, eno presaditev pa so opravili pri bolniku, ki so mu pljuca dokoncno odpovedala zaradi zapletov po covidu-19. Pediatricne transplantacije delno opravljajo v UKC Ljubljana, delno pa v bližnjih evropskih trans-plantacijskih centrih (ledvice v LKH v Gradcu in Hannovru, jetra v Bergamu in Hamburgu). Za obravnavo in pripravo pred presaditvijo in zdravljenje ter sledenje bolnika po presaditvi organa poskrbijo na pristojnih oddelkih v UKC Ljubljana. Presajeni cvrsti organi umrlih darovalcev v UKC Ljubljana v letu 2020 in primerjava z Eurotransplantom -absolutno število in število na milijon prebivalcev (NMP) Ledvica MD Srce Jetra Pljuca Trebušna slinavka SKUPAJ Št. NMP Št. NMP Št. NMP Št. NMP Št. NMP Št. NMP SLO 46 21,8 24 11,4 25 11,8 16 7,6 2 1 113 53,5 ET 2.851 20,6 587 4,3 1.470 10,7 1.279 4,8 154 1,2 6.356 40,1 Vir: arhiv Slovenija-transplanta in http://statistics.eurotransplant.org/ 25 20 15 10 5 0 SLO ET LEGENDA Število presajenih cvrstih organov umrlih darovalcev na milijon prebivalcev (NMP) v Sloveniji leta 2020 in primerjava z državami Eurotransplanta Država ET Ledvica Jetra Srce Pljuca Trebušna slinavka Število presaditev/NMP 2020 1. Avstrija (AV) 32,7 16,9 6,6 12,0 2,2 67,7 2. Belgija (BE) 28,2 18,5 4,7 8,1 1,2 58,8 3. Slovenija (SLO) 21,8 11,8 11,4 7,6 1,0 53,5 4. Hrvaška (HR) 23,4 23,2 6,2 / 0,2 52,2 5. Nizozemska (NL) 25,4 9,3 2,4 5,0 1,7 42,1 6. Nemcija (NE) 17,5 9,3 4,1 4,1 1,1 34,6 7. Madžarska (MAD) 17,6 5,1 4,6 1,7 0,6 29,1 NMP 50 40 30 20 10 0 Vir: arhiv Slovenija-transplanta in http://statistics.eurotransplant.org/ 67,7 58,8 53,5 52,2 42,1 34,6 29,1 LEGENDA Ledvica Srce Jetra Pljuca Trebušna slinavka Število presajenih cvrstih organov umrlih darovalcev v Sloveniji oz. slovenskim prejemnikom od leta 1970 do 2020 Leto Ledvica Srce Jetra Pljuca* Trebušna slinavka SKUPAJ Od 1970 do 1985 1 1 1986 7 7 1987 18 18 1988 16 16 1989 14 14 1990 17 1 1 19 1991 11 11 1992 20 20 1993 4 1 5 1994 14 2 16 1995 10 3 1 14 1996 6 2 8 1997 19 6 1 26 1998 46 4 4 54 1999 37 7 9 3 56 2000 44 7 10 1 62 2001 47 4 9 1 61 2002 55 3 11 69 2003 43 3 9 2 57 2004 55 3 15 73 Vir: arhiv Slovenija-transplanta Leto Ledvica Srce Jetra Pljuca* Trebušna slinavka SKUPAJ 2005 28 5 13 2 48 2006 48 8** 8 2 66 2007 30 11 10 1 52 2008 52 6 22 4 84 2009 43 18 18 2 2 83 2010 61 19 23 3 1 107 2011 46 14 20 7 1 88 2012 62 29*** 27 2 120 2013 60 30 21 8 4 123 2014 55 33 31 3 122 2015 64 24 24 7 5 124 2016 44 31 27 10 5 117 2017 46 24 23 8 101 2018 54 23 27 7 3 114 2019 38 22 24 11 1 96 2020 46 24 25 16 2 113 SKUPAJ 1.261 367 411 101 25 2.165 * Vecina presaditev pljuc pri slovenskih prejemnikih je bila do vkljucno leta 2018 opravljena v AKH na Dunaju, z izjemo 2003 (1 presaditev v UKC LJ) in 2018 (2 presaditvi v UKC LJ). V letu 2019 je bilo v UKC Ljubljana opravljenih 10 presaditev pljuc in ena pediatricna presaditev v AKH Dunaj, v letu 2020 so bile vse presaditve opravljene v UKC Ljubljana. ** Eno srce slovenskega darovalca je bilo presajeno slovenskemu bolniku v Gradcu. *** Eno srce je bilo skupaj s pljuci presajeno slovenskemu bolniku na Dunaju. Število presajenih cvrstih organov umrlih darovalcev v Sloveniji od leta 1970 do 2006 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Vir: arhiv Slovenija-transplanta LEGENDA Ledvica Srce Jetra Pljuca Trebušna slinavka Število presajenih cvrstih organov umrlih darovalcev v Sloveniji od leta 2007 do 2020 2.165 presajenih cvrstih organov umrlih darovalcev v SLO od 1970 do 2020 140 120 100 80 60 40 20 0 52 84 83 107 88 120 123 122 124 117 100 114 96 113 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 LEGENDA Vir: arhiv Slovenija-transplanta Ledvica Srce Jetra Pljuca Trebušna slinavka Število presajenih ledvic od živega darovalca Zaenkrat je v Sloveniji za casa življenja možno darovati le ledvico med sorodniki ali custveno povezanimi osebami. Vsak primer presoja Eticna komisija za presaditve, ob upoštevanju nacela, da mora biti tveganje za zdravje darovalca sorazmerno v primerjavi s pricakovano koristjo za prejemnika. Ob zacetku slovenskega transplantacijskega programa, od leta 1970 dalje, so sprva prevladovale presaditve ledvic od živih sorodnih darovalcev, od leta 1986 naprej pa je bila z ra­zvojem nacionalnega donorskega programa vecina organov za presaditev pridobljenih od umrlih darovalcev. Program presaditev organov od živih darovalcev je pocasi zamrl, vendar se od leta 2016 ponovno obuja. V letih 2016, 2017 in 2018 sta bili tako v UKC Ljubljana opravljeni po dve presaditvi ledvice živega darovalca, v letu 2020 pa ena tovrstna presaditev. Število presajenih ledvic od živega darovalca 1970 - 2020 Leto Št. Leto Št. Leto Št. Leto Št. Leto Št. Leto Št. 1970-85 43 1991 3 1997 2 2003 0 2009 1 2015 0 1986 23 1992 5 1998 1 2004 0 2010 0 2016 2 1987 14 1993 5 1999 0 2005 0 2011 0 2017 2 1988 13 1994 0 2000 0 2006 0 2012 0 2018 2 1989 10 1995 1 2001 0 2007 1 2013 0 2019 0 1990 2 1996 2 2002 0 2008 0 2014 0 2020 1 SKUPAJ 133 Deleži presajenih ledvic živih in umrlih darovalcev v % od 1970 do 2020 % 100 80 60 40 20 0 2 23 56 78 58 89 79 80 44 100 91 75 90 98 100 100 100 100 100 100 100 89 77 44 22 42 21 20 56 25 2 10 11 9 1970-85 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 % 100 80 60 40 20 0 100 97 100 98 100 100 100 100 100 100 96 96 96 100 98 LEGENDA Delež presajenih ledvic živih darovalcev = SKUPAJ 9,5 Delež presajenih ledvic umrlih darovalcev = SKUPAJ 90,5 REZULTATI SLOVENSKIH PROGRAMOV ZA PRESADITVE ORGANOV Preživetje bolnikov po presaditvi srca Od 1990 do 2020 je bilo v UKC Ljubljana opra­vljenih 367 presaditev srca. V letu 2020 smo pre­ sadili 24 src, od tega je bilo 17 (71 %) bolnikov transplantiranih urgentno, 7 (29 %) pa elektivno. Najpogostejša vzroka za presaditev sta bili dila­tativna kardiomiopatija (38 %) in ishemicna bole-zen srca (25 %), ostali vzroki pa so bili valvularna bolezen srca (21 %), nekompakcijska kardiomio­patija (8 %), amiloidoza srca (4 %) in kongenital­ne hibe (4 %). Glede na podatke Eurotransplanta se je UKC Ljubljana ponovno uvrstil med prvih 10 (od 42) najvecjih centrov za presaditve srca v obmocju Eurotransplanta. Po številu opravljenih presaditev se lahko primerja z najvecjimi centri v Nemciji, Belgiji, Avstriji in na Madžarskem. Vecletno povprecje (2009-2020) cakalne dobe za elektivno presaditev srca znaša 239 dni, za ur­gentno presaditev srca pa 56 dni. V 2020 je bila povprecna cakalna doba za elektivno presaditev srca 295 dni, za urgentno presaditev pa 38 dni. Rezultati preživetja bolnikov po presaditvi so pri­merljivi z rezultati iz mednarodnega referencne­ga registra ISHLT (The International Society for Heart & Lung Transplantation). 100 75 50 25 0 % Preživetje odraslih bolnikov po presaditvi srca v % (za obdobje 1990–2020, n = 367) 30-dnevno preživetje Enoletno preživetje Petletno preživetje 93 % 87 % 77 % Vir: Porocilo o delovanju programa za napredovalo srcno popušcanje in presaditev srca za leto 2020 (KO za kardiologijo, UKC Ljubljana) Preživetje bolnikov po presaditvi ledvice V Sloveniji je bilo v obdobju po prikljucitvi Eu-rotransplantu (1. 1. 2000–31. 12. 2020) presa­jenih 1.030 ledvic umrlih (1021 ledvic) in živih (9 ledvic) darovalcev. Nekaterim prejemnikom so ledvico presadili v kombinaciji z drugimi or-gani: 24 pacientom skupaj s trebušno slinavko, trem pacientom skupaj s srcem in dvema pa-cientoma skupaj z jetri. V prvem letu po presa­ditvi so pri 12,8 % vseh bolnikov s presajenim organom zaznali klinicno, z biopsijo dokazano akutno zavrnitev presadka. Pojavnost klinicne, z biopsijo dokazane zavrnitve presajene ledvi­ce je primerljiva s podatki v literaturi in z drugi-mi centri v razvitem svetu. Mediani cas od uvrstitve na cakalni seznam do presaditve je približno 300 dni za obdobje od 2010 do 2019. V letu 2020 je bil mediani cas od vkljucitve na cakalni seznam do presaditve 440 dni. * krnjeno za smrt z delujocim presadkomAktualno 1- in 5-letno preživetje slovenskih bolnikov in presadkov je po po­datkih Eurotransplanta za obdobje 2000–2014 nad povprecjem držav clanic Eurotransplanta in je primerljivo z najrazvitejšimi centri v svetu. Vir: Kazalniki kakovosti Centra za transplantacijo ledvic (KO za nefrologijo, UKC Ljubljana) 100 95 90 85 80 75 70 65 60 % Preživetje bolnikov in presadkov po presaditvi ledvice v % (za obdobje 2000–2020, n = 1030) Enoletno preživ etje Petletno preživetje Bolniki 98 % 93,6 % Presadki 93,9 % 86,6 % 94,8 %* 90,3 %* 98 93,9 93,6 86,6 Enoletno Petletno PREŽIVETJE LEGENDA % bolnikov % presadkov Preživetje bolnikov po presaditvi jeter V obdobju od 1995 do 31. 12. 2020 je bilo v UKC Ljubljana opravljenih 411 presaditev jeter. 63 % bolnikov je potrebovalo presadi­ tev zaradi ciroze jeter, 10 % zaradi akutne odpovedi jeter, 9,7 % zaradi raka na jetrih, 9,3 % zaradi holestatske/kongenitalne bole-zni in 2,1 % zaradi presnovne bolezni jeter. Med ostale vzroke za presaditev (5,9 %) sodijo še benigni jetrni tumorji ali policistic­na bolezen jeter in Budd-Chiarijev sindrom. Povprecna cakalna doba za presaditev je­ter za leto 2020 brez visoko urgentnih pri­merov je približno 290 dni, mediana znaša 124 dni. Skupaj z visoko urgentnimi primeri pa je povprecna cakalna doba 268 dni, me-diana 105 dni. Vir: Podatki KO za gastroenterologijo, UKC Ljubljana Preživetje bolnikov in presadkov po presaditvi jeter v % (za obdobje 1988–2019*, n = 291, bolniki) in (n = 323, presadki)) Enoletno preživetje Triletno preživetje Petletno preživetje Bolniki 86 % 81 % 79 % Presadki 79 % 74 % 71 % ELTR (European Liver Transplant Registry, SLLUBL: Specific Analyses, june 2019) * Podatki za leto 2020 bodo na voljo šele v sredini leta 2021, zato objavljamo razpoložljive podatke za obdobje od 1988 do junija 2019. 90 PREŽIVETJE 85 80 75 70 65 60 % Enoletno Triletno Petletno Bolniki Presadki LEGENDA Preživetje bolnikov po presaditvi trebušne slinavke (socasno z ledvico) V obdobju od februarja 2009 do 31. 12. 2020 je bilo v Sloveniji opravljenih 24 socasnih presaditev ledvice in trebušne slinavke. V letu 2020 sta bili opravljeni dve socasni pre­saditvi ledvice in trebušne slinavke. Eno leto po presaditvi je bilo delujocih 18 trebušnih slinavk, 5 trebušnih slinavk je bilo odstranjenih v zgodnjem po-transplantacij­skem obdobju. En bolnik je umrl v zgodnjem po-transplantacijskem obdobju zaradi okuž-be. Konec leta 2020 smo imeli v Sloveniji 16 bolnikov z delujoco presajeno trebušno slinavko in ledvico Preživetje bolnikov in presadkov po socasni presaditvi trebušne slinavke in ledvice v % (za obdobje 2009–2020, n = 24 (bolniki) in n = 19 (presadki)) Enoletno preživetje Triletno preživetje Bolniki 95,8 % 95,8 % Presadki T. slinavka Ledvica T. slinavka Ledvica 75 % 91,7 % 75 % 91,4 % Vir: Porocilo – izr. prof. dr. Damjan Kovac, dr. med. (KO za nefrologijo, UKC Ljubljana) 100 95 90 85 80 75 70 65 60 % PREŽIVETJE / PRESADKI / BOLNIKI LEGENDA Ledvica Trebušna slinavka Bolniki Enoletno Triletno Preživetje bolnikov po presaditvi pljuc V obdobju 1997–2020 je bilo pri slovenskih bol­nikih opravljenih 85 presaditev pljuc, od tega je bila pri enem bolniku opravljena ponovna pre­ saditev. V letu 2020 so v UKC Ljubljana opravili 16 presaditev pljuc, od tega 14 presaditev obeh pljucnih kril in dve presaditvi enega pljucnega krila. Pet presaditev je bilo nujnih, med njimi je bil bolnik, ki je potreboval presaditev pljuc za­radi sindroma akutne dihalne stiske po okužbi s covid-19. Najpogostejši vzrok za presaditev pljuc (od zacetka izvajanja programa presaditev za slovenske bolnike na Dunaju in od leta 2018 v Ljubljani) so bili cisticna fibroza (27 %), kro­nicna obstruktivna pljucna bolezen (26 %), pljucna fibroza (26 %) in pljucna hipertenzija. Ce upoštevamo samo presaditve, opravljene v UKC Ljubljana od 2018 do 2020, so bili glavni vzroki za presaditev pljuc kronicna obstruktivna pljucna bolezen (36 %), pljucna fibroza (26 %), cisticna fibroza (18 %) in bronhiektazije (7 %). Celokupna povprecna cakalna doba za presa­ditev pljuc (za redne in nujne presaditve) je bila v letu 2019 148 dni, v letu 2020 pa 78 dni. Leta 2020 je bila za nujne transplantacije pov­precna cakalna doba 7 dni, za redne pa 111 dni. Preživetje bolnikov po presaditvi pljuc v % (za obdobje 1997–2020, n = 101) Enoletno preživetje Triletno preživetje Petletno preživetje Bolniki 87,3 % 80,2 % 76,2 % Vir: Porocilo - doc. dr. Matevž Harlander, dr. med. (KO za pljucne bolezni in alergologijo, UKC Ljubljana) Bolniki LEGENDA 90 85 80 75 70 65 60 % Enoletno Triletno Petletno PREŽIVETJE Tkiva in celice PRESADITVE KRVOTVORNIH MATICNIH CELIC Presaditev krvotvornih maticnih celic (KMC) je najbolj razširjena oblika celicnega zdravljenja, saj se na ta nacin zdravi vec kot 70 malignih in nemalignih bolezni, pri dolocenih hematoloških obo­lenjih pa je glavna terapevtska in tudi edina možnost za ozdravitev. Sodoben nacin zdravljenja s KMC v optimalnih pogojih dosega vec kot 90-odstotno uspešnost (http://www.ztm.si). Za takšen uspeh pa je potrebno dobro imunsko (HLA) ujemanje darovalca in prejemnika. Sistem HLA je pri vsakem cloveku raznolik in zato je najti ustrezen par zelo zahtevno delo. V mednarodni skupnosti so se zdravniki odlocili za ustanovitev vecjih registrov tipiziranih prostovoljnih darovalcev KMC, ki bi omogocali bistveno vecjo možnost za ujemanje HLA in s tem uspešnost presaditve. Poznamo vec vrst ujemanja med darovalcem in prejemnikom. Kadar je možno uporabiti lastne KMC, to imenujemo avtologno darovanje. Ce to ni možno, išcemo drugega darovalca, ki je s pre­jemnikom v sorodu ali pa ne. Darovanje drugega darovalca imenujemo tudi alogenicno, pri cemer išcemo darovalca najprej v Sloveniji in nato v tujini. Register Slovenija Donor V Sloveniji je bil leta 1991 ustanovljen register nesorodnih darovalcev Slovenija Donor, ki je naslednje leto postal polnopravni clan svetovnega registra Bone Marrow Donors Worldwide (BMDW). Na dan 31. 12. 2020 je bilo v register Slovenija Donor vpisanih 20.453 oseb, od tega jih je bilo v svetovni register BMDW vpisanih 20.255. Presaditve KMC v Sloveniji od leta 2000 do 2020 Tip presaditve 2000-2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 AUTO 531 68 101 74 63 84 86 92 88 89 104 ALO-ŽSD 102 9 8 7 11 10 15 12 13 11 10 ALO-ŽND 84 18 22 31 26 24 26 28 26 31 17 AUTO in ALO-ŽSD 21 SKUPAJ 738 95 131 112 100 118 127 132 127 131 131 AUTO – avtologne presaditve, ALO – alogenske presaditve, ŽSD – živi sorodni darovalec, ŽND – živi nesorodni darovalec Vir: Letno porocilo ZTM – Slovenija donor, podatke mesecno zbiramo za arhiv Slovenija-transplanta. 700 600 500 400 300 200 100 0 140 120 100 80 60 40 20 0 PROGRAM PRIDOBIVANJA IN PRESADITVE ROŽENIC Zdravljenje s presaditvijo roženic je ena najpogostejših in tudi najuspešnejših presaditev tkiv na svetu. Takšen nacin zdravljenja pogosto predstavlja edini nacin, s katerim izboljšamo vid zaradi predhodnega obolenja oz. poškodb. Pridobljene in presajene roženice od leta 2010 do 2020 Leto Št. pridobljenih roženic *Št. presajenih roženic 2010 122 72 2011 91 40 2012 101 67 2013 116 74 2014 116 87 2015 102 76 2016 104 83 2017 138 91 2018 84 66 2019 108 88 2020 92 72 140 130 120 110 100 90 80 70 60 50 40 * Podatki o presaditvah na Ocesni kliniki UKC Ljubljana v obdobju 2010–2017, od leta 2018 dalje pa so vkljucene tudi presaditve na Oddelku za ocesne bolezni UKC Maribor Vir: arhiv Slovenija-transplant V Sloveniji pridobivamo roženice od umrlih darovalcev po dokoncni zaustavitvi srca ali po dokaza­ni možganski smrti. Odvzem roženic je možen po predhodni privolitvi umrle osebe v casu življenja oz. ob nenasprotovanju bližnjih. Dokoncno odlocitev o primernosti roženice za presaditev vselej sprejme prejemnikov odgovorni zdravnik. Presaditev roženice izvajamo v dveh transplantacijskih centrih: na Ocesni kliniki v UKC Ljubljana ter na Oddelku za ocesne bolezni v UKC Maribor. Cakalni seznam bolnikov za presaditev roženice na Ocesni kliniki v UKC Ljubljana (na dan 22. 3. 2021) in UKC Maribor (na dan 11. 2. 2021) Diagnoza Število bolnikov Keratokonus 40 Ostale diagnoze 199 SKUPAJ 239 232 bolnikov UKC Ljubljana, 7 bolnikov UKC Maribor LEGENDA Keratokonus: 40 bolnikov (17 %) Ostale diagnoze: 199 bolnikov (83 %) (poškodbe, degeneracija, retransplantacija, makule roženice, distrofija Fuchs, endotelna distrofija, cornea guttata, afaka in psevdofaka, keratopatija bullosa, vnetja, drugo) Vir: UKC Ljubljana, Ocesna klinika; UKC Maribor, Oddelek za ocesne bolezni OSTALA TKIVA IN CELICE Sledljivost in transparentnost v programih presaditve oz. uporabe tkiv in celic za namen zdravljenja V Slovenija-transplantu smo vzpostavili sodelovanje z vsemi ustanovami za tkiva in celice, ki imajo veljavno dovoljenje Javne agencije za zdravila in medicinske pripomocke (v nadaljevanju: JAZMP). Sledljivost in transparentnost zagotavljamo z zbiranjem in pregledovanjem sprotnih po­rocil ustanov za tkiva in celice, ki nam porocajo o darovanju, pridobivanju, procesiranju, shranje­vanju, dodeljevanju, uporabi in unicenju tkiv in celic. Po zakljucku leta na osnovi letnih porocil posameznih ustanov za tkiva in celice v Slovenija-tran­splantu pripravimo zbirno letno porocilo. Prav tako pripravimo letno zakljucno porocilo o hudih neželenih dogodkih in reakcijah ter ga posredujemo JAZMP, ki nato poroca Evropski komisiji. Ustanove za tkiva in celice ter zagotavljanje kakovosti in varnosti V Sloveniji je na nacionalni ravni v dejavnost preskrbe s tkivi in celicami vkljucenih 27 ustanov. Od tega je v program vkljucenih 15 bolnišnic in znotraj teh 40 klinicnih oddelkov. Glede na status je 18 ustanov za tkiva in celice javnih in 9 ustanov zasebnih. Zasebne ustanove imajo dovoljenje izkljucno za avtologno pridobivanje tkiv in celic. Slovenija-transplant in JAZMP zagotavljata delovanje sistema ter sproti ugotavljata in obravna­vata vse odklone, ki lahko vplivajo na kakovost in varnost tkiv in celic darovalcev, prejemnikov in osebja, ki je vkljuceno v posamezne procese. Za pridobitev dovoljenja mora vsaka ustanova izpolnjevati stroge strokovne in zakonske pogoje. Vse ustanove imajo vzpostavljen sistem kakovosti, v katerem so opisani vsi postopki za zagota­vljanje pogojev za kakovost tkiv in celic ter varnost prejemnikov. Vse ustanove redno nadzoruje JAZMP, v preverjanje sporocenih podatkov pa je vkljucen tudi Slovenija-transplant. Oploditev z biomedicinsko pomocjo in reproduktivne celice V Sloveniji so registrirani 4 centri za dejavnost oploditve z biomedicinsko pomocjo parom, ki ne morejo zanositi po naravni poti: OBMP Ljubljana, OBMP Maribor, OBMP Postojna in ZC Dravlje. Obseg dejavnosti je razviden iz tabele o pridobljenih in uporabljenih tkivih in celicah. Omenjeno podrocje spada po številu izvedenih postopkov med najobsežnejše. V letu 2019 je Ministrstvo za zdravje RS vzpostavilo strokovno skupino, v kateri sodelujejo centri za OBMPLjubljana, Maribor, Postojna, zasebni zavod Zdravje in zavod Slovenija-transplant. Skupina pripravlja strokovne smernice in zakonodajo za vzpostavitev nacionalnega registra OBMP, v kate­rega bodo posamezni centri OBMPv predvidenem casovnem roku sporocali podatke o svoji dejav­nosti. Upravitelj registra bo NIJZ, kjer bo ta register tudi fizicno namešcen. Slovenija-transplant bo imel dostop do podatkov za namen zagotavljanja sledljivosti, transparentnosti ter kakovosti in var-nosti tkiv in celic. V letu 2020 je bilo delo strokovne skupine ustavljeno zaradi epidemije covid-19. Pridobivanje in shranjevanje popkovnicne krvi in popkovnice V Sloveniji pridobivamo tudi krvotvorne maticne celice iz popkovnicne krvi in popkovnice ter tu­di drugih tkiv (npr. mlecni zobje). Dovoljenje za delo imajo ena javna tkivna banka – Zavod za transfuzijsko medicino (v nadaljevanju: ZTM) in tri zasebne ustanove (Izvorna celica, Biobanka in FH-S). Javna banka popkovnicne krvi pri ZTM je s 1. 12. 2014 zakljucila s sprejemanjem vzorcev popkovnicne krvi, saj je bilo zbranih in shranjenih zadostno število vzorcev, da lahko zadostijo potrebam v Sloveniji. Vir: http://www.ztm.si/register-darovalcev/javna-banka-popkovnicne-krvi/ Število pridobljenih tkiv in celic od 2009 do 2020 Leto 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Koža* 28 45 22 36 85 89 52 57 32 22 24 10 Kosti* 38 123 108 67 93 82 147 74 80 78 71 59 Mehkokostni presadki* 22 39 / 3 11 3 9 / 12 / / / Hrustanec* 37 21 4 12 11 11 12 / / / / / Reproduktivne celice (št. celic) 15.854 43.472 8.640 27.479 41.929 37.542 39.769 26.191 36.338 13.778 26.813 28.209 *Enota: število odvzetih vzorcev Število uporabljenih tkiv in celic od 2009 do 2020 Leto 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Koža* 36 10 14 34 67 23 31 28 / 20 3 / Kosti* 23 47 57 97 59 62 92 82 72 71 81 101 Mehkokostni presadki* 12 / 2 2 3 4 3 5 2 3 5 4 Hrustanec* 15 / 3 7 4 9 5 1 / / 1 / Reproduktivne celice* 1.450 2.018 29.651 23.330 23.506 27.271 31.127 26.620 31.817 12.110 5.109 14.255 *Enota: število uporabljenih vzorcev Vir: arhiv Slovenija-transplanta Število enot pridobljene popkovnicne krvi Ustanova / Leto 2015 2016 2017 2018 2019 2020 Izvorna celica 76 144 107 82 81 81 Biobanka 175 178 266 110 224 197 FH-S 8 45 101 169 192 206 Neocelica 238 0* 0* 0* 0* 0* *Ustanova prenehala z delovanjem Število enot pridobljene popkovnice Ustanova / Leto 2015 2016 2017 2018 2019 2020 Izvorna celica 60 116 96 52 73 75 Biobanka 32 150 222 96 212 184 FH-S 8 42 96 114 196 213 Neocelica 198 0* 0* 0* 0* 0* *Ustanova prenehala z delovanjem Vir: arhiv Slovenija-transplanta Neželeni dogodki in reakcije Slovenija-transplant je odgovoren za obravnavo neželenih dogodkov in reakcij ter odklonov na podrocju preskrbe s tkivi in celicami zaradi presaditve, t. i. histovigilanco. Namen zbiranja porocil o neželenih dogodkih in reakcijah ali tudi postavitev suma nanje, je zagotavljanje kakovosti po­stopkov in s tem preprecevanja tveganja za zdravje pacientov, osebja, škode ali celo izgube tkiv in celic. Porocanje poteka na predpisanih obrazcih, za posamezen primer je treba oddati zacetno in konc­no porocilo. Oba obrazca sta prilogi Pravilnika o histovigilanci. Porocanje poteka v vec fazah: zaznava odklona, natancen opis, sprejem ustreznih ukrepov za preprecitev škode na tkivih in celicah ter ljudeh, porocanje pristojnim inštitucijam in obvešcanje vseh ustanov za tkiva in celice, ki so dobila tkiva in celice, pri katerih je prišlo do odklona. Vsi podatki, ki se zbirajo v sistemu histovigilance, so anonimizirani, da se zagotovi zasebnost in na drugi strani upošteva t. i. kulturo neobtoževanja, kar pomeni, da se spodbuja porocanje, išcejo se rešitve oz. izboljšave in ni obsojanja izvajalcev na osebni ravni. V letu 2020 je Slovenija-transplant prejel 3 porocila o neželenih dogodkih, ki so nastali v verigi preskrbe s tkivi in celicami. Vsi trije primeri so bili zaznani v Ortopedski bolnišnici Valdoltra pri pri­dobivanju kosti. Pripravili smo analizo in korektivne ukrepe. V vseh treh primerih ni bilo posledic, tveganje za ponovitev je bilo ocenjeno kot nizko. V centru OBMP smo obravnavali tudi 10 primerov neželenih reakcij. V treh primerih je šlo za sin-drom ovarijske hiperstimulacije, kjer so 3 pacientke sprejeli v bolnišnicno zdravljenje. V 7 primerih pa je prišlo do mocnejše venozne krvavitve, a hospitalizacija ni bila potrebna. Ugotavljamo, da je treba zaradi boljše ozavešcenosti organizirati dodatno izobraževanje na temo histovigilance in porocanja o neželenih dogodkih, saj je možno, da je sporocanje podatkov glede vigilancnih primerov nekoliko podcenjeno. Število neželenih dogodkov in reakcij od 2009 do 2020 18 16 14 12 10 8 6 4 2 0 LEGENDA Neželene reakcije Neželeni dogodki OBJAVE IN PREDAVANJA NA KONFERENCAH Pregledni in izvirni znanstveni clanki • Avsec D, Šimenc J. Donorski program po cirkulatorni smrti v Sloveniji: analiza stališc stro­kovne javnosti in nadaljnji razvoj. Zdravstveni vestnik 2020; 89(5-6): 255-67 (izvirni znan­stveni clanek). Dostopno na: https://www.slovenija-transplant.si/uploads/upload/clanek%20 dcd-ZV2020.pdf. • Arnol M, Smrkolj T, Avsec D, Gadžijev A, Kneževic I. An increase in kidney transplantation procedures from deceased donors during the COVID-19 epidemic in Slovenia. Transplant International, 7.8.2020 (kratek znanstveni prispevek). Dostopno na: https://onlinelibrary. wiley.com/doi/full/10.1111/tri.13715. Strokovni clanki • Avsec D. Intervju z Ano Peres Silvo (izvajanje konvencije proti trgovini z organi). Isis 2 (februar) 2020. Dostopno na: https://www.zdravniskazbornica.si/informacije-publikacije-in­-analize/publikacije-zbornice-isis/revija/isis-februar-2020. • Avsec D. Donorska in transplantacijska dejavnost v casu epidemije covid-19. Isis 7 (junij) 2020: 27-30. Dostopno na: http://online.pubhtml5.com/agha/dzcl/#p=27. • Avsec D, Šimenc J. 20 let sodelovanja z Eurotransplantom. Novis, glasilo Združenja zdra­vstvenih zavodov Slovenije, št. 1/2 2020. Dostopno na https://zdrzz.si/f/docs/Aktualno/No­vis_januar-februar_2020.pdf). • Avsec D. Prilagoditve zavoda Slovenija-transplant na epidemijo. Novis št. 5/6 2020. • Šimenc J, Avsec D. Evropski dan darovanja: Strokovnost, solidarnost in humanizem kljubuje­jo krizi. Transplant: glasilo Slovenskega društva Transplant, december 2020 : 4–5.2019 : 5–7. • Avsec, D. (2019). Obdobje virusa vidim kot zelo dobro ucno priložnost (intervju). Transplant: glasilo Slovenskega društva Transplant, december 2020 : 9–13. • Avsec D, Uštar B. (ur). Daj življenju priložnost: donorska in transplantacijska dejavnost v Sloveniji v letu 2019. Ljubljana: Zavod RS za presaditve organov in tkiv Slovenija-trans­plant. Dostopno na: https://www.slovenija-transplant.si/uploads/upload/Daj-Zivljenju-Prilo­znost-2019.pdf. Predavanja na konferencah (v kronološkem redu) • Danica Avsec: Slovenija-transplant kot nosilec pogodbe z Eurotransplantom in razvoj dejav­nosti. 20 let sodelovanja Slovenije z Eurotransplantom, UKC Ljubljana, 17. 1. 2020. • Andrej Gadžijev: Nacionalna donorska mreža in sistem zagotavljanja kakovosti. 20 let sode­lovanja Slovenije z Eurotransplantom, UKC Ljubljana, 17. 1. 2020. • Andrej Gadžijev: Darovanje organov in tkiv v Sloveniji. Kongres Misli na srce, Transplantaci­je in transfuzije, Medicinska fakulteta v Ljubljani, 5. 3. 2020. • Andrej Gadžijev: Komunikacija s svojci pred odvzemom. Sprednji ocesni segment – diagno­stika in zdravljenje, Kongres Zbornice Zveze, Ljubljana, 6. 3. 2020. VIRI • Spletna stran Zavoda Slovenija-transplant: http://www.slovenija-transplant.si/. • Spletna stran Zavoda RS za transfuzijsko medicino: http://www.ztm.si/register-darovalcev/slovenija-donor/. • Zakon o pridobivanju in presaditvi delov cloveškega telesa zaradi zdravljenja (ZPPDCT), Ur. l. RS, št. 56/2015. • Council of Europe Convention against Trafficking in Human Organs (CM, 9. 7. 2014). • Spletna stran Eurotransplanta: http://www.eurotransplant.org/cms/. • Spletna stran European Directorate for the Quality of Medicines and Healthcare EDQM: https://www.edqm.eu/. • Guide to the Quality and Safety of Organs for Transplantation. European Committee (Partial Agreement) on Organ Trans­plantation (CD-P-TO), European Directorate for the Quality of Medicines & Health Care, Strasbourg; 7th ed. 2018. • Guide to the Quality and Safety of Tissues and Cells for human application. European Committee (Partial Agreement) on Or­gan Transplantation (CD-P-TO), European Directorate for the Quality of Medicines & Health Care, Strasbourg; 4th ed. 2019. • The Madrid Resolution on Organ Donation and Transplantation: https://www.edqm.eu/sites/default/files/article_the_madrid_ resolution_on_organ_donation_and_transplantation_transplantation_journal_june_2011.pdf • Razvoj Transplantacijske medicine v Sloveniji: programi, smernice in perspektive. Urednici Danica Avsec in Zvonka Zupanic Slavec; ilustracije Radko Oketic. Ljubljana: Zavod RS za presaditve organov in tkiv Slovenija-transplant; Celje: Celjska Mohorjeva družba: Društvo Mohorjeva družba, 2016. • Donorski program: Postopki za izvajanje v donorskih bolnišnicah. Avtorji: Andrej Gadžijev, Danica Avsec. Ljubljana: Zavod RS za presaditve organov in tkiv Slovenija-transplant. Ljubljana, 2018. • Preliminary numbers 2020, IRODaT (International Registry in Organ Donation and Transplantation), www.irodat.org. • Donorski program po cirkulatorni smrti v Sloveniji: analiza stališc strokovne javnosti in nadaljnji razvoj. Zdravstveni vestnik, 2020. Avtorici: Danica Avsec in Jana Šimenc. https://www.slovenija-transplant.si/uploads/upload/clanek%20dcd-ZV2020.pdf • An increase in kidney transplantation procedures from deceased donors during the COVID-19 epidemic in Slovenia. Trans­plant International, 2020. Avtorji: Miha Arnol, Tomaž Smrkolj, Danica Avsec, Andrej Gadžijev, Ivan Kneževic. https://onlineli­brary.wiley.com/doi/full/10.1111/tri.13715. • Donorska in transplantacijska dejavnost v casu epidemije covid-19. Isis, 2020. Avtorica: Danica Avsec. http://online.pub­html5.com/agha/dzcl/#p=27 Donation and transplantation activity in Slovenia in 2020 77 Introductory words Our annual publication »Give life a chance« presents statistical data and key highlights of donation and tran­splantation activity in Slovenia in 2020. Last year we celebrated an important anniversary of 20 years of Slovenia's successful cooperation with Eurotransplant. Asolemn symposium was held in January in coope­ration with University Medical Center Ljubljana. In the last year, marked with covid-19 epidemic, Slovenia ones more proved its quality in deceased donati­on program and transplant treatment. We achieved excellent results, the number of deceased organ donors and transplantations were even higher compared to 2019. Despite demanding and unpredictable working conditions in overwhelming healthcare crisis, programmes have remained active. Appropriate safety measu­res and adjustments in professional protocols were issued frequently. We are especially pleased we have managed to uphold the tonus of national deceased donation programme. Namely lack of human resources and facilities were especially noticeable in the intensive care units, where deceased donors are identified, evaluated and maintained. Every day we have been faced with ever chan­ging working conditions and in case of organ exchange within Eurotransplant, adaptations to the rules in in­ternational traffic and safety protocol in donor centres abroad. Under these difficult conditions, every utilized deceased donor and transplantation was a big professional and logistical success. With regular interpersonal communication, daily or weekly videoconferences we sustained motivation, dedi­cation and cohesiveness of co-workers in national transplant network. From the start of epidemics, our focus was on keeping the donation and transplantation programmes active, on the usage of every procured organ and on assuring transplanttreatment for patientson a waiting list. On this occasion, we also expressour sin­cere gratitude to the relatives of the deceased. With consent to donation they demonstrated humanity and care for others in these particularly perplexing times. Chief Phys. Danica Avsec, MD, Councillor, Director of the Slovenija-transplant Institute and responsible physician for donation activity The Slovenija-transplant institute Since 2002 the Institute of the Republic of Slovenia for the Transplantation of Organs and Tissues Slovenija-transplant has been the central national expert institution for connecting, co-ordinating, promoting and supervising donor and transplant activity in Slovenia. Established in 1998, Slovenija--transplant is the primary co-ordination office of the national transplantation network. The national network consists of 11 donor hospitals across Slovenia, the Transplantation Centre at the Ljubljana University Medical Centre, and the Tissue Typing Centre within the Blood Transfusion Centre of Slovenia. It operates the donor and recipient programme, while also ensuring that medical treatment with a transplant is possible for all who need it. The national network operates continuously and its expert teams are in a state of readiness 24 hours a day, every day of the year. Since 2000 Slovenia has been a member of Eurotransplant, a non-profit organisation for organ and tissue exchange. After meeting the demanding entry criteria, it was the first country in the region to join the group offive successful countries in the area of transplant treatment,i.e. Germany, Austria, Belgium, Luxembourg and the Netherlands. In 2002, Slovenija-transplant signed a co-operation agreement with Eurotransplant. Today, Eurotransplant, with its registered seat in Leiden in the Netherlands, brings together 8 countries and over 137 million inhabitants. This membership is important for our patients because, upon joining Eurotransplant, the chances of their survival and transplant treatment outcomes have improved considerably, especially for life-threatening condi­tions like acute heart and liver failure and other special cases (e.g. children, hypersensitive pati­ ents). Thanks to our co-operation, the waiting lists have been shortened significantly, the national transplant programmes are fully operating and we have also introduced combined transplants. First and foremost, we have been able to ensure greater donor–recipient tissue compatibility. Tissue incompatibility can make finding an appropriate organ for certain patients impossible in Slovenia. In 2020 we celebrated our impressive 20th anniversary of our successful co-operation with Euro-transplant by organising a series of events. SLOVENIJA-TRANSPLANT INSTITUTE Since being established, the Institute has been constantly developing in line with international guidelines. We strive to create an educated and motivated professional public and, by way of mul­tipronged communication, consistently increase the public’s trust in transplantation medicine. Our membership in international professional committees and participation in European projects has given us an equal footing in the international arena, including as active co-creators of strategies, development and expert training in international donor and transplant activities. We continue to set an internationally recognised example of how a national donor programme should be organi­sed and managed. In its management and leadership of activities for procuring and using parts of the human body for medical treatment purposes, Slovenija-transplant consistently complies with the legislation, European directives and adopted international conventions. We also ensure that national legisla­tion and expert protocols are promptly updated. Any changes we introduce are based on expert medical decisions and proposals, critical social considerations as well as the principles of medical ethics and deontology. The key guidelines of our Institute’s operations include: self-sufficiency I patient equality and safety I optimal effectiveness I quality I traceability I professionalism I non-commercialism I trans­parency I voluntary donation I prevention of abuse. Since being established, Slovenia-transplant’s Director has been Chief Phys. Danica Avsec, MD, Councillor and the responsible physician for donor activity. The Institute operates under the au­ spices of the Ministry of the Republic of Slovenia for Health. In 2020, the Institute employed 9 full-time staff and was working with 90 people under contract in the donor programme. www.slovenija-transplant.si @SloTransplant Achievements and highlights of 2020 Successfuly meeting the challenges of the Covid-19 epidemic Number of deceased donors and transplantation of solid organ was higher compared to 2019. Due to restrictions in international transport, logistics, and various epidemiological protocols in the countries additional efforts were made to ensure continuous cooperation and exchange of organs and tissues with Eurotransplant member states. High level of consent to donation 70 explanatory interviews with relatives were performed. Bigmajority of relatives (76%) gave con­sent to donation, which indicates a high public trust in our work and the donation system. Moving professional milestones in the national lung transplant program at University Medical Center Ljubljana First paediatric lung transplantation was performed and a 34-year-old patient needed urgent lung transplantation due to complications after Covid-19 disease. Professionally demanding lung tran­splantation was performed at the Transplantation center of University Medical Center Ljubljana. This is internationally rare and exceptional professional achievement. Continuous success of the national heart transplant program at University Medical Center Ljubljana Slovenia has been a world leader in the number of transplanted hearts per million people in the past few years. 50th anniversary of the first kidney transplantation Exactly fifty years passed from the first organ transplantation – a kidney of a living donor – in Slovenia and also in the area of former Yugoslavia. Excellent cooperation with the media We have published more than 40 in-depth newspapers interviews and appeared in the media more than 180 times. In cooperation with RTV Slovenia, we developed 12-minute documentary about organ donation and transplantation. New informative leaflets on organ and tissue donation We have designed and printed new information leaflets with basic information on organ and tissue donation. The content is interesting and useful for the general public, primary care health profes­ sionals and the media. 13,000 copies of the new leaflets were distributed in 76 primary health centres in Slovenia. Celebration of the 20th anniversary of cooperation with Eurotransplant In January, we celebrated the 20th anniversary of excellent cooperation with Eurotransplant. Gala symposium was co-organized with the University Medical Centre Ljubljana. Signing of a new agreement with University Medical Center Ljubljana After 17 years we have signed a new agreement of cooperation with University Medical Cen­ ter Ljubljana in the field of organ donation and transplantation. The agreement brings novelties mainly with a clear definition and division of tasks between all parties involved in the donor and transplantation program, and also the role of the hospital transplant coordinator and division of costs in University Medical Center Ljubljana is redefined. Decline in the number of donation declarations in the national register Compared to previous years, fewer people have made a declaration in the national register of designated persons, despite the possibility of making the declaration electronically. CELEBRATION OF THE 20TH ANNIVERSARY OF COOPERATION WITH EUROTRANSPLANT, UMC LJUBLJANA, JANUARY 2020 FOTO: ANDREJ ZORE 20 years of Slovenia’s successful cooperation with Eurotransplant 2020 was marked with the important 20th anniversary of Slovenia’s successful cooperation with Eurotransplant (ET), an international non-profit organization for the exchange of organs and tis­sues. After years of preparation, Slovenia fulfilled the demanding entry requirements in 2000 and was the first country in the region of South East Europe to join ET. We have thus joined a large group of five successful and advanced countries in the field of transplant treatment (Germany, Austria, and Benelux). Today, the organization brings together eight countries with a total popu­lation of over 137 million. The responsibility of every country and health care system is to ensure patients have access to quality and ethical transplant treatment and to establish a transparent and safe organ and tis­ sue donation system. In Slovenia, the national transplant network was established in 1998, but unfortunately some patients did not receive the appropriate organ and treatment in time due to tissue incompatibility. For a small country like Slovenia, cooperation enabled significantly better treatment outcomes for many patients, who benefited from a larger “donor pool” within ET. More consistent tissue matching between kidney donors and recipients was made possible (before ET in the period 1970-1998, HLA tissue compatibility was achieved in 20-35% of cases). Moreover better treatment options were assured for special cases (children, hypersensitive patients) and high-urgent cases (e.g. acute heart and liver failure). The accession contributed to significant improvements in national donor and transplant programs in Slovenia. Direct positive impact was seen in the significant rise of national deceased donation rates, reduced loses of procured organs, and optimizations in programs for kidney, heart, lungs, and liver transplantation (the number of kidney transplants from deceased donors was 2.8 times higher per year than in the previous 14 years, kidney transplant from living donors were carried out only sporadically). Combined transplantations were also launched. 20 YEARS OF SLOVENIA’S SUCCESSFUL COOPERATION WITH EUROTRANSPLANT In addition to patients, professionals also benefited from cooperation. Constant exchange of kno­wledge and experiences between Member States has contributed to the development of program-mes at national and international level. This enabled to enforce and adapt to the quality standards of larger countries with a longer tradition and great potential for progress. ET’s professional deci­sions and orientations have always been made through co-decision of experts from all Member States and verification of compliance with national laws. In addition to experts from the University Medical Center Ljubljana, this task has been performed by the Slovenija-transplant. To celebrate this important anniversary, a symposium with solemn opening was held on 17th of January 2020 at the University Medical Centre Ljubljana. The event attracted large professional audience, with many prominent figures from medicaland political sphere. The presentations gave an in-depth overview of the whole chain in donation and transplantation activities: from tissue typing, donor detection and evaluation, education of healthcare professionals, raising public awa­ reness, organization of national donor network and allocation, to techniques, achievements and challenges in transplantation programmes and post-operative care of patients. Altogether, the excellent all-day symposium demonstrated the connectedness, high professiona­lism, enthusiasm, complexity, advances, innovativeness and successes in organ donation and transplantation in Slovenia. The event was also an opportunity to celebrate well-established co­operation in the national transplant network between Slovenija-transplant, transplant centre at UMC Ljubljana and donor hospitals around Slovenia. With good inter personal communication and collaboration we will continue to ensure high quality, accessible and safe transplant treatment for Slovenian patients in need. Key statistics for 2020 47 KIDNEY HEART LIVER LUNG PANCREAS CORNEA 6817 3413 4 92 LUNG LIVER 7 URGENT 89 Solid organs NATIONAL WAITING LIST FOR ORGAN TRANSPLANTATION The waiting list is a list of patients needing a part of a human body for medical transplantation purposes. The indications for transplantation are specific to each organ/tissue/cell. All patients in the Republic of Slovenia have the same possibility of being included on the list of recipients and have equal access to this treatment. By the end of 2020, 204 patients were waiting for an organ transplant. The number was lower compared to 2019 due to Covid-19 epidemic. The average waiting period for all organs is relatively short compared to other countries. On average, Slove­nian patients wait for a heart, liver or kidney transplant for less than 1 year. For more information on average waiting periods for specific organs please see chapter The Results of Slovenian Or­gan Transplant Programmes. In 2020, 93 Slovenian patients have been included on the waiting list for the first time: 27 for a kid­ney, 29 for a heart, 8 for a lung, 28 for a liver and 1 for a pancreas (in combination with a kidney) transplant. Status of the national waiting list on 31.12.2020 (all patients) Kidney Heart Lung Liver* Pancreas** 115 53 5 32 4 TOTAL 204 patients * 2 in combination with a kidney ** 4 in combination with a kidney Source: http://statistics.eurotransplant.org/ Status of the national waiting list in the 2011-2020 period (on 31.12., all patients) Year Kidney Heart Lung* Liver Pancreas TOTAL 2011 120 46 17 183 2012 113 38 18 2 169 2013 114 39 19 1 171 2014 136 31 21 11 188 2015 110 52 29 11 190 2016 95 58 28 7 181 2017 112 56 35 8 203 2018 135 65 35 6 234 2019 138 55 35 5 227 2020 115 53 5 32 4 204 Source: http://statistics.eurotransplant.org// * Before 2020, Slovene patients, waiting for a lung transplant, were included on Austrian waiting list A share of patients on the national waiting list according to organ in 2020 LEGEND Lung (5) Heart (53) Kidney (115) 53 Liver (32) Pancreas (4) Trends in patient numbers on the waiting list, by organ and the total for the 2011-2020 period 140 130 120 110 100 90 80 70 60 50 40 30 20 10 Waiting list mortality 2011-2020 Year Kidney Kidney and pancreas Heart Lung Liver TOTAL 2011 6 8 3 17 2012 2 8 7 17 2013 2 5 5 12 2014 4 5 2 11 2015 1 1 3 5 10 2016 3 7 3 13 2017 1 6 6 13 2018 1 2 6 5 14 2019 1 6 5 12 2020 1 2 1 4 Source: http://statistics.eurotransplant.org/ Trends in waiting list mortality 2011-2020 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Source: http://statistics.eurotransplant.org/ LEGEND Kidney and pancreas Heart Kidney Liver * Trends NUMBER OF DECEASED DONORS In 2020, Slovenian donor hospitals acquired 47 actual deceased donors who were medically su­itable and for whom consent had been obtained from their relatives. Data at the beginning show the number of actual deceased donors in Slovenia compared to other countries around the world. Below are details on the number of utilised deceased donors, which means that at least one organ was transplanted from each donor. Compared to other Eurotransplant members, in 2020 Slovenia was again ranked fourth in terms of the number of utilised deceased donors per million people. Number of actual deceased donors (DD) per million people (PMP) in Slovenia in 2020 and a comparison with other countries Country No. of DD/PMP2020 1. USA 38,35 2. Spain 37,4 3. Portugal* 33,8 4. Czech Republic 27,14 5. Belarus* 26,2 6. Malta* 25 7. United Kingdom* 24,88 8. Estonia 24,83 9. Austria 23,9 10. Croatia 23,7 Country No. of DD/PMP2020 11. France** 22,4 12. Slovenia 22,25 13. Finland** 21,9 14. *Canada** 21,87 15. Belgium** 21,12 16. Italy** 20,5 17. Denmark** 20,4 18. Uruguay 19,2 19. Norway** 18,8 20. Australia** 18,53 Country No. of DD/PMP2020 21. Switzerland* 18,4 22. Slovakia* 17,96 23. Lithuania 17,5 24. Sweden** 16,8 25. Netherlands** 16,67 26. Brazil** 15,5 27. New Zealand* 15 28. Iran* 14,34 29. Ireland* 12,8 30. Cuba* 12 * Data from 2019 ** Total utilized donors Country No. of DD/PMP2020 31. Hungary** 11,3 32. Iceland** 10,9 33. Germany** 10,77 34. Chile* 10,4 35. Poland 10,27 36. Latvia* 9,9 37. Argentina 9,78 Country No. of DD/PMP2020 38. Israel 9,2 39. South Korea* 8,68 40. Columbia* 8,4 41. Equador* 7,78 42. Turkey* 7,54 43. Cyprus* 6,86 44. Costa Rica* 6,66 Country No. of DD/PMP2020 45. Greece* 5,5 46. Russia* 5,14 47. Luxembourg** 5 48. Mexico* 4,45 49. Romania* 4,39 50. Panama* 4,29 51. China* 4,16 * Data from 2019 ** Total utilized donors Number of actual deceased donors (DD) per million people (PMP) in Slovenia in 2020 DD/PMP 50 40 30 20 10 0 ZDA SPA POR CZ BLR MAL UK EST AUT CRO FR SLO FIN CAN BEL ITA DEN URG NOR AVT SWI SLOV LIT SWE NL BRA N.ZE IRA IRL CUB HUN ICE GER CIL POL LAT Country No. of DD/PMP2020 Country No. of DD/PMP2020 Country No. of DD/PMP2020 52. Moldova* 4,1 59. Northern Macedonia* 1,43 66. Nicaragua* 0,32 53. Bulgaria 4 60. UAE 1 67. Philippines 0,05 54. Hong Kong* 3,86 61. Japan* 0,99 55. Kuwait 3,5 62. Trinidad and Tobago * 0,72 56. Qatar* 2,96 63. Malaysia* 0,53 57. Peru* 2,28 64. India* 0,52 58. Saudi Arabia 1,9 65. Dominican Republic 0,4 IRODaT (International Registry in Organ Donation and Transplantation), www.irodat.org, * Data from 2019 ** Total utilized donors DD/PMP 50 40 30 20 10 0 ARG IZR S.CO COL EKV TUR CIP KOS GRE RUS LUX MEX ROM PAN CHI MOL BOL H.K. KUW KAT PER S.AR. N.MK JAE JAP T&T MAL IND D.RE. NIC PHI Number of utilised deceased donors (DD) per million people (PMP) in Slovenia in 2020 and a comparison with all Eurotransplant countries Country Slovenia Eurotransplant Number of DD 39 1.837 DD/PMP 18.5 13.2 Number of utilised deceased donors per million people (DD/PMP) and a comparison with other Eurotransplant countries in 2020 ET Country Number of DD/PMP in 2020 1.Croatia (CRO) 23,9 2. Belgium(BE) 21,2 3. Avstria (AT) 21,1 4. Slovenia (SLO) 18,5 5. Netherlands (NL) 14,4 6. Hungary (HU) 11,0 7. Germany (DE) 10,7 8. Luxembourg (LU) 4,8 Source: http://statistics.eurotransplant.org/ Number of utilised deceased donors (DD) and number of utilised deceased donors per million people (DD/PMP) in Slovenia in the 1998-2020 period Year Number of DD Number of DD/PMP 1998 27 13,6 1999 26 13,1 2000 22 11,1 2001 23 11,6 2002 35 17,6 2003 28 14 2004 36 18 2005 21 10,5 2006 30 15 2007 22 10,9 2008 36 17,8 2009 33 16,2 2010 40 19,5 Year Number of DD Number of DD/PMP 2011 31 15,1 2012 46 22,4 2013 45 21,9 2014 43 20,9 2015 53 25,7 2016 41 19,9 2017 39 18,9 2018 40 19,4 2019 38 18,3 2020 39 18,5 TOTAL 794 17,0 Source: http://statistics.eurotransplant.org/ Number of utilized deceased donors (DD) and number of utilized deceased donors per million people (DD/PMP) in Slovenia in the 1998-2020 period 30 25 20 15 10 5 0 The critical Pathway for Organ Donation POSSIBLE DECEASED ORGAN DONOR A patient with a devastating brain injury or lesion OR a patient with circulatory failure AND apparently medically suitable for organ donation Donation after Circulatory Death (DCD) Treating physician to Identify/refera potential donor Donation after BrainDeath (DBD) POTENTIAL DCD DONOR a. A person whose circulatory and respiratory func­tions have ceased and resuscitative measures are not to be attempted or continued. OR b. A person in whom the cessation of circulatory and respiratory functions is anticipated to occur within a time frame that will enable organ recovery. Reasons why a potential donor does not become a utilized donor SYSTEM - Failure to identify/refer a potential or eligible donor - Brain death diagnosis not confirmed (e.g. does not fulfil criteria) or completed (e.g. lack of tehnical resources or clinician to make diagnosis or perform confirmatory tests) - Circulatory death not declared within the appropriate time frame - Logistical problems (e.g. no recovery team) - Lack of appropriate recipient (e.g. child, blood type, serology positive) DONOR/ORGAN - Medical unsuitability (e.g. serology positive, neoplasia) - Haemodynamic instability/unanticipated cardiac arrest - Anatomical, histological and/or functional abnormalities of organs - Organs damaged during recovery - Inadequate perfusion of organs or thrombosis PERMISSION - Expressed intent of deceased not to be donor - Relative’s refusal of permission for organ donation - Refusal by coroner or other judical officer to allow donation for forensic reasons POTENTIAL DBD DONOR A person whose clinical condition is suspected to fulfill brain death criteria. ELIGIBLE DCD DONOR A medicaly suitable person who has been declared dead based on the irreversible absence of circulatory and respiratory functions as stipulated by the law of the relevant jurisdiction within a time frame that enables organ recovery. ELIGIBLE DBD DONOR A medicaly suitable person who has been declared dead based on neurologic criteria as stipulated by the law of the relevant jurisdiction. ACTUAL DCD DONOR A consented eligible donor: a. In whom an operative incision was made with the intent of organ recovery for the purpose of transplantation. OR b. From whom at least one organ was recovered for the purpose of transplantation. ACTUAL DBD DONOR A consented eligible donor: a.In whom an operative incision was made with the intent of organ recovery for the prupose of transplantation. OR b. From whom at least one organ was recovered for the purpose of transplantation. UTILIZED DCD DONOR An actual donor from whom at least one organ was transplanted. UTILIZED DBD DONOR An actual donor from whom at least one organ was transplanted. The »dead donor rule« must be respected. That is, patients may only become donors after death, and the recovery of organs must not couse a donor´s death. Source: The Madrid Resolution on Organ Donation and Transplantation REGISTER FOR DONATION DECLARATIONS Every Slovenian citizen has the right and possibility during their lifetime to decide to donate their organs and tissues. This decision is formally confirmed when it is entered in the national regi­ster of designated persons, set up back in 2004. The donor statement may be signed at many authorised donor registration points around Slovenia (a detailed list is published at www.slove­nija-transplant.si) or electronically using a digital signature on the eAdministration (“eUprava”) portal (https://e-uprava.gov.si/). Since June 2017, a declaration against making organ donation is also possible. Compared to previous years, fewer people have made a declaration in the national register of designated persons due to Covid-19 epidemic, despite the possibility of making the declaration electronically. In 2020, we collected a total of 752 declarations (746 FOR and 6 AGAINST). As at 31.12.2020, 10.618 declarations were found on the register (10,598 FOR and 20 AGAINST). Since 2018, when electronic declaration was made possible, 1785 persons used this option. Ye­ arly aproximately 40 % of declarations are submitted ellectronicaly, rising to 61 % in 2020 due to covid-19 situation. Number of declarations in the register, by year, in the 2004-2019 period Source: archive of Slovenija-transplant Year No. of declarations 2004 91 2005 228 2006 308 2007 386 2008 460 2009 513 Year No. of declarations 2010 382 2011 381 2012 312 2013 300 2014 739 2015 632 Year No. of declarations 2016 594 2017 1.523 2018 1.763 2019 1.254 2020 752 TOTAL 10.618 Number of declarations regarding donation in the register, by year, in the 2004-2020 period 1800 1650 1500 1350 1200 1050 900 750 600 450 300 150 0 PERCENTAGE OF CONSENT FOR DONATION A conversation about donation with the close relatives of a potential deceased donor is conducted in every case when the donation of organs for transplantation is feasible. It is only after the death has been confirmed and the time of death registered that the transplantation co-ordinator checks the register to see whether the deceased was a designated after-death donor. Despite knowing about the designation, the central transplantation co-ordinator always holds a conversation with the deceased person’s close relatives about donation. During this conversation, they try to find out what the deceased person's position was regarding after-death organ donation. If their intention is unknown, the close relatives make the decision. All procedures are carried out with a high level of sensitivity, understanding of the extremely difficult emotional circumstances and in line with the legislative provisions and the medical doctrine. In 2020 donation was refused by 24 % of relatives. As the death of a close relative is a difficult experience for anyone, Slovenija-transplant offers the donor’s relatives an opportunity to be given grief counselling by a professionally trained and experienced experts. Percentage of consent for donation in the 1998-2020 period Source: archive of Slovenija-transplant Year % 1998 79 1999 70 2000 63 2001 64 Year % 2002 78 2003 77 2004 70 2005 81 Year % 2006 80 2007 85 2008 80 2009 85 Year % 2010 80 2011 86 2012 69 2013 69 Year % 2014 80 2015 81 2016 76 2017 83 Year % 2018 66 2019 77 2020 76 Percentage of consent for donation in the 1998-2020 period 90 80 70 60 OPERATIONS OF THE DONOR CENTRES Eleven donor hospitals or centres are active in the Slovenian donor programme: the Ljubljana UMC and Maribor UMC and the general hospitals in Celje, Murska Sobota, Nova Gorica, Izola, Ptuj, Novo mesto, Slovenj Gradec, Jesenice and Brežice. The following activities are performed in a donor centre: • identifying potential deceased donors; • performing diagnostics of brain death; • establishing the suitability of organs and tissues for removal and transplantation; • informing the deceased person’s close relatives about the possibility of organ donation and obtaining their consent; • preserving the functioning of deceased donors’ organs - in intensive care and during organ removal; and • participating in organ- and tissue-removal procedures performed by Slovenian and foreign teams of surgeons. The highest number of donors is provided by the Ljubljana UMC with the greatest number of beds in intensive care units. In 2020, 22 utilised deceased donors were procured there. Good results were also achieved by the UMC Maribor where in 2020 they procured 7 utilised deceased donors and by Celje GH with 5 utilised donors. Izola GH, Nova Gorica GH, Murska Sobota GH, Jesenice GH and Ptuj GH each procured one utilised deceased donor in 2020. Number and share of utilised deceased donors in individual donor centres (DC) in 2020 Donor centre Number of DD Share in % Ljubljana UMCTOTAL 22 56 of which NICU* 10 of which CICU** 9 of which CDIIM*** 3 Maribor UMC 7 18 Celje GH 5 13 Jesenice GH 1 2,6 Nova Gorica GH 1 2,6 Izola GH 1 2,6 Murska Sobota GH 1 2,6 Ptuj GH 1 2,6 TOTAL 39 100 * NICU – Neurological Intensive Care Unit, ** CICU – Central Intensive Care Unit, *** CDIIM – Clinical Department of Internal Intensive Medicine. Izola GH Source:archive of Slovenija-transplant Murska sobota GH Ptuj GH 8TH INTENSIVE COURSE IN TRANSPLANT COORDINATION, LOGARSKA DOLINA, JANUARY 2020 FOTO: JANA ŠIMENC Number of utilised deceased donors in donor centres in the 1998-2020 period Year LJ UMC MB UMC CE GH MS GH NG GH Izola GH Ptuj GH Jesenice GH NM GH SG GH Brežice GH 1998-2009 176 95 22 7 10 9 7 6 3 4 2010 26 8 2 2 1 1 2011 21 6 2 1 1 2012 22 8 9 3 1 2 1 2013 21 8 7 5 3 1 2014 31 4 3 1 1 2 1 2015 25 11 10 2 1 1 1 1 1 2016 28 2 7 1 2 1 2017 22 7 4 2 1 1 2 2018 18 13 4 2 1 1 1 2019 15 8 6 3 1 3 1 1 2020 22 7 5 1 1 1 1 1 TOTAL 427 177 81 24 25 17 14 14 7 6 2 Source: archive Slovenija-transplant Number of utilized deceased donors in donor centres in the 1998-2020 period LEGEND Ljubljana UMC Maribor UMC Celje GH Murska Sobota GH Izola GH Jesenice GH Nova Gorica GH Ptuj GH Novo mesto GH Slovenj Gradec GH Brežice GH 1998 - 2009 2012 2013 2016 2017 2018 2019 2020 Potential and realisation in donor hospitals (analysis completed for 2020) The donation potential of an individual donor hospital is expressed as the percentage share of brain-dead donors of the total number of deceased persons in the intensive care unit (ICU). It in­dicates the number of deaths where the diagnostic of brain death was completed. The potential is directly associated with the identification of eligible donors in ICUs. Realisation in the donation process indicates the number of eligible donors (proven brain death) who became actual donors. It is expressed as the share of actual donors of the total number of deaths due to brain death in the ICUs. Source: archive Slovenija-transplant Donor hospital All deaths in the ICU PD ED *Potential (%) Available (%) AD Realisation (%) **Available (%) Ljubljana UMC 407 61 45 11.1 13.7 24 53 65 Maribor UMC 236 25 11 4.7 13.7 7 64 65 Novo mesto GH 99 3 0 0 8.3 0 / 55 Celje GH 180 18 12 6.7 8.3 7 58 55 Nova Gorica GH 72 7 1 1.3 8.3 1 100 55 Ptuj GH 48 3 2 4.2 8.3 1 50 55 Murska Sobota GH 96 7 5 5.2 8.3 3 80 55 Izola GH 76 3 1 1.3 8.3 1 100 55 Slovenj Gradec GH 78 0 0 0 8.3 0 / 55 Jesenice GH 48 2 2 4.2 8.3 2 100 55 Brežice GH 29 2 1 3.4 8.3 1 100 55 ICU – intensive care unit, PD – potential donor, ED – eligible donor (proven brain death), AD – actual donor (relatives’ consent, organ removal) Potential – % of brain-dead patients in total number of deceased persons in the ICU = % ED/total deaths in the ICU Realisation – % of actual donors in total number of brain-dead patients = % AD/ED *As expected, a donor hospital’s potential is higher among hospitals which operate their own neu­rosurgical unit and can even reach up to 13.7% (available potential). The Ljubljana UMC was quite close to its potential, whereas the Maribor UMC lagged behind its potential in 2020 due to Co­vid-19 epidemic which severely affected all their ICU Units. In hospitals without their own neurosur­gical unit, the available donation potential reaches up to 8.3%.This figure was closely approached by the Celje GH, while Murska Sobota GH was relatively close. Most donor hospitals still lagged behind the available values in 2020, which shows we can further improve in the area of identifying eligible donors. However, all smaller hospitals were severely affected by Covid-19 epidemic as well since most of their ICU units were transformed into Covid-19 intensive care units.. **Realisation mainly depends on the percentage share of absolute medical contraindications and refused donation by relatives in the period under scrutiny. Available realisation considers up to 20% of absolute medical contraindications and up to 10% of refused donation by relatives, while also distinguishing between donor hospitals with a neurosurgical unit and those without one (10% difference); other obstacles in the donor process in total account for up to 5%. Thus, the available realisation for hospitals with a neurosurgical unit was calculated at 65% and for those without such a unit 55%. In 2020, the available realisation was exceeded in the Murska Sobota GH and Celje GH, while Maribor UMC was close. Some deviations were found in low values of the po­tential, e.g. in Izola GH, Nova Gorica GH and Brežice GH, where 100% realisation was achieved in one case – there were no medical contraindications for donation and the relatives gave their consent. In such cases a two-year balance is more accurate and in line with expected results. In hospitals where there were no proven brain deaths in 2020 and no actual donors, the potential and the realisation were both 0% or non-measurable (/). List of authorised persons (i.e. hospital transplantation coordinators) in charge of the development, implementation and functioning of the donation programme in individual donor centres in 2020 Donor centre Transplantation coordinators Ljubljana UMC Chief Phys. Rade Stanic, MD, MSc Maribor UMC Tanja Kuprivec, MD Brežice GH Nataša Pirc, MD Celje GH Barbara Hudournik, MD Izola GH Damjan Polh, MD Jesenice GH Andraž Nastran, MD Murska Sobota GH Chief Phys. Daniel Grabar, MD Nova gorica GH Edyta Cerkini, MD Novo mesto GH Matej Godnic, MD Ptuj GH Chief Phys. Majda Šarman, MD (until February)/Mateja Prevolšek, MD (from March) Slovenj Gradec GH Rok Popic, MD CELEBRATION OF EUROPEAN DONATION DAY, UMC LJUBLJANA, OCTOBER 2020 FOTO: JANA ŠIMENC PROCURED SOLID ORGANS FOR THE PURPOSE OF MEDICAL TREATMENT The number of procured organs depends on the number of procured deceased donors, along with the age and any medical contraindications. Despite Covid-19 epidemic the number of pro­cured organs from deceased donors was slightly higher in 2020 than the year before. Data for 2020 and a comparison with previous years are given below. Number of procured organs of Slovenian deceased donors in 2020 Kidney Heart Liver Lung (both lobes) Pancreas TOTAL 68 17 34 13 4 136 Source: archive of Slovenija-transplant LEGEND Kidney Heart Liver Lung Pancreas Procured organs of deceased donors in Slovenia in the 2000-2020 period Year Kidney Heart Liver Lung (both lobes) Pancreas TOTAL 2000-2009 559 149 217 70,5 76 1.071,5 2010 80 20 37 13 8 158 2011 58 14 24 4 5 105 2012 89 25 39 8 5 166 2013 86 26 39 19 8 178 2014 80 16 38 11 2 147 2015 92 20 46 6 6 170 2016 68 13 39 13,5 2 135,5 2017 68 19 40 15 4 146 2018 79 17 34 9 3 142 2019 75 15 31 11 / 132 2020 68 17 34 13 4 136 TOTAL 1.402 351 618 193 123 2.687 Source: archive of Slovenija-transplant Procured organs of deceased donors in Slovenia in the 2010-2020 period 1.615 procured organs of deceased donors in Slovenia in the 2000-2020 period 100 90 80 70 60 50 40 30 20 10 0 Source: archive of Slovenija-transplant LEGEND Kidney Heart Liver Lung Pancreas TRANSPLANTED SOLID ORGANS There is one transplantation centre in Slovenia – the Ljubljana University Medical Center – at whi­ch programmes for organ transplantation are carried out. The organ distribution system ensures equal access to medical treatment with organ transplantation for all Slovenian citizens. The tasks of the transplantation centre include: • preparing recipients for inclusion on the waiting list; • organ transplantation; and • guiding patients after transplantation. Since 2014, the transplantation centre has been managed by the cardiovascular surgeon Dr. Ivan Kneževic, MD. In 2020, 114 organs were transplanted, 113 from deceased donors and one from the living donor. The most transplanted organ is the kidneys and we slightly exceed the average of Eurotransplant countries in terms of the number of all transplants from deceased donors per million people. Con­siderably higher is the number of transplanted hearts per million people, where in the past few years we have been a world leader. The Slovenian lung transplantation program became completely independent in 2020, and sixte­en lung transplants for Slovenian patients were performed at the Ljubljana University Medical Center. First paediatric lung transplantation was performed and a 34-year-old patient needed urgent lung transplantation due to complications after Covid-19 disease. Paediatric transplantations are partly performed in the Ljubljana UMC and partly in nearby Eu­ropean transplantation centres (kidneys in Graz and Hannover, and liver in Bergamo and Ham-burg).The relevant departments in the Ljubljana UMC are in charge of treatment and preparation before organ transplantation as well as medical treatment and monitoring of the patient after transplantation. Transplanted solid organs from deceased donors in the Ljubljana UMC in 2020 and a comparison with Eurotransplant – absolute number and per million people (PMP) Kidney DD Heart Liver Lung Pancreas TOTAL No. PMP No. PMP No. PMP No. PMP No. PMP No. PMP SLO 46 21,8 24 11,4 25 11,8 16 7,6 2 1 113 53,5 ET 2.851 20,6 587 4,3 1.470 10,7 1.279 4,8 154 1,2 6.356 40,1 Source: archiv Slovenija-transplant and http://statistics.eurotransplant.org/ 25 20 15 10 5 0 SLO ET LEGEND Number of transplanted solid organs from deceased donors per million people (PMP) in Slovenia in 2020 and a comparison with the Eurotransplant countries ET country Kidney Liver Heart Lung Pancreas Number of transplantations/PMP in 2020 1. Avstria (AT) 32,7 16,9 6,6 12,0 2,2 67,7 2. Belgium (BE) 28,2 18,5 4,7 8,1 1,2 58,8 3. Slovenia (SLO) 21,8 11,8 11,4 7,6 1,0 53,5 4. Croatia (CRO) 23,4 23,2 6,2 / 0,2 52,2 5. Netherlands (NL) 25,4 9,3 2,4 5,0 1,7 42,1 6. Germany (GE) 17,5 9,3 4,1 4,1 1,1 34,6 7. Hungary (HU) 17,6 5,1 4,6 1,7 0,6 29,1 PMP 50 40 30 20 10 0 67,7 58,8 53,5 52,2 42,1 34,6 29,1 Source: archive Slovenija-transplant and http://statistics.eurotransplant.org/ LEGEND Kidney Heart Liver Lung Pancreas AT BE SLO CRO NL GE HU Number of transplanted solid organs from deceased donors in Slovenia in the 1970-2020 period Year Kidney Heart Liver Lung* Pancreas TOTAL 1970 - 1985 1 1 1986 7 7 1987 18 18 1988 16 16 1989 14 14 1990 17 1 1 19 1991 11 11 1992 20 20 1993 4 1 5 1994 14 2 16 1995 10 3 1 14 1996 6 2 8 1997 19 6 1 26 1998 46 4 4 54 1999 37 7 9 3 56 2000 44 7 10 1 62 2001 47 4 9 1 61 2002 55 3 11 69 2003 43 3 9 2 57 2004 55 3 15 73 Source: archive of Slovenija-transplant Year Kidney Heart Liver Lung* Pancreas TOTAL 2005 28 5 13 2 48 2006 48 8** 8 2 66 2007 30 11 10 1 52 2008 52 6 22 4 84 2009 43 18 18 2 2 83 2010 61 19 23 3 1 107 2011 46 14 20 7 1 88 2012 62 29*** 27 2 120 2013 60 30 21 8 4 123 2014 55 33 31 3 122 2015 64 24 24 7 5 124 2016 44 31 27 10 5 117 2017 46 24 23 8 101 2018 54 23 27 7 3 114 2019 38 22 24 11 1 96 2020 46 24 25 16 2 113 TOTAL 1.261 367 411 101 25 2.165 * All lung transplants for Slovenian patients were performed in AKH Vienna with the exception of 2003 (1 transplant performed in Ljubljana UMC) and 2018 (2 transplants performed in Ljubljana UMC). In 2019, ten transplantations of both lung lobes were performed in the Ljubljana UMC and one paediatric lung transplantation in the University Hospital in Vienna (AKH). ** One heart from a Slovenian donor was transplanted to a Slovenian patient in Graz *** One heart was transplanted, together with lungs, to a Slovenian patient in Vienna Number of transplanted solid organs of deceased donors in Slovenia in the 1970-2006 period 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Source: archive of Slovenija-transplant LEGEND Kidney Heart Liver Lung Pancreas Number of transplanted solid organs of deceased donors in Slovenia in the 2007-2020 period 2.165 transplanted solid organs of deceased donors in SLO in the 1970-2020 period 140 120 100 80 60 40 20 0 52 84 83 107 88 120 123 122 124 117 100 114 96 113 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 LEGEND Source: archive of Slovenija-transplant Kidney Heart Liver Lung Pancreas Number of kidneys from living donors transplanted in Slovenia Currently, a living kidney donation in Slovenia is only possible for genetically or emotionally rela­ ted recipients. Each case of living donation is always reviewed and approved by the Transplant Ethics Committee. The risk to the donor's health must not be disproportionate to the expected be­nefit to the recipient. At the beginning of the transplantation programme in Slovenia, since 1970, living kidney donation was predominant. From 1986 on, with the establishment of the national donor programme, most organs were retrieved from deceased donors. The living kidney donation programme slowly declined, but in 2016 it was revived. In 2016, 2017 and 2018, two kidneys we­re transplanted from living donors and one such transplant was performed in 2020. Number of kidneys from living donors transplanted in Slovenia in the 1970-2020 period Year Nr. Year Nr. Year Nr. Year Nr. Year Nr. Year Nr. 1970-85 43 1991 3 1997 2 2003 0 2009 1 2015 0 1986 23 1992 5 1998 1 2004 0 2010 0 2016 2 1987 14 1993 5 1999 0 2005 0 2011 0 2017 2 1988 13 1994 0 2000 0 2006 0 2012 0 2018 2 1989 10 1995 1 2001 0 2007 1 2013 0 2019 0 1990 2 1996 2 2002 0 2008 0 2014 0 2020 1 TOTAL 133 Shares of transplanted kidneys from living and deceased donors in the 1970 – 2020 period % 100 80 60 40 20 0 2 23 56 78 58 89 79 80 44 100 91 75 90 98 100 100 100 100 100 100 100 89 77 44 22 42 21 20 56 25 2 10 11 9 1970-85 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 % 100 80 60 40 20 0 96 96 100 97 100 98 100 100 100 100 100 100 96 100 98 LEGEND Shares of transplated kidneys from living donors = TOTAL 9,5 Shares of transplated kidneys from deceased donors = TOTAL 90,5 THE RESULTS OF SLOVENIAN ORGAN TRANSPLANT PROGRAMMES Patient survival after a heart transplant From 1990 to the end of 2020, the Ljubljana UMC performed 367 heart transplants, 24 out of those in 2020. Seventeen (71 %) patients had an urgent and 7 (29 %) an elective trans­plant. According to Eurotransplant data, the Ljubljana UMC was again ranked in the top 10 (out of 42) largest heart transplant centres in the Eurotransplant area and may be compared by number of transplantations with the biggest centres in Germany, Belgium, Hungary and Austria. The multi-year average (2009–2020) wait­ing period for an elective heart transplant was 239 days and for an urgent heart transplant 56 days. In 2020, the average waiting period for an elective heart transplant was 295 days and for an urgent heart transplant 38 days. Of all patients with a heart transplant in 2020, 38 % needed the procedure due to dilated car-diomyopathy and 25 % due to ischemic heart disease. Other reasons for the transplant in­clude valvular heart disease (21 %), non-com­paction cardiomyopathy (8 %), cardiac amyloi­ dosis (4 %) and congenital heart defects (4 %). The patient survival rates are comparable with those from the international reference register kept by the International Society for Heart and Lung Transplantation (ISHLT). Survival of adult heart transplant recipients in % (1990–2020, n = 367) 30-day survival One-year survival Five-year survival 93 % 85 % 77 % 100 75 50 25 0 93 87 77 % 30-day One-year Five-year SURVIVAL Source: Report on implementation of the programme for advanced heart failure and heart transplantation for 2020 (Cardiology Department, Ljubljana University Medical Centre) Patient survival after a kidney transplant In the period in which Slovenija-transplant has been a member of Eurotransplant (1 January 2000–31 December 2020), 1030 kidneys of liv­ing (9) and deceased donors (1021) have been transplanted. Some recipients had a kidney transplanted in combination with other organs: 24 with pancreas, three with heart and two with liver. In the first post-transplantation year the clinical, biopsy-proven acute rejection of the transplant was reported in 12.8% of all patients. In the 2010–2019 period, the median time until transplantation was 300 days. In 2020 the me­dian time until transplantation was 440 days. According to Eurotransplant data for the 2001 – 2015 period, the current 1-year and 5-year sur­vival of Slovenian patients and grafts is above the Eurotransplant members’ average and comparable with the most developed centres around the world. Source: Quality indicators of the Kidney Transplantation Centre (Department of Nephrology, University Medical Centre Ljubljana) Survival of kidney transplant recipients and transplanted organs in % (2000–2020, n = 1030) One-year survival Five-year survival Patients 98 % 93,6 % Transplanted organs 93,7% / 94,8* 86,6 % / 90,3* * Censored for patient death 100 95 90 85 80 75 70 65 60 98 93,7 93,6 86,6 % One-year Five-year SURVIVAL Patients Transplanted organs LEGEND Patient survival after a liver transplant Between 1995 and 31. 12. 2020, the Uni­versity Medical Centre Ljubljana carried out 411 liver transplants. Of all patients with a liver transplant, 63 % needed the procedu­re due to cirrhosis of the liver, 10 % acute liver failure, 9.7 % liver cancer, 9.3 % cho­lestatic/congenital diseases, and 2.1 % due to metabolic liver disease. Other reasons for the transplant (5.9 %) include benign li­ver tumour or polycystic liver disease and Budd-Chiari syndrome. The average waiting period for a liver tran­splant in 2020 was about 290 days (me­dian: 124 days). Average waiting period including high urgency cases was 268 days (median 105 days). (source: Clinical Department of Gastroenterology, University Medical Centre Ljubljana). Source: ELTR (European Liver Transplant Registry, SLLUBL: Specific Analyses June 2019) Survival of liver transplant recipients and transplanted organs in % (1988–2019*, n = 291 (patients) and n = 323 (transplanted organs))* One-year survival Three-year survival Five-year survival Patients 86 % 81 % 79 % Transplanted organs 79 % 74 % 71 % * Data for 2020 will be available in mid 2021; published here are data from 1988 to June 2019 90 SURVIVAL 85 80 75 70 65 60 % One-year Three-years Five-years Patients Transplanted organs LEGEND Patient survival after a pancreas transplant (in combination with kidney) In the period from February 2009 to 31 De­cember 2020, 24 pancreas transplants were carried out, all concurrently with kidney. In 2020, two combined pancreas and kidney transplantation were performed. After one year, 18 pancreases were functio­ning, whereas 5 were removed in the early post-transplant period. One recipient died in the early post-transplant period due to in­fection. On 31 December 2020 there were 16 patients with functioning pancreas and kidney. Survival of combined pancreas-kidney transplant recipients and transplanted organs in % (1988–2020, n=24 (patients) in n=19 (transplanted organs)) One-year surv ival Three-year survival Patients 95,8 % 95,8 % Transplanted organs Pancreas Kidney Pancreas Kidney 75 % 91,7 % 75 % 91,4 % Source: Associate Professor Dr. Damjan Kovac, DMS (Department of Nephrology, UMC Ljubljana) 100 95 90 85 80 75 70 65 60 % SURVIVAL / TRANSPLANTED ORGANS / PATIENTS LEGEND Kidney Pancreas Patients One-year survival Three-year survival Patient survival after a lung transplant In the 1997–2020 period, 85 lung tran­splants were performed on Slovenian pa­tients, one of whom had to undergo a re­-transplant. In 2020 16 lung transplantati­ons were performed in UMC Ljubljana, of which 14 were of both lung lobes and two of a single lung lobe. Five transplantations were urgent, including a patient, who ne­eded urgent lung transplantation due to complications after covid-19 disease Most common indications for lung tran­splantation (since the beginning of the lung transplantation programme for Slovene patients in Vienna and from 2018 in Lju­bljana) were cystic fibrosis (27 %), chro­nic obstructive pulmonary disease (26 %), pulmonary fibrosis (26 %) and pulmonary hypertension. Indications for lung tran­splantations performed in Ljubljana UMC from 2018-2020 were chronic obstructi­ ve pulmonary disease (36 %), pulmonary fibrosis (26 %), cystic fibrosis (18 %) and bronchiectasis (7 %). Survival of lung transplant recipients in % (1997–2020, n=101) One-year survival Three-year survival Five-year survival Patients 87,3 % 80,2 % 76,2 % Source: doc. dr. Matevž Harlander, MD (Department of Pulmology and Alergology, University Medical Centre Ljubljana) 90 85 80 75 70 65 60 % One-year Three-year Five-year SURVIVAL Patients LEGEND Tissues and cells TRANSPLANTATION OF HAEMATOPOIETIC STEM CELLS The transplantation of haematopoietic stem cells (HSCs) is the dominant type of cell treatment since over 70 malignant and non-malignant diseases can be treated in this way, whereas for spe­ cific haematological diseases this is the main and only therapeutic possibility a patient’s recovery. The modern method of medical treatment using HSCs is more than 90% successful in optimal conditions (http://www.ztm.si). For such success, good donor-recipient immunological (HLA) mat­ching is required. The HLAsystem differs in every person and it is very demanding to find a suita­ble match. In the international community, doctors decided to establish large registers of typified volunteer donors of HSCs to improve the possibility of HLAmatching and thus also the outcomes of transplants. In Slovenia a register of non-related donors, Slovenia Donor, was established in 1991 and the next year it became a full member of the world register Bone Marrow Donors Worl­dwide (BMDW). All data are appropriately protected against unauthorised use. There are several types of donor-recipient matching. If it is possible to use a patient’s own HSCs, this is called an autologous donation. When this proves impossible, we look for another donor who may or may not be related to the recipient. Donation by another donor is called allogeneic and a donor is sought both in Slovenia and abroad. The Slovenija-donor register In Slovenia a register of non-related donors, Slovenia Donor, was established in 1991 and the following year it became a full member of the world register Bone Marrow Donors Worldwide (BMDW). On 31.12.2020, the Slovenia Donor register featured 20,453 people, of whom 20,255 were entered in the BMDW world register. HSC transplantations in Slovenia in the 2000-2020 period Transplantion type 2000-2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 AUTO 531 68 101 74 63 84 86 92 88 89 104 ALO-LRD 102 9 8 7 11 10 15 12 13 11 10 ALO-LUD 84 18 22 31 26 24 26 28 26 31 17 AUTO and ALO-LRD 21 TOTAL 738 95 131 112 100 118 127 132 127 131 131 AUTO – autologous transplantations, ALO – allogeneic transplantations, LRD – living related donor, LUD – living unrelated donor Source: Yearly report of ZTM – Slovenija donor, data collected monthly for Slovenija-transplant archives 700 140 600 120 500 100 400 80 300 60 200 40 100 20 0 0 LEGEND AUTO ALO-LRD ALO-LUD AUTO in ALO-LRD CORNEA PROCUREMENT AND TRANSPLANTATION PROGRAMME Cornea transplantation is one of the most frequent and most successful tissue transplantations in the world. This medical treatment is often the only method that can improve sight after a disease or injury. In Slovenia, corneas are procured from deceased donors after a cardiac arrest or proven Procured and transplanted corneas in the 2010-2020 period Year No. of procured corneas *No. of transplanted corneas 2010 122 72 2011 91 40 2012 101 67 2013 116 74 2014 116 87 2015 102 76 2016 104 83 2017 138 91 2018 84 66 2019 108 88 2020 92 72 140 130 120 110 100 90 80 70 60 50 40 * 2010–2017 – cornea transplants performed in Ljubljana UMC only; from 2018 on, cornea transplants performed in Ljubljana UMC and Maribor UMC Source: archive of Slovenija-transplant brain death. The removal of corneas is possible following consent given by the deceased person before their death or if their close relatives do not object. The final decision on the suitability of corneas for transplantation is always taken by the recipient’s responsible doctor. Corneas are transplanted in two transplantation centres: the Department of Ophthalmology in the Ljubljana UMC and the Department of Ophthalmology in the Maribor UMC. Waiting list of patients seeking a cornea transplant at the Department of Ophthalmology in the Ljubljana UMC (on 22 March 2021, as a percentage) and Maribor UMC (on 11 February 2021) Diagnosis Number of patients Keratokonus 40 Other diagnoses 199 TOTAL 239 232 Ljubljana UMC, 7 Maribor UMC LEGEND Diagnosis of keratoconus: 40 patients (17 %) Other diagnoses: 199 patients (83 %) (injuries, degeneration, retransplantation, corneal macula, Fuchs dystrophy, endothelial dystrophy, cornea guttata, aphakia and pseudophakia, bullous keratopathy, infections, other) Source: Ljubljana UMC, Department of Ophthalmology OTHER TISSUES AND CELLS Traceability and transparency in transplant programmes or tissue and cell use programmes for treatment purposes Slovenija-transplant has established co-operation with all tissue and cell institutions, which must hold a valid permit from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereinafter: JAZMP). We ensure traceability and transparency by promptly collecting and reviewing reports written by the institutions for tissues and cells which present the donation, procurement, processing, storing, allocation, use and disposal of tissues and cells. At the end of the year, Slovenija-transplant compiles an aggregate annual report based on annual reports issued by individual tissue and cell institutions. We also compile an annual final report on serious adverse events and reactions and submit it to the JAZMP, which then reports thereon to the European Commission. Tissue and cell institutions along with quality and safety assurance In Slovenia, 26 institutions are involved in the activity of procuring tissues and cells at the national level. Fifteen hospitals are included in the programme and, within these, 40 clinical departments. In terms of their status, 18 tissue and cell institutions are public and 8 privately owned. Private institutions hold a permit exclusively for the autologous procurement of tissues and cells. Slovenija-transplant and the JAZMP ensure that the system functions and promptly identify and discuss any deviations that could affect the quality and safety of the tissues and cells of donors, recipients as well as the staff involved in the processes. To obtain a permit, every institution must comply with strict expert and legal terms and provisions. All institutions have set up a quality assurance system where all the procedures for ensuring con­ ditions for tissue and cell quality and recipient safety are defined. They are regularly supervised by the JAZMP, whereas Slovenija-transplant also performs verification of the reported data. Artificial insemination with biomedical assistance and reproductive cells Four centres are registered in Slovenia for the activity of artificial insemination with biomedical assistance for couples incapable of conception to produce a child, namely the Ljubljana AIBA Centre, the Maribor AIBA Centre, the Postojna AIBA Centre and the Dravlje Health Centre. The scope of their activities is evident from the table showing the procured and used tissues and cells. This is the most comprehensive area in terms of the number of procedures conducted. In 2019, the Ministry of Health of the Republic of Slovenia formed an expert group, composed of the AIBA centres from Ljubljana, Maribor and Postojna, the Zdravje Private Health Institute and Slovenija-transplant. This group is drawing up expert guidelines and legislation for the establis­hment of a national AIBA register to which individual AIBA centres are to report their activities by certain deadlines. The register is to be managed by the National Institute of Public Health (NIJZ) on whose premises it will be physically installed. Slovenija-transplant will have access to the data for the purpose of ensuring the traceability, transparency as well as the quality and safety of tis­ sues and cells. The working group’s activities were put on hold in 2020 due to Covid-19 epidemic. Procuring and storing umbilical cord blood and the umbilical cord In Slovenia we also procure haematopoietic stem cells from umbilical cord blood and the umbili­cal cord as well as other tissues (e.g. milk teeth). One public tissue bank, i.e. the Blood Transfusi­on Centre of Slovenia (hereinafter: BTCS), and three privately-owned institutions (Izvorna celica, Biobanka and FH-S) hold a permit for this activity. The public umbilical cord blood bank within the BTCS has stopped accepting samples of umbilical cord blood because a sufficient number of samples had been collected and stored to cater to the needs of Slovenia. Number of procured tissues and cells in the 2009-2020 period Year 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Skin* 28 45 22 36 85 89 52 57 32 22 24 10 Bones* 38 123 108 67 93 82 147 74 80 78 71 59 Soft bone grafts* 22 39 / 3 11 3 9 / 12 / / / Cartilage* 37 21 4 12 11 11 12 / / / / / Reproductive cells (no. of cells) 15.854 43.472 8.640 27.479 41.929 37.542 39.769 26.191 36.338 13.778 26.813 28.209 * Unit: number of samples taken Number of tissues and cells used in the 2009-2020 period Year 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Skin* 36 10 14 34 67 23 31 28 / 20 3 / Bones* 23 47 57 97 59 62 92 82 72 71 81 101 Soft bone grafts* 12 / 2 2 3 4 3 5 2 3 5 4 Cartilage* 15 / 3 7 4 9 5 1 / / 1 / Reproductive cells 1.450 2.018 29.651 23.330 23.506 27.271 31.127 26.620 31.817 12.110 5.109 14.255 * Unit: number of samples used Source: archive of Slovenija-transplant Number of procured umbilical cord blood units Institution / Year 2015 2016 2017 2018 2019 2020 Izvorna celica 76 144 107 82 81 81 Biobanka 175 178 266 110 224 197 FH-S 8 45 101 169 192 206 Neocelica 238 0* 0* 0* 0* 0* * this institution stopped operating Number of procured umbilical cord units Institution / Year 2015 2016 2017 2018 2019 2020 Izvorna celica 60 116 96 52 73 75 Biobanka 32 150 222 96 212 184 FH-S 8 42 96 114 196 213 Neocelica 198 0* 0* 0* 0* 0* * this institution stopped operating Source: archive of Slovenija-transplant Adverse events and reactions Slovenija-transplant is responsible for monitoring adverse events and reactions as well as deviati­ ons in the area of the procurement of tissues and cells for transplantation and/or tissue vigilance. The aim of collecting reports on adverse events and reactions or even raising doubts about them is to assure the quality of procedures and thus prevent the damage or even loss of tissues and cells. Reporting takes place using prescribed forms, whereby initial and final reports must be submitted for each case. Both forms are attached to the Rules on Tissue Vigilance. Reporting entails seve­ ral phases: identification of deviation, detailed description, adoption of appropriate measures for preventing damage to tissues and cells as well as people, reporting to relevant institutions and notification of all tissue and cell institutions which were provided with tissues and cells in which deviations were identified. All data collected in the tissue vigilance system are anonymised so as to ensure privacy and, on the other hand, comply with the so-called culture of non-judgement, which means encouraging reporting along with searching for solutions and improvements, while not judging implementers on a personal level. In 2020, Slovenija-transplant received 3 reports on adverse events – all occurring in the tissue and cell procurement chain. All there cases were detected in Orthopedic Hospital Valdoltra in bone procurement. We prepared an analysis and applied corrective measures. There were no serious consequences in any of the three cases and the risk of reoccurrence was assessed to be low. An AIBA centre also dealt with 10 cases of adverse reactions. Three cases involved ovarian hyper-stimulation syndrome and three patients were hospitalised. In 7 cases, strong venous bleeding occurred, but hospitalisation was not required. We found that, in order to improve overall awareness, it is necessary to organise additional training on tissue vigilance and adverse event reporting because it is possible that the reporting of data on vigilance cases is slightly underrated. Number of adverse events and reactions in the 2009-2020 period 18 16 14 12 10 8 6 4 2 0 LEGEND Adverse reactions Adverse events PUBLICATIONS AND CONFERENCES Scientific articles • Avsec D, Šimenc J. Donor programme after circulatory death in Slovenia: Analysis of the views of professional community and future perspectives (original scientific article). Zdrav Vestn. 2020;89(5–6):255–67. Available at: https://vestnik.szd.si/index.php/ZdravVest/article/ view/2974. • Arnol M, Smrkolj T, Avsec D, Gadžijev A, Kneževic I. An increase in kidney transplantation procedures from deceased donors during the COVID-19 epidemic in Slovenia. Transplant International, 7.8.2020 (short scientific communication). Available at: https://onlinelibrary. wiley.com/doi/full/10.1111/tri.13715. Professional articles • Avsec D. Interview with Ana Peres Silva (international convention against organ trafficking). Isis 2 (February) 2020. Available: https://www.zdravniskazbornica.si/informacije-publikacije--in-analize/publikacije-zbornice-isis/revija/isis-februar-2020. • Avsec D. Donor and transplantation activities during the covid-19 epidemic / Donorska in transplantacijska dejavnost v casu epidemije covid-19. Isis 7 (June) 2020: 27-30. Available at: http://online.pubhtml5.com/agha/dzcl/#p=27. • Avsec D, Šimenc J. 20 years of cooperation with Eurotransplant. Novis, 1/2 2020. Available at: https://zdrzz.si/f/docs/Aktualno/Novis_januar-februar_2020.pdf. • Avsec D. The Institute Slovenija-transplant’s response to epidemic / Prilagoditve zavoda Slovenija-transplant na epidemijo. Novis, 5/6 2020. • Šimenc J, Avsec D. European donation day / Evropski dan darovanja: Strokovnost, solidar­nost in humanizem kljubujejo krizi. Transplant, December 2020 : 4–5. • Avsec, D. (2019). I see epidemic as an important learning opportunity / Obdobje virusa vidim kot zelo dobro ucno priložnost (interview). Transplant, December 2020 : 9–13. • Avsec D, Uštar B. (eds). Give life a chance: donation and transplantation activity in Slove­nia in 2019. Ljubljana: Institute for transplantation of organs and tissue of the republic of Slovenia. Available at: https://www.slovenija-transplant.si/uploads/upload/Daj-Zivljenju-Prilo­znost-2019.pdf. Oral presentations and lectures (in chronological order) • Danica Avsec: Slovenija-transplant as contract holder with Eurotransplant and development of donation programme. 20 years of cooperation between Slovenia and Eurotransplant (conference). UMC Ljubljana, 17. 1. 2020. • Andrej Gadžijev: National donation network and quality assurance programme. 20 years of cooperation between Slovenia and Eurotransplant (conference). UMC Ljubljana, 17. 1. 2020. • Andrej Gadžijev: Organ and tissue donation in Slovenia. Transplantation and transfusion (students’ congress). Medical faculty at the University of Ljubljana, 5. 3. 2020. • Andrej Gadžijev: Communication with family members before the donation. Diagnostics and treatment of anterior occular segment. Congress of Nursing and midwifes association of Slovenia, Ljubljana, 6. 3. 2020. REFERENCES • Website of the Institute Slovenija-transplant: http://www.slovenija-transplant.si/. • Website of The institute for transfusion medicine: http://www.ztm.si/register-darovalcev/slovenija-donor/. • Act Regulating the Obtaining and Transplantation of Human Body Parts for the Purposes of Medical Treatment / Zakon o pridobivanju in presaditvi delov cloveškega telesa zaradi zdravljenja (ZPPDCT), Ur. l. RS, 56/2015. • Council of Europe Convention against Trafficking in Human Organs (CM, 9. 7. 2014). • Website of Eurotransplant: http://www.eurotransplant.org/cms/. • Website of European Directorate for the Quality of Medicines and Healthcare EDQM: https://www.edqm.eu/. • Guide to the Quality and Safety of Organs for Transplantation. European Committee (Partial Agreement) on Organ Trans­plantation (CD-P-TO), European Directorate for the Quality of Medicines & Health Care, Strasbourg; 7th ed. 2018. • Guide to the Quality and Safety of Tissues and Cells for human application. European Committee (Partial Agreement) on Or­gan Transplantation (CD-P-TO), European Directorate for the Quality of Medicines & Health Care, Strasbourg; 4th ed. 2019. • The Madrid Resolution on Organ Donation and Transplantation: https://www.edqm.eu/sites/default/files/article_the_madrid_ resolution_on_organ_donation_and_transplantation_transplantation_journal_june_2011.pdf • Development of transplant medicine in Slovenia / Razvoj Transplantacijske medicine v Sloveniji: programi, smernice in pers­pektive. Editors Danica Avsec, Zvonka Zupanic Slavec; ilustracije Radko Oketic. Ljubljana: Zavod RS za presaditve organov in tkiv Slovenija-transplant; Celje: Celjska Mohorjeva družba: Društvo Mohorjeva družba, 2016. • Donation programme / Donorski program: Postopki za izvajanje v donorskih bolnišnicah. Authors: Andrej Gadžijev, Danica Avsec. Ljubljana: Zavod RS za presaditve organov in tkiv Slovenija-transplant. Ljubljana, 2018. • Preliminary numbers 2020, IRODaT (International Registry in Organ Donation and Transplantation), www.irodat.org. • Donor programme after circulatory death in Slovenia: Analysis of the views of professional community and future perspec­tives. Zdravstveni vestnik, 2020, 89(5–6):255–67. Authors: Danica Avsec, Jana Šimenc. https://www.slovenija-transplant.si/ uploads/upload/clanek%20dcd-ZV2020.pdf • An increase in kidney transplantation procedures from deceased donors during the COVID-19 epidemic in Slovenia. Transplant International, 2020. Authors: Miha Arnol, Tomaž Smrkolj, Danica Avsec, Andrej Gadžijev, Ivan Kneževic. https:// onlinelibrary.wiley.com/doi/full/10.1111/tri.13715. • Donor and transplantation activities during the covid-19 epidemic / Donorska in transplantacijska dejavnost v casu epidemije covid-19. Isis, 2020. Author: Danica Avsec. http://online.pubhtml5.com/agha/dzcl/#p=27 Zavod RS za presaditve organov in tkiv Slovenija-transplant Institute for Transplantation of Organs and Tissues of the Republic of Slovenia Zaloška 7, 1000 Ljubljana, Slovenija Spletna stran/web page: www.slovenija-transplant.si e-pošta/e-mail: info@slovenija-transplant.si Telefon: + 386 1 300 68 60 Faks: + 386 1 300 68 66 Direktorica/Director Prim. Danica Avsec, dr. med., svetnica GSM: + 386 41 760 917 E-pošta/e-mail: danica.avsec@slovenija-transplant.si