ISSN 2712-472X DAJ ŽIVLJENJU PRILOŽNOST GIVE LIFE A CHANCE DONORSKA IN TRANSPLANTACIJSKA DEJAVNOST V SLOVENIJI DONATION AND TRANSPLANTATION ACTIVITY IN SLOVENIA 2022 DAJ Življenju priložnost Donorska in transplantacijska dejavnost v Sloveniji v letu 2022 GIVE Life a chance Donation and transplantation activity in Slovenia in 2022 Daj življenju priložnost - Donorska in transplantacijska dejavnost v Sloveniji v letu 2022 Give life a chance – Donation and transplantation activity in Slovenia in 2022 Glavni urednik: Andrej Gadžijev Chief editor: Andrej Gadžijev Tehnična urednica: Barbara Uštar Technical editor: Barbara Uštar Avtorji: Andrej Gadžijev, Danica Avsec, Jana Šimenc, Barbara Uštar, Authors: Andrej Gadžijev, Danica Avsec, Jana Šimenc, Barbara Uštar, Gorazd Čebulc Gorazd Čebulc Lektorica: Nives Mahne Čehovin Translation: Nives Mahne Čehovin Oblikovanje in prelom: Vesna Žerjal, Domen Smerdelj Language editing: Murray Bales Natis: Cicero Begunje, d. o. o. Layout and design: Vesna Žerjal, Domen Smerdelj Kraj in leto izida: Ljubljana, 2023 Printed: Cicero Begunje, d. o. o. Založba: Zavod RS za presaditve organov in tkiv Slovenija-transplant Issued in: Slovenia, Ljubljana, 2023 Avtorske pravice: Zavod RS za presaditve organov in tkiv Slovenija- Original title: Daj življenju priložnost - Donorska in transplantacijska de- transplant javnost v Sloveniji v letu 2022 Naklada: 150 izvodov Publisher: Institute for Transplantation of Organs and Tissues of the Repub- Publikacija je bila izdana s pomočjo javnih sredstev iz proračuna Zavoda RS za presaditve organov in tkiv Slovenija-transplant. lic of Slovenia Slovenija-transplant Publikacija je brezplačna. lic of Slovenia Slovenija-transplant Copyright: Institute for Transplantation of Organs and Tissues of the RepubPrinted in 150 copies ISSN 2712-472X 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 statistične podatke in izbrane presežke v donorski in transplantacijski dejavnosti v letu 2022. Na področju donorske dejavnosti je bilo leto 2022 izjemno uspešno. Prineslo je številne presežke, v katere smo vložili nemalo truda tako na organizacijskem kot strokovnem nivoju. Izpeljali smo vrsto nalog, ki jih med pandemijo nismo mogli zaključiti, in postavili nove standarde, ki jim bomo v naslednjih letih skušali slediti ali jih celo nadgraditi. V donorskem programu smo izrazito presegli načrte, predvsem pri prepoznavanju primernih umrlih darovalcev. Po več letih smo ponovno presegli mejo 23 dejanskih darovalcev/milijon prebivalcev in se uvrstili na 3. mesto med državami članicami Eurotransplanta. Transplantacijski koordinatorji in koordinatorice so opravili skoraj dvakrat več pogovorov o soglasju za darovanje s svojci možnih umrlih darovalcev kot v letu 2021 in v nacionalni mreži donorskih bolnišnic uspešno koordinirali 56 postopkov večorganskih odvzemov od možgansko mrtvih darovalcev, ki so v povprečju darovali 3,5 organa, kar nas uvršča med najuspešnejše države na svetu. V UKC Maribor so bili preseženi pomembni strokovni mejniki, saj smo v letu 2022 prvič začeli aktivno izvajati program po novih smernicah pri zdravljenju in oskrbi kritično bolnih v enotah intenzivne medicine ter možnosti za darovanje organov in tkiv po smrti (program ICOD). Del tega programa je prvič stekel tudi v UKC Ljubljana. Za vsemi omenjenimi uspehi pa stojijo različni ljudje, ki s svojo predanostjo, izjemno energijo, entuziazmom, altruizmom in požrtvovalnostjo v tako prelomnem obdobju slovenskega zdravstva, kot smo mu priča danes, vsem državljanom Slovenije še naprej omogočajo kakovosten in varen način zdravljenja s presaditvijo organov in tkiv. Iskrena hvala. Andrej Gadžijev, dr. med. An Direktor rektor tor in odgovorni odgo zdravnik za donorsko dejavnost Kazalo 3 6 8 10 12 14 Uvodne besede Slovarček temeljnih izrazov Zavod Slovenija-transplant Presežki in zaznamki leta 2022 Razstava »MOJA BRAZGOTINA, MOJE ŽIVLJENJE« Ključne številke leta 2022 17 18 23 30 32 34 44 47 56 ČVRSTI ORGANI Nacionalni čakalni seznam za presaditve organov Število umrlih darovalcev Register opredeljenih oseb glede darovanja organov in tkiv po smrti Stopnja privolitev svojcev za darovanje Delovanje donorskih bolnišnic Pridobljeni čvrsti organi za namen zdravljenja Presajeni čvrsti organi Rezultati pri bolnikih, zdravljenih s presaditvijo 61 62 64 66 70 TKIVA IN CELICE Presaditve krvotvornih matičnih celic Program pridobivanja in presaditve roženic Ostala tkiva in celice Neželeni dogodki in reakcije 72 IZOBRAŽEVANJE IN OBVEŠČANJE STROKOVNE JAVNOSTI 74 MEDNARODNI PROJEKTI 78 VIRI 81 82 84 86 88 Table of contents Introductory words The Slovenija-transplant institute Outstanding achievements and highlights in 2022 The “My scar, my Life” Exhibition Key statistics for 2022 91 92 97 104 106 108 118 121 130 SOLID ORGANS National waiting list for organ transplantation Number of deceased donors Register for donation declarations Percentage of consent for donation Operations of the donor centres Solid organs procured for the purpose of medical treatment Transplanted solid organs The results in transplanted patients 135 136 138 140 144 TISSUES AND CELLS Transplantation of haematopoietic stem cells Cornea procurement and transplantation programme Other tissues and cells Adverse events and reactions 146 EDUCATING AND INFORMING THE PROFESSIONAL PUBLIC 148 INTERNATIONAL PROJECTS 152 REFERENCES Slovarček temeljnih izrazov BOLNIŠNIČNA KRVNA BANKA: enota, ki v bolnišnici shranjuje in razdeljuje kri ter krvne komponente in opravlja predtransfuzijsko testiranje ter bolnišnične transfuzijske dejavnosti. Za zbiranje krvi torej ni pooblaščena. DAROVANJE: darovanje dela telesa, namenjenega za zdravljenje s presaditvijo. BOLNIŠNIČNI TRANSPLANTACIJSKI KOORDINATOR: zakon določa način imenovanja, naloge bolnišničnih koordinatorjev in pravilnik o koordinatorjih. Naloge bolnišničnih transplantacijskih koordinatorjev so: organizacija in koordinacija dela na vseh področjih 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 področjih transplantacijske dejavnosti v bolnišnici oz. donorskem centru. DODELJEVANJE: postopek, po katerem se izbere najustreznejšega prejemnika. CENTRALNI TRANSPLANTACIJSKI KOORDINATOR: zdravnik z dodatnimi 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. ČAKALNI SEZNAM (PREJEMNIKOV): zbirka podatkov zaporedno vpisanih pacientov, ki čakajo na presaditev z namenom zdravljenja. Indikacije za presaditev so za vsak organ/tkivo/ celico specifične. 6 DAROVALEC: oseba, ki daruje del telesa za namen zdravljenja, ne glede na to, ali do darovanje pride za časa življenja ali po njeni/njegovi smrti. DEJANSKI UMRLI /MRTVI DAROVALEC: aktiven darovalec, od katerega je bil presajen vsaj en organ. 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 povzroči prenos nalezljive bolezni, smrt, ogrozi življenje, povzroči invalidnost ali nezmožnost za delo, katerega posledica je hospitalizacija ali obolevnost, ali ki podaljša hospitalizacijo ali obolevnost. HUDA NEŽELENA REAKCIJA: nenameren odziv, vključno 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 povzroča invalidnost ali nezmožnost za delo, ali katerega posledica je hospitalizacija ali obolevnost ali ki podaljša hospitalizacijo 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 klinično 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 izmenjavi podatkov med donorskimi centri, transplantacijskimi centri in drugimi državami članicami Evropske unije. PRIMEREN UMRLI/MRTVI DAROVALEC: medicinsko ustrezna oseba, pri kateri je bila ugotovljena smrt na podlagi nevroloških meril, glede na relevantno zakonodajo. SLEDLJIVOST: možnost, da se najde in identificira organ v vseh fazah preskrbe z organi ali uničenja, vključno z možnostjo, da se identificirata darovalec in donorski center, poiščejo prejemniki pri transplantacijskem centru ter identificirajo 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 prejemniku. TRANSPLANTACIJSKA DEJAVNOST: zdravstvena dejavnost, ki vključuje 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 presaditvijo 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 bolnišnične 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 povezovanje transfuzijske medicine z bolnišnično dejavnostjo. Zavod usklajuje vse dejavnosti v zvezi z izbiro krvodajalcev, zbiranjem, testiranjem, predelavo, hrambo in razdeljevanjem krvi ter krvnih pripravkov, klinično rabo krvi in nadzorom nad težkimi neželenimi dogodki oziroma reakcijami v zvezi s transfuzijo krvi. Zavod RS za transfuzijsko medicino na državni ravni usklajuje in povezuje mrežo bolnišničnih transfuzijskih oddelkov in bolnišničnih krvnih bank, vodi enoten informacijski sistem, strokovno izobraževanje in razvojno-raziskovalno dejavnost ter sodeluje z mednarodnimi organizacijami, zvezami in sorodnimi zavodi v drugih državah. 7 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 omogoča 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 vključena v neprofitno organizacijo za izmenjavo organov in tkiv Eurotransplant. Z izpolnjevanjem zahtevnih vstopnih pogojev se je prva iz regije priključila veliki skupini petih uspešnih držav na področju zdravljenja s presaditvijo, t. j. Nemčiji, 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. Članstvo je pomembno za naše bolnike, saj so se s priključitvijo bistveno izboljšale možnosti preživetja in izidi zdravljenja s presaditvijo, predvsem v visoko urgentnih, življenjsko ogrožajočih stanjih, kot sta akutna odpoved delovanja srca in jeter, ter v drugih posebnih primerih (npr. otroci, hipersenzibilizirani bolniki). S sodelovanjem so se tudi občutno zmanjšali čakalni seznami, nacionalni transplantacijski programi so se razmahnili, izvajati smo začeli kombinirane presaditve. Predvsem pa smo lahko omogočili optimalnejšo tkivno skladnost med darovalcem in prejemnikom. Nekateri bolniki zaradi tkivne neskladnosti ustreznega organa v Sloveniji sploh ne bi dočakali. V letu 2020 smo obeležili pomembno 20. obletnico uspešnega sodelovanja z Eurotransplantom. 8 Zavod Slovenija-transplant se od ustanovitve naprej nenehno razvija v skladu s priporočenimi mednarodnimi smernicami. Stremimo k ustvarjanju izobražene in motivirane strokovne javnosti ter z večplastnim komuniciranjem vztrajno povečujemo zaupanje v transplantacijsko medicino med splošno ZAVOD SLOVENIJA-TRANSPLANT javnostjo. Preko članstev 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 področju. Ostajamo mednarodno prepoznan in zgleden primer za varen ter učinkovit način organizacije in vodenja nacionalnega donorskega programa. Pri urejanju in vodenju področja pridobivanja in uporabe delov človeškega 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 vključujemo predloge in odločitve zdravstvene stroke, kritične družbene premisleke ter načela medicinske etike in deontologije. Ključne smernice delovanja zavoda so: samozadostnost – enakost in varnost za bolnike – optimalna učinkovitost – kakovost – sledljivost – profesionalnost – nekomercialnost – transparentnost – prostovoljno darovanje – preprečevanje zlorab. Zavod Slovenija-transplant vodi Andrej Gadžijev, dr. med., specialist travmatolog in odgovorni zdravnik za donorsko dejavnost. Kot odgovorna zdravnica je v zavodu imenovana tudi prim. Danica Avsec, dr. med., namestnica direktorja. V letu 2022 je bilo v organizaciji devet redno zaposlenih, v donorskem programu pa je sodelovalo 86 pogodbenih sodelavcev. Zavod deluje pod okriljem Ministrstva RS za zdravje. www.slovenija-transplant.si @SloTransplant 9 Presežki in zaznamki leta 2022 10 • V donorskem programu smo izrazito presegli predvideni načrt, predvsem pri številu primernih darovalcev. S 23,24 dejanskega darovalca na milijon prebivalcev pa smo se uvrstili na 3. mesto med državami članicami Eurotransplanta. • Izjemne rezultate smo dosegli pri številu pridobljenih src in pljuč, kjer smo načrt presegli za več kot 60 %, ter pri številu pridobljenih roženic – teh smo pridobili 51 več od predvidenih 120. • Za potrebe nacionalnega informacijskega sistema za tkiva in celice smo ustvarili slovensko nacionalno kodo za tkiva in celice, kar je unikatno in pionirsko delo na ravni EU. Natančna koda zagotavlja boljšo sledljivost in transparentnost za ustanove in darovalce ter za vsa tkiva in celice. • Izboljšali smo logistične procese in sistemsko uredili protokole za zagotavljanje izmenjave organov in tkiv z bližnjimi letališči v Münchnu, Gradcu in na Dunaju. • Za potrebe izvajanja presaditev jeter pri majhnih otrocih smo podpisali pogodbo o sodelovanju med Nacionalnim centrom za presaditve v Italiji, Eurotransplantom in Slovenija-transplantom. Našli smo inovativno možnost poravnave dolgovanih organov med članicami in nečlanicami Eurotransplanta preko evropske platforme za izmenjavo organov FOEDUS. • Centralni transplantacijski koordinatorji so uspešno koordinirali 56 postopkov večorganskih odvzemov od umrlih darovalcev v nacionalni mreži donorskih bolnišnic. • Transplantacijske koordinatorice in koordinatorji so opravili 92 pogovorov s svojci o soglasju za darovanje, kar je v primerjavi z letom 2021 skoraj dvakrat več. Nekoliko nižji je bil odstotek privolitev za darovanje, in sicer 68 %. PRESEŽKI IN ZAZNAMKI LETA 2022 • S 1. 9. 2022 je postala veljavna ratifikacija mednarodne Konvencije proti trgovanju s človeškimi organi. S spremembami v Kazenskem zakoniku je ratifikacija postala pomemben mejnik za Slovenijo, saj so v skladu s konvencijo jasno določena kazniva dejanja v zvezi z zlorabami v transplantacijski medicini. • Okrepili smo izobraževalno dejavnost za strokovno javnost. Med drugim smo izvedli šest seminarjev o osnovah donorskega programa, intenzivni tečaj s področja pridobivanja organov, dve delavnici o histovigilanci ter eno delavnico o sporočanju slabe novice in pogovoru o darovanju organov. • Uvedli smo e-novičnik za redno obveščanje in ozaveščanje strokovne javnosti. Na več kot 500 e-naslovov smo razposlali štiri številke Strokovnih novic s Slovenija-transplanta. • V sodelovanju z društvom pacientov, Slovenskim društvom Transplant, smo pripravili medijsko odmevno in v javnosti odlično sprejeto razstavo »Moja brazgotina, moje življenje«. V avli UKC Ljubljana smo jo otvorili ob evropskem dnevu darovanja. Razstava aktov oseb po presaditvi potuje po Sloveniji in je odlično komunikacijsko orodje za spodbujanje opredelitev za darovanje organov. • V nacionalnem registru opredeljenih oseb smo zabeležili največje število opredelitev glede darovanja na letni ravni. Svojo odločitev je uradno izrazilo 2010 ljudi. • Nadpovprečno smo bili uspešni na mednarodnih razpisih za projekte. V sodelovanju s tujimi partnerji smo pridobili kar tri nove projekte in s tem omogočili nadaljnji razvoj na področju odpornosti donorskih in transplantacijskih programov (BRAVEST), inovativnih pristopov komunikacije in ozaveščanja javnosti (You have more than one life) ter izobraževanja strokovne javnosti o novostih v donorski dejavnosti (Speed-In). • Uspešno smo izpeljali 1. nagradni natečaj za najboljše raziskovalno delo s področja donorske medicine. Prvo nagrado je osvojila Veronika Prtenjak z nalogo Pravne dileme darovanja organov. 11 Razstava »MOJA BRAZGOTINA, MOJE ŽIVLJENJE« Središčni dogodek Evropskega dneva darovanja, ki je bil 8. oktobra 2022, je bila otvoritev estetsko in vsebinsko presežne razstave »Moja brazgotina, moje življenje« v avli UKC Ljubljana. Razstava aktov s spremljajočimi izjavami in strokovnimi pojasnili ponuja neposreden vpogled v darovanje in presaditve organov in tkiv, kjer je veliko dobrih in uspešnih zgodb o solidarnosti, vrhunskih medicinskih dosežkih in uspehih v zdravljenju. Nastala je v sodelovanju med društvi pacientov (Slovensko društvo Transplant, Športno društvo Ditra) in Slovenija-transplantom. Na Slovenija-transplantu so jo soustvarjali prim. Danica Avsec, Andrej Gadžijev, dr. Jana Šimenc in Barbara Uštar. Avtor vrhunskih umetniških fotografij je fotograf Miran Juršič. Namen razstave je, da lahko v različnih vsakdanjih prostorih brez zadržkov govorimo o darovanju organov, pri tem razbijamo nepotrebne tabuje in spodbujamo darovanje. Tudi zato so osebe s presajenimi organi z veliko mero poguma in pozitivne energije razgalile svoje brazgotine, telesa in misli, da bi izrazile hvaležnost in podale ključno sporočilo: postanite darovalci in omogočite življenje. Kot je povedala Anja Garbajs, ena od avtoric razstave in članica društva Transplant: »Misel, da nekomu lahko podariš organ, je večja od življenja.« Razstava, na kateri žarita življenje in hvaležnost, pri gledalcih spreminja pogled na življenje, na začetke in konce. Fotografije dopolnjujejo panoji s strokovnimi pojasnili, spodbudami k pogovoru o darovanju in razlagami pogostih zmotnih prepričanj. V letu 2022 je gostovala v avli UKC Ljubljana, v avli Kirurške klinike v UKC Maribor ter v Pokrajinski in študijski knjižnici Murska Sobota. V splošni in strokovni javnosti ter v medijih je bila povsod sprejeta izjemno pozitivno. 12 Razstava je hkrati pobuda za okrogle mize, pogovore in tiskovne konference, kar širi razumevanje o darovanju organov. Odkar razstava potuje po Sloveniji, opažamo pomemben porast v številu opredelitev v nacionalnem registru. Predstavili smo jo tudi na Poljskem, kjer je že prepoznana kot model izjemne, inovativne in uspešne prakse komuniciranja o darovanju organov. V letu 2023 načrtujemo nadaljnja gostovanja v krajih po Sloveniji (med drugim v ZD Sevnica). Ključne številke leta 2022 UMRLI DAROVALCI 56 V LETU 2022 PO STAROSTNIH SKUPINAH 0<18LET 18-59LET +60LET 3 29 24 Povprečna starost je bila 54 let. DAROVALCI SO PODARILI 172 ORGANOV 2022 14 LEDVICE SRCE JETRA PLJUČA 82 20 45 20 T. SLINAVKA ROŽENICE 1 172 PRIVOLITEV SVOJCEV ZA DAROVANJE ORGANOV IN TKIV NACIONALNI REGISTER OPREDELJENIH OSEB GLEDE POSMRTNEGA DAROVANJA ORGANOV IN TKIV STOPNJA PRIVOLITVE: Slovenija se uvršča med najuspešnejše države glede stopnje soglasja za darovanje. Skupaj opredeljenih 13.579 ljudi 2.010 (54 proti) 68 % Transplantacijski koordinatorji so izvedli 92 pogovorov s svojci o darovanju. od tega 13.496 ZA in 83 PROTI. 2022 V CENTRU ZA TRANSPLANTACIJSKO DEJAVNOST V UKC LJUBLJANA SO PRESADILI 109 ORGANOV POVPREČNE ČAKALNE DOBE (v dnevih) 161 pacientov je bilo na čakalnem seznamu za presaditev (stanje na dan 31.12.2022) 250 370 SRCE LEDVICE 2022 51 LEDVICE 29 18 10 SRCE JETRA PLJUČA 1 122 T. SLINAVKA ROŽENICE 91 67 PLJUČA JETRA15 16 Čvrsti organi 17 ČVRSTI ORGANI NACIONALNI ČAKALNI SEZNAM ZA PRESADITVE ORGANOV Čakalni seznam je seznam bolnikov, ki čakajo na zdravljenje s presaditvijo organa. Indikacije za presaditev so za vsak organ/tkivo/celico specifične. Vsi bolniki v Republiki Sloveniji imajo enake možnosti za uvrstitev na čakalni seznam prejemnikov in zagotovljen enak dostop do presaditve delov človeškega telesa. Konec leta 2022 je na presaditev organa čakalo 161 bolnikov. Skupno število čakajočih se je v primerjavi s preteklim letom ponovno nekoliko zmanjšalo, predvsem na čakalnem seznamu za ledvico in jetra. Povprečna čakalna doba je za vse organe v primerjavi z ostalimi državami relativno kratka. Slovenski bolniki čakajo na presaditev srca, jeter ali ledvice v povprečju manj kot leto dni. Točnejši podatki o povprečnih čakalnih dobah za posamezen organ so v poglavju REZULTATI PRI BOLNIKIH, ZDRAVLJENIH S PRESADITVIJO. V letu 2022 je bilo v Sloveniji na čakalni seznam na novo uvrščenih 114 bolnikov, od tega 38 za presaditev ledvice (eden v kombinaciji z jetri, trije v kombinaciji s srcem in eden skupaj s trebušno slinavko), 40 za presaditev srca (3 skupaj z ledvico), 13 za presaditev pljuč, 22 za presaditev jeter (1 skupaj z ledvico) in en bolnik za presaditev trebušne slinavke (skupaj z ledvico). Stanje na nacionalnem čakalnem seznamu na dan 31. 12. 2022 (vsi čakajoči) Ledvica Srce*** Pljuča Jetra* Trebušna slinavka** 82 60 5 16 3 SKUPAJ 161 bolnikov * Od tega dva skupaj z ledvico. ** Od tega dva skupaj z ledvico. *** Od tega eden skupaj z ledvico. Vir: http://statistics.eurotransplant.org/ 18 ČVRSTI ORGANI Nacionalni čakalni seznam v obdobju 2011−2022 (stanje na dan 31. 12., vsi čakajoči) Leto Ledvica Srce Pljuča* Jetra 2011 120 46 17 2012 113 38 18 2013 114 39 2014 136 31 2015 110 2016 95 2017 2018 2019 Trebušna slinavka SKUPAJ 183 2 169 19 1 171 21 11 188 52 29 11 190 58 28 7 181 112 56 35 8 203 135 65 35 6 234 138 55 35 5 227 2020 115 53 5 32 4 204 2021 97 57 3 21 4 177 2022 82 60 5 16 3 161 *Do septembra leta 2020 so bili slovenski pacienti, ki so čakali na presaditev pljuč, uvrščeni na avstrijski čakalni seznami. Delež bolnikov na nacionalnem čakalnem seznamu po posameznem organu v letu 2022 Vir: http://statistics.eurotransplant.org/ 3 16 5 82 LEGENDA Ledvica (82) Pljuča(5) Srce (60) Jetra (16) 161 Trebušna slinavka (3) 60 19 ČVRSTI ORGANI Gibanje števila bolnikov na čakalni listi po organih in skupaj 2011−2022 140 130 120 110 100 90 LEGENDA 80 70 Ledvica Jetra Srce Pljuča Trebušna slinavka 60 50 40 30 20 10 2011 20 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 ČVRSTI ORGANI Število bolnikov, umrlih med čakanjem na presaditev organa 2011-2022 Podatki v spodnji tabeli prikazujejo število bolnikov, ki so bili uvrščeni na čakalni seznam za presaditev organa in so med čakanjem umrli. Vzrok smrti ni bil vedno povezan z odpovedjo organa, na katerega presaditev so čakali. Leto Ledvica Ledvica skupaj s trebušno slinavko Srce Pljuča Jetra SKUPAJ 2011 6 8 3 17 2012 2 8 7 17 2013 2 5 5 12 2014 4 5 2 11 3 5 10 7 3 13 6 6 13 6 5 14 12 2015 1 2016 3 2017 1 2018 1 1 2 2019 1 6 5 2020 1 2 1 4 2021 4 1 6 10* 2022 1 4 4 9** *En umrli bolnik je čakal na kombinirano presaditev ledvice in jeter ** En umrli bolnik je čakal na kombinirano presaditev ledvice in jeter. 1 Vir: http://statistics.eurotransplant.org/ 21 ČVRSTI ORGANI Gibanje števila bolnikov, umrlih med čakanjem na presaditev organa 2011-2022 20 * 15 * * 10 * * * * * * * 5 0 * 17 17 12 11 10 13 13 14 12 4 10* 9* 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 *En umrli bolnik je čakal na kombinirano presaditev ledvice in jeter LEGENDA Ledvica * 22 * Jetra Gibanje števila bolnikov Ledvica in trebušna slinavka Vir: http://statistics.eurotransplant.org/ Srce Pljuča ČVRSTI ORGANI ŠTEVILO UMRLIH DAROVALCEV V letu 2022 smo v slovenskih donorskih bolnišnicah pridobili 56 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 državami sveta, za katere so bili v času priprave te publikacije že na voljo podatki za leto 2022. 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 članicami Eurotransplanta se Slovenija po številu dejanskih umrlih darovalcev na milijon prebivalcev v letu 2022 uvršča na tretje mesto z rezultatom, ki je pomembno višji od povprečja v Eurotransplantu. Število aktivnih umrlih darovalcev (MD) na milijon prebivalcev (NMP) v Sloveniji v letu 2022 v primerjavi z ostalimi državami sveta Država Število MD/NMP 2022 Država Število MD/NMP 2022 1. Španija 46,03 10. Hrvaška 24,4 2. ZDA 44,5 11. Urugvaj 22,7 3. Portugalska 30,8 12. Združeno Kraljestvo 21,08 4. Belgija 29,4 13. Kanada 20,95 5. Češka 28,34 14. Švica 18,8 6. Slovenija 26,54 15. Estonija 18,77 7. Belorusija 26,04 16. Litva 17,96 8. Italija 25,5 17. Avstralia 17,48 9. Avstrija 25,17 18. Irska 16,78 23 ČVRSTI ORGANI Število MD/NMP 2022 Država Število MD/NMP 2022 Država 19. Argentina 16,67 26. Izrael 10,42 20. Brazilija 16,5 27. Nemčija 10,34 21. Slovaška 13,08 28. Kuvajt 22. Madžarska 12,59 29. J. Koreja 7,88 23. Nova Zelandija 12,31 30. Grčija 6,6 24. Iran 12,2 21. S. Makedonija 25. Poljska 11,76 32. ZAE 8 6 5,5 MD/NMP 46,03 Graf števila aktivnih umrlih darovalcev (MD) na milijon prebivalcev (NMP) v Sloveniji v letu 2022 v primerjavi z ostalimi državami sveta 44,5 50 21,8 20,95 18,8 18,77 17,96 17,48 16,78 16,67 16,5 7 8 9 10 11 12 13 14 15 16 17 18 19 20 ČEŠ SLO BEL ITA AUS HR URU ZK KAN ŠVI EST LIT AVS IRS ARG 12,31 24,4 6 12,59 25,17 5 20 13,08 25,5 4 22,7 26,04 26,54 28,34 30 28,4 30,8 40 21 22 23 10 0 24 1 2 ŠPA ZDA 3 POR BEL BRA SLOV MAD N.ZEL ČVRSTI ORGANI Število MD/NMP 2022 Država 33. Ciper Število MD/NMP 2022 Država 40. Mehika 3,05 34. Ukrajina 44,77 5 41. Bolgarija 2,31 35. Hong Kong 4,66 42. Moldavija 1,15 36. Romunija 4,5 43. Dominikanska Republika 37. Katar 4,13 44. Malezija 0,7 38. Savdijska Arabija 3,5 45. Filipini 0,18 39. Turčija 3,4 46. Nikaragva 1 0,14 Vir: IRODaT, International Registry in Organ Donation and Transplantation. Preliminary numbers 2022, July 2023. MD/NMP 40 30 4,13 3,5 3,4 3,05 2,31 1,15 1 0,7 0,18 NEM KUV J.KOR. GR 4,5 IZR 4,66 POL 29 4,77 IRA 28 5 27 5,5 26 6 25 0,14 6,6 0 7,88 10,34 24 10 8 10,42 11,76 12,2 20 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 S.MAK ZAE CIP UKR H.K. ROM KAT S.AR. TUR MEH BOL 46 MOL D.RE. MAL FIL NIK 25 ČVRSTI ORGANI Število dejanskih umrlih darovalcev (MD) in število MD na milijon prebivalcev (NMP) v Sloveniji v letu 2022 in v primerjavi z Eurotransplantom. Država Število MD MD/NMP Slovenija (SLO) Eurotransplant (ET) 49 1.938 23,3 13,8 Vir: http://statistics.eurotransplant.org/ Število dejanskih umrlih darovalcev na milijon prebivalcev (MD/NMP) ter primerjava z državami članicami Eurotransplanta v letu 2022 Država ET Število MD/NMP 2022 1. Belgija (BE) 26,6 2. Hrvaška (HR) 23,5 50 40 3. Slovenija (SLO) 23,3 4. Avstrija (AV) 22,1 5. Nizozemska (NL) 16,2 20 6. Luksemburg (LU) 12,4 10 7. Madžarska (MAD) 12,3 8. Nemčija (NE) 10,1 MD/NMP 30 0 ET (13,8) 1 2 3 4 5 6 7 8 BE HR H SLO SL LO AV V NL NL LU LU MAD MA M AD A NE NE Vir: http://statistics.eurotransplant.org/ 26 ČVRSTI ORGANI Število dejanskih umrlih darovalcev (MD) ter število dejanskih umrlih darovalcev na milijon prebivalcev (MD/NMP) Sloveniji v letih od 1998 do 2022 Leto Število MD Število MD/NMP Leto Število MD Število MD/NMP 1998 27 13,6 2011 31 15,1 1999 26 13,1 2012 46 22,4 2000 22 11,1 2013 45 21,9 2001 23 11,6 2014 43 20,9 2002 35 17,6 2015 53 25,7 2003 28 14 2016 41 19,9 2004 36 18 2017 39 18,9 2005 21 10,5 2018 40 19,4 2006 30 15 2019 38 18,3 2007 22 10,9 2020 39 18,5 2008 36 17,8 2021 39 18,5 2009 33 16,2 2022 49 23,3 2010 40 19,5 SKUPAJ 882 17,3 Vir: http://statistics.eurotransplant.org/ 27 ČVRSTI ORGANI Število dejanskih umrlih darovalcev (MD) in število dejanskih umrlih darovalcev na milijon prebivalcev (MD/NMP) v Sloveniji v letih od 1998 do 2022 Število MD v posameznem letu 60 50 40 30 20 10 0 27 26 22 23 2000 000 01 0 1998 9998 99 20 30 35 28 0022 03 0 36 21 30 22 36 33 40 31 04 05 0 06 07 0088 09 0 20 2010 0100 11 46 45 1 13 12 43 53 41 39 40 38 39 39 49 1 15 14 1 16 17 18 19 2020 2211 22 Število MD/NMP v posameznem letu 25 20 15 10 5 0 28 13,6 13,1 11,1 11,6 17,6 14,0 18,0 10,5 15,0 10,9 17,8 16,2 19,5 15,1 22,4 21,9 20,9 25,7 19,9 18,9 19,4 18,3 18,4 18,4 23,3 1998 99 2000 01 02 03 04 05 06 07 08 09 2010 11 12 13 14 15 16 17 18 19 2020 21 22 ČVRSTI ORGANI Klasifikacija umrlih darovalcev organov MOREBITEN UMRLI DAROVALEC ORGANOV Bolnik s hudo poškodbo možganov ALI bolnik z zaustavitvijo krvnega obtoka IN očitno medicinsko primeren za darovanje organov Darovanje po smrti zaradi zaustavitve krvnega obtoka (DSK) 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 mogoče predvideti, da se bo v določenem časovnem okviru zaustavilo delovanje krvnega obtoka in dihanje, kar bo omogočilo pridobitev organov. 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 časovnem okviru, ki omogoča pridobitev organov. 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. Lečeči zdravnik prepozna/opozori na možnega darovalca Darovanje po možganski smrti (DMS) 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 zaključen (npr. ker ni na voljo ustreznih diagnostičnih naprav oz. osebja, ki bi opravilo potrditveni test), - Smrt zaradi zaustavitve krvnega obtoka ni pravočasno potrjena, - Logistične 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 časa življenja izrazil voljo, da ne želi biti darovalec, - Zavrnitev svojcev umrlega, - Zavrnitev mrliškega oglednika ali preiskovalnega sodnika zaradi forenzičnih razlogov. MOŽEN DAROVALEC (DMS) Oseba, katere klinično stanje kaže na verjetnost, da izpolnjuje merila za možgansko smrt. PRIMEREN DAROVALEC (DMS) Medicinsko ustrezna oseba, pri kateri je bila ugotovljena smrt na podlagi nevroloških meril, glede na relevantno zakonodajo. 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) DEJANSKI DAROVALEC (DMS) Aktiven darovalec, od katerega je bil presajen vsaj en organ. 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 povzročiti smrti darovalca. Povzeto po Madridski resoluciji o darovanju organov in transplantaciji 29 ČVRSTI ORGANI REGISTER OPREDELJENIH OSEB GLEDE DAROVANJA ORGANOV IN TKIV PO SMRTI Vsak slovenski državljan ima v času življenja pravico in možnost, da se opredeli glede darovanja organov in tkiv. Od junija 2017 je poleg opredelitve za darovanje mogoča tudi opredelitev proti darovanju. Odločitev formalno potrdimo z vpisom v nacionalni register opredeljenih oseb, ki je bil vzpostavljen leta 2004. Obrazec za opredelitev glede darovanja lahko podpišemo elektronsko z digitalnim podpisom preko portala eUprava (https://e-uprava.gov.si/) ali osebno na številnih pooblaščenih mestih v več krajih po Sloveniji (seznam je objavljen na www.slovenija-transplant.si). V letu 2022 se je v nacionalni register opredeljenih oseb glede posmrtnega darovanja vpisalo največ oseb na letni ravni doslej. Zbrali smo 2.010 opredelitev (1.956 za, 54 proti). V nacionalnem registru opredeljenih oseb glede darovanja organov po smrti je bilo 31. 12. 2022 skupaj vpisanih 13.579 oseb (od tega 13.496 za in 83 proti). Elektronski način vpisa je od vzpostavitve v novembru 2018 uporabilo 4.183 oseb. V letu 2022 je elektronsko možnost uporabilo 80 % vseh opredeljenih. Število vpisanih v registru opredeljenih oseb glede darovanja organov in tkiv po letih v obdobju od 2004 do 2022 Vir: arhiv Slovenija-transplanta 30 Leto Št. vpisanih Leto Št. vpisanih Leto Št. vpisanih 2004 91 2011 378 2018 1.760 2005 228 2012 312 2019 1.252 2006 308 2013 299 2020 750 2007 383 2014 739 2021 976 2008 460 2015 630 2022 2010 2009 511 2016 593 SKUPAJ 13.579 2010 382 2017 1.517 ČVRSTI ORGANI Število vpisanih v registru opredeljenih oseb glede darovanja organov in tkiv po letih v obdobju 2004–2022 2010 Število vpisanih v register po letih 1.760 1.517 1.252 976 750 739 383 460 630 593 511 382 308 378 312 299 228 91 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 31 ČVRSTI ORGANI STOPNJA PRIVOLITEV SVOJCEV ZA DAROVANJE Pogovor s svojci oz. bližnjimi osebami možnega mrtvega darovalca glede darovanja se opravi v vseh primerih, ko je mogoče izpeljati postopke za darovanje organov za presaditev in odvzem od umrle osebe. Transplantacijski koordinator po potrditvi smrti in vpisu časa smrti preveri v registru, ali je bil umrli opredeljen kot darovalec organov. Kljub znani opredelitvi je treba v skladu z veljavno zakonodajo s svojci umrlega opraviti pojasnilni pogovor o darovanju. V primeru privolitve se nato v nadaljevanju pogovora pridobijo dodatni zdravstveni podatki, ki so pomembni za darovanje. Če volja umrlega ni znana, glede darovanja odločajo svojci. Pogovor je v tem primeru za zdravstveno osebje in še posebej za svojce bistveno zahtevnejši. Vsi postopki so izvedeni z visoko stopnjo sočutja, razumevanja izjemno težkih čustvenih okoliščin ter v skladu z zakonodajnimi določbami in medicinsko doktrino. V letu 2022 je soglasje za odvzem organov po smrti bližnjega podalo 68 % svojcev. Slovenija-transplant svojcem umrlih darovalcev nudi možnost posvetovanja ob žalovanju s strokovno usposobljenimi in izkušenimi strokovnjaki. Odstotki privolitev za darovanje v obdobju od 1998 do 2022 32 Leto % Leto % Leto % Leto % Leto % 1998 79 2003 77 2008 80 2013 69 2018 66 1999 70 2004 70 2009 85 2014 80 2019 77 2000 63 2005 81 2010 80 2015 81 2020 76 2001 64 2006 80 2011 86 2016 76 2021 84 2002 78 69 2017 83 2022 68 2007 85 2012 Vir: arhiv Slovenija-transplanta ČVRSTI ORGANI Odstotki privolitev za darovanje v obdobju od 1998 do 2022 90 Odstotki privolitev po letih 85 86 85 84 83 80 81 79 78 80 80 80 80 77 81 77 76 76 70 70 70 69 69 68 66 60 63 64 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 33 ČVRSTI ORGANI DELOVANJE DONORSKIH BOLNIŠNIC V slovenski donorski program je vključenih enajst donorskih bolnišnic oz. centrov: UKC Ljubljana in UKC Maribor ter splošne bolnišnice v Celju, Murski Soboti, Novi Gorici, Izoli, Novem mestu, Slovenj Gradcu, Brežicah, na Ptuju in Jesenicah. V donorskih bolnišnicah izvajajo naslednje dejavnosti: • prepoznavajo možne umrle 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 – na oddelkih intenzivne medicine in med odvzemom organov, • sodelujejo pri odvzemih organov in tkiv, ki jih izvajajo slovenske in tuje kirurške ekipe. Največ darovalcev v Sloveniji pridobijo v UKC Ljubljana, kjer imajo največje skupno število postelj na oddelkih intenzivne medicine. V letu 2022 so pridobili 22 dejanskih umrlih darovalcev. Donorski program učinkovito izvajajo tudi v UKC Maribor, kjer so pridobili 17 dejanskih umrlih darovalcev, in v SB Celje s petimi pridobljenimi dejanskimi umrlimi darovalci. Po dva dejanska darovalca so imeli v SB Murska Sobota in SB Slovenj Gradec, enega pa v SB Nova Gorica. 34 ČVRSTI ORGANI Število in delež dejanskih umrlih darovalcev v posameznih donorskih bolnišnicah (DC) v letu 2022 Donorska bolnišnica Število MD Delež v % UKC Ljubljana skupaj 22 44,9 Od tega ONIT* 6 Od tega CIT 7 SB MS 4,1 SB SG 4,1 SB CE 10,2 SB NG 2 Od tega KOIIM 6 Od tega KOOKIT 1 Od tega KVIT 1 Od tega RC 1 UKC Maribor 17 37,7 SB Celje 5 10,2 UKC MB 37,7 49 SB Murska Sobota 2 4,1 SB Slovenj Gradec 2 4,1 SB Nova Gorica 1 2 SB Ptuj 0 SB Brežice 0 UKC Ljubljana SB Novo mesto 0 UKC Maribor SB Jesenice 0 SB Celje SKUPAJ 49 UKC LJ 44,9 * ONIT – oddelek nevrološke intenzivne terapije, CIT – centralna intenzivna terapija, KOIIM – klinični oddelek interne intenzivne medicine, KOOKIT – klinični oddelek za otroško kirurgijo in intenzivno terapijo, KVIT – kardiovaskulrna intenzivna terapija, RC – respiratorni center IT KV KIT KOO 22 LEGENDA 100 RC KOIIM ONIT CIT SB Murska Sobota SB Slovenj Gradec SB Nova Gorica Vir: arhiv Slovenija-transplanta 35 ČVRSTI ORGANI Število dejanskih umrlih darovalcev v posameznih donorskih centrih v letu 2022 SB Mursk Murska sobota so 2 UKC Marib Maribor 17 SB Jesenice SB Ptuj 0 SB Celje 5 UKC Ljubljana SB Novaa Gorica 1 22 SB Brežice 0 SB Novo mesto 0 Vir: arhiv Slovenija-transplanta SB Izola 0 36 17. marca 2022 smo slovesno razglasili rezultate I. nagradnega natečaja Slovenija-transplanta za najboljše raziskovalno delo s področja donorske medicine/dejavnosti. 1. nagrada (800 €) Veronika Prtenjak: Pravne dileme darovanja človeških organov – darovanje ali trgovanje? 2. nagrada (500 €) Eneja Kovač: Človeško telo kot premoženje 3. nagrada (200 €) Ana Sevšek: Doživljanje svojcev pri odločitvi o darovanju organov možgansko mrtvega družinskega člana ČVRSTI ORGANI od 1998 do 2022 Vir: arhiv Slovenija-transplanta 38 Leto UKC LJ UKC MB SB CE SB MS SB NG SB Izola SB Ptuj SB JE SB NM SB SG 1998-2009 176 95 22 7 10 9 7 6 3 4 2010 26 8 2 2 1 2011 21 6 2 2012 22 8 9 3 2013 21 8 7 5 2014 31 4 3 1 2015 25 11 10 2016 28 2 7 2017 22 7 4 2018 18 13 4 2019 15 8 6 2020 22 7 5 2021 20 7 5 5 2022 22 17 5 2 1 SKUPAJ 469 201 91 31 26 1 1 1 3 1 2 1 1 1 2 2 1 1 2 1 2 1 2 1 1 3 1 1 1 1 SB Brežice 1 1 1 1 1 1 2 1 3 1 1 1 1 1 1 2 17 15 14 8 8 2 ČVRSTI ORGANI Število dejanskih umrlih darovalcev po donorskih centrih od 1998 do 2022 60 200 882 umrlih darovalcev v SLO od 1998 do 2022 50 LEGENDA 180 UKC Ljubljana 160 40 UKC Maribor SB Celje 140 SB Murska Sobota 120 30 SB Izola SB Jesenice 100 SB Nova Gorica 80 20 SB Ptuj SB Novo mesto 60 SB Slovenj Gradec 40 10 SB Brežice 20 0 193 146 1998 - 2009 0 40 31 46 45 43 2010 0110 2011 20 2012 2013 2014 53 41 39 40 38 39 38 49 2015 2016 2017 2018 2019 2020 2021 2022 39 ČVRSTI ORGANI Potencial in realizacija v donorskih bolnišnicah za leto 2022 Potencial za darovanje za posamezno donorsko bolnišnico se izraža kot odstotek možgansko umrlih od vseh umrlih na oddelku za intenzivno medicino (OIM). Pove nam, pri koliko umrlih je bila do konca izpeljana diagnostika možganske smrti. Potencial je v neposredni povezavi z odkrivanjem primernih darovalcev na OIM. 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 Vir: arhiv Slovenija-transplanta možgansko umrlih na OIM. 40 Donorska bolnišnica Vse smrti v OIM MD PD *Potencial (%) Dosegljivi (%) AD Realizacija (%) **Dosegljiva (%) UKC Ljubljana 372 64 41 11 13,7 25 61 65 UKC Maribor 228 32 26 11.4 13.7 18 69 65 SB Celje 179 11 10 5.6 8.3 8 80 55 SB Murska Sobota 133 12 5 3.8 8.3 2 40 55 SB Novo mesto 96 2 1 1 8.3 0 / 55 SB Nova Gorica 84 1 1 1.2 8.3 1 100 55 SB Slovenj gradec 60 4 3 5 8.3 2 67 55 SB Izola 58 1 1 1.7 8.3 0 / 55 SB Ptuj 56 0 0 0 8.3 0 / 55 SB Jesenice 43 0 0 0 8.3 0 / 55 SB Brežice 22 1 1 4.5 8.3 0 / 55 OIM – oddelek za intenzivno medicino, MD – možni darovalec, PD – primerni darovalec (dokazana možganska smrt), AD – aktivni darovalec (privolitev svojcev, odvzem organov), Potencial - % možgansko umrlih od vseh umrlih na OIM = % PD/vse smrti na OIM. Realizacija - % aktivnih darovalcev od vsem možgansko umrlih = % AD/PD ČVRSTI ORGANI *Potencial za donorsko bolnišnico je pričakovano višji za bolnišnice, ki imajo lastno nevrokirurško enoto in lahko dosežejo potencial tudi do 13,7 % (dosegljivi potencial). V letu 2022 se je UKC Ljubljana približal svojemu potencialu, saj OIM po marcu niso bili več prezasedeni s kovidnimi pacienti. Tudi bolnišnični koordinatorji za transplantacije, ki pravočasno prepoznavajo možne darovalce, so se vrnili na svoja redna delovišča. UKC Maribor je v letu 2022 naredil izjemen korak naprej in po doseženem potencialu celo prehitel UKC Ljubljana. Razlogi za tak uspeh so enaki kot v Ljubljani, poleg tega pa je izjemna ekipa koordinatorjev, kot prva v celotni nacionalni donorski mreži, začela uvajati program po novih smernicah pri zdravljenju in oskrbi kritično bolnih v enotah intenzivne medicine in možnosti za darovanje organov in tkiv po smrti (program ICOD). Za bolnišnice brez lastne nevrokirurške enote je dosegljivi potencial za darovanje do 8,3 %. Tej številki se je leta 2022 ponovno najbolj približala SB Celje; blizu so bile še SB Murska Sobota, SB Slovenj Gradec in SB Brežice, kjer pa ni bilo aktivnega darovalca zaradi odklonitve svojcev. Enega aktivnega darovalca je imela v letu 2022 SB Nova Gorica, v preostalih petih donorskih bolnišnicah pa ni bilo nobenega aktivnega darovalca, predvsem zaradi specifičnih lastnosti sprejetih bolnikov, pomanjkljive osveščenosti lečečih zdravnikov o detekciji možnih/primernih darovalcev in zaradi zavrnitve darovanja s strani svojcev. **V letu 2022 je pet donorskih bolnišnic, v katerih je bil vsaj en aktivni darovalec, preseglo dosegljivo realizacijo, in to kljub zelo visoki stopnji odklonitve soglasja svojcev pri pogovoru o darovanju (UKC LJ 38 % in UKC MB 32 % odklonitev). Rezultati na področju realizacije so tako dobri zaradi izjemnega dela, ki so ga v letu 2022 opravile ekipe, zadolžene za prepoznavanje darovalcev na oddelkih za intenzivno medicino, v primeru UKC Maribor pa tudi na Urgenci v sklopu prej omenjenega programa ICOD. V SB Murska Sobota je bila realizacija le 40-odstotna, odklonitev svojcev za darovanje pa kar 60-odstotna. Pri nizkih vrednostih potenciala zasledimo tudi odstopanja, kot npr. v SB Nova Gorica, kjer so dosegli 100-odstotno realizacijo pri edinem primeru, pri katerem ni bilo medicinskih kontraindikacij za darovanje, prav tako pa so svojci v darovanje privolili. V takih primerih je večletna bilanca natančnejša in v skladu s pričakovanimi rezultati. Pri bolnišnicah, v katerih leta 2022 ni bilo dokazanih možganskih smrti in ni bilo aktivnih darovalcev, sta potencial in realizacija prav tako 0 % oziroma nemerljiva (/). 41 ČVRSTI ORGANI Seznam odgovornih oseb (t. i. bolnišničnih transplantacijskih koordinatorjev), ki skrbijo za razvoj, potek ter delovanje donorskega programa v posameznih donorskih centrih za leto 2022 42 Donorski center Odgovorne osebe UKC Ljubljana prim. asist. mag. Rade Stanić, dr. med. UKC Maribor Tanja Kuprivec (do septembra)/Natalija Krope, 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 Čerkini, dr. med. SB Novo mesto Matej Godnič, dr. med. SB Ptuj Mateja Prevolšek, dr. med. SB Slovenj Gradec Rok Popič, dr. med. NA JAVNEM NATEČAJU NAJBOLJŠE PRAKSE V ZDRAVSTVU 2021 SMO PREJELI PRIZNANJE FINALISTI IZBORA 2021 (NAJBOLJŠI V KATEGORIJI TERCIARNA ZDRAVSTVENA DEJAVNOST) Portorož, 18. junij 2021 FOTO: Slovenija-transplant Izobraževanje: Osnove donorskega programa v Splošni bolnišnici Celje, 14. september 2022. FOTO: Slovenija-transplant ČVRSTI ORGANI PRIDOBLJENI ČVRSTI ORGANI ZA NAMEN ZDRAVLJENJA Število pridobljenih organov je odvisno od števila pridobljenih umrlih darovalcev, od njihove starosti in medicinskih kontraindikacij ter od vzdrževanja primerne funkcije organov pri umrlem darovalcu po dokazani možganski smrti. V letu 2022 je bilo število umrlih darovalcev visoko in delo bolnišničnih transplantacijskih koordinatorjev (BTK) med vzdrževanjem primernega darovalca izjemno, posledično pa smo pridobili tudi več organov. Darovalci so podarili 172 organov, kar je najvišje število po letu 2013. V nadaljevanju so prikazani podatki za leto 2022 in primerjava s preteklimi leti. Število pridobljenih organov slovenskih umrlih darovalcev v letu 2022 Ledvica Srce Jetra Pljuča (obe pljučni krili) Trebušna slinavka SKUPAJ 82 24 45 20 1 172 Vir: arhiv Slovenija-transplanta 20 1 82 45 LEGENDA Ledvica Srce Jetra Pljuča Trebušna slinavka 44 24 ČVRSTI ORGANI Pridobljeni organi slovenskih umrlih darovalcev od leta 2000 do 2022 Leto Ledvica Srce Jetra Pljuča (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 2021 60 13 32 18 2 125 2022 82 24 45 20 1 172 SKUPAJ 1.544 388 695 231 126 2.984 Vir: arhiv Slovenija-transplanta 45 ČVRSTI ORGANI Pridobljeni organi slovenskih umrlih darovalcev od 2010 do 2022 1.915,5 pridobljenih organov umrlih darovalcev v SLO od 2010 do 2022 100 90 80 158 105 166 178 147 170 135,5 146 142 132 136 125 172 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 70 60 50 40 30 20 10 0 LEGENDA Ledvica 46 Srce Jetra Pljuča Trebušna slinavka ČVRSTI ORGANI PRESAJENI ČVRSTI ORGANI V Sloveniji imamo en transplantacijski center, to je Univerzitetni klinični center v Ljubljani, kjer se izvajajo programi za presaditve čvrstih organov. Sistem razporejanja organov zagotavlja enako dostopnost do zdravljenja s presaditvijo organov vsem državljanom Slovenije. Naloge transplantacijskega centra so: • • • priprava prejemnikov za uvrstitev na čakalni seznam, presaditev organov, vodenje bolnikov po presaditvi. Center za transplantacijsko dejavnost (CTD) v UKC Ljubljana od leta 2014 vodi kardiovaskularni kirurg, doc. dr. Ivan Kneževič, dr. med. V letu 2022 je bilo opravljenih 111 presaditev organov, od tega je bilo 109 organov pridobljenih od umrlih darovalcev, dve ledvici pa od živih darovalcev. Največ je bilo presajenih ledvic. Po številu presajenih organov od umrlih darovalcev na milijon prebivalcev smo nekoliko nad povprečjem držav Eurotransplanta. Pomembno višje pa je število presaditev src na milijon prebivalcev, kjer smo v letu 2022 ponovno zasedli prvo mesto na svetu. Pediatrične transplantacije delno opravljajo v UKC Ljubljana, za najmlajše otroke pa v bližnjih evropskih transplantacijskih centrih (ledvice v Gradcu, jetra v Bergamu). Za obravnavo in pripravo pred presaditvijo in zdravljenje ter sledenje bolnika po presaditvi organa poskrbijo na pristojnih oddelkih v UKC Ljubljana. 47 ČVRSTI ORGANI Presajeni čvrsti organi umrlih darovalcev v UKC Ljubljana v letu 2022 in primerjava z Eurotransplantom absolutno število in število na milijon prebivalcev (NMP) Ledvica MD Srce Jetra Pljuča Trebušna slinavka SKUPAJ Št. NMP Št. NMP Št. NMP Št. NMP Št. NMP Št. NMP SLO 51 24,2 29 13,8 18 8,5 10 7,1 1 0,5 109 51,7 ET 2993 21,6 645 4,7 1456 10,9 604 4,4 114 0,9 5812 42,4 Vir: arhiv Slovenija-transplanta in http://statistics.eurotransplant.org/ 25 20 15 10 5 0 21,6 24,2 4,7 LEDVICA MD LEGENDA 48 13,8 SRCE ET 10,9 8,5 JETRA SLO 4,4 PLJUČA 7,1 0,9 0,5 TREBUŠNA SLINAVKA ČVRSTI ORGANI Število presajenih čvrstih organov umrlih darovalcev na milijon prebivalcev (NMP) v Sloveniji leta 2022 in primerjava z državami Eurotransplanta Država ET Ledvica Jetra Srce Pljuča Trebušna slinavka Število presaditev/NMP 1. Belgija (BE) 36,4 23,1 5,4 8,2 1,9 75 2. Avstrija (AV) 31,3 18,6 6,9 11,4 2 70,2 3. Hrvaška (HR) 26,3 22,9 9,8 2,6 1,5 63,1 4. Slovenija (SLO) 24,2 8,5 13,8 4,7 0,5 51,7 5. Nizozemska (NL) 28 10,5 2,9 6,9 2 50,3 6. Nemčija (NE) 17,2 8,5 4,3 3,1 0,5 33,6 7. Madžarska (MAD) 19,6 6,9 4,1 1,2 0,4 32,2 Vir: arhiv Slovenija-transplanta in http://statistics.eurotransplant.org/ NMP 75 70,2 63,1 51,7 50,3 33,6 32,2 50 LEGENDA 40 Ledvica 30 Jetra 20 Srce 10 Pljuča Trebušna slinavka 0 BE AV HR SLO NL NE MAD 49 ČVRSTI ORGANI Število presajenih čvrstih organov umrlih darovalcev v Sloveniji oz. slovenskim prejemnikom od leta 1970 do 2022 50 Leto Ledvica Od 1970 do 1985 1 Srce Jetra Pljuča* Trebušna slinavka SKUPAJ 1 1986 7 7 1987 18 18 1988 16 16 1989 14 1990 17 1991 11 11 1992 20 20 14 1 1 19 1993 4 1 5 1994 14 2 16 1995 10 3 1996 6 2 1997 19 6 1998 46 4 4 1999 37 7 9 3 56 2000 44 7 10 1 62 2001 47 4 9 1 61 2002 55 3 11 2003 43 3 9 2004 55 3 15 1 14 8 1 26 54 69 2 57 73 Vir: arhiv Slovenija-transplanta ČVRSTI ORGANI Leto Ledvica 2005 2006 Trebušna slinavka Srce Jetra Pljuča* 28 5 13 2 48 48 8** 8 2 66 2007 30 11 10 1 52 2008 52 6 22 4 2009 43 18 18 2 2 83 2010 61 19 23 3 1 107 1 SKUPAJ 84 2011 46 14 20 7 2012 62 29*** 27 2 88 2013 60 30 21 8 2014 55 33 31 3 2015 64 24 24 7 5 2016 44 31 27 10 5 2017 46 24 23 8 2018 54 23 27 7 3 2019 38 22 24 11 1 96 2020 46 24 25 16 2 113 2021 51 17 21 15 2022 51 29 18 10 1 109 SKUPAJ 1.363 413 450 126 26 2.378 120 4 123 122 124 117 101 114 104 * Večina presaditev pljuč pri slovenskih prejemnikih je bila do vključno 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 pljuč in ena pediatrična presaditev v AKH Dunaj, v letu 2020 in 2021 so bile vse presaditve opravljene v UKC Ljubljana. ** Eno srce slovenskega darovalca je bilo p resajeno slovenskemu bolniku v Gradcu. *** Eno srce je bilo skupaj s pljuči presajeno slovenskemu bolniku na Dunaju 51 ČVRSTI ORGANI Število presajenih čvrstih organov umrlih darovalcev v Sloveniji oz. slovenskim prejemnikom od leta 1970 do 2006 140 120 100 80 60 40 20 1 0 5 98 0-1 7 19 7 18 16 14 19 11 20 5 16 14 8 26 54 56 62 61 69 57 73 48 65 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 52 Srce Jetra Pljuča Trebušna slinavka ČVRSTI ORGANI Število presajenih čvrstih organov umrlih darovalcev v Sloveniji oz. slovenskim prejemnikom od leta 2007 do 2022 2.378 presajenih čvrstih organov umrlih darovalcev v SLO od 1970 do 2022 140 120 100 80 60 40 20 0 52 84 83 107 88 120 123 122 124 117 100 114 96 113 104 109 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Vir: arhiv Slovenija-transplanta LEGENDA Ledvica Srce Jetra Pljuča Trebušna slinavka 53 ČVRSTI ORGANI Število presajenih ledvic od živega darovalca V Sloveniji je za časa življenja možno darovati ledvico le med sorodniki ali čustveno povezanimi osebami. Vsak primer presoja Etična komisija za presaditve, ob upoštevanju načela, da mora biti tveganje za zdravje darovalca sorazmerno pričakovani koristi za prejemnika. Ob začetku slovenskega transplantacijskega programa, od leta 1970 dalje, so sprva prevladovale presaditve ledvic od živih sorodnih darovalcev, od leta 1987 naprej pa je bila z razvojem nacionalnega donorskega programa večina organov za presaditev pridobljena od umrlih darovalcev. Programa presaditev ledvice živega darovalca nekaj let niso izvajali, od leta 2016 dalje pa v UKC Ljubljana opravijo 1–2 presaditvi na leto. V letu 2022 sta bili opravljeni dve tovrstni presaditvi. Število presajenih ledvic od živega darovalca 1970 - 2022 Leto Št. Leto Št. Leto Št. Leto Št. Leto Št. Leto Št. 1970-85 43 1992 5 1999 0 2006 0 2013 0 2020 1 1986 23 1993 5 2000 0 2007 1 2014 0 2021 1 1987 14 1994 0 2001 0 2008 0 2015 0 2022 2 1988 13 1995 1 2002 0 2009 1 2016 2 1989 10 1996 2 2003 0 2010 0 2017 2 1990 2 1997 2 2004 0 2011 0 2018 2 1991 3 1998 1 2005 0 2012 0 2019 0 SKUPAJ 54 136 ČVRSTI ORGANI Deleži presajenih ledvic živih in umrlih darovalcev v % od 1970 do 2022 % 100 2 23 56 78 58 89 79 80 44 98 77 44 22 42 11 21 20 56 1986 1987 1988 1989 1990 1991 1992 1993 97 100 98 100 100 100 100 100 91 75 90 98 9 25 10 2 1994 1995 1996 1997 100 96 96 96 100 100 100 100 100 100 100 100 1998 1999 2000 2001 2002 2003 2004 2005 100 98 98 96 80 60 40 20 0 1970-85 % 100 100 LEGENDA 80 Delež presajenih ledvic živih darovalcev = SKUPAJ 12,2 % 60 Delež presajenih ledvic umrlih darovalcev 40 = SKUPAJ 87,8 % 20 3 0 2006 2007 2 2008 2009 2010 2011 2012 2013 2014 2015 4 4 4 2016 2017 2018 2019 2 2 4 2020 2021 2022 55 ČVRSTI ORGANI REZULTATI PRI BOLNIKIH, ZDRAVLJENIH S PRESADITVIJO Program za presaditev srca Od leta 1990 do konca 2022 je bilo v UKC Ljubljana opravljenih 412 presaditev srca, v letu 2022 so presadili 29 src. Kar 26 bolnikov (93 %) je bilo transplantiranih urgentno, dva bolnika (7 %) pa redno. UKC Ljubljana s svojim programom za presaditve srca sodi med največje centre za presaditev srca v območju Eurotransplanta in se po številu opravljenih presaditev lahko primerja z največjimi centri v Nemčiji, Belgiji, na Madžarskem in v Avstriji. Na področju Eurotransplanta je skupaj 42 centrov, ki opravljajo presaditve srca. Večletno povprečje (2009–2022) čakalne dobe za elektivno presaditev srca znaša okoli 250 dni, za urgentno presaditev srca pa približno 50 dni. 56 Najpogostejša vzroka za presaditev srca sta bila v letu 2022 dilatativna kardiomiopatija (48 %) in ishemična bolezen srca (31 %). Ostali vzroki so bili valvularna bolezen srca (7 %), aritmogena kardiomiopatija (7 %), hipertrofična kardiomiopatija (3,5 %) in kongenitalne hibe (3,5 %). Rezultati preživetja bolnikov po presaditvi so primerljivi z rezultati iz mednarodnega referenčnega registra ISHLT (The International Society for Heart & Lung Transplantation). Preživetje odraslih bolnikov po presaditvi srca v % (za obdobje 1990–2022, n = 412) 30-dnevno preživetje Enoletno preživetje Petletno preživetje 93 % 89 % 77 % Vir: Poročilo o delovanju programa za napredovalo srčno popuščanje in presaditev srca za leto 2022 (KO za kardiologijo, UKC Ljubljana) 100 75 93 89 77 50 25 0 % 30-dnevno 30-dne 30dnevno vno Eno Enolet letno no Enoletno PREŽIVETJE Petlet Pet letno no Petletno ČVRSTI ORGANI Program za presaditev ledvic V Sloveniji je bilo v obdobju po priključitvi Eurotransplantu (1. 1. 2000–31. 12. 2022) presajenih 1.135 ledvic, od tega 1.123 ledvic, podarjenih od umrlih, in 12 ledvic od živih darovalcev. Nekaterim prejemnikom so ledvico presadili v kombinaciji z drugimi organi, in sicer petindvajsetim skupaj s trebušno slinavko, šestim skupaj s srcem in trem skupaj z jetri. V letu 2022 je bilo presajenih skupaj 53 ledvic, od tega 51 od umrlega in dve od živega darovalca. V prvem letu po presaditvi so v obdobju 1. 1. 2000–31. 12. 2022 pri 12,7 % vseh bolnikov s presajenim organom zaznali klinično, z biopsijo dokazano akutno zavrnitev presadka; v letu 2022 se je to zgodilo pri 7,5 % vseh pacientov. Preživetje bolnikov in presadkov po presaditvi ledvice v % (za obdobje 2000–2022, n = 1.135) Enoletno preživetje Petletno preživetje Bolniki 98,1 % 93,6 % Presadki 94 % 86,3 % 94,9 %* 90,1 %* 100 94,9* 95 90,1* 90 85 Mediani čas od uvrstitve na čakalni seznam do presaditve je približno 370 dni za obdobje 2010–2022. V letu 2022 je bil mediani čas od vključitve na čakalni seznam do presaditve 214 dni (v letu 2021 566 dni). 80 75 70 98,1 94 93,6 86,3 65 60 % Enoletno Enolet Eno E letno noo Petlet Pet letnno n Petletno PREŽIVETJE Vir: Kazalniki kakovosti Centra za transplantacijo ledvic (KO za nefrologijo, UKC Ljubljana) * Zmanjšano za % bolnikov, ki so umrli z delujočim presadkom LEGENDA % bolnikov % presadkov 57 ČVRSTI ORGANI Program za presaditev jeter V obdobju od leta 1995 do 31. 12. 2022 je bilo v UKC Ljubljana skupaj opravljenih 450 presaditev jeter pri 406 bolnikih. 374 (92 %) presaditev je bilo rednih, zaradi zapletov jetrne ciroze oz. kroničnih jetrnih bolezni in jetrnih tumorjev, 32 (8 %) pa urgentnih, zaradi akutne jetrne odpovedi. Ponovno presaditev je potrebovalo 41 (10 %) bolnikov. Po ena bolnica je imela presaditev jeter zaradi HCC, Abernethyevega sindroma in zapletov jetrne ciroze, povzročene z avtoimunskim hepatitisom. Povprečna čakalna doba za redno presaditev jeter je v letu 2022 znašala 67 dni (mediana 62 dni). V primeru urgentne presaditve jeter je ustrezen organ navadno na voljo v nekaj dneh. V letu 2022 so v UKC Ljubljana opravili 18 presaditev jeter pri 18 bolnikih, od tega devetim moškim in devetim ženskam. Pri 17 bolnikih je bila presaditev redna, zaradi zapletov kronične jetrne bolezni, ena presaditev pa je bila urgentna, zaradi akutne jetrne odpovedi. 58 Petim bolnikom (27,8 %, 3 moški in 2 ženski) so bila presajena jetra zaradi primarnega sklerozirajočega holangitisa (PSC), dvema moškima (11,1 %) zaradi kriptogene in dvema moškima (11,1 %) zaradi etilične jetrne ciroze. Dvema bolnicama (11,1 %) so jetra presadili zaradi primarnega biliarnega holangitisa (PBC) in dvema bolnicama (11,1 %) zaradi policistične bolezni jeter. Pri eni od slednjih je bila sočasno presajena tudi ledvica. Enemu bolniku so jetra presadili zaradi jetrne ciroze ob kroničnem hepatitisu B in enemu bolniku zaradi akutne jetrne odpovedi, do katere je prišlo po obsežni resekciji jeter zaradi hepatocelularnega karcinoma (HCC). Preživetje bolnikov po presaditvi jeter v % (za obdobje 1988–2022) Enoletno preživetje Triletno preživetje Petletno preživetje 84 % 79 % 76 % Vir: Poročilo o delovanju programa za presaditev jeter za leto 2022 (KO za gastroenterologijo, UKC Ljubljana) LEGENDA Bolniki 85 80 75 70 65 84 79 Enoletno Triletno 76 60 % PREŽIVETJE Petletno ČVRSTI ORGANI Program za presaditev trebušne slinavke (sočasno z ledvico) V obdobju od februarja 2009 do 31. 12. 2022 je bilo v Sloveniji opravljenih 25 sočasnih presaditev ledvice in trebušne slinavke. V letu 2022 je bila opravljena ena sočasna presaditev. V celotnem obdobju od prve presaditve leta 2009 do 31. 12. 2022 je bilo pet trebušnih slinavk zaradi zapletov odstranjenih v zgodnjem potransplantacijskem obdobju. En bolnik je umrl v zgodnjem potransplantacijskem obdobju zaradi okužbe, trije bolniki pa v poznem potransplantacijskem obdobju. Konec leta 2022 je bilo v Sloveniji 16 bolnikov z delujočo presajeno trebušno slinavko in ledvico. Vsi bolniki z delujočo trebušno slinavko so bili inzulinsko neodvisni. Preživetje bolnikov in presadkov po sočasni presaditvi trebušne slinavke in ledvice v % (za obdobje 2009–2022, n = 25 (bolniki) in n = 20 (presadki) Enoletno preživetje Triletno preživetje Petletno preživetje Bolniki 96 % 96 % 96 % Presadki T. slinavka Ledvica T. slinavka Ledvica T. slinavka Ledvica 76 % 92 % 76 % 92 % 76 % 92 % Vir: Poročilo – izr. prof. dr. Damjan Kovač, dr. med. (KO za nefrologijo, UKC Ljubljana) PREŽIVETJE / PRESADKI / BOLNIKI 100 95 90 LEGENDA 85 Trebušna slinavka 80 75 Ledvica 70 Bolniki 65 76 92 96 76 92 96 76 92 59 60 % 96 Enoletno Triletno Petletno ČVRSTI ORGANI Program za presaditev pljuč Preživetje bolnikov po presaditvi pljuč v % (za obdobje 1997–2022)* V obdobju 1997–2022 je bilo pri slovenskih bolnikih opravljenih 126 presaditev pljuč. 72 presaditev je bilo opravljenih v bolnišnici AKH na Dunaju (do leta 2019), od tega ena ponovna presaditev ter ena kombinirana presaditev srca in pljuč. V letu 2022 so v UKC Ljubljana opravili 10 presaditev pljuč, pri devetih bolnikih je bila opravljena presaditev obeh pljučnih kril. V enem primeru je šlo za ponovno presaditev. Najpogostejša vzroka za presaditev pljuč v UKC Ljubljana sta bili kronična obstruktivna pljučna bolezen (38 %) in pljučna fibroza (21 %). Presaditve pri bolnikih s cistično fibrozo so postale redke zaradi uvedbe zelo učinkovitih zdravil za to bolezen. Zadnja presaditev s to indikacijo je bila v letu 2020. V letu 2022 presaditev zaradi posledic bolezni covid-19 ni bilo. Enoletno preživetje Triletno preživetje Petletno preživetje Bolniki 83,5 % 79,6 % LEGENDA 74 % Bolniki 85 80 75 70 65 83,5 79,6 74 60 Mediana čakalna doba za presaditev pljuč v obdobju 2018–2022 je bila 91 dni, za nujne presaditve pa sedem dni. Vir: Poročilo o delovanju programa za presaditev pljuč (doc. dr. Matevž Harlander, dr. med., predstojnik KO za pljučne bolezni in alergologijo, UKC Ljubljana) 60 % Enoletno Triletno Petletno PREŽIVETJE *Desetletno preživetje slovenskih bolnikov po presaditvi pljuč je 60,0 %. Pri bolnikih, ki so jim pljuča presadili v UKC Ljubljana, je bilo v obdobju 2018–2022 enoletno preživetje 83,9-odstotno in triletno preživetje 80,1-odstotno. Tkiva in celice 61 TKIVA IN CELICE PRESADITVE KRVOTVORNIH MATIČNIH CELIC Presaditev krvotvornih matičnih celic (KMC) je najbolj razširjena oblika celičnega zdravljenja. Na ta način se zdravi več kot 70 malignih in nemalignih bolezni, pri določenih hematoloških obolenjih pa je presaditev glavna terapevtska in tudi edina možnost za ozdravitev. Sodoben način zdravljenja s KMC v optimalnih pogojih dosega več kot 90-odstotno uspešnost (http://www.ztm. si). Za takšen uspeh pa je potrebno dobro imunsko (HLA) ujemanje darovalca in prejemnika. Zato je Slovenija vključena v svetovni register Bone Marrow Donors Worldwide (BMWR), v katerem so vpisani prostovoljni darovalci, ki so tipizirani. V primeru skladnosti se izvedejo postopki za odvzem in presaditev. V nekaterih primerih je za zdravljenje možno uporabiti lastne KMC, kar imenujemo avtologno darovanje. Pogosteje gre za darovanje na osnovi ustrezne tkivne skladnosti med sorodniki. Po slovenski zakonodaji se lahko izvedeta tudi odvzem in presaditev med nesorodnimi osebami, pri čemer se upošteva princip anonimnosti. Darovanje drugega darovalca imenujemo tudi alogensko, pri čemer iščemo 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 član svetovnega registra Bone Marrow Donors Worldwide (BMDW). Na dan 31. 12. 2022 je bilo v register Slovenija Donor vpisanih 25.190 oseb, od tega jih je bilo v svetovni register BMDW vpisanih 21.727. 62 TKIVA IN CELICE Presaditve KMC v Sloveniji od leta 2000 do 2022 Tip presaditve 2000-2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 AUTO 531 68 101 74 63 84 86 92 88 89 104 89 121 ALO-ŽSD 102 9 8 7 11 10 15 12 13 11 10 10 13 ALO-ŽND 84 18 22 31 26 24 26 28 26 31 17 23 27 95 131 112 100 118 127 132 127 131 131 122 161 AUTO in ALO-ŽSD 21 SKUPAJ 738 AUTO – avtologne presaditve, ALO – alogenske presaditve, ŽSD – živi sorodni darovalec, ŽND – živi nesorodni darovalec Vir: Letno poročilo ZTM – Slovenija donor, podatke mesečno zbiramo za arhiv Slovenija-transplanta. 2.225 presaditev KMC v SLO od 2000 do 2022 160 700 140 600 120 500 100 400 80 300 60 200 40 100 738 0 2000-2010 20 0 95 131 112 100 118 127 132 127 131 131 122 161 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 LEGENDA AUTO ALO-ŽSD ALO-ŽND AUTO in ALO-ŽSD 63 TKIVA IN CELICE PROGRAM PRIDOBIVANJA IN PRESADITVE ROŽENIC Zdravljenje s presaditvijo roženic je ena najpogostejših in tudi najuspešnejših presaditev tkiv pri nas in v svetu. Takšen način zdravljenja pogosto predstavlja edini način, s katerim izboljšamo vid zaradi predhodnega obolenja oz. poškodb. Pridobljene in presajene roženice od leta 2010 do 2022 64 180 Leto Št. pridobljenih roženic *Št. presajenih roženic 2010 122 72 140 2011 91 40 130 101 67 120 2013 116 74 110 2014 116 87 2015 102 76 2016 104 83 138 91 138 122 122 116 2018 84 66 2019 108 88 60 2020 92 72 50 2021 98 74 40 2022 172 122 102 108 104 87 74 72 67 83 98 92 91 91 90 80 116 101 100 70 * Podatki o presaditvah na Očesni kliniki UKC Ljubljana v obdobju 2010–2017, od leta 2018 dalje pa so vključene tudi presaditve na Oddelku za očesne bolezni UKC Maribor 172 160 2012 2017 Vir: arhiv Slovenija-transplanta 88 84 76 72 74 66 40 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 SKUPAJ 1.444 pridobljenih od 2010-2022 SKUPAJ 1.012 presajenih od 2010-2022 TKIVA IN CELICE V Sloveniji pridobivamo roženice od umrlih darovalcev po dokončni zaustavitvi srca ali po dokazani možganski smrti. Odvzem roženic je možen po predhodni privolitvi umrle osebe v času življenja oz. ob nenasprotovanju bližnjih. Poleg pridobljenega soglasja je potrebna še natančna ocena primernosti roženice za presaditev, ki jo sprejme prejemnikov zdravnik. Presaditev roženice izvajajo v dveh transplantacijskih centrih: na Očesni kliniki v UKC Ljubljana ter na Oddelku za očesne bolezni v UKC Maribor. Čakalni seznam bolnikov za presaditev roženice na Očesni kliniki v UKC Ljubljana (na dan 16. 1. 2023) in UKC Maribor (na dan 11. 1. 2023) Diagnoza Število bolnikov Keratokonus 41 Ostale diagnoze 240 SKUPAJ 281 281 bolnikov (275 UKC Ljubljana, 6 UKC Maribor) (100%) 281 LEGENDA Keratokonus: 41 bolnikov (15 %) Vir: UKC Vi KC Lj Ljubljana, blj b Očesna klinika; UKC Maribor, Oddelek za očesne bolezni Ostale diagnoze: 240 bolnikov (85 %) (poškodbe, degeneracija, retransplantacija, makule roženice, distrofija Fuchs, endotelna distrofija, cornea guttata, afaka in psevdofaka, keratopatija bullosa, vnetja, drugo) 65 TKIVA IN CELICE OSTALA TKIVA IN CELICE Sledljivost in transparentnost v programih presaditve oz. uporabe tkiv in celic za namen zdravljenja Ustanove za tkiva in celice morajo imeti veljavno dovoljenje za delo, ki ga izda Javna agencija za zdravila in medicinske pripomočke (JAZMP). Zavod Slovenija-transplant je odgovoren za sledljivost in transparentnost, kar zagotavljamo z zbiranjem in pregledovanjem sprotnih poročil ustanov za tkiva in celice, ki nam na osnovi zakonskih zahtev in sklenjenih pogodb poročajo o darovanju, pridobivanju, procesiranju, shranjevanju, dodeljevanju, uporabi in uničenju tkiv in celic. Po zaključku leta na osnovi letnih poročil posameznih ustanov za tkiva in celice v Slovenijatransplantu pripravimo zbirno letno poročilo. Prav tako smo pooblaščeni za pripravo letnega zaključnega poročila o hudih neželenih dogodkih in reakcijah ter ga posredujemo JAZMP, ki nato poroča Evropski komisiji. Ustanove za tkiva in celice ter zagotavljanje kakovosti in varnosti V Sloveniji je na nacionalni ravni v dejavnost preskrbe in uporabe tkiv in celic za zdravljenje vključenih 27 ustanov. Od tega je v program vključenih 15 bolnišnic in znotraj teh 40 kliničnih oddelkov. Glede na status je 18 ustanov za tkiva in celice javnih in devet zasebnih. Zasebne ustanove imajo dovoljenje izključno za avtologno pridobivanje tkiv in celic. Slovenija-transplant in JAZMP zagotavljata transparentno 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 vključeno v posamezne procese. 66 TKIVA IN CELICE 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 podatkov pa je vključen tudi Slovenija-transplant. Oploditev z biomedicinsko pomočjo in reproduktivne celice V Sloveniji so registrirani 4 centri za dejavnost oploditve z biomedicinsko pomočjo 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 področje spada po številu izvedenih postopkov med najobsežnejše. Pridobivanje in shranjevanje popkovnične krvi in popkovnice V Sloveniji pridobivamo in shranjujemo za namen lastne uporabe tudi krvotvorne matične celice iz popkovnične krvi in popkovnice ter drugih tkiv (npr. mlečni zobje). Dovoljenje za delo imajo ena javna tkivna banka – Zavod za transfuzijsko medicino (ZTM) in tri zasebne ustanove (Izvorna celica, Biobanka in FH-S). Javna banka popkovnične krvi pri ZTM je s 1. 12. 2014 prenehala sprejemati vzorce popkovnične krvi, saj je bilo zbranih in shranjenih zadostno število vzorcev, da lahko zadostijo potrebam v Sloveniji. Ne glede na to potekajo pogovori o nadaljevanju zbiranja in shranjevanja ne le za lastno uporabo, pač pa tudi za vsakogar, ki bi takšne celice potreboval. Gre za alogensko darovanje, ki bi bilo omogočeno z javnim financiranjem. Vir: http://www.ztm.si/register-darovalcev/javna-banka-popkovnicne-krvi/ 67 TKIVA IN CELICE Število pridobljenih tkiv in celic v obdobju od 2009 do 2022 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Koža* Leto 28 45 22 36 85 89 52 57 32 22 24 10 46 63 108 67 93 82 147 74 80 78 71 59 256 87 Kosti* 38 123 Mehkokostni presadki* 22 39 / 3 11 3 9 / 12 / / / 0 0 Hrustanec* 37 21 4 12 11 11 12 / / / / / 0 0 15.854 43.472 8.640 27.479 41.929 37.542 39.769 26.191 36.338 13.778 26.813 28.209 24.736 25.721 2017 2018 2019 2020 2021 2022 Reproduktivne celice (št. celic) *Enota: število odvzetih vzorcev Število uporabljenih tkiv in celic v obdobju od 2009 do 2022 2009 2010 2011 2012 2013 2014 2015 2016 Koža* Leto 36 10 14 34 67 23 31 28 / 20 3 / 47 43 Kosti* 23 47 57 97 59 62 92 82 72 71 81 101 123 90 Mehkokostni presadki* 12 / 2 2 3 4 3 5 2 3 5 4 2 6 Hrustanec* Reproduktivne celice* 15 / 3 7 4 9 5 1 / / 1 / 3 0 1.450 2.018 29.651 23.330 23.506 27.271 31.127 26.620 31.817 12.110 5.109 14.255 27.547 28.194 *Enota: število uporabljenih vzorcev 68 Vir: arhiv Slovenija-transplanta TKIVA IN CELICE Število enot pridobljene popkovnične krvi v obdobju od 2015 do 2022 2015 2016 2017 2018 2019 2020 2021 2022 Izvorna celica Ustanova / Leto 76 144 107 82 81 81 78 73 Biobanka 175 178 266 110 224 197 241 170 8 45 101 169 192 206 245 293 238 0* 0* 0* 0* 0* 0* 0* FH-S Neocelica *Ustanova prenehala z delovanjem Število enot pridobljene popkovnice v obdobju od 2015 do 2022 Ustanova / Leto 2015 2016 2017 2018 2019 2020 2021 2022 Izvorna celica 60 116 96 52 73 75 77 71 Biobanka 32 150 222 96 212 184 236 170 FH-S 8 42 96 114 196 213 247 301 198 0* 0* 0* 0* 0* 0* 0* Neocelica *Ustanova prenehala z delovanjem Vir: arhiv Slovenija-transplanta 69 NEŽELENI DOGODKI IN REAKCIJE Slovenija-transplant je odgovoren za obravnavo neželenih dogodkov in reakcij ter odklonov na področju preskrbe s tkivi in celicami zaradi presaditve, t. i. histovigilanco. Namen zbiranja poročil o neželenih dogodkih in reakcijah ali tudi postavitev suma nanje je zagotavljanje kakovosti izvajanja postopkov in s tem preprečevanja tveganja za zdravje pacientov, osebja, škode ali celo izgube tkiv in celic. Poročanje poteka na predpisanih obrazcih, za posamezen primer je treba oddati začetno in končno poročilo. Oba obrazca sta prilogi Pravilnika o histovigilanci. Poročanje poteka v več fazah: zaznava odklona, natančna ocena in opis primera, sprejem ustreznih ukrepov za preprečitev škode na tkivih in celicah ter ljudeh, poročanje pristojnim inštitucijam in obveščanje vseh ustanov za tkiva in celice, ki so dobile 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. kultura neobtoževanja, kar pomeni, da se spodbuja poročanje, iščejo se rešitve oz. izboljšave in ni obsojanja izvajalcev na osebni ravni. 70 Število neželenih dogodkov in reakcij od 2011 do 2022 SKUPAJ NEŽELENI DOGODKI = 87 SKUPAJ NEŽELENE REAKCIJE = 106 18 16 14 12 10 8 6 4 2 0 1 21 2011 0111 1 14 2012 220012 5 11 2013 2 01 3 30 8 17 17 22014 20 0 4 014 2015 220001 0155 LEGENDA Neželene reakcije 0 0 20 2016 4 7 2017 201 20 00177 0 2 220188 20 18 4 10 3 17 0 3 22019 20 0 19 22020 020 200 22021 20 021 2022 0 Vir: arhiv Slovenija-transplanta Neželeni dogodki 71 IZOBRAŽEVANJE IN OBVEŠČANJE STROKOVNE JAVNOSTI Izobraževanje in obveščanje zdravstvenih delavcev in delavk sta ključnega pomena za uspešen razvoj in delovanje donorske ter transplantacijske dejavnosti. V letu 2022 smo močno okrepili izobraževalne aktivnosti. Vse izobraževalne programe smo posodobili v skladu z novostmi in sodobnimi strokovnimi smernicami ter vključili oziroma okrepili predstavitev aktualnih tem, kot so darovanje organov po cirkulatorni smrti (DCD), možnosti aktivne detekcije možnih umrlih darovalcev, nove smernice pri zdravljenju in oskrbi kritično bolnih v enotah intenzivne medicine, možnosti za darovanje organov in tkiv po smrti (program ICOD) ter osnovna izhodišča preprečevanja trgovine z organi. Za obveščanje strokovne javnosti o novostih smo uvedli e-novičnik. Izobraževanje »Osnove donorskega programa« Osnovno izobraževanje izvajamo v vseh bolnišnicah, ki so vključene v donorsko dejavnost. Udeležencem predstavimo donorsko dejavnost, delovanje programa in rezultate. Izobraževanje smo v letu 2022 izvedli v šestih izbranih donorskih bolnišnicah: UKC Ljubljana (46 udeležencev), UKC Maribor (64 udeležencev), SB Celje (45 udeležencev), SB Murska Sobota (33 udeležencev), SB Izola (27 udeležencev) in SB Nova Gorica (24 udeležencev). Izobraževanj se je skupaj udeležilo 239 udeležencev, zdravnikov in medicinskih sester oz. zdravstvenikov, ki so vsa predavanja ocenili z visokimi ocenami. Razširjeno izobraževanje in usposabljanje za zdravstvene delavce 72 Intenzivni tečaj s področja pridobivanja in presaditve organov (Intermediate Training Course in Transplant Coordination) po programu TPM izvajamo v sodelovanju s špansko organizacijo DTI. Cilj tečaja je razvoj donorskega programa ter poglobljeno izobraževanje zdravnikov in ostalih sodelavcev v enotah za intenzivno medicino iz vseh donorskih bolnišnic. V letu 2022 smo tečaj izjemoma izvedli preko spleta z uporabo platforme za avdio in video komuniciranje. Udeležilo se ga je 30 udeležencev iz vseh slovenskih donorskih bolnišnic in mladi transplantacijski koordinatorji iz Slovenija-transplanta. Predavanja in delavnice so izvedli predavatelji iz Slovenija-transplanta in UKC Ljubljana, španski strokovnjaki pa so predstavili svetovne trende in novosti, s poudarkom na darovanju po cirkulatorni smrti (DCD), novih smernicah pri zdravljenju in oskrbi kritično bolnih v enotah intenzivne medicine ter možnostih za darovanje organov in tkiv po smrti (program ICOD). Delavnica »Sporočanje slabe novice in pogovor o darovanju« Glavni cilji delavnice so učenje komunikacijskih veščin in načinov sporočanja slabe novice, ustrezen odziv na žalovanje svojcev, izpeljava pogovora o darovanju organov in razumevanje vrednosti pomena odločitve za darovanje organov za žalujoče svojce. Delavnica je namenjena transplantacijskim koordinatorjem, zdravnikom in medicinskim sestram oz. zdravstvenikom, zaposlenim na oddelkih intenzivne medicine. V letu 2022 smo izvedli eno osnovno delavnico za šest novih sodelavcev v ekipi centralnih transplantacijskih koordinatorjev. Delavnica o histovigilanci Delavnica je namenjena odgovornim osebam ustanov za tkiva in celice (UTC), bolnišničnim in centralnim transplantacijskim koordinatorjem (BTK in CTK) ter vsem ostalim strokovnim delavcem, ki sodelujejo pri postopkih odvzema, presaditve in obdelave tkiv in celic za namen zdravljenja s presaditvijo. V letu 2022 smo izvedli dve delavnici, ki se ju je skupaj udeležilo 46 udeležencev. Predstavili smo histovigilančni sistem v EU, sistem nacionalnega poročanja, uporabo orodja za vrednotenje histovigilančnih primerov in histovigilančne primere iz prakse. Sledila sta praktično delo v skupinah in diskusija. Novičnik Slovenija-transplanta Strokovne novice iz Slovenija-transplanta so namenjene strokovni javnosti in informiranju o novostih, dejavnostih zavoda, medijskih objavah, statističnih podatkih in izobraževanjih. Cilj komunikacijskega orodja je doseči dobro informirano, povezano in razvojno usmerjeno strokovno javnost. V letu 2022 smo izdali štiri številke novičnika, ki smo ga razposlali na več kot 500 e-naslovov. 73 MEDNARODNI PROJEKTI BRAVEST – Building Resilience Against crisis: a systematic and global approach to adVancE organ Safety and supply in Transplantation Trajanje: 1. 9. 2022–28. 2. 2025 Sofinanciranje: Program EU4HEALTH Slovenija-transplant je partner v prestižnem projektu, ki ga vodi Evropsko združenje za transplantacijo organov (ESOT), zanj dr. Luciano Potena, dr. med. Člani vrhunske mednarodne interdisciplinarne ekipe bomo analizirali dejavnike, ki so vplivali na uspešnost donorske in transplantacijske dejavnosti pred izbruhom epidemije, med izbruhom in med epidemijo SARS-CoV-2. Na osnovi različnih izkušenj bomo identificirali dobre prakse (klinične primere, organizacijsko podporo, sistemske rešitve) ter razvili algoritem in paradigmo za boljšo odpornost nacionalnih sistemov ter njihovo neprekinjeno, uspešno in varno delovanje v času nepredvidljivih dogodkov in raznih kriz (npr. epidemija, ekološke nesreče, potres, vojna …). V okviru projekta bo nastala zasnova za zbiranje podatkov v zvezi s transplantacijsko dejavnostjo in pridobivanjem organov v registre na evropski ravni. 74 Slovenija-transplant je član konzorcija in vodi 5. delovni sklop (trajnost rezultatov) ter je vključen v vse delovne sklope in aktivnosti projekta. V slovenski ekipi sodelujeta prim. Danica Avsec, dr. med., in dr. Jana Šimenc. Zagonsko projektno srečanje je potekalo v Bologni 19. in 20. oktobra 2022. Več informacij o projektu: https://www.bravest-project.eu/. 75 76 YOU HAVE MORE THAN ONE LIFE – ADULT EDUCATION FOR PROMOTION OF TRANSPLANTATION Trajanje: 1. 11. 2022–31. 7. 2023 Financiranje: EU program ERASMUS+ Projekt »Vsi imamo več kot eno življenje« izvajamo v sodelovanju s poljsko partnersko organizacijo Fundacja Pasjonaci Życia, ki je tudi nosilka projekta. Projekt naslavlja področje ozaveščanja javnosti o pomenu darovanja organov. S partnerji bomo delili znanje, izdelali nabor dobrih praks s področja komuniciranja v t. i. brošuri znanja, na tridnevni delavnici izobrazili 15 oseb po presaditvi o javnem nastopanju ter posneli 15 kratkih videov z osebnimi izkušnjami in nagovori »ambasadorjev« k darovanju. Delavnice in partnerski obiski bodo potekali na Poljskem in v Sloveniji. Novo gradivo bo pomemben doprinos k sodobnemu komuniciranju Slovenija-transplanta. Zagonski sestanek je potekal 14. decembra 2022 (prek spleta). Več informacij o projektu je na voljo na Facebook profilu Slovenija-transplanta. 77 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 človeškega telesa zaradi zdravljenja (ZPPDČT), 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 Zupanič Slavec; ilustracije Radko Oketič. 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. Newsletter Transplant, International Figures on Donation and Transplantation 2021, EDQM. https://freepub.edqm.eu/publications/PUBSD-87/detail Kandus A, Bren F. B. (2016). Transplantacija ledvic v Sloveniji od 1970 do 2013. V Avsec D in Zupanič Slavec Z (ur.), Razvoj transplantacijske medicine v Sloveniji: programi, smernice in perspektive (str. 138). Ljubljana: Zavod RS za presaditve organov in tkiv Slovenija-transplant; Celje: Celjska Mohorjeva družba: Društvo Mohorjeva družba. Gadžijev A, Avsec D: Darovanje in presaditve organov in tkiv uspešno tudi v letu 2021. Isis, julij 2022: 43–46. Dostopno na https://online.pubhtml5. com/agha/qrnc/#p=43. Šimenc J, Avsec D, Gadžijev A: Rezultati 1. nagradnega natečaja Slovenija-transplanta za najboljše raziskovalno delo s področja donorske medicine. Isis, maj 2022: 74–75. Dostopno na: https://online.pubhtml5.com/agha/xtio/#p=74. VIRI PODATKOV 78 Donorski program: • Arhiv Slovenija-transplanta • Eurotransplant Statistics Library: https://statistics.eurotransplant.org/ • Preliminary numbers 2022, IRODaT (International Registry in Organ Donation and Transplantation), www.irodat.org. Prejemniški program: • Letna poročila prejemniških kliničnih oddelkov UKC Ljubljana Donor and transplantation activity in Slovenia in 2022 79 80 Introductory words Our annual publication “Give Life a Chance” presents statistical data and key highlights of donor and transplantation activity in 2022. The year 2022 was very successful for donor activity. It brought a number of surpluses, in which we invested a lot of effort on both the organisational and professional levels. We carried out several tasks that we were unable to complete during the pandemic and established new standards which we will seek to follow or even build on in the coming years. In the donor programme, we significantly exceeded our plans, especially in the identification of eligible deceased donors. After several years, we once again exceeded the limit of 23 utilised donors per million inhabitants and ranked 3rd among Eurotransplant member states. Transplant coordinators conducted almost twice as many consent interviews with relatives of potential deceased donors as in 2021 and successfully coordinated 56 multi-organ removals from brain-dead donors in the national network of donor hospitals, with an average donation of 3.5 organs, making us one of the best performing countries in the world. The UMC Maribor passed important professional milestones since in 2022 we started to actively implement the programme according to the new guidelines for the treatment and care of critically ill patients in intensive care units and the option for organ and tissue donation after death (ICOD programme). Part of this programme was also launched for the first time at the UMC Ljubljana. Yet, behind all these successes are various people who, with their dedication, exceptional energy, enthusiasm, altruism and self-sacrifice, continue to make it possible for all Slovenian citizens to receive high-quality and safe organ and tissue transplantation treatment at such a crucial time in Slovenian healthcare as we are witnessing today. Thank you all sincerely. Andrej Gadžijev, MD, Director and physician responsible for donor activities 81 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. This 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. Slovenia has been a member of Eurotransplant, a non-profit organisation for organ and tissue exchange, since 2000. After meeting the demanding entry criteria, it was the first country in the region to join the group of five 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 patients). 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 the impressive 20th anniversary of our successful co-operation with Eurotransplant. 82 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-commercial orientation I transparency I voluntary donation I prevention of abuse. Slovenija-transplant is led by Andrej Gadžijev, MD, a specialist traumatologist and physician responsible for donation activity. Danica Avsec, MD, deputy director, is also appointed as a physician responsible for donation activity. In 2022, the Institute employed 9 full-time staff and was working with 86 people under contract in the donor programme. The Institute operates under the auspices of the Ministry of Health of the Republic of Slovenia. www.slovenija-transplant.si @SloTransplant 83 Outstanding achievements and highlights of 2022 84 • In the donor programme, we considerably outperformed our plan, especially in the number of eligible donors. With 23.24 utilised donors per million inhabitants, we rank 3rd among Eurotransplant member countries. • We achieved outstanding results in the number of procured hearts and lungs, where we exceeded the plan by over 60%, and in the number of procured corneas – 51 more than the 120 planned. • We created a Slovenian national tissue and cell code for the National Tissue and Cell Information System, representing unique and pioneering work on the EU level. A precise code ensures better traceability and transparency for institutions and donors, and for all tissues and cells. • We improved the logistical processes and systemised protocols to ensure the exchange of organs and tissues with nearby airports in Munich, Graz and Vienna. • We signed a cooperation agreement between the National Transplant Centre in Italy, Eurotransplant and Slovenija-transplant to perform liver transplants in young children. We found an innovative way to settle outstanding organ debts between Eurotransplant members and nonmembers through the European organ exchange platform FOEDUS. • Central transplant coordinators successfully coordinated 56 deceased multi-organ removal procedures in the national network of donor hospitals. • Transplant coordinators conducted 92 consent interviews with relatives, almost double the number in 2021. The percentage of consents to donate was slightly lower at 68%. ACHIEVEMENTS AND HIGHLIGHTS OF 2022 • Ratification of the International Convention against Trafficking in Human Organs became effective on 1 September 2022. With the amendments to the Criminal Code, ratification has become an important milestone for Slovenia as the Convention clearly defines the criminal offences related to abuses in transplantation medicine. • We strengthened our educational activities for the professional public. Among others, we held six seminars on the basics of the donor programme, an intensive course on organ procurement, two workshops on histovigilance and one workshop on breaking bad news and talking about organ donation. • We launched an e-newsletter to regularly inform and raise awareness among the professional public. Four issues of Expert News from Slovenija-transplant were sent to more than 500 e-mails. • In cooperation with the patients’ society, the Slovenian Transplant Society, we organised a media-hyped and well-received public exhibition “My Scar, My Life”. It was opened in the lobby of the UMC Ljubljana on the occasion of the European Day of Donation. The exhibition of posttransplant artistic photos is travelling around Slovenia and is an excellent communication tool for encouraging people to donate their organs. • The National Register of Designated Persons recorded the highest number of donation declarations on the annual level: 2,010 people formally expressed their decision to donate. • We had above-average success in international tenders for projects. We won three new projects in cooperation with international partners, enabling further development in the areas of donor and transplant programme resilience (BRAVEST), innovative approaches to communication and public awareness (You have more than one life) and educating the professional public about new developments in donation (Speed-In). • We successfully ran a competition for the best research work in donor medicine. First prize was awarded to Veronika Prtenjak for her thesis entitled Legal dilemmas of organ donation. 85 THE “MY SCAR, MY LIFE” EXHIBITION The centrepiece of the European Day of Donation on 8 October 2022 was the opening of the aesthetically and conceptually outstanding exhibition “My Scar, My Life” in the lobby of the UMC Ljubljana. The exhibition of artistic photos, with accompanying statements and expert explanations, offers first-hand insights into organ and tissue donation and transplantation, where there are many good and successful stories of solidarity, medical excellence and healing victories. It is a collaboration between patient societies (Slovenian Transplant Society, Ditra Sport Society) and Slovenija-transplant. At Slovenija-transplant, the exhibition was co-created by Danica Avsec, Andrej Gadžijev, Jana Šimenc and Barbara Uštar. The photographer Miran Juršič took the superb artistic photographs. The exhibition’s aim is to be able to talk about organ donation in different everyday spaces, breaking unnecessary taboos, and promoting donation. This also explains why organ transplant recipients, with a great deal of courage and positive energy, bared their scars, bodies and minds to express their gratitude and deliver the key message: become a donor and make life possible. As Anja Garbajs, one of the exhibition’s creators and a member of the Transplant patients' society, stated: “The thought that you can donate an organ to someone is bigger than life”. The exhibition, which glows with life and gratitude, changes the way viewers look at life, at beginnings and endings. The photographs are complemented by panels with expert explanations, prompts to talk about donation, and clarifications of common misconceptions. In 2022, the exhibition will be held in the lobby of the UMC Ljubljana, in the lobby of the Division of Surgery at the UMC Maribor, and in the Murska Sobota Regional and Study Library. It was received extremely positively by the general and professional public and the media everywhere. 86 The exhibition also acts as an incentive for roundtables, talks and press conferences, which broadens the understanding of organ donation. Since the exhibition has been travelling around the country, we have seen a significant rise in the number of declarations in the national register. We also presented it in Poland where it has already been recognised as a model of outstanding, innovative and successful organ donation communication practice. In 2023, we are planning further visits to locations across Slovenia (including the Sevnica Community Healthcare Centre). 87 Key statistics for 2022 DECEASED DONORS 56 DECEASED DONORS IN 2022 BY AGE GROUPS 0<18 YEARS 3 18-59 YEARS +60 YEARS 29 24 Average age was 54 years. DECEASED DONORS DONATED 172 ORGANS 2022 88 KIDNEY HEART LIVER LUNG PANCREAS CORNEA 82 20 45 20 1 172 CONSENT FOR ORGAN AND TISSUE DONATION NATIONAL REGISTER OF DESIGNATED PERSONS ABOUT POST-MORTEM ORGAN AND TISSUE DONATION CONSENT RATE Slovenia ranks among most successful countries in terms of the consent rate for donation. Registered 13.579 people 2.010 (54 against) 68 % Transplant coordinators performed 92 family interviews with relatives of the deceased. of which 13.496 FOR, and 83 against. 2022 IN THE CENTRE FOR TRANSPLANTATION ACTIVITY IN UKC LJUBLJANA 109 ORGANS WERE TRANSPLANTED AVERAGE WAITING TIME (IN DAYS) 161 patients are on the waiting list for transplantation (status on 31.12.2022) 250 370 HEART KIDNEY 2021 51 KIDNEY 29 18 10 1 122 HEART LIVER LUNG PANCREAS CORNEA 91 67 LUNG LIVER89 90 Solid organs 91 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. At the end of 2022, 161 patients were waiting for an organ transplant. The number was again lower compared to the previous year, especially for the kidney and liver waiting lists. 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 the chapter The Results in Transplanted Patients. In 2022, 114 Slovenian patients were included on the waiting list for the first time: 38 for a kidney (one in combination with a liver, three in combination with a heart and one in combination with a pancreas), 40 for a heart (three in combination with a kidney), 13 for a lung, 22 for a liver (one in combination with a kidney) and one for a pancreas transplant (in combination with a kidney). Status of the national waiting list on 31.12.2022 (all patients) Kidney Heart*** Lung Liver* Pancreas** 82 60 5 16 3 TOTAL 161 patients * 2 in combination with a kidney ** 2 in combination with a kidney ***1 in combination with a kidney Source: http://statistics.eurotransplant.org/ 92 SOLID ORGANS Status of the national waiting list in the 2011-2022 period (as at 31.12., all patients) Year Kidney Heart Lung* Liver 2011 120 46 17 2012 113 38 18 2013 114 39 2014 136 31 2015 110 2016 95 2017 2018 2019 Pancreas TOTAL 183 2 169 19 1 171 21 11 188 52 29 11 190 58 28 7 181 112 56 35 8 203 135 65 35 6 234 138 55 35 5 227 2020 115 53 5 32 4 204 2021 97 57 3 21 4 177 2022 82 60 5 16 3 161 * Before 2020, Slovenian patients, waiting for a lung transplant, were included on the Austrian waiting list A share of patients on the national waiting list by organ in 2022 Source: http://statistics.eurotransplant.org// 3 16 5 82 LEGEND Kidney (82) Lung (5) Heart (60) Liver (16) 161 Pancreas (3) 60 93 SOLID ORGANS Trends in patient numbers on the waiting list, by organ and total for the 2011-2022 period 140 130 120 110 100 90 LEGEND 80 70 Kidney Liver Heart Lung Pancreas 60 50 40 30 20 10 2011 94 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 SOLID ORGANS Waiting list mortality for the 2011-2022 period The following data show the number of patients who were included on the waiting list for an organ transplant and died during the waiting period. The cause of death was not always related to the failure of the organ for which they were waiting to be transplanted. Year Kidney Kidney and pancreas Heart Lung Liver TOTAL 2011 6 8 3 17 2012 2 8 7 17 12 2013 2 5 5 2014 4 5 2 11 2015 1 3 5 10 1 2016 3 7 3 13 2017 1 6 6 13 6 5 14 6 5 12 2018 1 2019 1 2 2020 1 2 1 4 2021 4 1 6 10* 2022 1 4 4 9** */**One deceased patient was waiting for a combined kidney and liver transplant 1 Source: http://statistics.eurotransplant.org/ 95 SOLID ORGANS Trends in waiting list mortality for the 2011-2022 period 20 * 15 * * 10 * * * * * * * 5 0 * 17 17 12 11 10 13 13 14 12 4 10* 9* 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 *One of the deceased patients waited for a combined kidney and liver transplant LEGEND Kidney * 96 * Trends Liver Kidney and pancreas Source: http://statistics.eurotransplant.org/ Heart Lung SOLID ORGANS NUMBER OF DECEASED DONORS In 2022, Slovenian donor hospitals acquired 56 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 selected 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 member countries, in 2022 Slovenia was ranked third in terms of the number of utilised deceased donors per million people, with this result being significantly higher than the Eurotransplant average. Number of actual deceased donors (DD) per million people (PMP) in Slovenia in 2022 and a comparison with other countries* Country No.of DD/PMP 2022 Country No.of DD/PMP 2022 1. Spain 46.03 10. Croatia 2. USA 44.5 11. Uruguay 22.7 3. Portugal 30.8 12. United Kingdom 21.08 4. Belgium 29.4 13. Canada 20.95 5. Czech Republic 28.34 14. Switzerland 18.8 6. Slovenia 26.54 15. Estonia 18.77 7. Belarus 26.04 16. Lithuania 17.96 8. Italy 25.5 17. Australia 17.48 9. Austria 25.17 18. Ireland 16.78 * we included all countries that submitted data for 2022 to Irodat by July 2023 24.4 97 SOLID ORGANS No.of DD/PMP 2022 Country No.of DD/PMP 2022 Country 16.67 26. Israel 10.42 20. Brazil 16.5 27. Germany 10.34 21. Slovakia 13.08 28. Kuwait 22. Hungary 12.59 29. S. Korea 7.88 23. New Zealand 12.31 30. Greece 6.6 24. Iran 12.2 21. N. Macedonia 25. Poland 11.76 32. UAE 19. Argentina 8 6 5.5 DD/PMP 46.03 Number of actual deceased donors (DD) per million people (PMP) in Slovenia in 2022 and a comparison with selected world countries 44.5 50 16 17 18 19 20 EST LIT AUS IRE ARG 12.31 15 12.59 14 13.08 CAN SWI 16.5 UK 16.67 URU 16.78 13 17.48 ITA 12 17.96 BEL 11 18.77 10 20 18.8 9 20.95 8 21.8 24.4 7 22.7 25.17 5 25.5 4 26.54 26.04 28.34 30 28.4 30.8 40 21 22 23 10 0 98 1 2 SPA USA 3 POR BEL 6 CZ.R. SLO AUS CRO BRA SLOV HUN N.ZE. SOLID ORGANS No.of DD/PMP 2022 Country No.of DD/PMP 2022 Country 33. Cyprus 5 40. Mexico 3.05 34. Ukraine 44.77 41. Bulgaria 2.31 35. Hong Kong 4.66 42. Moldova 1.15 36. Romania 4.5 43. Dominican Republic 37. Quatar 4.13 44. Malaysia 0.7 38. Saudi Arabia 3.5 45. Philippines 0.18 39. Turkey 3.4 46. Nicaragua 0.14 1 Source: Newsletter Transplant, International Figures on Donation and Transplantation 2022. Preliminary report, July 2023. DD/PMP 40 30 37 38 39 40 41 42 43 44 MOL D.RE. MAL 0.18 36 0.7 2.31 35 1 3.05 34 UKR H.K. ROM QUA S.AR. TUR MEX BUL 1.15 3.4 33 3.5 32 4.13 31 4.5 30 4.66 29 GER KUW S.KOR. GR N.MAC UAE CYP 0.14 4.77 28 5 10.34 27 5.5 26 ISR 6 25 POL 6,6 24 IRA 7.88 0 8 10 10.42 11.76 12.2 20 45 46 PHI NIC 99 SOLID ORGANS Number of utilised deceased donors (DD) per million people (PMP) in Slovenia in 2022 and a comparison with all Eurotransplant countries Country Number of DD DD/PMP Slovenia Eurotransplant 49 1938 23.3 13.8 Source: http://statistics.eurotransplant.org/ Number of utilised deceased donors per million people (DD/PMP) and a comparison with other Eurotransplant countries in 2022 ET Country Number of DD/PMP in 2022 1.Belgium (BE) 26.6 2. Croatia (CRO) 23.5 3. Slovenia (SLO) 23.3 4. Austria (AT) 22.1 5. Netherlands (NL) 16.2 20 6. Luxembourg (LU) 12.4 10 7. Hungary (HU) 12.3 8. Germany (DE) 10.1 50 MD/NMP 40 30 0 ET (13,8) 1 2 3 4 5 6 7 BE CRO CR RO S SLO LO AT A NL N LU LU HU HU 8 DE DE Vir: http://statistics.eurotransplant.org/ 100 SOLID ORGANS Number of utilised deceased donors (DD) and number of utilised deceased donors per million people (DD/PMP) in Slovenia in the 1998-2022 period Year Number DD Number DD/PMP Year Number DD Number DD/PMP 1998 27 13.6 2011 31 15.1 1999 26 13.1 2012 46 22.4 2000 22 11.1 2013 45 21.9 2001 23 11.6 2014 43 20.9 2002 35 17.6 2015 53 25.7 2003 28 14 2016 41 19.9 2004 36 18 2017 39 18.9 2005 21 10.5 2018 40 19.4 2006 30 15 2019 38 18.3 2007 22 10.9 2020 39 18.5 2008 36 17.8 2021 39 18.5 2009 33 16.2 2022 49 23.3 2010 40 19.5 TOTAL 882 17.3 Source: http://statistics.eurotransplant.org/ 101 SOLID ORGANS Number of utilised deceased donors (DD) and number of utilised deceased donors per million people (DD/PMP) in Slovenia in the 1998-2022 period The number of DD by year 60 50 40 30 20 10 0 27 26 22 23 2000 01 20 0 999 2000 1998 9 998 30 35 28 02 03 0 02 36 21 30 22 36 33 40 31 04 05 04 06 06 08 09 20 0010 100 11 07 08 2010 46 45 1122 13 43 53 41 39 40 38 39 39 49 1144 15 1 16 17 18 19 2020 2211 22 The number of DD/PMP by year 25 20 15 10 5 0 102 13,6 13,1 11,1 11,6 17,6 14,0 18,0 10,5 15,0 10,9 17,8 16,2 19,5 15,1 22,4 21,9 20,9 25,7 19,9 18,9 19,4 18,3 18,4 18,4 23,3 1998 99 2000 01 02 03 04 05 06 07 08 09 2010 11 12 13 14 15 16 17 18 19 2020 21 22 SOLID ORGANS 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/refer a potential donor POTENTIAL DCD DONOR Reasons why a potential donor does not become a utilized 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. 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) 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. 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. UTILIZED DCD DONOR An actual donor from whom at least one organ was transplanted. 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 Donation after BrainDeath (DBD) POTENTIAL DBD DONOR A person whose clinical condition is suspected to fulfill brain death criteria. 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 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 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 103 SOLID ORGANS 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, established 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 an organ donation is also possible. In 2022, we collected the highest number of declarations so far in a single year. A total of 2,010 declarations was collected (1,956 FOR and 54 AGAINST). As at 31 December 2022, 13,579 declarations were entered on the register (13,496 FOR and 83 AGAINST). Since 2018, when the making of an electronic declaration was enabled, 4,183 individuals have used this option. In 2022, 80% of declarations were submitted electronically. Number of declarations in the register, by year, in the 2004−2022 period Source: archive of Slovenija-transplant 104 Year No. of declarations Year No. of declarations Year No. of declarations 2004 91 2011 378 2018 1760 2005 228 2012 312 2019 1252 2006 308 2013 299 2020 750 2007 383 2014 739 2021 976 2008 460 2015 630 2022 2010 2009 511 2016 593 TOTAL 13579 2010 382 2017 1517 SOLID ORGANS Number of declarations in the register, by year, in the 2004-2022 period 2010 Number of declarations by the year 1.760 1.517 1.252 976 750 739 383 460 630 593 511 382 308 378 312 299 228 91 105 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 SOLID ORGANS 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, a conversation with the deceased person’s close relatives about donation is carried out. During this conversation, transplant coordinators try to determine what the deceased person’s position was regarding after-death organ donation. If their intention is unknown, the close relatives make the decision. In this case, the conversation is significantly more difficult for medical staff and especially for their family. 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 2022, consent for donation was given by 68% of relatives. Slovenija-transplant offers the deceased donor’s relatives an opportunity to be given grief counselling by professionally trained and experienced experts. Percentage of consent for donation in the 1998-2022 period 106 Year % Year % Year % Year % Year % 1998 79 2003 77 2008 80 2013 69 2018 66 1999 70 2004 70 2009 85 2014 80 2019 77 2000 63 2005 81 2010 80 2015 81 2020 76 2001 64 2006 80 2011 86 2016 76 2021 84 2002 78 2007 85 2012 69 2017 83 2022 68 Source: archive of Slovenija-transplant SOLID ORGANS Percentage of consent for donation in the 1998−2022 period 90 % of consent for donation 85 86 85 84 83 80 81 79 78 80 80 80 80 77 81 77 76 76 70 70 70 69 69 68 66 60 63 64 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 107 SOLID ORGANS 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: • identification of potential deceased donors; • diagnostics of brain death; • evaluation of the suitability of organs and tissues for removal and transplantation; • communication with the relatives of the deceased about the possibility of organ donation; • maintenance of the functioning of deceased donors’ organs ‒ in intensive care and during organ removal; and • participation 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, where the largest intensive care units are in place. In 2022, 22 utilised deceased donors were procured there. Good results were also achieved by the UMC Maribor which in 2022 procured 17 utilised deceased donors, and by Celje GH with 5 utilised donors. Murska Sobota GH and Slovenj Gradec GH each procured 2 utilised deceased donors and Nova Gorica GH 1 utilised deceased donor. 108 SOLID ORGANS Number and share of utilised deceased donors by individual donor centres (DC) in 2022 Donor centre Number of DD Share in% Ljubljana UMC Ljubljana total 22 44.9 of which NICU* 6 of which CICU 7 MS GH 4,1 6 1 of which CVIT 1 NG GH 2 MB UMC 37,7 49 of which RC 1 Maribor UMC 17 37.7 Celje GH 5 10.2 Murska Sobota GH 2 4.1 Slovenj Gradec GH 2 4.1 Nova Gorica GH 1 2 Jesenice GH 0 Brežice GH 0 Ljubljana UMC Novo mesto GH 0 Maribor UMC Ptuj GH 0 TOTAL 49 LJ UMC 44,9 CDIIM RC of which CDIIM of which CDPSIT SG GH 4,1 CE GH 10,2 IT CV SIT CDP 22 LEGEN NICU CICU Celje GH 100 *NICU – Neurological Intensive Care Unit, CICU – Central Intensive Care Unit, CDIIM – Clinical Department of Internal Intensive Medicine, CDPSIT – Clinical Department of Paediatric Surgery and Intensive Therapy, CVICU – Cardiovascular Intensive Care Unit, RC – Respiratory Centre Murska Sobota GH Slovenj Gradec GH Nova Gorica GH Source:archive of Slovenija-transplant 109 SOLID ORGANS Number of utilized deceased donors in individual donor centres in 2022 Murska sobota GH 2 17 Jesenice GH Ptuj GH 0 0 Celje GH 5 Ljubljana UMC 22 Brežice GH 0 Novo mesto GH 0 Source: archive Slovenija-transplant Izola GH 0 110 We recorded the highest number of donation declarations on the annual level: 2,010 people formally expressed their decision to donate. 111 SOLID ORGANS Number of utilised deceased donors by donor centres in the 1998-2022 period Year LJ UMC MB UMC CE GH MS GH NG GH Izola GH Ptuj GH Jesenice GH NM GH SG GH 1998-2009 176 95 22 7 10 9 7 6 3 4 2010 26 8 2 2 1 1 2011 21 6 2 2012 22 8 9 3 1 2013 21 8 7 5 3 2014 31 4 3 1 1 2015 25 11 10 2016 28 2 7 2017 22 7 4 2 1 2018 18 13 4 2 1 1 2019 15 8 6 3 1 2020 22 7 5 1 1 2021 20 7 5 5 2022 22 17 5 2 1 TOTAL 469 201 91 31 26 1 1 Brežice GH 1 1 2 1 1 2 2 1 2 1 1 1 1 1 1 1 2 1 3 1 1 1 1 1 1 2 17 15 14 8 8 2 Source: archive Slovenija-transplant 112 SOLID ORGANS Number of utilized deceased donors by donor centres in the 1998−2022 period 60 200 882 deceased donors in SLO from 1998 to 2022 50 180 LEGEND 160 Ljubljana UMC 40 Maribor UMC 140 Celje GH 120 Murska Sobota GH 30 Izola GH 100 Jesenice GH 80 Nova Gorica GH 20 Ptuj GH 60 Novo mesto GH 40 Slovenj Gradec GH 10 Brežice GH 20 0 193 146 1998 - 2009 0 40 31 46 45 43 2010 0100 2011 20 2012 2013 2014 53 41 39 40 38 39 38 49 2015 2016 2017 2018 2019 2020 2021 2022 113 SOLID ORGANS Potential and realisation in donor hospitals 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 114 Donor hospital All deaths in the ICU PD ED Ljubljana UMC 372 64 Maribor UMC 228 32 Novo mesto GH 179 Celje GH 133 Nova Gorica GH 96 Ptuj GH *Potential (%) Available (%) AD Realisation (%) **Available (%) 41 11 13.7 25 61 65 26 11.4 13.7 18 69 65 11 10 5.6 8.3 8 80 55 12 5 3.8 8.3 2 40 55 2 1 1 8.3 0 / 55 84 1 1 1.2 8.3 1 100 55 Murska Sobota GH 60 4 3 5 8.3 2 67 55 Izola GH 58 1 1 1.7 8.3 0 / 55 Slovenj Gradec GH 56 0 0 0 8.3 0 / 55 Jesenice GH 43 0 0 0 8.3 0 / 55 Brežice GH 22 1 1 4.5 8.3 0 / 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 SOLID ORGANS *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). UMC Ljubljana came close to its potential in 2022 as the intensive care units were not overloaded with COVID patients after March. In 2022, Maribor UMC took an extraordinary step forward, even surpassing Ljubljana UMC in terms of potential achieved. The reasons for this success are the same as in Ljubljana, and in addition, the exceptional team of coordinators was the first in the entire national donor network to start implementing a programme based on new guidelines for the treatment and care of critically ill patients in intensive care units and the possibility of organ and tissue donation after death (ICOD programme). In hospitals without their own neurosurgical unit, the available donation potential reaches up to 8.3%. This figure was again closely approached by the Celje GH. Also close were Murska Sobota GH, Slovenj Gradec GH and Brežice GH, where there was no active donor due to family refusal. Nova Gorica GH had one actual deceased donor in 2022, while in the remaining five donor hospitals there were no actual deceased donors, which is mainly due to the lack of awareness of the treating physicians and family refusals. ** In 2022, the available realisation was exceeded by all five donor hospitals with at least one actual donor, despite the very high family refusal rate (refusal rates at Ljubljana UMC of 38% and Maribor UMC of 32%). The results in the area of realisation are so good because the teams responsible for identifying donors in the intensive care units and, in the case of UKC Maribor, also in the emergency department as part of the above-mentioned ICOD programme, did an excellent job in 2022. In SB Murska Sobota, the realisation rate was only 40%, and the refusal of relatives to donate was as high as 60%. Some deviations were found in low values of the potential, e.g., in Nova Gorica 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, the situation over a 2-year time frame is more accurate and in line with the expected results. In hospitals where there were no proven brain deaths in 2021 and no actual donors, the potential and the realisation were both 0% or un-measurable (/). 115 SOLID ORGANS List of authorised persons (hospital transplantation coordinators) in charge of the development, implementation and functioning of the donor programme in individual donor centres in 2022: 116 Donor centre Transplantation coordinators Ljubljana UMC Chief Phys. Rade Stanić, MD, MSc Maribor UMC Tanja Kuprivec, MD (until September)/Natalija Krope, 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 Čerkini, MD Novo mesto GH Matej Godnič, MD Ptuj GH Mateja Prevolšek, MD Slovenj Gradec GH Rok Popič, MD Transplant coordinators conducted 92 consent interviews with relatitves, almost double the number in 2021. 117 FOTO: Slovenija-transplant SOLID ORGANS SOLID ORGANS PROCURED FOR THE PURPOSE OF MEDICAL TREATMENT The number of procured organs depends on the number of procured deceased donors, along with the age, any medical contraindications, and appropriate brain-dead donor maintenance. In 2022, the number of deceased donors was high, and the work of the hospital transplant coordinators during the maintenance of a suitable donor was exceptional, which meant we also procured more organs. Deceased donors donated 172 organs, namely, the highest number since 2013. Data for 2022 and a comparison with previous years are given below. Number of procured organs of Slovenian deceased donors in 2022 Kidney Heart Liver Lung (both lobes) Pancreas TOTAL 82 24 45 20 1 172 Source: archive of Slovenija-transplant 20 1 82 45 LEGEND Kidney Heart Liver Lung Pancreas 118 24 SOLID ORGANS Procured organs of Slovenian deceased donors in the 2000-2022 period Year Kidney Heart Liver Lung (both lobes) Pancreas TOTAL 2000-2009 559 149 217 70,5 76 1071.5 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 2021 60 13 32 18 2 125 2022 82 24 45 20 1 172 TOTAL 1544 388 695 231 126 2984 Source: archive of Slovenija-transplant 119 SOLID ORGANS Procured organs of Slovenian deceased donors in the 2010–2022 period 1.915,5 procured organs of deceased donors in Slovenia in the 2010−2022 period 100 90 80 158 105 166 178 147 170 135,5 146 142 132 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 136 125 172 2020 2021 2022 70 60 50 40 30 20 10 0 Source: archive of Slovenija-transplant LEGEND Kidney 120 Heart Liver Lung Pancreas SOLID ORGANS TRANSPLANTED SOLID ORGANS There is one transplantation centre in Slovenia – the Ljubljana University Medical Centre – 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 Kneževič, MD. In 2022, 111 organs were transplanted, 109 from deceased donors and two kidneys from living donors. 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 2022 we were again the world’s most successful country. In the last 2 years, Slovenia has been one of the most successful countries in the world also in terms of the lung transplant programme. Paediatric transplantations are partly performed in the Ljubljana UMC and for younger children in nearby European transplantation centres (kidneys in Graz, liver in Bergamo). 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. 121 SOLID ORGANS Transplanted solid organs from deceased donors in the Ljubljana UMC in 2022 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 51 24.2 29 13.8 18 8.5 10 7.1 1 0.5 109 51.7 ET 2993 21.6 645 4.7 1456 10.9 604 4.4 114 0.9 5812 42.4 Source: http://statistics.eurotransplant.org/ 25 20 15 10 5 0 21.6 24.2 4.7 KIDNEY DD LEGEND 122 13.8 10.9 HEART ET 8.5 LIVER SLO 4.4 7.1 LUNG 0.9 0.5 PANCREAS SOLID ORGANS Number of transplanted solid organs from deceased donors per million people (PMP) in Slovenia in 2022 and a comparison with the Eurotransplant countries ET country Kidney Liver Heart 1. Belgium (BE) 36.4 23.1 2. Avstria (AT) 31.3 18.6 3. Croatia (CRO) 26.3 Number of transplantations/ PMP in 2022 Lung Pancreas 5.4 8.2 1.9 75 6.9 11.4 2 70.2 22.9 9.8 2.6 1.5 63.1 4. Slovenia (SLO) 24.2 8.5 13.8 4.7 0.5 51.7 5. Netherlands (NL) 28 10.5 2.9 6.9 2 50.3 6. Germany (DE) 17.2 8.5 4.3 3.1 0.5 33.6 7. Hungary (HU) 19.6 6.9 4.1 1.2 0.4 32.2 Source: http://statistics.eurotransplant.org/ PMP 75 70.2 63.1 51.7 50.3 33.6 32.2 50 LEGEND 40 Kidney 30 Heart Liver 20 Lung 10 Pancreas 0 BE AT CRO SLO NL DE HU 123 SOLID ORGANS Number of transplanted solid organs from deceased donors in Slovenia in the 1970-2022 period Year Kidney 1970 - 1985 1 Heart Liver Lung* Pancreas TOTAL 1 1986 7 7 1987 18 18 1988 16 16 1989 14 1990 17 1991 11 11 1992 20 20 1993 4 1 1994 14 2 1995 10 3 1996 6 2 1997 19 6 1998 46 4 4 1999 37 7 9 14 1 1 19 5 16 1 14 8 1 26 54 3 56 2000 44 7 10 1 62 2001 47 4 9 1 61 2002 55 3 11 2003 43 3 9 2004 55 3 15 69 2 57 73 Source: archive of Slovenija-transplant 124 SOLID ORGANS 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 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 2013 60 30 21 8 2014 55 33 31 3 2015 64 24 24 7 5 124 2016 44 31 27 10 5 117 2017 46 24 23 8 2018 54 23 27 7 3 2019 38 22 24 11 1 96 2020 46 24 25 16 2 113 2021 51 17 21 15 2022 51 29 18 10 1 109 TOTAL 1363 413 450 126 26 2378 84 120 4 123 122 101 114 104 * 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, 10 transplantations of both lung lobes were performed in the Ljubljana UMC and 1 paediatric lung transplantation in the University Hospital in Vienna (AKH). Since 2020, all lung transplants have been performed in UMC Ljubljana. ** 1 heart from a Slovenian donor was trans planted to a Slovenian patient in Graz *** 1 heart was transplanted, together with lungs, to a Slovenian patient in Vienna 125 SOLID ORGANS Number of transplanted solid organs of deceased donors in Slovenia in the 1970−2006 period 140 120 100 80 60 40 20 1 0 85 -19 70 19 7 18 16 14 19 11 20 5 16 14 8 26 54 56 62 61 69 57 73 48 65 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 126 Heart Liver Lung Pancreas SOLID ORGANS Number of transplanted solid organs of deceased donors in Slovenia in the 2007−2022 period 2.378 transplanted solid organs of deceased donors in SLO in the 1970−2022 period 140 120 100 80 60 40 20 0 52 84 83 107 88 120 123 122 124 117 100 114 96 113 104 109 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Source: archive of Slovenija-transplant LEGEND Kidney Heart Liver Lung Pancreas 127 SOLID ORGANS Number of kidneys transplanted from living donors in Slovenija A living kidney donation in Slovenia is only possible for genetically or emotionally related 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 start of the transplantation programme in Slovenia in 1970, living kidney donation was predominant. From 1986 on, with the establishment of the national donor programme, most organs were retrieved from deceased donors. After a few years break, the living kidney donation programme was revived in 2016 with 1–2 living kidney transplants performed yearly in UMC Ljubljana. Two such transplants were performed in 2022. Number of kidneys transplanted from living donors (LD) in Slovenija in the 1970–2022 period Year Nr. Year Nr. Year Nr. Year Nr. Year Nr. Year Nr. 1970-85 43 1992 5 1999 0 2006 0 2013 0 2020 1 1986 23 1993 5 2000 0 2007 1 2014 0 2021 1 1987 14 1994 0 2001 0 2008 0 2015 0 2022 2 1988 13 1995 1 2002 0 2009 1 2016 2 1989 10 1996 2 2003 0 2010 0 2017 2 1990 2 1997 2 2004 0 2011 0 2018 2 1991 3 1998 1 2005 0 2012 0 2019 0 TOTAL 128 136 SOLID ORGANS Shares of transplanted kidneys from living and deceased donors in the 1970 – 2022 period % 100 2 23 56 78 58 89 79 80 44 98 77 44 22 42 11 21 20 56 1970-85 1986 1987 1988 1989 1990 1991 1992 1993 100 97 100 98 100 100 100 100 100 91 75 90 98 9 25 10 2 1994 1995 1996 1997 100 96 96 96 100 100 100 100 100 100 100 100 1998 1999 2000 2001 2002 2003 2004 2005 100 98 98 96 80 60 40 20 0 % 100 LEGEND 80 Shares of transplated kidneys from living donors = TOTAL 12,2 % 60 Shares of transplated kidneys from deceased donors = TOTAL 87,7 % 40 20 3 0 2006 2007 2 2008 2009 2010 2011 2012 2013 2014 2015 4 4 4 2016 2017 2018 2019 2 2 4 2020 2021 2022 129 SOLID ORGANS THE RESULTS IN TRANSPLANTED PATIENTS Heart transplant programme congenital heart defects (3.5%). From 1990 to the end of 2022, the Ljubljana UMC performed 412 heart transplants, with 29 of those occurring in 2022. Twenty-six (93%) patients had an urgent and two (7%) an elective transplant. The Ljubljana UMC is ranked among largest heart transplant centres in the Eurotransplant area and may be compared by number of transplants with the biggest centres in Germany, Belgium, Hungary and Austria. There is a total of 42 heart transplant centres in the Eurotransplant area. The patient survival rates are comparable with those from the international reference register kept by the International Society for Heart and Lung Transplantation (ISHLT). The multi-year average (2009–2022) waiting period for an elective heart transplant was approximately 250 days and for an urgent heart transplant about 50 days. 130 Of all patients with a heart transplant in 2022, 48% needed the procedure due to dilated cardiomyopathy and 31% due to ischemic heart disease. Other reasons for the transplant included valvular heart disease (7%), arrhythmogenic cardiomyopathy (7%), hypertrophic cardiomyopathy (3.5%) and Survival of adult heart transplant recipients in % (1990–2022, n = 412) 30-day survival One-year survival Five-year survival 93 % 89 % 77 % 100 75 93 89 77 One-year One-year year Five-year Fivee-year Fiv year 50 25 0 % 30-day 30 day SURVIVAL Source: Report on implementation of the programme for advanced heart failure and heart transplantation for 2022 (Cardiology Department, Ljubljana University Medical Centre) SOLID ORGANS Kidney transplant programme In the period in which Slovenija-transplant has been a member of Eurotransplant (1 January 2000–31 December 2022), 1,135 kidneys of deceased donors (1,123) and living donors (12) have been transplanted. Some recipients had a kidney transplanted in combination with other organs, including 25 with pancreas, 6 with heart and 3 with liver. In the first post-transplantation year, the clinical, biopsy-proven acute rejection of the transplant was reported in 12.7% of all patients (1 January 2000–31 December 2022), and in 7.5% of all patients in 2022. In the 2010–2022 period, the median waiting time until transplantation was 370 days. In 2022, the median waiting time until transplantation was 214 days (in 2021 it was 566 days). Survival of kidney transplant recipients and transplanted organs in % (2000–2022, n = 1135) One-year survival 98.1 % 93.6 % Transplanted organs 94.1 % 87.1 % 95 %* 90.6 %* 100 94,9* 95 90,1* 90 85 80 75 70 98,1 93,6 86,3 94 65 60 % Source: Quality indicators of the Kidney Transplantation Centre (Department of Nephrology, *Censored for patient death with a functioning kidney graft Five-year survival Patients One-year One -ye -y yyeeear ar Fivee-yyea Fiv yearr Five-year SURVIVAL LEGEND Patients Transplanted organs 131 SOLID ORGANS Liver transplant programme Between 1995 and 31 December 2022, the University Medical Centre Ljubljana performed 450 liver transplants in 406 patients: 374 (92%) patients had elective liver transplantation due to cirrhosis of the liver, chronic liver diseases and liver tumours; 32 (8%) had urgent liver transplantation due to acute liver failure. In 2022, 18 liver transplants were performed in 18 patients (9 men and 9 women) at the UMC Ljubljana: 17 patients had elective liver transplantation and 1 had urgent liver transplantation. Five patients (27.8%, 3 men and 2 women) needed the procedure due to primary sclerosing cholangitis, 2 male patients (11.1%) due to cryptogenic cirrhosis and 2 male patients (11.1%) due to etilic cirrhosis of the liver. Two female patients (11.1%) had a liver transplant due to primary biliary cholangitis and 2 female patients (11.1%) due to polycystic liver disease. One of these patients had a liver transplanted in combination with a kidney. One male patient had a liver transplantation because of cirrhosis of the liver with chronic hepatitis B and one patient 132 Report on implementation of the programme for liver transplantation for 2022 (Clinical Department of Gastroenterology, University Medical Centre Ljubljana) because of acute liver failure after extensive resection of liver due to hepatocellular carcinoma (HCC). One patient each had liver transplantation for HCC, Abernethy syndrome, and complications of liver cirrhosis caused by autoimmune hepatitis. The average waiting time for liver transplantation in 2022 was 67 days, with a median of 62 days. In cases of great urgency, a suitable organ was usually available within a few days. Survival of liver transplant recipients and transplanted organs in % (1988–2022) One-year survival Three-year survival Five-year survival 84 % 79 % 76 % LEGEND Patients 85 80 75 70 65 84 79 76 Three-years Five-years 60 % One-year SURVIVAL SOLID ORGANS Pancreas transplant programme (in combination with kidney) In the period from February 2009 to 31 December 2022, 25 pancreas transplants were carried out, all concurrently with kidney. One pancreas and kidney transplantation was performed in 2022. In the period from February 2009 to 31 December 2022, five pancreases were removed in the early post-transplant period. One recipient died in the early post-transplant period due to infection. On 31 December 2022, there were 16 patients with a functioning pancreas and kidney. Survival of combined pancreas-kidney transplant recipients and transplanted organs in % (2009–2022, n=25 (patients) in n=20 (transplanted organs)) One-year survival Three-year survival Five-year survival Patients 96 % 96 % 96 % Transplanted organs Pancreas Kidney Pancreas Kidney Pancreas Kidney 76 % 92 % 76 % 92 % 76 % 92 % Source: Report on implementation of the programme for pancreas transplantation for 2022 Associate Professor Dr Damjan Kovač (Department of Nephrology, UMC Ljubljana) SURVIVAL / TRANSPLANTED ORGANS / PATIENTS 100 95 90 LEGEND 85 80 Kidney 75 Pancreas 70 65 76 92 96 76 92 96 76 92 96 Patients 60 % One-year survival Three-year survival Five-year survival 133 SOLID ORGANS Lung transplant programme In the period from 1997 to 2022, 126 lung transplants were performed in Slovenian patients: 72 transplants were performed at AKH Vienna (until 2019), including 1 retransplantation and 1 combined lung-heart transplantation. In 2022, 10 lung transplants were performed at UMC Ljubljana, 9 of them were of both lung lobes, in 1 case a lung retransplantation was required. The most common indications for lung transplantation at the UMC Ljubljana were chronic obstructive pulmonary disease (38%) and pulmonary fibrosis (21%). Transplants in patients with cystic fibrosis have become rare due to the introduction of highly effective drugs for this disease. The last transplant with this indication was in 2020. There were no transplants in 2022 due to the consequences of the COVID-19 disease. 134 The median waiting time for elective lung transplantation in the period 2018–2022 was 91 days, for urgent transplantations 7 days. Survival of lung transplant recipients in % (1997–2022)* One-year survival Three-year survival Five-year survival Patients 83.5 % 79.6 % 74 % Source: Report on implementation of the programme for lung transplantation for 2022, Doc. Dr. Matevž Harlander, MD (Department of Pulmonology and Allergology, University Medical Centre Ljubljana) LEGEND Patients 85 80 75 70 65 83,5 79,6 74 60 % One-year Three-year Five-year SURVIVAL *Ten-year survival of Slovenian patients after lung transplantation is 60.0%. In the period 2018–2022, the 1-year survival rate was 83.9% and the 3-year survival rate was 80.1% for patients who underwent a lung transplant at the Ljubljana UMC. Tissues and cells 135 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 specific haematological diseases this is the main and only therapeutic possibility for 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. Therefore, Slovenia has been included in the World Registry (BMWR), where voluntary donors are registered and typed, and where collection and transplantation procedures are performed if a match is found. In some cases, it is possible to use a patient’s own HSCs, this is called an autologous donation. More often a donation is based on match between relatives. According to Slovenian legislation, collection and transplantation can also be performed between unrelated persons, while respecting the principle of anonymity. 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 in the following year it became a full member of the world register Bone Marrow Donors Worldwide (BMDW). On 31 December 2022, the Slovenia Donor register included 25,190 people, of whom 21,727 were entered on the BMDW register. 136 TISSUES AND CELLS HSC transplantations in Slovenia in the 2000-2022 period Transplantion type 2000-2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 AUTO 531 68 101 74 63 84 86 92 88 89 104 89 121 ALO-LRD 102 9 8 7 11 10 15 12 13 11 10 10 13 18 22 31 26 24 26 28 26 31 17 23 27 95 131 112 100 118 127 132 127 131 131 122 161 ALO-LUD 84 AUTO and ALO-LRD 21 TOTAL 738 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 2.225 HSC transplantations in Slovenia in the 2000-2022 period 160 700 140 600 120 500 100 400 80 300 60 200 40 100 738 0 2000-2010 20 0 95 131 112 100 118 127 132 127 131 131 122 161 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 LEGEND AUTO ALO-LRD ALO-LUD AUTO in ALO-LRD 137 TISSUES AND CELLS CORNEA PROCUREMENT AND TRANSPLANTATION PROGRAMME Cornea transplantation is one of the most frequent and most successful tissue transplantations in Slovenia and 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 Procured and transplanted corneas in the 2010−2022 period Source: archive of Slovenija-transplant 138 *No. of transplanted corneas 180 Year No. of procured corneas 2010 122 72 140 2011 91 40 130 2012 101 67 120 2013 116 74 2014 116 87 2015 102 76 2016 104 83 2017 138 91 2018 84 66 70 2019 108 88 60 2020 92 72 50 2021 98 74 40 2022 172 122 Source: Archive of Slovenija-transplant * 2010–2017 – cornea transplants performed in Ljubljana UMC only; from 2018 on, cornea transplants performed in Ljubljana UMC and Maribor UMC 172 160 138 122 122 116 116 110 108 104 87 74 72 67 83 98 92 91 91 90 80 102 101 100 88 84 76 72 74 66 40 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 TOTAL 1.444 procured corneas from 2010-2022 TOTAL 1.012 transplanted corneas from 2010-2022 TISSUES AND CELLS cardiovascular death or a 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. In addition to the consent obtained, a detailed assessment of the suitability of the cornea for transplantation by the physician responsible for the recipient is required. 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 16 January 2023) and Maribor UMC (on 11 January 2023) Diagnosis Number of patients Keratoconus 41 Other diagnoses 240 TOTAL 281 Total: 281 patients (275 Ljubljana UMC, 6 Maribor UMC) (100%) 281 LEGEND Diagnosis of keratoconus: 41 patients (15%) Other diagnoses: 240 patients (85%) (injuries, degeneration, retransplantation, corneal macula, Fuchs dystrophy, endothelial dystrophy, cornea guttata, aphakia and pseudophakia, bullous keratopathy, infections, other) Source: Ljubljana UMC, Department of Ophthalmology, UMC Maribor Department of Ophthalmology 139 TISSUES AND CELLS OTHER TISSUES AND CELLS Traceability and transparency in transplant programmes or tissue and cell use programmes for treatment purposes Tissue and cell institutions must hold a valid permit issued by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereinafter: JAZMP). Slovenija-transplant ensures 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 are also authorised to compile an annual final report on serious adverse events and reactions and submit it to the JAZMP, which then reports about this to the European Commission. Tissue and cell institutions along with quality and safety assurance In Slovenia, 27 institutions are involved in the activity of procuring and using tissues and cells on 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 9 privatelyowned. Private institutions hold a permit exclusively for the autologous procurement of tissues and cells. Slovenija-transplant and the JAZMP ensure that the system functions transparently 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. 140 TISSUES AND CELLS 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 the conditions 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 data reported. 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; 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. 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. However, discussions are underway to continue collecting and storing not only for autologous use, but also for anyone who would need such cells. We are talking about an allogeneic donation that would be made possible by public funds. Source: http://www.ztm.si/register-darovalcev/javna-banka-popkovnicne-krvi/ 141 TISSUES AND CELLS Number of procured tissues and cells in the 2009−2022 period 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Skin* Year 28 45 22 36 85 89 52 57 32 22 24 10 46 63 Bones* 38 123 108 67 93 82 147 74 80 78 71 59 256 87 Soft bone grafts* 22 39 / 3 11 3 9 / 12 / / / 0 0 Cartilage* 37 21 4 12 11 11 12 / / / / / 0 0 15854 43472 8640 27479 41929 37542 39769 26191 36338 13778 26813 28209 24736 25721 2017 2018 2019 2020 2021 2022 Reproductive cells (no. of cells) * Unit: number of samples taken Number of tissues and cells used in the 2009−2022 period 2009 2010 2011 2012 2013 2014 2015 2016 Skin* Year 36 10 14 34 67 23 31 28 / 20 3 / 47 43 Bones* 23 47 57 97 59 62 92 82 72 71 81 101 123 90 Soft bone grafts* 12 / 2 2 3 4 3 5 2 3 5 4 2 6 Cartilage* Reproductive cells * Unit: number of samples used 142 15 / 3 7 4 9 5 1 / / 1 / 3 0 1450 2018 29651 23330 23506 27271 31127 26620 31817 12110 5109 14255 27547 28194 Source: Archive of Slovenija-transplant TISSUES AND CELLS Number of procured umbilical cord blood units in the period 2015–2022 2015 2016 2017 2018 2019 2020 2021 2022 Izvorna celica Institution / Year 76 144 107 82 81 81 78 73 Biobanka 175 178 266 110 224 197 241 170 8 45 101 169 192 206 245 293 238 0* 0* 0* 0* 0* 0* 0* FH-S Neocelica * this institution stopped operating Number of procured umbilical cord units in the period 2015–2022 Institution / Year 2015 2016 2017 2018 2019 2020 2021 2022 Izvorna celica 60 116 96 52 73 75 77 71 Biobanka 32 150 222 96 212 184 236 170 FH-S 8 42 96 114 196 213 247 301 198 0* 0* 0* 0* 0* 0* 0* Neocelica * this institution stopped operating Source: Archive of Slovenija-transplant 143 ADVERSE EVENTS AND REACTIONS Slovenija-transplant is responsible for monitoring adverse events and reactions as well as deviations 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 several phases: identification of deviation, detailed assessment and description of the case, adoption of appropriate measures for preventing damage to tissues and cells as well as people, reporting the case 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. 144 Number of adverse events and reactions in the 2012-2022 period TOTAL ADVERSE EVENTS = 87 TOTAL ADVERSE REACTIONS = 106 18 16 14 12 10 8 6 4 2 0 1 21 2011 0111 1 14 2012 2200122 5 11 2013 2 01 3 30 8 17 17 2014 2200144 2015 2001 20 0155 0 0 2016 20 7 2017 201 0177 0 2 2018 20 8 18 4 10 3 17 0 3 2019 220119 20 2020 2 0 22021 20 021 2022 0 Source: Archive of Slovenija-transplant LEGEND Adverse reactions 4 Adverse events 145 EDUCATING AND INFORMING THE PROFESSIONAL PUBLIC Educating and informing healthcare professionals is vital for the successful development and functioning of the donor and transplantation activities. In 2022, we significantly stepped up our educational activities. All educational programmes were updated in line with new developments and modern professional guidelines and included or strengthened the presentation of topical issues like donation after circulatory death (DCD), options for the active detection of possible deceased donors, new guidelines for the treatment and care of critically ill patients in intensive care units, options for organ and tissue donation after death (ICOD programme) and the basics of preventing organ trafficking. An e-newsletter was launched to keep the professional public informed of new developments. “Basics of the Donor Programme” training Basic training is provided in all hospitals involved in donor activities. Participants are given an overview of the donor programme, its activities and results. In 2022, we delivered the training in six selected donor hospitals: UMC Ljubljana (46 participants), UMC Maribor (64 participants), Celje GH (45 participants), Murska Sobota GH (33 participants), Izola GH (27 participants) and Nova Gorica GH (24 participants). A total of 239 participants, doctors and nurses, attended the training sessions and rated all the lectures highly. Expanded education and training for health professionals 146 The Intermediate Training Course in Transplant Procurement Management according to the TPM programme is delivered in collaboration with the Spanish organisation DTI. The aim of the course is to develop the donor programme and provide in-depth training for doctors and other staff in intensive care units from all donor hospitals. In 2022, as an exception we delivered the course online using an audio and video communication platform. It was attended by 30 participants from all Slovenian donor hospitals and young transplant coordinators from Slovenija-transplant. Lectures and workshops were given by lecturers from Slovenija-transplant and UMC Ljubljana, while Spanish experts presented global trends and innovations, with a focus on donation after circulatory death (DCD), new guidelines in the treatment and care of critically ill patients in intensive care units, and options for organ and tissue donation after death (Intensive Care Organ Donation - ICOD programme). “Breaking the bad news and talking about donation” workshop The workshop’s main objectives are to teach communication skills and ways to communicate bad news, to respond appropriately to bereaved relatives, to have a conversation about organ donation and to understand the value of the decision to donate organs for bereaved relatives. The workshop is intended for transplant coordinators, doctors and nurses working in intensive care units. In 2022, one basic workshop was held for six new colleagues in the team of central transplant coordinators. Histovigilance workshop This workshop is aimed at responsible persons at tissue and cell institutes, hospital and central transplant coordinators and all other professionals involved in the procurement, transplantation and processing of tissues and cells for transplantation therapy. Two workshops were held in 2022, attended by a total of 46 participants. We presented the EU histovigilance system, the national reporting system, use of the histovigilance case evaluation tool and histovigilance cases from practice. This was followed by practical group work and a discussion. Slovenija-transplant e-newsletter The professional news from Slovenija-transplant is targeted at the professional public, informing them about novelties, activities of the institute, media publications, statistics and training. The aim of this communication tool is to reach a well-informed, connected and development-oriented professional public. In 2022, we published four issues of the newsletter, as sent out to more than 500 email addresses. 147 INTERNATIONAL PROJECTS BRAVEST – Building Resilience Against crisis: a systematic and global approach to adVancE organ Safety and supply in Transpla ntation Duration: 1 September 2022 – 28 February 2025 Co-financing: EU4HEALTH Programme Slovenija-transplant is a partner in a prestigious project led by the European Society for Organ Transplantation (ESOT) for which Dr Luciano Potena, MD, PhD, is responsible. Members of a top international interdisciplinary team will analyse the factors that influenced the success of donation and transplantation activities before, during and after the SARS-CoV-2 outbreak. Based on different experiences, we will identify good practices (clinical cases, organisational support, system solutions) and develop an algorithm and paradigm to improve the resilience of national systems and their continuous, successful and safe operation in times of unpredictable events and various crises (e.g., epidemic, ecological disasters, earthquake, war etc.). The project will develop a design for the collection of data related to transplantation activities and organ procurement in registers on the European level. 148 Slovenija-transplant is a member of the consortium, leads Work Stream 5 (Sustainability of results) and is involved in all work streams and activities of the project. The Slovenian team includes Chief Phys. Danica Avsec, MD, PhD, and Jana Šimenc, MD. The project kickoff meeting took place in Bologna on 19 and 20 October 2022. More information about the project: https://www.bravest-project.eu/. 149 150 YOU HAVE MORE THAN ONE LIFE – ADULT EDUCATION FOR PROMOTION OF TRANSPLANTATION Duration: 1 November 2022 – 31 July 2023 Financing: ERASMUS+ EU Programme The project “You have more than one life” is implemented in cooperation with the Polish partner organisation Fundacja Pasjonaci Życia, which is also the project’s promoter. The project addresses the area of raising public awareness about the importance of organ donation. We will share knowledge with our partners, produce a set of good practices in the field of communication in a “knowledge brochure”, train 15 posttransplant people in public speaking during a 3-day workshop and make 15 short videos with personal experiences and appeals from ‘ambassadors’ to donate. The workshops and partner visits will take place in Poland and Slovenia. The new material will make an important contribution to the modern communication of Slovenija-transplant. The launch mee ng took place on 14 December 2022 (online). More informa on about the project is available on the Facebook profile of Slovenija-transplant. 151 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 človeškega telesa zaradi zdravljenja (ZPPDČT), 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 Zupanič Slavec; ilustracije Radko Oketič. 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. Newsletter Transplant, International Figures on Donation and Transplantation 2021, EDQM. https://freepub.edqm.eu/publications/ PUBSD-87/detail DATA SOURCES Donor programme: • Archive of Slovenija-transplant • Eurotransplant Statistics Library: https://statistics.eurotransplant.org/ • Preliminary numbers 2022, IRODaT (International Registry in Organ Donation and Transplantation), www.irodat.org. Transplant programmes: • Reports on implementation of the transplant programmes of Ljubljana UMC for 2022 152 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 Direktor/Director Andrej Gadžijev, dr. med. Telefon: +386 1 300 68 64 E-pošta/e-mail: andrej.gadzijev@slovenija-transplant.si