Outcome of transplant surgery performed outside the regular working hours. Jore Hendrikx Prof. Dr. S. Rex

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1 Outcome of transplant surgery performed outside the regular working hours Jore Hendrikx Prof. Dr. S. Rex

2 Overzicht Achtergrondinformatie Hypothese Methode en materialen Resultaten Conclusie

3 Background information 2000: rapport van the American National Academy of Medicine: doden jaarlijks < medische fouten - Chirurgische complicaties: 2e meest voorkomende oorzaak (Kohn, et al: To Err is Human: Building a Safer Health System. National Academy Press) Sindsdien veel onderzoek naar de verbanden tussen slaapdeprivatie en medische fouten Voor heelkunde specifiek: geen eenduidig verband tussen slaapdeprivatie en slechtere outcome in morbiditeit en mortaliteit Toegenomen mortaliteit bij niet electieve operaties uitgevoerd s nachts (Pearse, et al: Mortality after surgery in Europe: a 7 day cohort study. The Lancet 2012; 380: )

4 Background information Transplantaties: specifieke heelkunde 1. Ernstige onderliggende pathologie -> reeds hoger perioperatief risico 2. Non-electieve procedures -> onvoorspelbare start heelkunde Risico bij uitstel van transplantaties Kwaliteit van donororgaan in gedrang door toegenomen risico op cardiocirculatoire instabilisatie van donor Interferentie met electieve operatie-programma Reservatie van ICU bedden en dus andere opnames blokkeren Negeren van wens van familie Toegenomen ischemie tijden als recipient heelkunde wordt uitgesteld

5 Hypothesis Is er een verband tussen startuur van transplantatie-chirurgie en outcome van de patiënt?

6 Methods & materials: datasearch PubMed database Search strategy: zoektermen gebaseerd op 3 concepten 1. Transplant surgery 2. Time factors 3. Outcome Review referenties van relevante artikels

7 Methods & materials: study selection Inclusie criteria Vergelijking van outcome voor transplant-chirurgie tussen dag/nacht of weekend/week Exclusie criteria Case reports, comments, discussion letters, no full text available, conference abstracts, alle talen in niet-engels, pediatrische populatie Primary outcome Mortaliteit na bepaalde duur (7 dagen, 30 dagen, 1 jaar,..) Secondary outcome Complicaties gerelateerd aan heelkunde

8 Results PubMed search: citaten 11 relevante artikels: retrospectieve cohort studies 8 niertransplanten 2 levertransplanten 1 thoracale orgaan transplanten

9 Results: Renal transplant surgery

10 Author, country, date Anderson et al, England 2016 Patient group Donor type Outcomes measurements Results (%) Results reference P value Adjusted HR (95% CI) January 2003 December 2014 (N = ) Weekday: Monday to Thursday (N = 7724, 60%) Weekend: Friday to Sunday (N = 5178, 40%) DCD: 25.8% (week) vs 24.2% (weekend) DBD: 20.9% (week) vs 21.3% (weekend) Mortality 30 days 1 year Allograft complications Kidney allograft failure/rejection <1 year DGF Health resource implications LOS (days) 1-year readmission risk (7-15) (7-14) ( ) 1.00( ) 0.99( ) Comments No inferior short-term outcome on 1-year risk for rehospitalisation, mortality and failure/rejection for renal transplants performed on weekdays. Length of stay was significantly longer for weekday surgery. Baid-Agrawal et al, USA 2016 April 1994 September 2010 (N = ) DCD Renal transplants Weekday: Monday to Friday (N = , 72%) Weekend: Saturday or Sunday (N = , 28%) Primary outcomes Patient survival Death-censored survival Overall allograft survival Secondary outcomes Dialysis within the first week LOS Acute rejection in the first year (5-10) (5-9) ( ) 1.01( ) 1.01( ) The day of surgery does not affect the outcome of renal transplants. A shorter length of stay was the only significant association (6 days vs. 7 days) with transplants performed during the weekend. Manfredini et al, Italy 2016 January 2000 December 2013 (N = 9063) Weekday: Monday to Friday (N = 7572, 84%) Weekend: Friday 12 pm to Sunday 12 pm (N = 1491, 16%) Unknown LOS (days) In-hospital mortality Cardiovascular events 10.5 (±10.8) (±12.3) ns ns Renal transplant recipients are not exposed to higher risk of adverse outcome during weekend transplantations. Only duration of hospitalisation was increased. Özdemir- van Brunschot et al, The Netherlands 2015 January 2000 December 2013 (N = 4519) Day: 8 am 8 pm (N = 3039, 67%) Night: 8 pm 8 am (N = 1480, 33%) DCD: 42.1% (day) vs 36.4% (night) DBD: 57.9% (day) vs 63.2 (night) Primary outcome Technical graft failure excluding PNF and NVK Secondary outcome Technical graft failure including PNF and NVK Acute rejection within 10 days Daytime surgery was an independent predictor of pure technical graft failure. Fechner et al, USA (N = 260) Day: 8 am 8 pm (N = 166, 64%) Night: 8 pm 8 am (N = 94, 36%) Unknown Graft failure 1 year 5 years All complications, required re-operation <30d Ureteral Vascular Thrombosis graft vein Hematoma Nephrectomy for ischemia < 0.05 < 0.01 ns < 0.01 ns ns ns Surgery performed at night enhances the risk for complication and graft failure. Kienzl-Wagner et al, Austria 2013 January 2000 December 2009 (N = 873) Day: 8 am 8 pm (N = 610, 70%) Night: 8 pm 8 am (N = 263, 30%) Deceased donors, not futher specified Primary endpoints Patient survival 1 year 5 years Graft survival 1 year 5 years Night-time kidney transplants are neither associated with poorer graft or patient survival nor higher surgical complication rates. Secondary endpoints Delayed graft function Acute rejection Surgical complications Seow et al, UK 2004 January 1998 June 2001 (N = 322) Day: 7.30 am 6 pm (N = 138, 43%) Evening: 6 12 pm (N = 139, 43%) Night: am (N = 45, 14%) Deceased donors, not further specified Complications overall Evening: 26.1 Night: Complication rates are not increased when operating out of hours. Moreover a prolonged CIT had no effect on incidence of complications. Additional research did detect a decrease in complication ratio when a surgical consultant was present. Shaw et al, USA 2012 March 2000 December 2008 (N = 633) Day: 6 am 6 pm (N = 415, 66%) Night: 6 pm 6 am (N = 208, 34%) DCD: 16.3% (day) vs 14.5% (night) DBD: data not given Primary outcomes LOS (days) ICU LOS (days) DGF Complications Wound related Vascular Urological Gastro-intestinal Bleeding ( ) 1.07 ( ) 1.19 ( ) 0.12 ( ) 2.69 ( ) 3.38 ( ) 0.71 ( ) Only vascular complications were slightly less frequent to occur during night-time surgery.

11 Results: Renal transplant surgery 8 studies: in totaal patiënten Week vs weekend: patiënten, dag vs nacht: 6285 patiënten Geen verschil in outcome: 2 studies Slechtere outcome bij transplantaties na de kantooruren Toegenomen hospitalisatie duur in 2 studie (weekend groep) Toegenomen risico op complicaties en orgaan falen (nachtgroep) Betere outcome bij transplantaties uitgevoerd na de kantooruren Verminderde hospitalisatie duur in 1 studie (weekend groep) Verminderd technisch orgaan falen 1 studie (nacht groep) Minder vasculaire complicaties in 1 studie (nacht groep)

12 Results: Liver transplant surgery Author, country, date Patient group Donor type Outcomes measurements Results (%) Results reference P value Adjusted HR (95% CI) * Comments Orman et al, USA 2012 October 1987 December 2010 (N = ) Day: 7 am 7 pm (N = , 62%) Night: 7 am 7 am (N = , 38% ) Weekday: Monday 8 am Friday 5 pm (N = , 65%) Weekend: Friday 5 pm Monday 8 am (N = , 35%) 82% of all donors were deceased of whom 3% DCD Mortality 30 days 90 days 365 days Graft failure 30 days 90 days 365 days Mortality 30 days 90 days 365 days Night Weekend Day Weekday ( ) 0.98 ( ) 0.99 ( ) 1.00 ( ) 1.00 ( ) 1.01 ( ) 0.93 ( ) 0.98 ( ) 1.02 ( ) Night-time and weekend operations for liver transplantations did not affect graft or patient survival. There is a statistically significant decline in graft survival 365 days after transplantation when the surgery occurred during the weekend Graft failure 30 days 90 days 365 days ( ) 1.04 ( ) 1.05( ) Lonze et al, USA 2010 June 1995 October 2008 N = 578 Day: 3 am 3pm (N = 388, 67%) Night: 3 pm 3 am (N = 190, 33%) 6.1% of all donors were DCD. Postoperative complications Wound related Vascular Biliary Other Early deaths < 1 week Sepsis PNF Operative time (h) PRBC (units) FFP (units) 5 year survival ( ) 1.24 ( ) 1.56 ( ) 1.03 ( ) 0.84 ( ) 2.85 ( ) 1.55 ( ) 1.50 ( ) 42.19( ) 1.14 ( ) Complications were not significantly different but night-time transplants were longer in duration and associated a twofold greater risk of early death compared to daytime transplant. Long-term survival did not differ between the subgroups. HR = hazard ratio; CI = confidence interval; DCD = donation after cardiac death; PNF: primary graft non-function; PRBC: packed red blood cells; FFP: fresh frozen plasma * Lonze et al. adjusted HR for recipients age, race, gender, body mass index (BMI), model for end-stage liver disease (MELD) score, indication for transplantation, diabetes, transplantation as Status 1, donor age, gender, body mass index, donation after cardiac death (DCD), and CIT. Orman et al. adjusted HR for nighttime procurement, CIT, donor age, graft type (split liver), DCD, recipient sex and age, indication for transplantation, donor location, dialysis, vasopressor use, portal vein thrombosis, previous abdominal surgery, retransplantation, and pre-meld era versus MELD era

13 Results: Liver transplant surgery 2 studies: in totaal patiënten 1 studie: zowel nacht vs dag als weekend vs weekdag Geen verschil in outcome: De studie van Orman die dag en nacht transplantaties vergelijkt, Slechtere outcome bij transplantaties na de kantooruren Verminderde overleving na 365 dagen (weekend groep) Toegenomen operatie duur en verdubbeld risico op vroegtijdige dood (nacht groep) MAAR geen verschil in lange termijn overleving tussen beide groepen,

14 Results: Thoracic organ transplant surgery Author, country, date Patient group Donor type Outcomes measurements Results (%) Results reference P value Adjusted HR (95% CI) * Comments George et al, USA 2016 January June 2010 (N = ) Day: 7 am - 7 pm (N = 8 346, 70% ) Unknown Heart transplants Survival 30 days 90 days 365 days Night Day ( ) 1.05 ( ) 1.05 ( ) No clinical significant difference associated with survival. Complications and length of stay are not influenced by operation time Night: 7 pm - 7 am (N = 8 227, 30%) Complications Reoperation need Pacemaker placement Noncardiac surgery Infection Cerebrovascular accident New-onset dialysis LOS (days) 14 (10-21) 14 (10-20) 0.08 Lung transplants Survival 30 days 90 days 365 days Complications Reoperation need Pacemaker placement Noncardiac surgery Infection Cerebrovascular accident New-onset dialysis Night Day ( ) 1.23 ( ) 1.08 ( ) LOS (days) 15 (10-26) 15 (10-25) 0.12 HR = hazard ratio; CI = confidence interval; DCD = donation after cardiac death; LOS = length of stay

15 Results: Thoracic organ transplant surgery 1 studie: in totaal patiënten (dag vs nacht transplantaties) harttransplantaties en longtransplantaties Geen verschil in outcome Enkel toegenomen mortaliteit 90 dagen post longtransplant MAAR geen verschil in mortaliteit 1 jaar postoperatief

16 Conclusion De resultaten zijn inconclusief In de meerderheid van studies kon er geen verslechtering van outcome bij studies uitgevoerd tijdens de nacht of in het weekend Mogelijke verklaringen hiervoor: I. Gespecialiseerde transplant teams tijdens wachten II. Overdag mogelijks meer training van jonge chirurgen en residenten III. Goede follow-up programma s pre-operatief IV. Operatie tijd wordt bepaald door beschikbaarheid van donor orgaan V. Compensatie door meer ICU-opnames VI. Rustigere omgeving, minder onderbrekingen s nachts, fysiologische verandering => Omdat het onmogelijk is om de beschikbaarheid van een donor orgaan te voorspellen, blijft transplantatie-heelkunde na de kantoor -uren een veilige optie