Farmeco 2015;16(Suppl 1)3-16.html Farmeconomia. Health economics and therapeutic pathways 2015; 16(Suppl 1): 3-16 http://dx.doi.org/10.7175/fe.v16i1S.1201 Original Research Comparison between traditional and goal directed perfusion in cardiopulmonary by-pass. Adaptation of a differential cost analysis Massimiliano Povero 1, Lorenzo Pradelli 1 1 AdRes Health Economic and Outcome Research, Torino, Italy Abstract BACKGROUND: A previous patient-level discrete event simulation (DES) model was developed to perform an economic evaluation of GDP strategy with respect to TP in US. Aim of this supplement is provide results of the adaptations of the differential cost analysis to Belgium, Canada, France, Germany, Italy, and UK. METHODS: A Discrete Event Simulation model was developed to compare TP and GDP strategy in patients undergoing CPB. National perspective was adopted to calculate costs associated to each event while GDP strategy was exploited the introduction of Sorin Heartlink (HL) Card/GDP Card and Sorin Connect (electronic data management system). RESULTS: GDP reduces the total cost with respect to traditional perfusion; furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay. CONCLUSION: GDP seems to improve significantly the main outcomes related to CPB surgery, when compared to TP techniques. Additional costs due to perform GDP strategy have no impact on the total cost since completely offset by the savings in hospital cost. Keywords Cardiopulmonary bypass; Traditional perfusion; Goal directed perfusion Corresponding author Massimiliano Povero m.povero@adreshe.com Disclosure This supplement was funded by Sorin Group. Introduction A previous patient-level discrete event simulation (DES) model was developed incorporating baseline outcomes rates and comparative efficacy data from published literature, and US hospital cost data [1] to compare traditional perfusion (TP – targeted on BSA and CPB temperature) and goal-directed perfusion (GDP – specifically aimed at maintaining DO2 over the critical threshold)in patients undergoing CPB. This supplement provides results of the adaptations of the differential cost analysis to Belgium, Canada, France, Germany, Italy, and UK. Methods Model structure The patient’s pathway (Table I) is detailed below. During CPB: Each patient is characterized by sampling a nadir haematocrit (HCT) value; this is independent of the perfusion strategy considered. According to the HCT level (> or < 26%), patients reach DO2 target with a probability that depends on the perfusion strategy. According to transfusion protocol (depending on HCT level) patients can receive packed red cells (PRCs). Patients are at risk of renal adverse events: AKI, with probabilities depending on DO2 level (target reached or not). Renal failure needing RT (only for patients experiencing AKI) with probabilities that also depend on DO2 level (target reached or not). Post CPB: During the post-operative period, patients can die with probability that depends on renal complications (AKI or not) and can receive PRCs. Post-operative length of stay (LOS) in ICU depends on DO2 level during CPB. LOS in ward (only for patients discharged alive from ICU) depends on DO2 level during CPB. All clinical input parameter was described in [1]. Event Depending on During CPB surgery Reaching DO2 target HCT, P* PRCs transfused HCT Renal disease (AKI) DO2 AKI needing of RT DO2 In ICU (post-CPB) LOS DO2 PRCs transfused HCT Death AKI In ward LOS DO2 Table I. Events evaluated during the simulation * perfusion strategy (traditional or GDP) AKI = acute kidney injury; HCT= nadir haematocrit; LOS = length of stay; PRCs = packed red cells References 1. Povero M, Pradelli L. Comparison between traditional and goal directed perfusion in cardiopulmonary by-pass. A differential cost analysis in US. Farmeconomia. Health Economic and Therapeutic Pathways 2015; 16: ;http://dx.doi.org/10.7175/fe.v16i3.1200 Belgium Cost input The cost of GDP strategy was calculated considering the introduction of Sorin Heartlink (HL) Card/GDP card and Sorin Connect (electronic data management system); for every cost the worst case (i.e. higher possible price) was considered: cost of the card was € 80.00 and cost of Connect per patient, calculated dividing the total hospital cost for GDP monitors (assuming three system per hospital) by the number of cases per HL Card/GDP Card and the Connect lifetime (10 years), results in € 14.93. Cost items Unit cost Source Renal replacement therapy (€/day) 105.92 [2] ICU (€/day) 705.79 [3] Ward (€/day) 500.58 [3] PRC unit transfused (€) 93.00 [4] Table I. Unit cost used in the model, updated to 2014 Resulted costs (€) [Mean (95% CI)] TP strategy GDP strategy Savings (GDP vs. TP) Hospital stay 8,830 (6,094-11,465) 6,907 (4,619-9,249) 1,922 (734-2,959) ICU stay 2,565 (1,502-3,667) 1,779 (1,000-2,674) 786 (193-1,301) Renal complication 15 (0-37) 4 (-3-12) 10 (-4-32) Transfusion 231 (139-321) 232 (139-322) -1 (-2-0) GDP (HL Card+connect) NA 95 (60-131) -95 (-131- -60) Total cost 9,075 (6,341-11,715) 7,238 (4,943-9,586) 1,837 (644-2,883) Table II. Resulted cost for traditional and goal directed perfusion: mean results from base case (10,000 simulated patients) while the 95% CI is calculated from PSA (1,000 x 1,000 simulation) Figure 1. Deterministic sensitivity analysis – tornado diagram for saving Unit costs, updated to 2014 using official inflation indices [1], are summarized in Table I. Results GDP reduces the total cost with respect to traditional perfusion (about € 7,200 vs. € 9,000); furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay (Table II). Total saving is mostly influenced by nadir haematocrit, hospital length of stay and hospital cost per day, both in ICU and ward (Figure 1). References 1. Eurostat. HICPs (Harmonized Indices of Consumer Prices) – Health sector. Available at: http://ec.europa.eu/eurostat (Last accessed March 2015) 2. Vanholder R, Davenport A, Hannedouche T, et al. Reimbursement of dialysis: a comparison of seven countries. J Am Soc Nephrol 2012; 23: 1291-8 3. Nosocomial Infections in Belgium, part 2: Impact on Mortality and Costs KCE reports 102C. Federaal Kenniscentrum voor de Gezondheidszorg Centre fédéral d’expertise des soins de santé Belgian Health Care Knowledge Centre, 2009 4. Etude d’une méthode de financement alternative pour le sang et les dérivés sanguins labiles dans les hôpitaux KCE reports vol. 12 B. Federaal Kenniscentrum voor de Gezondheidszorg Centre Fédéral d’Expertise des Soins de Santé, 2005 Canada Cost input The cost of GDP strategy was calculated considering the introduction of Sorin Heartlink (HL) Card/GDP card and Sorin Connect (electronic data management system); for every cost the worst case (i.e. higher possible price) was considered: cost of the card was $CAN 80.00 and cost of Connect per patient, calculated dividing the total hospital cost for GDP monitors (assuming three system per hospital) by the number of cases per HL Card/GDP Card and the Connect lifetime (10 years), results in $CAN 10.05. Cost items Unit cost Source Renal replacement therapy ($CAN/day) 500.07 [2] ICU ($CAN/day) 1,662.38 [3] Ward ($CAN/day) 816.02 [3] PRC unit transfuse ($CAN) 347.99 [4] Table I. Unit cost used in the model, updated to 2014 Resulted costs ($CAN) [Mean (95% CI)] TP strategy GDP strategy Savings (GDP vs. TP) Hospital stay 16,254 (11,417-20,956) 12,550 (8,542-16,728) 3,704 (1,417-5,687) ICU stay 6,042 (3,537-8,637) 4,190 (2,355-6,299) 1,852 (456-3,065) Renal complication 69 (1-174) 19 (-14-58) 49 (-20-150) Transfusion 863 (519-1,200) 867 (521-1,205) -3 (-8-1) GDP (HL Card+connect) NA 90 (57-125) -90 (-125- -57) Total cost 17,186 (12,353-21,914) 13,526 (9,490-17,731) 3,660 (1,361-5,685) Table II. Resulted cost for traditional and goal directed perfusion: mean results from base case (10,000 simulated patients) while the 95% CI is calculated from PSA (1,000 x 1,000 simulation) Figure 1. Deterministic sensitivity analysis – tornado diagram for saving Unit costs , updated to 2014 using official inflation indices [1], are summarized in Table I. Results GDP reduces the total cost with respect to traditional perfusion (about $CAN 13,500 vs. $CAN 17,200); furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay (Table II). Total saving is mostly influenced by nadir haematocrit, hospital length of stay and hospital cost per day, both in ICU and ward (Figure 1). References 1. Eurostat. HICPs (Harmonized Indices of Consumer Prices) – Health sector. Available at: http://ec.europa.eu/eurostat (Last accessed March 2015) 2. Berbece AN, Richardson RMA. Sustained low-efficiency dialysis in the ICU: cost, anticoagulation and solute removal. Kidney Int 2006; 70: 963-8; http://dx.doi.org/10.1038/sj.ki.5001700 3. Bagai A, Cantor WJ, Tan M, et al. Clinical outcomes and cost implications of routine early PCI after fibrinolysis: One-year follow-up of the Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) study. Am Heart J 2013; 165: 630-7; http://dx.doi.org/10.1016/j.ahj.2012.12.016 4. Amin M, Fergusson D, Wilson K, et al. The societal unit cost of allogenic red blood cells and red blood cell transfusion in Canada. Transfusion 2004; 44: 1479-86 France Cost input The cost of GDP strategy was calculated considering the introduction of Sorin Heartlink (HL) Card/GDP card and Sorin Connect (electronic data management system); for every cost the worst case (i.e. higher possible price) was considered: cost of the card was € 80.00 and cost of Connect per patient, calculated dividing the total hospital cost for GDP monitors (assuming three system per hospital) by the number of cases per HL Card/GDP Card and the Connect lifetime (10 years), results in € 9.71. Cost items Unit cost Source Renal replacement therapy (€/day) 154.20 [2] ICU (€/day) 1,336.62 [3] Ward (€/day) 447.37 [4] PRC unit transfused (€) 183.84 [5] Table I. Unit cost used in the model, updated to 2014. Resulted costs (€) [Mean (95% CI)] TP strategy GDP strategy Savings (GDP vs. TP) Hospital stay 10,457 (7,402-13,460) 7,952 (5,464-10,603) 2,504 (937-3,858) ICU stay 4,858 (2,844-6,945) 3,369 (1,893-5,065) 1,489 (366-2,464) Renal complication 21 (0-54) 6 (-4-18) 15 (-6-46) Transfusion 456 (274-634) 458 (275-636) -2 (-4-1) GDP (HL Card+connect) NA 90 (56-124) -90 (-124- -56) Total cost 10,934 (7,881-13,944) 8,506 (6,006-11,167) 2,428 (855-3,796) Table II. Resulted cost for traditional and goal directed perfusion: mean results from base case (10,000 simulated patients) while the 95% CI is calculated from PSA (1,000 x 1,000 simulation) Figure 1. Deterministic sensitivity analysis – tornado diagram for saving Unit costs, updated to 2014 using official inflation indices [1]. are summarized in Table I. Results GDP reduces the total cost with respect to traditional perfusion (about € 8,500 vs. almost € 11,000); furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay (Table II). Total saving is mostly influenced by nadir haematocrit, hospital length of stay and hospital cost per day, both in ICU and ward (Figure 1). References 1. Eurostat. HICPs (Harmonized Indices of Consumer Prices) – Health sector. Available at: http://ec.europa.eu/eurostat (Last accessed March 2015) 2. Journal Officiel De La République Française Arrêté du 28 février 2012 (JO du 29 février) fixant pour l’année 2012 les éléments tarifaires mentionnés aux I et IV de l›article L. 162-22-10 du code de la sécurité sociale et aux IV et V de l›article 33 modifié de la loi de financement de la sécurité sociale pour 2004 3. Bernard GARRIGUES. Etude CRRéa: Evaluation médico-économique du Coût Réel d’une journée en RÉAnimation. Séminaire ENC 2-09 et 10 Décembre 2010 4. WHO-CHOICE 2011. Econometric estimation of unit costs for France 2008 5. Ministère Du Travail, De L’emploi Et De La Santé. Arrêté du 12 avril 2011 modifiant l’arrêté du 9 mars 2010 relatif au tarif de cession des produits sanguins labiles Germany Cost input The cost of GDP strategy was calculated considering the introduction of Sorin Heartlink (HL) Card/GDP card and Sorin Connect (electronic data management system); for every cost the worst case (i.e. higher possible price) was considered: cost of the card was € 80.00 and cost of Connect per patient, calculated dividing the total hospital cost for GDP monitors (assuming three system per hospital) by the number of cases per HL Card/GDP Card and the Connect lifetime (10 years), results in € 9.26. Cost items Unit cost Source Renal replacement therapy (€/day) 72.78 [2] ICU (€/day) 1,141.86 [3] Ward (€/day) 448.44 [4] PRC unit transfused (€) 105.53 [5] Table I. Unit cost used in the model, updated to 2014 Resulted costs (€) [Mean (95% CI)] TP strategy GDP strategy Savings (GDP vs. TP) Hospital stay 9,762 (6,899-12,564) 7,472 (5,121-9,954) 2,290 (867-3,520) ICU stay 4,150 (2,430-5,933) 2,878 (1,618-4,327) 1,272 (313-2,105) Renal complication 10 (0-25) 3 (-2-8) 7 (-3-22) Transfusion 262 (157-364) 263 (158-365) -1 (-2-0) GDP (HL Card+connect) NA 89 (56-123) -89 (-123--56) Total cost 10,034 (7,172-12,837) 7,827 (5,471-10,314) 2,207 (780-3,445) Table II. Resulted cost for traditional and goal directed perfusion: mean results from base case (10,000 simulated patients) while the 95% CI is calculated from PSA (1,000 x 1,000 simulation) Figure 1. Deterministic sensitivity analysis – tornado diagram for saving Unit costs , updated to 2014 using official inflation indices [1], are summarized in Table I. Results GDP reduces the total cost with respect to traditional perfusion (about € 7,800 vs. € 10,000); furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay (Table II). Total saving is mostly influenced by nadir haematocrit, hospital length of stay and hospital cost per day, both in ICU and ward (Figure 1). References 1. Eurostat. HICPs (Harmonized Indices of Consumer Prices) – Health sector. Available at: http://ec.europa.eu/eurostat (Last accessed March 2015) 2. Einheitlicher Bewertungsmaßstab für ärztliche Leistungen (official reference costs for medical procedures). Erstellt am 19.03.2012 (V. 7.1) 3. Neilson AR, Moerer O, Burchardi H, et al. A new concept for DRG-based reimbursement of services in German intensive care units: results of a pilot study. Intensive Care Med 2004; 30: 1220-3 4. WHO-CHOICE 2011. Econometric estimation of unit costs for Germany 2008. 5. Heimer P. Die Blutspendedienste des Deutschen Roten Kreuzes in der Bundesrepublik Deutschland: Entwicklung, Struktur und Leistungen, Perspektiven. Haemotherapie 2010; 14: 4-15 Italy Cost input The cost of GDP strategy was calculated considering the introduction of Sorin Heartlink (HL) Card/GDP card and Sorin Connect (electronic data management system); for every cost the worst case (i.e. higher possible price) was considered: cost of the card was € 80.00 and cost of Connect per patient, calculated dividing the total hospital cost for GDP monitors (assuming three system per hospital) by the number of cases per HL Card/GDP Card and the Connect lifetime (10 years), results in € 12.12. Cost items Unit cost Source Renal replacement therapy (€/day) 340.20 [2] ICU (€/ day) 1,018.44 [3] Ward (€/day) 441.18 [4] PRC unit transfused (€) 153.00 [5] Table I. Unit cost used in the model, updated to 2014 Resulted costs (€) [Mean (95% CI)] TP strategy GDP strategy Savings (GDP vs. TP) Hospital stay 9,223 (6,504-11,875) 7,087 (4,844-9,441) 2,136 (813-3,281) ICU stay 3,702 (2,167-5,292) 2,567 (1,443-3,859) 1,135 (279-1,878) Renal complication 47 (0-118) 13 (-10-40) 34 (-13-102) Transfusion 380 (228-528) 381 (229-530) -1 (-3-1) GDP (HL Card+connect) NA 92 (58-127) -92 (-127--58) Total cost 9,649 (6,937-12,317) 7,573 (5,317-9,942) 2,076 (744-3,251) Table II. Resulted cost for traditional and goal directed perfusion: mean results from base case (10,000 simulated patients) while the 95% CI is calculated from PSA (1,000 x 1,000 simulation) Figure 1. Deterministic sensitivity analysis – tornado diagram for saving Unit costs , updated to 2014 using official inflation indices [1], are summarized in Table I. Results GDP reduces the total cost with respect to traditional perfusion (about € 7,500 vs. € 9,600); furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay (Table II). Total saving is mostly influenced by nadir haematocrit, hospital length of stay and hospital cost per day, both in ICU and ward (Figure 1). References 1. ISTAT 2012. Indici nazionali dei prezzi al consumo per le famiglie di operai e impiegati - generale al netto dei tabacchi 2. Vitale C, Bagnis C, Marangella M, et al. A. Cost analysis of blood purification in intensive care units: continuous versus intermittent hemodiafiltration. J Nephrol 2003; 16: 572-9 3. Tarricone R, Torbica A, Franzetti F, et al. Hospital costs of central line-associated blood stream infections and cost effectiveness of closed vs. open infusion containers. The case of Intensive Care Units in Italy. Cost Eff Resour Alloc 2010, 8: 8; http://dx.doi.org/10.1186/1478-7547-8-8 4. Bartoli S, Saia F, Marrozzini C et al. Il costo dell’innovazione nel trattamento della stenosi aortica: l’impianto transcatetere di protesi valvolare aortica. Giornale Italiano di Cardiologia 2012; 13: 50-8 5. Recepimento dell’Accordo tra il Ministro della Salute, le Regioni e le Province Autonome di Trento e di Bolzano sul documento recante: “Aggiornamento del prezzo unitario di cessione del sangue e degli emocomponenti tra servizi sanitari pubblici” – 24 luglio 2003 – Regioni Lombardia, Emilia Romagna, Piemonte United Kingdom Cost input The cost of GDP strategy was calculated considering the introduction of Sorin Heartlink (HL) Card/GDP card and Sorin Connect (electronic data management system); for every cost the worst case (i.e. higher possible price) was considered: cost of the card was £ 80.00 and cost of Connect per patient, calculated dividing the total hospital cost for GDP monitors (assuming three system per hospital) by the number of cases per HL Card/GDP Card and the Connect lifetime (10 years), results in £ 12.90. Cost items Unit cost Source Renal replacement therapy (£/day) 159.65 [2] ICU (£/day) 1,841.76 [3] Ward (£/day) 402.67 [4] PRC unit transfused (£) 167.55 [5] Table I. Unit cost used in the model, updated to 2014 Resulted costs (£) [Mean (95% CI)] TP strategy GDP strategy Savings (GDP vs. TP) Hospital stay 11,733 (8,245-15,211) 8,767 (5,998-11,789) 2,966 (1,056-4,613) ICU stay 6,694 (3,919-9,569) 4,642 (2,609-6,979) 2,052 (505-3,396) Renal complication 22 (0-55) 6 (-5-19) 16 (-6-48) Transfusion 416 (250-578) 417 (251-580) -1 (-4-1) GDP (HL Card+connect) NA 93 (58-128) -93 (-128--58) Total cost 12,171 (8,687-15,652) 9,284 (6,507-12,312) 2,887 (971-4,549) Table II. Resulted cost for traditional and goal directed perfusion: mean results from base case (10,000 simulated patients) while the 95% CI is calculated from PSA (1,000 x 1,000 simulation) Figure 1. Deterministic sensitivity analysis – tornado diagram for saving Unit costs , updated to 2014 using official inflation indices [1], are summarized in Table I. Results GDP reduces the total cost with respect to traditional perfusion (about £ 9,300 vs. £ 12,200); furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay (Table II). Total saving is mostly influenced by nadir haematocrit, hospital length of stay and hospital cost per day, both in ICU and ward (Figure 1). References 1. Eurostat. HICPs (Harmonized Indices of Consumer Prices) – Health sector. Available at: http://ec.europa.eu/eurostat (Last accessed March 2015) 2. Department of Health. 2010-11 reference costs publication. 17 November 2011 3. Edbrooke DL, Ridley SA, Hibbert CL, Corcoran M. Variations in expenditure between adult general intensivecare units in the UK. Anaesthesia 2001; 56: 208-16 4. WHO-CHOICE 2011. Econometric estimation of unit costs for UK, 2008 5. Martinez V, Monsaingeon-Lion A, Cherif Ket al. Transfusion strategy for primary knee and hip arthroplasty: impact of an algorithm to lower transfusion rates and hospital costs. Br J Anaesth 2007; 99: 794-800