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Francesco Locatelli

Teramo 11-12 Ottobre 2013. Aggiornamenti in Nefrologia Clinica XIII incontro. La scelta della terapia dialitica in tempi di spending review. Francesco Locatelli. Dipartimento di Nefrologia, Dialisi e Trapianto Renale. Ospedale “Alessandro Manzoni” – Lecco.

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Francesco Locatelli

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  1. Teramo 11-12 Ottobre2013 Aggiornamenti in Nefrologia Clinica XIII incontro La sceltadellaterapiadialitica in tempi di spending review Francesco Locatelli Dipartimento di Nefrologia, Dialisi e Trapianto Renale Ospedale “Alessandro Manzoni” – Lecco

  2. Responsabilità Professionale l’essenza stessa della professione sanitaria Non è un buon segno che l’espressione «responsabilità Professionale» sia, nel comune linguaggio degli addetti ai lavori,ritenuta una mera variante semantica di «colpa professionale» La «responsabilità» è e resta una categoria pregiuridicae deontologica; rappresentando l’essenza stessa della professione sanitaria

  3. RESPONSABILITA’PROFESSIONALE ACCEZIONE NEGATIVA Sinonimo di colpa • Valutazione a posteriori da parte di un soggetto esterno • Sanzioni • Conseguenze: esasperazione degli aspetti formali, Medicina difensiva

  4. RESPONSABILITA’PROFESSIONALE ACCEZIONE POSITIVA PROMUOVE COMPORTAMENTI CORRETTI • CONSENTE DI EVITARE DANNI ALLA PERSONA • PRESUPPONE AUTONOMIA (CAPACITA’ DI GOVERNARSI CON LE PROPRIE LEGGI), VALUTAZIONE DA PARTE DELLO STESSO SOGGETTO AGENTE , COMPETENZA ( CAPACITA’ DI AFFRONTARE LA COMPLESSITA’ , L’IMPREVEDIBILITA’ E IL CAMBIAMENTO)

  5. Codice Deontologico - Dicembre 2006, capo 4 (Accertamenti Diagnostici e Trattamenti Terapeutici) art. 13 (Prescrizione e Trattamento Terapeutico) Le prescrizioni e i trattamenti devono essere ispirati ad aggiornate e sperimentate acquisizioni scientifiche tenuto conto dell’ uso appropriato delle risorse, sempre perseguendo il beneficio del paziente secondo criteri di equità. Il medico è tenuto a una adeguata conoscenza della natura e degli effetti dei farmaci, delle loro indicazioni, controindicazioni, interazioni e delle reazioni individuali prevedibili, nonché delle caratteristiche di impiego dei mezzi diagnostici e terapeutici e deve adeguare, nell’interesse del paziente, le sue decisioni ai dati scientifici accreditati o alle evidenze metodologicamente fondate

  6. Teramo 11-12 Ottobre 2013Aggiornamenti in Nefrologia ClinicaXIII incontro Quale sceltadellaterapiadialitica in tempi di spending review? • Francesco Locatelli

  7. GFR (ml/min) Initiation of dialysis at higher GFRs: is the apparent rising tide of early dialysis harmful or helpful? Patients starting dialysis at higher GFRs Rosansky SJ, et al. Kidney Int 2009; 76: 257-261

  8. 25% Age and comorbidity may explain the paradoxical association of an early dialysis start with poor survival eGFR >10 ml/min Lassalle M, et al. Kidney Int 2010; 77: 700-707

  9. To examine whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. Primary outcome: death from any cause. — — Multicenter, randomized, controlled trial

  10. Primary Outcome Kaplan–Meier Curves for Time to Death Cooper BA et al. N Engl J Med 2010;363:609-19

  11. Early initiation of dialysis, which has enormous implications in terms of cost and organization, had no significant effect on clinical outcomes (rate of death from any cause, cardiovascular or infectious events or complications of dialysis) — Dialysis should not be started on the basis of an estimate of GFR alone. With careful clinical management of CKD, dialysis can be delayed for some patients until GFR drops below 7.0 ml/min or until more traditional clinical indicators for HD initiation are present — A randomized, controlled trial of early versus late initiation of dialysis Conclusions of the Authors Early initiation of dialysis had no significant effect on clinical outcomes Dialysis should not be started on the basis of GFR alone Cooper BA et al. N Engl J Med 2010;363:609-19

  12. Lessons learnt from the IDEAL study No benefit from “early-dialysis” — Conservative therapy is possible also till GFR <10 ml/min (corresponding to 6 months dialysis delay) — Importance of close clinical follow up in non-dialysis CKD stage 5 patients — Pay more attention to patient symptoms than to eGFR — Importance of nutritional status assessment — Data from 24 hour urine collection (urea, sodium) are mandatory — It is possible to safely reduce economic burden due to earlier dialysis — Locatelli F et al. Contrib Nephrol 2011

  13. Metabolic disturbance Malnutrition Fluid overload diuretic-refractory Uremic signs and symptoms Dialysis beginning according to international guidelines and clinical data EBPG 2005 and ERBP 2011 Theoretical lower eGFR limit K/DOQI 2006 eGFR 6 15 10 – 8 10 – 6 (ml/min/1.73 m2) CARI 2005 Locatelli F et al. Contrib Nephrol 2011

  14. Lessons from recent trials in hemodialysis The IDEAL study: what can we learn? Even if with some limitations, the IDEAL study represents a very important trial. Its main message is the lack of a fixed GFR value at which to start dialysis in asymptomatic patients, suggesting to give more relevance to close patient monitoring (uremic signs and symptoms, fluid overload, malnutrition, etc.) This approach has been proven to be safe for the patients and effective in temporary delaying the need for dialysis — — Locatelli F et al. Contrib Nephrol 2011

  15. European Renal Best Practice When to start dialysis: Updated guidance following publication of the Initiating Dialysis Early and Late (IDEAL) study James Tattersall, Friedo Dekker, Olof Heimbürger, Kitty Jager, Norbert Lameire, Elizabeth Lindley, Wim Van Biesen, Raymond Vanholder, Carmine Zoccali on behalf of the ERBP Advisory board. Updated guidance The 2002 guidance is not significantly changed. The evidence levels are increased by the studies published since 2002. The caution against using creatinine and CC to guide dialysis start is strengthened. A caution that eGFR calculated by the MDRD method is not useful in determining need for dialysis has been added. The emphasis on using GFR of 6 ml/min/1.73m2 as an absolute lower limit to starting dialysis is made more vague. Support for establishing advanced CKD clinics has been added. Nephrol Dial Transplant 2011,

  16. J Am Soc Neprol 20: 645 – 654, 2009

  17. MPO : Kaplan-Meier Survival Analysis ≤ 4g/dl Alb P=0.0320 No. at risk High-flux 250 212 173 134 85 44 26 7 Low-flux 243 202 152 117 67 41 15 3 Locatelli F et al. J Am Soc Nephrol. 2009 Mar; 20 (3): 645-54 XLV ERA-EDTA CONGRES – MAY 2008

  18. MPO : Kaplan-Meier Survival AnalysisSubgroup Analysis – Diabetics* *Pts. with both serum albumin ≤ 4 and > 4 g/dl albumin P=0.0385 No. at risk High-flux 83 67 55 46 27 14 7 3 Low-flux 74 59 40 29 19 11 3 0 Locatelli F et al. J Am Soc Nephrol. 2009 Mar; 20 (3): 645-54 XLV ERA-EDTA CONGRES – MAY 2008

  19. Randomised studies on the effect of High-Flux Haemodialysis on mortality risk Design Treatment (patients) Sample size % relative risk reduction P value Locatelli et al. 1996 Randomised, prospective Cuprophan-HD (132) LF-HD (147) HF-HD (51) HDF (50) 380 NS Eknoyan et al. 2002 Randomised, prospective HF-HD (921) LF-HD (925) 1,846 8 NS Locatelli et al. 2009 Randomised, prospective Albumin ≤ 4 g/dl HF-HD (279) LF-HD (283) 562 37 0.032 Randomised, prospective Albumin > 4 g/dl HF-HD (84) LF-HD (92) 176 NS Randomised, prospective, post-hoc analysis Diabetics HF-HD (83) LF-HD (74) 157 38 0.039 LF-HD: low-flux haemodialysis; HF-HD: high-flux haemodialysis; HDF:haemodialfiltration Locatelli F et al. Contrib Nephrol 2011; 168: 5-18

  20. Editorial Comment to MPO Study: Locatelli F et al. J Am Soc Neprol 20: 645 – 654, 2009 The results of the MPO Study can be interpreted as a supporting rationale for the use of high-flux dialysis membranes if they are financially affordable. A K Cheung T Green J AmSocNephrol 20: 462-464, 2009

  21. European Renal Best Practice High-flux or low-flux dialysis: a position statement following publication of the MPO study MPO study provides sufficient evidence to upgrade the strength of guideline 2.1 to a level 1A (strong recommendation, based on high-quality evidence):high-flux HD should be used to delay long-term complications of hemodialysis in the case of high-risk patients (comparable to the low-albumin group of the MPO study) n Because the substantial reduction of an intermediate marker (beta2-microglobulin) in the high-flux group of the MPO study, synthetic high-flux membranes should be recommended even in low-risk patients (level 2b: weak recommendation, low quality evidence) n Tattersal J et al. Nephrol Dial Transplant 2010; 25(4):1230-1232

  22. Water quality and distribution system Dialysate Extracorporeal circuit Dialysis dose and frequency Membranes and convective treatments Online treatments Quality of dialysis procedure HDF

  23. Observational studies on the effect of Haemofiltration and/or Haemodiafiltration on mortality risk Design Treatments (patients) Sample size Relative risk reduction P value Locatelli et al. 1999 Historical, prospective HDF or Haemofiltration (188) HD (6,256) 6,444 10% NS Historical, prospective Canaud et al. 2006 LF-HD (1,366) HF-HD (546) Low-efficiency HDF (156) High-efficiency HDF (97) 2,165 35% (High-efficiency HDF vs LF-HD) 0.01 Prospective Panichi et al. 2008 Bicarbonate-HD* (424) HDF (204) On-line HDF (129) 757 22% (HDF and On-line HDF vs Bicarbonate-HD) 0.01 LF-HD: low-flux haemodialysis; HF-HD: high-flux haemodialysis; HDF: haemodiafiltration; * Including LF-HD (403 patients) and HF-HD (21 patients) Locatelli F et al. Contrib Nephrol. 2011

  24. Randomised studies on the effect of Hemofiltration and/or Hemodiafiltration on mortality risk Design Treatments (patients) Sample size Relative risk reduction P value Randomised, prospective Cuprophan-HD (132) LF-HD (147) HF-HD (51) HDF (50) 380 NS Locatelli et al. 1996 Wizemann et al. 2000 Randomised, prospective HDF (23) LF-HD (21) 44 NS Santoro et al. 2008 Randomised, prospective On-line Hemofiltration (32) LF-HD (32) 64 55% 0.05 Locatelli et al. 2010 Randomised, prospective LF-HD (70) On-line Hemofiltration (36) On-line HDF (40) 146 NS LF-HD: low-flux hemodialysis; HF-HD: high-flux hemodialysis; HDF: hemodiafiltration Locatelli F et al. Contrib Nephrol. 2011

  25. Potential strategies to improve hemodialysis efficiency Francesco Locatelli and Bernard Canaud Nephrol.Dial Transpl. 2012

  26. J Am Soc Nephrol 2010 21:1798-807

  27. 7.1% 7.9% 9.8% 8.0% 10.6% 5.2% P <0.001 7.5% Sessions with intradialytic hypotension (%) Locatelli et al. J Am Soc Nephrol. 2010; 21(10):1798-807

  28. Number needed to treat Hemofiltration Hemodiafiltration *Patient performing 3 dialytic treatments/week from Locatelli et al. J Am Soc Nephrol. 2010; 21(10):1798-807

  29. Italian Study Conclusions Thisis the first multicenterrandomizedcontrolled trial simultaneouslycomparingthreeextracorporealtreatments with differentlevels of convection and diffusion on intra-dialyticcardiovascularstability of chronichemodialysispatients — The mainfindingis the demonstration of a lowerfrequency of intradialyticsymptomatichypotension in patientstreated with pure (HF) or mixed (HDF) convection in comparison with patientstreated with a diffusive technique (lowflux HD) — Thiseffectwas more pronounced in online pre-dilution HDF — Locatelli et al. J AmSocNephrol. 2010; 21(10):1798-807

  30. Tolerance of CKD patients receiving HDF and HF versus HD F.Locatelli B. Canaud, Nephrol Dial Transplant. 2012 Aug;27(8):3043-8

  31. Observational studies on the effect of Convective Treatments on Anaemia correction Design Treatments Sample size Haemoglobin Haematocrit Epo dose Kawano et al. 1994 Prospective LF-HD to HF-HD 10 NA ¯ Villaverde et al. 1999 Prospective Cellulose-HD to polysulphone-HD 31 = ¯ Maduell et al. 1999 Prospective Conventional HDF to On-line HDF 37 ¯ ­ Lin et al. 2002 Prospective Conventional HD to On-line HDF 92 ­ ¯ Prospective Cuprophan HD to On-line HDF 32 Bonforte et al. 2002 ­* ¯# Historical, prospective HF-HD vs LF-HD And Cellulose vs Biocompatible 1,207 = = Yokoyama et al. 2008 LF-HD: low-flux haemodialysis; HF-HD: high-flux haemodialysis; HDF: haemodiafiltration; NA: not available; * Only in patients not receiving Epo therapy; # Only in patients receiving Epo therapy Locatelli F et al. Contrib Nephrol 2011; 168: 162-72

  32. Randomised studies on the effect of Convective Treatments on Anaemia correction Analysis Treatments (patients) Sample size Haemoglobin Haematocrit Epo dose Locatelli et al. 1996 Secondary Cuprophan-HD (132) LF – Ps HD (147) HF – Ps HD (51) HDF Ps (50) 380 ­ (HF-HD vs LF-HD) NA Locatelli et al. 2000 Primary HF-PMMA HD (42) Cellulose-HD (42) 84 = = Ward et al. 2000 Primary On-line HDF vs HF-HD 44 = ­ Wizemann et al. 2000 Primary LF-HD (21) On-line HDF (23) 44 = = Ayli et al. 2004 Primary HF-HD vs LF-HD 48 ­ ¯ Vaslaki et al. 2006 Primary (cross-over) On-line HDF vs HD 70 ­ ¯ Locatelli et al. 2009 Secondary LF–HD (375) HF–HD (363) 738 = = HF-HD+Vit. E coated membranes vs HF-HD 20 = = Primary Andrulli.. and Locatelli 2010 Secondary = ¯ LF-HD: low-flux haemodialysis; HF-HD: high-flux haemodialysis; HDF: haemodiafiltration; NA: not available; Ps: Polysulphone; BK-F polymethylmetacrylate Locatelli F et al. Contrib Nephrol 2011; 168: 162-72

  33. Is hemodiafiltration the future? Barriers to its large use Chan CT… Locatelli F. et al Kidney Int. 2013 Jan 16

  34. Barriers to larger use of Hemodiafiltration • Lack of convincing evidence of survival benefit • Lack of convincing cost saving – varies from country to country • Safety concerns using large volume of on-line prepared substitution fluid • Regulatory issues regulation of on-line fluid preparation (cumbersome and costly) • Inadequate vascular access for Qb requirements • Education and training • Cost of OL-HDF machine Chan CT… Locatelli F. et al Kidney Int. 2013 Jan 16

  35. Randomized clinical trials in Europeevaluating HDF vs HD LFHD vs HF/HDF 150/75/75 Tolerance Morbidity Mortality 24 months HFHD vs HDF > 65y 300/300 Tolerance CV events Mortality 24 months HFHD vs HDF 300/300 CV events Mortality 24 months HFHD vs HDF 300/300 CV events Mortality 24 months Italian Trial CONVESTUDY CONTRAST LFHD vs HDF 350/350 CV events Mortality 36 months French Trial Turkish Trial Catalonian Trial ESHOL Dutch Trial 410 patients; enrollment closed Dec 31, 2010; Results by Dec , 2013? ~900 patients; JASN 2013 ~ 800 patients NDT 2012 715 enrolled JASN 2012 70 HD; 40 HDF & 36 HF patients JASN 2010

  36. 36 months survival in the intention to treat population (p=0,001 by the long rank test) F. Maduell et al. J Am Soc Nephrol 24: 2013

  37. Outcome data: Hospitalizations and intradialysis symptoms F. Maduell et al. J Am Soc Nephrol 24: 2013

  38. CONCLUSIONS • Online Haemodiafiltration, is an established RRT modality in routine clinical practice for over two decades. • Several clinical studies have reported upon the improved patient outcomes with Online Haemodiafiltration. • Ever since the DOPPS data indicating that patient high-efficiency Online Haemodiafiltration improves outcomes, the focus has been on randomised controlled trials examining the impact of high convective volumes on patient survival.

  39. CONCLUSIONS • OL‑HDF currently represents the most technically advanced dialysis treatment available. • Widespread clinical experience with this RRT modality for ~ 3 decades has confirmed its safety and efficacy. • Widespread implementation of this technique has been delayed pending conclusive evidence of its benefits from randomized studies. The results of the ESHOL Study should be considered as an important step towards making OL‑HDF a gold standard treatment for patients with CKD. Locatelli, F. & Hörl, W. H. Nat. Rev. Nephrol. Advance online publication 16 April 2013

  40. Codice Deontologico - Dicembre 2006, capo 4 (Accertamenti Diagnostici e Trattamenti Terapeutici) art. 13 (Prescrizione e Trattamento Terapeutico) La prescrizione di un accertamento diagnostico e/o di una terapia impegna la diretta responsabilità professionale ed etica del medico …. Su tale presupposto al medico è riconosciuta autonomia nella programmazione, nella scelta e nella applicazione di ogni presidio diagnostico e terapeutico, anche in regime di ricovero, fatta salva la libertà del paziente di rifiutarle e di assumersi la responsabilità del rifiuto stesso

  41. le attività connesse con la prescrizione farmacologica sono perseguibili dalla Corte dei Conti

  42. Ai Medici sono in capo diversi tipi di responsabilità: 1) Responsabilità deontologica 2) Responsabilità penale 3) Responsabilità civile 4) Responsabilità amministrativa In questo ambito giuridico diverse sono le disposizioni che interessano, infatti "i funzionari i quali" nell'esercizio delle loro funzioni (artt.13lett.h e 52 r.d. 12.07.1934,art.82 r.d.18.11.1923 n.2440,art.18 D.P.R.10.01.1957 n.3 artt.2 comma 4 e 59 comma 1 D.P.R:n.29/1993), con fatti od omissioni commessi con dolo o con colpa grave (art.1 legge 14.01.1994 modificata dalla legge n.639/1996),"cagionino danno allo stato" (cit.art.52), "sono tenuti al risarcirlo" (ct.art.82) e, a tal fine, "sono sottoposti alla giurisdizione della Corte dei conti" (cit.artt. 13,52 e 1).

  43. Secondo la Corte dei Conti i piani terapeutici hanno il carattere di "indicazioni". In questo modo i medici curanti possiedono un margine di discrezionalità nella valutazione degli indirizzi terapeutici provenienti dalle competenti strutture sanitarie, che consente loro di adottare le soluzioni terapeutiche che meglio si adattano al caso in esame. … sempre che …

  44. Corte dei Conti ed inappropriatezzaprescrittiva Qualora il medico che ha scelto, del tutto liberamente, di esercitare l’attività professionale con il servizio sanitario nazionale prescriva, utilizzando il ricettario pubblico, una terapia farmacologica che, per dosi, tempi, modalità di somministrazione non possa essere, secondo le note CUF (oggi AIFA), addebitata al servizio sanitario nazionale, pone in essere un comportamento connotato da inescusabile negligenza, tenuto conto anche della circostanza che il danno che ne deriva è agevolmente prevedibile e prevenibile. Corte dei Conti – Sez. Giur. Campania; Sent. n. 1308 del 18.07.2011

  45. settimana 1200 € 648 € 564 € 885 € 846 €

  46. costi direttisono compresi tutti i costi monetari generati direttamente dal trattamento dialitico a regime della terapia (costi di gestione) costi indirettisi intendono invece tutti i costi monetari, a carico del centro stesso o di altre articolazioni del Servizio Sanitario, che rendono possibile il trattamento ma che non sono da esso direttamente generati (dunque i costi di trasporto e i rimborsi ai pazienti, i costi alberghieri e i costi generali amministrativi) Regioni studiate: Piemonte, Lombardia, Lazio, Campania, Calabria consulenza nefrologica: F.Locatelli,G.Cancarini

  47. 49548 € 35063 € Δ14485 € Villa et al, NDT 2011; 26: 3709–14

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