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9-11 MAGGIO 2014

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  1. IL TUO CUORE SI STA SCOMPENSANDO? Mancanza di fiato, gambe gonfie, facile affaticabilita’ senza ragione? Chiedi consiglio al tuo medico Consulta il sito www.heartfailurematters.org GIORNATE EUROPEE PER LO SCOMPENSO CARDIACO 9-11 MAGGIO 2014 9-11 MAGGIO 2014

  2. Seminario di Aggiornamento ANMCO CARDIOPATIA ISCHEMICA STABILE E SCOMPENSO CARDIACO: DUE PRIORITA’ TRA OSPEDALE E TERRITORIO GESTIONE CLINICA E CURA DELLA FASE ACUTA

  3. Graduatoria primi 5 DRG degli acuti in regime ordinario - 2007

  4. Temporal Trends in Hospitalizations in Italy 200.000 DRG 127 200.609 150.000 100.000 127.043 50000 1996 1998 1999 2000 2001 2002 2003 2007 1997 Fonte Ministero della Salute

  5. IN-HF Outcome Acute HF: all-cause mortality 27.7% 24.0% 19.2% (n. 1855) (n. 1058) (n. 797) Oliva F, Mortara A, Cacciatore G et al EJHF 2012

  6. Direct HF-relatedhealth care costs Distribution per type of expenditure 50 Milion € 40 Hospital admissions for HF 30 Drug therapy Cardiological outpatient care 20 10 0 0-19 20-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90+ Age distribution, decades De Maria R et al. G Ital Cardiol 2006

  7. Acute Heart Failure Syndromes (AHFS) Since 2005, 4largeinternationalphase III trials ( VERITAS, SURVIVE, EVEREST, PROTECT) havefailed. Evenfordrugsapprovedfor AHFS treatment ( milrinone and nesiretide in US and levosimendan in Europe) therehavebeenconcernsaboutsafety. The pharmacologicarmamentariumfor AHFS islargelyunchangedfrom 1970.

  8. Acutely Decompensated CHF Acute CHF Pulmonary edema RV failure Acute HFClinical Classification It’ s not a singular entity with a unique cause but a spectrum of complex multisystem pathologies historically bound by a limited number of shared clinical charactheristics Cardiogenic shock Hypertensive AHF ACS and HF ESC Guidelines 2008

  9. Durante un ricovero per SC acuto, valutazione clinico-strumentale e decisioni terapeutiche iniziano nel DE e procedono affiancate dinamicamente fino ( e oltre) alla fase di dimissione European Heart Journal 2012 doi:10.1093/eurheartj/ehs104

  10. European Heart Journal 2012 doi:10.1093/eurheartj/ehs104

  11. Initial assessment of patient with suspected acute heart failure Authors/Task Force Members et al. Eur Heart J 2012;33:1787-1847

  12. IN-HF Outcome Acute HF: All-cause mortality by SBP (Quartiles) 35.9% 24.0% 20.5% 20.3% 16.9% SBP (mmHg) (n. 1855) (n. 524) (n. 469) (n. 420) (n. 425) SBP is available for 1838 pts Oliva F, Mortara A, Cacciatore G et al EJHF 2012

  13. 1. Terapia acuta in base al profilo emodinamico Felker et al Circ Heart Fail 2010;3;314-325

  14. Unloading Therapy with SNP in Pts > 70 years Cioffi G. et al Am J Cardiol 2003

  15. Pregnancy & Acute Heart Failure • Relaxin has been shown to mediate these adaptations, as well as to have anti-ischemic, anti-inflammatory, anti-fibrotic effects. • Relaxin, and its signaling systems, are present in both men and women and is elevated up to pharmacologic levels during 9 months of pregnancy • Serelaxin (recombinant human relaxin-2) may produce these beneficial effects in patients with acute heart failure Baylis, C. Am J Kid Dis 1999; Schrier, RW, et al. Am J Kid Dis 1987; Jeyebalan, A, et al. Adv Exp Med Biol 2007;Teichman SL et al. Curr Heart Fail Rep 2010;7:75–82. Helal I, et al. Nature Reviews 2012;293-300.

  16. The RELAX-AHF Program

  17. Key Inclusion Criteria Hospitalized for AHF Dyspnea at rest or with minimal exertion Pulmonary congestion on chest radiograph BNP ≥350 pg/mL or NT-pro-BNP ≥1400 pg/mL Received ≥40 mg IV furosemide (or equivalent) at any time between admission to emergency services (either ambulance or hospital, including the ED) and the start of screening for the study Systolic blood pressure >125 mmHg Impaired renal function on admission (sMDRD eGFR 30-75 mL/min/1·73 m2) Randomized within 16 hours from presentation Age ≥18 years of age Body weight <160 kg Key Exclusion Criteria Current or planned treatment with any IV therapies [i.e. other vasodilators, (nesiritide), positive inotropic agents and vasopressors] or mechanical circulatory, renal, or ventilatory support, with the exception of IV furosemide (or equivalent), or of IV nitrates if patient has screening SBP >150 mmHg AHF and/or dyspnea from arrhythmias or non-cardiac causes, such as lung disease, anemia, or severe obesity Infection or sepsis requiring IV antibiotics Pregnant or breast-feeding Stroke within 60d; ACS within 45d; major surgery within 30d Presence of acute myocarditis, significant valvular heart disease, hypertrophic/ restrictive/ constrictive cardiomyopathy Inclusion and Exclusion Criteria

  18. 1°Endpoint: Dyspnea Relief(VAS AUC) Placebo 19.4% increase in AUC with serelaxin from baseline through day 5 (Mean difference of 448 mm-hr) Serelaxin Change from baseline (mm) AUC with placebo, 2308 ± 3082 AUC with serelaxin, 2756 ± 2588 p=0.0075 12 hrs 6 Days Teerlink … Metra. Lancet 2013; 381: 29-39

  19. 2°Endpoint: CV Death or HF/RF Re-hospitalization through Day 60 Composite event components (%) K-M estimate for time to first CV Death or HF/RF re-hosp (%) CV death: (% subjects) HF/RF re-hospitalization (% subjects) Serelaxin 14 HR 1.02 ( 0.74, 1.41) p=0.89 HR=1.2 p=0.32 HR=0.7 p=0.23 12 10 Placebo 8 6 4 2 60 n=27 n=19 n=50 n=60 0 Days 0 14 30 45 580 559 539 522 501 581 563 531 514 498 p value by log rank test HR estimate by Cox model

  20. CV Death through Day 180 K-M estimate for CV Death ITT (%) 14 Number ofEvents, n (KM%)* 12 HR 0.63 (0.41, 0.96); p=0.028 Placebo (N=580) 10 55 (9.6%) NNT = 29 8 35 (6.1%) 6 Serelaxin (N=581) 4 2 0 Days 0 14 30 60 90 120 150 180 580 567 559 547 535 523 514 444 Placebo 581 573 563 555 546 542 536 463 Serelaxin Teerlink … Metra. Lancet 2013; 381: 29-39

  21. All-cause Death through Day 180 K-M estimate for All-cause Death ITT (%) 14 Number ofEvents, n (KM%) 12 65 (11.3%) Placebo (N=580) HR 0.63 (CI 0.43, 0.93); p=0.020 10 NNT = 25 8 42 (7.3%) 6 Serelaxin (N=581) 4 2 0 Days 0 14 30 60 90 120 150 180 580 567 559 547 535 523 514 444 Placebo 581 573 563 555 546 542 536 463 Serelaxin Teerlink … Metra. Lancet 2013; 381: 29-39

  22. Prognostic value of a >30% NT-proBNP decrease from baseline at Day 2 and effects of serelaxin p = 0.0002 Metra M … Teerlink JR J Am Coll Cardiol. 2013 Jan 15;61(2):196-206.

  23. Prognostic value of a >20% hs-cTnT increase from baseline and effects of serelaxin p = 0.0001 Metra M … Teerlink JR J Am Coll Cardiol. 2013 Jan 15;61(2):196-206.

  24. 2.Terapia acuta in base al profilo emodinamico Felker et al. Circ Heart Fail 2010;3;314-325

  25. European Heart Journal 2012 doi:10.1093/eurheartj/ehs104

  26. Algorithm for management of acute pulmonary oedema/congestion European Heart Journal 2012 doi:10.1093/eurheartj/ehs104

  27. Mean Change in Creatinine Level Composite End Point of Death, Rehospitalization, or ED visit. Felker et al. N Engl J Med 2011;364:797-805

  28. IN-HF Outcome Acute HF: acute treatment(n. 1868 pts) Oliva F, Mortara A, Cacciatore G et al EJHF 2012

  29. Renal Vasodilatory Action of Dopamine Elkayam, U. et al. Circulation 2008;117:200-205 Low-Dose Dopamine on Survival in 324 Pts WithRenal Dysfunction European Heart Journal 2012 doi:10.1093/eurheartj/ehs104 ANZICS Clinical Trials Group. Lancet 2000

  30. ESCAPE Trial Weight Loss as a Function of Maximum In-hospital Diuretic Dose Relation between dose of diuretics and outcomes in HF Hasselblad V Eur J Heart Failure 2007

  31. Effetto dell’Insufficienza renale e dello SC sulla curva di dose-risposta della Furosemide Resistenza ai diuretici e aumento di mortalità Neuberg Am Heart J 2002 Ellison DH, Cardiology 2001;96:132-143

  32. Cardio-Renal Syndrome Increased Morbidity And Mortality Neurohormonal Activation Diminished Blood Flow Impaired Renal Function Decreased Renal Perfusion

  33. Congestione venosa e disfunzione renale L’aumento della pressione veosa centrale riduce il gradiente netto di filtrazione glomerulare da 14 a 4 mmHg M Jessup, MR Costanzo JACC 2009 W Mullens et al J Am Coll Cardiol 2009;53:589–96

  34. Fluid Removal by Ultrafiltration Ultrafiltration removes fluid from the blood at the same rate that the fluid can be naturally recruited from the tissue. This “balanced diuresis” maintains sufficient intravascular volume during the restoration of the body’s fluid balance, decreasing the risk of hypotension. In addition, the electrolyte composition of blood and ultrafiltrate remains in balance, resulting in removal of excess fluid

  35. UNLOAD trial J Am Coll Cardiol 2007;49:675–83)

  36. Snodi critici: • Quando iniziare la RRT in ICU • Scelta del tipo di RRT (cont/interm) • Accessi vascolari (rischio trombosi/stenosi) • Impatto emodinamico (ipotensione) • Anticoagulanti Giornale Italiano di Nefrologia / Anno 21, S-28 2004/pp. S1-S10

  37. Changes in serum creatinine and weight at 96 hours In 188 CHF patients with WRF (within 12 weeks before or 10 days after index admission for heart failure) The primary end point was the change in creatinine levels and in weight In the first 96 hours. Bart BA et al. (CARESS-HF investigators). NEJM 2012

  38. P=0.03 Bart BA et al. for the CARESS-HF investigators. NEJM 2012

  39. Ultrafiltration • Major gaps in knowledge remain and include: short- and long-term safety, patient impact, cost-effectiveness of this approach compared with diuretic management • In particular issues related to venous access, systemic anticoagulation and bleeding risks, and acute kidney injury need to be explored in larger patient cohorts. Givertz J Cardiac Fail 2013

  40. Patients admitted with evidence of significant fluid overload should initially be treated with loop diuretics….. • ……When a patient with congestion fails to respond to initial doses of intravenous diuretics, several options may be considered: • right heart catheterization • a thiazide or spironolactone can be added • continuous infusion of the loops diuretic may be considered • ….. If all diuretic strategies are unsuccessful, ultrafiltration or another renal replacement strategy may be reasonable. Jessup M. et al. Circulation 2009

  41. IN-HF Outcome Acute HF: diagnostic test performed during hospitalization (2) Oliva F, Mortara A, Cacciatore G et al EJHF 2012