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I Registri: quello che sappiamo e quello che vorremmo sapere

SCOMPENSO CARDIACO ACUTO: NUOVE ACQUISIZIONI. I Registri: quello che sappiamo e quello che vorremmo sapere. Michele Senni U.S.D. Medicina Cardiovascolare Dipartimenti Cardiovascolare e di Medicina Interna Ospedali Riuniti - Bergamo. Why Focus on Acute Heart Failure?.

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I Registri: quello che sappiamo e quello che vorremmo sapere

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  1. SCOMPENSO CARDIACO ACUTO: NUOVE ACQUISIZIONI I Registri: quello che sappiamo e quello che vorremmo sapere Michele Senni U.S.D. Medicina Cardiovascolare Dipartimenti Cardiovascolare e di Medicina Interna Ospedali Riuniti - Bergamo

  2. Why Focus on Acute Heart Failure? • Clinical trials in heart failure: Focus on… Omit… - Stable outpatients - Criteria for admission to hospital - Systolic dysfunction - Treatments for acute heart failure - Enroll relatively younger - Diastolic dysfunction pts and exclude many pts with co-morbidities

  3. Definition of a Patient Registry • A registry is an observational study of actual medical practice • Registries do not specify that any specific treatment be given or procedure be performed • Registries collect data on what is done based on clinical circumstances • Data are analyzed in a periodic fashion to permit analysis of trends

  4. Advantages All inclusive. Patients with co-morbidities, women of child bearing potential, elderly included. “Real-world” Can provide detailed information of patient characteristics, treatment strategies, and outcomes of interest Disadvantages Potential selection, observational, and investigator bias and can be confounded by variety of factors Observational Studies

  5. Registries or surveys • TEMISTOCLE Survey1 • EuroHeart Failure Survey2 • ADHERE registry3 • Impact-HF4 • ANMCO Survey (Survey on Acute Heart Failure)5 • Registro Niguarda6 • EFFECT7 • EFICA8 • OPTIMIZE-HF9 1- Di Lenarda Am Heart J 2003 2- Cleland Eur Heart J 2002 3- Adams Am Heart J 2005 4 -O’Connor J Cardiac Failure2005 5- Tavazzi Eur Heart J 2006 6- Oliva Cardiologia 2003 7- Lee. JAMA 2003 8- Zannand Eur Heart J 2002 9- Fonarow JAMA 2005

  6. Registries or surveys • TEMISTOCLE Survey1 • EuroHeart Failure Survey II2 • ADHERE registry3 • Impact-HF4 • ANMCO Survey (Survey on Acute Heart Failure)5 • Registro Niguarda6 • EFFECT7 • EFICA8 • OPTIMIZE-HF9 1- Di Lenarda Am Heart J 2003 2- Cleland Eur Heart J 2002 3- Adams Am Heart J 2005 4 -O’Connor J Cardiac Failure2005 5- Tavazzi Eur Heart J 2006 6- Oliva Cardiologia 2003 7- Lee. JAMA 2003 8- Zannand Eur Heart J 2002 9- Fonarow JAMA 2005

  7. Survey on ACUTE HEART FAILURE STUDY POPULATION SCREENING 2807 consecutive patients admitted with a diagnosis of acute HF from March 1 to May 31, 2005 in 206 cardiology with ICU • INCLUSION CRITERIA • NYHA III-IV Class (in AMI patients Killip class III-IV) or pulmonary edema or cardiogenic shock • Intravenous drug therapy Tavazzi et al. Eur Heart J 2006

  8. ADHERE Registro 282 ospedali community, tertiary e accademici Tutte le regioni degli USA Tutti i ricoveri con diagnosi di scompenso acuto (ICD-9) Electronic case report Anonimo: possibili più ospedalizzazioni per lo stesso paziente 1° paz: 1 ottobre 2001 Fino a 4 gennaio 2004: 107.362 ospedalizzazioni Adams et al. Am Heart J 2005

  9. Euro Heart Failure Survey II(October 2004 - August 2005) • 30 countries • 133 hospitals • Emergency area, internal medicine, cardiology wards, CCU, ICU • 3.580 patients enrolled with heart failure • Inclusion criteria: dyspnea, signs of HF and lung congestion on chest X-ray Nieminen et al. Eur Heart J 2006

  10. Euro Heart VMAC ADHERE OPTIME ANMCO Registri Scompenso AcutoEtà Età media (anni) Registri RCT

  11. Euro Heart VMAC ADHERE OPTIME ANMCO Registri Scompenso AcutoSesso femminile % sesso femminile Registri RCT

  12. Registri Scompenso AcutoEziologia ADHERE Registry EuroHeart Survey ISCHEMICA ANMCO Survey VALVOLARE IPERTENSIVA IDIOPATICA

  13. ANMCO Survey on Acute Heart Failure CLINICAL PRESENTATION (2807 patients) 54.8% Worsening CHF 44.0% De Novo HF 1.2% Transplant list

  14. ANMCO Survey on Acute Heart Failure CLINICAL PRESENTATION (2807 patients) 7.7% Cardiogenic Shock 25.8% NYHA III 49.6% Pulmonary Edema 16.9% NYHA IV

  15. YES NO ANMCO Survey on Acute Heart Failure ISCHEMIC EPISODE AS PRECIPITATING FACTOR OF AHF (2807 patients) 100 % 80 60.2% 68.6% 72.6% 60 40 20 39.8% 31.4% 27.4% 0 De Novo HF (n. 1235) Worsening CHF (n. 1537) Transplant list (n. 35)

  16. Registri Scompenso AcutoLVEF > 40% * % *LVEF 45%

  17. EuroHeart Survey II Prevalence of valvular dysfunction

  18. IPERTENSIONE DIABETE INSUFF. RENALE PNEUMOPATIA Registri Scompenso AcutoComorbilità %

  19. EuroHeart ADHERE ANMCO Registri Scompenso AcutoTerapia Farmacologica e.v. %

  20. IN-HOSPITAL IV TREATMENTS (2807 patients)

  21. Registri Scompenso AcutoTerapia Non Farmacologica ADHERE % EuroHeart ANMCO

  22. Registri Scompenso AcutoPrescrizione Trattamenti Farmacologici Raccomandati Euro Heart ADHERE ANMCO % pz. dimessi

  23. Registri Scompenso AcutoDegenza Media giorni

  24. Registri Scompenso AcutoMortalità Intraospedaliera % 7.3% 6.6% 4%

  25. IN-HOSPITAL DEATH (205 patients) 25.4% 7.3% 6.5% 5.0% NYHA III-IV (n. 60) Pulmonary edema (n. 90) Cardiogenic shock (n. 55) Total (n. 205)

  26. Independent predictors of in-hospital all-cause death L Tavazzi et al. Eur Heart J 2006

  27. ADHERE CART: Predictors of Mortality BUN 43 N=33,324 Less than Greater than 2.68% n=25,122 8.98% n=7,202 < > < > SYS BP 115 n=24,933 SYS BP 115 n=7,150 15.28% N=2,048 6.41% n=5,102 5.49% n=4,099 2.14% n=20,834 < > Cr 2.75 2,045 Highest to Lowest Risk Cohort OR 12.9 (95% CI 10.4-15.9) 21.94% n=620 12.42% n=1,425 Fonarow Circulation 2003;108:IV-693

  28. Registri Scompenso AcutoFollow Up MORTALITA’ RIOSPEDALIZZ. % (6 mesi)

  29. Obiettivi di un Registro Scompenso Cardiaco Acuto • Descrivere le caratteristiche demografiche e cliniche dei pazienti ospedalizzati • Evidenziare gli attuali modelli di gestione di questi pazienti • Definire le strategie di trattamento associate ai migliori outcomes clinici e al più efficiente utilizzo delle risorse • Aiutare nella valutazione e nel miglioramento della qualità dell’assistenza

  30. Performance Indicators for Heart Failure Patient Care (JCAHO) 100 90 80 70 83 60 73 Patients Treated (%) 50 40 30 36 20 29 10 0 Performance Indicator HF-1 Complete Discharge Instructions HF-2 LVF Measured or Scheduled HF-3 ACE Inhibitor at Discharge for LVSD HF-4 Smoking Cessation HF-1: n=28,776; HF-2: n=34,397; HF-3: n=12,725; HF-4: n=5,475 Fonarow J Card Failure 2003;9:S79

  31. 5% P=0.003 4% P=0.003 116% P<0.0001 70% P<0.0001 Trends in Quality of Care at Discharge in ADHERE: Q1 2002 to Q4 2003 Q1 2003 n=17,735 Q2 2003 n=16,719 Q3 2003 n=13,984 Q4 2003 n= 10,265 Q1 2002 n= 8,198 Q2 2002 n=11,289 Q3 2002 n=14,430 Q4 2002 n=16,925 Baseline Characteristics Similar All 8 Quarters

  32. Studi Osservazionali e RegistriScompenso AcutoIl Futuro… • Individuazione e validazione di nuovi trattamenti farmacologici e non • Identificazione e sperimentazione di modelli di continuità assistenziale. • Integrazione dei dati scompenso cardiaco cronico/scompenso cardiaco acuto nella popolazione reale

  33. Acute Exacerbations May Contribute to the Progression of the Disease With each event, hemodynamic alterations and myocardial damage contribute to progressive ventricular dysfunction Acute event Ventricular function Time From Gheorghiade . Am J Cardiol 2005 (modified)

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