Il Defibrillatore Impiantabile nella pratica clinica

Транскрипт

1 Il Defibrillatore Impiantabile nella pratica clinica Cattedra di Cardiologia, Clinica Cardiologica Università degli Studi dell Insubria, Ospedale di Circolo e Fondazione Macchi, Varese

2 Morte Improvvisa: killer n 1!!! Stroke 3 167,366 Lung Cancer 2 157,400 SCA claims more lives each year than these other diseases combined 450,000 SCD 4 Breast Cancer 2 AIDS 1 40,600 42,156 1 U.S. Census Bureau, Statistical Abstract of the United States: American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures Heart and Stroke Statistical Update, American Heart Association. 4 Circulation. 2001;104:

3 Morte Improvvisa: chi piú a rischio? Rischio %/aa Incidenza Eventi/aa Zipes et al, Circulation 1998; 98: 2334

4 Morte Improvvisa: epidemia!!! Zipes et al, Circulation 1998; 98: 2334

5 Morte Improvvisa: substrato < 35 anni > 35 anni Zipes et al, Circulation 1998; 98: 2334

6 Morte Improvvisa: fisiopatologia Substrato anatomofunzionale Trigger Meccanismi elettrofisiologici Zipes et al, Circulation 1998; 98: 2334

7 Morte Improvvisa e Scompenso Cardiaco NYHA II NYHA III NYHA IV CHF 12% Altro 24% CHF 26% Altro 15% CHF 56% SCD 64% SCD 59% SCD 33% Altro 11% MERIT-HF Study. Lancet 1999

8 Morte Improvvisa e Farmaci Antiaritmici Mortalitá totale Morte improvvisa Singh et al, N Engl J Med 1995; 333: 77

9 Morte Cardiaca Improvvisa: PREVENZIONE SECONDARIA

10 AVID, CASH, CIDS: Meta-analisi analisi Mortalitá totale Morte improvvisa HR: % riduzione di mortalità HR: % riduzione di mortalità Connolly et al, Eur Heart J 2002; 21: 2071

11 AVID, CASH, CIDS: Meta-analisi analisi EF > 35% EF < 35% Connolly et al, Eur Heart J 2002; 21: 2071

12 CIDS Trial: a chi serve l ICD? Favors ICD Favors Amiodarone Connolly et al, Circulation 2000; 101: 1297

13 Morte Cardiaca Improvvisa: PREVENZIONE PRIMARIA

14 MADIT P < 0,009 N= 196 pz Post IMA EF < 35% SEF + Moss et al, N Engl J Med 1996; 335: 1933

15 MADIT: ICD e CHF Pazienti senza CHF Pazienti con CHF Moss et al, N Engl J Med 1996; 335: 1933

16 MADIT II P < 0,007 N= 1232 pz Post IMA EF < 30% Moss et al, N Engl J Med 2002; 346: 877

17 MADIT II: SCD e QRS Popolazione totale Pazienti con QRS >120 msec 0.78 P= P= HR: % riduzione di mortalità HR: % riduzione di mortalità Moss et al. N Engl J Med 2002; 346: 877

18 DINAMIT Trial N= 674 pz 6-40 gg post IMA EF < 35% Ridotta HRV Mesi Stratificare il rischio aritmico dopo la completa risoluzione di un evento ischemico acuto! Hohnloser et al, N Engl J Med 2004; 351: 2481

19 SCD-HeFT Trial Mortalitá N= 2521 pz NYHA II-III CAD o DCM EF < 35% Mesi ICD in tutti pz con SCC e LVEF < 35%??? Bardy et al, N Engl J Med 2005; 352: 225

20 COMPANION Trial N= 1520 pz NYHA III-IV CAD o DCM QRS > 120 ms Bristow et al, N Engl J Med 2004; 350: 2140

21 COMPANION e SCD-HeFT rinforzano il MADIT II Nisam, Nopper CVCT Cannes, F. 2005

22 CARE-HF Trial N= 813 pz NYHA III-IV CAD o DCM QRS > 120 ms Cleland et al, N Engl J Med 2005; 352: 1539

23 ICD: salva vita? Numerosi trial hanno dimostrato che l ICD riduce la mortalitá del 30-50%. 40 Mortalitá totale (%) % 20% 73% 38% 8 51% 54% 0% 31% 41% Control ICD 0% 36% 23% 0 AVID CIDS DUTCH CASH DEBUT MUSTT MADIT CABG MADIT II DEF- DINA- COMP SCD CES Patch NITE MIT HeFT SECONDARY PREVENTION PRIMARY PREVENTION S. Nisam, updated from 2002

24 ICD: Metanalisi Comparison: Outcome: 01 ICD vs. Control (Overall) 01 All-cause Mortality Study or sub-category Treatment n/n Control n/n RR (random) 95% CI Weight % RR (random) 95% CI AMIOVIRT 6/51 7/ [0.32, 2.42] CABG Patch 101/446 95/ [0.84, 1.39] CAT 13/50 17/ [0.45, 1.52] COMPANION 105/ / [0.66, 1.05] DEFINITE 28/229 40/ [0.45, 1.09] DINAMIT 62/332 58/ [0.80, 1.52] MADIT 1 15/95 39/ [0.24, 0.69] MADIT 2 105/742 97/ [0.56, 0.92] MUSTT 35/ / [0.34, 0.62] SCD HeFT 182/ / [0.65, 0.90] Total (95% CI) [0.63, 0.91] Total events: 652 (Treatm ent), 983 (Control) Test for heterogeneity: Chi 2 =29.67, df = 9 (P=0.0005), I 2 = 69.7% Test for overall effect: Z = 3.00 (P=0.003) 25% risk reduction Favours treatment Favours control Nanthakumar et al, JACC 2004; 44: 2166

25 ICD/CRT-D: D: salva vita? 31% risk reduction Desai et al, JAMA 2004

26 The Centers for Medicare and Medicaid Services (CMS): recent clinical evidence is adequate to conclude that ICD therapy is reasonable and necessary for patients with: Ischemic dilated cardiomyopathy*, documented prior MI and LVEF < 35% Non-ischemic dilated cardiomyopathy (NIDCM) > 9 months and LVEF < 35% CRT candidates, Class IV * Exclusions: MI < 40 days, CABG or PCI < 3 months Centers for Medicare/Medicaid Services (CMS) Decision Memo (CAG-00157R3), January 27, 2005

27 ICD: numero di pazienti da trattare per salvare una vita Number needed to treat to save one life (NNT)* ICD Therapy MUSTT MADIT MADIT II AVID SAVE Merit-HF 4S ISIS-2 (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) Streptokinase (2 Yr) 20 captopril Drug Therapy 26 metoprolol succinate 28 simvastatin 24 Streptokinase *NNT = 100 / (% mortality control group - % mortality treatment group)

28 ICD benefit ICD benefit (life-years gained): increases dramatically with follow-up time 1.0 Device implanted Sopravvivenza Life years gained by device implantation No device implanted Follow-up (anni) Salukhe et al, Circulation 2004; 109: 1848

29 ICD: costo-efficacia? Costo ( ) per anno vita salvata CABG (3 vessel) vs. medical management CABG (3 vessel) vs. PTCA ICD therapy vs. Rx tpa vs. streptokinase in acute MI survivors Dialysis for end-stage renal disease CABG (2 vessel) vs. medical management Adapted from Simoons EHJ 2002

30 ICD: costo-efficacia? Costo/die dell ICD < normali terapie farmacologiche Euro/die ACE Amio Statine 2 β-blocc 1 Antibiotic 1 ICD 3 Anti- Betaferon 4 Imatinib 5 Anti Inibitori 1 -darone 1 epilettici 1 (for multiple (for chronic AIDS 6 sclerosis) myeloid leukaemia) Source: 1 NHS UKMiCentral Medicines Information service for drugs 2 EURO-MED-STAT Guidant estimates (based on 6 yrs longevity) 4 Jim Furniss, 3 rd September 2003, London 5 Gleevec: success by design in oncology,columbia University 6 Diffusion of medicines in Europe, Olivier Schoffski, December 2002

31 ICD: costo-efficacia? Spesa annuale in billion ,49 6,14 2,71 1,94 0, ,3,4 ICD Statins ACE inhibitors * 3,4,5 Ca channel * blockers Beta blockers 3,4,5 3,4,5 * Source: 1 Guidant estimates 2 EURO-MED-STAT 2004, 3 Ministry of Health-Italy, 4 Prescription Pricing Authority-NHS UK, 5 OECD Health Working Paper 2003; * Includes only Fr,De, It, UK

32 ICD: costi US $ Billion AIDS 1,2 Stroke 3 Lung Breast ICD/ Cancer 4 Cancer 4 CRT-D 3 1 Bozzette et al., Accessed 2/04/ Morgan-Stanley hospital supplies and medical technology. April Accessed 12/07/2002

33 ICD: costi Cost to healthcare billion 2,5 2 1,5 1 0, ICD Pacemakers CABG* PTCA* Source: PMSI France, National Schedule of Reference costs UK, G-DRG catalog Germany, Guidant internal estimates * Includes only Fr, De, It, UK

34 Il Defibrillatore Impiantabile nella Pratica Clinica Morte improvvisa: killer n 1 I defibrillatori impiantabili salvano vite I defibrillatori impiantabili sono cost-effective I defibrillatori impiantabili sono significativamente sottoutilizzati