Trattamento elettrico dello scompenso cardiaco

Dimensione: px

Iniziare la visualizzazioe della pagina:

Download "Trattamento elettrico dello scompenso cardiaco"

Gilberto Danieli
7 anni fa
Visualizzazioni

1 Trattamento elettrico dello scompenso cardiaco Dr. Leonardo Calo Laboratorio di aritmologia clinica ed interventistica Policlinico Casilino - Roma

11 Pazienti con insufficienza cardiaca in Classe NYHA II: Punti chiave Due recenti sperimentazioni prospettiche multicentriche randomizzate sull'insufficienza cardiaca lieve (MADIT-CRT e REVERSE) dimostrano una morbilità ridotta. Il 18% dei pazienti in REVERSE e il 15% dei pazienti in MADIT-CRT erano nella classe NYHA I alla baseline, sebbene la maggior parte di questi pazienti fosse stata precedentemente sintomatica. Il miglioramento si è osservato principalmente nei pazienti con QRS 150 ms e/o LBBB tipico. Nel MADIT-CRT, le donne con LBBB hanno mostrato una risposta particolarmente favorevole. Vantaggio in termini di sopravvivenza non stabilito. In MADIT-CRT l'estensione del rimodellamento inverso era concordante e predittiva del miglioramento nei risultati clinici Focused Update of ESC guidelines on device therapy in Heart Failure, K.Dickstein et al., European Heart Journal doi: /eurheartj/ehq337

12 C. Linde: the REVERSE trial 2009 CRITERI D INCLUSIONE E METODO Classe NYHA I-II; LVEDD>55mm; FE: <40%; RS; QRS>120ms CRT on (con o senza ICD) vs CRT off (con o senza ICD)

13 C. Linde

14 C. Linde

15 RISULTATI NEJM Risposta notevolmente precoce nel braccio CRT-D a partire dai primi 2 mesi SOTTOANALISI LBBB* CON ULTERIORI 6 MESI DI FOLLOW-UP 2 ENDPOINT PRIMARIO PER TUTTI I PAZIENTI Riduzione relativa del 34% della mortalità per tutte le cause o del primo evento di insufficienza cardiaca (p=0,001) ENDPOINT PRIMARIO PER I PAZIENTI LBBB Riduzione del 57% della mortalità per tutte le cause o del primo evento di insufficienza cardiaca rispetto al solo ICD (p<0,001) 1. N Engl J Med Oct 1;361(14): Cardiac-resynchronization therapy for the prevention of heart-failure events. MADIT-CRT Trial Investigators. 2. Indicazione FDA 2010 per il sistema CRT-D COGNIS (solo USA). *Il blocco di branca sinistro (LBBB) non era un parametro di inclusione per la sperimentazione MADIT-CRT. È stata tuttavia rilevata un'interazione significativa tra il trattamento e la morfologia del blocco di branca sinistro. Ulteriori analisi hanno evidenziato che il blocco di branca sinistro (LBBB) è una discriminante oggettiva del beneficio assicurato al paziente dalla CRT-D indipendentemente da altre caratteristiche alla baseline.

16 Inclusion Criteria MADIT CRT REVERSE No pts EF <30% <40% LVEDD> 55 mm no yes QRS duration (ms) Results MADIT CRT REVERSE EF 24%-24% 26.4%-26.8% QRS duration (ms) Mortality % % No Effects QRS < 150 ms QRS < 150 ms

17 Criterio Elettrocardiografico: QRS > 120 msec

18 Reliability and Reproducibility of QRS Duration Results: Significant interobserver differences (P < 0.001) were found between each combination of paired observers, with an up to 50-ms absolute variability between cardiologists and low concordance with computerized measurements. Intraobserver absolute variability was also significant (P < 0.01) for the 3 observers. These significant differences persisted (P < 0.01) when focusing our interest on the ECGs in the ms range (defined as at least one out of the 4 measures in this range). Considering the 120 ms limit, 22 (27.5%) ECGs were differently classified by at least one of the cardiologists. We observed similar interobserver differences between each combination of paired observers with a 50 mm/s sweep speed. Guillebon et al. J Cardiovasc Electrophysiol, Vol. pp. 1-3, In press.

19 Evidences from randomized clinical trials QRS duration (msec) COMPANION CARE-HF MUSTIC < 147 NO advantage No advantage in primary end-point > 168 CRT better < 160 NO advantage > 160 CRT better Only > 150 enrolled MADIT-CRT REVERSE > 150 CRT better < 150 No advantage > 152 CRT better

20 Effectiveness of Cardiac Resynchronization Therapy by QRS Morphology in the Multicenter Automatic DefibrillatorImplantation Trial Cardiac Resynchronization Therapy (MADIT-CRT) Circulation. 2011;123:

22 CRT in Patients with HF and Narrow QRS (RethinQ) trial Ischemic or nonischemic cardiomyopathy Ejection fraction 35% NHYA class III heart failure QRS interval <130 msec Mechanical dyssynchrony as measured on echocardiography. Primary end point Proportion of patients with an increase in peak oxygen consumption of at least 1.0 ml per kilogram of body weight per minute during cardiopulmonary exercise testing at 6 months.

23 CRT in Patients with HF and Narrow QRS (RethinQ) trial CRT did not improve peak oxygen consumption in patients with moderate-to-severe HF, providing evidence that patients with HF and narrow QRS intervals may not benefit from CRT. Peak oxygen consumption and the NYHA class improved in patients in the CRT group with a QRS 120 msec. However, no difference was observed in the quality-of-life score and the 6- minute walking test in either stratum.

24 Criterio Clinico: Classe NYHA

25 The limitations of the NYHA functional classification system Raphael et al. Heart 2007;93:

26 The limitations of the NYHA functional classification system Raphael et al. Heart 2007;93:

27 Terapia Medica Ottimale

28 Euro Heart Failure Survey 2003 Only 17% of the population received the Recommended Triple Association: Diuretic, ACE- Inhibitor, Beta-blocker. M. Komajda et al. European Heart Journal (2003)

29 Euro Heart Failure Survey II 2009 M. Komajda et al. European Heart Journal (2009)

30 Pennsylvania, USA Voigt A. et al. Clin Cardiol 2010

31 Criterio Ecocardiografico: FE < 35%

32 Sugeng L et al Circulation 2006;114:654

33 RENAL FUNCTION AND CRT Overall survival among CRT-D recipients stratified according to baseline GFR category ADELSTEIN ET AL. PACE 2010; 1 10.

34 Heart Failure Monitor for the early detection of decompensation in HF pts Atrial and ventricular arrhythmias SDANN Mean heart rate / 24 h Mean heart rate at rest % CRT Ac=vity / 24h Thoracic Fluid (intrathoracic impedance) Hemodynamics (intracardiac impedance) BP/WEIGHT

35 Trend: which information? AT/AF BURDEN V rate during AT/AF OptiVol Fluid Index Patient Activity Avg. V rate Thoracic Impedance Heart rate variability % Pacing/day

36 We retrospectively reviewed HM report database and hospital files of 92 consecutive patients routinely implanted with a CRT-D device in our centre from February 2006 to May HM Group. 26 patients (28%) were remotely followed with HM in addition to in-office visits scheduled every 4 months; SF Group. 66 patients (72%) were followed with a standard program of quarterly in-office visits. PACE 2011

38 Clinical AE Survival Rates Kaplan-Meier curves Complete observations Censore Clinical AE survival rates 1,0 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 SF Group p= HM Group Time (days from implant) De Ruvo,, Calo PACE 2011

39 Effect of Evaluation Frequency More frequent evaluations enhance risk stratification. Monthly evaluations provide reasonable balance of risk stratification benefit and clinician effort.

40 Majority of pts retired (81%) and accompanied by a relative or a carer (72%) who, in 43% of the pts, had to ask for a special permission at work. Private car was the most commonly used means of transportation, with a median home-to-hospital distance of about 20 Km. Median waiting time for a visit 20 minutes. Overall time spent by a pt for a single visit (home-to-hospital trip, waiting time, visit time and return trip) was about 2 hours. No significant differences were observed between the two groups for any of these data.

41 Calo Heart Rhythm 2012

42 HF admission in our Hospital (2009) - Internal Medicine: 123 pts - Emergency Department 56 pts - Cardiology Division 17 pts - Intensive Unit Care: 2 pts

43 NUMBER OF ADMISSIONS IN EAD FOR ACUTE HF (2009) N acces. N paz % , , , , , , , , , ,15 totale

44 HF MANAGEMENT Euvolemia Stable NYHA Class Optivolemia; Stable NYHA Class Filling Filling pressures Pressures increase Increase, Sympathetic Sympathetic Activation Stable activation; NYHA Class Impedence Change reduction in Stable NYHA Impedance Class Worsening Symptoms or Weight Change Symptoms or Increase of weight E.R. Hospitalization Hospitalization, ER visit, Urgent Care Days > a -7-6 a -2 0 a 5 Days > to -7-6 to -2 0 to 5 New active phase Pre-active Pre-active phase phase Reactive phase Reactive phase

45 HF-Management

46 HF-Clinical Decision and Outcome

47 Partners Criteria

48 Il Risk Score normalizzato dovrà essere nell intervallo [0, 10] La fascia di rischio proposta è la seguente: Basso Medio Alto Livello Di Rischio

49 Il risk score viene confrontato con due ulteriori soglie che permesono di assegnare il livello di rischio (basso, medio, alto)

50 Per ogni criterio, visione del n di pazien= per cui è soddisfaso ciascun criterio, isolatamente o accompagnato da almeno un altro

53 Grazie!! Alessio Borrelli Cosimo Commisso Ermenegildo de Ruvo Lucia De Luca Alessandro Fagagnini Fabrizio Guarracini Emanuele Guerra Renzo Iulianella Chiara Lanzillo Anna Maria Martino Marta Marziali Monia Minati Giovanna Navone Francesca Nuccio Lorena Pisciella Marco Rebecchi Antonio Scara Luigi Sciarra Roberto Scioli Francesco Sebastiani Fabio Sperandii Antonella Sette Marco Topai Claudia Tota

Documenti analoghi

Linee guida all impianto di ICD per la prevenzione primaria della morte cardiaca improvvisa nei pazienti con grave disfunzione ventricolare

Linee guida all impianto di ICD per la prevenzione primaria della morte cardiaca improvvisa nei pazienti con grave disfunzione ventricolare Dr Calogero Puntrello UOC Cardiologia ASP Trapani L evento finale