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Herzinsuffizienz Register (HIR) Austria 2006-2009 1648 Patienten wurden von 5/06-3/09 eingeschlossen Bei 1246 Patienten war 1 Jahres FU möglich Bei 768.

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Präsentation zum Thema: "Herzinsuffizienz Register (HIR) Austria 2006-2009 1648 Patienten wurden von 5/06-3/09 eingeschlossen Bei 1246 Patienten war 1 Jahres FU möglich Bei 768."—  Präsentation transkript:

1 Herzinsuffizienz Register (HIR) Austria Patienten wurden von 5/06-3/09 eingeschlossen Bei 1246 Patienten war 1 Jahres FU möglich Bei 768 Patienten (62%) wurde das 1 J FU tatsächlich durchgeführt: Hospitalisierung wegen kardialer Dekompensation 9.6% 1 Jahresmortalität 10.3%

2 Kandidaten für Gerätetherapie im Österrreichischen HIR NYHA III/IV 30% / 1.7% NYHA III/IV 30% / 1.7% LSB27% LSB27% LVEF <35% (HIR < 40%)66% LVEF <35% (HIR < 40%)66% Optimized Medical Therapy ? Optimized Medical Therapy ?

3 Richtliniengetreue HI Therapie bei Erstvorstellung

4 Optimierung der HI Therapie im HIR Nahezu drei Viertel der Patienten erhielten nach 1 Jahr mehr als 50% der Zieldosis

5 Geräte Therapie im HIR

6 Offene Fragen: Auswahl der geeigneten Patienten mit Herzinsuffizienz zur Gerätetherapie des geeigneten Gerätes bei Herzinsuffizienz: AICD oder CRT oder CRT+AICD Auswahl des geeigneten Gerätes bei Herzinsuffizienz: AICD oder CRT oder CRT+AICD Überweisung an Rhythmologen oder HI Ambulanz Nachsorge nach Implantation: Niedergelassener Bereich Herzinsuffizienzambulanz CRT Ambulanz / PM Ambulanz AICD Ambulanz Echokardiographielabor

7 Herzinsuffizienz vor/bei AICD Implantation 40% 60%

8 AICD 10 Jahres Überlebensrate in Abhängigkeit von Herzinsuffizienz (n=633) n=.. P<0.001 No HF; n=251 HF; n=382 P<0.0001

9 AICD 10 Jahres Überlebensrate in Abhängigkeit von Herzinsuffizienz und LSB P<0.001

10 COMPANION (3): All-cause death: reduced only for CRT/ICD (4) Bristow MR, N Engl J Med 2004;350:

11 (4) Bristow MR, N Engl J Med 2004;350:

12 It is important to note that the study was not designed or powered to evaluate effects on total mortality nor to compare CRT-P and CRT- D, and conclusive data comparing the effect of CRT-P to CRT-D are not available (1). Furthermore, COMPANION was prematurely terminated (median follow-up of only 16 months) (1) ESC guidelines 2008

13 Recommendations for cardiac resynchronization therapy (1) NYHA III/IV and QRS>120ms and LVEF 120ms and LVEF<35% under optimized medical therapy: Class I Level A To improve symptoms/reduce hospitalization: To improve symptoms/reduce hospitalization: Class I Level A To reduce mortality: To reduce mortality: Class I Level A (1) ESC guidelines 2008

14 (3) Bardy GH, N Engl J Med Jan 20;352(3):

15 (2) Cleland JG, N Engl J Med 2005;352:

16

17 (6) J Card Fail Oct;14(8): SCD in CARE-HF

18 Conclusion CRT monotherapy is an effective treatment (2) No effect of an ICD in SCD-HEFT in patients with NYHA III (3) No difference between CRT and CRT/ICD (4) Stating that CRT/ICD is superior to CRT based on COMPANION is in contradiction to the NYHA III population of SCD-HEFT. (2) Cleland JG, N Engl J Med 2005;352: (3) Bardy GH, N Engl J Med Jan 20;352(3): (4) Bristow MR, N Engl J Med 2004;350:

19 No.at risk CRT CRT/ICD p<0.001 CRT/ICD n=110 CRT n=95 Adlbrecht C, et al. Eur J Clin Invest. 2009

20 CRT vs CRT+ICD Gesamtmortalität P=0.7 CRT-Mono; n=95 CRT/ICD; n=110

21 The survival advantage of CRT/ICD vs. CRT has never been adequately addressed. Due to the documented effectiveness of ICD therapy in the prevention of sudden cardiac death, the use of a CRT/ICD device is commonly preferred in clinical practice in patients satisfying CRT criteria including an expectation of survival with good functional status for >1 year (1). (1) HF guidelines ESC 2008

22 Geräte Therapie im HIR

23 Offene Fragen: Nachsorge nach Implantation: Niedergelassener Bereich Herzinsuffizienzambulanz CRT/PM Ambulanz AICD Ambulanz Echokardiographielabor

24 (8) Adlbrecht C, et al. Eur J Clin Invest. 2009, As in the real world, medical therapy is not always up-titrated to the desirable dosages, this provides the opportunity to evaluate the impact of optimizing medical therapy in patients who had received a device therapy Although recommended, the need for optimization of medical therapy following device implantation has never been proven. We hypothesized that failure to optimize medical therapy impacts on outcome of patients with CRT or CRT/ICD although device therapy itself has been demonstrated to affect outcome. We hypothesized that failure to optimize medical therapy impacts on outcome of patients with CRT or CRT/ICD although device therapy itself has been demonstrated to affect outcome.

25 No.at risk Optimized Non-optimized p=0.003 Optimized patients n=56 Non-optimized patients n=148

26 Optimierung der HI Therapie im HIR Nahezu drei Viertel der Patienten erhielten nach 1 Jahr mehr als 50% der Zieldosis

27 Conclusion Our data showing worse outcome for CRT/ICD patients should be interpreted with caution, but underscore the fact, that combined systems should not be implanted routinely. The impact of quality of baseline pharmacotherapy exceeds the effect of the device implanted. Pharmacotherapy must be optimized before device and re-evaluated after implantation. At present no general advise for the selection of patients who will profit most of CRT/ICD can be made. Finally, the higher costs of a CRT/ICD compared to a CRT device have to be kept in mind.

28 Die Bedeutung der Echokardiographie zur AV Optimierung nach CRT Implantation

29 A B p<0.001 Patients at risk: Evaluated: Not scheduled: Patients at risk: Evaluated: Not scheduled: evaluated not scheduled evaluated not scheduled

30 optimized judged fine not scheduled impossible p<0.001 Patients at risk: Optimized: Judged fine: Not scheduled: Impossible:

31 Zusammenfassung 1: Obwohl 27% der Patienten im HIR einen LSB aufweisen, ist die Zahl der CRT Kandidaten nicht bekannt Obwohl 27% der Patienten im HIR einen LSB aufweisen, ist die Zahl der CRT Kandidaten nicht bekannt Bei Erstvorstellung ist eine leitliniengestützte Pharmakotherapie selbst bei einem positiv selektionierten Krankengut vebesserungswürdig Für die vermehrte Implantation von Kombinationsgeräten mangelt es an Evidenz Auswahl und Nachsorge der Patienten sollte in erster Linie über Herzinsuffizienz- und CRT Ambulanz erfolgen.

32 Zusammenfassung 2: Morbidität und Mortalität wird durch Morbidität und Mortalität wird durch AV-Optimierung und Pharmakologische Optimierung verbessert ABER NICHT DURCH vermehrte Implantation von Kombinationsgeräten

33 Danke Prof. Pölzl und Prof. Fruhwald für die HIR Daten Prof. Graf und Prof. Binder für die Echokardiographiedaten Prof. Gwechenberger für die Daten der AV-Optimierung Dr. Adlbrecht für die Daten der medikamentösen Optimierung Fa. Guidant/Boston Scientific und Fa. Medtronic für die Stiftung des Echocardiographiegerätes

34 (6) Auricchio A, Am J Cardiol 2007;99:232–238

35 REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) trial (4) CRT, in combination with optimal medical therapy, reduces the risk for heart failure hospitalization and improves ventricular structure and function in NYHA functional class I and II patients with previous HF symptoms. (5) Linde C, JACC, 2008

36 Predictors of mortality from pump failure and sudden cardiac death in patients with systolic heart failure and left ventricular dyssynchrony: results of the CARE-HF trial. There was a risk reduction for SCD by CRT of 0.47 (95% confidence interval ; P =0.002) (7) Uretsky BF, J Card Fail Oct;14(8):670-5.

37 Methods This observational cohort study (n=205) retrospectively assessed the real life- impact of concomitant pharmacotherapy and the effect of CRT compared to CRT/ICD therapy on outcome. Outcome of patients with guideline recommended renin- angiotensin system inhibitor and ß-blocker dosages were compared to patients who did not receive the desired dosages. Co-morbidities were accounted for by application of a risk stratification score which included age, NYHA functional class, renal function, atrial fibrillation, and QRS duration. The validity of this score has already been proven for device patients (9). (9) Goldenberg I, et al. JACC 2008;51:

38

39 non-optimizedoptimizedp-value (n=148)(n=56) Age (years)67.1± ±11.3 p=0.003 Male sex n (%)112 (76)46 (82)p=0.324 Failed RAAS_BL_100% BL137 (93)17 (30)p<0.001 HF unit follow-upn (%)34 (23)41 (73)p<0.001 Diuretics n (%)109 (74)41 (73)p=0.950 Aldosterone antagonist n (%)87 (59)34 (61)p=0.843 Digitalis n (%)43 (29)13 (23)p=0.404 Ischemic heart disease 75 (51)19 (34)p=0.032 Hypertensionn (%)102 (69)42 (75)p=0.395 Diabetes n (%)30 (21)17 (30)p=0.177 Sodium (mmol/L) 138.0± ±2.6p=0.172 Hemoglobin (mg/dL) 12.9± ±1.8p=0.526 GFR_MDRD (mL/min/1.73 m2) 54.2± ±24.0p=0.191 NT-proBNP (pg/mL) ± ±6848.4p=0.513 QRS duration (ms)155±34156±30p=0.993 NYHAp=0.759 NYHA II n (%)3 (2)2 (4) NYHA III n (%)124 (84)45 (80) NYHA IV n (%)21 (14)9 (16) LVEF (%)27.2± ±8.5p=0.722 Risk stratification score (3)p= (0)1 (2) I13 (9)5 (9) II65 (44)28 (50) III45 (30)19 (34) IV25 (17)3 (5)

40 No.at risk Optimized Non-optimized p=0.004 Optimized patients n=56 Non-optimized patients n=148

41 Stepwise multivariate Cox regression: All cause death Including failed pharmacotherapy optimization at follow-up, the co-morbidity score and CRT/ICD vs. CRT WaldHRCIsignificance Failed RAAS_BB_FU

42 Stepwise multivariate Cox regression: All cause death and cardiac hospitalisation BSEWaldSig.HR95% CI Failed RAAS_BL_100% FU CRT/ICD versus CRT < Stepwise Cox regression model including the co-morbidity risk stratification score, failure to reach 100% of the recommended ß-blocker and RAAS antagonist dosages at follow-up and the device mode (CRT vs. CRT/ICD).

43 Goldenberg Score I

44 Goldenberg Score II To test the validity of the Goldenberg score in our population at baseline we assessed the prognostic value of this score (0-4) on mortality, receiving a proof for generalizability of the score for our patients (HR=1.728 [ ], p=0.015).

45 ESC guidelines 2008 In COMPANION, CRT-P and CRT-D were both associated with a 20% reduction in the primary combined end-point of all-cause mortality and all-cause hospitalization (P, 0.01). CRT-D was associated with a significant decrease in total mortality (P=0.003), whereas reduction in mortality associated with CRT- P was not statistically significant (P=0.059). It is important to note that the study was not designed or powered to evaluate effects on total mortality nor to compare CRT-P and CRT-D, and conclusive data comparing the effect of CRT-P to CRT-D are not available. In the CARE-HF trial, CRT-P was associated with a significant reduction of 37% in the composite end-point of total death and hospitalization for major cardiovascular events (P=0.001) and of 36% in total mortality (P=0.002).

46 (5) Moss A et al. N Engl J Med 2009; /NEJMoa MADIT CRT (5): NYHA I & II ischemics, NYHA II non-ischemics, QRS 130 ms, LVEF 30%

47 ESC CRT guidelines 2007 Class I, level of evidence A: For CRT to reduce morbidity and mortality Class I, level of eviddence B: CRT/ICD is an acceptable option for patients who have expectancy of survival with a good functional status for more than 1 year.

48 (6) Auricchio A, Am J Cardiol 2007;99:232–238

49 (6) J Card Fail Oct;14(8):670-5.

50 Macht der ICD als Add-on zum CRT Sinn? – Risiko versus Effekt Christopher Adlbrecht Medical University of Vienna, Department of Internal Medicine II, Division of Cardiology, Vienna, Austria

51 No.at risk CRT CRT/ICD p=0.031 CRT/ICD n=110 CRT n=95 Adlbrecht C, et al. Eur J Clin Invest. 2009, in press

52 No.at risk CRT CRT/ICD p<0.001 CRT/ICD n=110 CRT n=95

53 No.at risk CRT CRT/ICD p=0.031 CRT/ICD n=110 CRT n=95

54 (3) Bardy GH, N Engl J Med Jan 20;352(3):

55

56 Auswahl der geeigneten Patienten mit Herzinsuffizienz zur Gerätetherapie des geeigneten Gerätes bei Herzinsuffizienz: AICD oder CRT oder CRT+AICD Auswahl des geeigneten Gerätes bei Herzinsuffizienz: AICD oder CRT oder CRT+AICD Überweisung an Rhythmologen oder HI Ambulanz


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