1 / 56

Herzinsuffizienz Register (HIR) Austria 2006-2009

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 Patienten (62%) wurde das 1 J FU tatsächlich durchgeführt: Hospitalisierung wegen kardialer Dekompensation 9.6%

sade-gallegos
Download Presentation

Herzinsuffizienz Register (HIR) Austria 2006-2009

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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 Patienten (62%) wurde das 1 J FU tatsächlich durchgeführt: • Hospitalisierung wegen kardialer Dekompensation 9.6% • 1 Jahresmortalität10.3%

  2. Kandidaten für Gerätetherapie im Österrreichischen HIR • NYHA III/IV 30% / 1.7% • LSB 27% • LVEF <35% (HIR < 40%) 66% • 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: • Auswahlder geeigneten Patienten mit Herzinsuffizienz zur Gerätetherapie • 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) No HF; n=251 n=.. P<0.001 P<0.0001 HF; n=382

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

  10. COMPANION (3): All-cause death: reduced only for CRT/ICD (4) Bristow MR, N Engl J Med 2004;350:2140-50.

  11. (4) Bristow MR, N Engl J Med 2004;350:2140-50

  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<35% under optimized medical therapy: Class I Level A • To improve symptoms/reduce hospitalization: Class I Level A • To reduce mortality: Class I Level A (1) ESC guidelines 2008

  14. (3) Bardy GH, N Engl J Med. 2005 Jan 20;352(3):225-37.

  15. (2) Cleland JG, N Engl J Med 2005;352:1539-49.

  16. (2) Cleland JG, N Engl J Med 2005;352:1539-49.

  17. SCD in CARE-HF (6) J Card Fail. 2008 Oct;14(8):670-5.

  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;352:1539-49. (3) Bardy GH, N Engl J Med. 2005 Jan 20;352(3):225-37. (4) Bristow MR, N Engl J Med 2004;350:2140-50

  19. CRT n=95 p<0.001 CRT/ICD n=110 No.at risk CRT 95 68 44 34 3 CRT/ICD 110 56 31 8 1 Adlbrecht C, et al. Eur J Clin Invest. 2009

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

  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. 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. (8) Adlbrecht C, et al. Eur J Clin Invest. 2009,

  25. p=0.003 Optimized patients n=56 Non-optimized patients n=148 No.at risk Optimized 56 46 24 16 0 Non-optimized 147 78 51 26 4

  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. p<0.001 p<0.001 „evaluated“ „not scheduled“ „evaluated“ „not scheduled“ A B Patients at risk: “Evaluated”: 133 99 79 56 30 6 “Not scheduled”: 72 34 23 11 6 2 Patients at risk: “Evaluated”: 133 128 122 91 52 14 “Not scheduled”: 72 53 43 24 15 3

  30. p<0.001 „optimized“ „judged fine“ „not scheduled“ „impossible“ Patients at risk: “Optimized”: 58 48 43 30 16 3 “Judged fine”: 46 35 28 21 12 3 “Not scheduled”: 72 34 23 11 6 2 “Impossible: 29 16 8 4 2 0

  31. Zusammenfassung 1: • 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 • 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 0.29-0.76; P =0.002) (7) Uretsky BF, J Card Fail. 2008 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;51:288-96.

  38. non-optimized optimized p-value (n=148) (n=56) Age (years) 67.1±11.1 61.8±11.3 p=0.003 Male sex n (%) 112 (76) 46 (82) p=0.324 Failed RAAS_BL_100% BL 137 (93) 17 (30) p<0.001 HF unit follow-up n (%) 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 Hypertension n (%) 102 (69) 42 (75) p=0.395 Diabetes n (%) 30 (21) 17 (30) p=0.177 Sodium (mmol/L) 138.0±3.6 138.7±2.6 p=0.172 Hemoglobin (mg/dL) 12.9±1.8 13.1±1.8 p=0.526 GFR_MDRD (mL/min/1.73 m2) 54.2±20.8 58.9±24.0 p=0.191 NT-proBNP (pg/mL) 3861.9±5065.0 4863.4±6848.4 p=0.513 QRS duration (ms) 155±34 156±30 p=0.993 NYHA p=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±10.0 27.8±8.5 p=0.722 Risk stratification score (3) p=0.132 0 0 (0) 1 (2) I 13 (9) 5 (9) II 65 (44) 28 (50) III 45 (30) 19 (34) IV 25 (17) 3 (5)

  39. p=0.004 Optimized patients n=56 Non-optimized patients n=148 No.at risk Optimized 56 56 56 14 2 Non-optimized 147 117 86 38 7

  40. Stepwise multivariate Cox regression: All cause death Including failed pharmacotherapy optimization at follow-up, the co-morbidity score and CRT/ICD vs. CRT Wald HR CI significance Failed RAAS_BB_FU 5.296 10.4 1.416-76.923 0.021

  41. Stepwise multivariate Cox regression: All cause deathand cardiac hospitalisation B SE Wald Sig. HR 95% CI Failed RAAS_BL_100% FU 0.732 0.295 6.154 0.013 2.080 1.166-3.710 CRT/ICD versus CRT 0.918 0.245 14.078 <0.001 2.504 1.550-4.045 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).

  42. Goldenberg Score I

  43. 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 [1.114-2.679], p=0.015).

  44. 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).

  45. MADIT CRT (5): NYHA I & II ischemics, NYHA II non-ischemics, QRS≥ 130 ms, LVEF≤ 30% (5) Moss A et al. N Engl J Med 2009;10.1056/NEJMoa0906431

  46. 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.

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

  48. (6) J Card Fail. 2008 Oct;14(8):670-5.

  49. 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

More Related