Η αμφικοιλιακή βηματοδότηση σε ασθενείς με ήπια έκπτωση της συστολικής λειτουργίας της ΑΚ

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1 Καρδιακή Ανεπάρκεια - Αρρυθμίες Η αμφικοιλιακή βηματοδότηση σε ασθενείς με ήπια έκπτωση της συστολικής λειτουργίας της ΑΚ Εμμ. Μ. Κανουπάκης Πανεπιστημιακό Νοσοκομείο Ηρακλείου

2 Η αρχική ιδέα Circulation 1989;79:

3 Η επιβεβαίωση Mechanical effect of LBBB

4 Πριν από 20 περίπου χρόνια

5 Μια προσωρινή λύση Cazeuau S et al, PACE 1994; 17(Pt. II}:

6 Μια μόνιμη θεραπεία Θεραπεία επανασυγχρονισμού (CRT)

7 Αναζητώντας αποδείξεις

8 Strong evidence that CRT reduces mortality and hospitalization, improves cardiac function and structure, in symptomatic chronic HF patients despite OMT, severely depressed LVEF (i.e. 35%) and complete LBBB

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10 2016 ESC Guidelines for HF Ponikowski P et al, Eur Heart J. 2016;37:

11 ΜΙΑ ΜΑΤΙΑ ΣΤΗΝ ΠΡΑΓΜΑΤΙΚH ΖΩΗ

12 Trends in HF Among 110,621 pts only 50% (55,083) had HF-reduced EF Mortality has not dropped in HF pts with LVEF >40% Steinberg B et al, Circulation. 2012;126:65-75

13 Μια πιθανή εξήγηση Lack of evidence based therapies for heart failure pts with less severe LV dysfunction

14 Mortality in CRT pts In 14,946 Medicare pts even with ΟΜΤ and state of the art CRT-D, approximately one third died during the first 3 yrs of follow-up after CRT-D, and about half either died or were hospitalized for HF Bilchick K et al, Circulation. 2010;122:

15 Μήπως;

16 Μια υπόθεση Treatments that are introduced earlier in the disease process may exert greater benefits

17 QRS prolongation in HF QRS prolongation and LBBB are equally often in preserved EF and milder HF, and are also independent risk factors for all-cause mortality Lund L et al, Eur Heart J 2013;34:

18 Το παράδειγμα της ήπιας ΚΑ REVERSE MADIT-CRT - 53 % relative risk reduction - 41 % relative risk reduction Reduction in heart failure related hospitalizations Linde C et al, J Am Coll Cardiol 2008; 52: Moss A et al, N Engl J Med 2009;361:

19 Το παράδειγμα της ήπιας ΚΑ REVERSE MADIT-CRT Reverse remodeling develops in full over 2 years and is thereafter maintained Linde C et al, J Am Coll Cardiol 2008; 52: Moss A et al, N Engl J Med 2009;361:

20 Το παράδειγμα της ήπιας ΚΑ REVERSE MADIT-CRT Mortality was very low compared to NYHA III/IV trials Linde C et al, Eur Heart J 2013;34: Goldenberg I et al, N Engl J Med 2014;370:

21 ΙΣΧΥΕΙ Η ΥΠΟΘΕΣΗ ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ ΗΠΙΑ ΕΚΠΤΩΣΗ ΤΟΥ ΚΕ;

22 Observational data in patients with moderate LV systolic dysfunction, wide QRS and NYHA III CRT appears to be beneficial in terms of cardiac structure remodeling and leads to similar changes in symptoms and functional capacity in patients with either an LVEF >35% or 35% Fung et al, J Cardiovasc Electrophysiol 2006;17: Foley et al, PACE 2009; 32:S186 S189

23 Sub-studies of large CRT clinical trials A large proportion of patients (24% - 38%) had LVEFs higher than the inclusion criteria based on expert core laboratory analysis

24 MADIT-CRT LVEF <30% NYHA I II QRS >130 ms LVEF was >30% (range %) in 696 patients (38%) when analysed by the echo core lab Kutyifa V et al, J Am Coll Cardiol 2013;61:936 44

25 MADIT-CRT The clinical benefit of CRT was evident regardless of baseline LVEF, including those with LVEF >30% Kutyifa V et al, J Am Coll Cardiol 2013;61:936 44

26 MADIT-CRT The echocardiographic response to CRT-D was even more pronounced among patients with higher LVEFs Kutyifa V et al, J Am Coll Cardiol 2013;61:936 44

27 REVERSE Study LVEF 40% NYHA I or II QRS 120 ms almost 24% of pts had LVEF >30%, with slightly more than 12% having an LVEF >35% Linde C et al, Circ Heart Fail. 2013;6:

28 REVERSE Study CRT in patients with LVEF >30% was associated with a significant prolongation in time to mortality or hospitalizations for HF Linde C et al, Circ Heart Fail. 2013;6:

29 REVERSE Study In patients with LVEF >30%, CRT was associated with significant reduction in LVESVi and LV mass consistent with reverse remodeling Linde C et al, Circ Heart Fail. 2013;6:

30 Metanalysis All-cause mortality Death or HF hospitalization Pts with an LVEF >35% derive similar benefit from CRT compared with pts with a lower LVEF even though the entry criteria of most trials exclude them Cleland J et al, Eur Heart J 2013;34:

31 Η ΠΡΟΣΠΑΘΕΙΑ ΝΑ ΕΠΙΒΕΒΑΙΩΘΕΙ Η ΥΠΟΘΕΣΗ

32 MIRACLE-EF study If CRT-P ON compared to CRT-P OFF will reduce HF events and mortality in patients with NYHA II-III, LBBB and LVEF>36-50% Enrollment began Jan 2013 but was terminated Feb 2014 due to recruitment failure with less than 0.1pt/center/month Linde C et al, ESC Congress 2014

33 MIRACLE-EF study In the small number of pts, CRT appeared to reduce LV volumes over 6 months Linde C et al, ESC Congress 2014

34 Difficulties to enroll pts Middle child syndrome Large gaps in the prevalence, pathophysiology, and optimal treatment of these patients

35 ΣΥΝΕΧΙΖΟΝΤΑΣ ΤΟ ΨΑΞΙΜΟ ΟΙ ΒΗΜΑΤΟΔΟΤΟΕΞΑΡΤΩΜΕΝΟΙ

36 MOST trial Patients with RV pacing 40% were found to have a 2.5-fold increased risk of HF hospitalization compared with those with <40% RV pacing Sweeney M et al, Circulation. 2003;107:

37 DAVID trial DDDR pacing at 70 b.p.m. was significantly associated with a higher risk of the combined endpoint of death from any cause or hospitalization for HF Wilkoff B et al, JAMA. 2002;288:

38 CRT for bradycardia and normal EF In patients with normal systolic function, conventional RVA pacing resulted in adverse LV remodeling and in a reduction in the LVEF These effects were prevented by biventricular pacing Yu CM et al, N Engl J Med 2009;361:

39 The first prospective RCT BiV vs. conventional RV apical pacing among patients with AV block I III, HF (NYHA I III), and subnormal LVEF Mean LVEF was 40%, almost 70% of patients had LVEF >35%

40 BLOCK-HF CRT was associated with a statistically significantly lower incidence (26% risk reduction) of the primary composite endpoint of all-cause death, HF-related urgent care visit, and >15% increase in LVESVi and a 27% risk reduction in allcause mortality and HF-related urgent care Curtis A et al, N Engl J Med 2013;368:

41 BLOCK-HF message For patients who require chronic RV pacing, treatment with CRT leads to significant improvement of LV function and reduction of adverse clinical events, even in patients with milder forms of HF and less severe LV dysfunction

42 2016 ESC Guidelines for HF Ponikowski P et al, Eur Heart J. 2016;37:

43 BioPace study Is BiV pacing superior to RV pacing in patients with AVB who require permanent ventricular pacing? Blanc JJ, ESC Congress 2014

44 BioPace study the BioPace study cohort is quite different from the BLOCK-HF study population Blanc JJ, ESC Congress 2014

45 BioPace study a non statistically significant trend in favor of BiV over RV pacing mode in combination of time-to-death or first hospitalization due HF Blanc JJ, ESC Congress 2014

46 BLOCK-HF vs. BioPace The discrepancy may be due at least in part to different patient characteristics: BLOCK HF appeared to have sicker patients with a lower average LVEF, more LBBB, and more AF

47 ΤΕΛΙΚΑ ΧΡΕΙΑΖΕΤΑΙ?

48 Οι θεραπευτικοί μας στόχοι στην ΚΑ Mathias, A. et al. J Am Coll Cardiol. 2016;68:

49 Πως επιτυγχάνεται; CRT is among the most powerful agents of reverse remodeling after beta-blockers Kramer D et al, J Am Coll Cardiol 2010;56:

50 Reverse remodeling even in mref CRT benefits did not appear to vary with LVEF

51 Reverse remodeling & arrhythmias REVERSE MADIT-CRT Reverse remodeling was associated with a significant reduction in the risk of subsequent life-threatening VTAs Gold M et al, Heart Rhythm 2011;8: Barsheshet A et al, J Am Coll Cardiol 2011;57:

52 Reverse remodeling & survival A 68% reduction in mortality was observed in patients with >15% decrease in LVESVi compared to the rest of the pts The change in LVESV after 6 months of CRT is a strong independent predictor of long- term survival in mild HF Gold M et al, Heart Rhythm 2015;12:

53 Η θεωρία the healthiest benefit the most? Gasparini M, J Am Coll Cardiol 2013;61:945 47

54 Εμφύτευση CRT

55 Οι κίνδυνοι Kirkfeldt RE et al., Eur Heart J 2014;35:

56 Στην πρακτική μας

57 Of 1,436 patients at 5 years, 59% of patients had died, had further reduction in their LVEF to 35% or less, had a sustained VA, or required device implantation

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59 True dyssynchronopathy A.H. Maass and B. Daan Westenbrink, Eur J Heart Failure 2015;17:

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