Ηρακλής Μαυράκης Διευθυντής ΕΣΥ Ηλεκτροφυσιολογικό Εργαστήριο ΠΑΓΝΗ

1. Εξάντληση γεννήτριας σε βηματοδοεξαρτώμενο ασθενή με χαμηλόκλάσμα εξώθησης: Aντικατάσταση γεννήτριας, αμφικοιλιακός βηματοδότης ή απινιδωτής Ηρακλής Μαυράκης Διευθυντής ΕΣΥ Ηλεκτροφυσιολογικό Εργαστήριο ΠΑΓΝΗ

2. Pacemaker vs CRT-P vs CRT-D

3. Ερωτήματα ? • Ιστορικό • Ηλικία ασθενούς • Λειτουργικό στάδιο NYHA • Υπερηχογραφικά ευρήματα • Ευρήματα από τον έλεγχο του βηματοδότη • Συμπαρομαρτούντα νοσήματα • Προσδόκιμο επιβίωσης

5. Evidence-based medicine Randomized controlled trials Consensus guidelines Clinical practice

6. Pacemaker vs CRT-P

7. Patients with conventional pacemaker indications and heart failure • Previous studies have clearly shown that RV apical pacing might have deleterious effects on cardiac structure and function. • Moreover, different clinical trials have shown that there was a positive correlation between the rate of RV pacing and the occurrence of adverse events. • For patients with conventional pacemaker who develop HF, upgrading fromVVI or DDD to CRT devices represents an important part of thepatient population implanted with a CRT device, being 23–28% ofthe CRT implantations in different registries. Leclercq C, Cazeau S, Lellouche D, Fossati F, Anselme F, Davy JM, Sadoul N, Klug D,Mollo L, Daubert JC. Upgrading from single chamber right ventricular to biventricularpacing in permanently paced patients with worsening heart failure: TheRD-CHF Study. Pacing Clin Electrophysiol 2007;30 Suppl 1:S23–30.

8. Haemodynamic and mechanical effects of CRT

9. What do the guidelines say ? ACC/AHA ESC

10. Patients with conventional pacemaker indications and heart failure • The additional benefit of biventricular pacing should be considered in patients requiring permanent or frequent RV pacing for bradycardia, who have symptomatic HF and low LVEF. • The patients had conventional bradycardia indications (mostly permanent AV block), severe symptoms of HF (mostly NYHA class III or IV) and depressed EF mostly <35-40%. • During the CRT study phase, the pts consistently showed clinical subjective improvement, less hospitalization and improved cardiac function, compared with the RV study phase.

11. Patients with conventional pacemaker indications and heart failure

12. Patients with conventional pacemaker indications and heart failure

13. Upgrade to CRT and survival

14. Upgrade to CRT is associated with a high complication rate, which ranges 11 - 18.7% in prospective trials. The decision to upgrade should therefore be made after careful assessment of the risk–benefit ratio.

15. Indication for upgraded or de novo CRT in pts with conventional pacemaker indications and heart failure

16. CRT-P vs CRT-D

17. Benefit of adding ICD in patients with indications for CRT • Even though the theoretical reason for adding an ICD to CRT is clear —to reduce of the risk of arrhythmic death—the survival benefit of CRT-D over CRT-P is still a matter of debate, mainly because no RCT has been designed to compare these treatments. • The evidence from RCTs is insufficient to show the superiority of combined CRT and ICD over CRT alone. Nevertheless the Bayesian analysis, based on an extrapolated analysis, suggests that it is probable that combined therapy is the best option (probability of 75% in analysis).

18. CRT-P vs CRT-D

19. CRT-P vs CRT-D Task Force is of the opinion that no strict recommendations can be made, and prefers to merely offer guidance regarding the selection of patients for CRT-D or CRT-P, based on overall clinical condition, device-related complications and cost. CRT-D is beneficial in all disease states, but the benefit appears relatively small in end-stage HF, in which the main reason for choice of device is related to improvement of quality of life and reduction of HF-related hospitalizations and death.

20. CRT-P vs CRT-D

21. CRT-D vs CRT-P

22. Risk score από απλούςκλινικούς δείκτες • ηλικία (>70) • παρουσία κολπικής μαρμαρυγής • βαθμός καρδιακής ανεπάρκειας (>II NYHA) • διάρκεια QRS (>120ms) • βαθμός νεφρικής δυσλειτουργίας (BUN >26 mg/dl) Onlypatients with an intermediate score (1-2) benefitedfrom ICD implantation. Goldenberg et al, JACC 2008;51:288–96

23. Mortality & clinical risk score Long term results (8 yrs) Survival benefit even in low-risk pts NNT: 6 at 8 yrs f-up vs. 17 at 2 yrs Intermediate risk Low risk High risk Barsheshet et al. J Am CollCardiol2012 :59:2075–9

24. CRT-P vs CRT-D • In the extension of CARE-HF study with a 37.4-month follow-up time, there was a significant 5.6% reduction in the absolute risk of dying suddenly. • The results imply that, although the risk of dying from HF is immediately lowered by CRT, the reduction of risk of sudden cardiac death evolves at a much slower rate. • It is very probable that reduction in risk of sudden cardiac death by CRT is related to the extent of reverse remodelling.

25. Απόκριση στην θεραπεία • reverse remodeling της αρ. κοιλίας • βελτίωση των συμπτωμάτων • μείωση νοσηλειών για ΚΑ/θνητότητας • συνδυασμός των παραπάνω Non-response to CRT occurs in 30% - 45% of patients

26. Μελέτες που αφορούνsuper-responders μετά CRT • Αφορά το 10-30%των ασθενών, με ποικίλα κριτήρια που αφορούν μεταβολές: • κλάσμα εξώθησης • τελοσυστολική διάμετρος αρ κοιλίας • τελοδιαστολική διάμετρος αρ κοιλίας • ΝΥΗΑ ταξινόμηση

27. Υπερ-απόκριση & κοιλιακές αρρυθμίες In MADIT-CRT, reverse remodeling was associatedwith a significant reduction in the risk of subsequent life-threatening VTAs Barsheshet A et al, J Am CollCardiol 2011;57:2416–23

28. MADIT-CRT data • Patients who achieve LVEF normalization (>50%) have very low absolute and relative risk of VTAs and a favorable clinical course within 2.2 years of f-up. • Risk of inappropriate ICD therapy is still present (up to 15%) Ruwald M et al, Circulation. published online October 9, 2014

29. SVT ResponsestoAdenosine

30. Complications

31. Complications • Device upgrade or revision is associated with a complication risk ranging from 4% of patients who had a generator replacement only, to 15.3% of patients who had a generator replacement or upgrade combined with one or more transvenous lead insertions. • Major complications were higher with CRT-D, compared with PM replacements. • Complications were highest in patients who had an upgrade to - or a revised CRT device (18.7%). • These data support careful decision-making before device replacement and when considering upgrades to more complex systems.

32. Risk & predictors of any complication Nationwide cohort in Denmark: Kirkfeldt R E et al. Eur Heart J 2014;35:1186-1194

33. Complications • A meta-analysis of 9082 patients in 25 CRT trials showed that the implantation success rate was 94.4%: • peri-implantation deaths occurred in 0.3% of trial participants, • mechanical complications (including coronary sinus dissection or perforation, pericardial effusion or tamponade, pneumothorax and haemothorax) in 3.2%, • lead problems in 6.2% • and infections in 1.4%. Al-Majed NS et al. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart failure. Ann Intern Med 2011

34. Device infections

35. The increase in number of CIED infections1993-2008 USA data

36. Operator experience Long procedure duration Fever 24 hrs before implantation Temporary pacemaker No antibiotic prophylaxis Device revision /replacement Complexity of procedure /Hardware items Risk factors - Procedure Baddour LM et al, Circulation 2010

37. Incidence of pacemaker infections

38. Incidence of pacemaker infections

40. Clinicalfactorsinfluencingthelikehoodtorespondto CRT

41. PM vs CRT-P vs CRT-D • Ιστορικό:Yπέρταση-ΣΔ-Πλήρης ΚΚΑ • Ηλικία ασθενούς:85 • Λειτουργικό στάδιο NYHΑ: II-III • Υπερηχογραφικά ευρήματα: EF:35-40% • Συμπαρομαρτούντα νοσήματα:Ca Πνεύμονος • Προσδόκιμο επιβίωσης:<1 έτος PACEMAKER

42. PM vs CRT-P vs CRT-D • Ιστορικό:Yπέρταση-Πλήρης ΚΚΑ • Ηλικία ασθενούς:65 • Λειτουργικό στάδιο NYHΑ: III • Υπερηχογραφικά ευρήματα: EF:30% • Επεισόδια VT από τον έλεγχο του βηματοδότη • Συμπαρομαρτούντα νοσήματα:Όχι • Προσδόκιμο επιβίωσης:>1 έτος CRT-ICD

43. PM vs CRT-P vs CRT-D • Ιστορικό:Yπέρταση-Πλήρης ΚΚΑ • Ηλικία ασθενούς:75 • Λειτουργικό στάδιο NYHΑ: II • Υπερηχογραφικά ευρήματα: EF:35% • Επεισόδια VT από τον έλεγχο του βηματοδότη • Συμπαρομαρτούντα νοσήματα:Όχι • Προσδόκιμο επιβίωσης:>1 έτος ICD

45. Real life… Σεπτέμβριος 2018