Μη φαρμακευτική θεραπεία στην Χρόνια Καρδιακή Ανεπάρκεια Νεότερες συσκευές. Ξυδώνας Σωτήριος, MD, PhD, FESC

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1 ΠΑΝΕΛΛΗΝΙΑ ΣΕΜΙΝΑΡΙΑ ΟΜΑΔΩΝ ΕΡΓΑΣΙΑΣ 2017 ΟΜΑΔΑ ΕΡΓΑΣΙΑΣ ΚΑΡΔΙΑΚΗΣ ΑΝΕΠΑΡΚΕΙΑΣ Μη φαρμακευτική θεραπεία στην Χρόνια Καρδιακή Ανεπάρκεια Νεότερες συσκευές Ξυδώνας Σωτήριος, MD, PhD, FESC Καρδιολογικό Τμήμα, Γ.Ν.Α. «Ο Ευαγγελισμός»

2 Σύγκρουση Συμφερόντων Bayer, Boehringer Ingelheim, Boston Scientific, Elpen, Medtronic, Merck, Novartis, Pfizer, Servier

3 CRT non responders Cardiac Contractility Modulation Autonomic Nervous System Devices Spinal Cord Stimulation Vagus Nerve Stimulation Carotid Sinus Nerve Stimulation Interatrial shunt

4 CRT non responders Cardiac Contractility Modulation Autonomic Nervous System Devices Spinal Cord Stimulation Vagus Nerve Stimulation Carotid Sinus Nerve Stimulation Interatrial shunt

5 CRT response Response to CRT is determined by a host of parameters, including patient symptoms, objective measurements of functional capacity, and cardiac function. Those who demonstrate improvement in these parameters are termed responders, with superresponders referring to a subgroup with near normalization of LV function. Patients who demonstrate stabilization of LV function without experiencing the progressive decline that is expected with heart failure are termed non-progressors. A small proportion of patients may experience a rapid decline in LV function following CRT (negative responders) Circulation 2014;130:87 90.

6 Multicomponent CRT pacing system Electrode Receiver Energy transfer 0,05cc Transmitter Battery Sub-pectoral pocket Acoustic window Subcutaneous pocket Left lateral chest J Am Coll Cardiol 2017;69:

7 Multicomponent CRT pacing system

8 WiSE-CRT: feasibility study Expert Rev Med Devices 2016;13:

9 Multicomponent CRT pacing system

10 SELECT-LV study Expert Rev Med Devices 2016;13:

11 CRT non responders Cardiac Contractility Modulation Autonomic Nervous System Devices Spinal Cord Stimulation Vagus Nerve Stimulation Carotid Sinus Nerve Stimulation Interatrial shunt

12 Cardiac Contractility Modulation Delay 30 ms Two biphasic +/- 7 V pulses Duration of 20 ms Energy delivered: times PM CCM signals are biphasic pulses, delivered after a defined delay from detection of local electrical activation. ECG leads V1 V6 showing one beat prior to initiating CCM signals and the first two beats of CCM signal application. Page 12 Am J Physiol Heart Circ Physiol 2005;288:H2550-H2556. Europace 2014;16:

13 OPTIMIZER System implant One lead is placed in RA, and two leads are placed on the RV septum (RV1, RV2) approximately mid-way between the base and apex, one near the anterior and one near the posterior interventricular groove. The LAO caudal view shows the electrode tips point toward the left side of the patient s body, into the septum. A micromanometer (Millar) is placed temporarily to measure physiologic response to acute CCM signal application J Am Coll Cardiol 2005;46:

14 Cardiac Contractility Modulation Page 14 Effects of CCM signals on global function assessed by PV relations and on regional Baseline shown in blue; measurements during CCM signal application shown in red J Am Coll Cardiol 2005;46:

15 CCM and molecular alterations Page 15 Eur J Heart Fail 2011;13:

16 FIX-HF-5: RCT in CCM Page 16 Am Heart J 2011;161: e2.

17 CCM and all cause mortality Strata of the all-cause mortality in patients with high (.1.45) and low ( 1.45) Seattle Heart Failure Model score treated with CCM. The log-rank test shows significant different survival (P<0.01). The determined Kaplan Meier curves are nearly identical to the survival predicted by the SHFM for both high and low SHFM cores. Due to the low case number the follow-up period was limited to 2.5 years (912 days). Page 17 Europace 2011;13:

18 Cardiac Contractility Modulation? pacing configuration? daily duration of application? pacing sites? number of pacing? AF or ectopy Page 18 Europace 2014;16:

19 CRT non responders Cardiac Contractility Modulation Autonomic Nervous System Devices Spinal Cord Stimulation Vagus Nerve Stimulation Carotid Sinus Nerve Stimulation Interatrial shunt

20 Extra-cardiac Devices Page 20 Europace 2016;18:

21 Autonomic Nervous System Devices Page 21 Europace 2014;16:

22 Autonomic Dysfunction and HF Pathogenesis Page 22 Europace 2016;18: Circulation 2008;118:

23 Spinal Cord Stimulation Page 23 Europace 2014;16:

24 Spinal Cord Stimulation Characteristics Stimulation of afferent spinal nerve fibers central vagal tone sympathetic tone via central reflex activation Effects CO SVR cardiac work efficiency myocardial O 2 demand cardiac ischaemia affects positively the NO/NOS and cytokines system VAs Page 24 Europace 2014;16:

25 Spinal Cord Stimulation Page 25 Heart Rhythm 2015;12:

26 Spinal Cord Stimulation Page 26 J Am Coll Cardiol HF 2016;4:

27 Cervical Vagal Nerve Stimulation Eur Heart J 2015;36:

28 Cervical Vagal Nerve Stimulation Rate slowing effects negative chronotropic and dromotropic effects Antiarrhythmic effects ventricular refractory period, epicardial APD, ventricular vulnerability to ventricular, potent antifibrillatory effects as demonstrated during CVNS Antifibrotic effects ventricular replacement fibrosis and to blunt the development of CHF-associated cellular hypertrophy of remaining myocytes Anti-inflammatory effects blunt HF-associated increases of TNF-a, IL-6, and CRP in two animal models of HF Reverse remodelling LVESD, LVEDD and LVEF, NT-proBNP in a dog HF model Page 28 Europace 2014;16:

29 Cervical Vagal Nerve Stimulation Page 29 Eur Heart J 2011;32:

30 Cervical Vagal Nerve Stimulation Page 30 JACC Heart Fail 2015;3:

31 J Am Coll Cardiol 2016;68:

32 Carotid sinus nerve stimulation Page 32 JACC Heart Fail 2015;3:

33 Carotid sinus nerve stimulation Baroreflex Activation Therapy Lowers BP in Patients With Resistant hypertension Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial Page 33 J Am Coll Cardiol 2011;58:

34 Carotid sinus nerve stimulation Baroreflex activation as a novel therapeutic strategy for HFpEF Page 34 Clin Res Cardiol 2011;100:

35 Page 35 Barostim HOPE4HF

36 Carotid sinus nerve stimulation Stimulation of afferent fibers coupled to arterial baroreceptors central vagal tone sympathetic tone via central reflex activation Improves systolic and diastolic LV function Slight HR and BP? Surgical complications, hypoglossal nerve injury, respiratory complications? Unilateral or Bilateral? Type of pacing? Hypotensive patients? Hard End-points Page 36

37 CRT non responders Cardiac Contractility Modulation Autonomic Nervous System Devices Spinal Cord Stimulation Vagus Nerve Stimulation Carotid Sinus Nerve Stimulation Interatrial shunt

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39 Left to Right interatrial shunt Lancet 2016; 387:

40 Left to Right interatrial shunt Lancet 2016; 387:

41 Conclusions Multi-Component Pacing in CHF appears promising Special focus is given to patients with HF NYHA III - IV and narrow QRS, who represent the largest group in HF compared with patients with wide QRS complex Relatively poor clinical outcome / mortality data are available (except for CCM and Baroreflex Activation Therapy) Negative results from RCTs with hard endpoints till now Ongoing RCTs Page 41

42 1934 Page 42