Η χρήση των νέων καθετήρων με αισθητήρα πίεσης Κλινικά δεδομένα και παραδείγματα

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1 Η χρήση των νέων καθετήρων με αισθητήρα πίεσης Κλινικά δεδομένα και παραδείγματα Νικόλαος Φραγκάκης Επίκουρος Καθηγητής Καρδιολογίας ΑΠΘ Γ Κ/Δ Κλινική Ιπποκράτειο Νοσοκομείο Θεσσαλονίκης

2 Why Contact Force? Non-transmural lesion Edema Lengthy procedure Inconsistent outcomes Risk of tamponade Risk of pops Efficacy Balancing Act Safety

3

4 Circ Arrhythm Electrophysiol. 2014;7:

5 M. Efremidis et al. Europace 2015;17:

6 Direct contact force measurement TactiCath Quartz, Endosense No calibration plug and play Dedicated interface all Contact Force information at once 50 Hz sampling rate real-time highly accurate information

7 Graphic User Interface Parameters The user interface captures all Contact Force information at a glance. Ball Indicator for directionality Total force value Lateral force value Axial force value LSI value Stability Indicator FTI value Force History Window Reset button Reset baseline between ablations Reset FTI / LSI during ablations 7 ID A EN (06/14)

8 multi-center clinical studies investigating Contact Force ablation TOCCASTAR Evaluated safety and effectiveness of TactiCath Ablation Catheter Supplemental study with new generation TactiCath Quartz Catheter EFFICAS II Significantly better outcome at using Contact Force recommendations EFFICAS I Contact Force recommendations Minimum Contact Force Minimum Force Time Integral (FTI Index) TOCCATA Safety and feasibility of Force Sensing Importance of average Contact Force and Force Time Integral

9 HIGH VARIABILITY WITHOUT CONTACT FORCE Heart Rhythm 2012;9:18 23

10 HAVE OUR HOPES BEEN REALIZED WITH CF? There is a significant relationship between AF recurrence at 12-month and Contact Force applied during ablations Reddy et al. Heart Rhythm 2012;9:

11 EFFICAS I & II: IDENTIFY AND VALIDATE CF RECOMMENDATIONS IDENTIFY RECOMMENDATIONS VALIDATE RECOMMENDATIONS EFFICAS I 46 pts Formulate CF Recommendations EFFICAS II 46 pts Study Design Single arm, prospective, 3 European centers, with 10 operators Ablation parameters Blinded to CF, standard RF Active use of CF Guidelines Endpoint Gap vs. No gap at 3M follow-up 1. Reduce CFvariability 2. Superior PV isolation outcome Study endpoint method Invasive EP investigation after 3 months EM-EUPACE (1). Approved for global use. 11

12 EFFICAS I: Minimum CF & FTI are Stronger Gap Predictors Circulation Arrhythmia and Electrophysiology 2013;6:

13 Circulation Arrhythmia and Electrophysiology 2013;6: EFFICAS I: Minimum FT > 400 gs is associated with significantly higher PVI success Relationship between Min FTI and % of gap in PV segments 21% 5% 95% P= OR= % Recommendation minimum FTI > 400 gs for any ablation points

14 EFFICAS I: Fewer Lesions, Created Efficiently, have Higher Probability of Success Recommendation achieve transmurality in one shot Circulation Arrhythmia and Electrophysiology 2013;6:

15 CONTACT FORCE RECOMMENDATIONS CF Target 20 g (range g) 1,2 CF Min 10 g for any ablation points 1,2 FTI Min 400 g-s for any ablation points 1 ONE SHOT Transmurality should be achieved in one shot 1. EM-EUPACE (1). Approved for global use. 15

16 EFFICAS II RESULTS 3 EFFICAS I EFFICAS II Comments Investigators in analysis 5 (physicians who treated patients in both studies) Durable PV Isolation at 3 months 72% (73/102) 85% (77/91) p = % ablations with CF 10 30g 49% 68% % ablations with FTI > 400 gs 55% 78% Odds Ratio = 2.2 p < Odds Ratio = 2.9 p < Average Power 24.4 W 23.3W p = NS # of ablations (15% reduction from EFFICAS I) p = 0.05 Durable PVI with low CI* (<6) 81% (39/48) 98% (56/57) p = *Continuity Index EM-EUPACE (1). Approved for global use. 16

17

18 EFFICAS I Vs. EFFICAS II

19

20

21 conclusions Optimal Contact Force with the TactiCath catheter reduces occurrence of PV gaps at 3 months, proven with prospective clinical studies. Durable PV isolation appears to be further improved when ablation lesions are deployed point-by-point continuously around the pulmonary vein. The number of lesions necessary to complete PVI is reduced when maintaining optimal contact force parameters during ablation.

22 Η εμπειρία του εργαστηρίου ηλεκτροφυσιολογίας της Γ Κ/Δ Κλινικής με τον καθετήρα κατάλυσης TactiCath S.Jude 5 περιστατικά 3 κατάλυσης κοιλιακών ταχυκαρδιών επί ισχαιμικής νόσου (2 ασθενείς σε ηλεκτρική θύελλα) 2 κατάλυσης δεξιού ισθμού επί τυπικού κολπικού πτερυγισμού

23 Patient in electrical storm (1) Male, 57 years old Extensive anterior MI, By-pass (2014), ICD DR (2014) HF (NYHA III) EF~ 20%, Dilated LV, MR (mild to moderate) Previous VT ablation (3/12 ago) for ES Medications: b-blockade, ARB, Eprenerol, antiplatelets Amiodarone, Mexiletine Frequent shocks (some failed) Occasionally VT acceleration during ATP therapies

24 Heamodynamically unstable VT with negative concordance and inferior axis

25 Unmappable VT due to heamodynamic instability

26 High density voltage map >350 points at the apical area

27 Isthmus channel with late potentials

28 RF in isthmus area

29 Patient with CAD - preserved EF and sustained VT Male, 46 years old Long lasting symptomatic palpitations (dizziness, weakness, SOB) NSVT during exercise test inferior MI (2014), PCI (RCA), negative for ischemia Th scan NYHA I EF~ 50%, inferior hypokinesis, Medications: b-blockade, antiplatelets

30 Easily induced sustained VT during EPS

31 Presumed site of origin according to the ECG

32 High density voltage map in infero-basal area

33 Isthmus channel

34 Fractionated potentials within isthmus

35 His His

36 Late potentials within isthmus

37 Non inducible VT post-rf

38 Non inducible VT post-rf

39 Patient in electrical storm (2) Male, 76 years old By-pass (1997), PCA X2, inferior MI (2013), ICD VVIR (2013, due to episode of aborted sudden death), Stroke HF (NYHA III), HP EF~ 25%, Dilated LV, MR (moderate) Medications: b-blockade, ARB, Eprenerol, antiplatelets Amiodarone

40 Clinical VT Slow VT (below the ICD activation zone for therapy (120 bpm) Intermittent shocks Failed any attempt to terminate VT with overdrive pacing

41 Activation map during tachycardia

42

43 Concealed Entrainment 12/12, PPI-TCL=20ms, short stim to QRS

44 Entrainment 12/12, stim to QRS 90ms

45 FIRST TACHY TERMINATION ON APICAL EARLY ACTIVATION SITE

46 TOTAL RF TIME TO TACHY TERMINATION 12,3 sec

47 Voltage map with TactiCath catheter

48 Mid diastolic potentials during VT in lateral wall isthmus

49 RF from isthmus area

50 post RF non inducibility with 3 extras

51 Patient with typical AFL/AF? Male, 64 years old Documented typical AFL (frequent recurrent episodes) History of AF (but not documented) Sinus bradycardia Intolerant to Antiarrhythmic therapy EF~ 50%, mildly dilated LA Medications: NOAC, b-blockade (small dose)

52 Typical AFL (anticlockwise)

53 Propagation map

54 AFL termination during RF

55 AFL termination during RF

56 RF in Isthmus area

57 RF in Isthmus area

58 Bidirectional block

59 Bidirectional block

60 3 key tips of success in VT ablation Obtain an accurate 3D reconstruction Good catheter tip/wall contact precise demarcation of the scar zone

61 Contact Force Controlled Ablation

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