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
Why Contact Force? Non-transmural lesion Edema Lengthy procedure Inconsistent outcomes Risk of tamponade Risk of pops Efficacy Balancing Act Safety
Circ Arrhythm Electrophysiol. 2014;7:281-287
M. Efremidis et al. Europace 2015;17: 741-746
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
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-2001440 A EN (06/14)
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
HIGH VARIABILITY WITHOUT CONTACT FORCE Heart Rhythm 2012;9:18 23
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;9:1789-95
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-0615-0037(1). Approved for global use. 11
EFFICAS I: Minimum CF & FTI are Stronger Gap Predictors Circulation Arrhythmia and Electrophysiology 2013;6:327-333
Circulation Arrhythmia and Electrophysiology 2013;6:327-333 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=0.0004 OR=0.21 79% Recommendation minimum FTI > 400 gs for any ablation points
EFFICAS I: Fewer Lesions, Created Efficiently, have Higher Probability of Success Recommendation achieve transmurality in one shot Circulation Arrhythmia and Electrophysiology 2013;6:327-333
CONTACT FORCE RECOMMENDATIONS CF Target 20 g (range 10 30 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-0615-0037(1). Approved for global use. 15
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 = 0.037 % ablations with CF 10 30g 49% 68% % ablations with FTI > 400 gs 55% 78% Odds Ratio = 2.2 p < 0.001 Odds Ratio = 2.9 p < 0.001 Average Power 24.4 W 23.3W p = NS # of ablations 1818 1372 (15% reduction from EFFICAS I) p = 0.05 Durable PVI with low CI* (<6) 81% (39/48) 98% (56/57) p = 0.005 *Continuity Index EM-EUPACE-0615-0037(1). Approved for global use. 16
EFFICAS I Vs. EFFICAS II
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.
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
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
Heamodynamically unstable VT with negative concordance and inferior axis
Unmappable VT due to heamodynamic instability
High density voltage map >350 points at the apical area
Isthmus channel with late potentials
RF in isthmus area
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
Easily induced sustained VT during EPS
Presumed site of origin according to the ECG
High density voltage map in infero-basal area
Isthmus channel
Fractionated potentials within isthmus
His His
Late potentials within isthmus
Non inducible VT post-rf
Non inducible VT post-rf
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
Clinical VT Slow VT (below the ICD activation zone for therapy (120 bpm) Intermittent shocks Failed any attempt to terminate VT with overdrive pacing
Activation map during tachycardia
Concealed Entrainment 12/12, PPI-TCL=20ms, short stim to QRS
Entrainment 12/12, stim to QRS 90ms
FIRST TACHY TERMINATION ON APICAL EARLY ACTIVATION SITE
TOTAL RF TIME TO TACHY TERMINATION 12,3 sec
Voltage map with TactiCath catheter
Mid diastolic potentials during VT in lateral wall isthmus
RF from isthmus area
post RF non inducibility with 3 extras
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)
Typical AFL (anticlockwise)
Propagation map
AFL termination during RF
AFL termination during RF
RF in Isthmus area
RF in Isthmus area
Bidirectional block
Bidirectional block
3 key tips of success in VT ablation Obtain an accurate 3D reconstruction Good catheter tip/wall contact precise demarcation of the scar zone
Contact Force Controlled Ablation