Disclosures 8/29/2016. VT Ablation 2016: Indications and Expected Outcomes. Medtronic: advisory board, review panel. St Jude Medical: speakers bureau

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1 VT Ablation 2016: Indications and Expected Outcomes California Heart Rhythm Symposium 2016 Henry H. Hsia, MD, FACC, FHRS San Francisco VA Medical Center, University of California, San Francisco Disclosures Medtronic: advisory board, review panel St Jude Medical: speakers bureau Biosense-Webster: speakers bureau, fellowship support VytronUs: consultant Post-infarction VT Trends in Catheter VT Ablation N =81,539 Post-infarct VT: catheter ablation increased from 2.8% (2002) 10.8% (2011); (p <0.001). Palaniswamy C. Heart Rhythm 2014;11:2056 VT in Nonischemic Cardiomyopathy UCLA: 6/2004-7/2011 VT ablation: The proportion of NICM has increased from 27% ( ) to 35% ( ) (P=0.06) Nakahara S. JACC 2010;55: Sacher F. Circ Arrhythm Electrophysiol 2008;1;153 1

2 Anatomical Substrate Post-Myocardial Infarction Slow conduction in the infarcted tissue, with zigzag' course of activation Tung R. Circulation 2011;123:2284 debakker J. Circulation 1988; 77:589 debakker J. Circulation 1993;88;915 RBRS VT: Entrainment with Concealed Fusion Isthmus, #196 Sti-QRS=Egm-QRS 142 msec I II III AVR AVL AVF V 1 sti-qrs 142 ms Egm-QRS 142ms V 2 V 3 V 4 V 5 V 6 Abl d PPI=360 ms VTCL=363 ms Abl p His d His p RV Inferolateral Scar AoV RBRS VT Outer Loop Exit Ent LP 180ms Isth Dysynchrony on ICE 2

3 Ablation at Isthmus: RBRS VT Termination in 1.5 sec I II III AVR AVL AVF V 1 V 2 V 3 V 4 V 5 V 6 Abl d Abl p His d His p RV Stim mv mv mv I II III AVR AVL AVF V 1 V 2 V 3 V 4 V 5 V 6 Late potentials with decremental local conduction delay Abl d Abl p His RVA I II III avr Pacemap within the channel avl avf V 1 V 2 Spontaneous LBB-RI VT V 3 V 4 V 5 V 6 LP 180 ms LP 171 ms LP 194 ms Perfect pacemap Decremental LP delay mv mv 3

4 Kaplan Meier Estimate of Survival Free from ICD (Shock & ATP) Therapy Ablation Kaplan-Meier Estimates for Survival Free from VT or VF P=0.007 Control P=0.045 SMASH VT Trial VTACH Trial Ablation Control Thermocool VT Ablation Trial N=231, VT (median, 11 in preceding 6 mo), primary end point of freedom from VT after 6 month f/u. VT episodes were reduced from a median of 11.5 to 0 (P<0.0001). Reddy VY. NEJM 2007;357: Kuck KH. Lancet 2010; 375: Stevenson WG. Circ 2008;118: Catheter Ablation in Post-infarct VT N Indications LVEF (%) Acute success Follow-up (months) Recurrent VT/ICD Rx Adverse events SMASH-VT (2007) ThermoCool (2008) VTACH (2010) Euro-VT (2010) Yokokawa (2012) Silberbauer (2014) Dinov (2014) 64 Recur/induc VT/VF 31± %* 4.6% 231 MMVT 25 49% 6 47% 7.3% 52 Stable VT 34± ±8.3 53% 3.8% 63 Recur VT 30±13 81% 12±3 49% 5% Recur VT ICD Rx Drug refractory VT 27±13 63% 35±23 34% 7.1% 31± ~19 32% 7% 164 Recur VT 32± % 27 43% 11.1% VT Recurrences After the Ablation Procedure Age Thermocool VT Ablation (2008) Success (123) 65 (58-70) Failure (108) 69 (62-73) p Heart failure 52% 73% LVEF (%) 25 (20-35) 25 (15-35) Multiple MI 5% 14% VT events in prec 6 mo # induced VT/pt Longest VT CL Shortest VT CL Total # RF lesions Postop VT Induction 10 (4-30) 3 (2-4) 440 ( ) 330 ( ) 24 (11-32) 14 (6-38) 4 (3-6) 450 ( ) 305 ( ) 26 (16-39) <0.001 Yokokawa et al (2012) No recurr VT (65) Recurrent VT (33) LVEF (%) 29 ± ± Anterior MI 18 (28%) 14 (42%) 0.14 Scar area (cm 3 ) 69 ± ± # clinical VT 4 ± 5 3 ± Clinical VT CL # induced VT Identified critical sites RF duration (min) Postop VTnonclinical Postop VTclinical 359 ± ± (20%) 9 (27%) ± 2 4 ± ± ± /63 (38%) 11/32 (34%) /63 (0%) 0/63 (0%) 1.0 p 4

5 Percentage of Patients (%) 8/29/2016 VT Recurrence Rate vs Ablation Strategies Recurrence Rate During Follow-up 13.4 ± 4 months All Patients (n=50) 9.5% 12.5% 75% Complete LP abolition No VT inducible Incomplete LP abolition Persistent VT inducibility 50% Silberbauer J et al. Circ Arrhythm Electrophysiol, (3): Local Abnormal Ventricular Activities 5 (LAVA) Freedom from Recurrent VT or Death Regional Variation of LAVA Latency * Latency of LAVA is affected by locations. Only 3% of septal LAVA were separated from far-field ventricular egm Jais P. Circulation 2012;125:2184 Komatsu Y. Heart Rhythm 2013;10:1630 Ventricular Arrhythmia/ICD Therapy-Free Survival by the Ablation Approach In Post-infarct VT N=92, f/u of 25±10 months N= 160, f/u ~19 months Homogenization (Endo ± Epi): 19% 16% P<0.001 VT non-inducible+lp abolition p=0.006 Endo substrate ablation: 47% VT non-inducible, no LP abolition VT inducible DiBiase L. JACC 2012;60:132 Silberbauer J. Circ Arrhythm Electrophysiol. 2014;7:424 5

6 16.4% Scar De-channeling Berruezo A. Circ Arrhythm Electrophysiol. 2015;8: Recurrence after Catheter Ablation of Post-infarct VT Limited substrate ablation Extensive substrate modification 38% RRR Santangeli et al, Indication for Ablation and Trials, Ventricular Tachycardia Ablation: A Practical Guide, CardioText Differences Between NICM and ICM Substrates Endo Scar and Endo DS area : ICM >> NICM Endo and Epi LP: ICM >>NICM. LP-targeted ablation was more effective in ICM (82% non-recurrence at 12±10 mon f/u) vs NICM patients with less favorable outcomes (50% at 15±13 mon f/u). 101±55 4.3% 56±33 55±41 53±28 4.1% 1.3% 2.1% Nakahara S. JACC 2010;55:

7 Epicardial VT Ablation: A Multicenter Safety Study Characteristics of the Patient Population Ischemic CMP (n=51) Dilated CMP (n=39) ARVC (n=14) No CMP (n=17) Other CMP (n=13) Total patients (n=134) Relative to a control population(n=722) 16% 35% 41% 6% 18% 19% Sex (Male %) 48 (94%) 32 (82%) 9 (64%) 10 (59%) 10 (77%) 109 (81%) Prior endocardial ablation 46 (90%) 33 (85%) 9 (64%) 15 (88%) 12 (92%) 115 (86%) Epicardial mapping and ablation 42 (82%) 36 (92%) 14 (100%) 12 (71%) 9 (69%) 113 (84%) Sacher F. JACC 2010; 55: 2366 Epicardial vs Endocardial Low Voltage Scar Distributions in Non-Ischemic Cardiomyopathy Scar area (cm 2 ) Endo Epi Wide/split/late egm: epicardial (49.7%) controls (2.3%). Soejima K. JACC 2004; 43;10:1834 Cano O. JACC 2009;54: Endo-Epicardial Mapping in Patient with Nonischemic Cardiomyopathy LV endocardium: minimal scar MV LV epicardium: extensive scar MV I II III AVR AVL Entrainment with concealed fusion: Isthmus AVF V 1 V 2 V 3 V 4 V 5 V 6 Abl d Abl p RV 7

8 Scar Patterns and Ablation in Nonischemic Cardiomyopathy Basal anteroseptal scar (42%): -aortic root ± anteroseptal endo LV (89%) -anterior cardiac vein (11%), with -RV septum (22%) -epicardium (11%) Green: good pacemap Yellow: ECF White: VT termination Inferolateral scar (47%): -epicardium (63%) -inferolateral endo LV (37%) Piers, S. Circ Arrhythm Electrophysiol. 2013;6:875 Nonischemic Cardiomyopathy: Anteroseptal vs Inferolateral Scar Endocardial unipolar voltage: -Anteroseptal (AS): 44/87 (51%) -Inferolateral (IL): 43/87 (49%) -AS has more extensive endo unipolar scar, freq involves an intramural septal substrate. INFEROLATERAL GROUP Epi LPs: common in the IL (81%) vs AS (4%), p<0.001) and correlated with VT termination sites (p=0.014). VT recurred in 44 patients (51%) during a median f/u 1.5 years. AS scar was associated with higher VT recurrence (74% vs 25%, p<0.001) and redo procedure rates (59% vs 7%, p<0.001). Oloriz, T. Circ Arrhythm Electrophysiol. 2014;7: Outcome of Catheter Ablation in Nonischemic Cardiomyopathy N F/U (months) Approach Acute Noninducibility No Recurrence Marchlinski (2000) Hsia (2003) 8 10 Endo 1 (12%) 3 (38%) Endo 8 (42%) 5 (26%) Soejima (2004) 22 11±9 Endo (22) ± Epi (7) 12/22 (55%) 6/6 (100%) 12/22 (55%) 4/6 (67%) Cano (2009) 22 18±7 Endo+Epi (22) 14/21 (67%) 12/17 (71%) 15/21 (71%) 12/14 (86%) Kuhne (2010) Endo (24) ± Epi (7) 45/67 (67%) 67% if LP+ 7% if LP- Della Bella (2011) 67 17±18 Endo+Epi (57) Epi only (10) 45/67 (67%) 60.7% Tung (2013) Endo only (35) Endo+Epi (29) 40% 45% 33% 36% Dinov (2014) Endo only (43) Endo+Epi (20) 42 (66.7%) 23% 8

9 Outcomes in VT Ablation in Nonischemic vs Ischemic Cardiomyopathy Heart Centre of Leipzig VT (HELP-VT) Study Kaplan Meier Curves for VT Free Survival N=227: 63 NIDCM vs 164 ICM 57% ICM 40.5% 43% NICM 23% Dinov B. Circulation. 2014;129: VT Ablation in Nonischemic vs Ischemic Cardiomyopathy NICM (n=63) ICM (n=164) P value Epicardial abl, n(%) 19 (30.2) 2 (1.2) Noninducible PES, n(%) 9 (15.8) 14 (9.9) Substrate mapping, n(%) 42 (66.7) 147 (89.6) < VT induced, n/pt 2.1 ± ± VT mappable, n/pt 1.61 ± ± VT ablated, n/pt 1.40 ± ± Clinical VT CL (ms) 364 ± ± Procedure time (min) 181 ± ± Fluoroscopy time (min) 39 ± ± Failure, n(%) 7 (11.1) 8 (4.9) Dinov B. Circulation. 2014;129: Catheter VT Ablation in Nonischemic vs Ischemic Cardiomyopathy Predictors of Short-term Success OR; 95% CI P Age (yr) NICM 1.02 ( ) 0.60 ICM 0.99 ( ) 0.82 ES NICM 1.98 ( ) 0.37 ICM 0.96 ( ) EF% NICM 1.00 ( ) ICM 0.99 ( ) VTCL,ms NICM 1.00 ( ) 0.47 ICM 1.00 ( )) 0.66 #VT NICM 0.46 ( ) induced ICM 0.61 ( )) Epi Abl NICM 10.5 ( ) Dinov B. Circulation. 2014;129: Incomplete success and failure Acute complete success 9

10 Scar Progression in Nonischemic Cardiomyopathy 7 ARVC and 13 NICM: interprocedural delay 28±18 months Disease progression occurred in 75% of cohorts: -ventricular dilation in 45% [ARVC 71%; NICM 38%] -decreased EF in 60% [RVEF in ARVC 71%; LVEF in NICM 54%] -scar progression in 50% [ARVC 57% and NICM 46%] Index VT recurrence was observed in 40%. Redo ablation sites were located in previously un-ablated regions inside the index scar in 70% of patients. Berte B. J Cardiovasc Electrophysiol, 2016; 27:80-87 Relationship of Transplant-free Survival and VT Recurrence In patients with EF <30% and across all NYHA classes, improved transplant-free survival in those without VT recurrence [83% vs 59%, HR 8.35], P <0.001 [53% vs 1%, HR 6.75], P <0.001 Tung et al, Heart Rhythm2015;12: [93% vs 89%, HR 3.19], P =0.002 [96% vs 84%, HR 9.29], P <0.001 Structural Heart Disease Guidelines, Recommendations for Catheter VT Ablation 2009 EHRA/HRS Expert Consensus on Catheter Ablation of VT Symptomatic VT despite AADs or when AADs are not tolerated. 2. Incessant VT or VT storm not due to a transient or reversible cause. 3. Frequent PVCs, NSVT associated with ventricular dysfunction. 4. Bundle branch/interfascicular VTs. 5. Recurrent polymorphic VT and VF refractory to AADs with suspected trigger 1. Recurrent VT episodes despite therapy with one or more Class I or III AADs 2. VT due to prior MI, LVEF >30%, and is an acceptable alternative to amiodarone. 3. Hemodynamically stable VT due to prior MI who have LVEF 35% even if they have not failed AADs. Recommended Should be considered 2015 ESC Guidelines for Management of Ventricular Arrhythmias 1. In patients with scar-related heart disease with incessant VT/storm 2. In patients with ischemic heart disease & recurrent ICD shocks due to VT 3. In patients with bundle branch reentrant VT 4. As additional therapy or an alternative to ICD in patients with CHD with recurrent VT or ICD therapies refractory to drug therapy. 1. After first sust VT episode in patients with ischemic heart disease and ICD 2. May be considered in patients with DCM and VA not caused by bundle branch reentry refractory to medical therapy. 3. In patients with LV dysfunction associated with freq PVCs, NSVT 10

11 Guidelines, Recommendations for Catheter VT Ablation 2009 EHRA/HRS Expert Consensus on Catheter Ablation of VT ESC Guidelines for Management of Ventricular Arrhythmias Should be considered 4. May be considered in patients with Brugada syndrome with electrical storms or repeated ICD shocks. Structural Heart Disease Not recommended For asymptomatic infrequent PVC in patients with congenital heart disease (CHD) and stable ventricular function. No Structural Heart Disease Guidelines, Recommendations for Catheter VT Ablation 2009 EHRA/HRS Expert Consensus on Catheter Ablation of VT Monomorphic VT that is causing severe symptoms. 2. Monomorphic VT when AADs are not effective, Recommended Should be considered 2015 ESC Guidelines for Management of Ventricular Arrhythmias 1. In symptomatic patients with outflow tract VT failed AAD or in those with a decline in LV function due to PVC burden. 2. As first-line treatment in symptomatic patients with idiopathic left VTs. 3. PVCs triggering recurrent VF leading to ICD interventions 1. In symptomatic patients with LVOT/ aortic cusp/epicardial VT/PVC after failure of class IC agents or to avoid long-term AAD therapy 2. After failure/intolerance of class IC AAD in symptomatic patients with papillary muscle tachycardia-under echo guidance 3. In symptomatic patients with mitral and tricuspid annular tachycardia. 4. In patients with short-coupled torsade de pointes for long-term suppression/ prevention of electrical storm/icd shock Substrate Modification or VT Induction as the First Step? N=48 patients: 37 ischemic cardiomyopathy, 10 NICM, 1 ARVC were randomized to: Group 1, n=24: Substrate ablation with scar de-channeling first Group 2, n=24: Standard VT induction, mapping, ablation first followed by scar dechanneling Kaplan-Meier Curves for VT Recurrence followup of 22±14 months P=0.557 Group 1 has shorter procedural parameters compared to Group 2: -procedure time (209±70 vs 262±63 min; P=0.009) -fluoroscopy time (14±6 vs 21±9 min; P=0.005) -electrical cardioversion (25% vs 54%; P=0.039) Noninducibility of any VT was achieved in 87.5% and 70.8% of patients (P=0.155). VT induction and mapping before substrate ablation prolongs the procedure, radiation exposure, and the need for cardioversion without improving acute results and long-term outcomes. Fernández-Armenta J. Heart Rhythm2016;13:

12 Role of Early Prophylactic Catheter VT Ablation Early referral HR 2 vs 1=1.85; p=0.009 HR 3 vs 1=2.04; p=0.001 P=0.01 (1) <30 days Late referral Ischemic 63% Nonischemic 37% Ischemic 68% Nonischemic 32% (2) 30 days-12 months (3) >12 months N=98, 1/2008-4/2009, with VT and SHD: -58% in VT storm and 67% on high dose amiodarone. Early referral (N=36) Late referral (N=62): 2 episodes of VT, separated by >1 month In Kaplan Meier analysis, the early referral group had superior 1-year VT free survival (P=0.01). N=300 cath abl of sustained VT. -Group 1 (25%): <30 days after 1 st VT -Group 2 (28%): 30 days-12 months -Group 1 (47%): >12 months In Kaplan-Meier curves of VT-free survival, cath abl within 30 days after 1 st VT event is associated with improved acute and long-term success. Frankel DS. J Cardiovasc Electrophysiol, 2011; 22:1123. Dinov B. Circ Arrhythm Electrophysiol. 2014;7:1144 Other Clinical Trials in VT Catheter Ablations ASPIRE: Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators stopped enrollment STRATUM-VT: Stepwise AppRoAch To substrate Modification for Ventricular Tachycardia stopped enrollment STAR-VT: Substrate Targeted Ablation using the FlexAbility Ablation Catheter System for the Reduction of Ventricular Tachycardia prophylactic scar-based VT ablation (both ischemic and non-ischemic) stopped enrollment VANISH: Ventricular Tachycardia Ablation or Escalated Drug Therapy significantly lower rate of the composite outcome of death, VT storm, or appropriate ICD shock in patients undergoing catheter ablation than those receiving an escalation in antiarrhythmic drug therapy PARTITA: Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator? VT Ablation 2016: Indications and Expected Outcomes Persistent inducibility is associated with VT recurrence and poor long-term results in both NIDCM and ICM. A substrate-based, extensive ablation strategy is associated with improved outcomes. Post-infarction VTs are often associated with a relatively stable substrate. Catheter ablation for post-infarct VT is becoming more mainstream and not limited to a last-resort strategy. NIDCM consists of a heterogeneous group of conditions with unknown factors leading to modification of arrhythmia substrate over time. Disease/scar progression is the rule. However, incomplete ablation is the most common finding, strongly suggesting the need for more extensive ablation. Successful VT ablation has been associated with an mortality benefit with an improved transplant-free survival in those without VT recurrence Early intervention and a substrate ablation-first approach may be preferable compared to antiarrhythmic drug use and the standard VT induction protocol. Evolving with expanded and specific indications for VT ablations that include (1) PVCs induced LV dysfunction, (2) Brugada syndrome with electrical storms, (3) short-coupled torsade de pointes, (4) annular-lvot-epicardial arrhythmias 12

13 REFERENCES: Palaniswamy C, et al. Catheter ablation of post infarction ventricular tachycardia:ten-year trends in utilization, in-hospital complications, and in-hospital mortality in the United States. Heart Rhythm, (11): Sacher F, et al. Ventricular tachycardia ablation: Evolution of patients and procedures over 8 years. Circ Arrhythmia Electrophysiol., : Nakahara S, et al. Characterization of the Arrhythmogenic Substrate in Ischemic and Nonischemic Cardiomyopathy: Implications for Catheter Ablation of Hemodynamically Unstable Ventricular Tachycardia. J Am Coll Cardiol, (21): de Bakker J, et al. Slow conduction in the infarcted human heart: "Zigzag" course of activation. Circulation, (3): Reddy V, et al. Prophylactic Catheter Ablation for the Prevention of Defibrillator Therapy. N Engl J Med, :(26): Kuck K, et al. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): A multicentre randomised controlled trial. Lancet, (9708): Stevenson W, et al. Irrigated Radiofrequency Catheter Ablation Guided by Electroanatomic Mapping for Recurrent Ventricular Tachycardia After Myocardial Infarction: The Multicenter Thermocool Ventricular Tachycardia Ablation Trial. Circulation, : Tanner H, et al. Catheter Ablation of Recurrent Scar-Related Ventricular Tachycardia Using Electroanatomical Mapping and Irrigated Ablation Technology: Results of the Prospective Multicenter Euro-VT-Study. J Cardiovasc Electrophysiol, (1): Yokokawa M, et al. Reasons for recurrent ventricular tachycardia after catheter ablation of postinfarction ventricular tachycardia. J Am Coll Cardiol, (1): Silberbauer J, et al. Noninducibility and late potential abolition: A novel combined prognostic procedural end point for catheter ablation of postinfarction ventricular tachycardia. Circ Arrhythm Electrophysiol, (3): Dinov B, et al. Outcomes in catheter ablation of ventricular tachycardia in dilated nonischemic cardiomyopathy compared with ischemic cardiomyopathy: Results from the Prospective Heart Centre of Leipzig VT (HELP-VT) Study. Circulation, (7): Jaïs P, et al. Elimination of Local Abnormal Ventricular Activities: A new end point for substrate modification in patients with scar-related ventricular tachycardia. Circulation, (18): Di Biase L, et al. Endo-epicardial homogenization of the scar versus limited substrate ablation for the treatment of electrical storms in patients with ischemic cardiomyopathy. J Am Coll Cardiol, (2):

14 Berruezo A, et al. Scar de-channeling: New method for scar-related left ventricular tachycardia substrate ablation. Circ Arrhythm Electrophysiol, (2): Santangeli et al, Indication for Ablation and Trials, Ventricular Tachycardia Ablation: A Practical Guide, CardioText Sacher F, et al. Epicardial VT ablation: A multicenter safety study. J Am Coll Cardiol, (21): Cano O, et al. Electroanatomic Substrate and Ablation Outcome for Suspected Epicardial Ventricular Tachycardia in Left Ventricular Nonischemic Cardiomyopathy. J Am Coll Cardiol, (9): Piers S, et al. Contrast-enhanced MRI-derived scar patterns and associated ventricular tachycardias in nonischemic cardiomyopathy: Implications for the ablation strategy. Circ Arrhythm Electrophysiol, (5): Oloriz T, et al. Catheter ablation of ventricular arrhythmia in non-ischaemic cardiomyopathy: Anteroseptal versus inferolateral scar sub-types. Circ Arrhythm Electrophysiol, (3): Dinov B, et al. Early referral for ablation of scar-related ventricular tachycardia is associated with improved acute and long-term outcomes: Results from the heart center of leipzig ventricular tachycardia registry. Circ Arrhythm Electrophysiol, (6): Berte B, et al. VT recurrence after ablation: Incomplete ablation or disease Progression? A multicentric European study. J Cardiovasc Electrophysiol, (1): Tung R, et al. Freedom from recurrent ventricular tachycardia after catheter ablation is associated with improved survival in patients with structural heart disease: An International VT Ablation Center Collaborative Group study. Heart Rhythm, (9): Fernández-Armenta J, et al. Substrate modification or ventricular tachycardia induction, mapping, and ablation as the first step? A randomized study. Heart Rhythm, (8): EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: Heart Rhythm, (6): ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Eur Heart J, (41):