9/14/2019 Disclosures I have disclosed relationships with the - PDF document

9/14/2019 Disclosures • I have disclosed relationships with the following commercial Debate: VT Ablation Should be interests: First Line Therapy Before ICD Biosense-Webster, Grant/Research Support Implantation Boston Scientific, Consultant Abbott, Consultant William H. Sauer, MD Chief, Cardiac Arrhythmia Services Brigham and Women’s Hospital Member of the Faculty at Harvard Medical School Debate Strategy Debate Strategy 1 Use ad hominem attacks and exploit the Canadian stereotypes* for politeness and aversion to confrontation until Dr. Leong-Sit concedes and apologizes for even bringing up the question. vs. *Avoid any references to hockey or government or education or healthcare 1

9/14/2019 Debate Strategy 2 – What My Opponent Will Use Debate Strategy 3 – Logic and Science • Use logic, science, and physiology as a foundation for an argument Use false information, anecdotal evidence, and misleading statistics to that addresses our mission as physicians to relieve suffering and support my case and distract from opponent’s argument.* improve quality of life *This strategy is better for the con side of the debate and it is likely what Dr. Leong-Sit will use Number of VT Episodes Prior to Ablation Attempt Logic and Science • History of VT Ablation Timing • 1999: Daily • How did VT Ablation change from treatment to last resort to consideration of primary prevention • 2004: Monthly • Rationale for Early and Preventive VT Ablation • Can VT Ablation Save Lives? • 2009: Once after Failed AARx • Clinical Trial and Observational Research Results and Analysis • 2019: Instead of AArx; Primary Prevention? • Early VT Ablation Associated with Improved Mortality • Early VT Ablation Results in Reduced ICD Therapies 2

9/14/2019 2008 1999 55 VT 50 45 episodes 16 patients 40 per month median F/U 8 months 35 30 25 20 15 median response 10 5 0 1 month 1 month 3-6 6-9 9-12 12-15 >15 pre post months months months months months Marchlinski, et al. Circulation 2000 Stevenson, et al. Circulation 2008 3

9/14/2019 Catheter Ablation is Recommended: VT Ablation History (20 years) • For symptomatic sustained monomorphic VT (SMVT), including VT terminated by an • Improved Mapping Techniques ICD, that recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are • Activation Mapping not tolerated or not desired • Entrainment Mapping • For control of incessant SMVT or VT storm that is not due to a transient reversible • Electroanatomical Mapping cause • For patients with frequent PVCs, NSVTs, or VT that is presumed to cause ventricular • Improved Imaging and Image Integration dysfunction • • Improved Power Delivery For bundle branch reentrant or interfascicular VTs • For recurrent sustained polymorphic VT and VF that is refractory to antiarrhythmic • Cooled Tip Ablation therapy when there is a suspected trigger that can be targeted for ablation • Epicardial Access Arvind N. Kanagasundram, MD, Roy M. John, MBBS, PhD, William G. Stevenson MD Circulation 2018 Audience Response – VT Treatment Antiarrhythmic Drugs • What works better to control VT? • A) Drugs • B) Ablation 4

9/14/2019 Vaughn-Williams Antiarrhythmic Drug Classification Antiarrhythmic Drugs to Prevent ICD Shocks • Amiodarone is effective at reducing shocks (HR 0.27; P<0.01) • Also very likely to be discontinued due to side effects and toxicities • Sotalol is effective (HR 0.56; P<0.01) • May not be as effective compared to other BB • Azimilide and Dofetilide are not more effective than beta-blocker Vince Vaughn Robin Williams Ferreria-Gonzalez, et al. European Heart Journal 2007; Pacifico, et al. NEJM 1999 Page 1 Page 5 Text Text 5

9/14/2019 Page 18 Page 35 Conclusion: “At this point, no further research is needed for this question – don’t wait to refer a patient for VT ablation” Conclusion: “Ablation is more effective than escalation of antiarrhythmic drugs. Only a Canadian fool would argue otherwise.” Dinov, Hindricks, et al. Circ AEP 2014 6

9/14/2019 Early Referral for VT Ablation Dinov, Hindricks, et al. Circ AEP 2014 Conclusion: “For the love of God, don’t delay VT Ablation! VT Ablation Should be First Line Therapy Before an ICD is Implanted.” Reddy V et al. N Engl J Med 2007; 357:2657-2665. 7

9/14/2019 SMASH-VT • Randomized Trial of VT Ablation + ICD vs ICD • 128 patients with VT • Endpoints: • ICD therapy • ICD shocks • Mortality Reddy V et al. N Engl J Med 2007; 357:2657-2665. SMA MASH-VT: Cl Clinical Out utcomes Can Early VT Ablation Save Lives? • VT Ablation would be expected to improve mortality in a End point Ablation group Control group Hazard ratio (95% population without ICDs (n=64), n (%) (n=64), n (%) CI) • VT ablation reduces the number of shocks that patients receive 0.35 (0.15 – 0.78) ICD events 8 (12) 21 (33) • Shocks are not 100% effective • Shocks can be exhausted in the case of incessant VT/VF 0.27 (0.11 – 0.67) ICD shocks 6 (9) 20 (31) 0.30 (0.09 – 1.00) ICD storm 4 (6) 12 (19) 0.59 (0.22 – 1.59) Death 6 (9) 11 (17) Reddy V et al. N Engl J Med 2007; 357:2657-2665. 8

9/14/2019 Number of Ablated Cases with Reported Recurrence and Mortality Rates in the Literature = 1421; IVTCC = 2061 Conclusions – VT Ablation Timing Thank You • VT Ablation is no longer a treatment of last resort • Historical Improvements in VT Ablation • Observational data supports an early approach of VT ablation for prevention of VT recurrence • SMASH-VT failed to reveal a mortality benefit of preventive VT ablation in patients with ischemic cardiomyopathy and an ICD but demonstrated reduction in Appropriate ICD therapies (Fewer Shocks) 9

9/14/2019 Rebuttal and Additional Slides Correlation Vs. Causation 10

9/14/2019 Randomized Trial Data BERLIN-VT* • The randomized BERLIN-VT multicenter trial was conceived to determine the optimal timing of catheter ablation in post-MI patients with VT and an indication for an ICD • Two treatment strategies: Preventive ablation before Deferred ablation after 2007 2019 vs. 3 rd appropriate ICD shock ICD implantation SMASH-VT BERLIN-VT *Presented at HRS 2019 LBCT 11

9/14/2019 Secondary endpoint – Appropriate ICD therapy Primary endpoint • Composite of all-cause death and unplanned rehospitalization for (worsening) heart failure or ventricular arrhythmia 26.1% 41.7% 27.8% 47.9% * *Hazard ratio: preventive vs. deferred ablation BERLIN VT Summary Final Conclusions • Preventive ablation in the BERLIN-VT trial resulted in: • The United States is the Greatest Country in the History of Civilization and is Superior to Canada. ➢ 38% reduction in risk of sustained VT/VF recurrence • Apology Accepted ➢ 45% reduction in risk of appropriate ICD therapy • VT Ablation Should be First Line Therapy Before ICD Implantation 12

9/14/2019 Thank You 13