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Debate: VT Ablation Should be First Line Therapy Before ICD Implantation

William H. Sauer, MD Chief, Cardiac Arrhythmia Services Brigham and Women’s Hospital Member of the Faculty at Harvard Medical School

Disclosures

• I have disclosed relationships with the following commercial

interests: Biosense-Webster, Grant/Research Support Boston Scientific, Consultant Abbott, Consultant

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. *Avoid any references to hockey or government or education or healthcare

vs.

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Debate Strategy 2 – What My Opponent Will Use

Use false information, anecdotal evidence, and misleading statistics to support my case and distract from opponent’s argument.* *This strategy is better for the con side of the debate and it is likely what Dr. Leong-Sit will use

Debate Strategy 3 – Logic and Science

• Use logic, science, and physiology as a foundation for an argument

that addresses our mission as physicians to relieve suffering and improve quality of life

Logic and Science

• History of VT Ablation Timing
• How did VT Ablation change from treatment to last resort to consideration of

primary prevention

• Rationale for Early and Preventive VT Ablation
• Can VT Ablation Save Lives?
• Clinical Trial and Observational Research Results and Analysis
• Early VT Ablation Associated with Improved Mortality
• Early VT Ablation Results in Reduced ICD Therapies
• 1999: Daily
• 2004: Monthly
• 2009: Once after Failed AARx
• 2019: Instead of AArx; Primary Prevention?

Number of VT Episodes Prior to Ablation Attempt

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

2008

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• For symptomatic sustained monomorphic VT (SMVT), including VT terminated by an

ICD, that recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or not desired

• For control of incessant SMVT or VT storm that is not due to a transient reversible

cause

• For patients with frequent PVCs, NSVTs, or VT that is presumed to cause ventricular

dysfunction

• For bundle branch reentrant or interfascicular VTs
• For recurrent sustained polymorphic VT and VF that is refractory to antiarrhythmic

therapy when there is a suspected trigger that can be targeted for ablation Catheter Ablation is Recommended:

• Improved Mapping Techniques
• Activation Mapping
• Entrainment Mapping
• Electroanatomical Mapping
• Improved Imaging and Image Integration
• Improved Power Delivery
• Cooled Tip Ablation
• Epicardial Access

VT Ablation History (20 years) Arvind N. Kanagasundram, MD, Roy M. John, MBBS, PhD, William G. Stevenson MD Circulation 2018

• What works better to control VT?
• A) Drugs
• B) Ablation

Audience Response – VT Treatment

Antiarrhythmic Drugs

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Vaughn-Williams Antiarrhythmic Drug Classification Vince Vaughn Robin Williams

• 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

Ferreria-Gonzalez, et al. European Heart Journal 2007; Pacifico, et al. NEJM 1999 Antiarrhythmic Drugs to Prevent ICD Shocks Text Page 1 Text Page 5

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

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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.

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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. Reddy V et al. N Engl J Med 2007; 357:2657-2665.

SMA MASH-VT: Cl Clinical Out utcomes

End point Ablation group (n=64), n (%) Control group (n=64), n (%) Hazard ratio (95% CI) ICD events 8 (12) 21 (33) 0.35 (0.15–0.78) ICD shocks 6 (9) 20 (31) 0.27 (0.11–0.67) ICD storm 4 (6) 12 (19) 0.30 (0.09–1.00) Death 6 (9) 11 (17) 0.59 (0.22–1.59)

Can Early VT Ablation Save Lives?

• VT Ablation would be expected to improve mortality in a

population without ICDs

• VT ablation reduces the number of shocks that patients

receive

• Shocks are not 100% effective
• Shocks can be exhausted in the case of incessant VT/VF

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Number of Ablated Cases with Reported Recurrence and Mortality Rates in the Literature = 1421; IVTCC = 2061

Conclusions – VT Ablation Timing

• 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)

Thank You

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Rebuttal and Additional Slides Correlation Vs. Causation

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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 ICD implantation Deferred ablation after 3rd appropriate ICD shock

vs.

*Presented at HRS 2019 LBCT 2007 2019 SMASH-VT BERLIN-VT

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Primary endpoint

• Composite of all-cause death and unplanned

rehospitalization for (worsening) heart failure or ventricular arrhythmia

*Hazard ratio: preventive

• vs. deferred ablation

*

26.1% 27.8% 41.7% 47.9%

Secondary endpoint – Appropriate ICD therapy BERLIN VT Summary

• Preventive ablation in the BERLIN-VT trial resulted in:

➢ 38% reduction in risk of sustained VT/VF recurrence ➢ 45% reduction in risk of appropriate ICD therapy

Final Conclusions

• The United States is the Greatest Country in the History of Civilization

and is Superior to Canada.

• Apology Accepted
• VT Ablation Should be First Line Therapy Before ICD Implantation

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Thank You