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Risk-Benefit Analysis of Vernakalant Injection for Atrial Fibrillation Management

This assessment evaluates the risks and benefits of vernakalant injection for patients with atrial fibrillation (AF). Key findings indicate a high success rate in restoring sinus rhythm, with a 97% maintenance at 24 hours. While risks include transient hypotension and bradycardia, serious adverse events are low. Notably, vernakalant is effective even in patients with common comorbidities, such as hypertension and ischemic heart disease. The data suggest that vernakalant is a safe and effective treatment alternative for acute symptomatic AF.

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Risk-Benefit Analysis of Vernakalant Injection for Atrial Fibrillation Management

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  1. Risk/Benefit Assessment Jeremy N. Ruskin, M.D. Director, Cardiac Arrhythmia Services Massachusetts General Hospital

  2. AF PopulationBaseline Characteristics Nieuwlaat R et al. Eur Heart J. 2005; 26:2422-34 The AFFIRM Writing Group N Engl J Med, 2002;347:1825-33

  3. Risks of Vernakalant Injection0-24 Hours – All Patients * Based on Exact Methodology, 1-sided 95% confidence interval † SAE or discontinuation of study drug due to hypotension or bradycardia

  4. Risks of Vernakalant Injection • QT prolongation – moderate, transient • TdP – 1 event within 24 hours of vernakalant infusion and immediately following infusion of ibutilide • Hypotension – peri-infusional, generally transient, usually responds to saline and positioning • Bradycardia – associated with cardioversion

  5. Risks of Vernakalant Injection By History of CHF * Based on events occurring within 0-24 hour time period

  6. Benefits of Vernakalant Injection Patients withoutAF Symptoms at Min. 90 (AF >3h - ≤7d) Consistent Conversion Rates All Patients

  7. Benefits of Vernakalant Injection • Maintenance of sinus rhythm at 24 hours - 97% • Can be administered with background rate (72%) or rhythm control (20%) medications • Electrical cardioversion is effective in non-responders (vernakalant - 88%; placebo - 90%) • Safe and effective in patients with common co-morbidities, including: • Hypertension (52% of patients in P2/3 studies) • History of ischemic heart disease (24% of patients in P2/3 studies)

  8. Risk/Benefit of Vernakalant Injection Profile of ventricular arrhythmias within the first 24 hours • Ventricular Fibrillation – 2/773 (0.26%) • Torsade de Pointes (TdP) – 1/773 (0.13%) • Ventricular Tachycardia

  9. Vernakalant Injection Risk/Benefit Summary • Effective for the rapid conversion of AF to sinus rhythm with reduction of AF symptoms • An important treatment alternative for patients with acute symptomatic atrial fibrillation, including post-cardiac surgery patients

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