1. Ventricular Arrhythmias:A General Cardiologist’s Assessment of Therapies in 2004 C.Richard Conti M.D. MACC

2. Evaluation of PVCs Start with the History and physical examination. Documentation of the arrhythmia is critical. –ECG. –Holter monitor. –Event monitor. –Reveal monitor.

3. Management Management of PVCs differs in patients with and without structural heart disease. To define structural heart disease, consider: –Echocardiography. –ETT. –Left heart catheterization.

4. PVCs in the Absence of Structural Heart Disease In the absence of structural heart disease, ventricular ectopy is generally benign, carrying no prognostic significance. Treatment with antiarrhythmic therapy is not indicated unless the patient is unacceptably symptomatic.

5. PVCs in the Absence of Structural Heart Disease Treatment –Reassurance. –Avoidance of stimulants. Caffeine. Cigarettes. –Beta blockers. –Antiarrhythmic drugs as a last resort.

6. PVCs in the Absence of Structural Heart Disease If antiarrhythmic drugs are necessary: –Class 1C: Flecainide. Propafenone. –Mexilitene. –Amiodarone is rarely, if ever, indicated.

7. Management of Ventricular Ectopy in the Presence of Structural Heart Disease

8. AVID Antiarrhythmics Versus Implantable Defibrillators Sponsored by:–National Institutes of Health Entry Criteria:–VF –VT with syncope –VT without syncope, with EF <.40, and SBP < 80mm Hg, chest pain, CHF, or near syncope Treatment:–ICD vs. empiric amiodarone or Holter/EP-guided sotalol Primary endpoint:–Total mortality AVID Investigators. N Engl J Med. 1997;337(22):1576-1583.

9. Survival in AVID Patients Adapted from: Domanski MJ, et al. J Am Coll Cardiol 1999; 34:1090-1095. LVEF <0.20 (Group 1) LVEF 0.20 - 0.34 (Group 2) LVEF > 0.34 (Group 3) 1.0.9.8.7.6.4.3.2.1 0 01224 Survival.5 Device Drug 1. 0.9.9.8.8.7.7.6.6.4.4.3.3.2.2.1.1 0.5.5 Cumulative Survival 0 12 24 Device Drug 1. 0.9.9.8.8.7.7.6.6.4.4.3.3.2.2.1.1 0.5.5 Cumulative Survival 012 24 Device Drug

10. ICD Therapy for Sustained Ventricular Arrhythmias: Secondary Prevention Conclusions The results of AVID support using the ICD as front-line therapy to prolong total and sudden death survival in patients at high risk for sudden death e.g.Poor LV function. This trial included patients with both ischemic and nonischemic substrates.

11. ICD Therapy Primary Prevention ICM

12. MADIT Multicenter Automatic Defibrillator Implantation Trial Hypothesis: ICD will reduce mortality (all-cause) in high-risk CAD patients. Moss AJ. N Engl J Med. 1996;335:1933-1940.

13. MADIT Inclusion Criteria Prior Q-wave MI Nonsustained VT EF < 35% Inducible, non-suppressible VT NYHA Class I – III Age 25 - 80 > 3 weeks from last MI No requirement for revascularization Moss AJ. N Engl J Med. 1996;335:1933-1940.

14. MADIT Patient Flow Non-inducible (n = 139) Patients meeting inclusion criteria (N = 483) EP study Suppressible with IV procainamide (n = 91) Refused study (n = 57) Inducible (n = 344) Non-suppressible (n = 253) Signed consent form, randomized (n = 196) MADIT FDA Info Pack. May 16, 1996.

15. MADIT Survival Moss AJ. N Engl J Med. 1996;335:1933-1940. 1.0 0.8 0.6 0.4 0.2 0.0 012345 Year Probability of survival Conventional therapy Defibrillator

16. MADIT Conclusion In patients with a prior MI who are at a high risk for ventricular tachyarrhythmia, prophylactic therapy with an implanted defibrillator leads to improved survival as compared with conventional medical therapy. Moss AJ. N Engl J Med. 1996;335:1933-1940.

17. MUSTT M ulticenter U n S ustained T achycardia T rial Sponsors: NHLBI and Industry Buxton AE. N Engl J Med. 1999;341:1882-90.

18. MUSTT Hypothesis Antiarrhythmic (AA) therapy guided by EP testing can reduce the risk of arrhythmic death and cardiac arrest in patients with: CAD EF < 0.40 Asymptomatic nonsustained VT ( > 3 beats, 100 bpm) Buxton AE. N Engl J Med. 1999;341:1882-90.

19. MUSTT Endpoints Primary: Arrhythmic death or cardiac arrest Secondary: Total mortality Cardiac mortality Spontaneous, sustained VT Buxton AE. N Engl J Med. 1999;341:1882-90.

20. MUSTT Initial Protocol EPS N=2202 Evaluate and Treat Ischemia No Sustained VT Induced N=1435 (65%) Inducible Sustained VT N=767 (35%) Registry Randomize d N=704 (92%) Refused Randomization N=63 (8%) CAD, NSVT, EF < 0.40 Buxton AE. N Engl J Med. 1999;341:1882-90.

21. MUSTT Protocol Randomized Treatment Groups Inducible Sustained VT N=704 No EP-Guided Rx ACE I & ßB N=353 EP-Guided Rx ACE I & ßB N=351 Buxton AE. N Engl J Med. 1999;341:1882-90.

22. MUSTT Conclusions For CAD patients with EF <.40, asymptomatic NSVT and inducible VT: ICD therapy significantly reduces the incidence of: »Arrhythmic death or cardiac arrest (73% – 76% reduction) »Total mortality (55% – 60% reduction) EP-guided pharmacologic antiarrhythmic therapy provides no survival benefit Buxton AE. N Engl J Med. 1999;341:1882-90.

23. Nonischemic Cardiomyopathy and NSVT DEFIbrillators in Non ICM Treatment Evaluation (DEFINITE). –Multicenter randomized trial. –Non Ischemic Cardiomyopathy –LVEF < 35%. –Symptomatic heart failure.

24. DEFINITE Spontaneous arrhythmia (>10 PVCs/hr or 3 beats NSVT. Randomized ICD vs. no ICD. Standard heart failure medications. Primary endpoint mortality.

25. Image (Heart Failure/Transplant) DEFINITE Trial 39 KB File Type: GIF Click here to enlarge / download for presentation use (ie. PowerPoint) Click here to enlarge / download for presentation use (ie. PowerPoint) Source Clinical Trials image provided by the American College of Cardiology Foundation DEFINITE

26. Overall Conclusions Asymptomatic patients with ventricular arrhythmias and no underlying heart disease do not need to be treated. Symptomatic patients with arrhythmias should be treated with standard therapy and ICD. Management depends on the frequency and severity of the patient’s arrhythmia.

27. Conclusions The results of AVID support using the ICD as first-line therapy to prolong total and/or sudden death survival in patients with documented unstable VT or VF.

28. Conclusions MUSTT is concordant with MADIT, suggesting that risk stratification using invasive techniques should be the standard of care for post-infarction patients who have NSVT and significant LV dysfunction.

29. Conclusions The patient with NICM and NSVT is difficult to risk stratify. If syncope has occurred, there is some data to support implantation of an ICD. In the asymptomatic patient, the answer is not clear at this time.