Published on May 13, 2016
1. SCD-HEFT: AMIODARONE OR AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR FOR CONGESTIVE HEART FAILURE BARDY GH, LEE KL, MARK DB, POOLE JE, PACKER DL, ET AL. N ENGL J MED. 2005 JAN 20;352(3):225-37. SALT-E: OVMC LANDMARK TRIAL SERIES 2016 ACCESS ON WEBSITE: HTTP://TINYURL.COM/SALTE2
2. CLINICAL QUESTION ICD placement in post-MI patients with LVEF ≤ 30% was shown to improve survival (MADIT-II, 2002) What is the role of ICDs and amiodarone in patients with heart failure with reduced EF regardless of MI history?
3. STUDY DESIGN Multicenter double-blinded, parallel-group, randomized placebo-controlled trial N = 2521 Amiodarone (n = 845) Shock-only ICD (n = 829) Placebo (n = 847) Median follow up: 45.5 month
4. STUDY DESIGN (CONT’D) Inclusion criteria Age > 18 years NYHA class II-III chronic stable HF due to ischemic or nonischemic causes LVEF ≤ 35%
5. INTERVENTION Randomized to ICD vs amiodarone vs placebo All patient received conventional medical therapy as well
6. OUTCOMES Primary outcome: all-cause mortality ICD vs placebo: 22% vs 29% (p = 0.007) Amiodarone vs placebo: 28 vs 29% (p = 0.53) Subgroup analysis NYHA class III Amiodarone -- 44% increase in risk of death compared to placebo (HR 1.44, 97.5 CI 1.05 – 1.97) ICD therapy -- no reduction in risk of death with ID therapy compared to placebo
7. CRITICISMS Based on subgroup analysis, ICD therapy only shown to have significant benefit in patients with NYHA class II, but not in those with NYHA class III
8. BOTTOM LINE ICDs reduce mortality compared to conventional therapy or amiodarone among patients with HF with EF<35%, NYHA II/III
9. DISCUSSION QUESTION Patients with what types of heart failure and what ejection fraction should be considered for ICD placement? Why don’t we use amiodarone for patient’s with HFrEF? What is the primary end-point for this study?
10. CLINICAL APPLICATION You are in clinic seeing Mr. Rodriguez, a 59YO M with DM, HTN, HL, OSA, obesity, and CAD s/p MI in 2013 with two stents placed in his LAD. Most recent ejection fraction was 15-20%. He denies shortness of breath at rest but states that he has difficulty breathing after walking 2-3 blocks. Current medications include atorvastatin 80 mg PO daily, lasix 20 mg PO daily, Coreg 12.5 mg PO BID, and benazepril 40 mg PO daily.What is the most appropriate next step in management?
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