SCD-HEFT:

AMIODARONE OR AN IMPLANTABLE

CARDIOVERTER-DEFIBRILLATOR FOR

CONGESTIVE HEART FAILUREBARDY 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

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?

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

STUDY DESIGN (CONT’D)

Inclusion criteria

Age > 18 years

NYHA class II-III chronic stable HF due to ischemic or nonischemic causes

LVEF ≤ 35%

INTERVENTION

Randomized to ICD vs amiodarone vs placebo

All patient received conventional medical therapy as well

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

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

BOTTOM LINE

ICDs reduce mortality compared to conventional therapy or amiodarone among

patients with HF with EF<35%, NYHA II/III

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?

CLINICAL APPLICATION

You are in clinic seeing Mr. Rodriguez, a 59 YO 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?