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September 25, 2018 Circulation. 2018;138:e272–e391. DOI: 10.1161/CIR.0000000000000549 e304

CLINICAL STATEMENTS AND GUIDELINES IIa B-NR 5. In nonhospitalized patients with NYHA class IV symptoms who are candidates for cardiac transplantation or an LVAD, an ICD is reasonable if meaningful survival of greater than 1 year is expected.S7.1.2-6–S7.1.2-9

III: No Benefit C-EO 6. An ICD is not indicated for NYHA class IV patients with medication-refractory HF who are not also candidates for cardiac transplantation, an LVAD, or a CRT defibrillator that incorporates both pacing and defibrillation capabilities.

Recommendation-Specific Supportive Text

1.	 The rationale for recommending that an ICD be offered to patients with NYHA class II or III HF, in addition to LVEF ≤35%, is based on the survival benefit observed in SCD-HeFT and MADIT-II (which used LVEF cutoff of below 35% and 30%, respectively). Selection for implantation of an ICD must be individualized. Patients with serious comorbidities associated with a survival of <1 year are generally not considered ICD candidates. The recommendation to wait at least 40 days after an MI before implanting a primary prevention ICD is based on the fact that such patients were excluded from MADIT-II and SCD-HeFT and 2 other RCTs showed no survival benefit from ICDs implanted early after an acute MI.S7.1.2-10,S7.1.2-11

2.	 In the MADIT-II trial,S7.1.2-2 which randomized patients with LVEF ≤30% and prior MI to an ICD or not,  approximately one third of the patients had NYHA class I symptoms. A subgroup analysis supported benefit of the ICD on survival in this subgroup.S7.1.2-2 3.	 Economic outcomes of ICD implantation for primary prevention of SCD were assessed in 3 RCTs [MADIT-I,S7.1.2-12 MADIT-II,S7.1.2-13 and SCD- HeFTS7.1.2-14], 1 observational study,S7.1.2-15 and 4 simulation models,S7.1.2-16–S7.1.2-19 which all had generally consistent results. All studies reported increased survival and life expectancy, and higher lifetime costs of medical care with an ICD than without an ICD. The incremental cost-effectiveness ratios were generally <$50 000 per year of life added by an ICD, which provides high value according to the benchmarks adopted for the current guideline.S7.1.2-20 The value provided by an ICD was consistently high when life expectancy was projected to increase by >1.4 years.S7.1.2-18 In

Figure 4. Primary prevention of SCD in patients with ischemic heart disease. Colors correspond to Class of Recommendation in Table 1. See Section 7.1.2 for discussion. *Scenarios exist for early ICD placement in select circumstances such as patients with a pacing indication or syncope †Advanced HF therapy includes CRT, cardiac transplant, and LVAD thought due to VT. These are detailed elsewhere in an HRS/ACC/AHA expert consensus statement.S7.1.2-24 CRT indicates cardiac resynchronization therapy; EP, electrophysiological; GDMT, guideline-directed management and therapy; HF, heart failure; ICD, implantable cardioverter-defibrillator; IHD, ischemic heart disease; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NSVT, nonsustained ventricular tachycardia; NYHA, New York Heart Association; pts, patients; SCD, sudden cardiac death; VT, ventricular tachycardia; and WCD, wearable cardioverter-defibrillator.

Recommendations for Primary Prevention of SCD in Patients With Ischemic Heart Disease (Continued)

COR LOE Recommendations

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