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May 3, 2022 Circulation. 2022;145:e895–e1032. DOI: 10.1161/CIR.0000000000001063 e942

CLINICAL STATEMENTS AND GUIDELINES 2a B-NR 8.	 For patients who have LVEF ≤35%, sinus rhythm, LBBB with a QRS duration of 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT, CRT can be useful to reduce total mortality, reduce hospitalizations, and improve symptoms and QOL.16–21,28–33

2a B-NR 9.	 In patients with AF and LVEF ≤35% on GDMT, CRT can be useful to reduce total mortality, improve symptoms and QOL, and increase LVEF, if: a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) atrioventricular nodal ablation or pharmacological rate control will allow near 100% ventricular pacing with CRT.16–21,28–33

2a B-NR 10.	 For patients on GDMT who have LVEF ≤35% and are undergoing placement of a new or replacement device implantation with anticipated requirement for significant (>40%) ventricular pacing, CRT can be useful to reduce total mortality, reduce hospitalizations, and improve symptoms and QOL.16–21,28–33

2a B-NR 11.	 In patients with genetic arrhythmogenic cardiomyopathy with high-risk features of sudden death, with EF ≤45%, implantation of ICD is reasonable to decrease sudden death.36,37

2b B-NR 12.	 For patients who have LVEF ≤35%, sinus rhythm, a non-LBBB pattern with QRS duration of 120 to 149 ms, and NYHA class III or ambulatory class IV on GDMT, CRT may be considered to reduce total mortality, reduce hospitalizations, and improve symptoms and QOL.16–21,28–33

2b B-NR 13.	 For patients who have LVEF ≤30%, ischemic cause of HF, sinus rhythm, LBBB with a QRS duration ≥150 ms, and NYHA class I symptoms on GDMT, CRT may be considered to reduce hospitalizations and improve symptoms and QOL.16–21,28–33 3: No Benefit B-R 14.	 In patients with QRS duration <120 ms, CRT is not recommended.36–41

3: No Benefit B-NR 15.	 For patients with NYHA class I or II symptoms and non-LBBB pattern with QRS duration <150 ms, CRT is not recommended.16–21,28–33

3: No Benefit C-LD 16.	 For patients whose comorbidities or frailty limit survival with good functional capacity to <1 year, ICD and cardiac resynchronization therapy with defibrillation (CRT-D) are not indicated.1–9,16–21

Synopsis RCTs have informed the decisions regarding cardiac implantable devices (ICDs and CRTs) over the past 20 years. In fact, the seminal RCTs for ICDs and CRTs are unlikely to be repeated. Subgroup analyses of these trials have also informed decisions, but these were not the primary endpoints of these studies and thus should be interpreted with caution. GDMT is optimized before ICD and CRT implantation to assess whether the LVEF improves. Figures 8 and 9 summarize device and interventional therapy recommendations. Recommendation-Specific Supportive Text

1.	 ICDs were first assessed in patients who had been resuscitated from a cardiac arrest. In AVID (Antiarrhythmics versus Implantable Defibrillators trial), CASH (Cardiac Arrest Study Hamburg), and CIDS (Canadian Implantable Defibrillator StudyS), benefit was observed in those who were randomized to ICDs.1–3 Extension of benefit was then shown in other patient populations that were at perceived risk of SCD. In the first MADIT (Multicenter Automated Defibrillator Implantation Trial) trial, patients with previous MI, LVEF ≤35% with nonsustained VT had a mortality benefit with ICD.4 Similar populations in MUSTT (Multicenter UnSustained Tachycardia Trial) also showed benefit.5 In MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II), patients with no arrhythmia qualifier but with previous MIs and LVEF ≤30% derived benefit from ICD.6 The DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation) study included only nonischemic patients with LVEF ≤35% and frequent premature ventricular contractions (PVCs) or nonsustained ventricular tachycardia (VT).7 There was a trend to mortality benefit, but it ultimately did not achieve significance. In SCD-HEFT (Sudden Cardiac Death in Heart Failure Trial), patients with ischemic and nonischemic cardiomyopathy, LVEF ≤35%, and HF class II to III showed benefit with an ICD compared with either amiodarone or placebo.8 More recently, the DANISH (Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure) trial enrolled patients with nonischemic cardiomyopathy and LVEF ≤35% to ICD or standard care.9 There was no reduction in the primary endpoint of total mortality, but there was a reduction in SCD risk. In the DANISH trial, 58% of patients in each limb received CRT, possibly mitigating the benefit of an ICD. 2.	 Economic outcomes of ICD implantation for primary prevention of SCD were assessed in 3 RCTs (MADIT-I,13 MADIT-II,15 and SCD-HeFT,12 1 observational study,10 and 3 simulation models,11,14,42 all of which 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 costeffectiveness ratios were generally <$60 000 per year of life added by an ICD, which provides high value according to the benchmarks adopted for the current guideline. The value provided by an ICD was consistently high when life expectancy was projected to increase by >1.4 years.14 In contrast, when survival was not increased by ICD implantation, as in the coronary artery bypass graft (CABG) Patch trial,43 the ICD did not provide value, because

Recommendations for ICDs and CRTs (Continued)

COR LOE Recommendations

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