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Circulation. 2022;145:e895–e1032. DOI: 10.1161/CIR.0000000000001063 May 3, 2022 e941 CLINICAL STATEMENTS AND GUIDELINES age, has impaired renal function, or has a low lean body mass. Higher doses (eg, digoxin 0.375 to 0.50 mg daily) are rarely used or needed in the management of patients with HF. 7.3.9.3 Pharmacological Treatment for Stage C HFrEF: Soluble Guanylyl Cyclase Stimulators Recommendation for Pharmacological Treatment for Stage C HFrEF: Soluble Guanylyl Cyclase Stimulators Referenced studies that support the recommendation are summarized in the Online Data Supplements. COR LOE Recommendation 2b B-R 1. In selected high-risk patients with HFrEF and recent worsening of HF already on GDMT, an oral soluble guanylate cyclase stimulator (vericiguat) may be considered to reduce HF hospitalization and cardiovascular death.1 Synopsis In patients with progression of HFrEF despite GDMT, there may be a role for novel therapeutic agents. Oral soluble guanylyl cyclase stimulator (eg, vericiguat) directly binds and stimulates sGC and increases cGMP production. cGMP has several potentially beneficial effects in patients with HF, including vasodilation, improvement in endothelial function, as well as decrease in fibrosis and remodeling of the heart.2–7 The VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial randomized 5050 higher-risk patients with worsening HFrEF to vericiguat versus placebo.1 Recommendation-Specific Supportive Text 1. Patients with HFrEF in the VICTORIA trial had LVEF <45%, NYHA class II to IV, were on GDMT, with elevated natriuretic peptides (BNP ≥300 pg/mL or NT-proBNP ≥1000 pg/mL if in sinus rhythm; higher cutoffs with AF), and recent HF worsening (hospitalized within 6 months or recently received intravenous diuretic therapy without hospitalization). Patients on long-acting nitrates, with SBP <100 mm Hg, or eGFR <15 mL/min/1.73 m2 were excluded.1 Over a median follow-up of 10.8 months, the primary outcome, cardiovascular death or HF hospitalization, occurred in 35.5% with vericiguat compared with 38.5% with placebo (HR, 0.90; P=0.019). All-cause mortality occurred in 20.3% in the vericiguat group and 21.2% in the placebo group (HR, 0.95; 95% CI, 0.84-1.07; P=0.38) and composite of any-cause death or HF hospitalization was also lower in the vericiguat group versus placebo group (HR, 0.90; 95% CI, 0.83–0.98; P=0.02). The relative risk reduction of 10% in the primary outcome was lower than expected, even in a higher risk population. Although not statistically significant, symptomatic hypotension (9.1% versus 7.9%; P=0.12) and syncope (4.0% versus 3.5%; P=0.30) were numerically higher in the vericiguat group versus placebo. There was heterogeneity by subgroup analysis, and patients in the highest quartile of NT-proBNP subgroup (NT proBNP level >5314 pg/mL) did not have benefit from vericiguat when compared with placebo. 7.4 Device and Interventional Therapies for HFrEF 7.4.1 ICDs and CRTs Recommendations for ICDs and CRTs Referenced studies that support the recommendations are summarized in the Online Data Supplements. COR LOE Recommendations 1 A 1. In patients with nonischemic DCM or ischemic heart disease at least 40 days post-MI with LVEF ≤35% and NYHA class II or III symptoms on chronic GDMT, who have reasonable expectation of meaningful survival for >1 year, ICD therapy is recommended for primary prevention of SCD to reduce total mortality.1–9 Value Statement: High Value (A) 2. A transvenous ICD provides high economic value in the primary prevention of SCD particularly when the patient’s risk of death caused by ventricular arrythmia is deemed high and the risk of nonarrhythmic death (either cardiac or noncardiac) is deemed low based on the patient’s burden of comorbidities and functional status.10–15 1 B-R 3. In patients at least 40 days post-MI with LVEF ≤30% and NYHA class I symptoms while receiving GDMT, who have reasonable expectation of meaningful survival for >1 year, ICD therapy is recommended for primary prevention of SCD to reduce total mortality.6 1 B-R 4. For patients who have LVEF ≤35%, sinus rhythm, left bundle branch block (LBBB) with a QRS duration ≥150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT, CRT is indicated to reduce total mortality, reduce hospitalizations, and improve symptoms and QOL.16–21 Value Statement: High Value (B-NR) 5. For patients who have LVEF ≤35%, sinus rhythm, LBBB with a QRS duration of ≥150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT, CRT implantation provides high economic value.22–27 2a B-R 6. For patients who have LVEF ≤35%, sinus rhythm, a non-LBBB pattern with a QRS duration ≥150 ms, and NYHA class II, III, or ambulatory class 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-R 7. In patients with high-degree or complete heart block and LVEF of 36% to 50%, CRT is reasonable to reduce total mortality, reduce hospitalizations, and improve symptoms and QOL.34,35 Downloaded from http://ahajournals.org by on October 7, 2026