Search

Aims: Vericiguat is a soluble guanylate cyclase stimulator and improves survival in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and an increased risk of decompensation. As real‐world data on how many patients could be eligible for vericiguat therapy derive from outdated registries, we aimed to assess eligibility in a prospective cohort of patients with HF. Methods and results: Data from consecutive HF patients undergoing an elective ambulatory visit at five university hospitals from 3 July to 28 July 2023 were collected. Independent investigators assessed which patients (i) met the eligibility criteria of the VICTORIA trial, (ii) complied with HF guideline recommendations, (iii) met regulatory agency criteria, or (iv) met criteria for refundability according to the Italian regulatory agency. Patients (n = 346, 72% men, median age 69 years) had HFrEF in 57% of cases, left ventricular ejection fraction < 45% in 68%, and New York Heart Association class II–IV symptoms in 76%. Patients meeting the eligibility criteria of the VICTORIA trial or European and American HF Guideline recommendations were 9% and 13%, respectively. Patients meeting Food and Drug Administration (FDA) or European Medicines Agency (EMA) label criteria were 19% and 17%, respectively. Drug costs would be covered by the Italian National Health System in 10% of patients [if a sodium‐glucose cotransporter‐2 inhibitor (SGLT2i) is not mandatory] or in 8% (if an SGLT2i is requested). Conclusions: In a real‐world study, 9% of patients met the eligibility criteria of the VICTORIA trial, but up to 13% complied with guideline recommendations and up to 19% met FDA or EMA criteria. In Italy, drug costs would be covered by up to 10% of patients. [ABSTRACT FROM AUTHOR]

Aims: Patients with heart failure (HF) remain often undertreated for multiple reasons, including treatment inertia, contraindications, and intolerance. The OPTIimal PHARMacological therapy for patients with Heart Failure (OPTIPHARM‐HF) registry is designed to evaluate the prevalence of evidence‐based medical treatment prescription and titration, as well as the causes of its underuse, in a broad real‐world population of consecutive patients with HF across the whole ejection fraction spectrum and among different clinical phenotypes. Methods: The OPTIPHARM‐HF registry (NCT06192524) is a prospective, multicenter, observational, national study of adult patients with symptomatic HF, as defined by current international guidelines, regardless of ejection fraction. Both outpatients and inpatients with chronic and acute decompensated HF will be recruited. The study will enroll up to 2500 patients with chronic HF at approximately 35 Italian HF centres. Patients will be followed for a maximum duration of 24 months. The primary objective of the OPTIPHARM‐HF registry is to assess prescription and adherence to evidence‐based guideline‐directed medical therapy (GDMT) in patients with HF. The primary outcome is to describe the prevalence of GDMT use according to target guideline recommendation. Secondary objectives include implementation of comorbidity treatment, evaluation of sequence of treatment introduction and up‐titration, description of GDMT implementation in the specific HF population, main causes of GDMT underuse, and assessment of cumulative rate of cardiovascular events. Conclusion: The OPTIPHARM‐HF registry will provide important implications for improving patient care and adoption of recommended medical therapy into clinical practice among HF patients. [ABSTRACT FROM AUTHOR]

Aims: The current European Society of Cardiology (ESC) guidelines provide clear indications for the treatment of acute and chronic heart failure (HF). Nevertheless, there is a constant need for real‐world evidence regarding the effectiveness, adherence, and persistence of drug therapy. We investigated the use of sacubitril/valsartan for the treatment of HF with reduced ejection fraction in real‐world clinical practice in Italy. Methods and results: An observational, retrospective, non‐interventional cohort study based on electronic medical records from nine specialized hospital HF centres in Italy was carried out on patients with prescription of sacubitril/valsartan. Overall, 948 patients had a prescription of sacubitril/valsartan, with 924 characterized over 6 months and followed up for 12 months. Pharmacoutilization data at 1 year of follow‐up were available for 225 patients {mean age 69.7 years [standard deviation (SD) = 10.8], 81.8% male}. Of those, 398 (45.2%) reached the target dose of sacubitril/valsartan of 97/103 mg in a mean time of 6.9 (SD = 6.2) weeks. Blood pressure and hypotension in 61 patients (65%) and worsening of chronic kidney disease in 10 patients (10.6%) were the main reasons for not reaching the target dose. Approximatively 50% of patients had a change in sacubitril/valsartan dose during follow‐up, and 158 (70.2%) were persistent with the treatment during the last 3 months of follow‐up. A sensitivity analysis (persistence during the last 4 months of follow‐up) showed persistence for 162 patients (72.0%). Adherence data, available for 387 patients, showed full adherence for 205 (53%). Discontinuation (102/717 patients, 14.2%) was mainly due to hypotension and occurred after a mean time of 34.3 (SD = 28.7) weeks. During follow‐up, out of 606 patients with available data, 434 patients (71.6%) had an HF add‐on drug or drugs concomitant with sacubitril/valsartan. HF‐related hospitalization during follow‐up was numerically higher in non‐persistent (16/67 patients, 23.9%) vs. patients persistent to sacubitril/valsartan (30/158, 19%) (P = 0.405). Conclusions: Real‐world data on the use of sacubitril/valsartan in clinical practice in Italy show a rapid titration to the target dose, high therapeutic adherence enabling a good level of therapeutic management in line with ESC guidelines for patients with reduced ejection fraction. [ABSTRACT FROM AUTHOR]

Background: Sacubitril/valsartan (S/V) is a cornerstone treatment for heart failure (HF). Beneficial effects on hospitalization rates, mortality, and left ventricular remodeling have been observed in patients with heart failure and reduced ejection fraction (HFrEF). Despite the positive results, the influence of S/V on renal function during long-term follow-up has received little attention. Aims: We investigated the long-term effects of S/V therapy on renal function in a large cohort of patients with HFrEF. Additionally, we examined the effects of the drug in patients with chronic kidney disease (CKD) compared to those with preserved renal function and identified primary risk characteristics Methods: We studied 776 outpatients with HFrEF and left ventricular ejection fraction (LVEF) <40% from an observational registry of the Italian Society of Cardiology, all receiving optimized standard-of-care therapy with S/V. The patients were included in a multicentric open-label registry from 11 Italian academic hospitals. Kidney function was evaluated at baseline, after 6 months of S/V, and at 4 years. Patients were followed-up through periodic clinical visits. Results: During a 48-month follow-up period, 591 patients remained stable and 185 patients (24%) experienced adverse events (85 deaths and 126 hospitalizations). S/V therapy marginally affects renal function during the follow-up period (estimated glomerular filtration rate (eGFR) at baseline 72.01 vs eGFR at follow-up 70.38 ml/min/m2, p = 0.01; and creatinine was 1.06 at baseline vs 1.10 at follow-up, p < 0.04). Among patients who maintained preserved renal function, 35% were in Dose 3 and 10% dropped out of S/V therapy (p < 0.006). Univariate analysis showed that Drop-out of S/V (HR 2.73 [2.01, 3.71], p < 0.001), history of previous HF hospitalization (HR 1.75 [1.30, 2.36], p < 0.001), advanced NYHA class (HR 2.14 [1.60, 2.86], p < 0.001), NT-proBNP values >1000 pg/ml (HR 1.95[1.38, 2.77], p < 0.001), furosemide dose >50 mg (HR 2.04 [1.48, 2.82], p < 0.001), and creatinine values >1.5 mg/dl occurred during follow-up (HR 1.74 [1.24, 2.43], p < 0.001) were linked to increased risk. At multivariable analysis, increased doses of loop diuretics, advanced NYHA class, creatinine >1.5 mg/dl, and atrial fibrillation were independent predictors of adverse events. Conclusion: Long-term S/V therapy is associated with improved outcomes and renal protection in patients with HFrEF. This effect is more pronounced in patients who tolerate escalating doses. The positive effects of the drug are maintained in both CKD and preserved renal function. Future research may study the safety and underlying causes of current protection. Plain language summary: Effects of sacubitril/valsartan on renal function and outcome in patients with heart failure and reduced ejection fraction: an Italian cohort study Despite the beneficial results, the influence of S/V on renal function during long-term follow-up has received little attention. We investigated the long-term effects of S/V therapy on renal function in a large cohort of patients affected by HFrEF. [ABSTRACT FROM AUTHOR]

Aims: Sacubitril/valsartan has changed the treatment of heart failure with reduced ejection fraction (HFrEF), due to the positive effects on morbidity and mortality, partly mediated by left ventricular (LV) reverse remodelling (LVRR). The aim of this multicenter study was to identify echocardiographic predictors of LVRR after sacubitril/valsartan administration. Methods and results: Patients with HFrEF requiring therapy with sacubitril/valsartan from 13 Italian centres were included. Echocardiographic parameters including LV global longitudinal strain (GLS) and global peak atrial longitudinal strain by speckle tracking echocardiography were measured to find the predictors of LVRR [= LV end‐systolic volume reduction ≥10% and ejection fraction (LVEF) improvement ≥10% at follow‐up] at 6 month follow‐up as the primary endpoint. Changes in symptoms [New York Heart Association (NYHA) class] and neurohormonal activations [N‐terminal pro‐brain natriuretic peptide (NT‐proBNP)] were also evaluated as secondary endpoints; 341 patients (excluding patients with poor acoustic windows and missing data) were analysed (mean age: 65 ± 10 years; 18% female, median LVEF 30% [inter‐quartile range: 25−34]). At 6 month follow‐up, 82 (24%) patients showed early complete response (LVRR and LVEF ≥ 35%), 55 (16%) early incomplete response (LVRR and LVEF < 35%), and 204 (60%) no response (no LVRR and LVEF < 35%). Non‐ischaemic aetiology, a lower left atrial volume index, and a higher GLS were all independent predictors of LVRR at multivariable logistic analysis (all P < 0.01). A baseline GLS < −9.3% was significantly associated with early response (area under the curve 0.75, P < 0.0001). Left atrial strain was the best predictor of positive changes in NYHA class and NT‐proBNP (all P < 0.05). Conclusions: Speckle tracking echocardiography parameters at baseline could be useful to predict LVRR and clinical response to sacubitril–valsartan and could be used as a guide for treatment in patients with HFrEF. [ABSTRACT FROM AUTHOR]

Aim: Echo‐derived haemodynamic classification, based on forward‐flow and left ventricular (LV) filling pressure (LVFP) correlates, has been proposed to phenotype patients with heart failure and reduced ejection fraction (HFrEF). To assess the prognostic relevance of baseline echocardiographically defined haemodynamic profile in ambulatory HFrEF patients before starting sacubitril/valsartan. Methods and results: In our multicentre, open‐label study, HFrEF outpatients were classified into 4 groups according to the combination of forward flow (cardiac index; CI:< or ≥2.0 L/min/m2) and early transmitral Doppler velocity/early diastolic annular velocity ratio (E/e′: ≥ or <15): Profile‐A: normal‐flow, normal‐pressure; Profile‐B: low‐flow, normal‐pressure; Profile‐C: normal‐flow, high‐pressure; Profile‐D: low‐flow, high‐pressure. Patients were started on sacubitril/valsartan and followed‐up for 12.3 months (median). Rates of the composite of death/HF‐hospitalization were assessed by multivariable Cox proportional‐hazards models. Twelve sites enrolled 727 patients (64 ± 12 year old; LVEF: 29.8 ± 6.2%). Profile‐D had more comorbidities and worse renal and LV function. Target dose of sacubitril/valsartan (97/103 mg BID) was more likely reached in Profile‐A (34%) than other profiles (B: 32%, C: 24%, D: 28%, P < 0.001). Event‐rate (per 100 patients per year) progressively increased from Profile‐A to Profile‐D (12.0%, 16.4%, 22.9%, and 35.2%, respectively, P < 0.0001). By covariate‐adjusted Cox model, profiles with low forward‐flow (B and D) remained associated with poor outcome (P < 0.01). Adding this categorization to MAGGIC‐score and natriuretic peptides, provided significant continuous net reclassification improvement (0.329; P < 0.001). Intermediate and high‐dose sacubitril/valsartan reduced the event's risk independently of haemodynamic profile. Conclusions: Echocardiographically‐derived haemodynamic classification identifies ambulatory HFrEF patients with different risk profiles. In real‐world HFrEF outpatients, sacubitril/valsartan is effective in improving outcome across different haemodynamic profiles. [ABSTRACT FROM AUTHOR]

Aims: Little research has investigated how sex may affect the prognosis of patients with chronic heart failure (HF). The present study was aimed at exploring sex-specific differences in prognosis in a cohort of patients with chronic HF, categorized according to severity of left ventricular dysfunction (HFrEF, HFmrEF and HFpEF), right ventricular (RV) dysfunction and ischemic (IHD) or nonischemic (no-IHD) etiology., Methods: This retrospective analysis included 1640 HF patients of whom 24% were females, 759 patients had IHD, 1110 patients had HFrEF, 147 patients had HFmrEF and 383 patients had HFpEF. The median follow-up period was 63 months (25th-75th 27-93)., Results: In the no-IHD group, no statistically significant sex differences emerged regarding survival, regardless of age and severity of cardiac dysfunction. In contrast, in the IHD group, females had a significantly lower event rate than males in the age group between 65 and 79 years [hazard ratio (HR) 0.39; 95% confidence interval (CI): 0.86-0.18; P  < 0.01]; in addition, a lower event rate was observed in females compared with males among patients with HFrEF (HR 0.47; 95% CI: 0.88-0.25; P  < 0.01), among patients without RV dysfunction (HR 0.58; 95% CI: 1.02-0.33; P  = 0.048) and among patients without diabetes (HR 0.44; 95% CI: 0.84-0.23; P  < 0.01)., Conclusion: In nonischemic patients there was no difference between males and females in terms of survival whereas in patients with ischemic etiology survival was better in females among elderly patients, in HFrEF patients, in the absence of RV dysfunction and in the absence of diabetes., (Copyright © 2024 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Heart failure (HF) is a clinical syndrome which is due to cardiac structural and/or functional abnormalities that result in elevated intra-cardiac pressures and/or inadequate cardiac output. Hemodynamic assessment in HF allows the identification and characterization of cardiac dysfunction, systemic and/or pulmonary congestion and the eventual impairment of systemic perfusion which are fundamental to phenotype HF, risk stratify HF patients and to guide their treatment. Patient hemodynamics can be characterized invasively with right heart catheterization but also non-invasively with the use of echocardiography and other non-invasive ultrasound tools. The aim of the present review is to summarize the main echocardiographic and ultrasound parameters to characterize the hemodynamics of patients with HF and help clinicians to make the most of these non-invasive tools to guide HF patient management.