bluuebunny/crossref_metadata_2025 huggingface dataset:
Randomized trial assessing worsening renal function with dapagliflozin addition in acute decompensated heart failure: ROAD-ADHF trial
Authors: Kawanami S , Egami Y , Abe M , Osuga M , Nohara H , Ukita K , Kawamura A , Yasumoto K , Okamoto N , Matsunaga Y , Yano M , Nishino M
Published: October 2024

Background

Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor, has shown to reduce cardiovascular mortality in patients with chronic heart failure.1) In addition, DAPA can enhance diuresis in patients with acute decompensated heart failure (ADHF).2) However, there is little known how early initiation of DAPA might impact the worsening renal function (WRF) when combined with standard decongestive therapy for ADHF.

Purpose

We aimed to evaluate the impact of initiating DAPA within 24 hours after ADHF admission on WRF, compared to standard decongestive therapy with loop diuretics alone.

Methods

We enrolled consecutive ADHF patients with a left ventricular ejection fraction (LVEF) less than 50%. The patients were prospectively randomized to either the DAPA group who received DAPA at a dose of 10 mg once daily within 24 hours of admission or the conventional therapy group (CON group) who received loop diuretics alone. Furosemide, loop diuretic, dosage was adjusted by increase or decrease of 10 mg to maintain urine output between a 1-2 mL/kg/hour.3) The primary endpoint was the incidence of WRF, which was defined as an increase in the serum creatinine of ≥ 0.3 mg/dL from baseline within 7 days of admission.4) Additionally, right heart catheterization (RHC) was performed before discharge if the consent was obtained.

Results

From May 2021 to May 2023, we analyzed a total of 114 patients (56 in the DAPA group and 58 in the CON group). The mean age was 73 years, 35% were female, and the mean LVEF was 32.5%. There was no significant difference in the incidence of WRF between two groups (16.1% in the DAPA group vs. 12.1% in the CON group, P=0.54, Figure 1). The cumulative loop diuretics dose over 7 days was lower in the DAPA group than CON group (184 ± 9.64 mg vs. 214 ± 9.81 mg, P=0.03, Figure 2). RHC before discharge was performed in 54 patients (96.4%) in the DAPA group and in 54 (93.1%) in the CON group. There were no significant differences in the pulmonary artery wedge pressure, pulmonary artery pressure, right atrial pressure, and cardiac index by the thermodilution method or the Fick method between two groups.

Conclusion

This randomized prospective trial revealed the early initiation of DAPA within 24 hours of admission for ADHF reduced loop diuretic demand without inducing WRF compared to standard decongestive therapy.Figure 1Figure 2
Effects of dapagliflozin on body composition and its relation to hemodynamics in heart failure with preserved ejection fraction: the CAMEO-DAPA randomized clinical trial
Authors: Naser J A , Tada A , Harada T , Reddy Y N , Carter R E , Testani J , Jensen M , Borlaug B A
Published: October 2024

Background

Excess fat, particularly visceral fat, plays an important role in the development of heart failure with preserved ejection fraction (HFpEF). Sodium glucose cotransporter-2 inhibitors improve hemodynamics, reduce symptom severity, and decrease risk of hospitalization, but their impact on body composition, as well as potential relationships between changes in body composition and hemodynamic effects, are unknown in HFpEF.

Purpose

Evaluate the effect of dapagliflozin on body and blood composition and examined the potential correlation of such changes on cardiac hemodynamics.

Methods

The CAMEO-DAPA trial, a single-center, double-blind, randomized, placebo-controlled study, showed that 24 weeks of dapagliflozin reduced resting and exercise pulmonary capillary wedge pressures (PCWP) in patients with HFpEF. This prespecified secondary analysis reports the effects of dapagliflozin on body composition using dual energy x-ray absorptiometry (DEXA), blood composition (radiolabeled iodinated albumin), and cardiac hemodynamics using high-fidelity micromanometers. Analysis was performed based on the intention-to-treat. Relative change was calculated by dividing the absolute change on the baseline value.

Results

Overall, 37 patients (67 years, 65% women, 70% with obesity, 27% overweight) completed the trial. As compared with baseline, dapagliflozin decreased total body fat compared with placebo [mean (SD) absolute change: -2.29 (2.94) kg vs -0.32 (1.84) in placebo, p=0.03; relative change: -4.6% (5.4) vs -0.8% (4.3), p=0.02], Figure 1. This was primarily due to greater loss of upper body trunk fat [absolute change: -1.53 (1.70) kg vs +0.31 (0.99) in placebo, p<.001; relative change: -5.2% (5.6) vs +1.1% (4.1), p<.001], Figure 1. Reductions in trunk fat were correlated with decreases in PCWP (r=0.41, p=0.03), Figure 2. Total body fat-free mass (FFM) tended to decrease in the dapagliflozin group [absolute change: -0.63 (1.85) kg vs +0.34 (1.76), p=0.12]; reductions in leg, android, and gynoid FFM were all greater than placebo (p<0.05). Dapagliflozin reduced plasma volume [absolute change: -170 (343) ml vs +112 (346), p=0.02] compared with placebo, and the decrease in plasma volume was correlated with the reduction in FFM (r=0.47, p=0.006), Figure 2. Treatment with dapagliflozin had no effect on resting metabolic rate but was associated with modest reduction in bone mineral content [-16 (47) g vs +26 (61), p=0.03].

Conclusions

In patients with HFpEF, dapagliflozin decreases body fat, particularly trunk fat, suggesting greater effect on visceral adipose, which is correlated with favorable hemodynamic effects. Dapagliflozin also tends to reduce FFM, which may relate to reduction in total body water with or without reduction is muscle mass, in tandem with modest decreases in bone mineral content.Figure 1:Relative change in fat massFigure 2
Home alone on milrinone: a novel way to deliver home inotropes as a bridge to heart transplantation
Authors: Easton K , Considine A , Warner V , Downes R , Varghese S , Tong B , Gutman S , Taylor A , Hare J , Leet A , Cheshire C , Bergin P , Kaye D , Patel H
Published: October 2024

Continuous ambulatory intravenous inotropes can be successfully used as a bridge to decision or heart transplant in patients with end-stage heart failure. The traditional model at our institute involved the Hospital in the Home (HITH) team, with daily nurse-led visits to the patients’ home, to safely maintain this treatment, which is otherwise largely restricted to the intensive care setting. In response to the COVID-19 pandemic, delivery of healthcare underwent a paradigm shift. Our model was changed to a patient led continuous intravenous inotrope program at home which obviated the need for a daily nurse visit. We describe our process and our early outcomes.

Fifteen patients were deemed suitable for the Independent at Home program. All patients needed to complete ambulatory intravenous inotrope education, pass competency testing and have implantable cardioverter-defibrillators inserted prior to discharge. Competencies included proficiency for troubleshooting the inotrope ambulatory delivery pump, monitoring of vital signs and ability to report decompensated heart failure symptoms.

Weekly outpatient visits to our heart failure clinic with nursing, medical and pharmacy reviews were scheduled. Emergency action plans were provided to patients.

73.3% of our cohort were male. The average age was 51 years. 46.6% had a diagnosis of dilated cardiomyopathy. 53.3% were listed for heart transplant and were bridge to transplant (BTT) and 46.7% were bridge to decision (BTD) for heart transplant. Over a study period of 35 months, seven (46.7%) patients were weaned off inotropes, three (20.0%) were escalated to durable mechanical circulatory support (one due to decompensated heart failure and two due to persistently elevated pulmonary pressures), four (26.7%) were transplanted and one (6.7%) chose to be palliated. Six patients had one admission, five patients had two admissions. Five readmissions were due to decompensated heart failure, four admissions were planned to optimize pulmonary hypertension following a right heart catheterization, three had peripherally inserted central catheter (PICC) line complications and two had non-cardiac admissions (refer to table 1). The median length of days on the Independent at Home program was 112 days with an interquartile range of 120 days. A comparative group consisting of consecutive patients treated under the previous Hospital in the Home model are presented in table 2; the Independent at Home cohort shows reduced unplanned admissions. The independent at home inotrope program is an effective and safe option to bridge to decision or bridge to cardiac transplantation.HITH vs Independent admission reasonHITH vs Independent admissions
Long-acting CRF2 receptor agonist COR-1389 improves cardiopulmonary function parameters in monocrotaline-induced pulmonary hypertension and right heart failure rat model
Authors: Kowala M C , Guignabert C , Thuillet R , Ottaviani M , Tu L , Ozoux M L , Lawson F C , Janiak P
Published: October 2024

Background

Pulmonary hypertension (PH) associated with right heart failure (RHF) poses a significant therapeutic challenge. Short term studies have shown that urocortin-2 (UCN-2) administration, either intravenously or subcutaneously, can ameliorate cardiac and/or pulmonary parameters in human heart failure (HF) and in animal models of PH and RHF.

Purpose

This study aimed to evaluate the potential benefits of COR-1389, a long-acting CRF2 receptor agonist, on cardiopulmonary function and adverse remodeling in a rat model of monocrotaline (MCT)-induced PH and RHF.

Method

Monocrotaline (40 mg/kg) was administered subcutaneously in rats on Day-0 to induce PH and RHF, while the control group received vehicle. After 14 days, MCT-injected rats were evenly allocated into two groups based on echocardiography parameters of accelerated time/ejection time ratio and tricuspid annular plane systolic excursion (TAPSE), before receiving either COR-1389 (100 ug/kg) or its vehicle subcutaneously every 4 days for 14 days. On Day-28, echocardiography was repeated in all groups, followed by right heart catheterization to directly measure pulmonary hemodynamics. Heart and lung samples were prepared for histological analysis.

Results

By Day-28, MCT-treated rats exhibited significantly elevated mean pulmonary arterial pressure (mPAP) and right ventricular (RV) mass (Fulton Index/BW), along with decreased RV function (increased TAPSE) and reduced cardiac output (CO) compared to control rats. These changes were accompanied by severe tissue remodeling, including increased vascular muscularization (alpha-smooth muscle actin content) and pulmonary arterial wall thickening, RV fibrosis, and cardiomyocyte hypertrophy. Following 14 days of curative treatment, MCT+COR-1389 compared to MCT, significantly decreased mPAP and RV mass (Fulton Index/BW), while RV function improved (reduced TAPSE) and CO was increased. Moreover, COR-1389 attenuated adverse pulmonary vascular remodeling (reduced muscularization and arterial wall thickening), RV fibrosis, and cardiomyocyte hypertrophy, consistent with its hemodynamic effects.

Conclusions

Chronic CRF2 agonism with COR-1389 improved dysregulated cardiac and pulmonary function and structure in the MCT rat model, suggesting its potential for the treatment of PH and RHF.
Treatment with flozins across the whole spectrum of heart failure in Poland between February 2022 and June 2023 based on Heart Failure Observational Study by Polish Cardiac Society.
Authors: Morawiec R , Drozdz J
Published: October 2024

Since the introduction of the ESC guidelines in 2021 and the increased level of recommendations in 2023, SGLT2 inhibitors (SGLT2i) have been widely used in all patients with heart failure (HF), improving their prognosis. Current guidelines recommend the use of SGLT2i across the entire spectrum of HF regardless of ejection fraction.

The aim of the study was to summarize the usage of SGLT2i in patients with HF in Poland, based on data gathered in the Heart Failure Observational Study (HEROES) conducted by the Polish Cardiac Society.

Overall, 1176 patients (enrolled between Feb 2022 and Jun 2023) were included in the analysis (hospitalizations: N=918, outpatient visits: N=258). Most of them were men (71.7%) with a median age of 69 years (IQR: 60-75). Patients with reduced ejection fraction (HFrEF) were the most numerous group (48%, N=565) followed by preserved (HFpEF, 22%, N=259) and mildly reduced (HFmrEF, 14%, N=166) ejection fraction. In 16% of cases, ejection fraction was not reported.

Only fewer than 60% of subjects were reported to be treated with SGLT2i (overall: 59.5%; HFrEF: 82.3%; HFmrEF: 48.8%, HFpEF: 32.4%). We divided the whole study group into 4 even quartiles based on the number of consecutive patients enrolled (Q1: Feb 2022-Dec 2022; Q2: Sep 2022; Q3: Mar 2023; Q4: Jun 2023). Results showed an overall increasing number of patients treated with SGLT2i in consecutive quartiles, especially in HFmrEF group (Fig. 1). However, in the last quartile (Q4), less than 40% usage of SGLT2i in HFpEF patients was observed (38.2%). The analyzed period ended before the release of the 2023 focused update of HF guidelines that strengthened recommendations for SGLT2i use to the first class of recommendations regardless of ejection fraction. This document will probably further increase the usage of SGLT2i in the Polish HF population. Nevertheless, our data are worrying, as overall more than 1/3 of HF patients in the last quartile were not treated with one of the basic and effective drugs in HF. It is worth mentioning that the 2021 HF guidelines recommended SGLT2i in the first class of recommendations only in HFrEF, but by that time, current clinical trial results had already shown great benefit in HFmrEF and HFpEF patients.SGLT2i treatment in PL (Feb2022-Jun2023)
Effect of stereotactic body radiation therapy on left ventricular diastole function in symptomatic patients with hypertrophic obstructive cardiomyopathy
Authors: Liu N , Peng B , Li X P , Zhu Z W , Xiao Y C , Fang Z F , Hu X Q , Gao Y W , Liu Q M , Zhou S H
Published: October 2024

Background

We applied stereotactic body radiotherapy (SBRT) for the first time in the treatment of patients with hypertrophic obstructive cardiomyopathy (HOCM), and significant improvements in symptoms and diastolic function were observed after treatment.

Objectives

To evaluate the impact of SBRT on cardiac structure, function, and clinical indicators in patients with HOCM.

Methods

This study included 12 drug-refractory symptomatic HOCM patients (6 who underwent SBRT and 6 who received pharmacological treatment alone) and conducted a retrospective analysis of their clinical data. Transthoracic echocardiography was used to assess various ultrasound parameters, including interventricular septal thickness, left ventricular outflow tract diameter, peak pressure gradient and diastolic function before treatment and at 1, 3, and 6 months after treatment. Additionally, assessments were made for symptoms; laboratory test results (NT-proBNP, cTnT, CK-mb, and CRP); 6-minute walk test results; New York Heart Association (NYHA) functional classification; and Kansas score before and 6 months after treatment.

Results

HOCM patients showed significant improvement in mitral valve systolic anterior motion after SBRT. Compared to that at baseline, the interventricular septum thickness gradually decreased at 1, 3, and 6 months after treatment (-8.8%, -8.0%, -14.4%, respectively) (P<0.05). Compared to those in the drug group, the left ventricular diastolic function and structural parameters, including the interventricular septum thickness (mean change from baseline of -3 mm [95% CI: -5.2 to -0.8 mm] and 1.3 mm [95% CI: 0.5 to 2.2 mm]; P<0.05), and the LA GLS (change of 2.1% [-0.03% to 4.2%] and -0.9% [-3.1% to 1.3%]; P<0.05), were significantly improved in HOCM patients at 6 months posttreatment. Similarly, the clinical indicators, including KCCQ, increased from baseline (61 (range, 47.3-70) to 84 (range, 70-89.5) at 6 months posttreatment (P<0.05), and the 6-minute walk test score increased from 187 meters (range, 50-370) to 401 meters (range, 280-540) (P<0.05).

Conclusion

SBRT significantly improved left ventricular diastolic function and reduced interventricular septum thickness in HOCM patients. Symptoms, exercise capacity and clinical indicators improved after SBRT in HOCM patients.
Comparison of ventricular tachyarrhythmias in HF patients on dapagliflozin versus empagliflozin
Authors: Wilson P , Miles B , Sills M
Published: October 2024

Background

Ventricular tachycardia (VT) and ventricular fibrillation (VF) are devastating tachyarrhythmias that can cause sudden cardiac death in patients with heart failure (HF) if not anticipated or treated promptly. Although post-hoc analysis in DAPA-HF showed promise in their benefit, Sodium-glucose transport protein 2 inhibitors (SGLT2i) have not yet been evaluated for their effect on these tachyarrhythmias. This retrospective analysis aims to compare the 2 most commonly used SGLT2i agents, dapagliflozin and empagliflozin, and the incidence of VT in patients with HF.

Methods

The TriNetX Research network was used for this study. The two initial patient cohorts were created using ICD-10 codes and medication codes from the TriNetX platform. Both cohorts consisted of patients over age 60 with a history of heart failure and either VF or VT. One cohort was on treatment with dapagliflozin and the other with empagliflozin. The cohorts were balanced by propensity score matching and the greedy nearest neighbor algorithm for age, gender, race, ethnicity, hyperkalemia, and the current use of spironolactone, amiodarone, metoprolol, and carvedilol, resulting in 9,841 patients in each arm. The cohorts were then evaluated for the development of VF or VT over the subsequent five years as well as all-cause mortality. Additional cohorts were created to evaluate dapagliflozin vs empagliflozin in diabetics, nondiabetics, and patients with ejection fractions less than 35%

Results

Dapagliflozin was associated with an increased risk of ventricular arrhythmia in heart failure patients compared to empagliflozin (46.0% vs. 40.8%, RR 1.13, 95% CI (1.09,1.16), P value < 0.0001). It was also associated with higher mortality at five years (RR 1.10, 95% CI (1.03,1.18), P value 0.0034).

Conclusions

In comparisons between dapagliflozin and empagliflozin in heart failure patients with previously documented ventricular arrhythmias, empagliflozin had 13% less risk of recurrence of ventricular arrhythmias. Secondarily, the empagliflozin cohort also exhibited lower all-cause mortality (14.8% vs 16.3%) at five years from starting the drug. Our analysis does not disprove findings in DAPA-HF, but rather may support the potential class effect of SGLT2 inhibitors in their ability to suppress VT.(1)

Importantly, the overall incidence of ventricular tachyarrhythmias is high in both cohort, given we selected a high-risk population. Notably, our documented recurrence rate is similar to past reports of recurrence after VT ablation, the gold standard for treatment of VT. (2)

SGLT2 inhibitors have shown clear benefit in multiple placebo-controlled studies in terms of heart failure outcomes like mortality and readmission, but their effect on arrhythmias is one more additional benefit this class may have. (3) Given these associations, empagliflozin may be a more favorable options for HF patients who have already had VT or VF.
Cardiovascular mortality with oral potassium-binders in patients with CKD and heart failure
Authors: Barzkar H , Miles B , Mehta A
Published: October 2024

Introduction

Hyperkalemia is an inherent consequence of advancing chronic kidney disease (CKD) as a result of the kidney’s decreased ability to excrete potassium. Heart failure patients with concomitant CKD may not tolerate maximum doses of guideline-directed medical therapies (GDMT) like ACE inhibitors (ACEi), angiotensin receptor blockers (ARB), angiotensin receptor/neprilysin inhibitors (ARNI) and mineralocorticoid receptor antagonists (MRA) due to dose-limiting hyperkalemia. Many randomized controlled trials in heart failure exclude patients with advanced CKD. Two oral therapies exist to manage hyperkalemia - patiromer sorbitex calcium and sodium zirconium cyclosilicate. This study aims to identify the potassium-binder with better outcomes as defined by less readmissions, hyperkalemia episodes, and death.

Purpose

This project was undertaken to better understand the impact of using potassium-binders in CKD patients with heart failure. Improved management of hyperkalemia will be an avenue for optimization of GDMT in this population.

Methods and materials

The TriNetX research network was used for this study. Two cohorts of patients were created by using International Classification of Disease 10 (ICD-10) codes and CPT codes. Both cohorts consisted of patients with no prior history of hyperkalemia within 30 days of hospital discharge at which time one cohort was prescribed patiromer and the other received sodium zirconium cyclosilicate. Each cohort was prohibited from exposure to the other medication. The cohorts were balanced by propensity score matching and the greedy nearest neighbor algorithm for age, race, gender, ethnicity. They were also balanced for systolic and diastolic heart failure diagnoses, and for each individual stage of CKD (1 through 5 and end stage). They were also balanced for use of ACEi, ARBs, and MRAs. This resulted in 8,921 patients in each arm. They were then evaluated for the outcomes of hospital readmission, hyperkalemia episodes (>6.1 mmol/L), and death within 12 months.

Results

Patients treated with patiromer were more likely to be hospitalized over the following twelve months (44% vs 40%, RR 1.11, 95% CI (1.07,1.15), p value <0.0001). They were also more likely to experience hyperkalemia (11.7% vs 9.2%, RR 1.27, 95% CI (1.16,1.38), p value <0.0001). Patiromer was also associated with slightly greater all cause mortality (27% vs 25%, RR 1.08, 95% CI (1.03,1.13), p value 0.0021).

Discussion

This study demonstrates patiromer has more readmissions and hyperkalemia episodes along with greater mortality. In conclusion, sodium zirconium cyclosilicate was found to have better outcomes compared to that of patiromer. Further studies are necessary to better understand the utility of using sodium zirconium cyclosilicate as maintenance therapy for hyperkalemia in order to maximize GDMT in CKD patients with heart failure.
Real-life data on the tolerability of SGLT2 inhibitors in elderly patients with heart failure
Authors: Hacil A , Hanon O , Vidal J
Published: October 2024

Introduction

Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have demonstrated their effectiveness in improving the prognosis of heart failure. However, there is some hesitation in clinical practice to prescribe them to elderly patients due to a lack of long-term safety data. The SafeGLT2 study aims to evaluate the tolerance of SGLT2i in elderly patients with heart failure in real-life settings.

Methods

This is a prospective study conducted in acute geriatric units in the Île-de-France region between February 2020 and May 2023. All patients admitted for acute heart failure (AHF), aged 75 years and older, were included. The diagnosis was confirmed by an expert committee, and patients were followed for one year. Treatments were recorded upon admission and discharge, along with demographic characteristics and medical history. SGLT2i tolerance data were collected and analyzed, including renal insufficiency, hypovolemia, genital infections, urinary infections, hypoglycemia, diabetic ketoacidosis, fractures, amputations, etc. A comparison of tolerance data between heart failure patients treated with SGLT2i and those not receiving SGLT2i was performed.

Results

288 patients were included in the study with a mean age of 88 years, 53% (n=153) were female, and a median Charlson Comorbidity Index (CCI) of 8.77 [2.71]. 44.1% (n=127) of patients had neurocognitive disorders, 39.6% (n=114) were malnourished, 32.6% (n=94) were fallers, 53.8% (n=155) had renal insufficiency (eGFR < 60 ml/min), and 11.5% (n=33) lived in institutions. A total of 33% (n=95) were treated with SGLT2i upon discharge. No serious adverse effects were found in this very frail population receiving SGLT2i compared to the group not receiving SGLT2i (severe hypotension, hypovolemia, ketoacidosis, hypoglycemia, fracture, amputation). Beneficial effects on renal function (improvement of renal function at 6 months) were observed in the SGLT2i group despite a temporary decrease in glomerular filtration rate of less than 30% after SGLT2i initiation. However, a statistically significant increase in urinary tract infections (16.8% vs 4.15%), genital infections (12.6% vs 1.5%), and constipation (10% vs 1%) was found in the SGLT2i group compared to the group without SGLT2i.

Conclusion

These data indicate that SGLT2i are well tolerated in very elderly frail heart failure patients. However, the occurrence of urogenital infections appears to be more frequent in this population and requires particular surveillance.
Vericiguat in heart failure patients: analyzing safety, tolerability, and quality of life via meta-analysis of randomized controlled trials
Authors: Tanriverdi L H , Dogan M M , Banach M
Published: October 2024

Background

Heart failure (HF) poses a significant burden on global healthcare systems, necessitating effective therapeutic interventions. Vericiguat, a novel agent targeting soluble guanylate cyclase, has emerged as a potential treatment for HF.

Purpose

To understand its impact on patient outcomes, including safety, tolerability, and quality of life (QoL).

Methods

A comprehensive meta-analysis was conducted, encompassing four randomized controlled trials (RCTs) identified through Cochrane CENTRAL, Ovid Medline R, Pubmed, and Web of Science databases up to December 1, 2023. The primary efficacy outcome, Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (OSS), and the primary safety outcome, drug-related serious adverse events (AEs), were analyzed. Pooled mean differences (MD) and risk ratios (RR) were calculated using inverse variance common-effect model.

Results

The meta-analysis encompassed 5947 patients across the four RCTs. Our findings indicated that vericiguat did not demonstrate a significant beneficial effect on KCCQ-OSS (MD -0.13, 95% CI -1.32 to 1.05), suggesting no substantial impact on overall QoL, despite a statistically significant improvement in the KCCQ-Physical Limitation Score (PLS) (MD 3.74, 95% CI 0.24 to 7.24) compared to placebo. Notably, vericiguat exhibited a favorable safety and tolerability profile, with comparable risk for AEs leading to death (RR 1.32, 95%CI, 0.58 to 3.03), withdrawal due to AEs (RR 1.08, 95% CI 0.88 to 1.32) or serious AEs (RR 1,18, 95%CI, 0,50; 2,80), renal and urinary disorders (RR 0.99, 95% CI 0.88 to 1.11), symptomatic hypotension (RR 1.17, 95% CI 0.98 to 1.40), and acute kidney injury (RR 1.04, 95% CI 0.83 to 1.31) compared to placebo.

Conclusion

Vericiguat demonstrates promising safety and tolerability profiles in patients with HF. While our analysis reveals significant improvement in KCCQ-PLS, indicating enhanced physical limitation scores, the lack of statistically significant impact on overall QoL raises questions about its comprehensive efficacy. These findings underscore the need for further research to elucidate the holistic impact of vericiguat on patient-reported outcomes in heart failure management.Forest plot of quality of life outcomesForest plot of safety outcomes
Real world evidence of Sacubitril/Valsartan in octogenarian patients with heart failure. Results From the PARACHUTE-HF Study
Authors: Okuda N , Abe T , Sangen Y , Watarai M , Shimazaki K , Moriyama T , Murohashi A , Iwanami Y , Sasaki A , Saito K , Jujo K
Published: October 2024

Introduction

The beneficial effects of Angiotensin Receptor Neprilysin Inhibitors (ARNI) on heart failure (HF) patients, particularly those with reduced left ventricular ejection fraction (LVEF), have been highlighted in several randomized controlled trials. Since 2020, ARNI has been available for HF treatment in Japan, a country known for its aging population. However, the inclusion of octogenarians in previous trials has been limited, leaving a gap in evidence regarding ARNI's effectiveness in the elderly.

Objective

This study aims to explore the real-world efficacy and safety of ARNI treatment among octogenarian HF patients in Japan, reflecting its status as a leading aging society.

Methods

The Prospective Area Registry of ARNI for Congestive Heart failUre in Tokyo East (PARACHUTE) trial, a multicenter registry, was conducted. It involved patients newly prescribed ARNI for chronic HF regardless of LVEF between 2020 and 2021. We compared patient backgrounds, changes in NT-proBNP levels at 6 months, and the rate of ARNI discontinuation between groups aged below and above 80 years.

Results

The study enrolled 105 patients, with an average age of 75 years. Forty-six patients (44%) were over 80 years old, and the majority (72%) were male. Among the younger group, 50% had preserved LVEF, compared to 32% in the octogenarian group (p=0.01). Median NT-proBNP levels across all patients decreased significantly from 2,540 pg/mL at baseline to 998 pg/mL at 6 months. The reduction in NT-proBNP was similar between the two age groups, with no significant interaction (p=0.46). Discontinuation rates due to any cause were not significantly different between younger and older patients (7% vs. 13%, p=0.28).

Conclusion

ARNI treatment resulted in significant reductions in NT-proBNP levels in HF patients, both under and over 80 years of age, with comparable discontinuation rates. These findings highlight the effectiveness and safety of ARNI in the management of chronic HF in the elderly, offering valuable real-world evidence from Japan's unique demographic context.
The implementation of modern guideline-directed medical therapy among hospitalized patients with heart failure with reduced ejection fraction: real-world experience from two tertiary cardiac centers
Authors: Banfi-Bacsardi F , Kazay A , Fuzesi T , Pilecky D , Vamos M , Gergely T G , Majoros Z S , Torok G M , Borsanyi T D , Andreka P , Piroth Z S , Duray G Z , Kiss R G , Nyolczas N , Muk B
Published: October 2024

Background

According to the 2021 ESC HF Guidelines (GLs), the conventional triple therapy (TT) (RASi+βB+MRA) of HFrEF has been supplemented with the SGLT2 inhibitor dapa- and empagliflozin as the fourth pillar of the foundational quadruple therapy (QT) recommended for all HFrEF patients.

Aim

To assess the changes in the implementation of GDMT and investigate its impact on the prognosis among hospitalized HFrEF patients in light of the 2021 HF GLs.

Patients and methods

A retrospective data analysis of a consecutive cohort of HFrEF patients hospitalized due to HF between 01/01/2019 and 31/12/2023 at two tertiary cardiac centers was performed. Patients were classified into two groups: those hospitalized before and those after the publication of the 2021 ESC HF GLs (27/08/2021). Differences in the implementation of the drug therapy were analysed using the Chi-square test. 1-year all-cause mortality (ACM) was compared using Kaplan-Meier method and log-rank test. The independent predictors of the 1-year ACM were investigated with uni-, and multivariate Cox-regression analysis.

Results

A total cohort of 560 patients (male: 76%, age: 63 [51-72] years, coronary artery disease: 46%, diabetes: 38%, atrial fibrillation: 44%, LVEF: 25 [20-30]%, eGFR: 57 [43-74]mL/min/1.73m²; NT-proBNP: 5574 [2529-10960]pg/mL) was treated with a high proportion of TT (80%) and with QT (TT + SGLT2i) in 34% at discharge. After the publication of the 2021 ESC HF GLs, the proportion of patients on these SGTL2is improved (10% vs 57%, p<0.001; in the group before vs. after the publication of the GLs), resulting in an increased proportion of patients on QT (10% vs. 52%, p<0.001). There was no significant difference between groups regarding the use of TT (6% vs. 3%) or QT (1% vs. 3%) at target doses. The 1-year ACM was more favourable for those receiving QT (non-QT and non-TT: 41% vs. TT: 16% vs. QT: 11%, p<0.001).

According to the multivariate Cox-regression analysis, older age, and more advanced left ventricular systolic dysfunction proved to be negative independent predictors of 1-year ACM, while "de novo" diagnosis of HFrEF and the application of TT/QT (adjusted HR: 0.303, 95% CI: 0.207-0.445, p<0.001) resulted in better outcomes.

Conclusions

The 2021 ESC HF GLs have led to a breakthrough regarding the modern drug treatment recommended for all patients in HFrEF. Our results demonstrated that the introduction of SGLT2is and the use of QT was feasible even in the everyday practice among complex, multimorbid HFrEF patients requiring hospitalization and the implementation of TT/QT was accompanied by a better prognosis.
Real-world eligibility for GLP1-ra therapy in a cohort of heart failure patients
Authors: Villaschi A , Chiarito M , Pini D , Panico C , Pagliaro B , Pinto G , Maccallini M , Condorelli G
Published: October 2024

Background

GLP1-ra have demonstrated substantial cardiovascular (CV) benefits in diabetic and, more recently, non-diabetic patients, however their use in heart failure (HF) patients is still limited.

Purpose

To evaluate real-word eligibility to GLP1-ra in a cohort of HF patients.

Methods

Demographic and clinical data from HF patients evaluated at a single center HF unit from August 1st 2021 to November 29th 2023 were automatically retrieved from the electronic health record (EHR). Patients were deemed eligible to GLP1-ra based on (1) absence of ongoing treatment with GLP1-ra and (2) either having type 2 diabetes mellitus (T2DM) or satisfying the inclusion criteria of the SELECT trial or those of the STEP-HFpEF trial, which were adapted according to the available information. A sensitivity analysis lowering the body mass-index cut-off to >= 27 kg/m2 also for the STEP-HFpEF trial was performed.

Results

1754 patients with an established diagnosis of HF were included; median age was 78.3 (IQR 70.7-83.8) years and 697 patients were female (39.7%). 6 patients had type 1 diabetes mellitus. Among the remaining 1749 patients, 633 (36.2%) patients had T2DM and 14 were already treated with GLP1-ra. Among 1116 patients without diabetes, 302 (27.1%) were eligible to receive GLP1-ra according to the inclusion criteria of the SELECT or STEP-HFpEF trials. 226 (20.2%) satisfied the SELECT trial inclusion criteria and among them 100 (44.8%) had HF with reduced ejection fraction, whereas 136 patients (12.2%) were eligible to receive GLP1-ra according to the STEP-HFpEF trial. Changing the BMI cut-off to >= 27 kg/mq, as in the SELECT trial, 219 patients (19.6%) according to the STEP-HFpEF inclusion criteria and 344 (30.8%) overall were found to be eligible for GLP1-ra therapy.

Conclusion

Real-word eligibility to GLP1-ra may reach up to 55% of HF patients according to diabetes status or trial inclusion criteria.
Effects of dapagliflozin in heart failure according to duration of type 2 diabetes: a patient-level meta-analysis of DAPA-HF and DELIVER
Authors: Butt J , De Boer R A , Hernandez A , Inzucchi S E , Kosiborod M , Koeber L , Lam C S P , Martinez F A , Ponikowski P , Sabatine M S , Shah S , Vaduganathan M , Jhund P S , Solomon S D , Mcmurray J J V
Published: October 2024

Introduction

Type 2 diabetes (T2D) is a common comorbidity in heart failure (HF), and long-standing T2D is associated with worse outcomes.

Purpose

To investigate the efficacy and safety of dapagliflozin, compared with placebo, according to duration of T2D in patients with HF and established T2D.

Methods

We conducted a patient-level pooled analysis of the DAPA-HF and DELIVER trials, which evaluated the effects of dapagliflozin, compared with placebo, in patients with HF with reduced ejection fraction and HF with mildly reduced/preserved ejection fraction, respectively. T2D duration was categorized as <5 years, 6-10 years, and >11 years. The primary outcome was a composite of worsening HF or cardiovascular death.

Results

Of the 4,784 patients with a history of T2D, 1,879 (39.3%) had a T2D duration of <5 years, 1,074 (22.4%) 5-10 years, and 1,831 (38.3%) >11 years. Patients with longer-duration T2D were older, more often female, and White, and had a higher HbA1c, body mass index, and left ventricular ejection fraction. They were more likely to have ischaemic heart disease, peripheral artery disease, hypertension, and chronic kidney disease, but were less likely to have atrial fibrillation/flutter. Although patients with longer-duration T2D had longer duration of HF, they were not more likely to have a prior HF hospitalization or worse New York Heart Association functional class. Despite similar N-terminal pro-B-type natriuretic peptide levels, patients with longer-duration T2D had a higher risk of the primary outcome, even after adjustment for potential confounders (<5 years, reference; 6-10 years, HR 1.25 [95% CI, 1.06-1.46]; >11 years, HR 1.33 [1.15-1.54]). The benefit of dapagliflozin on the primary outcome was consistent across T2D duration category: <5 years, HR 0.85 (95% CI, 0.69-1.04); 5-10 years, HR 0.65 (0.51-0.83); >11 years, HR 0.84 (0.70-1.01) (Pinteraction=0.18). Dapagliflozin reduced the risk of secondary clinical outcomes and increased (improved) mean KCCQ scores from baseline to 8 months, regardless of T2D duration (Table). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of T2D duration.

Conclusions

Dapagliflozin reduced the risk of worsening HF or cardiovascular death, and improved symptoms, in patients with HF and T2D, irrespective of T2D duration.
Feasibility of hybrid telerehabilitation and telecare in heart failure patients with implanted left ventricular assist device LVAD
Authors: Piotrowicz E , Kowalik I , Chwyczko T , Piotrowicz R
Published: October 2024

Background

Left ventricular assist device (LVAD) implantation is increasingly used as a treatment option for patients with advanced heart failure (HF). There is a need to provide patients with LVAD with long-term care, preferably at home. The implementation of home-based telerehabilitation (HTR) and telecare offers new opportunities in this field.

Purpose

The purpose of this study was to assess feasibility and safety of HTR and telecare in HF patients with implanted LVAD and evaluate patients’ acceptance of and adherene to HTR.

Methods

The study enrolled 30 HF patients with recent implanted LVAD (21 Heart Mate III, 9 Heart Ware) (29 males, 19–67, mean 59 years) who underwent a 12-week telecare and HTR program based on walking, respiratory and resistance training, five times weekly. HTR was telemonitored with a device adjusted to register electrocardiogram (ECG) recording and to transmit data via mobile phone network to the monitoring center. The moments of automatic ECG registration were pre-set and coordinated with exercise. The influence on physical capacity was assessed by comparing changes in peak oxygen consumption (VO2 peak; [ml/kg/min]) and workload duration (t; [sec]) in cardiopulmonary exercise test.

Results

HTR resulted in a significant physical capacity improvement pVO2 12.5±2.9 vs 15.1±3.0 (p<0.001), and workload duration t 628±204 vs 728±222 (p<0.001) in cardiopulmonary exercise test. There were neither deaths nor adverse events during HTR. Patients accepted HTR, including the need for interactive everyday collaboration with the medical team from monitoring center. All patients completed HTR.

Conclusions

HTR is a feasible, safe form of rehabilitation, well accepted by patients. The adherence to HTCR was high.
Associated factors and percentage of cardiac recovery among patients using LVAD: a meta-analysis of 31 studies
Authors: Hasabo E A , Isik B , Bakr M S , Eljack M M F , Neirokh D , Nosir M Y , Ayhan C , Alzomor H , Sawabi R , Sultan S , Caliskan K , Soliman O
Published: October 2024

Introduction

Patients with advanced heart failure use left ventricular assist devices (LVAD) to improve their outcomes and enhance the reverse remodeling of the heart. There has been no previous meta-analysis on the percentage of cardiac recovery after LVAD. This study aims to find the pooled percentage of cardiac recovery after LVAD.

Methods

A systematic search was done in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to December 2023. We used the relevant keywords to include studies that reported the percentage of people who achieved cardiac recovery after LVAD. The percentage of participants using LVAD and achieving cardiac recovery was extracted from the studies. RevMan 5.4 was used for meta-analysis.

Results

Thirty-two studies totaling 39215 patients were included. Different types of LVAD were used among participants. Across studies, different definitions for cardiac recovery were used, and the most used one is device explant following cardiac recovery and achieving left ventricular ejection fraction (LVEF) ≥ 40% after using LVAD. The pooled percentage of people who achieved cardiac recovery was 5.06%, 95% CI [4.17, 5.95], and the result was heterogeneous (I2 = 94%, p < 0.00001).

Shorter duration of heart failure, female gender, younger age, presence of Implantable cardioverter-defibrillator (ICD) and low left ventricular end-diastolic diameter (LVEDD) were the most common mentioned factors associated with cardiac recovery.

Conclusion

Low cardiac recovery was found in patients using LVAD, and several factors were associated with cardiac recovery. Further action could be taken to improve the recovery among this population.
National trends of left ventricular assist device therapy in Germany
Authors: Seoudy H , Voran J C , Frank J , Kreidel F , Panholzer B , Huenges K , Lutter G , Sommer W , Warnecke G , Frank D
Published: October 2024

Background

The prevalence of advanced heart failure (HF) is increasing and prognosis remains poor. Although heart transplantation is still considered to be the gold standard for the treatment of advanced HF in selected patients, its use is limited by organ donor shortage and a growing burden of cormorbidities among potential recipients. The 2021 European Society of Cardiology (ESC) guidelines recommend consideration of long-term mechanical circulatory support with a left ventricular assist device (LVAD) in eligible patients with advanced heart failure (HF) who are refractory to medical/device therapy.

Purpose

The purpose of this study was to evaluate the national trends of LVAD in Germany. The main hypothesis was that LVAD therapy is still underutilized.

Methods

From the national database of the German Federal Statistical Office (DESTATIS), we identified all patients who underwent LVAD implantation in Germany between January 2011 and December 2022 (n = 9,232). We compared temporal trends and in-hospital outcomes.

Results

From 2011 to 2022, number of LVAD implantation was highest in the year 2017 (n = 914) and steadily decreased over the following years (2022: n = 617). Mean age of LVAD recipients was 56.2 years (2011-2015) and increased to 58.4 years (2020-2022). The majority of LVAD recipients are male (84,8 %), and this trend has been stable during the entire time period. In-hospital mortality after LVAD remains high, but has been decreasing (25.8% during 2011-2015 compared to 20.2% during 2020-2022).

Conclusion

Although LVAD is recommended in eligible patients with advanced HF, our study suggests an underutilization of LVAD in this patient population and especially in female patients.
Left atrial strain is associated with cardiovascular outcomes in children with congenitally corrected transposition of the great arteries
Authors: Iturralde Chavez A , Stephens S , Pignatelli R H , Penny D J , Doan T T
Published: October 2024

Background

The assessment of the systemic right ventricular (sRV) function in congenitally corrected transposition of the great arteries (ccTGA) by echocardiography is restricted by its complex geometry.

Purpose

To determine the utility of left atrial strain (LAS) and sRV longitudinal strain (sRV-LS) in the prediction of outcomes in children with ccTGA.

Methods

This nested case-control study included all patients <21 years old with unrepaired ccTGA at our tertiary pediatric institution who had an echocardiogram prior to cardiovascular outcomes (milrinone-dependent heart failure, ventricular assistant device, heart transplant or death). LAS (both R wave and P wave references) and sRV-LS were measured using TomTec AutoStrain. To account for potential confounders, cases and controls were matched (1 cases vs 3 controls) by age ± 1 year and tricuspid regurgitation (TR) severity (none/mild vs. moderate/severe). Univariable conditional logistic regression was employed to assess the association between LAS and sRV-LS with outcomes among matched patients.

Results

Of 101 patients (64% male) with echocardiogram performed at 1.78 years old (IQR 0.02, 9.80), 14 (14%) developed an outcome. Baseline characteristics, LAS, and sRV-LS are depicted in Table 1. LAS and sRV-LS were not discriminative between age-matched cases and controls. In the matched cases and controls for TR severity, each unit-increase in LAS conduit phase (LAScd R and LAScd P) was associated with 18% and 22% higher odds of outcomes respectively, although these did not achieve statistical significance (LAScd R OR 1.2, 95% CI 1.0-1.4, p=0.09; LAScd P OR 1.2, 95% CI 1.0-1.5, p=0.08, Table 2).

Conclusions

After controlling for TR severity as a potential confounding factor, the conduit phase of LAS by both R wave and P wave references may have clinical implications as predictors of cardiovascular outcomes in patients with ccTGA. Larger and more well-powered studies are needed to further evaluate this association and studying longitudinal changes in LAS may provide insight in the development of outcomes in this population.
Outcomes of bariatric surgery in obese patients with heart failure:a meta-analysis
Authors: Ahmed H , Mahmoud Ismayl M I , Manvir Mangat M M , Anirudh Palicherla A P , Thomas Rees Checketts T K , Rama Ellauzi R E , Ahmed El-Shaer A E , Jalal Dufani J D , Ahmed Aboeata A A , Nandan Anavekar N A , Andrew Goldsweig A G
Published: October 2024

Background

Patients with heart failure possess an increased risk for adverse outcomes with noncardiac surgery (1). While bariatric surgery is frequently performed in patients with obesity, there remains a limited understanding of the impact of bariatric surgery in obese patients with heart failure.

Purpose

The purpose of this study was to compare outcomes of bariatric surgery versus nonsurgical management in obese patients with heart failure.

Methods

We searched PubMed, EMBASE, and the Cochrane Library, through February 2024, for studies evaluating outcomes in obese patients with heart failure who underwent bariatric surgery compared to nonsurgical management. Outcomes assessed were postoperative atrial fibrillation, all-cause mortality, and hospital readmission. We used a fixed-effect model to calculate hazard ratios (HR) with 95% confidence intervals (CI) in R studio for outcomes assessed. In outcomes where significant heterogeneity was found (P< 0.05 and I2 > 60%), a random effects model was used.

Results

A total of 3 studies were identified, consisting of 260,186 patients. Compared to nonsurgical management, bariatric surgery was associated with a significant reduction in postoperative atrial fibrillation (HR 0.72; 95% CI: 0.62-0.84), all-cause mortality (HR 0.50; 95%CI 0.35-0.72), and hospital readmission (HR 0.73; 95% CI 0.69-0.78) in obese patients with heart failure.

Conclusion

Our study suggests that bariatric surgery significantly reduces post-operative atrial fibrillation, mortality, and hospital readmission among obese patients with heart failure.Our findings demonstrate that bariatric surgery should be considered as a viable intervention in obese patients with heart failure. Further studies are warranted to confirm our findings.Forest Plots of Outcomes Assessed