Pro B-type Natriuretic Peptide Levels Research Articles

Utilizing synchronous care to improve cardiovascular and renal health among patients with type 2 diabetes: Proof-of-concept results from the DECIDE-CV clinical programme.

The management of patients with type 2 diabetes is asynchronous, i.e. not coordinated in time, resulting in delayed access to care and low use of guideline-directed medical therapy (GDMT). We retrospectively analysed consecutive patients assessed in the 'synchronized' DECIDE-CV clinic. In this outpatient clinic, patients with type 2 diabetes and cardiovascular or chronic kidney disease are simultaneously assessed by an endocrinologist, cardiologist and nephrologist in the same visit. The primary outcome was use of GDMT before and after the assessment in the clinic, including sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, renin-angiotensin system blockers and mineralocorticoid receptor antagonists. Secondary outcomes included the baseline-to-last-visit change in surrogate laboratory biomarkers. The first 232 patients evaluated in the clinic were included. The mean age was 67 ± 12 years, 69% were men and 92% had diabetes. In total, 73% of patients had atherosclerotic cardiovascular disease, 65% heart failure, 56% chronic kidney disease and 59% had a urinary albumin-to-creatinine ratio ≥30 mg/g. There was a significant increase in the use of GDMT:sodium-glucose cotransporter 2 inhibitors (from 44% to 87% of patients), glucagon-like peptide 1 receptor agonists (from 8% to 45%), renin-angiotensin system blockers (from 77% to 91%) and mineralocorticoid receptor antagonists (from 25% to 45%) (p < .01 for all). Among patients with paired laboratory data, glycated haemoglobin, urinary albumin-to-creatinine ratio and N-terminal proB-type natriuretic peptide levels significantly dropped from baseline (p < .05 for all). Joint assessment of patients with diabetes in a synchronized cardiometabolic clinic holds promise for enhancing GDMT use and has led to significant reductions in surrogate cardiovascular and renal laboratory biomarkers.

Improvement in Echocardiographic and Diagnostic Biomarkers after Systemic Glucocorticoid Therapy in Infants with Pulmonary Hypertension

To assess the effect of treating pulmonary hypertension (PH) in infants less than 1 year of age with systemic glucocorticoids while using echocardiographic and diagnostic biomarkers as measures of efficacy. A retrospective chart review was performed on 17 hospitalized infants less than one year of age at St. Louis Children's Hospital who received a five- to seven-day course of systemic glucocorticoid treatment followed by a three-week taper with no significant intracardiac shunts from January 1, 2017, to December 31, 2021. Quantitative echocardiographic indices for PH, N-terminal pro b-type natriuretic peptide (NT-proBNP) and/or b-type natriuretic peptide (BNP) levels were collected pre-glucocorticoid treatment, after the glucocorticoid burst, and following the 21-day taper. Mean (+/- SD) gestational age was 32.1 (+/-5.8) weeks, 5 infants were (29%) concomitantly treated with sildenafil, and 8 were male. Twelve were classified as World Health Organization (WHO) group 3 PH (71%), and 5 WHO group 1 PH. There were significant improvements 30 days post-glucocorticoid initiation in BNP levels (p=0.008), partial pressure of carbon dioxide (p=0.03), eccentricity index (p=0.005), RV ejection time (p=0.04), pulmonary artery acceleration time (PAAT) (p=0.002), and PAAT to right ventricular ejection time ratio (PAAT/RVET) (p=0.02). Tricuspid regurgitation velocity was not able to be assessed. There were no mortalities during the study timeline. In our retrospective study, systemic glucocorticoid therapy was well tolerated and appeared to be associated with significant improvement in cardio-pulmonary function in infants with PH. Further prospective study in a larger sample is warranted.

Bridging the STRONG Gap: Call to Optimize Heart Failure Treatment After Hospitalization in Women and Men in Taiwan

The benefits of rapidly up-titrating evidence-based treatments following heart failure (HF) hospitalizations were demonstrated in the STRONG-HF trial and emphasized in contemporary HF guideline. We aimed to assess up-titration patterns of guideline-directed medical treatments in Taiwanese HF population. Combining data from the TSOC-HFrEF registry and the TAROT-AHF study cohort, we formed the “Taiwan real-world cohort”. We compared these data with subgroups of patients with left ventricular ejection fraction ≤ 40% in the STRONG-HF trial. Patients in the Taiwan exhibited similar blood pressure, heart rate and N-terminal pro B-type natriuretic peptide levels at discharge compared to those in the STRONG-HF trial. A higher proportion of patients in the STRONG-HF high-intensity care group received up-titrations compared to those in the usual care group and the Taiwan cohort. Composite all-cause mortality or HF hospitalization at 180 days for patients in the high-intensity care group, usual care group, and Taiwan cohort were 17.4%, 23.7%, and 31.9%, respectively, with differences largely contributed by HF hospitalization (10.1%, 17.9%, and 27.6%, respectively), while all-cause mortality rates were similar (11.0%, 9.6%, and 9.3%, respectively). Gender did not affect this trend. In conclusion, our data highlights a treatment gap between the STRONG-HF trial and real-world practices in Taiwan, urging prompt optimization of HF therapy.

Validation of a Supportive and Palliative Care Indicator Tool Among Patients Hospitalized Due to Heart Failure

Palliative care, including symptom alleviation and advance-care planning, is relevant for patients with heart failure (HF). The Supportive and Palliative Care Indicator Tool (SPICT) is a tool for identifying patients who may benefit from palliative-care assistance but has not been validated in patients hospitalized due to HF. Clinical backgrounds, symptom burdens and outcomes were evaluated using the SPICT as assessed on admission in consecutive hospitalized patients with HF. SPICT-positive was defined when 2 or more general indicators and a New York Heart Association class ≥ III were present. Of 601 patients hospitalized due to HF (mean age: 79 ± 12 years; male, 314 [52%]; and mean left ventricular ejection fraction: 44 ± 18%), 100 (17%) patients were SPICT-positive. SPICT-positive patients were older (85 ± 9 vs 78 ± 12 years; P < 0.001) and had higher clinical frailty scales (6 ± 1 vs 4 ± 1 points; P < 0.001), whereas symptom burdens assessed by the Integrated Palliative care Outcome Scale were not different (17 [13, 28] vs 20 [11, 26] points; P = 0.97) when compared with patients who were SPICT-negative. During the median follow-up period of 518 days, 178 patients (30%) died. Being SPICT-positive was independently associated with higher all-cause mortality (hazard ratio: 3.49, 95% confidence interval: 2.41-5.05; P < 0.001) after adjusting for age, sex, New York Heart Association class IV, Get-With-The-Guideline risk score, N-terminal pro B-type natriuretic peptide levels, and left ventricular ejection fractions. In patients admitted for HF, being SPICT-positive was significantly associated with higher all-cause mortality rates, suggesting the utility of the SPICT as an indicator to initiate advance-care planning for end-of-life care among patients hospitalized due to HF.

Does black widow spider bite the heart?

BackgroundBlack widow spider (BWS) bites account for 0.5 % of global poisonings and 21 % of poisonings in North-East Iran. In addition to local reactions, systemic cardiovascular manifestations are likely to occur. ObjectiveThis study aims to present cases of patients who experienced cardiac symptoms after being envenomed by BWS. MethodsA descriptive retrospective cross-sectional evaluation was conducted on all patients who were bitten by a BWS in 2020 and presented with cardiac manifestations. They were referred to our tertiary pediatric cardiology center in Mashhad, Iran for evaluation. All accessible variables including history, physical examination, laboratory tests prioritizing cardiology, as well as electrocardiography and echocardiography findings, were evaluated. ResultSix patients, ranging in age from 5.5 to 13 years old, were bitten by BWS. None of the patients had a past or drug history and were admitted due to pain complaints at various bite sites that radiated in different directions. Four patients showed signs of tachycardia, and two showed hypertension, but no signs of infection were observed. Half of the patients experienced systemic complications. Upon arrival at the hospital, four patients showed elevated CKMB levels, which decreased during their hospitalization. Troponin I and N-Terminal Pro B-type Natriuretic Peptide levels were high in all patients. One patient with unstable hemodynamics showed pro-BNP over 35,000. T wave inversion was observed in six patients, ST segment depression in three patients, and ST-segment elevation in one patient, with overlap between them. ConclusionTaking notice of cardiovascular presentations after a BWS bite is considerable.

Gut permeability, circulating bacterial fragments and measures of congestion in peritoneal dialysis.

Limited data exist on the association between gut permeability, circulating bacterial fragment and volume overload in peritoneal dialysis (PD) patients. We measured circulating bacterial fragments, N-terminal pro B-type natriuretic peptide (NT-proBNP), calprotectin and zonulin levels, and evaluate their association with the clinical outcomes in PD patients. This was a single-center prospective study on 108 consecutive incident PD patients. Plasma endotoxin and bacterial DNA, and serum NT-proBNP, calprotectin and zonulin levels were measured. Primary outcomes were technique and patient survival, secondary outcomes were hospitalization data. There was no significant correlation between plasma endotoxin and bacterial DNA, and serum NT-proBNP, calprotectin and zonulin levels. The Homeostatic Model Assessment for Insulin Resistance (HOMA)-2β index, which represents insulin resistance, positively correlated with plasma bacterial DNA (r=0.421, P<.001) and calprotectin levels (r=0.362, P=.003), while serum NT-proBNP level correlated with the severity of volume overload and residual renal function. Serum NT-proBNP level was associated with technique survival even after adjusting for confounding factors [adjusted hazard ratio (aHR) 1.030, 95% confidence interval 1.009-1.051]. NT-proBNP level was also associated with patient survival by univariate analysis, but the association became insignificant after adjusting for confounding factors (aHR 1.010, P=.073). Similarly, NT-proBNP correlated with the number of hospitalizations and duration of hospitalization by univariate analysis, but the association became insignificant after adjusting for confounding factors. There was no correlation between markers of gut permeability, circulating bacterial fragments and measures of congestion in PD patients. Bacterial fragments levels and gut permeability are both associated with insulin resistance. Serum NT-proBNP level is associated with the severity of volume overload and technique survival. Further studies are required to delineate the mechanism of high circulating bacterial fragment levels in PD patients.

Recurrent Hospitalizations and Response to Vericiguat in Heart Failure and Reduced Ejection Fraction

BackgroundIn VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction), vericiguat compared with placebo reduced cardiovascular death or heart failure (HF) hospitalization in patients with HF with reduced ejection fraction. ObjectivesThis study explored the association between vericiguat and recurrent hospitalizations and subsequent mortality after HF hospitalization. MethodsThe treatment effect of vericiguat on the burden of HF hospitalizations was evaluated by assessing total HF hospitalization and cardiovascular death in the overall trial and based on baseline N-terminal pro–B-type natriuretic peptide levels with and without adjustment for VICTORIA model covariates (ie, baseline variables associated with the primary endpoint) assessed via the Andersen-Gill method. Associations between vericiguat and recurrent hospitalization and mortality adjusted for VICTORIA model covariates are reported. ResultsThere were 1,222 total HF hospitalizations and cardiovascular deaths among 2,526 patients in the vericiguat group and 1,336 total events among 2,524 patients in the placebo group (unadjusted HR: 0.89 [95% CI: 0.81-0.97] and adjusted HR: 0.92 [95% CI: 0.84-1.01]). In the subgroup with N-terminal pro–B-type natriuretic peptide levels ≤2,816 pg/mL (ie, Q1 and Q2; median or below), there was a suggestion of a benefit with vericiguat (adjusted HRs of 0.80 [95% CI: 0.64-1.01] and 0.77 [95% CI: 0.62-0.94], respectively) compared with those above this value (adjusted HRs of 1.12 [95% CI: 0.93-1.34] and 0.87 [95% CI: 0.74-1.04] for Q3 and Q4). There was no significant difference in treatment effect between patients with vs without an HF hospitalization. After HF hospitalization, the all-cause mortality rate (events per 100 patient-years) was 48.6 for vericiguat and 44.1 for placebo. ConclusionsAdditional investigation of the association between vericiguat and cardiovascular death and total HF hospitalizations by recurrent event analysis did not show a statistically significant reduction in events. Mortality was high after HF hospitalization, emphasizing the need for further therapies to reduce morbidity and mortality. (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction [VICTORIA]; NCT02861534)

Effects of SGLT2 inhibitors on cardiac function and health status in chronic heart failure: a systematic review and meta-analysis

PurposeNumerous clinical studies have explored sodium–glucose cotransporter 2 inhibitor (SGLT2i) in patients with chronic heart failure (CHF), with or without type 2 diabetes mellitus (T2DM), and SGLT2i were proved to significantly reduce CHF hospitalization, cardiovascular death, cardiovascular mortality, all-cause mortality and myocardial infarction in patients with or without T2DM. However, only a limited few have investigated the effects of SGLT-2i on HF disease-specific health status and cardiac function. This meta-analysis aims to assess the effects of SGLT2i on disease-specific health status and cardiac function in CHF patients.MethodsA comprehensive search was conducted of trials by searching in PubMed, EMBASE, CENTRAL, Scopus, and Web of Science, and two Chinese databases (CNKI and Wanfang), Clinical Trials (http://www.clinicaltrials.gov) were also searched.ResultsA total of 18 randomized controlled trials (RCTs) involving 23,953 participants were included in the meta-analysis. The effects of SGLT2 inhibitors were compared with control or placebo groups in CHF with or without T2DM. The SGLT2 inhibitors group exhibited a significant reduction in pro b-type natriuretic peptide (NT-proBNP) levels by 136.03 pg/ml (95% confidence interval [CI]: −253.36, − 18.70; P = 0.02). Additionally, a greater proportion of patients in the SGLT2 inhibitors group showed a ≥ 20% decrease in NT-proBNP (RR = 1.45, 95% CI [0.92, 2.29], p = 0.072). However, no statistically significant difference was observed for the effects on B-type natriuretic peptide (BNP). The use of SGLT-2 inhibitors led to a noteworthy improvement in LVEF by 2.79% (95% CI [0.18, 5.39];P = 0.036). In terms of health status, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance, SGLT2 inhibitors led to a significant improvement in KCCQ clinical summary (KCCQ-CS) score (WMD = 1.7, 95% CI [1.67, 1.73], P < 0.00001), KCCQ overall summary (KCCQ-OS) score (WMD = 1.73, 95% CI [0.94, 2.52], P < 0.00001), and KCCQ total symptom (KCCQ-TS) score (WMD = 2.88, 95% CI [1.7, 4.06], P < 0.00001). Furthermore, the occurrence of KCCQ-CS and KCCQ-OS score increases ≥ 5 points had relative risks (RR) of 1.25 (95% CI [1.11, 1.42], P < 0.00001) and 1.15 (95% CI [1.09, 1.22], P < 0.00001), respectively. Overall, SGLT2 inhibitors increased the 6-minute walk distance by 23.98 m (95% CI [8.34, 39.62]; P = 0.003) compared to control/placebo from baseline.ConclusionsThe SGLT2 inhibitors treatment offers an effective strategy for improving NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire scores and 6-minute walk distance in CHF with or without T2DM. These findings indicate that SGLT2i improve cardiac function and health status in CHF with or without T2DM, and provide valuable guidance for clinicians making treatment decisions for patients with CHF.

Simultaneous initiation of quadruple therapy for heart failure with reduced ejection fraction: initial experience in Afro Caribbean Jamaican population

Background: Among Afro Caribbean Jamaican patients with heart failure with reduced ejection fraction (HFrEF), improvements in cardiac function associated with simultaneous initiation of quadruple therapy, have not been previously reported and we aimed to assess this special population. Methods: Combined quadruple therapy (angiotensin-receptor neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, and Sodium-glucose cotransporter-2 inhibitors) was simultaneously initiated in 120 Afro Jamaican patients with HFrEF from the Heart Institute of the Caribbean. Patient data was consecutively recorded in our electronic medical records. Changes in Ejection fraction (EF) and N-terminal pro b-type natriuretic peptide (NT-ProBNP) levels, were evaluated after 90 days and statistically analysed during this two-year study. Results: Patient mean age was 63 ± 12.7 years old, 68% male, with mean Body Mass index (BMI) 32.2±6.7 Kg/m2. Hypertension was observed in 62.5 %, T2Diabetes Mellitus in 31.7%, and history of old myocardial infarction in 15.7 %. Atrial fibrillation was present in 7.8% and left bundle branch block in 16.5 %. Other cardiomyopathies (idiopathic, peripartum and non-compaction) were noted in 16.6 %. After the quadruple therapy for a median follow-up period of 90 days, significant improvements of cardiac function were achieved. The mean NT pro-BNP level was significantly decreased from a Baseline of 3111.21 pg/mL ± 4535 to 1806.6 ± 2265.3 pg/ml. A mean change in NT Pro BNP of 1305 pg/mL ± 5069 (p &lt; 0.001). The mean left ventricle ejection fraction (LVEF) improved from a baseline of 33.4 % ± 7.8 to 44.4 % ± 10.9. A mean change in LVEF of 11.3% ± 9.1 (p &lt;0.001). Notably, an improvement of &gt;10% in the LVEF was observed in 41.5% of the total population. In a separate analysis, the subgroup with T2 Diabetes mellitus showed more pronounced (mean change in EF 9.1% ± 11.0) improvement in LVEF than the non-diabetic (mean change in EF 7.7% ± 11.7) but no significant differences in the change of the NT pro-BNP levels were noted between both subgroups. The most frequent therapy adverse effect was hypotension (13.63%) followed by cough (6.81%) and kidney dysfunction (2.27%) but none of the patients presented Angioedema. Conclusion: Among Afro Caribbean Jamaican patients with heart failure and reduced ejection fraction, simultaneous initiation of the quadruple therapy was demonstrated to be feasible, well tolerated and associated with significant functional improvement.

Clinical Study on Self-Made Lixin Granules Combined with Natriuretic Peptide in the Treatment of Refractory Heart Failure

Objective: To analyze the clinical effects of the combined application of self-made Lixin Granule and natriuretic peptide in treating refractory heart failure. Methods: From January 2022 to June 2023, 40 patients with refractory heart failure were randomly divided into groups using the envelope method. A reference group (n = 20) received conventional Western medicine treatment, while an observation group (n = 20) received self-made Lixin Granules and natriuretic peptide. Clinical efficacy, heart failure scores, traditional Chinese medicine (TCM syndrome scores, inspection indicators, and adverse reactions of the two groups were compared. Results: The effective treatment rate in the observation group was significantly higher than that in the reference group (P &lt; 0.05). There were no significant differences in heart failure scores and traditional Chinese medicine (TCM) syndrome scores between the two groups before treatment (P &gt; 0.05). However, both scores in the observation group were lower than those in the reference group after treatment (P &lt; 0.05). Before treatment, there were no significant differences in the inspection indicators between the two groups (P &gt; 0.05). After treatment, the left ventricular ejection fraction (LVEF) of the observation group was higher than that of the reference group, while the N-terminal pro b-type natriuretic peptide (NT-proBNP) level and fractional shortening (FS) of the observation group were lower than those of the reference group (P &lt; 0.05). There were no apparent adverse reactions in either group during treatment. Conclusion: The combined application of self-made Lixin Granules and natriuretic peptide in treating refractory heart failure improved clinical efficacy, alleviation of clinical symptoms, and enhanced cardiac function. This approach is deemed safe and holds high application value.

Laboratory Predictors of Mortality in Patients with Heart Failure and Reduced Left Ventricular Ejection Fraction

Introduction. Heart failure (HF) is a growing epidemic with high morbidity and mortality rates. In general, mortality in patients with HF is 10.4% after 30 days from admission, 22% after 1 year, and 42.3% after 5 years, despite the introduction of new evidence-based drug therapy and advance in surgical interventions. There is a range of predictors/ factors that need to be addressed to reduce the risk of mortality and to assess prognosis in patients with heart failure and reduced left ventricular ejection fraction.&#x0D; The aim. To determine the laboratory factors predicting 2-year mortality in patients with coronary artery disease and heart failure and reduced left ventricular ejection fraction after percutaneous coronary intervention (PCI) by analysis of basic patient data.&#x0D; Materials and methods. This one-center analysis, conducted at the Ukrainian Children’s Cardiac Center, Clinic for Adults, included 178 patients who had chronic stable coronary artery disease with heart failure and reduced left ventricular ejection fraction, who underwent PCI in the period between January 2020 and January 2022. The endpoint of our study was all-cause mortality. The studied group of patients was divided into two subgroups: S (“survival”) with patients who survived during the observation period after PCI, and D (“death”) including patients who died before the end of this observation period after the PCI. A p-value of less than 0.05 was considered statistically significant.&#x0D; Results. The mean length of hospital stay was 3 (1-5) days. Total bilirubin, total cholesterol, sodium, N-terminal pro B-type natriuretic peptide (NT-proBNP) level, hemoglobin, albumin and lymphocytes were significantly different in the two subgroups. In the multivariate model, the strongest independent predictors of patient mortality were: elevated NT-proBNP (adjusted hazard ratio [HR] for one standard deviation 1.44, 95% confidence interval [CI] 1.32 to 1.57, p&lt;0.0001), low albumin (HR 1.64, 95% CI 1.10 to 2.23, p=0.008), hyponatremia (HR 1.69, 95% CI 1.16 to 2.22, p&lt;0.001), lymphopenia (HR 1.54, 95% CI 1.10 to 2.20, р&lt;0.001, decreased hemoglobin level (HR 1.25, 95% CI 1.10 to 1.40, p&lt;0.001) and low cholesterol (HR 1.59, 95% CI 1.17 to 2.01, p&lt;0.001).&#x0D; Conclusion. In a population of patients with chronic stable coronary artery disease after myocardial revascularization with PCI, a decrease in the level of albumin, cholesterol, sodium, lymphocytes, hemoglobin, as well as an increase in the level of NT-proBNP were prognostic and statistically significant predictors of unfavorable prognosis in the form of all-cause mortality during 2 years of observation.

Circulating apelin, IL22RA2 and VEGF in pre-capillary pulmonary hypertension.

Cytokines can modulate vascular remodelling and the adaptation of the right ventricle in pre-capillary pulmonary hypertension (PH). However, detailed data on the circulating levels of cytokines in patients are limited. We measured blood cytokine concentration in 39 treatment-naïve patients (pulmonary arterial hypertension: N = 16, chronic thromboembolic PH: N = 15, PH due to lung disease: N = 8) and 12 control subjects using enzyme-linked immunoassays. Apelin concentration >1,261 ng/mL identified patients with PH (66% sensitivity and 82% specificity), and in patients it was related to systolic pulmonary arterial pressure (PAP) (r = 0.33, P = 0.04), right atrial pressure (r = 0.38, P = 0.02), cardiac index (r=-0.34, P = 0.04), and right ventricular stroke work index (r = -0.47, P = 0.003). IL22RA2 concentration correlated with mean PAP (r = -0.32, P = 0.04) and serum N-terminal pro B-type natriuretic peptide level (r = -0.42, P = 0.01). VEGF concentration increased in patients upon clinical improvement (N = 16, P = 0.02). Circulating apelin is a novel biomarker of pre-capillary PH. Apelin and IL22RA2 levels are related to right ventricular function upon diagnosis of PH.

Sex differences in clinical characteristics and long-term outcome in patients with heart failure: data from the KorAHF registry.

Sex differences in the prognosis of heart failure (HF) have yielded inconsistent results, and data from Asian populations are even rare. This study aimed to investigate sex differences in clinical characteristics and long-term prognosis among Korean patients with HF. A total of 5,625 Korean patients hospitalized for acute HF were analyzed using a prospective multi-center registry database. Baseline clinical characteristics and long-term outcomes including HF readmission and death were compared between sexes. Women were older than men and had worse symptoms with higher N-terminal pro B-type natriuretic peptide levels. Women had a significantly higher proportion of HF with preserved ejection fraction (HFpEF). There were no significant differences in in-hospital mortality and rate of guideline-directed medical therapies in men and women. During median follow- up of 3.4 years, cardiovascular death (adjusted hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.07-1.78; p = 0.014), and composite outcomes of death and HF readmission (adjusted HR, 1.13; 95% CI, 1.01-1.27; p = 0.030) were significantly higher in men than women. When evaluating heart failure with reduced ejection fraction (HFrEF) and HFpEF separately, men were an independent risk factor of cardiovascular death in patients with HFrEF. Clinical outcome was not different between sexes in HFpEF. In the Korean multi-center registry, despite having better clinical characteristics, men exhibited a higher risk of all-cause mortality and readmission for HF. The main cause of these disparities was the higher cardiovascular mortality rate observed in men compared to women with HFrEF.

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes

BackgroundSeveral orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. ObjectivesThis study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. MethodsThe TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. ResultsForty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro–B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. ConclusionsCaval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study – Safety and Efficacy of the TricValve® Device; NCT03723239)

Effect of Frailty on the Long-Term Prognosis of Elderly Patients with Acute Myocardial Infarction.

To investigate the effect of frailty on the long-term prognosis of elderly patients with acute myocardial infarction (AMI). The data of 238 AMI patients (aged ≥75 years) were retrospectively reviewed. They were divided into two groups according to the Modified Frailty Index (mFI): frailty group (mFI≥0.27, n=143) and non-frailty group (mFI<0.27, n=95). The major adverse cardiovascular and cerebrovascular events (MACEs) and Kaplan-Meier survival curves of the two groups were compared. Multivariate Cox regression analysis was used to identify the risk factors for MACEs. The frailty group showed a significantly older age as well as a higher N-terminal proB-type natriuretic peptide level, Global Registry of Acute Coronary Events score, and CRUSADE bleeding score compared with the non-frailty group (P<0.05). A significantly greater proportion of patients with combined heart failure, atrial fibrillation, comorbidity, and activities of daily living score of <60 was also observed in the frailty group compared with the non-frailty group (P<0.05). At 36 months after AMI, the frailty group vs the non-frailty group showed a significantly poorer survival (log-rank P=0.005), higher incidence of MACEs (50.35 vs 29.47, P=0.001), higher overall mortality rate (20.98% vs 7.37%, P=0.006), higher 30-day mortality rate (13.99% vs 5.26%, P=0.033), higher major bleeding rate (14.69% vs 5.26, P=0.018), and lower repeat revascularization rate (2.10% vs 8.42%, P=0.03). Frailty, type 2 diabetes, and N-terminal proB-type natriuretic peptide ≥1800 pg/mL were independent risk factors for MACEs. Frailty is an independent risk factor affecting the long-term prognosis of elderly patients with AMI.

Long-term effects of mavacamten treatment in obstructive hypertrophic cardiomyopathy (HCM): updated cumulative analysis of the EXPLORER cohort of MAVA-long-term extension (LTE) study up to 120 weeks

Abstract Introduction Mavacamten was efficacious and well tolerated in patients (pts) with obstructive HCM over a median follow-up of 62 weeks in a previous interim analysis of the ongoing MAVA-LTE study (NCT03723655) (data cut-off; August 31, 2021). Here, we report an updated cumulative analysis of the EXPLORER cohort of MAVA-LTE up to 120 weeks. Methods Pts who completed EXPLORER-HCM (NCT03470545) could enroll in MAVA-LTE. All pts initiated the study with mavacamten 5 mg/day per protocol; dose adjustments to 2.5, 10, or 15 mg were based on site-read Valsalva left ventricular outflow tract (LVOT) gradient and LV ejection fraction (LVEF). Results In total, 231 pts (median age, 61 years; 39% female) enrolled in the EXPLORER cohort of MAVA-LTE. Median time on study was 101 weeks at data cut-off (May 31, 2022) with variations due to differences in enrollment timing. At data cut-off, 215 pts remained on treatment (total adjusted exposure: 475 pt-years). Mavacamten dosing of pts who reached week 120 (n=80) was: 2.5 mg (27.5%); 5 mg (31.3%); 10 mg (26.3%); 15 mg (12.5%). Between weeks 48–120, 34 of 231 (14.7%) pts underwent dose adjustments. Mavacamten treatment showed sustained improvements in mean [SD] change from baseline to week 120 in LVOT gradients (resting, −35.3 [33.0] mmHg; Valsalva, −47.0 [37.3] mmHg), left atrial volume index (−8.5 [10.3] mL/m2) and E/e’ average (−3.9 [5.0]) (Table). At week 120, 83.5% of pts had a Valsalva LVOT gradient ≤30 mmHg. Mavacamten was associated with sustained reduction from baseline to week 120 in N-terminal pro B-type natriuretic peptide (NT-proBNP) level (Table); 75.9% of pts improved by ≥1 class New York Heart Association class (Figure). Mean (SD) LVEF decreased by 9.1% (7.1) from baseline to week 120 but remained in the normal range. Since the previous interim analysis (data cut-off: August 31, 2021), 1 additional transient reduction in LVEF &amp;lt;50% occurred resulting in temporary treatment interruption (a total of 13 pts [5.6%] experienced LVEF &amp;lt;50% from study initiation). The pt resumed treatment at a lower dose 4 weeks after the event. In total, 74 serious adverse events (SAE) were reported in 47 pts (20.3%), with 18 new SAEs and 13 additional pts (5.6%) with SAEs since the previous interim analysis, including 1 new SAE (atrial fibrillation) considered drug related. No new safety signals were identified. One additional death (leading to a total of 4) occurred, due to intracranial hemorrhage. Like the previous 3 deaths (due to acute myocardial infarction, cardiac arrest, and bacterial endocarditis) the event was considered unrelated to the study drug. Conclusions Long-term mavacamten treatment up to 120 weeks showed sustained improvements in LVOT obstruction, symptoms, and NT-proBNP levels in pts with symptomatic obstructive HCM consistent with the findings of the parent study. Mavacamten treatment continues to be well tolerated with no new safety signals observed.

Changes in standard of care (SOC) medication during long-term mavacamten treatment for obstructive hypertrophic cardiomyopathy (HCM): results from the EXPLORER cohort of MAVA-Long-Term Extension (LTE)

Abstract Introduction Mavacamten is efficacious and well tolerated in patients with obstructive HCM in the ongoing MAVA-LTE study (NCT03723655) as shown in previous interim analyses. Here, we present exploratory data from the EXPLORER cohort of MAVA-LTE investigating the effect of changes in SOC treatment on the efficacy and safety of mavacamten. Methods Patients who completed EXPLORER-HCM (NCT03470545) could enroll in MAVA-LTE and comprised the EXPLORER cohort. All patients in the EXPLORER cohort received mavacamten. Patients could receive beta blockers or nondihydropyridine calcium channel blockers (verapamil/diltiazem) as SOC treatment. After 24 weeks on study, SOC treatment could be adjusted. A cumulative interim analysis (data cut-off: May 31, 2022) was performed on patients who: received no SOC, discontinued SOC, had any reduction in SOC and had ≥50% reduction in SOC from baseline to data cut-off. Results In total, 231 patients (mean age, 60 years; 39% female) comprised the EXPLORER-LTE cohort (median time on study: 101 weeks at data cut-off). At baseline, 176 patients (76.2%) received beta blockers and 38 (16.5%) received nondihydropyridine calcium channel blockers. At data cut-off, 12 (5.2%) patients had received no SOC treatment from baseline, 11 (4.8%) patients had discontinued SOC, 27 (11.7%) patients had any dose reduction in SOC, 18 (7.8%) patients had a ≥50% reduction in SOC and 14 (6.1%) patients had an increase in SOC. In the no SOC subgroup, mavacamten treatment was associated with improvements from baseline to last visit in resting and Valsalva left ventricular outflow tract (LVOT) gradients, left atrial volume index (LAVI), and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels (Table 1). Improvements in these parameters were also observed in the SOC discontinuation and SOC dose reduction subgroups (Table 1). In the SOC discontinuation subgroup, improvements in resting and Valsalva LVOT gradients, LAVI, and NT-proBNP levels from baseline were maintained after SOC discontinuation (Table 1). SOC medications were discontinued or reduced over a mean (range) period of 63 (9–96) and 62 (3–133) weeks, respectively. At data cut-off, left ventricular ejection fraction remained within the normal range for all patients regardless of the SOC subgroup. Patients who reduced SOC medication had small increases in heart rate (within normal range) from baseline to last visit (Table 2). Overall, blood pressure remained stable across subgroups throughout the observation period (Table 2). No patients experienced worsening of NYHA class from baseline to last visit or from withdrawal to last visit. Conclusions Beneficial and sustained effects on LVOT obstruction, NT-proBNP levels and symptoms in patients with symptomatic obstructive HCM were observed with long-term mavacamten treatment alone or after SOC discontinuation or dose reduction.

Effects of dapagliflozin in heart failure with preserved ejection fraction and chronic obstructive pulmonary disease: an analysis of the DELIVER trial

Abstract Introduction Chronic obstructive pulmonary disease (COPD) is a common comorbidity in heart failure (HF) with preserved ejection fraction (HFpEF) and associated with worse outcomes. Purpose We investigated the relationship between COPD status and outcomes, and the efficacy of dapagliflozin, compared with placebo, according to COPD status in patients with heart failure (HF) with preserved ejection fraction (HFpEF) randomized in DELIVER. Methods A total of 6,263 patients with HF with New York Heart Association functional class II-IV, left ventricular ejection fraction &amp;gt;40%, evidence of structural heart disease, and elevated N-terminal pro–B-type natriuretic peptide levels were randomized to dapagliflozin or placebo. Clinical outcomes and the effect of dapagliflozin, according to COPD status at baseline, were examined. The primary outcome was a composite of cardiovascular death or worsening HF. Results Of the 6,261 patients with data on baseline COPD, 692 (11.1%) had a history of COPD. Compared with patients without COPD, those with COPD were older, more often men and current smokers, and they had a higher BMI, but lower systolic blood pressure. Patients with COPD also had a longer duration of HF, a higher rate of prior HF hospitalization, higher NT-proBNP, and worse NYHA functional class and KCCQ-TSS. The risk of the primary endpoint was higher in patients with COPD compared with those without COPD (adjusted HR: 1.29 (95% CI: 1.09-1.52). The benefit of dapagliflozin on the primary outcome was consistent irrespective of COPD status: no COPD, HR: 0.82 (95% CI: 0.72-0.93); COPD, HR: 0.84 (95% CI: 0.63-1.12) (Pinteraction = 0.92). Consistent effects were observed for HF hospitalization, cardiovascular death, and all-cause mortality (Table). Dapagliflozin, as compared with placebo, increased (improved) the KCCQ-TSS from baseline to 8 months to a similar extent in patients with and without COPD (Pinteraction = 0.75) (Table). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of COPD status. Conclusions COPD is common in patients with HFpEF and associated with worse outcomes. Dapagliflozin reduced the risk of worsening HF or cardiovascular death, and improved symptoms, similarly in patients with and without COPD. In addition, dapagliflozin was safe and well-tolerated, irrespective of COPD status.

Mavacamten for Obstructive Hypertrophic Cardiomyopathy With or Without Hypertension: Post-Hoc Analysis of the EXPLORER-HCM Trial

BackgroundHypertension (HTN) is common in patients with hypertrophic cardiomyopathy (HCM), but its effect on the treatment of left ventricular outflow tract (LVOT) obstruction is undefined. Although elevated systolic blood pressure (SBP) may impact dynamic LVOT gradients, its response to cardiac myosin inhibition is unknown. ObjectivesIn a post hoc exploratory analysis of the EXPLORER-HCM trial (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy), the authors examined the characteristics of patients with obstructive HCM and HTN and the associations between HTN, SBP, and the response to mavacamten treatment of LVOT obstruction. MethodsPatients were stratified by baseline history of HTN and mean SBP during 30-week treatment with mavacamten or placebo. The study estimated treatment differences and evaluated HTN and SBP groups by treatment interaction. Analysis of covariance was used to model changes in continuous endpoints, and a generalized linear model was used for binary endpoints. ResultsHTN was present in 119 of 251 patients (47.4%), including 60 receiving mavacamten and 59 receiving placebo. Patients with HTN vs no HTN were older (63.4 vs 54.0 years; P < 0.001), had higher SBP (134 ± 15.1 mm Hg vs 123 ± 13.8 mm Hg; P < 0.001), more comorbidities, and lower peak oxygen consumption (19 ± 3 vs 20 ± 4 mL/kg/min; P = 0.021). Patients with HTN had similar NYHA functional class (NYHA functional class II, 72% vs 73%), Valsalva LVOT gradients (72 ± 34 mm Hg vs 74 ± 30 mm Hg), Kansas City Cardiomyopathy Questionnaire–Clinical Summary Scores (70.6 ± 18.8 vs 68.9 ± 23.1), and NT pro–B-type natriuretic peptide levels (geometric mean 632 ± 129 pg/mL vs 745 ± 130 pg/mL). Mavacamten-treated patients had improvement in all primary, secondary, and exploratory endpoints regardless of HTN status or mean SBP. ConclusionsThe clinical benefits of mavacamten in symptomatic, obstructive HCM were similar in patients with and without HTN, despite differences in baseline characteristics. (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy [EXPLORER-HCM]; NCT03470545)

The relationship between serum pro-B type natriuretic peptide level and bone mineral density in peritoneal dialysis patients.

We aimed to evaluate the relationship between serum N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) and lumbar bone mineral density (BMD) in peritoneal dialysis (PD) patients. Fasting blood samples were obtained from 46 PD patients. BMD was measured by dual-energy X-ray absorptiometry of the lumbar vertebrae (L1-L4). Circulating serum NT-pro-BNP levels were measured using commercial kits compatible with the Roche Cobas e 601 immunoassay device. Forty-six patients were included in our study. Increased age, low body mass index (BMI), and high-serum NT-pro-BNP are significantly associated with decreased BMD. The results show a statistically positive correlation between lumbar T-score values and BMI (r = 0.456; P = .001), while lumbar T-score values and PTH (rho = -0.336; P = .022) and log-NT-pro-BNP. There is a statistically negative correlation between BNP (rho = -0.355; P = .015). The lumbar T-score value decreases by 0.800 units when log-NT-pro-BNP increases by 1 unit and increases by 0.323 units when BMI increases by 1 unit. The established model is statistically significant (F = 6.190; P < .001). Our study in PD patients showed that serum NT-pro-BNP level was negatively correlated and BMI was positively correlated with lumbar BMD.