Heart Failure NYHA Class Research Articles

Interatrial block and abnormal P-wave electrocardiographic parameters as non-invasive predictors of atrial fibrillation

Aim. To identify noninvasive markers of atrial electrical dysfunction and risk of nonvalvular atrial fibrillation (AF) and to develop a predictive mathematical model to estimate the AF risk based on electrocardiographic (ECG) P-wave parameters during sinus rhythm.Methods. The study included 211 patients with cardiovascular pathology (aged median 62 [52; 71] years, 67.8% male, NYHA heart failure class I-III). All patients (follow-up median 45 [26; 67] months) underwent a complex of studies: 12-lead ECG, echocardiography, 24-hour ECG monitoring. Based on surface ECG data during sinus rhythm, parameters of atrial electrical activation were assessed such as Morphology, Voltage and P waves duration (MVP) according to integral analysis by MVP score.Results. During 3.7-year period, 44 (20.8%) patients experienced new-onset sustained AF and 12 (5.69%) patients developed ischemic stroke. As a result of ROC analysis and univariate Cox regression, independent predictors of AF were identified: P-wave prolongation in the DII lead, 3rd degree or advanced interatrial block (aIAB), an increase P-wave terminal force in lead V1 (PTFV1), low-voltage P-wave in the DI lead and сalculated level of abnormal P-wave ≥3 points on the MVP score. Data from multivariate Cox proportional hazards regression analysis confirmed the prognostic significance for three independent predictors of AF: aIAB (hazard ratio (HR) 5.92; 95% confidence interval (CI) [2.48-4.12]; p=0.0001); PTFV1 (HR 1.14; 95% CI [1.04-1.24], p=0.003); low-voltage P-wave in lead DI <0.1 mV (HR 1.03; 95% CI [1.02-1.05]; p=0.0001); and as a result a mathematical model was created to predict AF risk (-2LL =258; χ2=105; p=0.0001). Predictors such as PTFV1 (HR 1.41; 95% CI [1.17-1.72], p=0.0001) and MVP score of abnormal P-waves (HR 1.85; 95% CI [1.27-1.72] 2.70], p=0.001) were associated with a high risk of stroke according to Cox regression model (-2LL= 62.5; χ2=38.4; p <0.001).Conclusion. Complex of ECG markers of atrial electrical dysfunction such as aIAB, PTFV1, level MVP score of abnormal P-wave and low P-wave voltage allows identifying patients at high risk of AF and ischemic stroke.

Vasopressin-mediated water conservation overrides the osmotic-diuretic effect of glucosuria during SGLT2 inhibition in patients with chronic heart failure (DAPA-Shuttle1: a mechanistic placebo-controlled, randomized trial)

Background: SGLT2 inhibitors may improve cardiac outcomes due to their osmotic-diureticpotential. We prospectively tested the hypothesis that vasopressin-driven urine concentration overrides the osmotic-diuretic driving force of dapagliflozin-induced glucosuria.Methods: DAPA-Shuttle1 was an investigator-initiated, mechanistic, single-center, randomized controlled trial at the National Heart Centre, Singapore. Eligible participants with heart failure NYHA classes I/II and reduced ejection fraction were randomly assigned to receive dapagliflozin 10mg daily or placebo (1:1) for 4 weeks. Participants, investigators, and study personnel were masked to assignment throughout the trial. The primary endpoint was change from baseline in urine osmolyte concentration. Secondary endpoints included changes in copeptin levels, solute free water clearance (FWC), and tissue Na+ content.Results: Between November 2019 and September 2021 forty participants were enrolled. Thirty three randomized, SGLT2 inhibitors naïve participants started the treatment intervention and completed the study, of which (placebo: n=14; dapagliflozin: n=15) provided accurate 24h urine collections (mean age 59±14 years, LVEF 31±9%). Dapagliflozin treatment increased glucosuria by 3.3 mmol/kg/d ([95%CI 2.51,4.04], p<0.0001) within 48h (early); this effect persisted after 4 weeks (late; 2.7 mmol/kg/d [95%CI 1.98,3.5], p<0.0001). Dapagliflozin treatment neither increased natriuresis (early: P=0.68; late: P=0.64), nor changed tissue Na+ content (early: P=0.62; late: P=0.90). Despite sustained glucosuria, urine volume did not significantly increase with dapagliflozin (mean difference early: +2.8 ml/kg/d [95%CI -1.97,7.48], P=0.25; late: +0.9ml/kg/d [95%CI -3.83,5.62], P=0.70). Dapagliflozin treatment increased plasma copeptin early (+5.5 pmol/L [95%CI 0.45,10.5], p<0.05) and late (+7.8 pmol/L [95%CI 2.77,12.81], p<0.01), leading to proportional reductions in FWC (early: -9.1 ml/kg/d [95%CI -14, -4.12], p<0.001; late: -11.0 ml/kg [95%CI -15.94, -6.07], p<0.0001) and increases in urine concentration (late: +134 mmol/L [95%CI 39.28, 229.12], p<0.01). This physiological-adaptive water conservation mechanism prevented a glucose-driven increase 70 in urine volume of approximately ≍10 ml/kg/d · 75 kg = 750 ml/d.Conclusions: SGLT2 inhibition with dapagliflozin caused relevant glucosuria, but adaptive physiological, vasopressin-driven water conservation virtually eliminated the expected osmotic diuretic potential of the drug. Therefore, the presented mechanistic-experimental evidence does not support the hypothesis that the beneficial effects of SGLT2 inhibitors in patients with heart failure are attributable to chronic cardiac decongestion. The DAPA-Shuttle1 study was an investigator-initiated trial funded by Astra Zeneca via the Externally sponsored scientific research program (ESR-18-13712). This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

SIMPLIFID LUNG ULTRASOUND IN DIAGNOSIS OF HEART FAILURE WITH PRESERVED EJECTION FRACTION IN ARTERIAL HYPERTENSION

Objective: About 30% of patients with heart failure (HF) have normal Ejection Fraction (HFpEF). Pulmonary congestion is useful marker of HFpEF. The aim of this study was to determine the efficacy of ultrasound in patients with DHF. Design and method: We studied 250 patients with Arterial Hypertension and III-IV NYHA class HF from which 70 patients had HFpEF (group 1) and 100 patients Left Ventricular Diastolic Dysfunction but without signs of HF (control, group 2). All participants undergone standard Echo Cardiography. Sonographic evaluation of a lung was done in horizontal or vertical positions of patient, from 10 points of thoracic wall (5 points from each side), which corresponded to the projection of lower, middle and upper lobes of a right lung and upper and lower lobes of left lung. Results: In patients with HFpEF we significantly often found multiple (3 or more) B-lines or Comet tail Phenomenon (CTPh), which was registered in 91.1%. In 40.0% of control group patients, we also registered B-lines, but the count of them was less than 3 lines per each registration point (the difference between control an HF groups was significant). The count of points from where the CTPh was registered was 6.8 in HFpEF gr. and 0.7 in control. The B-lines were registered from 3 or more points of thoracic wall in 82.86% of patients of I gr and only 5% in II gr participants. In HF groups CTPh was prominent and multiple while in the control group it was single and short lasting, like lightening. There was good correlation between the count of B-line registration points from the thoracic wall and the heart failure NYHA class (r=0.56), left ventricular systolic (r=0.40) and diastolic (r=0.32) diameters and negative MAPS and TAPS (r=-0.42 and 0.41 respectively). Conclusions: Thoracic US is a sensitive and accurate method for evaluation pulmonary congestion in patients with AH and HFpEF. The US sign of pulmonary congestion in HF are B-lines or Comet tail phenomenon, which is protracted, prominent, multiple and registered from larger area of thoracic wall (3 points or more).

Point-of-care N-terminal pro-brain natriuretic peptide testing in patients with heart failure: data from the DREAM study

Aim. To compare the blood levels of N-terminal pro-brain natriuretic peptide (NTproBNP), determined using a Russian semi-quantitative point-of-care test and quantitative laboratory tests, depending on the presence and severity of heart failure (HF) and left ventricular (LV) function.Material and methods. This Diagnosis of chRonic hEart fAilure using a NTproBNP test Multicenter study (DREAM) was conducted in 79 patients with HF and 24 healthy individuals. Blood NT-proBNP concentrations assessed using an immunochromatographic semiquantitative rapid test were compared with quantitative laboratory test results, severity of heart failure, and LV function.Results. The study showed that the NT-proBNP rapid test results were highly correlated (correlation coefficient 0,74) with the quantitative test. The NT-proBNP level assessed by the rapid test increases in patients with higher NYHA HF class and does not differ significantly from the quantitative test grades. The sensitivity, specificity, positive predictive value, and negative predictive value of the test result relative to natriuretic peptide quantification were 0,97, 0,78, 0,91, and 0,93, respectively. Sensitivity, specificity, positive and negative predictive value of the test result regarding NYHA classes II-IV were 0,95, 0,85, 0,95 and 0,85, and regarding LV ejection fraction <50% — 1,0, 0,24, 0,24, and 1,0, respectively. False-positive rate in the healthy individuals' group were low (4%).Conclusion. The results of the NT-proBNP rapid test demonstrated acceptable diagnostic accuracy compared to quantitative assessment in patients with HF of varying severity and LV ejection fraction.

Consensus Guidelines of Irreversible Electroporation for Pancreatic Tumors: Protocol Standardization Using the Modified Delphi Technique.

Since no uniform treatment protocol for pancreatic irreversible electroporation (IRE) exists, the heterogeneity throughout literature complicates the comparison of results. To reach agreement among experts, a consensus study was performed. Eleven experts, recruited according to predefined criteria regarding previous IRE publications, participated anonymously in three rounds of questionnaires according to a modified Delphi technique. Consensus was defined as having reached ≥80% agreement. Response rates were 100, 64, and 64% in rounds 1 to 3, respectively; consensus was reached in 93%. Pancreatic IRE should be considered for stage III pancreatic cancer and inoperable recurrent disease after previous local treatment. Absolute contraindications are ventricular arrhythmias, implantable stimulation devices, congestive heart failure NYHA class 4, and severe ascites. The inter-electrode distance should be 10 to 20 mm and the exposure length should be 15 mm. After 10 test pulses, 90 treatment pulses of 1,500 V/cm should be delivered continuously, with a 90-µs pulse length. The first postprocedural contrast-enhanced computed tomography should take place 1 month post-IRE, and then every 3 months. This article provides expert recommendations regarding patient selection, procedure, and follow-up for IRE treatment in pancreatic malignancies through a modified Delphi consensus study. Future studies should define the maximum tumor diameter, response evaluation criteria, and the optimal number of preoperative FOLFIRINOX cycles.

Body composition and functional activity in men with heart failure

Aim. To assess the body composition and functional activity (FA) parameters in men with heart failure (HF) of various nature depending on the stage, class and echocardiographic characteristics of the disease.Material and methods. The study included 100 men aged 23-70 years. The main group consisted of 60 men with HF, the control group — 40 men without HF. Quantitative body composition assessment (fat, lean and bone body mass) was carried out using dual-energy X-ray absorptiometry (DXA). Physical activity was assessed using handgrip test, short physical performance battery (SPPB) test, 6-minute walk test (6MWT), and Timed Up and Go (TUG) test.Results. In the HF group, there were a significant decrease in total bone mass, trunk and limb bone mass, total muscle mass, trunk and limbs’ muscle mass, appendicular skeletal muscle index (ASMI), and FA as HF class increased. Fat mass did not differ in individuals with different HF class and stage. HF class was an independent factor in the reduction of total bone mass (b=-301,9, p=0,015), total muscle mass (b=-1903, p=0,03), limb bone mass (b=-147,6, p=0,013) and appendicular muscle mass (AMM) (b=-1903, p=0,001). Total bone mass (b=-2,637, p=0,02) and AMM (b=-3,512, p=0,01) were independently associated with the Vasilenko-Strazhesko HF stage. AMM also had an independent association with left ventricular ejection fraction (LVEF) (b=0,274, p=0,03). The average body composition scores did not differ between the study and control groups, while the scores of handgrip test, 6MWT, SPPB and TUG test were significantly worse in the HF group. NYHA HF class, stage of HF, LVEF, left ventricular end-diastolic volume (LVEDV) and pulmonary artery systolic pressure (PASP) made an independent contribution to FA decrease in men with HF.Conclusion. In patients with HF, there was deterioration in musculoskeletal parameters depending on HF class, stage and LVEF, without significant differences compared to the control group. There was no association of fat mass with the disease, clinical and echocardiographic characteristics. The average parameters of muscle strength and tests of FA were reduced in men with HF compared with the control group and depended on the NYHA class and stage of HF, LVEF, LVEDV, and PASP.

The Prognostic Significance of Atrial Fibrillation and Left Atrium Size in Patients with Aortic Stenosis.

Aim Aortic stenosis increases left atrial (LA) pressure and may lead to its remodeling. This can cause supraventricular arrhythmia. The aim of this study was to determine if the size of the LA and the presence of atrial fibrillation are related to the prognosis of patients with aortic stenosis.Material and methods Clinical evaluation and standard transthoracic echocardiographic studies were performed in 397 patients with moderate to severe aortic stenosis.Results In all patients, LA dimension above the median (≥43 mm) was associated with a significantly higher risk of death [HR 1.79 (CL 1.06-3.03)] and a LA volume above the median of 80 ml was associated with a significantly higher risk of death [HR 2.44 (CI 1.12-5.33)]. The presence of atrial fibrillation was significantly associated with a higher risk of death (p <0.0001). The presence of atrial fibrillation [HR 1.69 (CI 1.02-2.86)], lower left ventricular ejection fraction [HR 1.23 (CI 1.04-1.45)], higher NYHA heart failure class [HR 4.15 (CI 1.40-13.20)] and renal failure [HR 2.10 (CI 1.31-3.56)] were independent risk factors of death in patients in aortic stenosis.Conclusion The size and volume of the LA and the occurrence of atrial fibrillation are important risk factors for death in patients with aortic stenosis. The presence of renal dysfunction, low left ventricular ejection fraction, high NYHA functional class and atrial fibrillation are independent risk factors of poor prognosis in patients with aortic stenosis.

Mortality in hypertrophic cardiomyopathy is unrelated to genotype

Abstract Background Hypertrophic cardiomyopathy (HCM) patients with a pathogenic variant are presumed to have worse prognosis than patients without a pathogenic mutation. However, the genetic basis of hypertrophic cardiomyopathy (HCM) is complex, and relationship between genotype status and outcomes have not been completely resolved. Objective We assessed a large international HCM cohort to define the natural history and clinical consequences of genotype status. Methods Consecutive patients (n=1468) with established clinical HCM diagnosis underwent genetic testing focused on HCM-related genes. Patients with pathogenic or likely pathogenic variants were considered genotype positive (G+), and those without definite disease-causing mutation or a variant of uncertain significance (VUS) were considered genotype negative (G-). Patients were followed for 9.6 ± 8.2 years for clinical outcomes. Results Of 1468 HCM patients, 1156 (79%) were G - and 312 (21%) were G+. Over the follow-up 116 (10%) G- patients died at 70 ± 14 years, including in 26 (2.2%) from HCM-related causes. HCM-related mortality was not significantly different in G- patients (0.3%/year) as compared to G+ patients (0.3%/year) when adjusted for age (HR 0.93, 95% CI 0.38-2.30, p=0.87). All-cause mortality was not different among these groups (0.7%/year G- vs. 0.6%/year G+) when adjusted for age (HR 0.62, 95% CI 0.3-1.2, p=0.14) or comorbidities (HR 0.78, 95% CI 0.46-1.31, p=0.35). Rate of progression to advanced heart failure NYHA class III/IV in nonobstructive patients was not different in G- (4%/ year) vs. G+ (3%/year, HR 1.20, 95% CI 0.63-2.26, p=0.58). Sudden death events (appropriate ICD shocks, aborted cardiac arrest and sudden death) were more frequent in G+ patients (1.7%/year) than in G- patients (0.5%/year), albeit of borderline statistical significance when adjusted for age and SD risk factors (HR 1.58, 95% CI 1.00-2.49, p=0.05). Conclusions In this large consecutive genotyped cohort, all-cause and HCM-related mortality was unrelated to genotype status. Substantial proportion of G- patients experienced progressive HF, at a similar rate when compared to G+ patients. Although G- patients had less frequently SD events, genotype negative status could not be considered benign.FiguresTable

Abstract 18143: Sudden Death in Heart Failure (HF) With Preserved Ejection Fraction: Clinical Profile and Role of Atrial Fibrillation (AF) and HF NYHA Class

Introduction: Clinical risk factors for sudden death(SD) in patients with HFpEF have not been hitherto well characterized nor is the impact of concomitant atrial fibrillation (AF) on SD risk in HFpEF defined. Methods: We evaluated 1765 HFpEF subjects from the TOPCAT Americas trial to identify potential clinical markers for SD risk. We also examined the role of AF presentation, comparing pts in sinus rhythm (SR, n=1319) to pts in AF at study entry with two different AF presentations (Any AF or AF on baseline ECG) during a mean follow up period of 2.9 years. Results: AF on baseline ECG was independently associated with excess CV mortality (HR 1.46, 95% CI 1.10-1.95, P = 0.009). SD occurred in 77 pts (4.4%) of all HFpEF subjects. 20 SD victims had concomitant AF on baseline ECG (26 % of all SD). SD events were significantly more frequent in males (p=.002), in black or other minority ethnicity (vs. white; p<0.001), diabetics (p=0.024), lower eGFR (p=0.035) and vascular disease (p=0.044). Multivariate Cox analysis identified significant increased SD risk in people with reduced eGFR (HR 0.98, CI: 0.97 to 1.00, p=0.005), reduced risk in females (HR 0.40, 95% CI 0.24,0.65, p<0.001) and increased risk in smokers (HR: 2.16, 95% CI: 1.03 to 4.54, p=0.042). In unmatched or propensity score matched cohorts, neither Any AF or AF on ECG was independently associated with increased SD risk (Figure; p>0.2). SD risk was also similar in early and advanced NYHA class HF. Conclusions: 1. SD risk in HFpEF is influenced by gender, race, lifestyle and systemic comorbidities. 2. In contrast to HF with reduced EF, SD risk is not impacted by concomitant AF, its presentation or HF NYHA class.

Giant myxoma of the right sections of the heart obstructing the inferior vena cava: A case report

Objective: We present a rare case of surgical management of giant myxoma of the right heart with obstruction of the orifice of the inferior vena cava (IVC), obstruction of the right atrioventricular orifice, with the development of high pulmonary hypertension, and severe heart failure. Case presentation: A 39 years old male patients applied to the consultative polyclinic with typical complaints of severe shortness of breath, palpitations, severe weakness, almost bed rest, severe swelling of the lower extremities, with a transition to the anterior abdominal wall (edema). On physical examination signs of severe heart failure NYHA class IV were revealed. Imaging demonstrated giant right atrial myxoma obstructing IVC with base originated in fossa ovalis, obstructing tricuspid valve and protruding in the right ventricle occupying 50% of its cavity. The surgical removal of the giant RA myxoma protruding the right ventricle and obstructing IVC and tricuspid valve was performed under cardiopulmonary bypass and hemodynamic support. The patient was discharged on the 10th day after surgery and only residual minimal tricuspid regurgitation was revealed on follow-up examination. Conclusion: The described case from our practice proves the possibility of a severe course of giant myxomas of the right heart, with the development of deep hemodynamic complications of systemic and pulmonary circulation. The chosen correct tactics of surgical treatment provided a favorable result, despite the severity of the initial condition and the degree of hemodynamic disturbance. Intraoperative tactics and technique for performing the stages of urgent surgery were chosen based on the situation, the features of the anatomical structure of the tumor, and the severe complications that arose. Our case proves the possibility of adequate implementation of such interventions, when choosing the right tactics of surgical treatment. Take home message: If clinical signs of circulatory failure, heart failure are detected, it is necessary to perform echocardiography. If mass formations of the heart chambers are detected, immediately refer the patient to specialized cardiac surgery clinics to resolve the issue of surgical correction of pathology.

Prognostic significance of NT-proBNP and sST2 biomarkers in patients with post-myocardial infarction heart failure after a coronavirus infection

Aim. To determine the prognostic significance of N-terminal pro-brain natriuretic peptide (NT-proBNP) and soluble ST2 (sST2) in patients with post-myocardial infarction heart failure after a coronavirus disease 2019 (COVID-19)Material and methods. Three following groups were formed: in patients of group I (main), who underwent inpatient treatment for COVID-19, the cause of heart failure (HF) was prior Q-wave myocardial infarction; in patients of group II (comparison) without COVID-19, the cause of HF was prior Q-wave myocardial infarction; Group III (comparison) — patients with HF of ischemic origin without postinfarction cardiosclerosis and COVID-19. Statistical processing was carried out using the software package IBM SPSS Statistics Version 26.0.Results. The patients of all three groups included in the present study were comparable. After 6 months in group I, HF course worsening was recorded. In patients of groups I and II, an increase in NYHA HF class from 2 to 3 and 4 was recorded, in contrast to patients of group III, among whom the number of patients with class 3 HF decreased by 25% due to compensation to class 2. Patients of the studied groups, who had elevated serum levels of NT-proBNP and sST2, had more pronounced structural and functional myocardial disorders than patients with normal levels of these biomarkers. Using analysis of adverse cardiovascular events, such as recurrent myocardial infarction, cerebrovascular accident, hospitalization due to coronary artery disease, decompensated HF, which required hospitalization, a predictive model was developed using a neural network. There were following most important factors of the developed model: age, level of NT-proBNP and sST2, lung involvement according to computed tomography.Conclusion. Modern biomarkers NT-proBNP and sST2 have sufficient predictive value to determine the risk of adverse events in HF.

Symplified pulmonary ultrasound in heart failure patients with preserved systolic function

Abstract Funding Acknowledgements Type of funding sources: None. Background About 1/3 of patients with heart failure (HF) have normal Ejection Fraction (HFpEF). Pulmonary congestion and Oedema is useful marker of HFpEF. The aim of this study was to determine the place of pulmonary ultrasound in patients with DHF. Methods We studied 250 patients with II-IV NYHA class HF from which 70 patients had HFpEF (I gr) and 100 patients Left Ventricular Diastolic Dysfunction but without signs of HF (control, II gr). All participants undergone standard EchoCG examination. Sonographic evaluation of a lung was done in horizontal or vertical positions of patient, from 10 points of thoracic wall (5 points from each side), which corresponded to the projection of lower, middle and upper lobes of a right lung and upper and lower lobes of left lung. Results In patients with HF we significantly often found multiple (3 or more) B-lines or "Comet tail Phenomenon" (CTPh), which was registered in 91.1%. In 40.0% of control group patients we also registered B-lines, but the count of them in was less than 3 lines per each registration point (the difference between control an HF groups was significant). The count of points from where the CTPh was registered was 6.8 in HFpEF gr. and 0.7 in control gr. The B-lines where registered from 3 or more points of thoracic wall in 82.86% of patients of I gr and only 5% in II gr participants. In HF groups CTPh was prominent, protracted and multiple while in the control group it was single and short lasting, like lightening. There was good correlation between the count of B-line registration points from the thoracic wall and the heart failure NYHA class (r=0.56), left ventricular systolic (r=0.40) and diastolic (r=0.32) diameters and negative MAPS and TAPS (r=-0.42 and 0.41 respectively). Conclusion Thoracic US is sensitive and accurate method for evaluation pulmonary congestion in patients with HFpEF. The US sign of pulmonary congestion in HF are B-lines or "Comet tail phenomenon", which is protracted, prominent, multiple and registered from larger area of thoracic wall (3 points or more).

ЧАСТОТА, ФАКТОРЫ РИСКА И ПРЕДИКТОРЫ РАЗВИТИЯ СИНДРОМА МАЛОГО СЕРДЕЧНОГО ВЫБРОСА ПОСЛЕ ОПЕРАЦИЙ НА ОТКРЫТОМ СЕРДЦЕ

Purpose. To study the incidence and to determine predictors of postcardiotomy low cardiac output syndrome after open-heart surgery. Methods. A retrospective, observational case-control study was conducted at the Republican Scientific and Practical Center of Cardiology for the period 2015–2017. The study included 1, 540 patients who underwent open-heart surgery. Intraoperatively and in early postoperative period, 46 patients developed postcardiotomy low cardiac output syndrome (PCLCOS) refractory to drug therapy, followed by mechanical circulatory support (the study group), the comparison group consisted of 1, 494 patients. Results. The incidence of PCLCOS was 2.98%. The predictors of PCLCOS included the following: reoperation OR = 3.65 (95% CI 1.40–9.51), myocardial infarction (30 days) before operation OR = 7.20 (95% CI 2.25–23.01), heart failure NYHA class III/IV OR = 2.38 (95% CI 1.30–4.37), and preoperative local contractility index more than 1.81, OR = 2.92 (95% CI 1.50–5.68). Conclusion. Postcardiotomy low cardiac output syndrome is still a big issue in cardiac surgery. Despite modern methods of myocardial protection and mechanical circulatory support (MCS), hospital mortality remains extremely high, up to 80%. Prognosis based on predictive mo-dels will allow timely selection of the required type of MCS, reducing the incidence of multiple organ failure, and, as a result, adverse outcomes of surgical treatment.

Reasons for Non-compliance with medication and Disease severity among heart failure patients at Benazir Bhutto Hospital Rawalpindi

Heart failure is a silent epidemic that is growing exponentially among both genders. Objectives: To determine the reasons for non-compliance with medication and severity of illness among heart failure patients. Methods: A cross-sectional descriptive study was done among 277 heart failure patients who visited Cardiology department of Benazir Bhutto Hospital during 2020 and enrolled in study through consecutive non-probability sampling. Data was gathered pertinent to demographics, hospital stay, comorbidities, drug compliance, physical activity and reasons for expiry. Severity of disease was categorized by using NYHA classification. Variations in mean age of the both genders and length of hospital stay between recovering and expiring patients were statistically determined by independent sample t-test. P-value ≤ 0.05 was taken significant. 95% CI were also computed. Results: Of the 277 patients, 56% and 44% were males and females respectively with mean age 56.5 ± 15.9 years. Most (65.7%) were illiterate. There was significant difference (P 0.003) (95%CI (1.85 – 9.35) in mean age of both genders. About 71.8% and 25.6% patients belonged to low and middle social class respectively and 68% of them were non-compliant with medication. 59.3% were non-compliant due to unawareness while 23.4% and 15.9% had non-compliance due to non-affordability and adversity of medicines respectively. Out of 15 expiring cases, 13 succumbed to cardiac arrest. Mean length of hospital stay was 5.92 ± 3.7 days. About 122 and 112 cases were in NYHA heart failure class III and IV respectively. Conclusion: Incognizance about the medication was the prime reasons for non-compliance

Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): German Federal Ministry of Education and Research Background Remote Patient Management (RPM) enables early detection and prevention of cardiac deterioration in heart failure (HF) patients by measuring vital signs. Clinical trials reported inconsistent results. Patient adherence was suggested to be one of the main reasons for inconsistent results in previous trials (2-4). The "Telemedical interventional management in heart failure II (TIM-HF2)" study showed the superiority of non-invasive RPM compared to usual care (UC) in terms of mortality and unplanned cardiovascular (CV) hospitalisation (1). Purpose The objective of the analysis is to assess the patient experience with RPM, the adherence to daily measurements and outline factors affecting both aspects. Methods TIM-HF2 was conducted 2013-2018 with 1,538 HF patients in a 12-month follow-up (5). Inclusion criteria were HF in NYHA class II or III with either LVEF ≤45% or, if LVEF >45%, patients had been treated with oral diuretics; and HF hospitalisation within the last 12 months. Patients with major depression were excluded. Patients were randomly assigned (1:1) to RPM or UC. RPM-Patients had to measure daily weight, blood pressure, ECG and self-rated health status. Data were sent automatically to the telemedical centre (TMC). In case of conspicuous findings, the TMC contacted the patient or GP for therapy adjustment. At the study end, RPM-patients were asked to evaluate the program through a 9-question survey. Adherence was distinguished between measurement of at least one (incomplete adherence- IA) and all vital parameters (complete adherence- CA) and defined as ratio of the number of days of measurements taken divided by the number of days of possible measurements. All data were analysed descriptively (mean ± standard deviation). Differences between groups were analysed by ANOVA and T-Test. Results The survey was answered by n=564 patients (response rate: 79.7%). The patients were satisfied with the program and device usability. CA was 89.1±14.1% and consistently high over the study course (table 1). Reasons for dropouts (n=37) were e.g. frustration with the devices and physical inability to complete the measurement protocol. Patients <70 years and living in rural areas had lower IA rates. The mean adherence was independent of severe of disease (LVEF, NTproBNP, NYHA). Patients (n=244) had significantly lower IA the week prior to an unplanned CV hospitalisation (difference by -5.2±20.5%) compared to the entire study period. IA was significantly lower by -12.8±24.7% in the week after an unplanned CV hospitalisation compared to the entire study period. Conclusions In a setting with user-friendly devices, pre-interventional patient training, regular TMC-patient contact and close cooperation between primary physicians and TMC a long-lasting and high adherence and satisfaction regarding RPM could be achieved. A change in adherence might detect deterioration in health status and indicate the need to intensify telemedical care.

Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC).

4577 Background: Treatment (tx) landscape has evolved significantly for cisplatin-ineligible mUC patients (pts). Carboplatin and gemcitabine followed by avelumab (Av) maintenance is the current preferred standard. Although pembrolizumab (P) and atezolizumab (At) were approved as 1L therapy for these pts in 2017, the FDA has now restricted the use of 1L P to “platinum ineligible” mUC pts. We previously suggested a consensus definition for “platinum-ineligible” pts with mUC (Gupta et al. ASCO GU 2019). We now updated the consensus definition for standard therapy and clinical trial eligibility in the current tx era. Methods: We surveyed 60 genitourinary medical oncologists in the US (similar cohort to 2019) using an online tool consisting of several clinical parameters used in our initial survey with additional questions related to current available tx options. Different age and creatinine thresholds in combination with ECOG PS along with other clinically relevant established criteria were analyzed. We compiled the responses to generate a consensus definition. Results: All 60 respondents provided 100% responses. Respondents (94%) reported using a carboplatin-based regimen followed by Av and 6% reported using carboplatin-based regimen followed by P for cisplatin-ineligible mUC pts. 17/60 (28.3%) and 29/60 (48.3%) checked PD-L1 status prior to using P or At respectively. Survey results for the most common responses are presented in the Table. Conclusions: Based on the survey, any mUC pt meeting one the following 5 parameters should be considered "platinum-ineligible”: ECOG PS > / = 3; Cr Cl < 30 ml/min; peripheral neuropathy > / =Grade 2; NYHA Heart Failure Class > 3; ECOG PS 2 AND Cr Cl < 30 ml/min. These criteria are proposed to guide treatment recommendations and standardization of eligibility criteria. [Table: see text]

Long-term results of cardiac contractility modulation in patients with chronic heart failure

Aim. Evaluate the overall effectiveness of cardiac contractility modulation (CCM) therapy in patients with chronic heart failure of various etiology.Methods. The study included 61 patients with chronic heart failure (NYHA class II-III), ejection fraction 20-40% and narrow QRS <130 ms, who were implanted the CCM devices. Depending on the etiology of heart failure, ischemic cardiomyopathy prevailed (41 patients). All patients were performed echocardiography, 6-min walk test and Minnesota Living with Heart Failure questionnaire (MHFLQ). Results. The observation period was 25 months. All 54 patients significantly improved left ventricular ejection fraction from 32.2% to 37.6% (р=0.026) and volume parameters (left ventricle end systolic volume from 150 to 137 ml (р=0.034), left ventricle end diastolic volume from 220 to 201 ml (р=0.044), reduced the heart failure NYHA class >1 in 29 (53.7%) patients (р=0.015), increased 6-min walk test from 265 to 343 m (р=0.029), and the MHFLQ improved from 46.1 to 35.8 (р=0.042). Non-ischemic cardiomyopathy was associated with significant improvement in MHFLQ (from 42.7 to 30.3, р=0.029) and lowering the heart failure NYHA class>1 (83.3%, vs 47.2%, p=0.012) compared to ischemic group. Conclusion. CCM is safe and effective in patients with chronic heart failure NYHA class II-III, ejection fraction 20- 40% and narrow QRS˂130 ms, who were implanted the CCM devices. Depending on the etiology of heart failure, ischemic cardiomyopathy prevailed (41 patients). All patients were performed echocardiography, 6-min walk test and Minnesota Living with Heart Failure questionnaire (MHFLQ).Results. The observation period was 25 months. All 54 patients significantly improved left ventricular ejection fraction from 32.2% to 37.6% (р=0.026) and volume parameters (left ventricle end systolic volume from 150 to 137 ml (р=0.034), left ventricle end diastolic volume from 220 to 201 ml (р=0.044), reduced the heart failure NYHA class >1 in 29 (53.7%) patients (р=0.015), increased 6-min walk test from 265 to 343 m (р=0.029), and the MHFLQ improved from 46.1 to 35.8 (р=0.042). Non-ischemic cardiomyopathy was associated with significant improvement in MHFLQ (from 42.7 to 30.3, р=0.029) and lowering the heart failure NYHA class>1 (83.3%, vs 47.2%, p=0.012) compared to ischemic group.Conclusion. CCM is safe and effective in patients with chronic heart failure NYHA class II-III, ejection fraction 20- 40% and narrow QRS˂130 ms. Non-ischemic etiology of cardiomyopathy was associated with significant improvement in MHFLQ and lowering the heart failure class.

Abstract P5-18-04: Combination plinabulin+pegfilgrastim (Plin+Peg) had better toxicity management and health related quality-of-life (HrQoL) compared to Peg alone in early-stage breast cancer (BC) patients (pts) treated with taxotere, doxorubicin and cyclophosphamide (TAC)

Abstract Introduction TAC chemotherapy may have better survival outcomes than TC or AC, but is used less often likely because of toxicity and reduced HrQoL (Fujii Jama Oncol 2005; Martin Annals of Oncol 2006). Combination Plin+Peg is superior to Peg alone for the prevention of chemotherapy-induced-neutropenia (CIN): 68% vs 86% grade (Gr) 4 neutropenia with Plin+Peg vs Peg (P=0.0015). FN rate was 3.6% vs 6.3% for Plin+Peg vs Peg. Here we analyzed the mitigating effects of Plin on toxicity and HrQoL impacted by adjuvant TAC in BC pts also receiving Peg. Methods In the randomized, double-blinded trial PROTECTIVE-2 (NCT0329457), Stage I,II,III BC pts received TAC (T dose 75mg/m2, A dose 50 mg/m2, C dose 500 mg/m2) with either the Plin+Peg combination (n=110) or Peg alone (n=111) for 4 cycles. Toxicity was evaluated by central laboratory (Covance) hematology and chemistry assessments, AE collection and 12-lead ECG. HrQoL was assessed by EORTC QLQ-C30 and EQ-5D-5L. pCR rate was assessed by pathological evaluation of excised BC tissue after surgery. Pts with abnormal cardiac function meeting any of the following criteria were excluded: 1. Prior doxorubicin (>240 mg/m2) or anthracycline exposure; 2. Cardiac ventricular dysfunction; 3. LVEF≤50%; 4. Congestive heart failure of NYHA Class II,III, IV cardiac disease; 5. History of myocardial infarction or coronary artery disease; 6. ECG findings consistent with active ischemic heart disease; angina pectoris requiring medication; 7. Arrhythmia requiring medication; severe conduction anomaly; 8. History of congenital QT prolongation; 9. Significant cardiac valvular disease; 10. Uncontrolled hypertension. Plin 40 mg fixed dose was given on day 1 (the day of TAC administration), and peg 6mg was given on day 2. Results All grade (Gr) AE frequency was 97% vs 96% in Plin+Peg vs Peg. However a shift to lower grade was noted. Gr 4 AE frequency was lower with Plin+ Peg vs Peg: 59% vs 80% (p<0.03). Gr3 (18% vs 6%) and Gr 2 (19% vs 9%) frequency was higher with Plin+Peg vs Peg. EQ-5D-5L utility values over all cycles had slightly increased with Plin+Peg, but steadily decreased with Peg alone (see table); Day -1 represent the score on the date before TAC dosing. ⋯add more HrQoL data⋯.pCR rates was numerically higher with Plin+Peg vs Peg (13.04% vs 12.5%). No cardiac dysfunction-related AEs were noted with Plin+Peg or Peg. Conclusion The addition of Plin to Peg for CIN prevention enables better management of TAC induced toxicity and HrQoL. TAC should be reevaluated in early stage BC patients in light of the improved outcomes with Plin+Peg support. EQ-5D-5L Utility values*+Cycle 1 Day -1Cycle 2 Day -1Cycle 3 Day -1Cycle 4 Day -1Plin +Peg (n=109)0.930.950.930.92Peg (n=106)0.930.910.890.87*p=0.0245 for Plin+Peg vs Peg favoring Plin+Peg +United States Valuation of EQ-5D-5L Health States Using (Pickard 2019). Citation Format: Douglas W. Blayney, Yvette Lelorier, Dominic Mitchell, Lan Huang, Ramon Mohanlal. Combination plinabulin+pegfilgrastim (Plin+Peg) had better toxicity management and health related quality-of-life (HrQoL) compared to Peg alone in early-stage breast cancer (BC) patients (pts) treated with taxotere, doxorubicin and cyclophosphamide (TAC) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-18-04.

765 Is acute response to calcium sensitizers drugs predictive of response to cardiac contractility modulation in NYHA IV patients?

Abstract A 53-years old man presented to our institution with a diagnosis of decompensated heart failure NYHA Class IV. He had a history of ischaemic heart disease with severe biventricular dysfunction, diabetes, hypertension, dyslipidaemia, advanced chronic kidney disease, previous explanation of dual-chamber implantable electronic device (ICD) due to endocarditis and subsequent implantation of subcutaneous ICD in primary prevention. Home therapy included uptitrated angiotensin-converting enzyme inhibitor, β-blocker, loop-diuretic, spironolactone, acetylsalicylic acid, and oral hypoglycemics. Clinical examination showed signs and symptoms of systemic and pulmonary congestion with pleural effusion and ascites. Echocardiography revealed diffuse left ventricular (LV) hypokinesis with an ejection fraction (EF) of 25%, severe right ventricular dysfunction and increased filling pressures. He was treated with high dose of i.v. diuretics with mild improvement of dyspnoea. However, haemodynamic stability was labile with worsening of symptoms as soon as mild down-titration of iv diuretics was attempted. Levosimendan, a calcium-sensitizer inodilator, indicated for short-term treatment of acutely decompensated severe chronic heart failure (HF), was administered with good clinical response. Thus, we thought that the patient could have benefited from contractility modulation therapy (CCM) which acts on intramyocardial calcium handling. CCM is a novel therapeutic option for patients with classes III–IV HF with EF ≥ 25% to ≤ 45% and narrow QRS complex that acts on intramyocardial calcium-handling. CCM proved effective in alleviating symptoms, improving exercise tolerance and quality of life, and reducing hospitalization rates in HF. It improves myocardial contractility, reverses the foetal myocyte gene program associated with HF and facilitates cardiac reverse remodelling. Therefore, an Optimizer Smart System (Impulse Dynamics) was implanted. Two pacing electrodes were placed on the interventricular septum in apical and mid-septal position, respectively. The leads were connected to a pulse-generator in a right pectoral pocket. In the following days, we observed a progressive improvement in clinical status, with gradual resolution of peripheral oedema, dyspnoea and fatigue and significant weight loss. Six-month echocardiography showed a stable value of EF and significant improvement in stroke volume (35.2 ml from 24.8 ml at baseline). The patient did not undergo further hospitalization for decompensated HF and was in stable ambulatory NYHA Class IV. We believe CCM is an option in patients with advanced HF in which avoiding recurrent hospitalizations, with their overt increase mortality, is often a challenging therapeutic goal. 765 Figure

Abstract 14295: Exploratory Findings Of A Quality Improvement Collaborative To Optimize Care Provided To Heart Failure Patient In A Network Of Heart Failure Clinics In Argentina

Introduction: The in-patient management of heart failure (HF) in Argentina has shown profound gaps in performance. Measurement and feedback as well benchmark comparisons showed increase in the use of evidence-based therapies, adherence to performance measures, and shortened lengths of stay in patients hospitalized with HF. Quality improvement collaboratives (QICs) have been used to improve health care for several decades. Our aim was to adopt a HF discharge bundle of care in 50% of enrolled subjects on discharge will reduce readmission by 10%. Methods: we are conducting a learning QIC, evaluated through a before-after design, from august 2020 to may 2021 (interim analysis), in 8 HF clinics of Argentina, where patients with newly diagnosed or known HF (LVEF <40%) were enrolled when their discharge process was started after an hospital admission. We implemented a HF bundle of care based on four categories that comprised 12 specific interventions: medication, continuum of care, lifestyle habits, pre-discharge exams. Local hospital teams were trained in improvement and change facilitation. The implementation of the bundle was laid out along 8 learning sessions and periods of action using Plan-Do-Check-Act-cycles and an online platform to register interventions and performance.This an ongoing collaborative to be ended in July 2021. IRB approval was granted in all sites. Results: we enrolled 84 patients during baseline (BP) and 96 patients so far after the start of the intervention (IP). No differences were observed related to age, sex, morbidities and left ventricular ejection fraction (LVEF) between periods. Few more patients had history of stroke in the IP period (BP 3.6% vs IP 9.3%, p<0.001). There wasn’t a statistical difference in the accomplishment of all the items of the intervention -all or nothing approach- (BP 10.7% vs IP 17.7%, p=0.183). However, there was a difference in the continuum of care category (BP 27.4% vs IP 53.6%, p<0.001). No differences were observed in the rate of readmissions (BP 8.3% vs IP 3.8%, p=0.231). Conclusions: Initial results of a QIC to improve care before discharge of in-patients with HF NYHA class II-III showed an increase in the adoption of an evidence based practices bundle and no changes were observed in the rate of readmissions.