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Background and Objectives: Sex-specific outcome in patients with acute myocardial infarction-related cardiogenic shock (AMI-CS) receiving temporary mechanical circulatory support remains controversial. Materials and Methods: Patients with AMI-CS who received Impella support were prospectively enrolled in the Japanese registry for Percutaneous Ventricular Assist Device. Patients enrolled between January 2021 and December 2022 were considered to be eligible. Patients with out-of-hospital cardiac arrest and those without revascularization were excluded. The sex disparity in the 30-day survival after the initiation of Impella support was evaluated. Results: A total of 924 patients (median age 73 years; 21% female) were included. Female patients were older and had a smaller physiques than male patients (p < 0.05 for both). Female sex was significantly associated with a higher 30-day mortality after adjustment for four other potential confounders with a hazard ratio of 1.365 (95% confidence interval 1.026–1.816, p = 0.0324). In the female cohort, patients who received Impella prior to revascularization (N = 138) had a greater survival rate compared to those who received Impella after revascularization (68.1% versus 44.8%, p = 0.0015). Conclusions: Among the patients with AMI-CS who received Impella support and underwent revascularization, female sex was independently associated with a lower 30-day survival. For female patients, early initiation of Impella support prior to revascularization may improve their clinical outcomes.

Background: Morbidity and mortality following trans-catheter aortic valve replacement (TAVR) remain high. Renin-angiotensin system inhibitors improve clinical outcomes in the cohort studied in this work. However, post-TAVR prognostic impact of mineralocorticoid receptor antagonist (MRA), another neuro-hormonal blocker, remains uncertain. Here, we hypothesized that MRA was associated with improved clinical outcomes in elderly patients with severe aortic stenosis receiving TAVR. Methods: Consecutive patients who received TAVR at our institute between 2015 and 2022 were considered for inclusion. Propensity score matching analysis was performed to match pre-procedural baseline characteristics between those with and without MRA. The prognostic impact of MRA use on the composite primary endpoint consisting of all-cause death and heart failure during the 2-year observational period following index discharge was evaluated. Results: Among 352 patients who received TAVR, 112 patients (median 86 years, 31 men) were included, consisting of baseline-matched 56 patients with MRA and 56 patients without MRA. Following TAVR, patients with MRA had more impaired renal function compared with no MRA group. Following index discharge, serum potassium tended to increase, and renal function tended to decline in patients with MRA. Patients with MRA had a higher cumulative incidence of the primary endpoints during a two-year observational period (30% versus 8%, p = 0.022). Conclusions: Routine prescription of MRA might not be recommended in elderly patients with severe aortic stenosis receiving TAVR, given its negative prognostic impact. Optimal patient selection for MRA administration in this cohort needs further study.

Background: Polypharmacy in elderly patients with various comorbidities is associated with mortality and morbidity. However, the prognostic impact of polypharmacy in patients with severe aortic stenosis receiving trans-catheter aortic valve replacement remains unknown. Methods: Patients with severe aortic stenosis who received trans-catheter aortic valve replacement between 2015 and 2022 and were followed up at our institute following index discharge were included in this retrospective study. The impact of polypharmacy, which was defined as medication numbers ≥10 at index discharge, upon 2-year all-cause death was investigated. Results: A total of 345 patients (median age 85 [83, 89] years old, 99 (29%) men) were included. Median medication number was 9 (7, 10) at the index discharge and 88 (26%) were classified as receiving polypharmacy. Frailty index, including mini-mental state examination and CSHA score, were not significantly different between those with and without polypharmacy (p > 0.05 for both). Polypharmacy was associated with higher 2-year cumulative mortality with an adjusted hazard ratio of 21.4 (95% confidence interval, 6.06–74.8, p < 0.001). As a sub-analysis, the number of cardiovascular medications was not associated with 2-year mortality (hazard ratio 1.12, 95% confidence interval 0.86–1.48, p = 0.46), whereas a higher number of non-cardiovascular medications was associated with an incremental increase in 2-year mortality with a hazard ratio of 1.39 (95% confidence interval, 1.15–1.63, p < 0.001). Conclusions: In elderly patients with severe aortic stenosis, polypharmacy was associated with worse short-term survival following trans-catheter aortic valve replacement. Prognostic implication of aggressive intervention to decrease the amount of medication among those receiving TAVR requires further prospective studies.

Background: The six-minute walk test is a practical tool for assessing functional capacity in patients with a variety of etiologies including pulmonary disease and heart failure. Six-minute walk distance (6MWD) is associated with mortality and morbidity in patients with a variety of comorbidities. We aimed to assess the prognostic impact of baseline 6MWD in patients with severe aortic stenosis undergoing trans-catheter aortic valve replacement (TAVR). Methods: Patients with severe aortic stenosis who underwent a six-minute walk test after index admission and underwent TAVR between 2015 and 2022 were included in this retrospective study. Patients were followed up for two years or until November 2022 following TAVR. The impact of baseline 6MWD on the primary composite outcome, defined as all-cause death and all-cause readmission during the 2-year observation period following index discharge, was assessed. Results: A total of 299 patients (median age 86 years old, 85 men) were included. They received a 6-min walk test prior to TAVR, underwent successful TAVR procedures, and were discharged alive. The median baseline 6MWD was 204 (143, 282) meters. Shorter baseline 6MWD was associated with higher cumulative incidence of the primary outcome with an adjusted hazard ratio of 0.76 (95% confidence interval 0.58–1.01, p = 0.055) with a cutoff 6MWD of 178 m during the 2-year observation period after index discharge. Conclusions: Overall, functional capacity was impaired in the elderly patients with severe aortic stenosis prior to TAVR. Patients with severe aortic stenosis having shorter baseline 6MWD tended to have higher rates of morbidity and mortality after successful TAVR. The clinical implication of aggressive cardiac rehabilitation to improve patients’ functional capacity and 6MWD-guided optimal patient selection remain the future concerns.

Background and Objectives: Small dense LDL cholesterol is a strong risk factor for atherosclerosis. However, few studies have investigated the impacts of this specific lipid profile on the incident risk of adverse cardiovascular events in patients with acute coronary syndrome. Materials and Methods: Patients with acute coronary syndrome, who underwent revascularization, were included and followed for 2 years. The levels of small dense LDL cholesterol were measured at index discharge (day 0) in the setting of newly administered therapies for secondary prevention, including aspirin and statins, during the index hospitalization. The prognostic impact of small dense LDL-cholesterol levels on the risk of a primary composite endpoint, including cardiac death, non-fatal myocardial infarction, unstable angina pectoris, stroke, and heart failure, was investigated. Results: In total, 46 patients (median 75 (59, 83) years old, 63% men) were included. Median small dense LDL cholesterol was 19.4 (13.5, 23.8) mg/dL at index discharge. All patients initiated statin treatment before the index discharge, with a median LDL-cholesterol level of 77 (64, 109) mg/dL. Small dense LDL-cholesterol level was independently associated with an incremental risk for the primary endpoint (p < 0.05 by adjusting for several potential risk factors, including LDL cholesterol) with a cutoff of 32.6 mg/dL. Conclusions: Small dense LDL-cholesterol level was a significant risk factor for cardiovascular events following presentations of acute coronary syndrome.

Background: Chest X-ray is a practical tool to semi-qualify pulmonary congestion. Remote dielectric sensing (ReDS) is a recently introduced, non-invasive, electromagnetic energy-based technology to quantify pulmonary congestion without expert technique. We compared these two modalities to clarify appropriate clinical situations for each modality. Methods: ReDS and chest X-ray measurements were prospectively performed on admission in consecutive hospitalized patients with cardiovascular diseases. In the chest X-ray, the congestive score index (CSI) was calculated blindly by two independent experts and averaged. CSIs were correlated with ReDS values. Results: A total of 458 patients (76 (69, 82) years old, 267 men, and 130 heart failure) were included. Median ReDS value was 28% (25%, 33%). There was a mild correlation between ReDS values and CSIs (r = 0.329, p < 0.001). The correlation between ReDS values and CSIs became stronger in the heart failure cohort (r = 0.538, p < 0.001). In patients with mild congestion (ReDS < 35%), ReDS values, instead of CSI, stratified the degree of congestion. In patients with severe congestion (ReDS > 35%), both modalities stratified the degree of congestion. Conclusions: Both chest X-ray and ReDS are useful for assessing severe pulmonary congestion, whereas ReDS would be preferred to chest X-ray in stratifying the severity of mild pulmonary congestion.

Background: In patients with essential hypertension, a non-dipping blood pressure pattern is a strong risk factor for cardiovascular diseases. However, background factors associating with such a blood pressure pattern remain unknown. Methods: Untreated essential hypertensive patients without chronic kidney diseases who were admitted to our outpatient clinic were included. Blood sampling and 24 h ambulatory blood pressure monitoring were mandatorily performed. Non-dipper status was defined as a maximum decrease in nocturnal systolic blood pressure within 10%. Clinical factors associating with non-dipper status were investigated. Results: A total of 154 patients (56 ± 12 years old, 86 men) were included. Among baseline characteristics, a higher serum uric acid level was independently associated with non-dipper status (odds ratio 1.03, 95% confidence interval 1.00–1.05, p < 0.05). Among those with non-dipper status, a higher high-sensitivity C-reactive protein level tended to be associated with incremental nighttime systolic blood pressure levels (p = 0.065). Conclusions: Hyperuricemia and micro-inflammation might be associated with attenuated nocturnal blood pressure dipping and incremental nighttime systolic blood pressure levels.

Background: Pulmonary congestion is quantified by a remote dielectric sensing (ReDSTM) system, while systemic congestion is estimated by calculated plasma volume. The type of clinical patient profile as defined by the ReDS system and calculated plasma volume remains uncertain. Methods: Hospitalized patients with or without heart failure were included in this prospective study. On admission, ReDS values were measured and plasma volume status (PVS) was estimated using their body weight at the same time. Cutoffs of ReDS value and PVS were defined at 34% and −2.7%, respectively. The association between the two parameters was assessed. Results: A total of 482 patients (median 76 years, 288 men) were included. The median ReDS value was 28% (25%, 32%) and median PVS was −16.4% (−26.3%, −5.9%). Of the patients, 64 had high ReDS value (and low PVS) and 80 had high PVS (and low ReDS value). The high ReDS group had a higher prevalence of clinical heart failure with a more elevated echocardiographic E/e’ ratio, whereas the high PVS group had a higher prevalence of chronic kidney disease (p < 0.05 for all). Four out of a total of six patients with high ReDS value and high PVS had both heart failure and chronic kidney disease profiles. Conclusion: The combination of ReDS value and PVS was able to clinically stratify the types of body fluid distribution and patient profiles. Utilizing these tools may assist the clinician in constructing a therapeutic strategy for the at-risk hospitalized patient.

Background: pemafibrate is a newly-introduced selective peroxisome proliferator-activated receptor-α modulator, which decreases serum triglyceride levels with few drug-related adverse events and may reduce the risk of adverse cardiovascular events in carefully selected patients with hypertriglyceridemia. We aimed to understand which specific cohorts may benefit or not from pemafibrate therapy for adverse cardiovascular event risk reduction. Methods: patients with hypertriglyceridemia at baseline received pemafibrate therapy for two years or until October 2022. The factors that were associated with an increased risk of adverse cardiovascular events, defined as heart failure hospitalization, stroke, and acute coronary syndromes, were investigated. Results: a total of 121 patients (median 62 years, 88 men) remained on pemafibrate therapy for a median of 566 days without any drug-related adverse events. During a 3-month therapeutic period, triglyceride levels improved significantly from 302 (205, 581) mg/dL to 178 (117, 253) mg/dL (p < 0.001). During the overall therapeutic period, there were nine cardiovascular events. Comorbid chronic heart failure, comorbid coronary disease, and a lower pemafibrate dosing were independently associated with the primary endpoint (p < 0.05 for all). Those with multiple risk factors (N = 30) had a significantly higher cumulative incidence of the primary endpoint as compared with others (27% versus 3%, p < 0.001). Conclusion: pemafibrate significantly improves hypertriglyceridemia. A higher dose of pemafibrate should be considered to reduce the risk of adverse cardiovascular events, particularly in patients with chronic heart failure or coronary disease.

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the risk of hospitalization for heart failure (HF) or death from cardiovascular causes among patients with chronic HF. However, little is known about the specific factors associated with clinical events during SGLT2i therapy in patients hospitalized for acute decompensated heart failure (ADHF). Methods: Consecutive patients who were hospitalized for ADHF and received SGLT2i during the index hospitalization between February 2016 and April 2021 were retrospectively evaluated. We investigated the factors associated with recurrent hospitalization for HF during the SGLT2i therapy. Results: A total of 143 patients (median age 73 years, 92 men) were included. Estimated glomerular filtration rate (eGFR) was negatively associated with a primary endpoint with a hazard ratio of 0.94 (95% confidence interval 0.90–0.98, p = 0.007). Those with lower eGFR < 40.9 mL/min/1.73 m2 (n = 47) had significantly lower freedom from HF hospitalization during 1-year therapeutic period (73% versus 94%, p = 0.005). Conclusions: Among patients who initiated medical therapy incorporating SGLT2i during the hospitalization for ADHF, a lower eGFR at baseline was associated with a recurrent hospitalization for HF. Early administration of SGLT2i prior to deterioration of renal function would be highly recommended to enjoy greater benefit from SGLT2i.

Background: The therapeutic strategy for mitral regurgitation (MR) in patients with advanced heart failure and wide QRS complex who are indicated for both intervention to MR and cardiac resynchronization therapy (CRT), remains unclear. Objective: We aimed to determine electrocardiogram parameters that associate with MR reduction following CRT implantation. Methods: Among the patients with advanced heart failure and functional MR who intended to receive CRT implantation, baseline QRS morphology, electrical axis, PR interval, QRS duration, and averaged S-wave in right precordial leads (V1 to V3) in surface electrocardiogram were measured. The impact of these parameters on MR reduction following CRT implantation, which was defined as a reduction in MR ≥1 grade six months later, was investigated. Results: In 35 patients (median 71 years old, 18 men), 17 (49%) achieved an MR reduction following CRT implantation. Among baseline characteristics, only the higher S-wave amplitude in right precordial leads was an independent predictor of MR reduction (odds ratio 14.00, 95% confidence interval 1.65–119.00, p = 0.016) with a cutoff of 1.3 mV calculated through the area under the curve. The cutoff significantly stratified the cumulative incidences of heart failure re-admission and percutaneous mitral valve repair following CRT implantation (p = 0.032 and p = 0.011, respectively). Conclusions: In patients with advanced heart failure and functional MR, the baseline higher amplitude of S-wave in the right precordial leads might be a good indicator of MR improvement following CRT.

Background: Percutaneous left atrial appendage closure using the WATCHMAN system, to prevent thrombosis and minimize anti-coagulant use in patients with non-valvular atrial fibrillation, has recently been introduced. The safety and efficacy of new-generation WATCHMAN FLX, as compared to conventional WATCHMAN 2.5, remain unknown. Methods: Consecutive patients who received percutaneous left atrial appendage closure using the WATCHMAN system in our institute, between June 2020 and December 2021, were retrospectively analyzed. Safety and efficacy during the 45-day observational period were compared between the two devices. Results: A total of 93 patients (73.0 ± 7.3 years old, 63 men) who received WATCHMAN FLX (n = 44) or WATCHMAN 2.5 (n = 49) were included. The device implant success rate was 100% in the FLX device group and 98% in the 2.5 device group. There were no procedure-related complications in the FLX group, and one non-relevant pericardial effusion in the 2.5 device group. During the 45-day observational period, there were no procedure-related adverse events. No patients in the FLX group had a peri-device leak >3 mm, whereas two patients in the 2.5 device group had a peri-device leak >3 mm. Anti-coagulants could be terminated in most of the patients (85% versus 88%; p = 0.68). Conclusions: Percutaneous left atrial appendage closure using new-generation WATCHMAN FLX seemed to be as safe and effective as conventional WATCHMAN 2.5 during the short-term observational period.

Background: Remote dielectric sensing (ReDS™) is an electromagnetic-based technology used to noninvasively measure lung fluid levels. The association between ReDS values and invasively measured hemodynamics, particularly among those with small physics, remains unknown. Methods: Consecutive patients with chronic heart failure who were admitted to our institute and underwent invasive right heart catheterization as well as simultaneous ReDS measurement at clinically stable conditions between September and November 2021 were prospectively included. The colinearity between ReDS values and pulmonary capillary wedge pressure was studied. Results: In total, 30 patients (median 79 (73, 84) years old, 13 men) were included. Median ReDS value was 26% (22%, 28%). ReDS values had a moderate collinearity with pulmonary capillary wedge pressure (r = 0.698, p < 0.001), even among those with a body height < 155 cm. ReDS values with a cutoff of 28% predicted a pulmonary capillary wedge pressure > 15 mmHg with sensitivity 0.70 and specificity 0.75. Conclusions: An electromagnetic-based engineering ReDS might be a potential tool to estimate cardiac pressure in patients with heart failure, including those with small physics.

Background and Objectives: Acquired von Willebrand syndrome (AVWS) develops not only in patients with durable ventricular assist devices but also in patients receiving temporary mechanical circulatory support (MCS). However, its prognostic implication remains unknown. Materials and Methods: Patients who received temporary MCS in our institute between August 2018 and September 2021 were included in this prospective study and the von Willebrand factor multimer analyses were performed following the initiation of temporary MCS supports. The von Willebrand factor large-multimer index was calculated as a normalized ratio of large-multimer proportion among total von Willebrand factor. Association between the large-multimer index and the 30-day survival was investigated. Results: A total of 31 patients (69 years old, 52% men) were included. Median large-multimer index was 63.0% (56.9%, 75.6%). The index was lowest in patients with extracorporeal membrane oxygenation than those receiving support from other devices. A lower index (

Background: Sodium zirconium cyclosilicate (SZC), a newly introduced specific potassium binder, is introduced to treat hyperkalemia. However, the implications of SZC in up-titrating renin–angiotensin–aldosterone system inhibitors in patients with systolic heart failure remain unknown. Methods and Results: Patients with heart failure with left ventricular ejection fraction

Background and objectives: Endothelial dysfunction is associated with exercise intolerance and adverse cardiovascular events. Transcatheter aortic valve implantation (TAVI) is applied to treat elderly patients with severe aortic stenosis, but less is known about the impact of TAVI on endothelial dysfunction, which can be assessed by measuring flow-mediated vasodilation (FMD). In this parameter, a low value indicates impaired endothelial function. Materials and Methods: Vascular endothelial function was evaluated by FMD of the brachial artery just before and one week after TAVI. Factors associated with the normalization of FMD and their prognostic impact were investigated. Results: Fifty-one patients who underwent TAVI procedure (median 86 years old, 12 men) were included. FMD improved significantly from baseline to one week following TAVI (from 5.3% [3.7%, 6.7%] to 6.3% [4.7%, 8.1%], p &lt, 0.001). Among 33 patients with baseline low FMD (≤6.0%), FMD normalized up to &gt, 6.0% following TAVI in 15 patients. Baseline higher cardiac index was independently associated with normalization of FMD following TAVI (odds ratio 11.8, 95% confidence interval 1.12–124, p &lt, 0.04). Conclusions: Endothelial dysfunction improved following TAVI in many patients with severe aortic stenosis. The implication of this finding is the next concern.

Background and objectives: Current guidelines criteria do not satisfactorily discriminate responders to cardiac resynchronization therapy (CRT). QRS amplitude is an established index to recognize the severity of myocardial disturbance and might be a key to optimal patient selection for CRT. Materials and Methods: (1) Initial R-wave amplitude, (2) S-wave amplitude, and (3) a summation of maximal R- or R′-wave amplitude and S-wave amplitude were measured at baseline. These parameters were averaged according to right (V1 to V3) or left (V4 to V6) precordial leads. The impact of these parameters on response to CRT, which was defined as a decrease in left ventricular end-systolic volume ≥15% at six-month follow-up, was investigated. Results: Among 47 patients (71 years old, 28 men) who received guideline-indicated CRT implantation, 25 (53%) achieved the definition of CRT responder. Among baseline electrocardiogram parameters, only the higher S-wave amplitude in right precordial leads was an independent predictor of CRT responders (odds ratio: 2.181, 95% confidence interval: 1.078–4.414, p = 0.030) at a cutoff of 1.44 mV. The cutoff was independently associated with cumulative incidence of heart failure readmission and appropriate electrical defibrillation following CRT implantation (p &lt, 0.05, respectively). Conclusions: Prominent S-wave in right precordial leads might be a promising index to predict left ventricular reverse remodeling and greater clinical outcomes following CRT implantation.

Background and objectives: Leadless pacemakers are less invasive but are as effective as conventional pacemakers and are increasingly implanted in elderly patients. However, the implantation procedure is sometimes challenging in patients with abnormal anatomy, particularly those with an enlarged right heart. We aimed to determine the right heart parameters that were associated with longer procedure times for leadless pacemaker implantation. Materials and Methods: Among 19 consecutive patients in whom Micra leadless pacemakers (Micra TPS, Medtronic, Minneapolis, MN) were implanted, the diameter and area of both the right atrium and right ventricle were measured by transthoracic echocardiography before the procedure. The right heart parameters that were associated with a procedure time &gt, 60 min were investigated. Results: In the 19 patients (median 81 years old, 10 male) who underwent implantation of the Micra system, 6 (32%) required a procedure time &gt, 60 min. Among the baseline right heart echocardiographic parameters, right atrial diameter and area were significantly associated with a procedure time &gt, 60 min (odds ratio 11.3, 95% confidence interval 1.09–1.17, p = 0.042, and odds ratio 1.57, 95% confidence interval 1.05–2.34, p = 0.029, respectively) at a cutoff of 4.0 cm and 17.0 cm2, respectively. Conclusions: Patients with an enlarged right atrium may not be good candidates for leadless pacemakers given the longer procedure time, and conventional pacemakers should perhaps be recommended as an alternative.