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Background Reducing complications at the puncture site after percutaneous coronary intervention (PCI) is important. The diameter of a 6.5-French (Fr) sheathless guiding catheter (GC) is smaller by approximately 2-Fr compared to a 6-Fr conventional sheath. In the present study, we investigated the post-PCI puncture site complications of a transradial approach in each gender while using a 6.5-Fr sheathless GC. Methods and results Our study consisted of 332 patients who underwent transradial coronary intervention (TRI) between August 2017 and July 2019. We classified the patients into either the 6.5-Fr sheathless GC (Asahi, Intecc, Aichi, Japan) Group (Sheathless group: n  = 182 males, 58 females) or the 6-Fr sheathed GC Group (Sheathed group: n  = 150 males, 36 females). We determined the complications at the puncture site: oozing, subcutaneous hemorrhage, formation of hematoma, pseudoaneurysms, and peripheral neuropathy. The body mass index of the patients was greater in the sheathless GC group compared to the sheathed GC group (24.5 ± 3.5 kg/m 2 vs. 23.6 ± 3.7 kg/m 2 , p  = 0.02). In males, there was no significant difference in the complication rate at the puncture site between the sheathless GC and sheathed GC groups (19.3% vs. 18.6%, p  = 0.88). However, the complication rate at the puncture site in females was higher in the sheathed GC group than in the sheathless GC group (36% vs. 15.5%, p  = 0.02). A multiple logistic regression analysis revealed that the use of a 6.5-Fr sheathless GC independently reduced the complications in female patients ( p  = 0.006). Conclusion The use of the 6.5-Fr sheathless GC system in a transradial approach reduced the complications at the puncture site in female patients. The 6.5-Fr sheathless GC system may be a safe option for them compared to the conventional sheath system.

Background The mechanisms underlying cardiorenal benefits of finerenone remain unclear. This mechanistic trial aimed to evaluate the effects of finerenone on vascular stiffness, as assessed using the cardio-ankle vascular index (CAVI), and cardiorenal biomarkers in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). Methods Eligible patients with T2D and CKD (estimated glomerular filtration rate [eGFR], 25 to < 90 mL/min/1.73 m 2 ; urinary albumin-to-creatinine ratio [UACR], 30 to < 3500 mg/g Cr) were randomly allocated to receive either dose-adjusted finerenone or matching placebo. The primary endpoint was the change in CAVI at week 24. The key secondary endpoint was the proportional change in UACR from baseline over 24 weeks. As an exploratory analysis, changes in circulating proteins were measured by using the Olink® Target 96 Cardiovascular III and Inflammation panels. Results This investigator-initiated, multicentre, prospective, two-arm parallel, placebo-controlled, double-blind, randomised clinical trial was conducted at 13 sites in Japan. Among 102 patients randomised, 101 (66.3% men; median age, 73 years; eGFR, 56.2 mL/min/1.73 m 2 ; and UACR, 193.8 mg/g Cr) were analysed. Changes in CAVI at week 24 were − 0.023 (95% confidence interval [CI], − 0.299 to 0.254) for finerenone and 0.011 (95% CI, − 0.245 to 0.267) for placebo. The group difference was − 0.057 (95% CI, − 0.428 to 0.314; P  = 0.760). Compared with placebo, finerenone led to a 29% reduction in UACR levels at weeks 12 (group ratio 0.706 [95% CI, 0.504 to 0.989; P  = 0.043]) and 24 (0.709 [95% CI, 0.506 to 0.994; P  = 0.046]). Finerenone also resulted in an early and sustained eGFR decline over 24 weeks, without increasing levels of urinary biomarkers of acute tubular injury. Finerenone, compared with placebo, was associated with nominal changes in the expression of 11 proteins among the 181 circulating proteins tested. Conclusions Finerenone did not affect changes in vascular stiffness but led to a significant and sustained reduction in albuminuria in patients with T2D and CKD. The clinical benefits of finerenone may result from lowering intraglomerular pressure rather than from its effect on vascular stiffness. Registration ClinicalTrial.gov (NCT05887817) and Japan Registry of Clinical Trials (jRCTs021230011). Graphical abstract This mechanistic clinical trial involving patients with T2D and CKD found that 24-week finerenone therapy did not significantly reduce CAVI from baseline compared with placebo (−0.057; 95% CI, −0.428 to 0.314), led to a 29% reduction (group ratio [finerenone vs. placebo] of 0.71) in UACR levels, and was associated with nominal changes in 11 circulating proteins (six upregulated and five downregulated) over 24 weeks. CAVI, cardio-ankle vascular index; CI, confidence interval; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; T2D, type 2 diabetes; UACR, urinary albumin-to-creatinine ratio.

Background The prevalence rates of heart failure (HF) and hyperpolypharmacy have increased with the aging population. While a negative impact of hyperpolypharmacy on HF clinical outcomes has already been reported, the effects of hyperpolypharmacy on patients with advanced HF with reduced ejection fraction (HFrEF) undergoing cardiac resynchronization therapy (CRT) remain unclear. Methods We retrospectively evaluated data from 147 patients with advanced HFrEF who underwent CRT between March 2004 and June 2020. Patients were divided into nonpolypharmacy (<5 medications) and polypharmacy (≥5 medications) groups, as well as nonhyperpolypharmacy (<10 medications) and hyperpolypharmacy (≥10 medications) groups. Results The mean age of the study population was 70.6 ± 9.7 years, and 90 patients (67.2%) were male. The median number of medications used was 10 (interquartile range: 7–13, range: 2–24); Kaplan–Meier survival analysis revealed that the hyperpolypharmacy group had a significantly worse long‐term survival rate in terms of major adverse cardiovascular events (MACE; p = 0.004) and all‐cause mortality (p = 0.005). Long‐term survival in terms of MACE and all‐cause mortality was not significantly different between the polypharmacy with cardiovascular medication and nonpolypharmacy with cardiovascular medication groups. By contrast, the polypharmacy with noncardiovascular medication group had a significantly worse long‐term survival rate in terms of MACE (p = 0.006) and all‐cause mortality (p = 0.003) than the nonpolypharmacy with noncardiovascular medication group. Conclusions Hyperpolypharmacy was significantly associated with adverse cardiovascular outcomes in patients with advanced HFrEF who underwent CRT. Noncardiovascular polypharmacy may underlie the harmful effects of hyperpolypharmacy. Hyperpolypharmacy was significantly associated with clinical outcome in patients who underwent cardiac resynchronization therapy. Noncardiovascular (CV) polypharmacy, but not CV polypharmacy, may be related to the adverse effects of hyperpolypharmacy.

Background During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, a global reduction in hospitalizations for acute myocardial infarction (AMI) was observed. Generally, patients experienced increased severity of AMI with delays in time from symptom onset to treatment during the pandemic. However, the impact of the COVID-19 pandemic on in-hospital mortality among patients with AMI remains unclear. This study aimed to compare the long-term prognosis of patients with AMI during the COVID-19 pandemic to that observed in the pre-pandemic period and to evaluate the influence of the COVID-19 pandemic on the prognosis of patients with AMI. Methods We reviewed the data of patients admitted to our hospital for AMI treatment between April 1, 2018, and March 31, 2021. The time from admission to major adverse cardiac events (MACE), as well as the time from admission to all-cause death, were examined between the pandemic period (April 1, 2020, to March 31, 2021) and the pre-pandemic period (April 1, 2018, to March 31, 2020). Results Eighty patients were included in the study, and those admitted during the pandemic exhibited a higher likelihood of advanced age, lower levels of LDL-cholesterol, and a reduced prevalence of hypertension. The 2.5-year MACE-free survival and overall survival rates between the patients during the pre-pandemic and pandemic periods were not significantly different. Conclusion The long-term prognosis of patients with AMI during the COVID-19 pandemic remains unclear. In this study, we reported that the 2.5-year MACE-free survival and overall survival rates of the patients with AMI admitted during the COVID-19 pandemic were not significantly different from those during the pre-pandemic period. The impact of the COVID-19 pandemic on the prognosis of patients with AMI appears to vary according to the study population.

Background The Shanghai Score System, which weighs electrocardiogram (ECG) findings reflecting repolarization abnormalities, has been proposed for diagnosis of early repolarization syndrome (ERS). However, recent studies have suggested the involvement of depolarization abnormalities in some ERS patients. The aim of this study was to validate the Shanghai Score System in predicting the recurrence of ventricular fibrillation (VF) in ERS patients. The predictive value of fragmented QRS (fQRS) was also investigated. Methods Fifteen consecutive ERS patients (14 males, median age of 47 years) with a history of VF were retrospectively reviewed. The Shanghai Score System points were calculated, and the presence of fQRS was evaluated. Results During the median follow‐up period of 79.2 months, five patients experienced VF recurrence. In the VF recurrence group, two patients showed augmented amplitude of J waves with horizontal ST‐segment, while the other three patients had dynamic changes in J‐wave amplitude. The Shanghai Score System points in the VF recurrence group were higher than those in the VF non‐recurrence group (6.5 [range: 5.8–6.8] vs. 4.5 [range: 4.0–4.5], p = 0.002). The presence of fQRS on standard 12‐lead ECG was more frequently observed in the VF recurrence group compared with the non‐recurrence group (100% vs. 10%, p = 0.002). Conclusions The present study demonstrated that the Shanghai Score System could effectively identify ERS patients at high risk for VF recurrence. The results also suggested that the presence of fQRS, a marker of depolarization abnormalities, may be useful for predicting VF recurrence in ERS patients.

Endothelial dysfunction may trigger coronary spastic angina (CSA). However, the risk factors for CSA in young patients remain unclear. This study aimed to investigate the age-dependent role of serum uric acid levels in patients with CSA. We enrolled 423 patients who underwent an ergonovine tolerance test during coronary angiography for the CSA evaluation. We categorized the patients as (1) young (age ≤ 65 years) CSA-positive ( n  = 33), (2) young CSA-negative ( n  = 138), (3) elderly (age > 66 years) CSA-positive ( n  = 42), and (4) elderly CSA-negative ( n  = 210) groups. In the young groups, the smoker proportion (57.6 vs. 38.4%, p  = 0.04) and serum uric acid levels (6.3 ± 1.4 vs. 5.4 ± 1.5 mg/dl, p  = 0.006) were significantly higher in the CSA-positive compared with the CSA-negative group. Conversely, in the elderly group, the male proportion (66.6 vs. 47.1%, p  = 0.02) and alcohol consumption level (40.5 vs. 21.0%, p  = 0.01) were significantly higher in the CSA-positive compared with the CSA-negative group. The multivariate analysis in young groups revealed the independent association between the serum uric acid level ( p  = 0.02) and the presence of CSA. Our results indicate that elevated serum uric acid levels may affect CSA development in young patients.

Background Variant angina (VA) is caused by reversible coronary artery spasm, which is characterized by chest pain with ST‐segment elevations on standard 12‐lead electrocardiogram (ECG) at rest. Ventricular fibrillation (VF) is often caused by VA attack, but the risk stratification is not well understood. The purpose of this study was to evaluate the impact of fragmented QRS (fQRS) on VF occurrence in VA patients. Methods Ninety‐four patients who showed ST elevation on 12‐lead ECGs with total or nearly total occlusion in response to coronary spasm provocation test were enrolled. Among them, 16 patients had documented VF before hospital admission (n = 12) or experienced VF during provocation test (n = 4) (VF occurrence group). The fQRS was defined as the presence of spikes within the QRS complex of two or more consecutive leads. Results The prevalence of fQRS was more often observed in the VF occurrence group than in the non‐VF occurrence group (63% [10/16] vs. 27% [21/78], p = 0.009). Univariate analyses revealed that age, history of syncope, QTc, and the presence of fQRS were associated with VF occurrence (p = 0.004, 0.005, 0.029, and 0.008, respectively). Furthermore, upon multivariate analyses using those risk factors, age, QTc, and fQRS predicted VF occurrence independently (p = 0.007, 0.041, and 0.014, respectively). Conclusions The present study demonstrated that fQRS in VA patients is a risk factor for VF. The fQRS may be a useful factor for the risk stratification of VF occurrence in VA patients.

Background Risk stratification for ventricular fibrillation (VF) in patients with Brugada syndrome (BrS) remains a significant clinical challenge. Atrial fibrillation (AF) is relatively common in BrS, suggesting arrhythmogenic abnormalities in both the atria and ventricles. The purpose of this study was to investigate the relationship between P‐waveforms and VF occurrence in patients with BrS. Method Eighty‐two patients with BrS were retrospectively evaluated and classified into two groups based on the occurrence of VF during the overall clinical course: VF occurrence (n = 34) and VF nonoccurrence (n = 48). The relationship between VF occurrence and parameters on 12‐lead electrocardiogram (ECG) at the initial visit, prior to any drug administration, was analyzed. Results During a median follow‐up of 75.0 months, VF occurred in 23 patients, including 19 recurrent and four new cases. Multivariable logistic regression identified notched P‐wave as an independent risk factor for VF occurrence in all models (odds ratios 6.45–8.45; all p < 0.01). Depending on the model, symptomatic BrS, early repolarization pattern, and fragmented QRS were also independently associated with VF. Kaplan–Meier analysis showed a significantly lower incidence of VF in patients with BrS who have neither a history of VF nor a notched P‐wave (p < 0.0001). Conclusions Notched P‐wave on 12‐lead ECG is a significant risk factor for the occurrence of VF in patients with BrS. Notched P‐wave in patients with BrS may indicate the presence of an underlying arrhythmogenic substrate predisposing to VF. Notched P‐waves on 12‐lead ECG are significantly associated with ventricular fibrillation in Brugada syndrome, suggesting their potential relevance in identifying patients at increased arrhythmic risk.

Overall mortality and neurologic outcome of patients treated by veno-arterial extracorporeal membrane oxygenation (V-A ECMO) was still not satisfactory. The aim of this study was to clarify the determinants of survival and favorable neurologic outcomes in patients with ischemic heart disease (IHD) treated by V-A ECMO. We identified IHD patients who received V-A ECMO, and divided those patients into the survived and the in-hospital death group. Multivariate logistic regression analysis was performed to identify the determinants of survival and favorable neurologic outcomes. Fifty-eight patients were divided into the in-hospital death group ( n  = 35) and the survived group ( n  = 23). Cardiogenic arrest for the reason for V-A ECMO introduction (vs. non-cardiac arrest: OR 0.34, 95% CI 0.002–0.65, P  = 0.03) and final thrombolysis in myocardial infarction (TIMI-3) flow grade (vs. TIMI ≤2 flow grade: OR 17.44, 95% CI 1.65–184.04, P  = 0.02) were determinants of in-hospital survival. Time from collapse to initiation of V-A ECMO was inversely associated with favorable neurologic function (10 min increase; OR 0.49, 95% CI 0.28–0.89, P  = 0.02), while final TIMI-3 flow grade was not associated with favorable neurologic function. In conclusion, the rapid establishment of V-A ECMO system as well as obtaining TIMI-3 flow grade should be sought for better survival with maintaining neurological function in IHD patients who requires V-A ECMO.

The prognosis of patients with acute myocardial infarction (AMI) in the initial stage of the coronavirus disease 2019 (COVID-19) outbreak has been reported globally. However, the reports on the prognosis of patients with AMI after the initial stage of the pandemic are limited worldwide. This retrospective observational study utilized data from the electronic medical records system of the Oita University Hospital. This study encompassed patients who were hospitalized at our hospital for AMI treatment between April 2018 and June 2022. The study period was categorized into the following three periods: the pre-pandemic period (April 2018 to March 2020), the first phase of the pandemic (April 2020 to March 2021), and the second phase of the pandemic (April 2021 to June 2022). The primary outcome was the duration from the initial admission for AMI treatment to the onset of major adverse cardiac events (MACE). The secondary outcome was the duration from the initial admission for AMI treatment to death from any cause. These outcomes were compared among patients with AMI admitted during the three periods. The one-year MACE-free survival rates did not differ significantly among the three periods (p = 0.146), whereas the one-year overall survival rates were significantly different (p = 0.022). Univariate Cox regression analysis showed that patients with AMI had poorer overall survival in the second phase of the COVID-19 pandemic compared to the pre-pandemic period (hazard ratio {HR}: 4.92, 95% confidence interval {CI}: 1.27-19.09, p = 0.021). However, multiple regression analysis did not show significant differences in the overall survival of patients with AMI across the three periods (HR: 2.77, 95% CI: 0.59-12.96, p = 0.196). The long-term impact of the COVID-19 pandemic on the prognosis of patients with AMI remains unclear. Further research is required to clarify the long-term impact by using larger cohorts that include pre-hospital data.