Current Balloon Devices for Ablation of Atrial Fibrillation.

Balloon-based catheter ablation is a valuable option for the treatment of atrial fibrillation (AF) because contiguous lesions can be created to achieve pulmonary vein isolation (PVI), and the method is less dependent than traditional ablation methods on the operator's skill and experience. Cryoballoon ablation is used universally worldwide, with its efficacy and safety being comparable to the efficacy and safety of standard radiofrequency ablation, and the procedure can be completed in a relatively short time. Hot balloon ablation was developed in Japan. The balloon maintains its compliance even during the energy delivery, and a large areal ablation lesion is created. Furthermore, the hot balloon system is the only system for which oesophageal cooling is a standard feature. Laser balloon ablation, which is performed under direct endoscopic vision, has proven to be effective and safe for achieving a PVI. The laser balloon system provides an improved field of view and automated circumferential ablation for a rapid and effective PVI. The authors have reviewed the currently available balloon systems as used for AF ablation, i.e., PVI, and have provided detailed insight and perspectives on the currently available cryoballoon and hot balloon technologies, plus laser balloon technology.

Guideline for gynecological practice in Japan: Japan Society of Obstetrics and Gynecology and Japan Association of Obstetricians and Gynecologists 2023 edition.

Twelve years after the first edition of The Guideline for Gynecological Practice, which was jointly edited by The Japan Society of Obstetrics and Gynecology and The Japan Association of Obstetricians and Gynecologists, the 5th Revised Edition was published in 2023. The 2023 Guidelines includes 5 additional clinical questions (CQs), which brings the total to 103 CQ (12 on infectious disease, 30 on oncology and benign tumors, 29 on endocrinology and infertility and 32 on healthcare for women). Currently, a consensus has been reached on the Guidelines, and therefore, the objective of this report is to present the general policies regarding diagnostic and treatment methods used in standard gynecological outpatient care that are considered appropriate. At the end of each answer, the corresponding Recommendation Level (A, B, C) is indicated.

Laparoscopic Sacrohysteropexy for Pelvic Organ Prolapse and the Technique Used for Uterine Preservation: A Case Report.

Pelvic organ prolapse (POP) is prevalent among middle-aged and older women, and its prevalence is expected to increase in Japan in the future. Laparoscopic surgery for POP is covered by insurance and is currently a minimally invasive procedure. There are multiple treatment approaches for the uterus, especially sacrohysteropexy, for patients who wish to preserve their uterus. This approach requires an understanding of its anatomical characteristics, including how the arm is threaded. However, specific techniques for uterine preservation have not yet been thoroughly investigated or reported. Here, we discuss the innovative operative techniques for uterine preservation and mesh application achieved by laparoscopic sacrohysteropexy performed at our hospital. A 34-year-old woman presented at our hospital with a uterine prolapse in the hope of undergoing laparoscopic sacrohysteropexy. The anterior vaginal wall was dissected, the mesh fixed, and the right and left intrauterine foramina next to the cervix were deployed and released. The anterior vaginal wall mesh penetrated the released mesentery and was integrated with the mesh of the posterior vaginal wall. It was fixed to the anterior aspect of the cape angle by using a subperitoneal tunnel. This surgical case is currently under follow-up, with no recurrence to date. We elaborate upon the ingenious insertion site of the port for the preservation of the uterus, the secure fixation of the mesh to the uterus, and the traction method. Unlike laparoscopic sacrocolpopexy and sacrocervicopexy, laparoscopic sacrohysteropexy necessitates at least the aforementioned techniques. At our institution, we perform sacrohysteropexy following the method outlined in this case. A more efficient technique is expected to emerge as larger-scale studies accumulate additional cases, ultimately leading to widespread acceptance and standardization of the approach.

[Investigation of the Correlation between Patient Characteristics and Contrast Enhancement during Hepatic Dynamic CT Scan: Comparison by the Sex].

The purpose of this study was to investigate the correlation between patient characteristics and contrast enhancement during the hepatic arterial phase (HAP) and portal venous phase (PVP) CT scanning. All were examined using a hepatic dynamic CT protocol; the scanning parameters were tube voltage 120 kVp, tube current 50 to 600 mA (noise index 8.0 HU), 0.5-s rotation, 5-mm detector row width, 0.813 or 0.825 beam pitch, and the contrast material 600 mg/kg iodine. We calculated contrast enhancement (per gram of iodine: ΔHU/gI) of the abdominal aorta during the HAP and that of the hepatic parenchyma during the PVP. There was a significant difference in the contrast enhancement of the abdominal aorta during the HAP (8.6±2.7 ΔHU/gI) and (9.5±1.7 ΔHU/gI) and that of the hepatic parenchyma during the PVP (1.4±0.5 ΔHU/gI) and (2.9±0.5 ΔHU/gI) between male and female patients (p<0.05). A significant positive correlation was seen between the ΔHU/gI of aortic enhancement and age in male and female patients (r=-0.382 and 0.213) (p<0.05). A significant inverse correlation was observed between the ΔHU/gI of aortic enhancement and the height (HT; r=-0.466 and -0.251), total body weight (TBW; r=-0.609 and -0.535), body mass index (BMI; r=-0.505 and -0.465), lean body weight (LBW; r=-0.642 and -0.576), and body surface area (BSA; r=-0.644 and -0.557) (p<0.05 for all) in male and female patients. A significant positive correlation was seen between the ΔHU/gI of hepatic parenchymal enhancement and the patient age in male and female patients (r=0.258 and 0.150) (p<0.05). A significant inverse correlation was observed between the ΔHU/gI of hepatic parenchymal enhancement and the HT (r=-0.487 and -0.321), TBW (r=-0.580 and -0.525), BMI (r=-0.473 and -0.413), LBW (r=-0.615 and -0.576) (p<0.05 for all), and BSA (r=-0.617 and -0.558) in male and female patients. The BSA was significantly correlated with the ΔHU/gI of aortic and hepatic parenchymal enhancement of the hepatic dynamic CT in male patients. However, LBW was significantly correlated with the ΔHU/gI of aortic and hepatic parenchymal enhancement of the hepatic dynamic CT in female patients. Since the patient factors that affect the contrast enhancement of the abdominal aorta and hepatic parenchyma may differ from facility to facility, we should therefore consider reassessing at each facility.

A 70-year-old Woman with Asymptomatic Ferroportin Disease.

A 59-year-old Japanese woman presented with hyperferritinemia. We decided against iron removal treatment because there were no symptoms or signs of iron-induced organ damage. A follow-up study revealed a gradual increase in transferrin saturation. The patient underwent a second examination at 66 years old. A liver biopsy showed substantial iron deposits in hepatocytes and Kupffer cells but no inflammation or fibrosis. Serum hepcidin-25 levels were highly parallel with hyperferritinemia. A genetic analysis revealed a G80S mutation in SLC40A1. These features are compatible with those of ferroportin disease. The patient remained asymptomatic at 70 years old, suggesting that the iron-loading condition may have been benign.

Efficient Surface Passivation of Ti-Based Layered Materials by a Nonfluorine Branched Copolymer for Durable and High-Power Sodium-Ion Batteries.

There is a crucial need for low-cost energy storage technology based on abundant sodium ions to realize sustainable development with renewable energy resources. Poly(vinylidene fluoride) (PVDF) is applied as a binder in sodium-ion batteries (SIBs). Nevertheless, PVDF is also known to suffer from a larger irreversible capacity, especially when PVDF is used as the binder of negative electrode materials. In this research, a poly(acrylonitrile)-grafted poly(vinyl alcohol) copolymer (PVA-g-PAN) is tested as a binder with Ti-based layered oxides as potential negative electrode materials for SIBs. The chemical stability tests of PVDF and PVA-g-PAN contacted with metallic sodium have been conducted, which reveals that PVDF experiences a defluorination process, while PVA-g-PAN demonstrates excellent chemical stability. Composite electrodes with PVA-g-PAN demonstrate superior electrochemical performances when compared with the PVDF binder, allowing improvement for initial CE, higher rate capability, and long cyclability over 1500 cycles. Detailed characterization of electrodes via soft X-ray photoelectron spectroscopy and field emission scanning electron microscopy demonstrates that the PVA-g-PAN branched structure allows a more uniform distribution of acetylene black with higher coatability, unlocking enhanced rate performances and efficient passivation of Ti-based oxides without the excessive electrolyte decomposition. These findings open a new way to design practical and durable sodium-ion batteries with a high-power density.

Cardiovascular Outcomes after Paclitaxel-Coated Balloon Angioplasty versus Drug-Eluting Stent Placement for Acute Coronary Syndrome: A Systematic Review and Meta-Analysis.

Background: We conducted a systematic review and meta-analysis to examine the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo lesions in patients with acute coronary syndrome (ACS) by comparing with drug-eluting stent (DES) placement. Methods: By a systematic literature search, nine (five randomized controlled, two retrospective propensity-score matched, and two retrospective baseline-balanced) studies comparing the midterm clinical and angiographic outcomes after PCB angioplasty and DES placement were included, yielding 974 and 1130 ACS cases in PCB and DES groups, respectively. Major adverse cardiac event (MACE) was defined as a composite of cardiac mortality (CM), all-cause mortality (ACM), myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). Late luminal loss (LLL) and bleeding events (BLD) were also estimated. Results: The frequencies of MACE in PCB and DES groups were 8.42% and 10.62%, respectively. PCB angioplasty had no significant impacts on all of MACE (risk ratio: 0.90, 95%CI: 0.68-1.18, p = 0.44), CM, ACM, MI, TVR, TLR, BLD, and LLL, compared to DES placement in random-effects model. Conclusions: The present systematic review and meta-analysis showed the feasibility of PCB angioplasty for the de novo lesions in patients with ACS in comparison with DES placement by the emergent procedures.

A Revised Classification of Primary Iron Overload Syndromes.

Background and Aims: The clinical introduction of hepcidin25 (Hep25) has led to a more detailed understanding of its relationship with ferroportin (FP) and divalent metal transporter1 in primary iron overload syndromes (PIOSs). In 2012, we proposed a classification of PIOSs based on the Hep25/FP system, which consists of prehepatic aceruloplasminemia, hepatic hemochromatosis (HC), and posthepatic FP disease (FP-D). However, in consideration of accumulated evidence on PIOSs, we aimed to renew the classification. Methods: We reviewed the 2012 classification and retrospectively renewed it according to new information on PIOSs. Results: Iron-loading anemia was included in PIOSs as a prehepatic form because of the newly discovered erythroferrone-induced suppression of Hep25, and the state of traditional FP-D was remodeled as the BIOIRON proposal. The key molecules responsible for prehepatic PIOSs are low transferrin saturation in aceruloplasminemia and increased erythroferrone production by erythroblasts in iron-loading anemia. Hepatic PIOSs comprise four genotypes of HC, in each of which the synthesis of Hep25 is inappropriately reduced in the liver. Hepatic Hep25 synthesis is adequate in posthepatic PIOSs; however, two mutant FP molecules may resist Hep25 differently, resulting in SLC40A1-HC and FP-D, respectively. PIOS phenotypes are diagnosed using laboratory tests, including circulating Hep25, followed by suitable treatments. Direct sequencing of the candidate genes may be outsourced to gene centers when needed. Laboratory kits for the prevalent mutations, such as C282Y, may be the first choice for a genetic analysis of HC in Caucasians. Conclusions: The revised classification may be useful worldwide.

An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).

Aspirin-free strategy for percutaneous coronary intervention in acute coronary syndrome based on the subtypes of acute coronary syndrome and high bleeding risk: the STOPDAPT-3 trial.

BACKGROUND AND AIMS: High bleeding risk (HBR) and acute coronary syndrome (ACS) subtypes are critical in determining bleeding and cardiovascular event risk after percutaneous coronary intervention (PCI). METHODS AND RESULTS: In 4476 ACS patients enrolled in the STOPDAPT-3, where the no-aspirin and dual antiplatelet therapy (DAPT) strategies after PCI were randomly compared, the pre-specified subgroup analyses were conducted based on HBR/non-HBR and ST-segment elevation myocardial infarction (STEMI)/non-ST-segment elevation ACS (NSTE-ACS). The co-primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke at 1 month. Irrespective of the subgroups, the effect of no-aspirin compared with DAPT was not significant for the bleeding endpoint (HBR [N = 1803]: 7.27 and 7.91%, hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.65-1.28; non-HBR [N = 2673]: 3.40 and 3.65%, HR 0.93, 95% CI 0.62-1.39; Pinteraction = 0.94; STEMI [N = 2553]: 6.58 and 6.56%, HR 1.00, 95% CI 0.74-1.35; NSTE-ACS [N = 1923]: 2.94 and 3.64%, HR 0.80, 95% CI 0.49-1.32; Pinteraction = 0.45), and for the cardiovascular endpoint (HBR: 7.87 and 5.75%, HR 1.39, 95% CI 0.97-1.99; non-HBR: 2.56 and 2.67%, HR 0.96, 95% CI 0.60-1.53; Pinteraction = 0.22; STEMI: 6.07 and 5.46%, HR 1.11, 95% CI 0.81-1.54; NSTE-ACS: 3.03 and 1.71%, HR 1.78, 95% CI 0.97-3.27; Pinteraction = 0.18). CONCLUSION: In patients with ACS undergoing PCI, the no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of HBR and ACS subtypes. The numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events was observed in patients with HBR and in patients with NSTE-ACS.

Aspirin-Free Strategy for Percutaneous Coronary Intervention in Patients With Oral Anticoagulation: Prespecified Subgroup Analysis From the STOPDAPT-3 Trial.

BACKGROUND: The effects of aspirin-free strategy on bleeding and cardiovascular events in patients undergoing percutaneous coronary intervention with oral anticoagulation (OAC) have not been fully elucidated. METHODS AND RESULTS: We conducted the prespecified subgroup analysis based on the use of OAC, including vitamin K antagonist and direct oral anticoagulants, within 7 days before percutaneous coronary intervention in the STOPDAPT-3 (Short and Optimal Duration of Dual Antiplatelet Therapy-3) trial, which randomly compared prasugrel monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The coprimary end points were major bleeding events (Bleeding Academic Research Consortium types 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. Among 5966 study patients, there were 530 patients (8.9%) with OAC (no aspirin: N=248, and DAPT: N=282) and 5436 patients (91.1%) without OAC (no aspirin: N=2736, and DAPT: N=2700). Regardless of the use of OAC, the effects of no aspirin compared with DAPT were not significant for the bleeding end point (OAC: 4.45% and 4.27%, hazard ratio [HR], 1.04 [95% CI, 0.46-2.35]; no-OAC: 4.47% and 4.75%, HR, 0.94 [95% CI, 0.73-1.20]; P for interaction=0.82), and for the cardiovascular end point (OAC: 4.84% and 3.20%, HR, 1.53 [95% CI, 0.64-3.62]; no-OAC: 4.06% and 3.74%, HR, 1.09 [95% CI 0.83-1.42]; P for interaction =0.46). CONCLUSIONS: The no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of the use of OAC. There was a numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events in patients with OAC.

Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial.

The current guidelines for acute coronary syndrome (ACS) discourage the use of anticoagulation after percutaneous coronary intervention (PCI) without specific indications, although the recommendation is not well supported by evidence. In this post hoc analysis of the ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3) trial, 30-day outcomes were compared between the 2 groups with and without post-PCI heparin administration among patients with ACS who did not receive mechanical support devices. The co-primary end points were the bleeding end point, defined as the Bleeding Academic Research Consortium type 3 or 5 bleeding, and the cardiovascular end point, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Among 4,088 patients with ACS, 2,339 patients (57.2%) received post-PCI heparin. The proportion of patients receiving post-PCI heparin was higher among those with ST-elevation myocardial infarction compared with others (72.3% and 38.8%, p <0.001), and among patients with intraprocedural adverse angiographic findings compared with those without (67.6% and 47.5%, p <0.001). Post-PCI heparin compared with no post-PCI heparin was associated with a significantly increased risk of the bleeding end point (4.75% and 2.52%, adjusted hazard ratio 1.69, 95% confidence interval 1.15 to 2.46, p = 0.007) and a numerically increased risk of the cardiovascular end point (3.16% and 1.72%, adjusted hazard ratio 1.56, 95% confidence interval 0.98 to 2.46, p = 0.06). Higher hourly dose or total doses of heparin were also associated with higher incidence of both bleeding and cardiovascular events within 30 days. In conclusion, post-PCI anticoagulation with unfractionated heparin was frequently implemented in patients with ACS. Post-PCI heparin use was associated with harm in terms of increased bleeding without the benefit of reducing cardiovascular events. Trial identifier: STOPDAPT-3 ClinicalTrials.gov number, NCT04609111.

A novel ryanodine receptor 2 inhibitor, M201-A, enhances natriuresis, renal function and lusi-inotropic actions: Preclinical and phase I study.

BACKGROUND AND PURPOSE: The ryanodine receptor 2 (RyR2) is present in both the heart and kidneys, and plays a crucial role in maintaining intracellular Ca2+ homeostasis in cells in these organs. This study aimed to investigate the impact of M201-A on RyR2, as well as studying its effects on cardiac and renal functions in preclinical and clinical studies. EXPERIMENTAL APPROACH: Following the administration of M201-A (1,4-benzothiazepine-1-oxide derivative), we monitored diastolic Ca2+ leak via RyR2 and intracellular Ca2+ concentration in isolated rat cardiomyocytes and in cardiac and renal function in animals. In a clinical study, M201-A was administered intravenously at doses of 0.2 and 0.4 mg·kg-1 once daily for 20 min for four consecutive days in healthy males, with the assessment of haemodynamic responses. KEY RESULTS: In rat heart cells, M201-A effectively inhibited spontaneous diastolic Ca2+ leakage through RyR2 and exhibited positive lusi-inotropic effects on the rat heart. Additionally, it enhanced natriuresis and improved renal function in dogs. In human clinical studies, when administered intravenously, M201-A demonstrated an increase in natriuresis, glomerular filtration rate and creatinine clearance, while maintaining acceptable levels of drug safety and tolerability. CONCLUSIONS AND IMPLICATIONS: The novel drug M201-A inhibited diastolic Ca2+ leak via RyR2, improved cardiac lusi-inotropic effects in rats, and enhanced natriuresis and renal function in humans. These findings suggest that this drug may offer a potential new treatment option for chronic kidney disease and heart failure.