Coronary artery disease (CAD) remains a leading cause of mortality and morbidity in developed countries. Although urgent revascularization is the cornerstone of management of acute coronary syndrome ...(ACS), for patients with stable CAD recent large-scale clinical trials indicate that a mechanical ‘fix’ of a narrowed artery is not obviously beneficial; ACS and stable CAD are increasingly recognized as different clinical entities. We review the perspectives on (1) modifying the diagnostic pathway of stable CAD with the incorporation of modern estimates of pretest probability, (2) non-imaging evaluations based on their availability, (3) the optimal timing of invasive coronary angiography and revascularization, and (4) the implementation of medical therapy during the work-up.
Cardioembolic stroke accounts for over 20% of ischemic strokes and is associated with worse outcomes than other types of strokes. Atrial fibrillation (AF) is the most common risk factor for ...cardioembolic stroke. In this narrative review, we present an update about cardioembolic stroke mainly related to AF and atrial cardiopathy. Direct oral anticoagulants (DOACs) have revolutionized stroke prevention in patients with AF; however, their efficacy in preventing recurrent embolic stroke of unknown source remains uncertain. Various cardiac monitoring methods are used to detect AF, which is crucial for preventing stroke recurrence. DOACs are preferred over warfarin for AF-related stroke prevention; however, the timing of initiation after acute ischemic stroke is debated. Resuming anticoagulation after intracerebral hemorrhage in AF patients requires careful assessment of the risks. While catheter ablation may reduce the incidence of cardiovascular events, its effect on stroke prevention is unclear, especially in heart failure patients. Atrial cardiopathy is the emerging cause of embolic stroke of unknown source, which indicates atrial structural and functional disorders that can precede AF. Future research should focus on refining stroke risk prediction models, optimizing AF detection, understanding the roles of ablation and anticoagulation in stroke prevention, and establishing atrial cardiopathy as a therapeutic target, which could significantly reduce the burden of stroke.
The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for ...patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes during a median of 3.2 years. Extended follow-up for mortality is ongoing.
ISCHEMIA participants were randomized to an initial invasive strategy added to guideline-directed medical therapy or a conservative strategy. Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and noncardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models, and Bayesian methods. Undetermined deaths were classified as cardiovascular as prespecified in the trial protocol.
Baseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23% women, 16% Hispanic, 4% Black, 42% with diabetes, and median ejection fraction 0.60. A total of 557 deaths accrued during a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 noncardiovascular deaths, and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate, 12.7% in invasive strategy, 13.4% in conservative strategy; adjusted hazard ratio, 1.00 95% CI, 0.85-1.18). There was a lower 7-year rate cardiovascular mortality (6.4% versus 8.6%; adjusted hazard ratio, 0.78 95% CI, 0.63-0.96) with an initial invasive strategy but a higher 7-year rate of noncardiovascular mortality (5.6% versus 4.4%; adjusted hazard ratio, 1.44 95% CI, 1.08-1.91) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease.
There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years.
URL: https://www.
gov; Unique identifier: NCT04894877.
This study aimed to evaluate the early and mid-term outcomes of transcatheter aortic valve implantation (TAVI) and to assess valve durability. A total of 146 consecutive patients who underwent TAVI ...for severe aortic stenosis between October 2013 and August 2018 were retrospectively reviewed. All patients (mean age, 84 ± 6 years; age range 53–98 years; 42 males 28.7%) had multiple comorbidities, with a mean logistic EuroSCORE of 30.9 ± 17.4%. Eighteen patients (12.3%) were aged 90 years or over. Five in-hospital deaths (3.4%) occurred, and 36 patients (24.7%) experienced major TAVI-related complications. With the transfemoral approach, 10 patients had major vascular complications, which mostly occurred with first-generation devices (
n
= 9) but less commonly with new-generation low-profile devices (
P
= 0.0078). During a follow-up period of 580 ± 450 (11–1738) days, 29 late deaths occurred. The survival rate was 86.0%, 78.0%, and 61.7% at 1, 2, and 3 years, respectively. Multivariate Cox hazard regression analysis revealed that more-than-moderate tricuspid regurgitation was the only independent risk factor for late deaths due to any cause (hazard ratio, 3.145; 95% confidence interval, 1.129–8.762;
P
= 0.0283). No statistically significant differences between post-TAVI before discharge from the hospital and at 4 years after TAVI were observed with respect to aortic valve area (1.76 ± 0.49 cm
2
vs. 1.64 ± 0.38 cm
2
;
P
= 0.1871) and mean pressure gradient (10.0 ± 4.6 mmHg vs. 7.9 ± 3.3 mmHg;
P
= 0.5032). TAVI was a feasible method with acceptable early and mid-term outcomes and valve durability for at least 4 years in poor-risk patients. Further close follow-up is essential to evaluate late outcomes and valve durability.
The Japanese Ministry of Health, Labour and Welfare approved a drug called borofalan (10B), a treatment system, and a dose calculation program for boron neutron capture therapy (BNCT) in March 2020. ...The application pertaining to the products submitted to the Pharmaceuticals and Medical Devices Agency was supported by a Japanese, open‐label, uncontrolled trial (Study 002) in patients with unresectable, locally recurrent head and neck squamous cell carcinoma after chemoradiotherapy or radiotherapy, or in those with unresectable locally advanced or locally recurrent (LA/LR) head and neck nonsquamous cell carcinoma. The drug was administered as a single intravenous dose using infusion rates of 200 mg/kg per hour for the first 2 hours after the start of administration and 100 mg/kg per hour during irradiation. Neutron irradiation was performed using the devices at a single dose of 12 Gy‐equivalent for oral, pharyngeal, or laryngeal mucosa for up to 60 minutes from 2 hours after the start of drug administration. The primary endpoint was the overall response rate (ORR). The results of Study 002 showed that the ORR based on an assessment of the Independent Central Review Committee per RECIST version 1.1 was 71.4% (90% confidence interval CI, 51.3%–86.8%). The lower limit of the 90% CI exceeded the prespecified threshold for ORR. When BNCT is applied to patients with unresectable LA/LR head and neck cancer, precautions should be taken, and patients should be monitored for possible onset of dysphagia, brain abscess, skin disorder, crystal urine, cataract, and/or carotid hemorrhage.
Implications for Practice
Borofalan (10B), a treatment system and a dose calculation program for boron neutron capture therapy (BNCT), demonstrated significant efficacy in an open‐label, uncontrolled trial in which overall response rate was the primary endpoint for patients with unresectable locally advanced or locally recurrent head and neck cancer. Although no information about survival benefits was obtained, BNCT will become an effective treatment option that is expected to manage local lesions that are intractable with any standard therapy. In addition, BNCT is expected to maintain quality of life of the intended patient population, on account of its high tumor selectivity and low invasiveness.
This article summarizes the regulatory review of data leading to the approval of borofalan in Japan.
Background: Patients with refractory cardiogenic shock (CS) necessitating peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) often require an intra-aortic balloon pump (IABP) or ...Impella for unloading; however, comparative effectiveness data are currently lacking.Methods and Results: Using Diagnosis Procedure Combination data from approximately 1,200 Japanese acute care hospitals (April 2018–March 2022), we identified 940 patients aged ≥18 years with CS necessitating peripheral VA-ECMO along with IABP (ECMO-IABP; n=801) or Impella (ECPella; n=139) within 48 h of admission. Propensity score matching (126 pairs) indicated comparable in-hospital mortality between the ECPella and ECMO-IABP groups (50.8% vs. 50.0%, respectively; P=1.000). However, the ECPella cohort was on mechanical ventilator support for longer (median interquartile range 11.5 5.0–20.8 vs. 9.0 4.0–16.8 days; P=0.008) and had a longer hospital stay (median interquartile range 32.5 12.0–59.0 vs. 23.0 6.3–43.0 days; P=0.017) than the ECMO-IABP cohort. In addition, medical costs were higher for the ECPella than ECMO-IABP group (median interquartile range 9.09 7.20–12.20 vs. 5.23 3.41–7.00 million Japanese yen; P<0.001).Conclusions: Our nationwide study could not demonstrate compelling evidence to support the superior efficacy of Impella over IABP in reducing in-hospital mortality among patients with CS necessitating VA-ECMO. Further investigations are imperative to determine the clinical situations in which the potential effect of Impella can be maximized.
The electronics fields face serious problems associated with electric power; these include the development of ecologically friendly power-generation systems and ultralow-power-consuming circuits. ...Moreover, there is a demand for developing new power-transmission methods in the imminent era of ambient electronics, in which a multitude of electronic devices such as sensor networks will be used in our daily life to enhance security, safety and convenience. We constructed a sheet-type wireless power-transmission system by using state-of-the-art printing technologies using advanced electronic functional inks. This became possible owing to recent progress in organic semiconductor technologies; the diversity of chemical syntheses and processes on organic materials has led to a new class of organic semiconductors, dielectric layers and metals with excellent electronic functionalities. The new system directly drives electronic devices by transmitting power of the order of tens of watts without connectors, thereby providing an easy-to-use and reliable power source. As all of the components are manufactured on plastic films, it is easy to place the wireless power-transmission sheet over desks, floors, walls and any other location imaginable.
Nivolumab is an immune-checkpoint inhibitor (ICI) that can induce unique treatment-related toxicities, such as immune-related adverse events (irAEs). Myocarditis is a serious irAE with an incidence ...between 0.06% and 1.14%. Although the peak onset of irAE is generally within three months from the start of treatment, we experienced an autopsy case of late-onset fulminant myocarditis caused by nivolumab in Epstein Barr virus-associated gastric cancer. Pathological complete remission of the primary lesion was confirmed by the autopsy. We should consider possible complications of cardiac irAEs, especially fulminant myocarditis, even beyond three months after starting ICI therapy.
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