Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7 months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

Biomarkers for Risk Stratification in Patients With Type A Acute Aortic Dissection.

Type A acute aortic dissection (AAD) is a fatal disease and thus, accurate and objective risk stratification is essential. In this study, we evaluated the prognostic value of readily available and assessable biomarkers in patients with type A AAD. This was a retrospective, multicenter, observational study. A total of 703 patients with type A AAD diagnosed using contrast-enhanced computed tomography were included. Therapeutic strategies were left to the physician's discretion in a real-world clinical setting. The prognostic value for in-hospital mortality was examined in 15 circulating biomarkers on admission, which are routinely available in clinical practice. Of the 703 patients, 126 (17.9%) died during the hospitalization. Of the 15 biomarkers, the multivariable analysis identified positive cardiac troponin, a low total bilirubin (T-Bil) level, and increased levels of brain natriuretic peptide (BNP) and lactate dehydrogenase (LDH) as significant predictors of in-hospital death. The receiver operating characteristics curve analysis showed that these 4 biomarkers had an independent additive prognostic value. With the cut-off values of T-Bil, BNP, and LDH, in combination with positive troponin, the increase in the number of positive biomarkers was progressively associated with higher in-hospital mortality from 1.3% to 9.8%, 20.5%, 36.4%, and 75.0% (p <0.001). In conclusion, in patients with type A AAD, positive cardiac troponin, a low T-Bil level, and increased levels of BNP and LDH on admission were related to higher in-hospital mortality, with an incremental prognostic value, suggesting that the readily available and assessable biomarkers can aid in decision-making in therapeutic strategies.

Clinical characteristics and outcomes in patients with acute type A aortic intramural hematoma.

BACKGROUND: Although type A acute aortic dissection (AAD) including classic double-channel aorta and intramural hematoma (IMH) is a life-threatening condition, the prognostic impact and predictors of IMH remain to be established. The present study evaluated the prevalence, baseline characteristics, and outcomes of IMH as compared with classic non-thrombosed type A AAD. METHODS: This multicenter registry in Japan retrospectively included 703 patients with type A AAD. IMH was defined as a crescentic or circular area along the ascending aortic wall without contrast enhancement on computed tomography (CT). Non-thrombosed type A AAD was defined as the classic double-channel ascending aorta on contrast-enhanced CT. The primary endpoint was in-hospital mortality. RESULTS: Of the 703 patients with type A AAD, 312 (44.3%) had IMH. Older age was an only baseline patient factor significantly associated with the presence of IMH in the multivariable analysis. The longitudinal extent of dissection was greater in patients with classic non-thrombosed AAD than those with IMH, resulting in an increased risk of end-organ malperfusion in the classic AAD group. During the hospitalization, 41 (13.1%) and 85 (21.7%) patients with and without IMH died (p < 0.001). IMH was associated with lower in-hospital mortality in a multivariable model, irrespective of age and the implementation of surgery. CONCLUSIONS: The present study showed that IMH on CT was frequent among patients with type A AAD. Although IMH was more likely to be present in the elderly, its effect on the better survival was independent of age and surgical treatment.

Stent Implantation and Thromboendarterectomy for the Common Femoral Artery in Real-World Practice.

PURPOSE: To compare the outcomes of thromboendarterectomy (TEA) and endovascular therapy (EVT) with stenting for patients with atherosclerotic common femoral artery (CFA) occlusive disease. MATERIALS AND METHODS: From a retrospective registry of 1193 consecutive patients with CFA treatment performed between 2018 and 2020 at 66 institutions in Japan, we identified patients who underwent TEA (n=432) or stent implantation (n=157). The primary outcome measures were the 1-year primary patency of TEA versus stenting with propensity score matching. The secondary outcome measures were perioperative complications, length of hospital stay, any reintervention, limb salvage, and overall survival. Interaction analysis for primary patency was performed with propensity score stratification to determine the appropriate target population for CFA stenting. RESULTS: Propensity score matching extracted 101 pairs (101 patients in the EVT group and 253 patients in the TEA group). The 1-year primary patency rate was significantly higher in the TEA cohort (92.8% vs 84.6%, p=0.006). The freedom from reintervention rate was also significantly higher in the TEA cohort (94.0% vs 89.9%, p=0.030). However, the 1-year limb salvage (98.7% vs 100.0%, p=0.32), 1-year overall survival (90.8% vs 85.0%, p=0.14), and frequency of perioperative complications were not significantly different between the cohorts (6.9% vs 14.2%, p=0.10). Based on interaction analysis, the superiority of TEA over EVT in terms of patency was less apparent in patients with advanced age and chronic heart failure. CONCLUSIONS: Thromboendarterectomy was superior to stenting in terms of primary patency and freedom from revascularization at 1 year. There was no significant difference in the incidence of perioperative complications between both groups. Thromboendarterectomy may be recommended as the standard treatment strategy for patients with atherosclerotic CFA disease, whereas stenting may be considered for patients with advanced age and chronic heart failure. CLINICAL IMPACT: Thromboendarterectomy compared to stenting was the preferred revascularization strategy for patients with CFA disease in terms of primary patency and freedom from target lesion revascularization during the 1st year. The difference was attenuated in subgroups with advanced age (85 years or older) or chronic heart failure, thus stenting may be considered in patients with these backgrounds.

Right versus left coronary artery involvement in patients with type A acute aortic dissection.

BACKGROUND: Type A acute aortic dissection (AAD) complicated by coronary malperfusion is a life-threatening disease. In the present study, we compared the clinical characteristics and prognostic impact of treatment strategies including surgical treatment and percutaneous coronary intervention (PCI) in type A AAD patients with RCA and LCA involvement. METHODS: This multicenter registry included 220 patients with type A AAD and either RCA or LCA involvement. Treatment strategies were left to treating physicians. The primary endpoint was in-hospital death. RESULTS: Of 220 patients, 115 (52.3%) and 105 (47.7%) had RCA and LCA involvement. Patients with LCA involvement were more1 likely to present with Killip class IV on admission than those with RCA involvement. Coronary angiography was performed in 52 of 220 (23.6%) patients, among whom 39 (75.0%) underwent subsequent PCI. During the hospitalization, 93 (42.3%) patients died. Patients with LCA involvement had an increased risk of in-hospital mortality compared to those with RCA involvement (54.3% vs. 31.3%, p < 0.001). In patients with RCA involvement, multivariable analysis identified Killip class IV and no surgical treatment as predictors of in-hospital death, while PCI and surgical treatment were indicated as factors associated with lower in-hospital mortality in patients with LCA involvement. CONCLUSIONS: The rates of RCA and LCA involvement were similar in type A AAD. Immediate PCI as a bridge to subsequent surgical treatment might improve survival in patients with type A AAD complicated by coronary malperfusion, especially in those with LCA involvement.

Prognostic Impact of Branch Vessel Involvement on Computed Tomography versus Clinical Presentation of Malperfusion in Patients With Type a Acute Aortic Dissection.

Type A acute aortic dissection (AAD) is a life-threatening disease. The use of contrast-enhanced computed tomography (CT) for diagnosing AAD has increased, and CT can provide pathophysiologic information on dissection such as intramural hematoma (IMH), longitudinal extent of dissection, and branch vessel involvement. However, the prognostic impact of these CT findings is poorly investigated. This multicenter registry included 703 patients with type A AAD. The longitudinal extent of dissection and IMH was determined on CT. Branch vessel involvement was defined as dissection extended into coronary, cerebral, and visceral arteries on CT. The evidence of malperfusion was defined based on clinical presentations. The primary endpoint was in-hospital death. Of 703 patients, 126 (18%) died during hospitalization. Based on contrast-enhanced CT findings, longitudinal extent of dissection was not associated with in-hospital death, while patients with IMH had lower in-hospital mortality than those without (13% vs 22%, p = 0.004). Coronary, cerebral, and visceral artery involvement on CT was found in 6%, 55%, and 32%. In patients with coronary artery involvement, 90% had clinical coronary malperfusion, while only 25% and 21% of patients with cerebral and visceral artery involvement had clinical evidence of corresponding organ malperfusion. Multivariable analysis showed evidence of malperfusion as a significant factor associated with in-hospital mortality. In conclusions, branch vessel involvement on CT was not always associated with end-organ malperfusion in patients with type A AAD, especially in cerebral and visceral arteries. Clinical evidence of malperfusion was significantly associated with in-hospital mortality beyond branch vessel involvement on CT.

Bacterial keratoconjunctivitis caused by Staphylococcus argenteus belonging to sequence type 1223 isolated in Japan.

Staphylococcus argenteus, characterized by the formation of non-pigmented (white) colonies, was recently identified as a new lineage separated from Staphylococcus aureus. However, correct identification of this lineage is difficult because of the similar characteristics to S. aureus. Here, we describe the first known case of keratoconjunctivitis due to S. argenteus in a 64-year-old man with diabetes. The symptoms of the patient were not improved by antibiotic therapy using levofloxacin eye drops (15 mg/mL). The conjunctival scraping was cultured, and coagulase-positive staphylococci forming white colonies were detected. Matrix-assisted laser desorption/ionization-time of flight mass spectrometry confirmed the species as S. argenteus with a spectral score of 1.97. After the antibiotic was changed to vancomycin eye drops (10 mg/mL), the patient's symptom clearly improved. Multi-locus sequence typing showed that this isolate belonged to sequence type 1223, which has been predominantly isolated worldwide. Furthermore, this isolate harbored various virulence genes associated with S. aureus, such as staphylococcal enterotoxins and leukocidin. Since only limited information is available for this organism, further studies are needed to establish the epidemiology of S. argenteus.

Positive Myocardial Uptake of Bone Scintigraphic Agents Associated with Cardiac Amyloidosis: Frequency of Positive Uptake Data Based on Daily Clinical Practice.

Objective: The bone scan plays an important role for detecting number of conditions relating to bones, including: bone cancer or bone metastasis, bone inflammation. Extraosseous uptake, in particular, myocardial uptake, was observed in some patients examined with the bone scans. Positive uptake of 99mTc-labeled bone radiotracers is associated with cardiac amyloidosis. However, the frequency and cause of positive cardiac 99mTc-MDP uptake have not been fully studied. In this regard, the aim of this study was to assess the frequency and characteristics of patients with high myocardi-al uptake of bone scintigraphy in daily clinical practice setting. Methods: We retrospectively analyzed 4180 bone scintigraphies performed in daily clinical practice during 7-years period. The intensity of the myocardial uptake was graded based on a visual scale ranging from 0 to 3 points. Score 0 indicates the absence of uptake. Score 1 defined uptake less than that of bone (referred to as the adjacent rib). Uptake similar to that of bone was classified score 2. Score 3 was defined as uptake greater than that of reference bone. Positive myocardial uptake included a visual score 2 or 3. Result: Positive 99mTc-MDP myocardial uptake occurred in 12 patients among 4180 patients (0.3%). 7 of 12 positive scan patients were consistent with amyloidosis confirmed by biopsy. In these patients, the mean age was 75.6 ± 5.2 years old. Ten cases showed biventricular uptake and 2 showed LV uptake only. Conclusion: Positive cardiac uptake of bone scintigraphic agents was present in 0.3% of bone scintigraphies in a clinical practice setting. This may be a sign of cardiac amyloidosis involvement which may give the presence of extraosseous bone tracer uptake its own importance and a new role.

Randomized controlled trial of TY-51924, a novel hydrophilic NHE inhibitor, in acute myocardial infarction.

BACKGROUND: In patients with ST-elevation acute myocardial infarction (STEMI), reperfusion therapy limits infarct size, but can directly evoke myocardial reperfusion injury. Activation of the Na(+)/H(+) exchanger (NHE) plays an important role in reperfusion injury. TY-51924, a novel NHE inhibitor, significantly reduced infarct size in animal studies and was well tolerated in early-phase clinical trials. This study aim was to evaluate the efficacy and safety of TY-51924 in patients with STEMI. METHODS: In this multicenter, randomized, double-blind, placebo-controlled Phase II trial, 105 patients with first anterior STEMI undergoing primary percutaneous coronary intervention (pPCI) were randomly assigned to receive an intravenous infusion of either TY-51924 or placebo. Primary endpoints were myocardial salvage index (MSI) as determined by single photon emission computed tomography (SPECT) 3-5 days after pPCI and safety up to 7 days. RESULTS: Baseline characteristics were similar in the two groups. MSI 3-5 days after pPCI (0.200 vs. 0.290, p=0.56), 3 months after pPCI (0.470 vs. 0.500, p=0.76), and the incidences of side effects did not differ between the two groups as a whole. However, on post hoc analysis of 52 patients with a large area at risk (AAR) (≥38%) and no antegrade coronary flow, MSI by SPECT at 3 months after pPCI was significantly higher in TY-51924 group (0.450 vs. 0.320, p=0.03). TY-51924 did not adversely influence hemodynamics. CONCLUSIONS: TY-51924 did not improve MSI or increase side effects as a whole. However, TY-51924 is potentially cardioprotective in the presence of a large AAR and no antegrade coronary flow.

Evaluation of the safety and efficacy of TY-51924 in patients with ST elevated acute myocardial infarction - Early phase II first in patient pilot study.

BACKGROUND: In myocardial ischemia-reperfusion injuries, the involvement of the Na(+)/H(+) exchanger (NHE) is considered to be one of the pathogenic mechanisms following reperfusion. TY-51924 is a novel hydrophilic NHE inhibitor with a lower risk of central neurotoxicity than previous NHE inhibitors. This open-label, dose-escalating study was undertaken to investigate the safety, efficacy, and pharmacokinetics of TY-51924 in patients with ST-elevation myocardial infarction (STEMI). METHODS: Consent was obtained from a total of 30 patients with first anterior STEMI. After 12 patients were determined to be ineligible, the remaining 18 patients, each of whom was undergoing primary percutaneous coronary intervention (pPCI), received TY-51924 intravenously up to 10, 20, or 30mg/kg as the low-, medium-, or high-dose groups, respectively (n=6 in each group). The primary endpoints were safety (up to 7 days) and plasma drug concentration. The myocardial salvage index (MSI) was measured by (201)Tl/(123)I-beta-methyl-p-iodophenyl pentadecanoic acid single photon emission computed tomography (SPECT) 3-5 days after pPCI. RESULTS: No side effects were observed. Plasma drug concentrations increased dose-dependently, and were subsequently eliminated rapidly. MSIs were 0.118, 0.335, and 0.192 in the low-, medium-, and high-dose groups, respectively. In additional analysis, the combined MSIs in the medium- and high-dose groups were significantly higher than those in the low-dose group, in patients with a longer time from symptom onset to reperfusion (p=0.0247). CONCLUSIONS: No side effects were observed even at the highest dose with this novel hydrophilic NHE inhibitor. Therefore, TY-51924 is thought to be safe in patients with STEMI, even at the highest dose. Potential cardioprotective effects of intravenous TY-51924 might be expected based on the results obtained for the MSIs using SPECT at 20-30mg/kg. However, further large-scale, double-blind, placebo-controlled clinical studies are required to confirm the efficacy and safety implied in the current study.

Daptomycin susceptibility of 833 strains of Gram-positive cocci from a university hospital in Japan (2009-2011).

The aim of this study was to confirm the daptomycin (DAP) susceptibility of bacteria isolated before the launch of DAP in Japan. DAP showed good activity against all 833 isolates (MIC90 = 0.25-0.5 mg/L for staphylococci, 0.5-4 mg/L for enterococci, and 0.25-0.5 mg/L for streptococci). This is the first report of the in vitro activity of DAP against Gram-positive cocci, including methicillin-resistant Staphylococcus aureus and enterococci, isolated in Japan.

Rationale and design of J-ACCESS 4: prognostic impact of reducing myocardial ischemia identified using ECG-gated myocardial perfusion SPECT in Japanese patients with coronary artery disease.

BACKGROUND: The findings of our recent study entitled, "Japanese Assessment of Cardiac Events and Survival Study by Quantitative Gated SPECT (J-ACCESS)" showed that myocardial perfusion single photon emission computed tomography (MPS) can detect coronary artery disease (CAD) and help to predict future cardiac events in patients with suspected or extant CAD. However, the extent of the benefit conferred by percutaneous coronary intervention (PCI) as an initial management strategy compared with optimal medical therapy remains controversial. Little evidence supports the notion that myocardial ischemia identified using MPS is an alternative target of coronary revascularization to reduce the likelihood of developing cardiac events. METHODS: The multicenter, prospective cohort J-ACCESS 4 study aims to clarify the prognostic impact of reducing myocardial ischemia determined using electrocardiogram-gated MPS in Japanese patients with coronary artery disease. We started to register patients in J-ACCESS 4 at 74 facilities during June 2012 and will continue to do so until December 2013 or until the cohort comprises 500 patients who will participate in the study from one month before, until two months after stress/rest MPS assessment. Imaging data, the background of the patients including coronary risk factors and treatment before MPS assessments will be analyzed. The patients will undergo coronary revascularization within two months after MPS and/or receive appropriate medical therapy. The second stress/rest MPS will be performed from 4 to 10 months after coronary revascularization or registration. They will be followed up for over one year after the second MPS assessment. The primary endpoints will be cardiac death, sudden death of unknown cause, non-fatal myocardial infarction, and hospitalization for heart failure. The secondary endpoints will comprise death due to all causes including non-cardiac death and any cardiovascular events. This study will be completed in 2015. Here, we describe the design of the J-ACCESS 4 study.

Contrast media injection into right coronary artery caused thrombus extraction to aorta that may have resulted in left main trunk thrombosis.

A 59-year-old man with inferior acute myocardial infarction underwent an urgent coronary angiography and as a result a total occlusion of the ostial right coronary artery (RCA) was observed. Interestingly, the thrombus in the RCA clearly shortened within 2.3 s during the contrast media injection. While we prepared for percutaneous coronary intervention (PCI) of the RCA, ventricular fibrillation occurred and pulseless electrical activity continued in spite of repeated cardioversion. Despite no stenosis in the left main trunk (LMT) in the initial coronary angiography, the LMT was totally occluded. Following aspiration therapy on the LMT with percutaneous cardiopulmonary support, PCI of the RCA was performed. A coronary angiography should be carefully performed if a lot of thrombi exist in the coronary ostium because LMT embolism may have been caused by thrombus extraction from the RCA by contrast media injection.

Gran fístula arteriovenosa como causa poco común de insuficiencia cardiaca / Enormous arteriovenous fistula as a rare cause of heart failure

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