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Frailty is strongly associated with poor short- and long-term prognoses in patients who undergo transcatheter aortic valve implantation (TAVI). However, limited data are available regarding the association between frailty and late bleeding events after TAVI. Of the 2,518 patients in the Japanese multicenter TAVI registry, 1371 patients with complete data on frailty parameters were analyzed. We developed a modified Essential Frailty Toolset (EFT) using 4 frailty parameters-gait speed, Mini-Mental State Examination (MMSE), anemia, and hypoalbuminemia-that are significant predictors of late bleeding events in this cohort. The predictive value of the modified EFT for late bleeding after TAVI was assessed in comparison with other clinical variables. Late bleeding events after TAVI occurred in 80 patients (5.8%). Gait speed, MMSE, anemia, and hypoalbuminemia were significantly associated with late bleeding. A modified EFT was developed to include these parameters, which were scored from 0 to 5 points comprising the following 4 items: gait speed (0:1.5 m/s, 1: 1.5 to 0.75 m/s, 2:0.75 m/s), cognition (1: MMSE18), anemia (1: hemoglobin13 g/100 ml in men or12 g/100 ml in women), and malnutrition (1: albumin3.5 g/100 ml). Multivariate Cox regression analysis revealed that the modified EFT was an independent predictor of late bleeding (adjusted hazard ratio 1.51, 95% confidence interval [CI] 1.19 to 1.92, p0.001) In conclusion, the modified EFT was found to be a significant predictive factor for late bleeding events after TAVI. Assessment of frailty is important to predict patients with high bleeding risk after TAVI.

Data regarding the incidence, predictive factors, and clinical outcomes of post-transcatheter aortic valve replacement (TAVR) bleeding is limited in the Asian cohort.This study sought to assess the predictors and prognostic impact of post-TAVR late bleeding.This study used the Japanese multicenter registry data to analyze 2,518 patients (mean age: 84.3 ± 5.2 years) who underwent TAVR. Late bleeding was defined as any postdischarge bleeding events after TAVR. Baseline characteristics, predictive factors, and clinical outcomes including death and rehospitalization were assessed in patients with and without late bleeding events.The cumulative incidence rate of all and major late bleeding and ischemic stroke were 7.4%, 5.2%, and 3.4%, respectively, 3 years after TAVR. The independent predictive factors of late bleeding were low platelet count, high score (≥4) on the clinical frailty scale, and a New York Heart Association functional class III/IV. The cumulative mortality rates up to 3 years were significantly higher in patients with late bleeding than in those without bleeding (Late bleeding after TAVR was not a rare complication, and it significantly increased long-term mortality. It should be carefully managed, especially when it is predictable in the high-risk cohort, and efforts should be taken to reduce bleeding complications even after a successful procedure.

Background: Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT). Methods and Results: The HOTFOOT study is a multicenter prospective randomized open blinded-endpoint trial that is to be conducted at 10 trial centers in Japan between February 2021 and February 2022. This study will enroll 140 patients with CLTI receiving successful EVT. Eligible participants will be allocated 1 : 1 to either the EVT+HBOT or EVT group; participants in the EVT+HBOT group will receive 30 HBOT sessions. The primary outcome is the time to complete wound healing over the 6-month follow-up. Secondary outcomes during the 6-month follow-up are the proportion of patients who achieved complete wound healing, freedom from major lower-limb amputation, amputation-free survival, and freedom from target lesion reintervention. Conclusions: This study is expects to assess whether HBOT, in combination with successful EVT, can improve lower-limb outcomes in CLTI patients.

Sepsis and bleeding can lead to life-threatening complications, such as stent-graft infection and pseudoaneurysm, after stent-graft implantation. An 83 year-old woman was admitted to our hospital for sepsis 14 months after treatment with a balloon-expandable stent-graft for an arterio-ureteral fistula (AUF) between the right external iliac artery and the right ureter. Blood cultures were positive for methicillin-resistant Staphylococcus aureus and Candida tropicalis. A giant infectious pseudoaneurysm (44 × 70 mm) at the distal edge of the stent-graft was suspected of having caused the sepsis. Although endovascular therapy (EVT) was planned to correct the pseudoaneurysm, the right iliac artery spontaneously became occluded from the ostium of the right common iliac artery to the common femoral artery 5 days after diagnosing the pseudoaneurysm; hence, EVT was not performed. Antibiotic administration was continued, and blood culture results were negative. Although EVT using a stent graft for AUFs is effective, data on the chronic phase outcomes are limited. Therefore, patients with AUFs treated using stent-grafts should be carefully followed up.

We aimed to assess the clinical performance and risk factors for patency loss within 2 years following the use of polymer-coated paclitaxel-eluting stents (PC-PESs) and drug-coated balloons (DCBs) in patients with lower extremity artery disease. Multi-center registry data from 151 patients (65 and 86 treated with PC-PES and DCB, respectively) were retrospectively investigated. Two-year primary patency (PP) and clinically driven target lesion revascularization (CD-TLR) were evaluated using Kaplan-Meier analysis. Predictors of restenosis within 2 years of the procedures were analyzed using the random survival forest method. The consistent predictors of restenosis within 1 and 2 years were assessed and validated using Kaplan-Meier analysis. Two-year PP was 77.2 and 57.2% (log rank p = 0.047) and freedom from CD-TLR was 84.4 and 84.8% in the PC-PES and DCB groups, respectively (log rank p = 0.89). In the DCB group, most of the patients (n = 77, 89.5%) were treated with high-dose DCB. Consistent predictors of restenosis were lower vessel diameter and severity of Clinical Frailty Scale in the PC-PES group, and severity of peripheral artery calcification scoring system grade, severity of post dissection pattern, and smaller vessel diameter in the DCB group. The validation analysis revealed that patients with consistent predictors had significantly worse PP values than that of those without in the PC-PES (87.9% vs. 55.3%, log rank p = 0.003) and DCB groups (75.9% vs. 35.2%, log rank p = 0.001). The 2-year PP of DCBs was lower than that of PC-PESs. A smaller vessel diameter could predict restenosis in both devices. Vessel calcification and dissection should be considered when using DCB to ensure longer term patency.

Purpose: Endovascular therapies (EVTs) for symptomatic lower extremity peripheral artery disease (PAD) are efficient and minimally invasive. However, patients with PAD tend to have high bleeding risk (HBR), and there are limited data regarding the HBR for patients with PAD after EVT. In this study, we investigated the prevalence and severity of HBR, as well as its association with clinical outcomes in the patients with PAD who underwent EVT. Materials and Methods: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria were applied to 732 consecutive patients with lower extremity PAD post-EVT to assess the prevalence of HBR, and its association with major bleeding events, all-cause mortality, and ischemic events. The ARC-HBR scores (1 point for each major criterion and 0.5 points for each minor criterion) were obtained and the patients were divided into four groups (score: 0–0.5; low risk, score: 1–1.5; moderate risk, score: 2–2.5; high risk, and score: ≥3; very high risk) according to the score. Major bleeding events were defined as Bleeding Academic Research Consortium type-3 or type-5 bleeding, and ischemic events were defined as the composite of myocardial infarction, ischemic stroke, and acute limb ischemia within 2 years. Results: High bleeding risk occurred in 78.8% of the patients. Major bleeding events, all-cause mortality, and ischemic events occurred in 9.7%, 18.7%, and 6.4% of the study cohort, respectively, within 2 years. During the follow-up period, major bleeding events significantly increased with the ARC-HBR score. The severity of the ARC-HBR score was significantly associated with an increased risk of major bleeding events (high risk: adjusted hazard ratio [HR] 5.62; 95% confidence interval [CI]: [1.28, 24.62]; p=0.022; very high risk: adjusted HR: 10.37; 95% CI: [2.32, 46.30]; p=0.002). All-cause mortality and ischemic events also significantly increased with higher ARC-HBR score. Conclusions: High bleeding risk patients with lower extremity PAD can be at a high risk of bleeding events, mortality, and ischemic events after EVT. The ARC-HBR criteria and its associated scores can successfully stratify HBR patients and assess the bleeding risk in patients with lower extremity PAD who undergo EVT. Clinical Impact Endovascular therapies (EVTs) for symptomatic lower extremity peripheral artery disease (PAD) are efficient and minimally invasive. However, patients with PAD tend to have high bleeding risk (HBR), and there are limited data regarding the HBR for patients with PAD after EVT. Post EVT, most of the patients with PAD were classified as having HBR using the Academic Research Consortium for HBR (ARC-HBR) criteria and the rate of bleeding events as well as mortality and ischemic events within 2 years increased as the ARC-HBR score increased in this retrospective study of 732 participants. HBR patients with PAD can be at high risk of not only bleeding events but also mortality and ischemic events in the mid-term. The ARC-HBR criteria and its associated scores can successfully stratify HBR patients and assess the bleeding risk in patients with PAD who underwent EVT.

Vascular closure devices (VCDs) are widely used to achieve rapid hemostasis after percutaneous intervention via the common femoral artery (CFA), with well-established efficacy and safety. Although VCD-related artery occlusion is rare, it can be critical. A 72-year-old female underwent endovascular therapy (EVT) for stent occlusion in the left superficial femoral artery through a 7-Fr guiding sheath from the right CFA. After the procedure, an acute right popliteal artery (POP-A) occlusion, associated with the EXOSEAL VCD plug, occurred. The plug material was successfully removed using a bidirectional approach. The migration plug was blocked to prevent distal vessel migration and pushed gently to close the antegrade system, using an over-the-wire balloon from the retrograde site. We named this the “Push balloon INto vessel and Close Embolus from Retrograde site” (PINCER) technique. Finally, the plug was successfully removed using biopsy forceps. Acute limb ischemia (ALI) caused by EXOSEAL is a rare condition. Removal of the emboli by EVT is clinically significant because it is minimally invasive. However, it is sometimes difficult to remove the embolus using only antegrade approach; thus, the bidirectional approach using the PINCER technique can be effective in these situations.

Background: Adipose tissue (AT) characteristics are considered to be a marker for predicting clinical outcomes. This study aimed to investigate the prognostic value of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) computed tomography (CT) assessment in patients who underwent transcatheter aortic valve replacement (TAVR). Methods: We used the Japanese multicentre registry data of 1372 patients (age: 84.5 ± 5.0 years, women: 70.6%) who underwent TAVR. The SAT and VAT were assessed according to the preprocedural CT area and density. Baseline characteristics and clinical outcomes were compared based on the differences in AT characteristics. The independent associations with all-cause mortality after TAVR were evaluated according to the CT area and density of AT. Results: Low-volume area of SAT and VAT was associated with worse clinical outcomes compared with high-volume area of SAT and VAT in patients who underwent TAVR (log-rank test P = 0.016 and P = 0.014). High CT density of SAT and VAT was associated with increasing mortality in comparison with low CT density of SAT and VAT (log-rank test P < 0.001 and P = 0.007). The Cox regression multivariate analysis demonstrated the independent association of increased all-cause mortality in the high SAT and VAT density (hazard ratio [HR]: 1.41, 95% confidence interval [CI]: 1.06-1.88, P = 0.019, and HR: 1.34, 95% CI: 1.03-1.76, P = 0.031, respectively), but not in the low SAT and VAT area (HR: 0.85, 95% CI: 0.74-1.29, P = 0.85, and HR: 0.78, 95% CI: 0.60-1.03, P = 0.085, respectively). Conclusions: CT-derived AT characteristics, particularly the qualitative assessments, were useful for predicting the prognosis in patients after TAVR. Résumé: Introduction: Les caractéristiques du tissu adipeux (TA) sont considérées comme un marqueur de la prédiction des résultats cliniques. La présente étude avait pour objectif d’examiner la valeur pronostique de l’évaluation par tomodensitométrie (TDM) du tissu adipeux sous-cutané (TASC) et du tissu adipeux viscéral (TAV) des patients qui subissaient un remplacement valvulaire aortique par cathéter (RVAC). Méthodes: Nous avons utilisé les données du registre multicentrique japonais de 1 372 patients (âge : 84,5 ± 5,0 ans, femmes : 70,6 %) qui subissaient un RVAC. Nous avons évalué le TASC et le TAV selon la surface et la densité à la TDM préinterventionnelle. Nous avons comparé les caractéristiques initiales et les résultats cliniques en nous basant sur les différences dans les caractéristiques du TA. Nous avons évalué les associations indépendantes à la mortalité toutes causes confondues après le RVAC selon la surface et la densité du TA à la TDM. Résultats: La surface de faible volume du TASC et du TAV était associée à de plus mauvais résultats cliniques que la surface de grand volume du TASC et du TAV chez les patients qui subissaient le RVAC (test logarithmique par rangs P = 0,016 et P = 0,014). La densité du TASC et du TAV à la TDM était associée à l’augmentation de la mortalité en comparaison d’une faible densité du TASC et du TAV à la TDM (test logarithmique par rangs P < 0,001 et P = 0,007). L’analyse multivariée selon le modèle de régression de Cox démontrait l’association indépendante de l’augmentation de la mortalité toutes causes confondues lors de densité élevée du TASC et du TAV (rapport de risque [RR] 1,41, intervalle de confiance [IC] à 95 %, 1,06-1,88, P = 0,019, et RR 1,34, IC à 95 %, 1,03-1,76, P = 0,031, respectivement), mais non lors de faible surface du TASC et du TAV (RR 0,85, IC à 95 %, 0,74-1,29, P = 0,85, et RR 0,78, IC à 95 % : 0,60-1,03, P = 0,085, respectivement). Conclusions: Les caractéristiques du TA acquises par TDM, particulièrement les évaluations qualitatives, étaient utiles à la prédiction du pronostic des patients après le RVAC.

Recently, Society for Vascular Surgery guideline recommends evaluating anatomic pattern with use of Global Limb Anatomic Staging System (GLASS) in Chronic Limb-Threatening Ischemia (CLTI) patients. The aim of this study is to validate GLASS stage into CLTI patients on hemodialysis (HD) and investigate the impact of GLASS stage to wound healing and amputation-free survival (AFS). Between April 2009 and March 2018, we performed EVT for 154 limbs in CLTI patients on HD. GLASS was defined as femoropopliteal (FP) and infrapopliteal (IP) segments separately graded (0–4), then combined into three GLASS stages for the limb (I–III). We divided them into three GLASS stages with using this system. We compared the clinical outcomes between three groups (GLASS I, GLASS II, and GLASS III). Patient characteristics were almost similar between the three groups. Lesion characteristics was more complex and the rate of success was lower in GLASS III. Cox regression multivariate analysis revealed that diabetes mellitus (HR 2.4, 95% CI 1.37–4.01, p

Purpose: Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear. Materials and Methods: Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect. Results: The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (Conclusion: In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. Clinical Impact EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.

Transcatheter aortic valve replacement (TAVR), as an alternative to open heart surgery, has been established as the standard therapy for patients with severe aortic valve stenosis. Vascular access management, the first step in a TAVR procedure, should be managed properly. Moreover, the transfemoral and alternatives such as the transaxillary/subclavian, transcarotid, transapical, and transcaval approaches are considered access routes during TAVR. More than 90% of cases can be treated via the transfemoral approach in the current TAVR era, whereas other approaches should be considered in patients in whom the transfemoral approach is not suitable. Vascular complications regardless of access route differences are a specific issue of TAVR caused by the use of large sheaths. With the increased number of TAVR cases, we must manage vascular complications and decrease the morbidity and mortality rates associated with TAVR procedures. Thus, this study aimed to review the vascular complications during TAVR and summarize their prognosis, prevention, and adequate management.

The coronary artery calcium score is a widely known independent predictor of cardiac events. Tibial artery calcification had been reported as an amputation risk, but the femoropopliteal artery calcium score is rarely known.A retrospective analysis was performed using the data collected from the patients who underwent endovascular treatment for the femoropopliteal artery between January 2010 and December 2017. The femoropopliteal artery calcium scores on preprocedural computed tomography were calculated according to the Agatston definition. The mean value of total of femoropopliteal artery calcium scores was used to divide the scores into two groups. The prognostic value of the calcium score was analyzed based on primary patency, clinically driven target lesion revascularization, major amputation, and all-cause death.In total, 132 consecutive limbs that underwent successful endovascular intervention were analyzed in this study; 44 and 88 limbs were assigned to the high and low calcium score groups, respectively. There were no significant differences between the two groups in terms of patient and lesion characteristics, except for chronic kidney disease (7% vs. 25%, P 0.01), hemodialysis (80% vs. 25%, P 0.01), and coronary artery disease (73% vs. 53%, P = 0.03). Compared with the low calcium score group, the high calcium score group had a significantly higher rate of loss of primary patency and clinically driven target lesion revascularization at one year, based on the Kaplan-Meier curve (55% vs. 81%, 44% vs. 8%, both P 0.01). There were no significant differences between the two groups in terms of major amputation and death. Multivariate analysis revealed that hemodialysis [hazard ratio (HR): 1.9; 95% confidence interval (CI): 1.01-5.28; P = 0.04] runoff grade 0 (HR: 2.9; 95% CI: 1.02-10.9; P = 0.04), lesion length 200 mm (HR: 3.9; 95% CI: 1.1-13.7; P = 0.03), and calcium score per 100 increase (HR: 1.05; 95% CI: 1.02-1.08; P 0.01) were predictors of clinically driven target lesion revascularization. As per receiver operating characteristic analysis, the best cutoff value of target lesion calcium score for target lesion revascularization was 206.A high femoropopliteal artery calcium score might increase loss of patency and the risk for clinically driven target lesion revascularization.

Objectives. Our aim was to evaluate the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) compared with durable polymer everolimus-eluting stents (DP-EES) in midterm. Background. There are few data about midterm clinical outcomes of BP-EES compared with DP-EES. Methods and Results. Between January 2016 and December 2017, 395 consecutive patients were treated with BP-EES and 391 consecutive patients were treated with DP-EES in Nagoya Heart Center. The primary endpoint was a 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel myocardial infarction (MI), and clinical indicated target lesion revascularization (TLR). Moreover, clinical indicated target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated as the secondary endpoints. After propensity score matching, 327 patients were selected in each group. At 3 years, the cumulative incidence of TLF was 4.5% in the BP-EES group versus 6.5% in DP-EES (adjusted HR 0.67 (95% CI 0.33–1.30), log-rank P=0.23). Regarding the individual components of the TLF at 3 years, the cumulative incidence of target vessel MI was significantly lower in BP-EES than in DP-EES (0% versus 1.9%: adjusted HR 0.83 (95% CI 0.71–0.97), log-rank P=0.01), but there was no difference between BP-EES and DP-EES in the incidence of cardiac death and clinically indicated TLR. The cumulative 3-year incidence of definite ST was significantly lower in BP-EES than in DP-EES (0% versus 1.6%, log-rank P=0.02). Conclusions. There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in midterm.

PM2.1 was collected at urban and suburban elementary schools in Shanghai during two sampling periods in cold and warm seasons in 2007. Nine polycyclic aromatic hydrocarbons (PAHs) and ten nitro-polycyclic aromatic hydrocarbons (NPAHs) in PM2.1 were determined. During both seasons, the concentrations of PAHs and NPAHs at urban and suburban schools were not significantly different (p>0.05) and were higher in the cold period than in the warm period. According to the diagnostic ratios, PAHs and NPAHs at both schools were subject to the mixed effects of vehicle emission and coal combustion during both periods. Moreover, the results of the backward trajectory showed that PAHs and NPAHs were more susceptible to external polluted air masses in the cold period. At both urban and suburban schools, the inhalation cancer risk of PAHs and NPAHs in PM2.1 for children during elementary period was dozens of times of the acceptable risk level regulated by the U.S.EPA, highlighting the adverse impact of exposure to PAHs and NPAHs on the healthy development of children.

Background Ventricular‐arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end‐systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular‐arterial coupling. We aimed to determine the prognostic value of ventricular‐arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events. Methods and Results We retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN‐TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: 0.666) during the midterm follow‐up after transcatheter aortic valve replacement. During a median follow‐up period of 736 days (interquartile range, 414–956), there were 247 (17.9%) all‐cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08–2.87 [ P =0.024]), group 3 (HR, 2.43; 95% CI, 1.53–3.86 [ P P P =0.015]). Conclusions These findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow‐up. Registration URL: https://www.upload.umin.ac.jp/ . Unique identifier: UMIN000020423.

Both polymer-coated paclitaxel-eluting stents (PC-PESs) and drug-coated balloons (DCBs) are used in conjunction with endovascular therapy (EVT) for the treatment of peripheral artery disease (PAD). We aimed to identify the risk factors for the loss of patency following the use of PC-PES and DCB in a real clinical setting. We assessed the multi-center registry data of 151 lesions from 151 patients who underwent EVT for symptomatic PAD in the superficial femoral and proximal popliteal arteries using PC-PES or DCB. One-year primary patency (PP) and clinically driven target lesion revascularization (CD-TLR) were evaluated using Kaplan–Meier analysis. The predictive risk factors for 1-year outcomes were analyzed using the random survival forest method. PC-PES and DCB were used in 65 (43.0%) and 86 (57.0%) cases, respectively. There were no significant differences in 1-year PP or freedom from CD-TLR between PC-PES and DCB. PP occurred in 85.4% and 80.2% of cases in the PC-PES and DCB groups, respectively (log-rank p = 0.65), while freedom from CD-TLR was noted in 92.7% and 94.1% of cases in the PC-PES and DCB groups, respectively (log-rank p = 0.73). In order of importance, a Clinical Frailty Scale score ≥ 6, female sex, lower proximal vessel diameter, lower body mass index, and younger and older age were identified as predictive risk factors of restenosis in the PC-PES group. Peripheral artery calcification scoring system grade of ≥ 2, post-dissection pattern ≥ D, lower proximal and distal vessel diameter, and lesion length ≥ 100 mm were identified as predictive risk factors of restenosis, in order of importance, in the DCB group. Both PC-PES and DCB were associated with favorable clinical outcomes within 1 year in patients with femoropopliteal artery disease. Furthermore, several factors that could predict restenosis within 1 year following the use of each device were detected.

The case of an 80-year-old male with claudication of his left foot who was referred to our hospital for evaluation and treatment. Computed tomography (CT) angiography revealed occlusion of left common and external iliac (EIA) arteries. Recanalization of the EIA lesion under intravascular ultrasound (IVUS) guidance and placement of 2 stent grafts was completed successfully. Nine months later, 27 × 29 mm pseudoaneurysm of the left EIA was identified that appeared to have developed secondary to migration of the original stent graft. A new stent graft was placed.

In recent years, various devices have been approved for peripheral artery disease with femoropopliteal lesions. However, treatment of long, calcified, and diffused lesions is still challenging because these lesions are associated with restenosis. This report described the case of an 82-year-old man with bilateral severely calcified and diffused long lesions in the superficial femoral artery that was treated using polymer-coated paclitaxel-eluting stent and interwoven nitinol stent. After 6 months, in-stent restenosis was observed at the implantation site of the interwoven nitinol stents. Polymer-coated paclitaxel-eluting stents were deployed at the in-stent restenosis site. After another 6 months, angiography and intravascular ultrasound imaging revealed no restenosis at the polymer-coated paclitaxel-eluting stent site. Optical coherence tomography was also performed, revealing that the stent struts were well covered by neointima, which was very thin at approximately 0.1 mm. This representative case demonstrated substantial differences in the effects of devices; in other words, the superiority of polymer-coated paclitaxel-eluting stent in treating long, diffuse, and calcified lesions indicated that its implantation is a reasonable option when the initial gain was obtained following sufficient vessel preparation.

Highlights • One of the complications of type B aortic dissection is organ ischemia. • TEVAR was performed for entry closure. • TEVAR improved malperfusion., Introduction A case of malperfusion in which the patient presented with aortic dissection is presented. Presentation of case A 69-year-old man with an acute aortic dissection (Stanford type B) had lower limb ischemia. Axillary-femoral bypass was performed, and his lower limb ischemia improved. Eight months after the onset of acute aortic dissection, he again had lower limb ischemia. Contrast-enhanced computed tomography showed axillary-femoral bypass occlusion and true lumen collapse, compressed by the increased false lumen pressure in the aorta. Thoracic endovascular aortic repair (TEVAR) was performed for entry closure. His lower limb ischemia was improved by TEVAR. Discussion One of the complications of type B aortic dissection is malperfusion. Endovascular therapy is a first step in treating the malperfusion of type B aortic dissection. It is important to seal the entry for the treatment of malperfusion. Conclusion If there is an entry, it is important to seal it for the treatment of malperfusion.

Today in Japan, comfortable lifestyle and environment realized by abundant electric power is being questioned by energy consumption reduction policies called “cool biz” in summer, and “warm biz” in winter. One reason of these policies is the bad energy consumption efficiency of current air-conditioning systems that cool or warm indirectly human body. Several researches have been investigating the effect of direct human body cooling and warming. However, most proposed solutions focus on direct head or neck cooling, using ice to cool a water circulating system, such temperature during use cannot be controlled accurately nor adapted to user and environment conditions. Recently, a Japanese research team developed a portable system using Peltier elements that can both cool and warm neck. Though cooling was demonstrated to affect positively both physiological and psychological state in summer heat environment, in cold climate it could be confirmed for only neck warming but not feet and hands. In our objective of developing effective energy saving technology for direct temperature-conditioning of human body, and in order to reduce the discomfort caused by body chillness, we have proposed and developed a Peltier element based wrist-mounted wearable device that directly warms human body. A first experimental study showed how wrist warming rhythm affects hyperthermic sensation. Then, we verified whether the thermal sensation of the body, including the extremities, is improved by changing the position where the wrist is warmed.

PURPOSE This study aimed to compare the efficacy of ultrasound-guided and angiography-guided intraluminal approach for femoropopliteal (FP) artery occlusive disease. METHODS A retrospective analysis was performed using the data collected regarding patients that underwent endovascular treatment (EVT) for FP artery occlusive disease between January 2010 and April 2018 at two centers. A total of 221 consecutive de novo lesions were analyzed according to the method of recanalization. Propensity score-matched analysis was performed to compare the clinical outcomes of recanalization methods for FP occlusive lesions. The prognostic value was analyzed based on the number of guidewires, wire cross time, distal puncture rate, radiation exposure, the amount of contrast media, primary patency, and clinically driven-target lesion revascularization (CD-TLR) at 1 year. RESULTS A total of 44 matched pairs of patients were analyzed after propensity score-matched analysis. The number of guidewires, distal puncture rate, wire passage time, radiation exposure, and the amount of contrast media were significantly lower in the ultrasound-guide group, with 3.4 vs. 4.7, 9.1% vs. 54.5%, 47 min vs. 83 min, 207 mGy vs. 821 mGy, 66 ml vs. 109 ml, respectively (p

Information on early to late-phase kidney damage in patients who underwent transcatheter aortic valve replacement (TAVR) is scarce. We aimed to identify the predictive factors for late kidney injury (LKI) at 1-year and patient prognosis beyond 1-year after TAVR.We retrospectively reviewed 1,705 patients' data from the Japanese TAVR multicenter registry. Acute kidney injury (AKI) and LKI, defined as an increase of at least 0.3 mg/dL in creatinine level, a relative 50% decrease in kidney function from baseline to 48 hours and 1-year, were evaluated. The patients were categorized into the 4 groups as AKI-/LKI- (n = 1.362), AKI+/LKI- (n = 95), AKI-/LKI+ (n = 199), and AKI+/LKI+ (n = 46).The cumulative 3-year mortality rates were significantly increased across the four groups (12.5%, 15.8%, 24.6%, 25.8%, P.001). Multivariate analysis revealed that chronic kidney disease, coronary artery disease, periprocedural AKI, and heart failure-related re-admission within 1-year were significantly associated with LKI. The Cox regression analysis revealed that AKI-/LKI+ and AKI+/LKI+ were independent predictors of increased late mortality beyond 1-year after TAVR (P = .001 and P = .01).LKI was influenced by adverse cardio-renal events and was associated with increased risks of late mortality beyond 1-year after TAVR.

Objectives Estimating 1‐year life expectancy is an essential factor when evaluating appropriate indicators for transcatheter aortic valve replacement (TAVR). Background It is clinically useful in developing a reliable risk model for predicting 1‐year mortality after TAVR. Methods We evaluated 2,588 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry from October 2013 to May 2017. The 1‐year clinical follow‐up was achieved by 99.5% of the entire population (n = 2,575). Patients were randomly divided into two cohorts: the derivation cohort (n = 1,931, 75% of the study population) and the validation cohort (n = 644). Considerable clinical variables including individual patient's comorbidities and frailty markers were used for predicting 1‐year mortality following TAVR. Results In the derivation cohort, a multivariate logistic regression analysis demonstrated that sex, body mass index, Clinical Frailty Scale, atrial fibrillation, peripheral artery disease, prior cardiac surgery, serum albumin, renal function as estimated glomerular filtration rate, and presence of pulmonary disease were independent predictors of 1‐year mortality after TAVR. Using these variables, a risk prediction model was constructed to estimate the 1‐year risk of mortality after TAVR. In the validation cohort, the risk prediction model revealed high discrimination ability and acceptable calibration with area under the curve of 0.763 (95% confidence interval, 0.728–0.795, p

An 88-year-old man was admitted with general fatigue. Computed tomography (CT) showed a descending aortic aneurysm. The laboratory data indicated severe infection. Despite negative blood cultures, broad-spectrum intravenous antibiotic therapy was started. Though antibiotic therapy was continued for about 2 weeks, the aneurysm extended 20 mm. Thoracic endovascular aortic repair was performed, and antibiotic therapy was continued for 4 weeks after the procedure, followed by oral antibiotics for 1 year. CT showed regression of the aneurysm 15 months after reconstruction. Antibiotic therapy, preoperatively and postoperatively, is important for a mycotic aortic aneurysm.

Skeletal muscle mass (SMM) as calculated by computed tomography (CT) is a predictor of all-cause mortality after transcatheter aortic valve replacement (TAVR), but it remains unclear whether using CT-determined density of skeletal muscle has additive prognostic value. We utilized the Japanese multicenter registry data of 1375 patients who underwent CT prior to TAVR. Sarcopenia status was defined by the CT-derived SMM index (threshold: men, 55.4 cm2/m2; women, 38.9 cm2/m2). The threshold for high and low CT density was based on the median value of the entire cohort (men: 33.4 HU; women: 29.5 HU). Sarcopenia was observed in 802 patients (58.3%) overall. Patients were categorized into non-sarcopenia and high-CT density (n = 298), non-sarcopenia and low-CT density (n = 275), sarcopenia and high-CT density (n = 399), and sarcopenia and low-CT density (n = 403) groups, and procedural outcomes and mortality compared. The cumulative 3-year mortality rates in these groups were 18%, 27%, 24%, and 32%, respectively. Cox-regression multivariate analysis revealed that low-CT density (compared with high-CT density) and sarcopenia and low-CT density (compared with non-sarcopenia and high-CT density as reference) increased mortality after TAVR (hazard ratios [HR]: 1.35 and 1.43, 95% confidence intervals [Cis]: 1.06–1.72 and 1.00–2.08, p = 0.01, and 0.049, respectively). However, sarcopenia alone was not related to an increased risk of mortality (HR 1.30, 95% CI 0.99–1.69, p = 0.52). In conclusion, CT density-based skeletal muscle quality assessment combined with the SMM index improves prediction of adverse outcomes after TAVR.

Background: Certain patients with critical limb ischemia (CLI) experience significant decline in activities of daily living (ADL) during hospitalization. The prognosis of decline in ADL during hospitalization remains unknown. Methods: A retrospective analysis was performed on collected data of patients with CLI treated by endovascular treatment between April 2007 and December 2015. We evaluated CLI in patients ADL at the time of hospitalization and after discharge using the Barthel index. We classified all patients into patients with decline in ADL and stable in ADL and compared clinical outcomes (cumulative incidence of wound healing, amputation-free survival at 1 year) between the 2 groups. Results: Two hundred and fifty-five consecutive patients with CLI (221 limbs), who underwent successful endovascular intervention, were enrolled in this study. Of all patients, 22 patients were classified into the decline group. The prevalence of wound, Ischemia, foot infection (WIfI) classification high grade was higher in the decline group (30.7% vs 63.6%; P < .01). The wound healing rates were worse in the decline group than in the stable group (40% vs 78% at 1 year; P < .01). The same trends were observed in the amputation-free survival (37% vs 78%; P < .01). After multivariate analysis, decline in ADL was an independent predictor of wound healing and amputation-free survival (odds ratio [OR]: 2.85, 95% confidence interval [CI]: 1.61-3.35, P < .01; OR: 2.46, 95% CI: 1.26-4.53, P = .01). Conclusions: Patients with CLI with decline in ADL during hospitalization were found to have a poor prognosis suggesting that a decline in ADL may affect the clinical outcomes.

Airborne particulates were collected at an urban site (site 1) from 2004 to 2010 and at a suburban site (site 2) in 2010 in Beijing. Nine polycyclic aromatic hydrocarbons (PAHs) and five nitropolycyclic aromatic hydrocarbons (NPAHs) in the airborne particulates were determined by HPLC with fluorescence and chemiluminescence detection, respectively. The concentrations of PAHs and NPAHs were higher in heating season than in non-heating season at the two sites. Both the concentrations of PAHs and NPAHs decreased in the non-heating season but only the concentrations of NPAHs decreased in heating season at site 1, from 2004 to 2010. These findings suggest that source control measures implemented by the city of Beijing helped to reduce air pollution in Beijing. The concentrations of PAHs increased at site 1 in 2010, possibly because of the transport of emissions from windward other areas, such as Shanxi province. Several diagnostic ratios of PAHs and NPAHs showed that the different sources contributed to Beijing's air pollution, although coal combustion was the main source in the heating season and vehicle emission was the main source in the non-heating season. An analysis of physical parameters at Beijing showed that high wind speed can remove atmospheric PAHs and NPAHs in the heating season and that high relative humidity can remove them in the non-heating season. © 2017 Elsevier Ltd, Embargo Period 12 months

Aim: To investigate the relationship between intravascular ultrasound (IVUS) findings and restenosis after stent implantation for long occlusive femoropopliteal (FP) lesions using the intraluminal approach. Methods: This was a single-center retrospective study of 45 patients (49 lesions) with de novo long occlusive FP lesions treated with bare metal stents implanted using the intraluminal approach under IVUS guidance from April 2007 to December 2014. All patients were followed up at least 12 months. The preprocedural and postprocedural IVUS findings were compared for patients with and without restenosis, which was defined as a peak systolic velocity ratio of > 2.4 on duplex ultrasonography or > 50% diameter stenosis on angiography. Results: Within 12 months, 13 patients (14 lesions) developed restenosis, whereas 32 patients (35 lesions) did not (restenosis rate = 29%). The male:female ratio and the prevalence of diabetes mellitus, hemodialysis, and critical limb ischemia were similar between the two groups. No significant differences were observed in lesion length, chronic total occlusion (CTO) length, and the percentage of involving popliteal lesion between the two groups. A whole intraplaque route was gained in 15 lesions (31%). Multivariate analysis revealed that the within-CTO intramedial route proportion and the distal lumen cross-sectional area (CSA) were independent predictors of restenosis. Receiver operating characteristic analysis showed that the best cutoff values of these parameters were 14.4% and 17.7 mm2, respectively. Conclusions: In patients with long occlusive FP lesions undergoing stent placement using the intraluminal approach, a whole intraplaque route was gained in 31%. Restenosis is more likely if IVUS shows a within-CTO intramedial route proportion of > 14.4% or distal lumen CSA of < 17.7 mm2.

Objective This study aimed to determine the clinical impact of the Global Limb Anatomical Staging System (GLASS) and develop a model to determine the grade of difficulty for target artery path (TAP) using GLASS stage. Methods This was a single centre retrospective study. Endovascular treatment (EVT) was performed for 400 lesions in 257 patients with critical limb threatening ischaemia (CLTI) between April 2009 and March 2018. All lesions were divided into three groups (GLASS Ⅰ, Ⅱ, and Ⅲ), which were compared in terms of patient characteristics, lesion characteristics, technical success, and procedural complications. All observations were then randomly assigned to the derivation set or validation set at a ratio of 2:1 (derivation set: 166 patients; validation set: 91 patients). Predictors of technical success for TAP were identified by multivariable analysis. Each predictor was assigned a score based on its regression coefficient, and the total score was calculated. This value was used to categorise all lesions into the following four groups: low (score 0), intermediate (score 1), difficult (score 2), and very difficult (score ≥ 3). Results No significant differences in patient characteristics were observed between the three GLASS groups. In GLASS Ⅲ group, anatomic/limb severity and procedural complications were observed frequently, and the technical success rate was lower than that in the other groups. Through multivariable analysis, absence of pedal modifier (P)0 or P1, GLASS Ⅲ, total occlusion, and severe calcification predicted technical failure. The four groups stratified according to GLASS score demonstrated stepwise and highly reproducible difference in the probability of technical success for TAP. The area under the receiver operating characteristic (ROC) curve was 0.95 in the development group and 0.93 in the validation sample. Conclusion In GLASS Ⅲ, anatomic/limb severity was more complex and procedural complications were more frequent. The GLASS scoring system reliably predicts the technical success of de novo TAP in patients with CLTI.

Purpose: To evaluate the clinical efficacy of poststenting fractional flow reserve (FFR) in terms of predicting restenosis in superficial femoral artery (SFA) disease. Methods: This prospective, single-center, nonrandomized study enrolled 48 patients (mean age 76±9 years; 38 men) with 51 SFA lesions from July 2013 to June 2014. Mean FFR (distal mean pressure/proximal mean pressure) and systolic FFR (distal systolic pressure/proximal systolic pressure) were calculated, and the relationship between these FFR values and restenosis at 12 months was investigated using receiver operating characteristic (ROC) curve analysis. Results: Poststenting FFR was significantly lower in the restenosis group (poststenting mean FFR 0.85±0.07 vs 0.93±0.05, p=0.001; poststenting systolic FFR 0.76±0.14 vs 0.87±0.08, p=0.015). The area under the ROC curve for restenosis in poststenting mean FFR was higher, but not statistically significant, than that in poststenting systolic FFR (0.84 vs 0.74, p=0.08). The best poststenting mean FFR cutoff value for predicting restenosis was 0.92 (sensitivity 0.64, specificity 0.91). The 4.5% restenosis rate at 12 months in the high (>0.92) poststenting mean FFR group was significantly lower (35.7%, p=0.008) than in the low (≤0.92) poststenting mean FFR group. Conclusion: Poststenting mean FFR is useful for predicting restenosis in SFA disease.