Comparison of the Pre-Established and Finally Selected Treatment Strategies for Endovascular Treatment in Femoropopliteal Artery Lesions.

This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.

Prognostic Impact of Reduced Left Ventricular Ejection Fraction After Endovascular Therapy for Lower Extremities.

BACKGROUND: The mechanism underlying a poor prognosis in patients with lower-extremity artery disease (LEAD) with heart failure is unknown. We examined the prognostic impact of the left ventricular ejection fraction (LVEF) in patients with LEAD who underwent endovascular therapy (EVT).Methods and Results: From August 2014 to August 2016, 2,180 patients with LEAD (mean age, 73.2 years; male, 71.9%) underwent EVT and were stratified into low-LVEF (LVEF <40%; n=234, 10.7%) and not-low LVEF groups. In the low- vs. not-low LVEF groups, there was a higher prevalence of heart failure (i.e., history of heart failure hospitalization or New York Heart Association functional class III or IV symptoms) (44.0% vs. 8.3%, respectively), diabetes mellitus, chronic kidney disease, below-the-knee lesion, critical limb ischemia, and incidence of major cardiovascular and cerebrovascular events (MACCEs) and major adverse limb events (MALEs) (P<0.001, all). Low LVEF independently predicted MACCEs (hazard ratio: 2.23, 95% confidence interval: 1.63-3.03; P<0.001) and MALEs (hazard ratio: 1.85, 95% confidence interval: 1.15-2.96; P=0.011), regardless of heart failure (P value for interaction: MACCEs: 0.27; MALEs: 0.52). CONCLUSIONS: Low LVEF, but not symptomatic heart failure, increased the incidence of MACCEs and MALEs. Intensive cardiac dysfunction management may improve LEAD prognosis after EVT.

End-of-Life Discussions and Their Timing for Patients With Cardiovascular Diseases　- From the Perspective of Bereaved Family Members.

BACKGROUND: Enhanced discussions regarding end-of-life (EOL) are crucial to provide appropriate care for seriously ill patients. However, the current status of EOL discussions, especially their timing and influencing factors, among patients with cardiovascular diseases (CVD) remains unknown.Methods and Results: We conducted a cross-sectional questionnaire survey of bereaved family members of CVD patients who died at 10 tertiary care institutes in Japan. In all, 286 bereaved family members (38.2% male; median age 66.0 [interquartile range 58.0-73.0] years) of CVD patients were enrolled; of these, 200 (69.9%) reported that their families had had EOL discussions with physicians. The major topic discussed was resuscitation (79.0%), and 21.5% discussed the place of EOL care. Most discussions were held during hospitalization of the patient (88.2%). More than half (57.1%) the discussions were initiated less than 1 month before the patient died, and 22.6% of family members felt that this timing of EOL discussions was late. Bereaved family members' perception of late EOL discussions was associated with the family members aggressive attitude towards life-prolonging treatment, less preparedness for bereavement, and less satisfaction with EOL care. CONCLUSIONS: Approximately 70% of bereaved family members of CVD patients had EOL discussions, which were often held shortly before the patient died. Further research is required to establish an ideal approach to EOL discussions at an appropriate time, which may improve the quality of EOL care.

A Case of Barbiturate Poisoning From Pentobarbital in a Young Japanese Patient.

Concomitant prescriptions of psychotropic drugs such as sleeping pills, antidepressants, and anti-anxiety medications are common. The relationship between the number of psychotropic drug prescriptions and the incidence of drug overdose has not been reported. However, efforts have been made to reduce the number of concomitant prescriptions hoping that fewer prescriptions of multiple drugs will lower the incidence of drug overdoses. Furthermore, among sleeping pills, prescriptions of barbiturates have been gradually decreasing due to the risk of severe side effects and addiction. This report features a case of an overdose of pentobarbital tablets that caused the classic medical triad (impaired consciousness, hypotension, and hypothermia) of barbiturate intoxication under the characteristics of borderline personality disorder.

The association of calcium channel blocker with risk of adverse limb events in patients with chronic limb-threatening ischemia after endovascular treatment.

Symptoms of lower-extremity artery disease (LEAD) emerge from impaired vascularization in distal circulation of the extremities. Calcium channel blockers (CCB) can improve distal circulation when used as adjunctive therapy with endovascular treatment (EVT), but few studies have evaluated that. We investigated the relationship between CCB therapy and post-EVT outcomes. Through a consecutive EVT registry, we evaluated those relationships in whole cohort and the following 2 subgroups; the patients suffered from intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI), with adjusting baseline characteristics by propensity score matchings. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE, a composite endpoint of all death, nonfatal myocardial infarction, and nonfatal stroke), and major adverse limb event (MALE, a composite of major amputation, acute limb ischemia, and surgical reintervention). The group that received CCB had less MALE in whole cohort (HR 0.31; 95% confidence interval (CI) 0.20-0.47), and less MACCE and MALE in CLTI cohort (HR 0.67; 0.50-0.89 and 0.32; 0.20-0.52 respectively) compared to the group that did not receive CCB. The relationships were common in the cohorts with baseline adjustment. MACCE and MALE in IC (HR 1.01; 0.57-1.80 and 0.60; 0.25-1.45, respectively) showed no significant differences both with and without baseline adjustment. CCB use was related to fewer MACCE and MALE events in adjusted patients who underwent EVT, and the trend was more evident, especially in the adjusted CLTI cohort. This study highlights the necessity of future studies regarding CCB. Clinical Trial Registration: URL: https://www.umin.ac.jp ; Unique identifiers: UMIN000015100.

Liver injury indicators and subsequent cancer development among non-fatty liver population.

BACKGROUND: Little is known about the association between liver indicators (The FIB-4 index, nonalcoholic fatty liver disease fibrosis score (NFS), and fatty liver index (FLI)) and cancer development in patients without preexisting liver disease. METHODS: We conducted a retrospective cohort study with participants who underwent voluntary health checkups and without fatty liver between 2005 and 2018. Our primary outcome was the development of any type of cancer, and its association with each liver indicator was evaluated. RESULTS: A total of 69,592 participants (mean age: 43.9 years, 29,984 (43.1%) were men) were included. During a median follow-up of 5.1 years, 3779 (5.4%) patients developed cancer. Compared to participants with a low NFS, those with a medium NFS had a higher risk of developing any type of cancer (adjusted hazard ratio [HR]: 1.18, 95% confidence interval [CI]: 1.07-1.31), whereas those with a medium FIB-4 index had a decreased risk of developing any type of cancer compared to those with a low FIB-4 index (adjusted HR: 0.91, 95% CI: 0.83-0.99). Patients with higher scores tended to have a higher risk of digestive organ cancer, regardless of the indicator. A high FLI was also associated with an increased risk of breast cancer (adjusted HR: 2.42, 95% CI: 1.24-4.71); however, those with a medium FIB-4 index (adjusted HR: 0.65, 95% CI: 0.52-0.81) and NFS (adjusted HR: 0.50, 95% CI: 0.35-0.72) had decreased risks of developing breast cancer compared to those with a high FIB-4 index and NFS, respectively. CONCLUSION: Among patients without fatty liver, a higher liver indicator score was associated with an increased risk of cancer in the digestive organs, regardless of the indicator. Notably, those with a medium FIB-4 index or NFS had a lower risk of developing breast cancer, whereas those with a medium FLI had an increased risk.

Differences in major limb outcomes by indication for lower extremity endovascular revascularization in patients receiving hemodialysis.

The incidence of lower extremity artery disease (LEAD) in patient receiving hemodialysis is remarkably higher than the general population. The treatment strategy and prognosis for LEAD patients differs depending on whether a patient has intermittent claudication (IC) or critical limb-threatening ischemia (CLTI). However, the distinction between the prognosis in HD-dependent patients with IC and CLTI has not been fully elucidated. This study is to determine whether indication of PAD has a distinct impact on major adverse cardiovascular and cerebrovascular events (MACCE) and limb events in patients receiving hemodialysis. The current study included 2321 prospectively enrolled patients from the Tokyo taMA peripheral vascular intervention research ComraDE registry (UMIN-CTR no. UMIN000015100) between September 2014 and December 2016. Out of the enrolled patients, 1644 were not receiving hemodialysis (non-HD patients) and 603 were receiving hemodialysis (HD patients). A composite of all-cause death, myocardial infarction, and stroke events defined as MACCE; while limb events were defined as a composite of unscheduled major amputation, unscheduled major lower limb surgery, acute limb ischemia, unscheduled endovascular treatment, and target lesion revascularization. Propensity score matching was applied among the non-HD and HD patients, in whole group, IC subgroup, and CLTI subgroup. Kaplan-Meier analysis was used for the analysis of outcomes for the whole group, IC subgroup, and the CLTI subgroup. CLTI accounted for 75.5% of the HD patients, whereas IC was 63.4% in the non-HD patients. The HD patients exhibited more frequent below-the-knee lesions than those in the non-HD patients in both IC (p = 0.01) and CLTI (p < 0.001) subgroups. Overall, HD patients exhibited a significantly higher rate of MACCE at 24 months. This trend was similar for limb events in whole group and CLTI subgroup. In contrast, no significant differences in outcomes for limb events were found in IC subgroup. Although, prognosis after EVT in HD patients were significantly worse than non-HD patients, comparable outcome with non-HD patients was observed in the patients treated for IC. Clinical trial registration: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR No. UMIN000015100).

Comparison of the incidence of depression before and after endovascular treatment in patients with lower limb peripheral artery disease.

Depression is a chronic illness that affects mood, physical health, and overall vitality and quality of life. Depression has been associated with an increased risk of all-cause and cardiovascular mortality among patients with peripheral arterial disease (PAD). Therefore, this study aimed to compare the incidence of depression before and after endovascular treatment in patients with lower limb PAD. This is an important clinical issue considering the worldwide increase in PAD with the aging population and the known negative impact of depression on recovery. This was a retrospective sub-analysis of data from the Tokyo Peripheral Vascular Intervention Study using the TOMA-CODE registry. The presence and extent of depressive symptoms were evaluated using the patient health questionnaire (PHQ-9), with a depressive tendency score of ≥ 5. The PHQ-9 score was evaluated before endovascular treatment (EVT) and at 4 (± 1) weeks after EVT. The study population consisted of 87 patients who completed the PHQ-9 before EVT, with 76 completing the post-EVT PHQ-9. Of these 76, 19 had a pre-EVT score ≥ 5. Overall, there was no difference in the pre- and post-EVT scores (P = 0.091). There was no significant change in the 19 patients with a pre-EVT score ≥ 5 (mean 9.2 ± 4.4); however, there was a tendency to improve in the pre- to post-EVT score (mean, 6.9 ± 5.2; P = 0.059). Diabetes was a significant negative factor for pre- to post-EVT score improvement (P = 0.023). Overall, symptoms of depression showed the tendency to improve at 30 days post-EVT. However, diabetes was associated with lower improvement in symptoms.

Prognostic impact of atrial fibrillation on the outcomes of peripheral artery disease according to preoperative symptoms for endovascular revascularization.

Peripheral artery disease (PAD) and atrial fibrillation (AF) are associated with major cardiovascular and cerebrovascular events (MACCE). However, outcomes stratified according to the preoperative symptoms of PAD in patients with AF have not been sufficiently investigated. This was a retrospective study of prospectively collected data pertaining to 2237 patients (1179 patients with intermittent claudication [IC] and 1058 patients with critical limb-threatening ischemia [CLTI]) who underwent endovascular therapy at 34 hospitals between August 2014 and August 2016. AF was present in 91 (7.7%) patients with IC and 150 (14.2%) patients with CLTI. In the CLTI group, patients with AF had a higher event rate of MACCE and all-cause death than those without AF (1-year rates of freedom from MACCE: 0.66 and 0.81 in patients with and without AF, respectively, p < 0.001). In contrast, in the IC group, there was no statistically significant difference in the rates of MACCE between patients with and without AF. In the Cox multivariate analysis, AF was a significant predictor of MACCE in patients with CLTI but not in patients with IC, even after adjusting for covariates. The impact of AF on the outcome of patients with PAD was greater in those with CLTI. Further studies are needed to clarify the possible mechanisms underlying these differences.

Two-year results of endovascular therapy for femoropopliteal artery disease in Japan during the introduction of drug-eluting devices.

Although various devices and strategies were introduced into endovascular therapy, factors associated with chronic outcomes remain unclear. Therefore, this study aimed to build preliminary data of Japanese femoropopliteal lesions in a period of transition from non-drug to drug technology. This research was a multicenter, prospective, and observational study. A total of 1003 consecutive patients with a mean age of 73.6 ± 8.3 years from 67 institutes were registered from February 2017 to June 2018 in Japan. In addition to the baseline data, angiographic findings affecting primary patency were studied. Lesion length was 16.4 ± 9.6 cm, and chronic total occlusion was found in 42%. Calcified lesions were found in 75% of patients. The 1-year and 2-year freedom from target lesion revascularization were 81% and 75%, respectively, and maximum walking distance showed improvement over the two years (pre; 234 m ± 211 m, 1-year; 402 m ± 241 m, 2-year; 428 m ± 231 m). The independent predictors for primary patency were pre-procedure ankle-brachial index, history of minor amputation, ostium lesion, and drug-coated balloon use. Angiographic analysis revealed that only lesion length and full cover stent were related to primary patency. Two-year freedom from target vessel revascularization was 75% in the Japanese transitional period of drug-eluting devices. Maximum walking distance was improved and well maintained for up to 2-year.

Low Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) Ratio Associated with Increased Cardiovascular Disease and its Risk Factors in Healthy Japanese Population.

AIMS: This study aimed to evaluate the association between aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio and cardiovascular disease, and risk factors in a healthy Japanese population. METHODS: A retrospective cohort study was conducted at St. Luke's International Hospital, Tokyo, Japan, between 2005 and 2018. We included all participants who visited the hospital for voluntary health checkups. Our primary outcome was the development of cardiovascular disease, and the secondary outcomes were cardiovascular risk factors. We grouped the participants into quartiles (Qs) according to their baseline AST/ ALT ratios and examined the outcomes of patients in each group. RESULTS: 87,740 participants were included in this study. The mean age of the participants was 44.9 years [standard deviation (SD): 12.1], and 43,191 (49.2%) were men. The mean AST and ALT levels were 21.7 IU/L (SD 10.0) and 22.4 IU/L (SD 16.5), respectively, resulting in a mean AST/ALT ratio of 1.1 (0.4). During the median follow-up of 1,829 days (interquartile range 756-3,470), 1,493 (1.7%) participants developed cardiovascular disease, 831 (1%) experienced ischemic heart disease, and 723 (0.8%) experienced strokes. Those in the Q1 AST/ALT ratio group had significantly higher hazard ratios compared to those in the Q3 AST/ ALT ratio group [adjusted hazard ratio (HR)=1.32, 95% confidence interval (CI): 1.12-1.56 for cardiovascular disease; HR=1.36, 95%CI: 1.09-1.68 for ischemic heart disease; HR=1.28, 95%CI: 1.00-1.65 for stroke]. However, those belonging to the Q4 or Q5 AST/ALT ratio groups was not statistically different for primary outcomes compared to the Q3 AST/ALT ratio group. In contrast, the adjusted HRs for all secondary outcomes decreased in a dose-dependent manner as the AST/ALT ratio increased. CONCLUSIONS: A Q1 AST/ALT ratio was associated with an increased risk of cardiovascular disease compared to the Q3 AST/ALT ratio in the Japanese population, which is in contrast with the Western population. In our study, Q4 or Q5 AST/ALT ratios were not associated with cardiovascular disease compared to the Q3 AST/ ALT ratio. As for cardiovascular risk factors, the risk decreased as the AST/ALT ratio increased.

[The case of an octogenarian who died of acute myocardial infarction complicated with acute pulmonary embolism from a right ventricular thrombus].

An 86-year-old female on dialysis experienced a decrease in blood pressure and worsening of her respiratory condition during dialysis, for which she visited our emergency unit. She was admitted to our Department of Cardiology with a diagnosis of acute myocardial infarction complicated with heart failure because of anterior wall of left ventricular dysfunction, positive troponin T levels and negative T wave on a precordial lead electrocardiogram. On the same day, she underwent coronary angiography and stenting at left anterior descending artery #7 with 99% stenosis. She also showed an elevated D-dimer level on admission, and contrast-enhanced computed tomography (CT) was performed the day after admission, considering the likelihood of respiratory failure due to pulmonary thromboembolism. However, the findings were negative. On the 4th day of hospitalization, she showed marked hypoxemia. Her D-dimer level was further elevated, and when she underwent enhanced CT again, there was no evidence of deep vein thrombosis, but thrombus in the pulmonary artery and apex of right ventricle was noted. She was therefore diagnosed with acute pulmonary embolism due to thrombosis from the right ventricle rather than from a deep vein. She rapidly received anticoagulant therapy and non-invasive positive pressure ventilation therapy for respiratory failure, but she entered cardiopulmonary arrest and quickly died. She was suspected to have been complicated with a right ventricular infarction and an acute anterior wall myocardial infarction, resulting in a large thrombus along the apex of the right ventricle. This case of both myocardial infarction and pulmonary embolism is very rare, and we report it here with consideration.

Introduction of Extracorporeal Membrane Oxygenation on Ninth Day of Ventilator Management for Severe Acute Respiratory Distress Syndrome due to COVID-19: A Case Report.

The reported case is of a 68-year-old man who was admitted to the ICU at our tertiary care medical center with severe COVID-19. He was admitted to the ICU due to a worsening respiratory condition during his hospitalization at the same medical center, which included the development of severe acute respiratory distress syndrome (ARDS). Ventilator management was started with alveolar protection in mind. On the ninth day of ventilator management, we judged that it was necessary to introduce extracorporeal membrane oxygenation (ECMO). Although the ninth day of ventilator management is considered relatively late for starting ECMO, there are no absolute contraindications for ECMO at this stage, and improvements in oxygenation can be expected. After introducing ECMO, the patient's oxygenation capacity improved, and ECMO was successfully withdrawn within 16 days. The patient required long-term rehabilitation but was discharged from the hospital to his home without lingering disease complications on the 150th day of illness and subsequently resumed his former work, daily activities, and quality of life. We conclude that, in regard to the introduction of ECMO for ARDS, it is necessary to reach a comprehensive judgment without being bound by any one index (such as the ventilation management period prior to ECMO introduction).

Caregiver experience with decision-making difficulties in end-of-life care for patients with cardiovascular diseases.

BACKGROUND: The decisional burden on caregivers in the end-of-life (EOL) care for patients with cardiovascular diseases (CVD) is unknown. We aimed to evaluate the frequency and circumstances of caregiver difficulties in decision-making during EOL care for CVD patients, its determinants, and associations with psychological distress in the bereaved caregivers. METHODS: We conducted a cross-sectional survey using a questionnaire for bereaved caregivers of CVD patients who had died in 10 tertiary care centers. We assessed their overall and situation-specific decision-making difficulties during EOL care. The questionnaire also covered the attitudes of patients, caregivers, and attending physicians during EOL care and the respondents' depression (Patient Health Questionnaire-9) and grief status (Brief Grief Questionnaire). RESULTS: We enrolled 266 bereaved caregivers [median age, 65 (57-72) years; 38.4% male] of CVD patients. Overall, 28.9% of them experienced difficulties in decision-making. The most difficult decision-making situations involved informing the patient of the prognosis (18.2%), life-prolonging treatment (17.9%), and discontinuation of hydration and artificial nutrition (15.6%). Difficulties were associated with patient and/or caregiver factors (poor understanding of disease status and the patient's wishes, caregiver's emotional inability), physician factors (poor understanding of the patient's and/or caregiver's values, inadequate support for decision-making), and both (insufficient communication, conflict of opinions and wishes). Decision-making difficulties were associated with subsequent depression (20.5% vs. 10.3%, p=0.029) and complicated grief (27.0% vs. 9.0%, p<0.001) among bereaved caregivers. CONCLUSIONS: Approximately 30% of bereaved caregivers experienced decisional burdens during EOL care of CVD patients. The caregiver's decisional burdens were associated with subsequent psychological distress.

Depression and complicated grief in bereaved caregivers in cardiovascular diseases: prevalence and determinants.

OBJECTIVES: Despite the recommendation that patients with cardiovascular disease (CVD) receive bereavement care, few studies have examined the psychological disturbances in bereaved caregivers. We examined the prevalence and determinants of depression and complicated grief among bereaved caregivers of patients with CVD. METHODS: We conducted a cross-sectional survey using a self-administered questionnaire for bereaved caregivers of patients with CVD who had died in the cardiology departments of nine Japanese tertiary care centres. We assessed caregiver depression and grief using the Patient Health Questionnaire-9 (PHQ-9) and Brief Grief Questionnaire (BGQ), respectively. The questionnaire also covered caregivers' perspectives toward end-of-life care and the quality of the deceased patient's death. RESULTS: A total of 269 bereaved caregivers (mean age: 66 (57-73) years; 37.5% male) of patients with CVD were enrolled. Overall, 13.4% of the bereaved caregivers had depression (PHQ-9 ≥10) and 14.1% had complicated grief (BGQ ≥8). Depression and complicated grief's determinants were similar (ie, spousal relationship, unpreparedness for the death, financial and decision-making burden and poor communication among medical staff). Patients and caregivers' positive attitudes toward life-prolonging treatment were associated with complicated grief. Notably, in caregivers with complicated grief, there was less discussion with physicians about end-of-life care. Caregivers who felt that the patients did not receive sufficient treatment suffered more frequently from depression and complicated grief. CONCLUSIONS: Approximately 15% of bereaved caregivers of patients with CVD suffered from depression and complicated grief. Cardiologists should pay particular attention to caregivers with high-risk factors to identify those likely to develop depression or complicated grief.

One-year limb outcome and mortality in patients undergoing revascularization therapy for acute limb ischemia: short-term results of the Edo registry.

The present study aimed to clarify the current status, therapeutic strategy, and 1-year outcome in acute limb ischemia (ALI) patients in Japan. The EnDOvascular treatment (Edo) registry database includes 324 patients from 10 institutes who were registered between November 2011 and October 2013. A total of 70 ALI patients (mean age 74.0 years) from the Edo registry database were enrolled in this study. Of the 70 included patients, 72.9% were male and 35.7% had embolism. Of patients, 38.6%, 42.9%, and 18.6% underwent EVT, surgery, and hybrid thrombectomy, respectively, in primary revascularization strategy. Limb ischemia was categorized into four classes at initial evaluation: SVS/ISCVS class I (n = 13, 18.6%), SVS/ISCVS class IIa (n = 36, 51.4%), SVS/ISCVS class IIb (n = 21, 30%), and SVS/ISCVS class III (n = 0, 0%). Three patients with SVS/ISCVS class IIb limb ischemia developed myonephropathic metabolic syndrome. No catheter-directed thrombolysis was employed as a primary revascularization strategy. The 1-year rates of all-cause death, major amputation, and a composite of perioperative death or major adverse limb event were 28.6%, 5.7%, and 40.0%, respectively. Lower age, male sex, dyslipidemia, high estimated glomerular filtration rate, high albumin level, and low C-reactive protein level were independent positive predictors of all-cause death. In this registry, SVS/ISCVS class IIa ALI was predominant. Approximately 40% of primary revascularization strategy was surgery and EVT, followed by hybrid therapy. All-cause death and major amputation rates at 1 year were less than 30% and 6%, respectively.

Optimal cut-off value of preprocedural geriatric nutritional risk index for predicting the clinical outcomes of patients undergoing endovascular revascularization for peripheral artery disease.

BACKGROUND: Malnutrition measured by the geriatric nutritional risk index (GNRI) was reported to be associated with poor prognosis for patients with peripheral artery disease (PAD). However, the optimal cut-off value of preprocedural GNRI for critical limb ischemia (CLI) and intermittent claudication (IC) is unknown. We aimed to determine its optimal cut-off value for CLI or IC patients requiring endovascular revascularization. METHODS: We explored data of 2246 patients (CLI: n = 1061, IC: n = 1185) registered in the Tokyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry, which prospectively enrolled consecutive PAD patients who underwent endovascular revascularization in 34 hospitals in Japan from August 2014 to August 2016. The optimal cut-off values of GNRI were assessed by the survival classification and regression tree (CART) analyses, and the survival curve analyses for major adverse cardiovascular and limb events (MACLEs) were performed for these cut-off values. RESULTS: In addition to the first cut-off value of 96.2 in CLI and 85.6 in IC, the survival CART provided an additional cut-off value of 78.2 in CLI and 106.0 in IC for further risk stratification. The survival curve was significantly stratified by the GNRI-based malnutrition status in both CLI [high risk: 47.7% (51/107), moderate: 30.1% (118/392), and low: 10.2% (53/520), log-rank p < 0.001] and IC [high risk: 14.3% (7/49), moderate: 4.5% (29/646), and low: 0.5% (2/407), log-rank p < 0.001]. The multivariate Cox-proportional hazard analysis showed that a higher GNRI was significantly associated with a better outcome in both CLI [hazard ratio (HR) per 1-point increase: 0.97, 95% CI: 0.96-0.98, p < 0.001] and IC (HR: 0.94, 95% CI: 0.91-0.97, p < 0.001). CONCLUSIONS: Preprocedural nutritional status significantly stratified future events in patients with PAD. Given that the optimal cut-off value of GNRI in CLI was almost 10-points lower than that of IC, using a disease-specific cut-off value is important for risk stratification.

Differences in Intravascular Ultrasound Measurement Values Between Treatment Modalities for Restenosis in Femoropopliteal Lesions.

BACKGROUND: The risk of restenosis after intervention is higher in femoropopliteal than in aortoiliac lesions. However, the appropriate endovascular therapy (EVT) for preventing restenosis after intervention for femoropopliteal lesions remains unknown. This study aimed to elucidate the relationship between lesion characteristics and patency after EVT using intravascular ultrasound (IVUS) measurement and to determine the predictors of restenosis on IVUS.Methods and Results:This prospective observational study was performed at 18 Japanese centers. We evaluated the lesion characteristics before and after EVT for femoropopliteal lesion using IVUS. Angiographic or duplex ultrasound follow-up was performed at 1 year after EVT. A total of 263 lesions underwent EVT between December 2016 and December 2017. In total, 20 lesions (8 cases of isolated common femoral artery lesion and 12 cases of restenosis lesion) were excluded, and 243 lesions were enrolled in this study. A total of 181 lesions were treated with stent placement, and 62 lesions were treated only with balloon angioplasty. In the case of stent use, a larger distal plaque burden was associated with restenosis, while a lower calcification angle was associated with higher patency in the case of balloon angioplasty alone. CONCLUSIONS: The factors related to patency differed depending on the treating modality. The findings suggest that IVUS is a useful tool for predicting patency because it can provide a more accurate evaluation after EVT for femoropopliteal lesions.

Clinical Outcome and Diverse Risk Factors for Different Therapeutic Target Locations of Peripheral Artery Disease.

AIM: Previous studies on peripheral artery disease (PAD) only enrolled patients with atherosclerotic lesion limited to any one of isolated locations (aortoiliac [AI], femoropopliteal [FP], and below the knee [BTK]). However, the interventions for PAD in a real-world clinical setting are often simultaneously performed for several different locations. METHODS: We conducted a prospective multicenter study that included 2,230 patients with PAD who received intervention for lower extremity lesions in each area and across different areas. Patients were divided into 7 groups according to the combination of treatment locations. Overall survival (OS), major adverse limb events (MALEs), and risk factors for OS and MALEs were statistically analyzed. RESULTS: After adjustment for confounding factors, the attributable risk for OS was similar among isolated AI, FP, and BTK treatments. MALEs increased in correlation with the number of treatment locations. Dialysis and critical limb ischemia were the common risk factors for OS and MALEs. However, the contribution of other factors such as type of drug usage was different according to treatment locations. CONCLUSIONS: In patients with PAD, OS was largely defined by comorbidities but not by lesion location. The background risk factors, underlying comorbidities, and event rates were different according to PAD location, suggesting that stratified treatment should be established for different patient populations.

Stent implantation for May-Thurner syndrome with acute deep venous thrombosis: acute and long-term results from the ATOMIC (AcTive stenting for May-Thurner Iliac Compression syndrome) registry.

The outcomes of stent implantation in managing May-Thurner syndrome (MTS) are not well understood. To clarify the acute and long-term outcomes of stent implantation in patients with MTS having acute deep venous thrombosis (DVT), we retrospectively investigated consecutive 59 patients from 10 hospitals in Japan who were treated with stents for left iliac vein stenosis with acute DVT. Stents were considered successful if the stent was patent at discharge, which in turn was defined as patient success. The primary endpoint for the study was stent patency, and the secondary endpoint was recurrence of DVT and development of post-thrombotic syndrome (PTS) during follow-up. The patient success was achieved in 56 patients (95%). Clinical follow-up was conducted for 50 patients (89%) for a median duration of 40 months (range 8-165 months). Among them, 44 patients (79%) were followed up using imaging modalities. During this period, stent occlusion was revealed in four patients (9%), and one patient was successfully treated using balloon angioplasty. Primary and secondary patency rates were 84% at 19 months and 93% at 20 months, respectively. Recurrence of DVT was documented in 3 (8%) patients. PTS was evaluated from 36 patients. Three patients (8%) had PTS; however, none of the patients had severe PTS. This multicenter retrospective study of the use of stents for treating patients with MTS having acute DVT demonstrated good acute and long-term outcomes and long-term stent patency.