Validation of the Usefulness of the Diameter Reduction, Spiral Shape, Flow Impairment, or Adverse Morphology Classification System in Real-World Clinical Practice.

AIM: The accuracy of the DISFORM (diameter reduction, spiral shape, flow impairment, or adverse morphology) classification system has not been validated. METHODS: This retrospective multicenter observational study enrolled 288 consecutive patients with lower extremity artery disease who underwent endovascular therapy with drug-coated balloons for femoropopliteal lesions between January 2018 and December 2021. Patients were classified into DISFORM I-IV groups. Primary patency (PP) and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months, and recurrence predictors at 12 months were investigated. RESULTS: In total, 183, 66, 11, and 28 patients were classified into DISFORM I, II, III, and IV groups, respectively. In the DISFORM I, II, III, and IV groups, the PP rates were 75.3%, 91.1%, 87.5%, and 50.0%, respectively, and freedom from CD-TLR rates were 86.0%, 91.6%, 88.9%, and 76.7%, respectively, at 12 months. In the DISFORM I-III and IV groups, the PP rates were 79.4% and 50.0%, respectively, and freedom from CD-TLR rates were 87.5% and 76.7%, respectively, at 12 months. Multivariate analysis showed that chronic limb-threatening ischemia, DISFORM IV, and Lutonix™ use were independent predictors of PP loss at 12 months. CONCLUSION: DISFORM IV had a lower PP rate than DISFORM I-III in midterm phase.

Chronic Limb-Threatening Ischemia is a Residual Bleeding Risk Factor among Patients with Lower Extremity Artery Disease.

AIM: Lower-extremity artery disease (LEAD) is a high-risk factor for bleeding. However, the specific risk factors for bleeding in patients with LEAD remain unclear. We aimed to identify risk factors for bleeding in patients with LEAD after endovascular treatment (EVT). METHODS: This multicenter, retrospective, observational study included 732 consecutive patients with LEAD who underwent EVT between January 2018 and December 2019. Patient characteristics, laboratory data, target lesions, and medications were compared between patients with and without chronic limb-threatening ischemia (CLTI). Predictive bleeding risk factors were explored using Cox regression analysis with differential models. RESULTS: In model 1, a body mass index (BMI) ＜18.5 kg/m2, prior heart failure, high bleeding risk, use of single antiplatelet therapy (SAPT) plus warfarin, and CLTI were predictive bleeding risk factors (hazard ratio [HR] 2.05; 95% confidence interval [CI] 1.13-3.52; p＜0.01; HR 2.15; 95% CI 1.28-3.55; p＜0.01; HR 3.40; 95% CI 1.28-3.55; p＜0.01; HR 2.05; 95% CI 1.33-5.84; p＜0.01; respectively). In model 2, a BMI ＜18.5 kg/m2, prior heart failure, anemia (＜11 g/dL), low platelet count (＜10*104/µL), chronic kidney disease, use of single antiplatelet therapy (SAPT) plus warfarin, and CLTI were independent risk factors for bleeding (model 2: HR 2.05; 95% CI 1.12-3.56; p=0.02; HR 2.35; 95% CI 1.39-3.90; p＜0.01; HR 2.71; 95% CI 1.64-4.50; p＜0.01; HR 2.66; 95% CI 1.00-5.89; p=0.05; HR 2.47; 95% CI 1.25-5.45; p＜0.01; HR 2.79; 95% CI 1.24-5.63; p=0.01; respectively) Conclusions: CLTI is a residual and predictive risk factor for bleeding in patients with LEAD. We have to pay attention to the bleeding events of patients with CLTI after EVT during follow-up.

Predictors of recurrence based on intravascular ultrasound findings after Eluvia placement in symptomatic peripheral arterial disease: A retrospective study.

Background and Aims: Polymer-coated drug-eluting stents (Eluvia) have shown favorable clinical outcomes in real-world registries. There are no reports on recurrent predictors after Eluvia placement based on intravascular ultrasound (IVUS) findings. Methods: We analyzed clinical data from the ASIGARU PAD registry, a retrospective, multicenter, observational study that enrolled patients who underwent endovascular therapy for superficial femoral and proximal popliteal arteries lesions using Eluvia or drug-coated balloon. The primary outcome was the identification of recurrent predictors, including IVUS parameters at 12 months. The rate of target lesion recurrence was also assessed. Results: IVUS images were obtained in 54 of 65 cases. Seven recurrent cases (13.0%) were observed within 12 months. The random survival forest method presented eight predictive variables of recurrence: Clinical Frailty Scale (CFS), distal stent edge area, distal plaque burden, age, sex, distal external elastic membrane (EEM) area, minimum stent area (MSA), and distal lumen area. Furthermore, the partial dependence plot showed that frailty (CFS ≥ 6), smaller distal stent edge area, higher and lower distal plaque burden, older and younger age, female sex, smaller distal EEM area, smaller MSA, and smaller and larger distal lumen area predicted recurrence after Eluvia placement within 12 months. Conclusion: CFS, distal stent edge area, distal plaque burden, age, sex, distal EEM area, MSA, and distal lumen area were significant recurrent predictors after Eluvia placement.

Clinical Outcomes Based on High Bleeding Risk in Patients With Lower Extremity Peripheral Artery Disease Who Have Undergone Endovascular Therapy.

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.

Association between High Bleeding Risk and 2-Year Mortality in Patients with Chronic Limb-Threatening Ischemia.

AIM: Patients with chronic limb-threatening ischemia (CLTI) have a high bleeding risk (HBR) and mortality rate. The 2-year life expectancy is an important factor in deciding the appropriate treatment strategy. This study aimed to assess the influence of HBR on the prognosis of patients with CLTI. METHODS: A total of 259 patients with CLTI who underwent endovascular therapy (EVT) (mean age, 76.2 years; male, 62.9%) between January 2018 and December 2019 were evaluated. The Academic Research Consortium for HBR (ARC-HBR) criteria were applied to each patient, and the ARC-HBR scores were calculated. The cut-off score for predicting all-cause mortality within two years was derived using a survival classification and regression tree (CART) model. Causes of death and the association between ARC-HBR scores and major bleeding events within two years were also investigated. RESULTS: Based on the CART model, patients were divided into three groups (low HBR score 0-1.0, 48 patients; moderate HBR score 1.5-3.0, 176 patients; and high HBR score ≥ 3.5, 35 patients). During the study period, 82 patients (39.6%) died due to cardiac (n=23) and non-cardiac causes (n=59). All-cause mortality increased significantly with increasing ARC-HBR scores. Cox multivariate analysis revealed a significant association between high ARC-HBR scores and the risk of all-cause mortality within two years. Major bleeding events increased significantly with increasing ARC-HBR scores. CONCLUSIONS: The ARC-HBR score could predict 2-year mortality in patients with CLTI who underwent EVT. Thus, this score can help determine the best revascularization strategy for patients with CLTI.

Two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease.

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.

Staphylococcus aureus Infection-Related Glomerulonephritis with Dominant IgA Deposition.

Since 1995, when we reported the case of a patient with glomerulonephritis with IgA deposition that occurred after a methicillin-resistant Staphylococcus aureus (MRSA) infection, many reports of MRSA infection-associated glomerulonephritis have accumulated. This disease is being systematized as Staphylococcus infection-associated glomerulonephritis (SAGN) in light of the apparent cause of infection, and as immunoglobulin A-dominant deposition infection-related glomerulonephritis (IgA-IRGN) in light of its histopathology. This glomerulonephritis usually presents as rapidly progressive glomerulonephritis or acute kidney injury with various degrees of proteinuria and microscopic hematuria along with an ongoing infection. Its renal pathology has shown several types of mesangial and/or endocapillary proliferative glomerulonephritis with various degrees of crescent formation and tubulointerstitial nephritis. IgA, IgG, and C3 staining in the mesangium and along the glomerular capillary walls have been observed on immunofluorescence examinations. A marked activation of T cells, an increase in specific variable regions of the T-cell receptor ß-chain-positive cells, hypercytokinemia, and increased polyclonal immune complexes have also been observed in this glomerulonephritis. In the development of this disease, staphylococcal enterotoxin may be involved as a superantigen, but further investigations are needed to clarify the mechanisms underlying this disease. Here, we review 336 cases of IgA-IRGN and 218 cases of SAGN.

Recurrent Mural Thrombosis of the Ascending Aorta in a Patient with Antiphospholipid Syndrome.

A 38-year-old man presented with embolic occlusion of the brachial artery. As per his computed tomography results, a pedunculated mass in the proximal ascending aorta was detected. Since discrimination between a thrombus and a tumor was deemed difficult, the patient underwent replacement of the ascending aorta. Histopathology revealed the mass to be a thrombus. The diagnosis of antiphospholipid syndrome was then confirmed postoperatively. Six months post-surgery, a new thrombus was detected in the vascular prosthesis. The thrombus resolved after treatment with edoxaban and aspirin. To the best of our knowledge, this is the first report on graft thrombosis in antiphospholipid syndrome, highlighting the importance of seamless anticoagulation therapy.

Impact of Serum Zinc Level and Oral Zinc Supplementation on Clinical Outcomes in Patients Undergoing Infrainguinal Bypass for Chronic Limb-Threatening Ischemia.

BACKGROUND: Zinc (Zn) has been reported to play an important role in wound healing (WH). Nevertheless, the effect of Zn in chronic limb-threatening ischemia (CLTI) patients is unclear. This study investigated the effect of Zn on the clinical outcomes of CLTI patients undergoing bypass surgery.Methods and Results: This study reviewed 111 consecutive patients who underwent an infrainguinal bypass from 2012 to 2020. Patients with Zn deficiency (serum Zn level <60 µg/dL) received oral Zn supplementation and maintained a normal level until WH. This study aimed to explore: (1) the effect of Zn deficiency; and (2) Zn supplementation in Zn-deficient patients on the clinical outcomes of this cohort. Patients with Zn deficiency, Zn supplementation, and no Zn supplementation despite Zn deficiency accounted for 48, 21, and 42 patients, respectively. (1) Zn deficiency was associated with WH (HR, 0.47; 95% CI, 0.29-0.78: P=0.003), major adverse limb events (MALE) (HR, 2.53; 95% CI, 1.26-5.09: P=0.009), and major amputation or death (HR, 3.17; 95% CI, 1.51-6.63: P=0.002). (2) Zn supplementation was positively related to WH (HR, 2.30; 95% CI, 1.21-4.34: P=0.011). This result was confirmed using propensity score matching (HR, 2.24; 95% CI, 1.02-4.87: P=0.043). CONCLUSIONS: The current study revealed that Zn level was associated with clinical outcomes in CLTI patients after bypass surgery. Oral Zn supplementation could improve WH in these patients.