Influence of inframalleolar modifier P0/P1 on wound healing in bypass surgery vs endovascular therapy in patients with chronic limb-threatening ischemia.

OBJECTIVE: This study aimed to compare the influence of inframalleolar (IM) P0/P1 on wound healing in bypass surgery vs endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI). METHODS: We retrospectively analyzed the multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. IM P represents target artery crossing into foot, with intact pedal arch (P0) and absent or severely diseased pedal arch (P1). The endpoints were wound healing, limb salvage (LS), and postoperative complications. RESULTS: We analyzed 66 and 189 propensity score-matched pairs in the IM P0 and IM P1 cohorts, respectively. In the IM P0 cohort, the 1-year wound healing rates were 94.5% and 85.7% in the bypass surgery and EVT groups, respectively (P = .092), whereas those in the IM P1 cohort were 86.2% and 66.2% in the bypass surgery and EVT groups, respectively (P < .001). In the IM P0 cohort, the 2-year LS rates were 96.7% and 94.1% in the bypass surgery and EVT groups, respectively (P = .625), and those in the IM P1 cohort were 91.8% and 81.5% in the bypass surgery and EVT groups, respectively (P = .004). No significant differences were observed between the bypass surgery and EVT in terms of postoperative complication rates in either the IM P0 or P1 cohorts. CONCLUSIONS: Bypass surgery facilitated better wound healing and LS than EVT in patients with IM P1. Conversely, no differences in wound healing or LS were observed between groups in patients with IM P0. Bypass surgery should be considered a better revascularization strategy than EVT in patients with tissue loss and IM P1 disease.

Infra-inguinal bypass surgery vs endovascular revascularization for chronic limb-threatening ischemia in average- and high-risk patients.

OBJECTIVE: This study aimed to evaluate treatment outcomes after bypass surgery or endovascular therapy (EVT) in average- and high-risk patients with chronic limb-threatening ischemia (CLTI). METHODS: We retrospectively analyzed multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. A high-risk patient was defined as one with estimated 30-day mortality rate ≥5% or 2-year survival rate ≤50%, as determined by the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) calculator. The amputation-free survival (AFS), limb salvage (LS), wound healing, and 30-day mortality were compared separately for the average- and high-risk patients between the bypass and EVT with propensity score matching. RESULTS: We analyzed 239 and 31 propensity score-matched pairs in the average- and high-risk patients with CLTI. In the average-risk patients, the 2-year AFS and LS rates were 78.1% and 94.4% in the bypass group and 63.0% and 87.7% in the EVT group (P < .001 and P = .007), respectively. The 1-year wound healing rates were 88.6% in the bypass group and 76.8% in the EVT group, respectively (P < .001). The 30-day mortality was 0.8% in the bypass surgery and 0.8% in the EVT group (P = .996). In the high-risk patients, there was no differences in the AFS, LS, and wound healing between the groups (P = .591, P = .148, and P = .074). The 30-day mortality was 3.2% in the bypass group and 3.2% in the EVT group (P = .991). CONCLUSIONS: Bypass surgery is superior to EVT with respect to the AFS, LS, and wound healing in the average-risk patients. EVT is a feasible first-line treatment strategy for high-risk patients with CLTI undergoing revascularization, based on the lack of significant differences in the 2-year AFS rate, between the bypass surgery and EVT cohorts.

Retrograde transvenous thoracic duct embolization for lymphatic leakage after retroperitoneal tumor and lymph node resection: a case report and literature review.

BACKGROUND: Postoperative lymphatic leakage is a complication of ineffective conservative treatment for retroperitoneal mass. Herein, we report a case of lymphatic leakage that arose after retroperitoneal tumor resection and that was treated with retrograde transvenous thoracic duct embolization. CASE PRESENTATION: A 28-year-old man with persistent abdominal pain was diagnosed with a large retroperitoneal metastatic tumor measuring 10 cm and a subdiaphragmatic lymph node originating from a testicular tumor. After high orchidectomy and neoadjuvant chemotherapy, the subdiaphragmatic lymph node and retroperitoneal tumor were resected together with the abdominal aorta; the latter was reconstructed using a prosthetic graft. Postoperatively, the patient developed chylothorax. No improvement was observed after conservative treatment that included fasting and somatostatin therapy. The leakage site could not be identified using antegrade lymphangiography of the bilateral inguinal lymph nodes, but was detected using retrograde transvenous lymphangiography. The leakage site was successfully embolized. CONCLUSION: This case report describes successful treatment with retrograde transvenous thoracic duct embolization for chylothorax following resection of a retroperitoneal tumor and lymph node. This approach is a less invasive and more effective mode of treatment for chylothorax and should be considered before surgical thoracic duct ligation when the leakage point cannot be identified using the antegrade approach.

Comparison of limb outcomes between bypass surgery and endovascular therapy in dialysis-dependent and -independent patients with chronic limb-threatening ischemia.

OBJECTIVE: To examine limb salvage (LS) and wound healing in dialysis-dependent and -independent patients with chronic limb-threatening ischemia (CLTI) after infrainguinal bypass surgery or endovascular therapy (EVT). METHODS: We retrospectively analyzed the multi-center data of patients who underwent infrainguinal revascularization for CLTI with Wound, Ischemia, and foot Infection (WIfI) stage 2 to 4 between 2015 and 2020. The primary endpoint was LS. The secondary endpoint included wound healing, amputation-free survival (AFS), periprocedural complications, and 2-year survival. Comparison of these outcomes were made after propensity score matching. RESULTS: We analyzed 252 dialysis-dependent (318 limbs) and 305 dialysis-independent (354 limbs) patients. Propensity score matching extracted 202 pairs with no significant differences in characteristics. The LS rate in bypass surgery was better than that in EVT in dialysis-dependent patients (P < .001). There was no significant difference in the LS rates between bypass surgery and EVT in dialysis-independent patients (P = .168). The wound healing rate of bypass surgery was better than that of EVT both dialysis-dependent and -independent patients with CLTI. The AFS rate of bypass surgery was better than that of EVT in dialysis-dependent patients (P < .001). There was no significant difference in the AFS rates between bypass surgery and EVT in dialysis-independent patients (P = .099). There was no significant difference in the occurrence of Clavien-Dindo ≥ IV and V between bypass surgery and EVT in dialysis-dependent and -independent patients. Age ≥75 years, serum albumin levels <3.5 g/dL, and non-ambulatory status were risk factors for 2-year mortality in dialysis-dependent patients. The 2-year survival rates in dialysis-dependent patients with risk factors of 0, 1, 2, and 3 were 82.5%, 67.1%, 49.5%, and 10.2%, respectively (P < .001). CONCLUSIONS: For LS and wound healing, bypass surgery was preferred for revascularization in dialysis-dependent patients with WIfI stage 2 to 4. Although dialysis dependency was one of the risk factors for 2-year mortality, dialysis-dependent patients, who have 0 to 1 risk factors, may benefit from bypass surgery, as 2-year survival of >50% is expected.

Validation of JCLIMB, SPINACH, and VQI Calculators for Prediction of Two Year Survival in Patients With Chronic Limb Threatening Ischaemia After Infra-Inguinal Surgical or Endovascular Revascularisation.

OBJECTIVE: This study aimed to evaluate three survival prediction models: the JAPAN Critical Limb Ischaemia Database (JCLIMB), Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischaemia (SPINACH), and Vascular Quality Initiative (VQI) calculators. METHODS: Multicentre data of patients who underwent infrainguinal revascularisation for chronic limb threatening ischaemia between 2018 and 2021 were analysed retrospectively. The prediction models were validated using a calibration plot analysis with the intercept and slope. The discrimination was evaluated using area under the curve (AUC) analysis. The observed two year overall survival (OS) was evaluated by the Kaplan - Meier method. The two year OS predicted by each model at < 50%, 50 - 70%, and > 70% was defined as high, medium, and low risk, respectively. RESULTS: A total of 491 patients who underwent infra-inguinal revascularisation were analysed. The rates of surgical revascularisation, endovascular therapy, and hybrid therapy were 26.5%, 70.1%, and 5.5%, respectively. The average age was 75.6 years, and the percentages of patients with diabetes mellitus and dialysis dependent end stage renal disease were 66.6% and 44.6%, respectively. The tissue loss rate was 85.7%. The intercept and slope were -0.13 and 1.18 for the JCLIMB, 0.11 and 0.82 for the SPINACH, and -0.15 and 1.10 for the VQI. The AUC for the two year OS of JCLIMB, SPINACH, and VQI were 0.758, 0.756, and 0.740, respectively. The observed two year OS rates of low, medium, and high risk using the JCLIMB calculator were 80.1%, 61.1%, and 28.5%, respectively (p < .001), using the SPINACH calculator were 81.0%, 57.0%, and 38.1%, respectively (p < .001), and using the VQI calculator were 77.8%, 45.8%, and 49.6%, respectively (p < .001). CONCLUSION: The JCLIMB, SPINACH, and VQI survival calculation models were useful, although the OS predicted by the VQI model appeared to be lower than the observed OS.

Bypass Surgery Provides Better Outcomes Compared with Endovascular Therapy in Patients with Chronic Limb-Threatening Ischemia Classified as Indeterminate Category According to the Global Vascular Guidelines.

BACKGROUND: The present study aimed to determine the preferred initial revascularization procedure between bypass surgery and endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI) categorized as indeterminate according to the Global Vascular Guidelines (GVG). METHODS: We retrospectively analyzed the multicenter data of patients who underwent infrainguinal revascularization for CLTI categorized as indeterminate according to the GVG between 2015 and 2020. The end point was the composite of relief from rest pain, wound healing, major amputation, reintervention, or death. RESULTS: A total of 255 patients with CLTI and 289 limbs were analyzed. Of the 289 limbs, 110 (38.1%) and 179 (61.9%) underwent bypass surgery and EVT, respectively. The 2-year event-free survival rates with respect to the composite end point were 63.4% and 28.7% in the bypass and EVT groups, respectively (P < 0.01). Multivariate analysis revealed that increased age (P = 0.03); decreased serum albumin level (P = 0.02); decreased body mass index (P = 0.02); dialysis-dependent end-stage renal disease (P < 0.01); increased Wound, Ischemia, and foot Infection (WIfI) stage (P < 0.01); Global Limb Anatomic Staging System (GLASS) III (P = 0.04); increased inframalleolar grade (P < 0.01); and EVT (P < 0.01) were independent risk factors for the composite end point. In the WIfI-GLASS 2-III and 4-II subgroups, bypass surgery was superior to EVT with regard to 2-year event-free survival (P < 0.01). CONCLUSIONS: Bypass surgery is superior to EVT in terms of the composite end point in patients classified as indeterminate according to the GVG. Bypass surgery should be considered an initial revascularization procedure, especially in the WIfI-GLASS 2-III and 4-II subgroups.

Left Renal Vein Division during Open Surgical Repair for Abdominal Aortic Aneurysm May Cause Long-Term Kidney Remodeling.

BACKGROUND: Left renal vein division (LRVD) is a maneuver performed during open surgical repair for abdominal aortic aneurysms. Even so, the long-term effects of LRVD on renal remodeling are unknown. Therefore, we hypothesized that interrupting the venous return of the left renal vein might cause renal congestion and fibrotic remodeling of the left kidney. METHODS: We used a murine left renal vein ligation model with 8-week-old to 12-week-old wild-type male mice. Bilateral kidneys and blood samples were harvested postoperatively on days 1, 3, 7, and 14. We assessed the renal function and the pathohistological changes in the left kidneys. In addition, we retrospectively analyzed 174 patients with open surgical repairs between 2006 and 2015 to assess the influence of LRVD on clinical data. RESULTS: Temporary renal decline with left kidney swelling occurred in a murine left renal vein ligation model. In the pathohistological assessment of the left kidney, macrophage accumulation, necrotic atrophy, and renal fibrosis were observed. In addition, Myofibroblast-like macrophage, which is involved in renal fibrosis, was observed in the left kidney. We also noted that LRVD was associated with temporary renal decline and left kidney swelling. LRVD did not, however, impair renal function in long-term observation. Additionally, the relative cortical thickness of the left kidney in the LRVD group was significantly lower than that of the right kidney. These findings indicated that LRVD was associated with left kidney remodeling. CONCLUSIONS: Venous return interruption of the left renal vein is associated with left kidney remodeling. Furthermore, interruption in the venous return of the left renal vein does not correlate with chronic renal failure. Therefore, we suggest careful follow-up of renal function after LRVD.

Interleukin-38 suppresses abdominal aortic aneurysm formation in mice by regulating macrophages in an IL1RL2-p38 pathway-dependent manner.

Macrophages play crucial roles in abdominal aortic aneurysm (AAA) formation through the inflammatory response and extracellular matrix degradation; therefore, regulating macrophages may suppress AAA formation. Interleukin-38 (IL-38) is a member of the IL-1 family, which binds to IL-36 receptor (IL1RL2) and has an anti-inflammation effect. Because macrophages express IL1RL2, we hypothesized that IL-38 suppresses AAA formation by controlling macrophages. We assessed a C57BL6/J mouse angiotensin II-induced AAA model with or without IL-38 treatment. RAW 264.7 cells were cultured with tumor necrosis factor-α and treated with or without IL-38. Because p38 has important roles in inflammation, we assessed p38 phosphorylation in vitro and in vivo. To clarify whether the IL-38 effect depends on the p38 pathway, we used SB203580 to inhibit p38 phosphorylation. IL1RL2+ macrophage accumulation along with matrix metalloproteinase (MMP)-2 and -9 expression was observed in mouse AAA. IL-38 reduced the incidence of AAA formation along with reduced M1 macrophage accumulation and MMP-2 and -9 expression in the AAA wall. Macrophage activities including inducible nitric oxide, MMP-2, and MMP-9 production and spindle-shaped changes were significantly suppressed by IL-38. Furthermore, we revealed that inhibition of p38 phosphorylation diminished the effects of IL-38 on regulating macrophages to reduce AAA incidence, indicating the protective effects of IL-38 depend on the p38 pathway. IL-38 plays protective roles against AAA formation through regulation of macrophage accumulation in the aortic wall and modulating the inflammatory phenotype. Using IL-38 may be a novel therapy for AAA patients.

Global Limb Anatomic Staging System Inframalleolar Modifier Predicts Limb Salvage and Wound Healing in Patients with Chronic Limb Threatening Ischaemia Undergoing Endovascular Infrainguinal Revascularisation.

OBJECTIVE: This study aimed to analyse the influence of the Global Anatomic Staging System (GLASS) and inframalleolar (IM) disease on the treatment outcomes of patients with chronic limb threatening ischaemia (CLTI) who undergo endovascular treatment (EVT) METHODS: Data of patients who underwent infrainguinal endovascular therapy (EVT) for CLTI between 2015 and 2019 at two centres were analysed retrospectively. The endpoints were major amputation, major adverse limb events (MALE), and wound healing. RESULTS: Overall, 276 patients and 340 limbs were analysed. The number of revascularisations for an infrapopliteal lesion was 48 (70.6%), 63 (63.0%), and 142 (82.6%) in the GLASS I, GLASS II, and GLASS III stages, respectively (p < .001). There was no statistically significant difference in limb salvage among the GLASS stages (p = .78). The limb salvage rates at one year were 94.6%, 88.0%, and 70.0% in the IM P0 P1, and P2 groups, respectively (p < .001). Multivariable analysis showed that Wound, Ischemia, and foot Infection (WIfI) stage, and IM grade were risk factors for major amputation. The freedom from MALE rates at two years were 60.5%, 45.3%, and 41.1% in the GLASS I, II, and III stages, respectively (p = .003) and 64.1%, 43.5%, and 18.4% in the IM P0, P1, and P2 groups, respectively (p < .001). Multivariable analysis demonstrated that WIfI stage, GLASS stage, IM grade, and infrapopliteal revascularisation were risk factors for MALE. There was no significant difference in wound healing among GLASS I - III (p = .75). The wound healing rates at 365 days were 78.6%, 68.6%, and 42.0% in the IM P0, P1, and P2 groups, respectively (p = .065). Multivariable analysis showed that WIfI stage and IM P2 were risk factors for incomplete wound healing. CONCLUSION: GLASS IM was associated with major amputation, MALE, and wound healing, while GLASS stage was associated with only MALE.

Evaluation of three nutritional indices as predictors of 2-year mortality and major amputation in patients with chronic limb-threatening ischemia.

OBJECTIVE: The present study aimed to examine which nutritional index, such as the controlling nutritional status (CONUT), prognostic nutritional index (PNI), and geriatric nutritional risk index (GNRI), is better for predicting prognosis in patients with chronic limb-threatening ischemia (CLTI) following revascularization. METHOD: We retrospectively analyzed data of patients who underwent revascularization for CLTI between 2008 and 2020. The endpoints were 2-year overall survival and limb salvage. The optimal cutoff values of 2-year overall survival and major amputation were determined by receiver operating characteristic curve analyses. RESULT: A total of 238 patients with CLTI and 289 limbs were analyzed. The 2-year overall survival rates were 48.9%, 54.6%, and 53.5% in patients with CONUT score ≥4, PNI score <42.6, and GNRI <98.4 compared with 80.0%, 80.0%, and 78.4% in patients with CONUT score <4, PNI score ≥42.6, and GNRI ≥98.4 (p < 0.01). Age, non-ambulatory status, hemodialysis, and nutritional indices were independent risk factors for 2-year mortality in the multivariate analyses. The 2-year limb salvage rates were 70.1%, 82.2%, and 81.9% in patients with CONUT score ≥7, PNI score <41.9, and GNRI <95.3 compared with 92.8%, 98.3%, and 94.2% in patients with CONUT score <7, PNI score ≥41.9, and GNRI ≥95.3 (p < 0.01). Wound, ischemia, and foot infection stage and each nutritional index (CONUT and PNI) were independent risk factors for major amputation in multivariate analyses. The overall survival and limb salvage rates of patients with malnutrition diagnosed by CONUT score were poor compared with those of normal nutrition or malnutrition diagnosed by PNI and/or GNRI scores. CONCLUSION: The CONUT, PNI, and GNRI scores can predict the 2-year overall survival in patients with CLTI after revascularization. The CONUT and PNI scores were associated with major amputation.

A systematic review of management of ureteroarterial fistula.

OBJECTIVE: Ureteroarterial fistula (UAF) is lethal condition. However, no consensus has been reached regarding the diagnosis and treatment of UAF owing to its rarity. The aim of our report was to present an actual case of UAF and systematically review the symptoms, risk factors, diagnosis, and treatment of this condition. METHODS: The case study was of a 52-year-old woman who had experienced a massive hemorrhage during urinary stent replacement. For the systematic review of studies of UAF, those written in English and reported from 1939 to 2020 were searched for on PubMed using the keywords "uretero-arterial fistula," "arterio-ureteral fistula," and "hematuria." RESULTS: We included 121 studies with 235 patients (mean age, 66.0 years; 139 women [59.1%]) in our review. UAF had occurred most frequently in the common iliac artery (n = 112; 47.7%). Almost all patients (n = 232; 98.7%) had complained of hematuria. The risk factors for UAF were pelvic surgery (n = 205; 87.2%), the long-term use of urinary stents (n = 170; 72.3%), oncologic radiotherapy (n = 107; 45.5%), and malignancy (n = 159; 67.7%). Although computed tomography can detect various useful findings such as extravasation, pseudoaneurysm, hydronephrosis, and opacification of ureters, it was diagnostically useful for only one third of the cases. Angiography was useful for the diagnoses of UAF for 124 (66.3%) of the 187 patients (79.6%) who had undergone angiography. With regard to treatment, endovascular approaches have been widely used in recent years because their invasiveness is lesser than that of open surgical repair. In the era of endovascular therapy, the indications for open surgical repair include ureteral-intestinal fistula, abscess formation, and graft infection after endovascular therapy. CONCLUSIONS: Computed tomography can be recommended as the first examination for patients with risk factors for UAF because of its usefulness. Subsequently, angiography should be considered because UAF can be treated using an endovascular approach after diagnostic angiography. The diagnosis and treatment of UAF can often be difficult; therefore, the important first step of diagnosis is suspecting the occurrence of UAF and using a multidisciplinary approach.

Internal Iliac Artery Aneurysm Ruptures with No Visualized Endoleak 2 Years after Endovascular Repair.

We report a case of an 83-year-old man with a ruptured internal iliac artery (IIA) aneurysm after endovascular repair, which was treated via the ligation of IIA and tight suture of the aneurysm sac. Although there were no findings of obvious endoleak after endovascular treatment, the IIA aneurysm increased in size and eventually ruptured. We presumed that pressure to IIA aneurysm via the embolized IIA led to rupture. Aneurysm sac expansion may lead to a rupture despite no endoleak being detected; therefore, close follow-up or re-intervention must be considered. Tight embolization of IIA may prevent endotension in the same case.

Effect of abdominal aortic aneurysm sac shrinkage after endovascular repair on long-term outcomes between favorable and hostile neck anatomy.

OBJECTIVE: The aim of the present study was to analyze the influence of abdominal aortic aneurysm sac shrinkage on the long-term outcomes after endovascular aneurysm repair (EVAR) between patients with favorable and hostile neck anatomy. METHODS: In the present study, we retrospectively analyzed data from 268 patients with fusiform aneurysm and sac behavior who had been evaluated for ≥1 year after EVAR. Hostile neck anatomy was defined as a proximal aneurysmal neck length of <10 mm or proximal neck angle of ≥60°. The primary end point was sac shrinkage, and the secondary end points included reintervention and a composite of rupture, type Ia endoleak, and late open conversion. RESULTS: No differences were found in sac shrinkage between the patients with favorable and hostile neck anatomy (P = .47). Multivariate analysis revealed that an occluded inferior mesenteric artery (P = .04), the presence of posterior thrombus (P < .01), and no antiplatelet therapy (P = .01) were positive factors for sac shrinkage. The reintervention-free survival rate was better for patients with sac shrinkage compared with those without sac shrinkage regardless of the proximal neck anatomy (P < .01). The event-free survival rate of the composite end point at 5 and 10 years was 97.5% and 83.5% for patients with favorable neck anatomy and 86.8% and 81.0% for those with hostile neck anatomy, respectively (P = .02). In the subgroup with sac shrinkage, the event-free survival rates at 5 and 10 years were 98.7% and 98.7% for those with favorable neck anatomy and 92.7% and 82.4% for those with hostile neck anatomy, respectively (P = .02). In contrast, the event-free survival for patients without sac shrinkage did not differ between those with favorable and hostile neck anatomy (P = .08). Multivariate analysis showed that a hostile neck anatomy (hazard ratio, 3.32; 95% confidence interval, 1.26-8.80; P = .02) and no sac shrinkage (hazard ratio, 3.88; 95% confidence interval, 1.25-12.0; P = .02) were significant risk factors for the composite end point of rupture, type Ia endoleak, and late open conversion. CONCLUSIONS: Proximal neck anatomy did not affect sac shrinkage after EVAR. Sac shrinkage has been a good surrogate marker of better long-term outcomes after EVAR for patients with favorable neck anatomy. In contrast, critical events such as rupture and type Ia endoleak can occur even after sac shrinkage has been achieved in patients with hostile neck anatomy.

Bypass Surgery Provides Better Outcomes Compared with Endovascular Therapy in the Composite Endpoint Comprising Relief from Rest Pain, Wound Healing, Limb Salvage, and Survival after Infra-inguinal Revascularisation in Patients with Chronic Limb Threatening Ischaemia.

OBJECTIVE: The present study aimed to determine the factors related to relief from rest pain, wound healing, major adverse limb events (MALEs), and prognosis after infrainguinal revascularisation in patients with chronic limb threatening ischaemia (CLTI). METHODS: The data of patients who underwent infrainguinal revascularisation for CLTI between 2010 and 2020 was analysed retrospectively. The endpoint was the composite of relief from rest pain, wound healing, MALE, or death. RESULTS: A total of 234 limbs in 187 patients with CLTI were analysed. Of the 234 limbs, 149 (63.7%) underwent bypass surgery and 85 (36.3%) underwent endovascular therapy (EVT). The event free survival rates with respect to the composite endpoint at two years were 30.4% in the EVT and 48.5% in the bypass groups, respectively (p = .005). The event free survival rates at two years were 56.7% in bypass surgery and 29.5% in EVT in the indeterminate subgroup (p = .051). Multivariable analysis revealed that age (hazard ratio [HR] 1.03; 95% confidence interval [CI] 1.01 - 1.05; p < .001), coronary artery disease (CAD) (HR 1.45; 95% CI 1.01 - 2.07; p = .042), haemodialysis (HR 1.74; 95% CI 1.22 - 2.48; p = .002), Wound, Ischaemia and foot Infection stage (HR 1.34; 95% CI 1.07 - 1.68; p = .012), Global Limb Anatomical Staging System stage (HR 1.31; 95% CI 1.01 - 1.72; p = .043), EVT (HR 1.90; 95% CI 1.31 - 2.74; p < .001), Geriatric Nutritional Risk Index (HR 0.98; 95% CI 0.97 - 0.99; p = .021), and non-ambulatory status (HR 1.89; 95% CI 1.31 - 2.74; p < .001) were risk factors for the composite endpoint. CONCLUSION: Bypass surgery is superior to EVT with respect to the composite endpoint including relief from rest pain, wound healing, MALE, or death. Bypass surgery may be considered as the treatment of choice, instead of EVT, in patients in the indeterminate group according to the Global Vascular Guidelines preferred revascularisation method.

A Pure Acute Subdural Hematoma Presenting with a Diploic Arteriovenous Fistula: Case Report and Literature Review.

Objective: We report a case of pure acute subdural hematoma (SDH) caused by a diploic arteriovenous fistula (AVF) and it is a first case report as far as we researched it. Case Presentation: A 19-year-old man was admitted as an emergency to our hospital with headache and nausea. CT scan on hospital admission showed a right acute SDH. Because there was no history of head trauma, MRI, MRA, and DSA were performed to identify a source of bleeding. DSA disclosed an AVF. The shunt was located between a frontotemporal branch of the middle meningeal artery (MMA) and a diploic vein, and its shunting point formed an aneurysmal sac, which was considered to have ruptured. Endovascular treatment was administered rather than surgical treatment to prevent re-bleeding because the patient was conscious and alert, CT showed a small SDH, and the left MMA near the shunting point was accessible for catheterization. A diluted mixture of 25% n-butyl-2-cyanoacrilate was injected into a left frontoparietal branch just before the shunting point and the shunt, including the aneurysmal sac, was obliterated. The patient's postoperative course was uneventful and he was discharged without neurological deficits. Conclusion: We experienced a patient with a pure acute SDH caused by diploic AVF. In patients with non-traumatic acute SDH, DSA is recommended to determine its underlying cause. Our review of published reports yielded few instances of non-traumatic pure acute SDH in young people. Possible causative factors should be investigated promptly and appropriate treatment provided immediately.

Pitavastatin-Incorporated Nanoparticles for Chronic Limb Threatening Ischemia: A Phase I/IIa Clinical Trial.

AIM: To assess the results of a phase I/IIa open-label dose-escalation clinical trial of 5-day repeated intramuscular administration of pitavastatin-incorporated poly (lactic-co-glycolic acid) nanoparticles (NK-104-NP) in patients with chronic limb threatening ischemia (CLTI). METHODS: NK-104-NP was formulated using an emulsion solvent diffusion method. NK-104-NP at four doses (nanoparticles containing 0.5, 1, 2, and 4 mg of pitavastatin calcium, n=4 patients per dose) was investigated in a dose-escalation manner and administered intramuscularly into the ischemic limbs of 16 patients with CLTI. The safety and therapeutic efficacy of treatment were investigated over a 26-week follow-up period. RESULTS: No cardiovascular or other serious adverse events caused by NK-104-NP were detected during the follow-up period. Improvements in Fontaine and Rutherford classifications were noted in five patients (one, three, and one in the 1-, 2-, and 4-mg dose groups, respectively). Pharmacokinetic parameters including the maximum serum concentration and the area under the blood concentration-time curve increased with pitavastatin treatment in a dose-dependent manner. The area under the curve was slightly increased at day 5 compared with that at day 1 of treatment, although the difference was not statistically significant. CONCLUSIONS: This is the first clinical trial of pitavastatin-incorporated nanoparticles in patients with CLTI. Intramuscular administration of NK-104-NP to the ischemic limbs of patients with CLTI was safe and well tolerated and resulted in improvements in limb function.

Validation of the GLASS Staging Systems in Patients With Chronic Limb-Threatening Ischemia Undergoing De Novo Infrainguinal Revascularization.

OBJECTIVES: The Global Limb Anatomic Staging System (GLASS) was proposed for evaluating the anatomic complexity of arterial disease in patients with chronic limb-threatening ischemia (CLTI). We aimed to examine the relationship between GLASS stage and treatment outcomes after infrainguinal revascularization in patients with CLTI. METHODS: We retrospectively analyzed data of patients undergoing infrainguinal revascularization for CLTI between 2010 and 2018 to examine whether GLASS stage affects the limb salvage, wound healing, and overall survival (OS). RESULTS: Throughout the study period, 153 CLTI patients and 190 limbs with Fontaine classification III and IV were analyzed for major amputation and OS, and 125 patients and 157 limbs of Fontaine classification IV were analyzed for wound healing. The number of patients with WIfI stage 1, 2, 3, and 4 was 14 (7.4%), 44 (23.2%), 65 (34.2%), and 67 (53.3%), respectively. The number of patients with GLASS stage I, II, and III was 23 (12.1%), 48 (25.3%), and 119 (62.6%), respectively. Among the 190 limbs, the number subject to bypass surgery, endovascular therapy, and hybrid therapy was 132 (69.5%), 39 (20.5%), and 19 (10.0%), respectively. A multivariate analysis showed that only WIfI stage and inframalleolar (IM) disease were risk factors for major amputation and impaired wound healing. There was no relationship between GLASS stage and limb salvage or wound healing. A multivariate analysis revealed that age, geriatric nutritional risk index and GLASS stage were risk factors for 2-year OS (P < 0.01). Patients with all risk factors had a poor prognosis (35.3% at 2 years). CONCLUSION: WIfI stage and IM disease predicted limb salvage and wound healing after infrainguinal revascularization in patients with CLTI. Although GLASS stage did not affect limb salvage or wound healing, it was a prognostic factor for poor OS. The GLASS staging could be useful for deciding between bypass surgery and endovascular therapy in prediction of prognosis.

Effects of Antithrombotic Therapy on Abdominal Aortic Aneurysm Sac Size after Endovascular Repair in Patients with Favorable Neck Anatomy.

PURPOSE: To evaluate the influence of antiplatelet or anticoagulant therapy on sac behavior after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). MATERIALS AND METHODS: This study retrospectively analyzed data from patients with favorable neck anatomy who underwent EVAR between 2007 and 2019. Patients with ruptured AAA and ≤1 year of sac behavior evaluation were excluded. Sac shrinkage after 1 year, persistent type II endoleak, and late sac expansion were examined. RESULTS: In total, 182 patients with favorable neck anatomy were included in this study. A multivariable analysis identified an occluded inferior mesenteric artery (IMA; P = .049), the presence of a posterior thrombus (P = .009), and no antiplatelet therapy (P = .012) as factors positively associated with sac shrinkage at 1 year. Persistent type II endoleak was detected in 56 (30.8%) patients, with patent IMA (P = .006), the lack of a posterior thrombus (P = .004), the number of patent lumbar arteries (P = .004), and antiplatelet therapy (P = .039) being identified as significant risk factors. The multivariable analysis identified a larger initial AAA diameter (P < .001), the lack of a posterior thrombus (P = .038), and antiplatelet and anticoagulant therapies (P = .038 and P = .003, respectively) as risk factors for late sac expansion. CONCLUSIONS: After EVAR in patients with favorable neck anatomy, antiplatelet therapy is associated with the lack of sac regression at 1 year, whereas antiplatelet and anticoagulant therapies are risk factors for late sac expansion.

Analysis of prognostic factors for postoperative complications and reinterventions after open surgical repair and endovascular aneurysm repair in patients with abdominal aortic aneurysm.

OBJECTIVE: A definitive treatment for patients with abdominal aortic aneurysm considering age and comorbidities has not been identified. In the present study, we retrospectively validated treatment outcomes in Japanese patients and proposed the treatment strategy of open surgical repair (OSR) and endovascular aneurysm repair (EVAR). METHODS: We retrospectively analyzed data for patients undergoing EVAR or OSR between 2006 and 2017. Patients with ruptured abdominal aortic aneurysm were excluded. We examined post-operative complications, operative mortality, re-intervention and prognosis. RESULTS: Throughout the study period, 405 patients underwent EVAR and 176 patients underwent OSR. The percentage of patients with post-operative complications was 35.8% in the OSR group, compared with 13.1% in the EVAR group (P < 0.01). The operative mortality rate was 0.49% in the EVAR group and 0.57% in the OSR group (P = 1.00). With a multivariate analysis, age, hemodialysis, modified Frailty Index (mFI), and OSR were risk factors for post-operative complications. The 5-year re-intervention free survival rate was 63.0 % with hostile neck EVAR compared with 83.1 % with favorable neck EVAR and 86.1 % with OSR group (P < 0.01). With a multivariate analysis, hemodialysis, mFI, and hostile neck EVAR were risk factors for re-intervention. The 5-year overall survival rate was 51.9 % with hostile neck EVAR compared with 73.2 % with favorable neck EVAR and 79.0 % with OSR group (P < 0.01). With a multivariate analysis, age, mFI, and hostile neck EVAR were poor prognostic factors. CONCLUSION: Age, mFI, hemodialysis and hostile neck anatomy are useful predictors of post-operative complications, re-intervention and overall survival, and could be useful for informing treatment selection between OSR and EVAR.

Platelet Count Recovery after Endovascular Aneurysm Repair for Abdominal Aortic Aneurysm.

Objective: To find a new predictor of endoleak (EL) and aneurysm sac expansion after endovascular aneurysm repair (EVAR), we evaluated the platelet count recovery (PCR) process after EVAR. Materials and Methods: Two hundred five patients treated with elective EVAR from 2007 to 2015 were retrospectively analyzed. We compared the platelet count ratio until postoperative day (POD) 7 to the presurgical baseline between patients with and without persistent EL (≥ 6 months). Subsequently, we calculated the optimal platelet count ratio for distinguishing persistent EL using receiver-operating characteristics analysis. A platelet count ratio on POD7 ≥118% was defined as the PCR. We evaluated the PCR's influence on the cumulative aneurysm sac expansion rate. Results: The average platelet count ratio on POD7 rose above baseline (112%), and the ratio was attenuated by persistent EL (103%). Of 205 patients, 126 (61%) were assigned to the disturbed PCR group (PCR(-) group). Cumulative aneurysm sac expansion rate was higher in the PCR(-) group than the PCR(+) group (34.4% vs. 12.8% in 5 years, p=0.01). Conclusion: Disturbed PCR after EVAR may be associated with ELs and eventual aneurysm sac expansion.