A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions.

Backgrounds and Objectives: Drug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for reintervention in comparison with regular balloon angioplasty. Due to the differences in excipients, paclitaxel dose, and coating techniques, variable clinical outcomes have been observed with different DCBs. In this study, we aimed to evaluate the safety and efficacy of a novel ZENFlow carrier-free DCB in the treatment of femoropopliteal artery occlusive disease. Methods: In this randomized controlled trial conducted at 15 sites, 192 patients with Rutherford class 3-5 were randomly assigned into two groups: drug-coated balloon group and percutaneous transluminal angioplasty group. The primary endpoint was a late lumen loss at 6 months based on blinded angiographic core laboratory evaluations, and the secondary endpoints included primary patency rate, binary restenosis, clinically driven target lesion revascularization, ankle-brachial index, Rutherford class change, and major adverse events. Results: In this multicenter trial, 93 patients received DCB angioplasty, whereas 99 patients underwent regular balloon angioplasty. The late lumen loss at 6-month follow-up was 0.50 ± 0.82 and 1.69 ± 0.87 mm in the drug-coated balloon and percutaneous transluminal angioplasty groups, respectively (p < 0.001). During the 12-month follow-up period, the drug-coated balloon group showed a significantly higher primary patency rate (54 vs. 31.3%, p = 0.009) and markedly lower rates of target vessel restenosis (22.1 vs. 64.3%, p < 0.001) and clinically driven target lesion revascularization rate (5.4 vs. 19.2%, p = 0.006) than the percutaneous transluminal angioplasty group. Compared with the percutaneous transluminal angioplasty group, the drug-coated balloon group had significant improvements in the ankle-brachial index and Rutherford class. The all-cause mortality rate was comparable, and no device-related deaths occurred in either groups. Conclusions: Balloon angioplasty using a ZENFlow carrier-free drug-coated balloon is a safe and effective treatment method for femoropopliteal artery lesions. This novel drug-coated balloon catheter achieved satisfactory early and 1-year outcomes in this trial. Clinical Trial Registration: https://clinicaltrials.gov, identifier: NCT03844724.

Role of Frailty and Comorbidity Status in Predicting Morbidity and Mortality in Patients with Acute Mesenteric Ischemia.

BACKGROUND: This study was performed to determine the association of frailty and comorbidity status with postoperative morbidity and mortality in patients with acute mesenteric ischemia (AMI). METHODS: Patients diagnosed with AMI between April 2006 and September 2019 were enrolled in this study. Frailty was evaluated by sarcopenia which was diagnosed by third lumbar vertebra psoas muscle area (PMA). Comorbidity status was evaluated by the Charlson Comorbidity Index (CCI) score. Univariate and multivariate analyses evaluating the risk factors for postoperative morbidity and mortality were performed. RESULTS: Of the 174 patients, 86 were managed conservatively and 88 underwent surgery. In surgically managed patients, 39.8% developed complications within 30 days of surgery. Ten patients died within 30 days of the operation. In the univariate analyses, white blood cell >10 g/L, low PMA, CCI score ≥2, and bowel resection were associated with postoperative complications. Multivariate analysis revealed that low PMA, CCI score ≥2, and bowel resection were independent predictors of postoperative complications. CONCLUSIONS: This study demonstrated that low PMA, CCI score ≥2, and bowel resection were independent risk factors for postoperative complications in patients with AMI. Preoperative assessment of frailty using PMA and the evaluation of comorbidity status using CCI may serve as helpful tools in preoperative risk assessment and should be integrated into scoring systems for surgically treated AMI.

Determination of Risk Factors and Establishment of a Prediction Model for Immediate Technical Failure during Endovascular Treatment of Femoropopliteal Occlusive Disease.

BACKGROUND: For long femoropopliteal occlusive lesions, the immediate technical failure (ITF) of endovascular treatment (EVT) is relatively high. Therefore, this study aims to reveal risk factors and establish a prediction model of ITF of EVT in femoropopliteal occlusive disease (FPOD) patients based on preoperative clinical date that may be helpful to the clinical procedures. METHODS: A retrospective analysis of 1,563 FPOD patients who underwent above-the-knee EVT was undertaken. Univariate analysis with chi-squared test was used to screen risk factors from preoperative clinical data. Multivariable analysis with logistic regression was used to generate a model for predicting the ITF rate of EVT, which was evaluated through the receiver operating characteristic curve and another independent cohort of 242 FPOD patients. RESULTS: Risk factors for ITF during EVT in FPOD included age (>80 years, X1), the absence of diabetes mellitus (X2), low-density lipoprotein (>160 mg/dL, X3), lesion calcification (X4), lesion length (>20 cm, X5), ostial occlusion of superficial femoral artery (SFA) (X6), and SFA lesion involving the popliteal artery (X7). A logistic regression model was established based on the equation: -6.504 + 1.236X1 + 0.945X2 + 1.406X3 + 1.136X4 + 1.059X5 + 2.307X6 + 2.194X7. Scores were given to risk factors as follows: X1 (yes = 12, no = 0), X2 (yes = 9, no = 0), X3 (yes = 14, no = 0), X4 (yes = 11, no = 0), X5 (yes = 11, no = 0), X6 (yes = 23, no = 0), and X7 (yes = 22, no = 0). We determined that the optimal comprehensive score for predicting EVT failure was 39, with a sensitivity of 0.847 and a specificity of 0.8. Among these 242 peripheral arterial disease patients, 12 of 14 patients who had failed EVT had a comprehensive score of >39. CONCLUSIONS: We identified a number of risk factors of ITF during the above-the-knee EVT and established a prediction model that may be used for guidance in clinical practice.

Induction of autophagy by salidroside through the AMPK-mTOR pathway protects vascular endothelial cells from oxidative stress-induced apoptosis.

Vascular endothelial cells are highly sensitive to oxidative stress, and this is one of the mechanisms by which widespread endothelial dysfunction is induced in most cardiovascular diseases and disorders. However, how these cells can survive in oxidative stress environments remains unclear. Salidroside, a traditional Chinese medicine, has been shown to confer vascular protective effects. We aimed to understand the role of autophagy and its regulatory mechanisms by treating human umbilical vein endothelial cells (HUVECs) with salidroside under oxidative stress. HUVECs were treated with salidroside and exposed to hydrogen peroxide (H2O2). The results indicated that salidroside exerted cytoprotective effects in an H2O2-induced HUVEC injury model and suppressed H2O2-induced apoptosis of HUVECs. Pretreatment with 3-methyladenine (3-MA), an autophagy inhibitor, increased oxidative stress-induced HUVEC apoptosis, while the autophagy activator rapamycin induced anti-apoptosis effects in HUVECs. Salidroside increased autophagy and decreased apoptosis of HUVECs in a dose-dependent manner under oxidative stress. Moreover, 3-MA attenuated salidroside-induced HUVEC autophagy and promoted apoptosis, whereas rapamycin had no additional effects compared with salidroside alone. Salidroside upregulated AMPK phosphorylation but downregulated mTOR phosphorylation under oxidative stress; however, administration of compound C, an AMPK inhibitor, abrogated AMPK phosphorylation and increased mTOR phosphorylation and apoptosis compared with salidroside alone. These results suggest that autophagy is a protective mechanism in HUVECs under oxidative stress and that salidroside might promote autophagy through activation of the AMPK pathway and downregulation of mTOR pathway.

The Use of the Angiosome Concept for Treating Infrapopliteal Critical Limb Ischemia through Interventional Therapy and Determining the Clinical Significance of Collateral Vessels.

BACKGROUND: The purpose of this study was to evaluate the clinical significance of the involvement of collateral vessels in interventional therapy based on the angiosome concept for infrapopliteal critical limb ischemia (CLI). METHODS: We enrolled 486 patients with unilateral infrapopliteal CLI (Rutherford Stage 5 or 6) treated at 2 hospitals from January 2005 to December 2014. Using the angiosome concept, the patients were categorized into 3 groups: the direct revascularization (DR) group, the indirect revascularization through collaterals (IR-tc) group, and the indirect revascularization without collaterals (IR-wc) group. The data from 1 year of follow-up after the initial surgery were analyzed for all 3 groups. RESULTS: During the 1-year follow-up, the unhealed ulcer rate of the IR-wc group was significantly higher than that of the DR group (83.4% vs. 31.7%, P < 0.001) and the IR-tc group (83.4% vs. 34.8%, P < 0.001). Furthermore, the limb salvage rate of the IR-wc group was significantly lower than that of the DR group (70.4% vs. 89.2%, P < 0.001) and the IR-tc group (70.4% vs. 85.4%, P = 0.0013). However, there were no differences in the unhealed ulcer rate or the limb salvage rate between the DR group and the IR-tc group (31.7% vs. 34.8%, P = 0.096 and 89.2% vs. 85.4%, P = 0.2834, respectively). In addition, within the IR-wc group, the unhealed ulcer rate of diabetic patients was higher than that of patients without diabetes (90.0% vs. 74.6%, P = 0.0116), but there was no difference in the limb salvage rate between diabetic and nondiabetic patients. No differences in the unhealed ulcer rate or the limb salvage rate were found between diabetic and nondiabetic patients in the other 2 groups. CONCLUSIONS: Following the angiosome model of perfusion for endovascular therapy, directly revascularizing the feeding artery and indirectly achieving revascularization through collaterals can effectively prompt the healing of ulcers and decrease the amputation rate in patients with infrapopliteal CLI. Collateral vessels play a crucial role in the treatment of ischemic foot.

Incidence and risk factors of early deep venous thrombosis after varicose vein surgery with routine use of a tourniquet.

INTRODUCTION: The incidence of early deep venous thrombosis (DVT) following varicose vein surgery (traditional open stripping) with routine use of a tourniquet remains unknown. MATERIALS AND METHODS: A retrospective analysis of all patients who underwent varicose vein surgery with a tourniquet in the authors' unit between 1 January 2012 and 30 November 2013 was undertaken. Cases of postoperative DVT were identified from the unit database, and re-assessments conducted 1, 3 and 6 months after the initial diagnosis were recorded from the outpatient department. RESULTS: Out of 1461 patients, 113 (7.7%) developed postoperative DVT. Nineteen (1.3%) patients had proximal DVT, and 94 (6.4%) patients had isolated distal DVT. The risk factors for postoperative DVT included old age (≥65 years), female sex and gastrocnemius vein dilation (GVD). GVD was found to be a significant independent risk factor for the occurrence of DVT, with an odds ratio of 2.437 (95% confidence interval 1.644-3.611). Five patients with distal DVT (5.7%) and eight patients with proximal DVT (44.4%) still exhibited a thrombus at 6-month follow-up, but with decreased size and at various stages of resolution. CONCLUSIONS: This study found a higher incidence of postoperative DVT (7.7%) with routine use of a tourniquet during varicose vein surgery than has been reported previously. Among the factors examined, GVD had the highest predictive power for postoperative DVT. Both distal and proximal DVT were associated with acceptable outcomes.