Safety and Efficacy of Excimer Laser Atherectomy Combined with a Drug-Coated Balloon in De Novo Femoral Popliteal Artery Disease: A Retrospective Study.

BACKGROUND: The effectiveness of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) for de novo femoropopliteal artery disease (FPAD) is currently unknown. This case series evaluated the clinical outcomes of ELA combined with DCB in de novo FPAD from a real-world clinical perspective. METHODS: We conducted a retrospective study of patients treated with ELA + DCB for de novo FPAD between November 2016 and January 2020. The primary efficacy endpoint was the initial patency rate; secondary endpoints included target lesion revascularization without clinically driven target lesion revascularization (CD-TLR) and technical success. Primary safety endpoints included all-cause death, unplanned major amputation, and postoperative complications. RESULTS: The mean follow-up was 37.8 ± 25.3 months and included 56 consecutive patients (68.23 ± 8.01 years, 41 men). Forty-three patients had lifestyle-restricted claudication, and 13 patients had critical limb-threatening ischemia. The mean length of the lesion was 178.41 mm in all patients. The total lesion occlusion rate was 48.2 (n = 27), and the overall technical success rate was 100%. The 12-month, 24-month, 36-month, and 48-month primary patency rates of the ELA + DCB group were 75%, 66.1%, 58.9%, and 42.8%, respectively. Freedom from CD-TLR at 12, 24, 36, and 48 months was 83.9%, 80.3%, 76.8%, and 57.1%, respectively. CONCLUSIONS: In real-world clinical practice, ELA + DCB appears to be a safe and effective endovascular treatment for de novo FPAD, with a low rate of freedom from CD-TLR and a good patency rate.

Comparison of Different Endovascular Treatments of Femoropopliteal Artery In-Stent Restenosis: A Systematic Review and Bayesian Network Meta-Analysis.

BACKGROUND: This Bayesian network meta-analysis (NMA) sought to evaluate the efficacy of different endovascular treatments for femoropopliteal artery in-stent restenosis (FP-ISR). METHODS: PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of science for clinical trials from database inception to March 31, 2023, with no language restrictions to retrieve randomized controlled trials or cohort studies evaluating the impact of any kind of endovascular treatments for FP-ISR. Pair-wise meta-analysis and Bayesian NMA were performed to pool the outcome estimates different endovascular treatments. The primary end points under consideration were primary patency rates at both 6-month and 12-month follow-up. RESULTS: A total of 15 studies with 1,424 patients were ultimately enrolled to be analyzed, 7 types of endovascular treatment were identified for comparison. In terms of primary patency and freedom from target lesion revascularization (TLR) at 6-month and12-month follow-up, the direct meta-analysis findings showed that drug-coated balloons (DCB) and covered stent (CS) are considerably superior to plain old balloon angioplasty (POBA), Excimer laser atherectomy (ELA) + DCB is significantly better than DCB. According to the meta-analysis based on Bayesian theory, during the 6-month and 12-months follow-up, we could not find significant difference between the different treatments in terms of the primary patency and the freedom from TLR, based on the surface values under the cumulative ranking curve (SUCRA), CS was considered the best treatment in terms of primary patency (6 months SUCRA = 85.2; 12 months SUCRA = 78.9) and freedom from TLR (6 months SUCRA = 84.9; 12 months SUCRA = 70.9); directional atherectomy + POBA may lead to higher survival rate at 12 months (SUCRA = 89.1) than others treatments; in addition, both ELA + POBA and ELA + DCB have higher limb salvage than POBA. CONCLUSIONS: The findings of this NMA suggest that CS showed positive encouraging results in primary patency and TLR in FP-ISR at 6 and 12 months. However, due to the potential influence of certain confounding factors, the long-term results necessitate validation through numerous randomized controlled trials.

Covered Cheatham-Platinum Stent for Treatment of Descending Thoracic Aortic Stenosis Caused by Takayasu Arteritis in Two Children.

Takayasu arteritis (TA) is a chronic type of systemic large vessel vasculitis, mainly involving the aorta and its main branches. Both surgical and endovascular revascularization are effective methods for treating TA-related stenosis of the aorta and its branches. By December 2020, there have been very limited reports on the use of coated Cheatham-Platinum (CP) stents in the treatment of TA associated descending thoracic aortic stenosis. Two children with thoracic aortic stenosis caused by TA who received the covered CP stent in Xuanwu Hospital of Capital Medical University were reported. The follow-up time was 1.5 years and 4 years, respectively. The covered cheatham-platinum (CP) stent may be an alternative treatment for TA associated children with descending aortic stenosis.

Directional atherectomy and drug-coated balloon angioplasty vs. bare nitinol stent angioplasty for femoropopliteal artery lesions.

Background: The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare nitinol stent (BNS). Patients and methods: This retrospective cohort study included patients with femoropopliteal artery lesions who underwent percutaneous endovascular surgery between January 2016 and June 2019. The primary outcome was the primary patency rate after 12, 24, and 36 months; the secondary outcomes comprised incidence of flow-limiting dissections, technical success, limb salvage, and all-cause death. Results: During the study period, 110 (44%) patients underwent DA+DCB, and 140 (56%) patients underwent bare nitinol stent (BNS). There were no differences in the 12- and 24-month patency rates of the two groups (98.2% vs. 93.6% and 68.2% vs. 60.0%, both p>.05). The 36-month primary patency rate in the DA+DCB group was significantly higher than that of the BNS group (27.3% vs. 15.7%, p=.003). The technical success rate and all-cause death were similar between groups (p>.05). Flow-limiting dissections occurred more frequently in the BNS group than in the DA+DCB group (27.9% vs. 10.9%, p=.033). After adjustment for potential confounders, such as sex, smoking, hypertension, hyperlipidemia, ABI after surgery, TASC II B, lesion length ≥15 cm, two-vessel runoff, and three-vessel runoff, the HR for primary patency rate comparing BNS to DA+DCB was 2.61 (95%CI: 1.61-4.25). Conclusions: In this retrospective cohort study, DA+DCB was associated with a higher 30-month primary patency rate and a lower flow-limiting dissection incidence than BNS.

Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans.

BACKGROUND: The "leave nothing behind" strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. METHODS: Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm. RESULTS: There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377). CONCLUSIONS: In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified.

Transforming Growth Factor-ß1 Inhibits Pseudoaneurysm Formation After Aortic Patch Angioplasty.

OBJECTIVE: Pseudoaneurysms remain a significant complication after vascular procedures. We hypothesized that TGF-ß (transforming growth factor-ß) signaling plays a mechanistic role in the development of pseudoaneurysms. APPROACH AND RESULTS: Rat aortic pericardial patch angioplasty was associated with a high incidence (88%) of pseudoaneurysms at 30 days, with increased smad2 phosphorylation in small pseudoaneurysms but not in large pseudoaneurysms; TGF-ß1 receptors were increased in small pseudoaneurysms and preserved in large pseudoaneurysms. Delivery of TGF-ß1 via nanoparticles covalently bonded to the patch stimulated smad2 phosphorylation both in vitro and in vivo and significantly decreased pseudoaneurysm formation (6.7%). Inhibition of TGF-ß1 signaling with SB431542 decreased smad2 phosphorylation both in vitro and in vivo and significantly induced pseudoaneurysm formation by day 7 (66.7%). CONCLUSIONS: Normal healing after aortic patch angioplasty is associated with increased TGF-ß1 signaling, and recruitment of smad2 signaling may limit pseudoaneurysm formation; loss of TGF-ß1 signaling is associated with the formation of large pseudoaneurysms. Enhancement of TGF-ß1 signaling may be a potential mechanism to limit pseudoaneurysm formation after vascular intervention.

In vivo evaluation of safety and performance of a tapered nitinol venous stent with inclined proximal end in an ovine iliac venous model.

A tapered stent with inclined proximal end is designed for fitting the iliac anatomically. The aim of the present study was to evaluate the safety and performance of the new stent in ovine left iliac veins. The experiment was performed in 30 adult sheep, and one nitinol-based VENA-BT® iliac venous stent (KYD stent) was implanted into each animal's left common iliac vein. Follow-up in all sheep consisted of angiographic, macroscopic, and microscopic examinations at Day 0 (< 24 h), Day 30, Day 90, Day 180 and Day 360 post-stenting (six animals per each time-point). 30 healthy ~ 50 kg sheep were included in this study and randomly divided into five groups according to the follow-up timepoint. All stents were implanted successfully into the left ovine common iliac vein. No significant migration occurred at follow-up. There is no statistically significant difference between the groups (p > 0.05), indicating no serious lumen loss occurred during the follow-up period. Common iliac venous pressure was further measured and the results further indicated the lumen patency at follow-up. Histological examinations indicated that no vessel injury and wall rupture, stent damage, and luminal thrombus occurred. There was moderate inflammatory cell infiltration around the stent in Day-0 and Day-30 groups with the average inflammation score of 2.278 and 2.167, respectively. The inflammatory reaction was significantly reduced in Day-90, Day-180 and Day-360 groups and the average inflammation scores were 0.9444 (p < 0.001, Day-90 vs Day-0), 1.167 (p < 0.001, Day-180 vs Day-0) and 0.667 (p < 0.001, Day-90 vs Day-0), respectively. The microscopic examinations found that the stents were well covered by endothelial cells in all follow-up time points. The results suggested that the KYD stent is feasible and safe in animal model. Future clinical studies may be required to further evaluate its safety and efficacy.

Comprehensive investigation of multiples factors in sulfuric acid pretreatment on the enzymatic hydrolysis of waste straw cellulose.

The prerequisite for cellulosic biochemical production from lignocellulosic materials is efficient enzymatic hydrolysis that is a complicated heterogeneous catalytic process and affected by the complex lignin-cellulose-hemicellulose network. Understanding the main influencing factors for enzymatic hydrolysis is of substantial significance to guide the design of a biorefinery process. An experimental study of the pretreatment indicated that acid pretreatment is preferable for herbaceous feedstocks. Therefore, the classic dilute sulfuric acid pretreatment was utilized to hydrolyze and remove hemicellulose from three representative types of agricultural straws at various intensities. From the enzymatic hydrolysis of residual cellulose perspective, the crystallinity index and enzyme accessibility of the pretreated materials were also mathematically correlated to hemicellulose removals, respectively. For the better insight and understanding of the mathematical logics, the linear and nonlinear kinetic models were therefore compared, and the relationship was established by the five-parameter logistic equations and Allosteric sigmoidal models with well fittings.

In Situ Chemical Locking of Acetates During Xylo-Oligosaccharide Preparation by Lignocellulose Acidolysis.

Xylo-oligosaccharides with high value could be obtained by acidolysis of lignocellulosic biomass with acetic acid, which was an urgent problem to solve for the separation of acetic acid from crude xylo-oligosaccharides solution. Four neutralizers, CaCO3, CaO, Na2CO3, and NaOH, were used for in situ chemically locking the acetic acid in the acidolyzed hydrolysate of corncob. The chemically locked hydrolysate was analyzed and compared using vacuum evaporation and spray drying. After CaCO3, CaO, Na2CO3, and NaOH treatment, the locking rates of acetic acid were 92.62%, 94.89%, 95.05%, and 95.58%, respectively, and 39.55 g, 41.13 g, 41.78 g, and 41.87 g of the compound of xylo-oligosaccharide and acetate were obtained. Sodium neutralizer had lesser effect on xylo-oligosaccharide content, and Na2CO3 was the best chemical for locking acetic acid among these four neutralizers. This process provides a novel method for effectively utilizing acetic acid during the industrial production of xylo-oligosaccharides via acetic acid.

A Retrospective Comparative Study of Twelve-Month Clinical Outcomes for Drug-Coating Balloon Angioplasty and Stent Implantation in Treating Patients with Popliteal Obstructive Lesions.

PURPOSE: Despite increased interest in treating superficial femoral and popliteal arteries with endovascular technology, there is little data regarding comparative results of different treatment modalities in the popliteal artery. It was hypothesized that to improve clinical outcomes in this segment, drug-coating balloon (DCB) angioplasty would not be inferior to stent implantation. METHODS: The records of consecutive Chinese patients with popliteal lesions who were treated with DCB or stenting between June 2016 and February 2017 were retrospectively reviewed. The preoperative demographic, lesion characteristics and postoperative outcomes were compared and statistically analyzed. All patients were divided into different subgroups according to the degree of calcium or degree of ischemia. RESULTS: One hundred two consecutive patients with popliteal lesions were treated with DCB or stenting and 95 (93.1%) completed a follow-up. Critical limb ischemia was present in 70.5% and occlusions were present in 61.1% of patients. DCB angioplasty was performed on 43 patients and angioplasty with primary stenting was performed on 52 patients. There was no difference in twelve-month primary patency (79.1% vs 82.7%; P = 0.687), secondary patency (95.3% vs 94.2%; P = 0.808) and amputation-free survival (93.0% vs 94.2%; P = 0.825) between the DCB group and stent groups. In patients with severe calcium, the twelve-month primary patency (61.1% vs. 79.2%; P = 0.239) and amputation-free survival (83.3% vs 87.5%; P = 0.739) did not differ between the DCB and stent groups. CONCLUSIONS: This study demonstrates that DCB treatment in Chinese patients with popliteal atherosclerotic occlusive lesions can be associated with similar twelve-month patency and amputation-free survival compared to stenting, even in patients with severe calcification. LEVEL OF EVIDENCE: Level 3a, Non-randomized follow-up study.

A systematic review and meta-analysis comparing the efficacy of cyanoacrylate ablation over endovenous thermal ablation for treating incompetent saphenous veins.

OBJECTIVES: The aim of this study was to systemically review and analyze the efficacy of cyanoacrylate ablation (CA) in comparison with endovenous thermal ablation (ETA) for the treatment of incompetent saphenous veins. METHODS: A systematic literature search was conducted using databases of Pubmed, Embase, and Cochrane Library from the times of their inception to April 2020. Studies were selected based on inclusion and exclusion criteria after assessing the risk of bias in comparative studies with Cochrane and rating quality of evidence with the GRADE methodology. The meta-analysis was carried out using the Review Manager 5.4 program to conduct homogeneity tests. RESULTS: One cohort study and three randomized controlled trials (RCT), including a total of 1457 participants were included in the meta-analysis. ETA included endovenous laser ablation (ELVA) and radiofrequency ablation (RFA) in the selected studies. Comparison between CA and a combination of EVLA and RFA or RFA alone were carried out in two of RCTs, while comparison between CA with EVLA was conducted in one RCT and the cohort study. There was no statistical difference in closure rates between CA and ETA after pooled analysis. Similar symptom alleviation observed between different groups. However, the CA group showed a lower ecchymosis rate than RFA and a significantly lower incidence of adverse events, such as ecchymosis, phlebitis and paresthesia, than EVLA. Compared with ETA, the patients received CA treatment exhibited lower pain scores in a shorter procedure duration without needing compression stocking, returned to normal life sooner, and had significantly better quality of care. There was no significant difference in the number needed to treat for additional therapy after three months of follow-up between groups. CONCLUSIONS: This meta-analysis indicates that CA has better overall outcomes than ETA and offers superior clinical benefits in the treatment of incompetent saphenous veins.

Gelatin coating promotes in situ endothelialization of electrospun polycaprolactone vascular grafts.

Rapid endothelialization is crucial for in situ tissue engineering vascular grafts to prevent graft failure in the long-term. Gelatin is a promising nature material that can promote endothelial cells (ECs) adhesion, proliferation, and migration. In this study, the internal surface of electrospun polycaprolactone (PCL) vascular grafts was coated with gelatin. Endothelialization and vascular wall remolding were investigated by imaging and histological studies in the rat abdominal aorta replacement model. The endothelialization of heparinized gelatin-coated PCL (GP-H) vascular grafts was more rapid and complete than heparinized PCL (P-H) grafts. Intimal hyperplasia was milder in the GP-H vascular grafts than the P-H vascular grafts in the long-term. Meanwhile, smooth muscle cells (SMCs) and extracellular matrix (ECM) regeneration were better in the GP-H vascular grafts. By comparison, an aneurysm was observed in the P-H group in 6 months. Calcification was observed in both groups. All vascular grafts were patient after implantation in both groups. Our results showed that gelatin coating on the internal surface of PCL grafts is a simple and effective way to promote endothelialization. A more rapid endothelialization and complete endothelium can inhibit intimal hyperplasia in the long-term.

Investigation on decolorization kinetics and thermodynamics of lignocellulosic xylooligosaccharides by highly selective adsorption with Amberlite XAD-16N.

Xylooligosaccharides (XOS) are booming in food, pharmacy and feed industries that they have attracted great interest in the high-value utilization of lignocellulose. Selective acidolysis dominates the commercial production of XOS except for intractable color contaminations derivate from ligoncellulosic degradation. Based on a detailed kinetics and thermodynamics investigation, Amberlite XAD-16N was designated as preferred decolorant because of its high adsorption-selectivity for XOS and the colored contaminants. The adsorption of the main compositions in lignocellulosic acidolysis solution was well described by Langmuir models, the kinetics were clearly fitted by Pseudo-second-order model, showing that the adsorption was controlled by electron sharing/transfer between the resin cross-linking groups and colorant. The adsorption mechanism was also verified by the adsorption-simulation of three detected typical colorants. The thermodynamics clearly indicated a spontaneous endothermic reaction. This study provides an important approach for industrial technology development to not only xylooligosaccharides production and lignocellulosic acidolysis, but also Amberlite XAD-16N adsorbent.

Comparison of selective acidolysis of xylan and enzymatic hydrolysability of cellulose in various lignocellulosic materials by a novel xylonic acid catalysis method.

An economically-prudent pretreatment is a crucial first step towards realization of the industrial lignocellulosic biorefinery. The aim of this study was to utilize lignocellulosic biomass to co-produce xylo-oligosaccharides (XOS) and glucose starting from a novel self-providing xylonic acid (XA) acidolysis method. Based on the optimization results of main acidolysis pretreatment parameters by uniform design experiments, we found that among various lignocellulosic materials, the highest yield of XOS from xylan was 54.16% with corncob, followed by 39.19% with wheat straw, 29.01% with corn straw and 30.23% with poplar sawdust. By effective degradation and removal of xylan constituents with XA acidolysis, enzymatic hydrolysabilities of inert cellulose constituents of corn cob, corn straw, wheat straw and poplar sawdust were achieved to 100%, 72.94%, 75.35% and 38.97%. Comparative mass balance diagrams of xylan and cellulose reveal that XA acidolysis pretreatment is environmental-friendly and effective for three agricultural residues, apart from woody poplar.

Drug-Coated Balloon Angioplasty and Debulking for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis.

The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, P < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, P < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, P < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, P < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, P = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, P < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, P = 0.40; RR 1.24, 95% CI 0.46 to 3.34, P = 0.67; RR 0.32, 95% CI 0.01 to 7.61, P = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, P < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, P < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, P = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, P = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.

Polyester vascular patches acquire arterial or venous identity depending on their environment.

Polyester is commonly used in vascular surgery for patch angioplasty and grafts. We hypothesized that polyester patches heal by infiltration of arterial or venous progenitor cells depending on the site of implantation. Polyester patches were implanted into the Wistar rat aorta or inferior vena cava and explanted on day 7 or 30. Neointima that formed on polyester patches was thicker in the venous environment compared to the amount that formed on patches in the arterial environment. Venous patches had more cell proliferation and greater numbers of VCAM-positive and CD68-positive cells, whereas arterial patches had greater numbers of vimentin-positive and alpha-actin-positive cells. Although there were similar numbers of endothelial progenitor cells in the neointimal endothelium, cells in the arterial patch were Ephrin-B2- and notch-4-positive while those in the venous patch were Eph-B4- and COUP-TFII-positive. Venous patches treated with an arteriovenous fistula had decreased neointimal thickness; neointimal endothelial cells expressed Ephrin-B2 and notch-4 in addition to Eph-B4 and COUP-TFII. Polyester patches in the venous environment acquire venous identity, whereas patches in the arterial environment acquire arterial identity; patches in the fistula environment acquire dual arterial-venous identity. These data suggest that synthetic patches heal by acquisition of identity of their environment. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 3422-3431, 2017.