Non-deteriorative eco-friendly water-saving tactic for removal of vegetable matters from wool fleece using xylanase and cellulase.

The carbonization of wool fleece (WF) is conducted to remove the adhered vegetable matter (VM) from contaminated WF using sulfuric acid, followed by drying and backing. This process has a deteriorative effect on WF and requires a tremendous quantity of water for rinsing WF after carbonization to remove any H2SO4 residuals. Herein, we propose an alternative eco-friendly water-saving process for the removal of VM from WF using enzymes. Cellulase-containing xylanase from the fungus Aspergillus terreus, and cellulase-free xylanase from the fungus Aspergillus flavus AW1 were used to remove the VM from WF. The effect of some process parameters on the amount of the removed VM was assessed. Alkali solubility as well as sulfur and cystine content were used to follow the alteration in the chemistry of the bio-treated WF. The fiber morphology was examined using scanning electron microscopy. The dyeability of the treated WF towards acid, reactive, and basic dyes was monitored. The results revealed that the removal of the VM from WF by applying the examined enzymes was effective and could be an appropriate, non-destructive, eco-friendly water-saving substitute to the conventional carbonization procedures. By virtue of enzyme specificity, the proposed process removed the VM without deteriorating the fiber.

Laser Fenestration in TEVAR: Perspectives and Future Directions.

Endovascular aortic repair has been increasingly used to treat a multitude of thoracic aorticpathologies. When placement of a thoracic endograft necessitates coverage of one or more of the great vessels, in situ laser fenestration is a safe and effective option for supra-aortic trunk revascularization. Certain anatomic factors may render laser fenestration more technically challenging, particularly depending on aortic arch type and branch vessel characteristics. Short-term and mid-term outcomes have shown promising results for mortality, stroke, and complication rates. Future developments may extend the utility of this approach and allow it to be applied to a more widespread set of patients with challenging anatomy.

Green method for improving performance attributes of wool fibres using immobilized proteolytic thermozyme.

Wool has the tendency to turn into felt during agitation in washing machines. Thus, a benign non-polluting method for the production of machine-washable wool was developed herein. Initially, a proteolytic bacteria was isolated from hot region soil. The bacterial isolate was identified as Bacillus safensis FO-36bMZ836779 according to the 16S rRNA gene sequencing. Afterwards, the extracellular protease produced by this isolate was covalently immobilized in order to enhance its stability under non-ambient conditions which are usually adopted in industrial sectors like textile industries. Sericin, which is usually discharged into degumming effluent of natural silk, was utilized to prepare the immobilization carrier. Box-Behnken design was adopted in order to hone the preparation of the sericin-polyethylene-imine-glutaraldehyde activated agar carrier. The pH and temperature profiles of the free and immobilized proteases were compared. Later, wool fibres were bio-treated with both the free and the immobilized enzymes. The effect of process conditions on the resistance of the bio-finished wool to felting was investigated. The alteration in the fibre morphology was monitored using SEM. Amino acid analysis and alkali solubility tests were adopted to assign any change in the chemical structure of the bio-treated wool. The influence of bio-treatment of wool on its inherent properties was assigned. Results revealed that bio-treatment of wool with the said enzyme led to production of machine-washable wool without severe deterioration in the fibres' properties. In an energy- and water-consuming process, the hot solution from bio-treatment bath was used successfully in dyeing of wool. Supplementary Information: The online version contains supplementary material available at 10.1007/s13205-022-03323-y.

Bioscouring of wool fibres using immobilized thermophilic lipase.

The hydrophobic nature of wool induced by its surface lipid barrier hinders its wettability during processing. Scouring of wool is conducted to remove this lipid barrier and facilitate any wet processes. Scouring of wool is conducted using soda ash followed by rinsing with huge amount of water to ensure complete removal of alkali. This work aimed at utilization of thermophilic lipase enzyme for removal of wool surface lipid barrier without deterioration on the fibre interior. A thermally stable lipase enzyme was produced from thermophilic microorganism; namely Bacillus aryabhattai B8W22, and was utilized in bio-scouring of wool. The produced enzyme was immobilized on sericin-based discs to enhance its stability and to make it reusable. The activity of both free and immobilized lipase enzymes at different conditions was assessed. The effects of bio-scouring of wool on its dyeability with acid, basic, and reactive dyes, as well as on some of its inherent properties, were monitored. Results showed that the bio-scoured wool exhibits enhanced dyeability with the said classes of dyes more than that of conventionally scoured samples. One-bath scouring and dyeing of wool fibres in two successive steps was conducted to reduce consumption of water and energy during wet processing of wool.

Endovascular repair and open repair surgery of thoraco-abdominal aortic aneurysms cause drastically different types of spinal cord injury.

Both endovascular repair (EVR) and open repair (OR) surgery of thoraco-abdominal aortic aneurysms cause spinal cord (SC) injury that can lead to paraparesis or paraplegia. It has been assumed that mechanisms responsible for SC damage after EVR are similar to those after OR. This pilot study compared the pathophysiology of SC injury after EVR versus OR using a newly developed EVR dog model. An increasing number of stents similar to those used in patients were inserted in the aorta of three dogs to ensure thoracic or thoracic plus lumbar coverage. The aorta of OR dogs was cross-clamped for 45 min. Behavior assessment demonstrated unique patterns of proprioceptive ataxia and evolving paraparesis in EVR versus irreversible paraplegia in OR. MRI showed posterior signal in lumbar SC after EVR versus central cord edema after OR. Histopathology showed white matter edema in L3-L5 localized to the dorsal column medial lemniscus area associated with loss of myelin basic protein but not neurons after EVR, versus massive neuronal loss in the gray matter in L3-L5 after OR. Metabolome analysis demonstrates a distinctive chemical fingerprint of cellular processes in both interventions. Our results call for the development of new therapeutics tailored to these distinct pathophysiologic findings.

Spinal cord injury after thoracic endovascular aortic aneurysm repair.

PURPOSE: Thoracic endovascular aortic aneurysm repair (TEVAR) has become a mainstay of therapy for aneurysms and other disorders of the thoracic aorta. The purpose of this narrative review article is to summarize the current literature on the risk factors for and pathophysiology of spinal cord injury (SCI) following TEVAR, and to discuss various intraoperative monitoring and treatment strategies. SOURCE: The articles considered in this review were identified through PubMed using the following search terms: thoracic aortic aneurysm, TEVAR, paralysis+TEVAR, risk factors+TEVAR, spinal cord ischemia+TEVAR, neuromonitoring+thoracic aortic aneurysm, spinal drain, cerebrospinal fluid drainage, treatment of spinal cord ischemia. PRINCIPAL FINDINGS: Spinal cord injury continues to be a challenging complication after TEVAR. Its incidence after TEVAR is not significantly reduced when compared with open thoracoabdominal aortic aneurysm repair. Nevertheless, compared with open procedures, delayed paralysis/paresis is the predominant presentation of SCI after TEVAR. The pathophysiology of SCI is complex and not fully understood, though the evolving concept of the importance of the spinal cord's collateral blood supply network and its imbalance after TEVAR is emerging as a leading factor in the development of SCI. Cerebrospinal fluid drainage, optimal blood pressure management, and newer surgical techniques are important components of the most up-to-date strategies for spinal cord protection. CONCLUSION: Further experimental and clinical research is needed to aid in the discovery of novel neuroprotective strategies for the protection and treatment of SCI following TEVAR.

Outcomes of intervention for cephalic arch stenosis in brachiocephalic arteriovenous fistulas.

BACKGROUND: Development of recalcitrant stenotic lesions of the cephalic arch is a significant cause of dysfunction of brachiocephalic access arteriovenous fistulas (AVFs). Endovascular and surgical therapy can be used to treat cephalic arch stenosis. The aim of this study was to evaluate the outcomes of endovascular and surgical interventions for cephalic arch stenosis. METHODS: A retrospective review of all patients during a 16-year period with a compromised but not occluded brachiocephalic AVF due to cephalic arch stenosis was undertaken. Patency, reintervention, infection, and functional dialysis rates were examined. RESULTS: From January 2000 to December 2015, 219 patients (67% female; mean age, 58 ± 20 years) with a failing brachiocephalic AVF underwent intervention at the cephalic arch. These interventions included angioplasty, primary stent placement, transposition, and bypass. The average time to intervention for cephalic arch stenosis was 1.7 years after primary access placement. The average number of percutaneous interventions before the decision to intervene surgically on the cephalic arch was three (range, two to six). Technical success was superior in the surgical groups (70% and 80% compared with 96% and 100% for balloon angioplasty, stenting, transposition, and bypass, respectively; P = .02). Major adverse cardiovascular events were overall low but significantly higher in the surgical groups (1%, 1%, 0.3%, and 0.3% for transposition, bypass, balloon angioplasty, and stenting, respectively; P = .02). Both surgical options carried significantly superior patency rates at 2 years for transposition, bypass, balloon angioplasty, and stenting, respectively (63%, 59%, 90%, and 92%; P = .04). There was a lower rate of interventions per person-year of follow-up in the surgical groups compared with the endovascular groups (1.9, 1.4, 3.5, and 3.1 for transposition, bypass, balloon angioplasty, and stenting, respectively; P = .04). Functional dialysis durations were significantly superior in the surgical groups compared with the endovascular group (P = .03). CONCLUSIONS: Cephalic arch stenosis is a significant cause of brachiocephalic AVF malfunction. Surgical options offer superior long-term patency and functional results and should be considered earlier in the treatment of this disease.

"In situ" endografting in the treatment of arterial and graft infections.

OBJECTIVE: Endografts (eg, aortic aneurysm device or covered stent) are increasingly being used to temporize or treat arterial and graft infections in inaccessible areas, in patients with compromised anatomy, or in the presence of active bleeding or rupture. This summary examines the evidence for "in situ" endografting in the treatment these conditions. METHODS: A two-level search strategy of the literature (MEDLINE, PubMed, Google Scholar, and The Cochrane Library) was performed for relevant articles listed between January 2000 and December 2015. The review was confined to patients with primary and secondary bacterial or viral arterial infections, with or without fistulization and infection of bypass grafts and arteriovenous accesses. For the purposes of this summary, endografts can be considered to be an aortic aneurysm device or a covered stent. RESULTS: There are no societal guidelines. Endografts have been successfully applied to mycotic arterial aneurysms, aortoenteric, aortobronchial, and arterioureteric fistulae, and to anastomotic bleeds secondary to infection. Multiple reports indicate success at the control of hemorrhage in all locations. Short-term outcomes are good, but fatal infection-related complications, especially if antibiotic therapy is halted, are well reported and necessitate a more definitive plan for the long term. CONCLUSIONS: Stent grafts remain an important and viable option for the treatment of mycotic aneurysms, aortoesophageal and aortobronchial fistulae, and infected pseudoaneurysms in anatomically or technically inaccessible locations. In patients with a short life span (<6 months), no further intervention is generally required. In patients with a predicted life span >6 months, careful consideration should be given to a more definitive procedure. Life-long appropriate antibiotic therapy is strongly recommended for any patient receiving an endograft in an infected field.

Single-center retrospective review of ultrasound-accelerated versus traditional catheter-directed thrombolysis for acute lower extremity deep venous thrombosis.

Objective Systemic anticoagulation remains the standard for acute lower extremity (LE) deep venous thrombosis (DVT), but growing interest in catheter-directed thrombolysis (CDT) and its potential to reduce the incidence of post-thrombotic syndrome (PTS) has led to advent of ultrasound-accelerated CDT (US-CDT). Few studies to date have examined the outcomes of US-CDT against traditional CDT (T-CDT). Methods This is a retrospective, single-center review of all patients treated for acute LE DVT over a five-year period with either US- and T-CDT. Patients were stratified based on demographics, presentation, co-morbidities, risk factors, and peri-procedural data. Results Seventy-six limbs in 67 patients were treated; 51 limbs in 42 patients were treated with US-CDT, and 25 limbs in 25 patients were treated with T-CDT. Adjuncts include: pharmacomechanical thrombolysis ( n = 28 vs. 20, p = 0.04), angioplasty ( n = 22 vs. 18, p = 0.11), stenting ( n = 30 vs. 6, p ≤ 0.001), and IVC filter insertion ( n = 5 vs. 0, p = 0.07). Mean lysis times were 21 ± 1.7 and 24 ± 1.8 h for US- and T-CDT, respectively ( p = 0.26). Thirty (25 ultrasound, 5 traditional) limbs had complete lysis. Thirty-one (22 ultrasound, 9 traditional) limbs had incomplete lysis. Fifteen (4 ultrasound, 11 traditional) limbs had ineffective lysis ( p = 0.002 in favor of ultrasound). Four patients (3 US-CDT, 1 T-CDT) had recurrent ipsilateral thrombosis within 30 days ( p = 0.60). By Kaplan-Meier analysis, there were no significant difference between primary patency, primary-assisted patency, secondary patency, re-thrombosis, and recurrent symptoms at 6, 12, and 24 months. Conclusion US-CDT does not significantly improve mid-term patencies but results in greater acute clot burden reduction in patients with acute LE DVTs compared to T-CDT, which may be beneficial in reducing the long-term incidence of PTS.

Treatment options and outcomes for caval thrombectomy and resection for renal cell carcinoma.

OBJECTIVE: Advanced renal cell carcinoma (RCC) has a significant predisposition to vascular invasion. Tumor vascular invasion and thrombus are found in the renal vein and the inferior vena cava (IVC) in up to 10% to 25% of patients. This study reviewed the current status of radical nephrectomy with IVC thrombectomy for advanced RCC. METHODS: A two-level search strategy of the literature (MEDLINE, PubMed, The Cochrane Library, and Google Scholar) for relevant articles listed between January 2000 and December 2015 was performed. The review was confined to patients with primary RCC associated with vascular invasion. RESULTS: Untreated RCC with intravascular thrombus has a median survival of 5 months. Surgical exposure and intervention are tailored to the level of tumor thrombus. The 30-day mortality for radical nephrectomy with IVC thrombectomy is low (1.5%-10%), and the complication rates have been reported to be 18%, 20%, 26%, and 47% for IVC tumor thrombus level I, II, III, and IV disease, respectively. Disease-specific survival ranges from 40% to 60% at 5 years after nephrectomy and removal of the intravascular tumor. CONCLUSIONS: Radical nephrectomy with IVC thrombectomy is an effective cancer control operation that can be safely performed with acceptable mortality and morbidity. Preoperative imaging coupled with perioperative surgical management of the IVC is critical to procedural success and patient outcomes.

The Role of Endovascular In Situ Revascularization in the Treatment of Arterial and Graft Infections.

Mycotic aneurysms and prosthetic graft infections are traditionally treated with excision of the infected tissue or graft, often requiring anatomical or extraanatomical bypass, carrying significant morbidity and mortality. Currently, the role of endovascular repair without excision in this setting has yet to be defined. We present 2 case scenarios, whereby mycotic pseudoaneurysms were successfully treated with endovascular stent-graft coverage and to present an in-depth review of endovascular in situ revascularization in the treatment of arterial and graft infections. There are data to support the use of stent grafting in mycotic aortic and iliac aneurysms, lower and upper extremity native arterial infections, lower extremity prosthetic bypass infections, and infections of carotid artery aneurysms. It is our belief that this technique may be utilized as primary therapy if there is no significant contamination and certainly serves an essential role in acute rupture or hemorrhage. In situations where there is significant tissue infection, stent grafting should be considered as a bridge if traditional excision is warranted.

Outcomes of native superficial femoral artery chronic total occlusion recanalization after failed femoropopliteal bypass.

OBJECTIVE: When a bypass fails, the options are lysis, redo bypass, or endovascular intervention. If lysis of the original bypass is not considered an option, which is better-redo bypass or attempts at endovascular recanalization of the native system? This retrospective study examined the outcomes of native superficial femoral artery (SFA) chronic total occlusion (CTO) recanalization compared with redo bypass after failed femoropopliteal bypass. METHODS: Patients presenting with a symptomatic failed femoropopliteal bypass that underwent attempted CTO endovascular (EV) recanalization of the native SFA or a redo femoropopliteal bypass (BP) from 2000 to 2015 were analyzed. Patients undergoing catheter-directed thrombolysis were excluded. Time-dependent outcomes were assessed with life-table analyses. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. RESULTS: A total of 104 patients (69% male; average age, 65 years) underwent EV (n = 40) or BP (n = 64) after presentation with symptomatic occlusion of a previous femoropopliteal bypass graft (rest pain in 84% and life-style limiting claudication in 16%, 79% to the above-knee popliteal, 81% prosthetic). According to the TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease classification, 91% of the lesions were category D and 19% were category C. Tibial runoff was one tibial vessel in 79% of the patients and two or more runoff vessels in the remainder. Lesions treated endovascularly underwent primary stenting with a median of 3 stents used. Of the bypasses performed, 69% were to the below knee popliteal and remainder were to the proximal tibials (68% of the patients had a venous conduit). At 30 days in EV vs BP, major adverse cardiovascular events were 3% and 8% (P = .24), major adverse limb events were 25% and 11% (P = .01), and the amputation rate was 8% and 8% (P = .96), respectively. Amputation-free survival was 33% ± 9% and 56% ± 8% (P = .02) and freedom from major adverse limb event was 19% ± 8% and 46% ± 7% (P = .04) at 3 years for EV vs BP, respectively. CONCLUSIONS: In a high-risk cohort when thrombolysis is excluded, BP is superior to EV after failure of a femoropopliteal bypass.

Popliteal Artery Cystic Adventitial Disease: Early Lessons in Treatment.

BACKGROUND: We present 6 patients who had operative repair of symptomatic popliteal cystic adventitial disease (pCAD). Developmental theories for pCAD and surgical alternatives are presented. METHODS: All patients who had repair of pCAD over the past 3 years are included. RESULTS: Three patients had cyst excision alone, whereas the remaining 3 had cyst and artery excision with interposition vein grafting. Cyst recurrence occurred in 2 patients who had cyst excision alone. Four of the patients had a patent communication between the cyst and the joint capsule. CONCLUSIONS: Our small series suggests that the articular (synovial) theory of development may be the most likely and that cyst and artery excision with interposition vein grafting may be preferred over cyst excision alone.

Equivalent outcomes with standard and heparin-bonded expanded polytetrafluoroethylene grafts used as conduits for hemodialysis access.

BACKGROUND: Obtaining and maintaining dialysis access after failure of autologous access sites remains a significant concern for patients on hemodialysis. Polytetrafluoroethylene (PTFE) is the most common conduit used. Heparin-bonded expanded PTFE (HB-PTFE) grafts have recently been introduced as an improved conduit, with suggestions that HB offers benefits because of its resistance to thrombosis. In this retrospective study, the outcomes of HB-PTFE were compared with standard wall PTFE (S-PTFE) arteriovenous grafts (AVGs). METHODS: From January 2004 to December 2014, 483 adults (46% male; mean age, 60 years; range, 25-87 years) with end-stage renal disease underwent placement of AVGs (234 HB-PTFE and 248 S-PTFE). The two groups did not differ significantly in demographics or access history. Patency, reintervention, infection, and functional dialysis rates were examined. RESULTS: Technical success was 99% in HB-PTFE and 98% in S-PTFE. The 30-day major adverse cardiovascular events were 2% in HB-PTFE and 3% in S-PTFE. Mean time to access was 5.1 ± 1.8 weeks for HB-PTFE and 6.9 ± 1.9 weeks for S-PTFE (P = .0001). Median follow-up was 23 months. The 2-year primary, assisted primary, and secondary patency rates were 20% ± 7% vs 18% ± 8% (P = .85), 35% ± 8% vs 28% ± 7% (P = .51), and 38% ± 6% vs 36% ± 7% (P = .83) for HB-PTFE vs S-PTFE, respectively. Both groups underwent a similar number of secondary interventions (2.1 and 1.9 interventions per person-year of follow-up for HB-PTFE vs S-PTFE respectively; P = .87). There were no significant differences in infection (11% vs 12%) or pseudoaneurysm formation (5% vs 6%) between HB-PTFE and S-PTFE groups. Functional dialysis durations were equivalent between HB-PTFE and S-PTFE groups. CONCLUSIONS: HB-PTFE grafts offer no distinct advantage over S-PTFE grafts for hemodialysis and should not be considered a preferential conduit for AVG.

Efficacy of prophylactic inferior vena caval filters in prevention of pulmonary embolism in the absence of deep venous thrombosis.

There is an increasing use of inferior vena caval filters (IVCFs) as prophylactic activity in the absence of a deep venous thrombosis (DVT) to prevent pulmonary embolism (PE) in high-risk patients. These devices are effective in preventing PE in the presence of lower extremity DVT, when anticoagulation is contraindicated or has failed. An electronic databases search of MEDLINE, PubMed, The Cochrane Library, and Google Scholar for relevant articles listed between January 2000 and December 2014 was performed. The review was confined to patients without a history of previous venous thromboembolism and no evidence of changes on venous duplex imaging suggestive of previous DVT. At present, the use of prophylactic IVCF is predominantly in the trauma, orthopedic, and bariatric surgical populations. Currently, no class I studies exist to support insertion of an IVCF in a patient without an established DVT or PE. However, there is a body of class II and class III evidence that would support the use of IVCFs in certain "high-risk" patients who do not have a documented DVT or the occurrence of a PE. Widespread use of prophylactic IVCFs is not supported by evidence and should be discouraged.

Current Status of Clot Removal for Acute Pulmonary Embolism.

Acute pulmonary embolism (PE) continues to carry a high mortality if not recognized early and treated aggressively. Rapid recognition and diagnosis remains the mainstay of all efforts. Risk stratification early is paramount to guide therapy and achieve successful outcomes. Pulmonary emboli can generally be classified as massive, submassive, or stable. Fibrinolysis and/or surgical embolectomy are recommended for the treatment of the patient with massive PE to rescue the patient and restore hemodynamic stability. Current trials support an aggressive approach. In submassive PE, determination of right ventricular (RV) strain by echocardiography and biomarker assessment (troponin and B-type natriuretic peptide) identify patients who can benefit from catheter-directed therapy with the therapeutic intent of achieving a rapid reduction of RV afterload, prevention of impending hemodynamic collapse and prolonged in-hospital and outpatient survival. Current trials have not shown long-term benefit for this approach to date, and thus, this therapy should only be offered to select patients. Stable PE can be treated using both an inpatient and an outpatient approach, based on the available infrastructure. Therapy for PE continues to evolve and stratification of risks and benefits remain the key to implementation of invasive strategies.

Retrograde Pedal Access and Endovascular Revascularization: A Safe and Effective Technique for High-Risk Patients with Complex Tibial Vessel Disease.

BACKGROUND: Endovascular revascularization is an established approach for limb salvage in the setting of critical limb ischemia. However, failure rate of antegrade recanalization in complex femoropopliteal to infrapopliteal occlusions is as high as 20%. We report a series of 21 patients who underwent retrograde pedal access and recanalization of below-the-knee chronic total occlusions after failed antegrade attempts. METHODS: This is a retrospective review of prospectively maintained data for all patients who underwent ultrasound-guided percutaneous pedal access for retrograde endovascular treatment of advanced tibial vessel disease between 2011 and 2014. All patients had undergone prior unsuccessful attempts at antegrade revascularization. Pedal vessel access was followed by angioplasty with selective stenting and completion angiogram. Patients were followed up with duplex ultrasound to evaluate for patency. Time-dependent outcomes were determined by Kaplan-Meier survival analyses. Median follow-up was 9 months. RESULTS: A total of 21 patients (17 men, 4 women, mean age 68) underwent retrograde tibial recanalization. Eighty-one percent of the patients presented with Rutherford category 4, 5, or 6 critical limb ischemia. The average Prevent III amputation risk score was 7.0 ± 2.9. Eighteen patients (86%) were medium or high risk (Prevent III amputation risk score ≥ 4). Retrograde pedal access was successful in 95% of the patients (dorsalis pedis = 11, posterior tibial = 5, anterior tibial = 4). Retrograde revascularization was achieved in 14 patients (67%) using balloon angioplasty (n = 14) and additional stent placement (n = 2). Revascularization failed in 7 patients (33%). There were no pedal access site complications. Forty-eight percent of the patients experienced improvement or resolution of their symptoms. The 30-day major adverse cardiac events (MACE), major adverse limb events (MALE), and amputations were all 5%. At 1 year, limb salvage was 88 ± 8% with amputation-free survival of 61 ± 12% and freedom from MALE of 81 ± 10%. Primary assisted and secondary patencies were both 84 ± 10% at 1 year. CONCLUSIONS: Early outcomes for ultrasound-guided retrograde pedal access show that it is safe, with low 30-day mortality, and a low rate of MACE. Freedom from MALE and limb salvage are both high at 1-year follow-up. This technique expands revascularization options after failed conventional endovascular antegrade approaches.

A randomized phase II study of Xilonix, a targeted therapy against interleukin 1α, for the prevention of superficial femoral artery restenosis after percutaneous revascularization.

OBJECTIVE: The purpose of this study was to evaluate an anti-interleukin 1α antibody for its ability to reduce acute postprocedural inflammation, thereby reducing neointimal hyperplasia and restenosis after superficial femoral artery (SFA) angioplasty. Restenosis of the SFA after endovascular intervention is a common problem leading to 1-year primary patency as low as 40%. These failures are primarily due to the development of neointimal hyperplasia, resulting from arterial wall inflammation. METHODS: This was a randomized, phase II trial examining SFA restenosis in patients after percutaneous revascularization. Randomization occurred after successful revascularization, and patients were assigned to either the standard of care arm or the Xilonix (XBiotech USA, Inc, Austin, Tex) plus standard of care arm (N = 43). Xilonix was administered immediately after revascularization, every 2 weeks intravenously for four doses, and monthly subcutaneously until month 12. The major efficacy end points were target vessel event-free survival and incidence of major adverse cardiovascular events (MACEs). RESULTS: At 12 months of follow-up, MACE (43% vs 36%; P = .76) and target vessel restenosis (24% vs 27%; log-rank, P = .79) rates were not significantly different between the groups. At 3-month follow-up, which covers the intravenous dosing period, a trend toward lower incidence of restenosis (0 of 22 [0%] vs 2 of 21 [10%]; P = .14) and MACE (2 of 22 [9%] vs 5 of 21 [24%]; P = .22) was observed in the Xilonix cohort. Adverse events were equally distributed in both arms. CONCLUSIONS: Xilonix was well tolerated. Observed tendency to improved vessel patency with intravenous dosing suggests Xilonix could potentially represent a safe and effective therapeutic approach to preserving vessel patency.

Objective performance goals after endovascular intervention for critical limb ischemia.

OBJECTIVE: During the last decade, primary endoluminal therapy for critical limb ischemia (CLI), assessed as rest pain and tissue loss of the lower extremity, has significantly increased. Reporting of patient-centered outcomes using the new Society for Vascular Surgery objective performance goals (OPGs) has been limited. This study examined the OPGs for infrainguinal endovascular management of CLI. METHODS: A prospective database of patients undergoing endovascular treatment of the lower extremity for CLI between 2000 and 2011 was queried. Evaluated were clinical efficacy (absence of recurrent symptoms, maintenance of ambulation and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention - new bypass graft, jump/interposition graft revision). RESULTS: A total of 728 patients (60% male; age, 68 ± 14 years) underwent lower extremity interventions for CLI (66% tissue loss); of these, 39% had superficial femoral artery and tibial interventions. Diabetes mellitus was present in 71%, hyperlipidemia in 64%, and chronic renal insufficiency in 37%. Technical success was 96%. The overall rate at 30 days of major adverse cardiovascular events (MACEs) was 3% and MALEs was 12%. At 5 years, clinical efficacy was (mean ± standard error of the mean) 42% ± 5%, amputation-free survival was 41% ± 7%, and freedom from MALEs was 51% ± 4%. Clinical efficacy was significantly different in those presenting with rest pain and tissue loss and in the anatomic high-risk group compared with the clinical high-risk group, and both were worse compared with the group without clinical or high-risk criteria. CONCLUSIONS: Endoluminal therapy for CLI is associated with early low MACE rates but high MALE rates. When the key outcome of amputation free survival is considered, predictors of a better outcome were absence of current smoking, a lower modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) amputation risk score, better preoperative ambulation status, lower MACEs, and discharge disposition to home. The presence of tissue loss and anatomic risk factors negatively affect outcomes. Longer-term outcomes after endovascular intervention for CLI remain relatively poor, with <40% success in objective performance outcomes at 5 years.

Outcomes of Isolated Tibial Endovascular Interventions for Tissue Loss in CLI Patients on Hemodialysis.

PURPOSE: To compare the objective performance goals (OPGs) and patient-centered outcomes of isolated tibial interventions in patients with tissue loss who were on hemodialysis (HD) to patients with tissue loss who were not on HD. METHODS: Interrogation of a prospectively maintained database identified 242 critical limb ischemia (CLI) patients who underwent isolated tibial interventions for tissue loss in a single limb between 2007 and 2012. The 78 patients (mean age 66±12 years; 44 men) on HD were compared with 164 patients (mean age 50±13 years; 82 men) who were not on HD. There was an equal distribution of the tibial vessels treated; 152 (63%) patients had more than one treated tibial vessel. Patient-centered outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and no major amputation), amputation-free survival (AFS), and freedom from major adverse limb events (MALE) were evaluated. The Society for Vascular Surgery OPGs were defined at 30 days and 1 year. RESULTS: The 30-day major adverse cardiac events was significantly higher (p=0.004) in the HD group (5, 5%) compared with the no-HD group (0%), but both remained under the stated OPG of ≤10%. The 30-day MALE rates were significantly higher than the stated ≤9% OPG at 13% and 18% for the no-HD and HD groups, respectively. At 1 year, the rates for AFS, freedom from MALE, limb salvage, and survival did not achieve the stated Society for Vascular Surgery OPGs in the HD group. Clinical efficacy was 61% and 25% at 3 years for the no-HD and HD groups, respectively (p<0.01). Overall, AFS was 54% and 22% and freedom from MALE was 56% and 27% at 3 years for the no-HD and HD groups, respectively (both p<0.01). CONCLUSION: Tibial intervention for tissue loss in patients on HD is a valid treatment option but is associated with a high MALE rate. Three-year outcomes remain relatively poor, with <25% success in terms of clinical efficacy and AFS.