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Background: Preclinical studies have demonstrated that therapeutic ultrasound (TUS) increases perfusion in peripheral artery disease (PAD). This pilot study assessed the safety and effectiveness of a noninvasive TUS device in patients with advanced PAD., Methods: A phased array of TUS transducers was fabricated on a wearable sleeve, designed to sonicate the posterior and anterior tibial arteries (and their collaterals) at the calf level. Twelve patients with PAD (Rutherford classes 3-5) were enrolled in a single-arm study in which they underwent 30-40 daily 90-minute TUS sessions to the diseased limb. Changes in pedal flow and tissue oxygenation (StO 2 ) were measured by laser speckle and spatial frequency domain imaging, respectively. A subset of five patients underwent evaluation by laser Doppler, transcutaneous oximetry (TcPO 2 ), and quality of life questionnaires (Vascular Quality of Life Questionnaire [VascuQoL] and the Walking Impairment Questionnaire [WIQ])., Results: Eleven out of 12 enrolled patients completed the study. During 90-minute TUS sessions pedal flow improved by 180% ( p < 0.001) on laser speckle imaging, and 18% ( p = 0.12) on laser Doppler. Tissue oxygenation improved by 18% ( p = 0.43) on TcPO 2 and by 6% ( p = 0.097) on StO 2 . After all sessions, tissue oxygenation improved by 17% ( p = 0.020) on StO 2 , without significant changes in laser Doppler (+39%, p = 0.41) or TcPO 2 (-3%, p = 0.70), which was largely in the normal range (56 ± 15 mmHg) at baseline. VascuQoL improved by 2.4 points (14%, p = 0.080) and WIQ improved by 8.2 points (11%, p = 0.053)., Conclusions: TUS for patients with symptomatic PAD was safe and well tolerated. Most metrics of tissue perfusion and oxygenation improved, but future sham-controlled studies are needed and planned., Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Drs. Nazer and Razavi are consultants for and have equity interests in Vibrato Medical. The remaining authors have no conflicts of interest to declare.

Purpose: To present the results of the Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating safety and efficacy of Lava Liquid Embolic System (Lava LES), an ethylene vinyl alcohol (EVOH), for peripheral arterial hemorrhage (PAH)., Materials and Methods: LAVA was a pivotal, prospective, multicenter, single-group, centrally adjudicated study of adults with active PAH. Patients received EVOH at one of two viscosities, administered by experienced physicians. Primary safety endpoint was freedom from 30-day major adverse events (MAE) defined as ischemia/infarction of target territory, non-target embolization, allergic reaction, and catheter breakage/entrapment. Primary efficacy endpoint was 30-day clinical success defined as absence of bleeding from target lesion after embolization without need for emergency surgery, re-embolization, or other target lesion re-interventions. Secondary endpoints included serious adverse events and mortality., Results: 113 patients (mean age 57.4 years [SD 18.0; range 18.0-93.0]; 63.7% male) with 148 lesions were enrolled at 19 US centers. Targeted areas included non-gastrointestinal (GI) visceral arteries (31.1%), kidneys (26.3%), upper GI (11.5%), lower GI (6.8%) and extremities (6.1%). Empiric embolization was performed for 20.9% of lesions. The primary efficacy endpoint was achieved in 94.3% of lesions (95.3% patients), exceeding the performance goal of 72%. Two target lesions treated with EVOH required subsequent re-embolization. No surgeries were performed for bleeding or ischemia. There were no MAEs reported per study definition. All-cause mortality rate at 30 days was 8.3%., Conclusions: The LAVA study suggests that EVOH is effective and can be safely used as an embolic agent for treatment of PAH., (Copyright © 2024. Published by Elsevier Inc.)

Objective: This retrospective, multicentre study aimed to assess the prognostic value of a proposed classification system for chronic venous obstruction (CVO) patients undergoing successful interventional procedures., Methods: This study analysed data from 13 vascular centres, including 1 033 patients with CVO treated between 2015 - 2019. The patients were classified into five category types: 1 - non-thrombotic iliac vein lesion; 2 - CVO of iliac segment; 3 - CVO of iliofemoral segment above common femoral vein confluence; 4 - CVO of iliofemoral segment extending into the femoral vein (FV) or deep femoral vein (DFV); and 5 - CVO of iliofemoral segment involving both DFV and FV. Stent deployment, complications, and follow ups were evaluated. Uni- and multivariable analyses were performed to identify predictors of primary patency loss., Results: The mean age of the patients was 44.0 ± 14.7 years, with 59.9% being women. A median of two stents was used for unilateral cases and five stents for bilateral cases. At twelve months follow up, primary patency rates for types 1 - 5 were 94.9%, 90.3%, 80.8%, 60.6%, and 39.4%, respectively. These rates were strongly correlated with the extent of CVO and showed significant differences between each type. Univariable analysis identified predictors of primary patency loss as the type of CVO, history of deep vein thrombosis, and the total number of stents. In the multivariable analysis, the significant independent predictors of primary patency loss were the type of CVO and the total number of stents., Conclusion: The proposed anatomical classification of iliofemoral CVO will help to predict intervention outcomes and facilitate comparison of stent outcomes in future studies. However, further evaluation and validation in prospective studies are needed to confirm the utility of this classification., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO., Methods: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score., Results: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p = .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score., Conclusion: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points., Study Registration Number: NCT03026049., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Purpose: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs)., Methods: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates., Results: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively., Conclusion: The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population., (Copyright © 2023 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract., Materials and Methods: Patients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed., Results: A total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture., Conclusions: The results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: Early and accurate prediction and diagnosis of deep vein thrombosis (DVT) is essential to allow for immediate treatment and reduce potential complications. However, all potentially strong risk factors have not been included in pretest probability assessments such as the Wells score. In addition, the Wells score might not be suitable for use in primary care because it was developed for secondary care. We hypothesized that the addition of more risk factors for DVT to existing diagnostic approaches could improve the prediction of DVT., Methods: All consecutive patients suspected of having DVT from 2004 to 2016 in a primary care setting were included in our retrospective study. All the patients had undergone Wells score, D-dimer, and duplex ultrasound assessments. The available recorded data of the patients were used to develop a model to predict DVT., Results: Of 3381 eligible patients, 489 (14.5%) had confirmed DVT. The developed model, which included the D-dimer level, Wells score, gender, anticoagulation use, age, and family history of venous thrombosis, was able to distinguish patients with DVT among those with suspected DVT with a sensitivity of 82% (95% confidence interval, 78%-86%) and specificity of 82% (95% confidence interval, 80%-83%)., Conclusions: The proposed model was able to predict for the presence of DVT among all patients with suspected DVT in a primary care setting with reasonable accuracy. Further validation in prospective studies is required., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To investigate the short-term results of single-session treatment of iliocaval and iliofemoral DVT using a single thrombectomy device., Materials and Methods: This prospective pilot study analyzed patients with acute iliocaval or iliofemoral DVT treated in a single session using the JETi thrombectomy system. All analyses were performed on an intention-to-treat basis. The cohort consisted of 53 limbs in 47 patients (27 women), with a mean age of 57 years (range, 16-88 years). The primary safety and efficacy endpoints were freedom from major adverse events (MAEs) and reestablishment of unobstructed flow in a single session, respectively., Results: The mean duration of symptoms was 8.5 days ± SD 9.2, with 10 patients (11 limbs, 21.3%) presenting with a symptom duration of >14 days. Twelve (25.5%) patients had thrombosis of the inferior vena cava and the iliofemoral segments. During the index procedure, unobstructed flow was reestablished in 47 of 53 (88.6%) limbs in 41 of 47 (87.2%) patients (primary endpoint) with no MAEs through 30 days. Overall, unobstructed flow was restored in 50 of 53 (94.3%) limbs and in 44 of 47 (93.6%) patients., Conclusions: Successful single-session treatment of patients with acute iliocaval and iliofemoral DVT is feasible with a high rate of efficacy and a low rate of adverse events. Such patients may be treated on an outpatient basis., (Copyright © 2021 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: Deep vein thrombosis (DVT) is a common condition with a high risk of post-thrombotic morbidity, especially in patients with a proximal thrombus. Successful iliofemoral clot removal has been shown to decrease the severity of post-thrombotic syndrome. It is assumed that earlier thrombus lysis is associated with a better outcome. Generally, the earlier IFDVT is confirmed, the earlier thrombus lysis could be performed. d-Dimer levels and Wells score are currently used to assess the preduplex probability for DVT; however, some studies indicate that the d-dimer value varies depending on the thrombus extent and localization. Using d-dimer and other risk factors might facilitate development of a model selecting those with an increased risk of IFDVT that might benefit from early referral for additional analysis and adjunctive iliofemoral thrombectomy., Methods: All consecutive adult patients from a retrospective cohort of STAR diagnostic center (primary care) in Rotterdam suspected of having DVT between September 2004 and August 2016 were assessed for this retrospective study. The diagnostic workup for DVT including Wells score and d-dimer were performed as well as complete duplex ultrasound examination. Patients with objective evidence of DVT were categorized according to thrombus localization using the Lower Extremity Thrombolysis classification. Logistic regression analysis was done for a model predicting IFDVT. The cut-off value of the model was determined using a receiver operating characteristic curve., Results: A total of 3381 patients were eligible for study recruitment, of whom 489 (14.5%) had confirmed DVT. We developed a multivariate model (sensitivity of 77% and specificity of 82%; area under the curve, 0.90; 0.86-0.93) based on d-dimer, Wells score, age, and anticoagulation use, which is able to distinguish IFDVT patients from all patients suspected of DVT., Conclusions: This multivariate model adequately distinguishes IFDVT among all suspected DVT patients. Practically, this model could give each patient a preduplex risk score, which could be used to prioritize suspected IFDVT patients for an immediate imaging test to confirm or exclude IFDVT. Further validation studies are needed to confirm potential of this prediction model for IFDVT., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Titanium and its alloys are considered as appropriate replacements for the irreparable bone. Calcium phosphate coatings are widely used to improve the osteoinduction and osseointegration ability of titanium alloys. To further improve the performance of the calcium phosphate-coated implants, strontium (Sr) was introduced to partially replace the calcium ions. In this study, the effect of Sr ion addition on the fluorohydroxyapatite (FHA)-coated Ti6Al4V alloy was investigated and all the coatings were treated under hydrothermal condition. X-ray diffraction (XRD) and scanning electron microscopy (SEM) were used to investigate the phases and microstructures, respectively. Shear tests were done to evaluate the bond strength of the coating layer. MTT, adhesion, and alkaline phosphatase tests were performed to evaluate the biocompatibility and osteogenic behavior of the samples. Results showed that the average crystallite size for the strontium-doped FHA samples was 48 nm and the bond strength had increased 13.15% in comparison with FHA-coated samples. Analysis of variance showed p value for all MTT tests at more than 0.322 and there was not any evidence of cell death after 7 days. The results of the ALP test showed that the increase of the cell activity in Sr samples from day 7 to 14 is three times higher than the FHA ones., (© 2021. Islamic Azad University.)

Objective: The impact of stent design on venous patency is not well studied. The purpose of this study was to investigate the effect of stent material burden on endothelial coverage of stented venous segments, which may contribute to vessel healing and patency., Methods: Segmented self expanding bare nitinol stents (18 × 50 mm) comprising 5 mm long attached metallic rings separated by 2, 5, or 8 mm gaps were implanted in the inferior vena cava (IVC) of 10 sheep. These stents were designed and manufactured for the purposes of this study. At six, 12, and 24 weeks after implantation the animals were euthanised and the stented vessels harvested for histomorphometric analysis. Three sections from the metallic part as well as the gaps between the struts were reviewed for quantification of endothelialisation after six, 12, and 24 weeks. The intimal thickness over and between the stent struts was measured. The endothelialisation score (graded from 1 for complete luminal endothelialisation to 5 for absence of endothelial cells) was determined., Results: All stents were successfully deployed and all 10 sheep survived until the time of harvesting. Macroscopic inspection after 24 weeks showed only partial endothelialisation over stents with 2 mm and 5 mm skipped segments, whereas the stents with 8 mm skipped segments were totally incorporated into the vein wall. After 24 weeks, the mean (SD) neointimal thicknesses over stent struts with 2 mm, 5 mm, and 8 mm skipped segments were 254.0 (51.6), 182.2 (98.1), and 194.6 (101.1) μm, respectively. Comparison of endothelialisation scores of stents over time showed statistically significantly better endothelialisation over stents with 8 mm gaps after 12 and 24 weeks., Conclusion: Stent designs providing structural support to veins with larger gaps between the scaffold material appear to lead to faster and more complete endothelialisation as well as a thinner intimal layer., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Purpose: To evaluate the feasibility of a new optical device that measures peripheral blood flow as a diagnostic and monitoring tool for patients with peripheral artery disease (PAD)., Materials and Methods: In this prospective study, 167 limbs of 90 patients (mean age, 76 y; 53% men) with suspected PAD were evaluated with the FlowMet device, which uses a new type of dynamic light-scattering technology to assess blood flow in real time. Measurements of magnitude and phasicity of blood flow were combined into a single-value flow-waveform score and compared vs ankle-brachial index (ABI), toe-brachial index (TBI), and clinical presentation of patients per Rutherford category (RC). Receiver operating characteristic curves were constructed to predict RC. Area under the curve (AUC), sensitivity, and specificity were compared among flow-waveform score, ABI, and TBI., Results: Qualitatively, the FlowMet waveforms were analogous to Doppler velocity measurements, and degradation of waveform phasicity and amplitude were observed with increasing PAD severity. Quantitatively, the flow, waveform, and composite flow-waveform scores decreased significantly with decreasing TBI. In predicting RC ≥ 4, the flow-waveform score (AUC = 0.83) showed a linear decrease with worsening patient symptoms and power comparable to that of TBI (AUC = 0.82) and better than that of ABI (AUC = 0.71). Optimal sensitivity and specificity pairs were found to be 56%/83%, 72%/81%, and 89%/74% for ABI, TBI, and flow-waveform score, respectively., Conclusions: The technology tested in this pilot study showed a high predictive value for diagnosis of critical limb ischemia. The device showed promise as a diagnostic tool capable of providing clinical feedback in real time., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Preoperative image-guided localization of lung nodules is necessary for successful intraoperative localization and resection. However, current localization techniques carry significant intraoperative disadvantages for surgeons. Articles were selected through multiple search engines using key search terms and reviewed to compare results, outcomes, advantages, limitations, and complications of various localization methods. Current methods utilize microcoils, hookwires, contrast media, dyes, cyanoacrylate, radiotracers, or fluorescence tracers, which are associated with many intraoperative disadvantages even when paired with other imaging modalities including computed tomography and bronchoscopy techniques. Novel technologies including robotic bronchoscopy, 4-hook anchor, SPiN Thoracic Navigation System, superDimension, Ion Endoluminal System, and the SCOUT system are reviewed including their advantages, which may change the future direction of minimal thoracoscopic surgery with potential to improve intraoperative accuracy and efficiency.

Purpose: Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction., Methods: Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30-79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction., Results: Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1 ± 30.6 and 19.1 ± 25.1 min, respectively. There were no device-related adverse events or catheter malposition., Conclusion: The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I 2  = 68.4 %], PMT 96 %, [I 2  = 0 %]; Q bet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I 2  = 15.6 %] versus 94 %; Q bet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I 2  = 0 %] versus 1.0 % [I 2  = 0 %]; Q bet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I 2  = 56 %] versus 91.3 % [I 2  = 91.7 %]; Q bet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Q bet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Q bet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

Purpose: To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions., Materials and Methods: A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter., Results: Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%., Conclusions: Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT)., Materials and Methods: Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months., Results: PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral-popliteal venous segments. For the overall proximal DVT population, and for the femoral-popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux., Conclusions: PCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Introduction: The development of thoracic central venous obstruction (TCVO) leads to narrowing of the vessel lumen which impacts blood flow and the placement of central venous access. The most common cause of TCVO is central venous catheters (CVCs) which can induce intravascular scarring or endoluminal obstruction via thrombus formation., Areas Covered: The Surfacer® System is used to obtain central venous access (CVA) in patients with TCVO by facilitating catheter insertion via the novel Inside-Out® approach. This review summarizes the results of clinical studies to date with the Surfacer System, focusing on how the procedure is performed, clinical efficacy and safety of the device and patient populations where the device offers substantial clinical benefit., Expert Opinion: The Surfacer System offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites. For dialysis patients, the device offers an alternative which avoids placement of dialysis catheters in veins which may impact the ability to achieve maturation of hemodialysis vascular access or in locations which have an increased risk of insertion-related complications or are associated with higher morbidity.

Purpose: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA)., Materials and Methods: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR])., Results: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes., Conclusions: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT., Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups., Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups., Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months., (Copyright © 2019 Society for Vascular Surgery. All rights reserved.)

Background: Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction., Methods: The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction. Patients included those with ≥50% obstruction on venography and Clinical, Etiology, Anatomic, Pathophysiology clinical classification ≥3, or at least moderate leg pain with a Venous Clinical Severity Score of 2 or greater. All patients were treated with a self-expanding nitinol stent developed for dedicated use in the venous system (Vici Venous Stent System, Veniti, Inc/Boston Scientific, Marlborough, MA). Patients returned for clinical and imaging follow-up visits at 1 month, 6 months, and 1 year. The primary safety outcome was freedom from major adverse events at 30 days. The primary effectiveness outcome was venographic primary patency at 1-year. Adverse events were adjudicated by a Clinical Events Committee, and all imaging including venograms, intravascular ultrasound, and Doppler examinations were assessed by respective core laboratories., Results: Between March 2015 and November 2016, 170 patients (127 chronic post-thrombotic, mean age 54 years, 56.4% female) at 22 sites underwent endovenous stent placement. Mean diameter stenosis was 78%, with 31.2% total occlusions. Mean lesion length was 111.3 mm, range 10 to 260 mm (mean 125.3 mm for post-thrombotic patients and 70.2 mm for nonthrombotic patients). Freedom from a major adverse event through 30 days was 98.8%. The 1-year primary patency rate for the entire group was 84.0%. Venographic patency rates for the nonthrombotic and chronic post-thrombotic groups were 96.2% and 79.8%, respectively. At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score., Conclusions: Twelve-month safety and effectiveness were demonstrated with the use of a dedicated venous stent to treat symptomatic iliofemoral venous obstructions, with reductions in clinical symptoms and improvements in quality of life, through 1-year follow-up., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02112877.

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335 .

Background: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients., Methods: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling., Results: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, P =0.02), smoked more frequently (86.6% versus 78.8%, P =0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, P =0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, P =0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; P <0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; P =0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; P =0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; P <0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; P =0.23)., Conclusions: The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.

Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA., Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders., Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA., Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background . Current techniques for localization and resection of lung nodules carry many intraoperative challenges for surgeons. This article proposes a new localization method for diagnosis and treatment of pulmonary nodules, which provides a navigational system for more accurate lung resection. Methods. We report the case of a 77-year-old female with a pulmonary nodule of the right lower lobe. A nonradioactive localization technology, known as SAVI SCOUT (Cianna Medical Inc, Aliso Viejo, CA), was placed by interventional radiology under computed tomography guidance preoperatively. Using the SCOUT Wire-Free Radar Localization System, the pulmonary nodule was robotically localized and resected. SCOUT removal was confirmed using the Trident Specimen Radiology System. The efficacy of this procedure was evaluated in terms of ease of use and procedure time by interventional radiology, surgical resection accuracy, diagnostic accuracy, simplicity, and ease to implement this technology in an existing hospital. Results . The SCOUT system allowed for the first reported case of successful SCOUT placement in lung tissue, targeted the pulmonary nodule intraoperatively, and facilitated accurate lung resection. Conclusions . The SCOUT system shows promising advancements in the ability to eliminate many challenges currently seen with lung nodule localization and resection.

Background: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis., Methods: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes., Results: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21)., Conclusions: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.

Objectives: This study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease., Background: Drug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy., Methods: The single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving percutaneous transluminal angioplasty (PTA) (n = 124) or atherectomy (ATX) (n = 159) in femoropopliteal lesions ≤15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire., Results: At 12 months, primary patency rates in DANCE-ATX and -PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE., Conclusions: Direct adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome., Methods: We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up., Results: Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups., Conclusions: Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).

Objective: In this paper, an adaptive method based on error entropy criterion is presented in order to eliminate noise from Electroencephalogram (EEG) signals., Method: Conventionally, the Mean-Squared Error (MSE) criterion is the dominant criterion deployed in the adaptive filters for this purpose. By deploying MSE, only second-order moment of the error distribution is optimized, which is not adequate for the noisy EEG signal in which the contaminating noises are typically non-Gaussian. By minimizing error entropy, all moments of the error distribution are minimized; hence, using the Minimum Error Entropy (MEE) algorithm instead of MSE-based adaptive algorithms will improve the performance of noise elimination., Results: Simulation results indicate that the proposed method has a better performance compared to conventional MSE-based algorithm in terms of signal to noise ratio and steady state error.

Patients with advanced post-thrombotic syndrome (PTS) and chronic iliac vein obstruction suffer major physical limitations and impairment of health-related quality of life. Currently there is a lack of evidence-based treatment options for these patients. Early studies suggest that imaging-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction and saphenous venous valvular reflux, resulting in reduced PTS severity; however, these observations have not been rigorously validated. A multidisciplinary expert panel meeting was convened to plan a multicenter randomized controlled clinical trial to evaluate endovascular therapy for the treatment of advanced PTS. This article summarizes the findings of the panel, and is expected to assist in developing a National Institutes of Health-sponsored clinical trial and other studies to improve the care of patients with advanced PTS., (© The Author(s) 2016.)

Background: Endovenous recanalization of iliofemoral stenosis or occlusion with angioplasty and stent placement has been increasingly used to maintain long-term venous patency in patients with iliofemoral venous outflow obstruction. The purpose of this systematic review and meta-analysis was to determine safety and effectiveness of venous stent placement in patients with iliofemoral venous outflow obstruction., Methods and Results: We searched MEDLINE and EMBASE for studies evaluating safety or effectiveness of stent placement in patients with iliofemoral venous outflow obstruction. Data were extracted by disease pathogenesis: nonthrombotic, acute thrombotic, or chronic post-thrombotic. Main outcomes included technical success, periprocedural complications, symptom relief at final follow-up, and primary/secondary patency through 5 years. A total of 37 studies reporting 45 treatment effects (nonthrombotic, 8; acute thrombotic, 19; and chronic post-thrombotic, 18) from 2869 patients (nonthrombotic, 1122; acute thrombotic, 629; and chronic post-thrombotic, 1118) were included. Technical success rates were comparable among groups, ranging from 94% to 96%. Complication rates ranged from 0.3% to 1.1% among groups for major bleeding, from 0.2% to 0.9% for pulmonary embolism, from 0.1% to 0.7% for periprocedural mortality, and from 1.0% to 6.8% for early thrombosis. Patient symptom relief data were reported inconsistently. At 1 year, primary and secondary patency were 96% and 99% for nonthrombotic, 87% and 89% for acute thrombotic, and 79% and 94% for chronic post-thrombotic., Conclusions: Stent placement for iliofemoral venous outflow obstruction results in high technical success and acceptable complication rates regardless of cause of obstruction., (© 2015 American Heart Association, Inc.)

Objective: The effect of stent graft fixation type on renal function after endovascular aneurysm repair (EVAR) remains controversial. This systematic review and meta-analysis was conducted to determine whether suprarenal (SR) or infrarenal (IR) fixation influences the risk of renal complications after EVAR., Methods: We searched MEDLINE and EMBASE with no date or language restrictions for comparative studies evaluating EVAR with SR vs IR fixation on renal dysfunction, renal artery stenosis, renal artery occlusion, renal infarction, and new need for hemodialysis. For each outcome, we calculated the absolute risk difference (RD) with a random effects meta-analysis and performed assessments of heterogeneity and publication bias. Post hoc subgroup analyses explored the influence of individual moderator variables., Results: A total of 21 nonrandomized studies comparing SR vs IR fixation representing 4474 unique patients (SR, 1949; IR, 2525) were included. Baseline patient characteristics were similar between the SR and IR groups. Median patient follow-up was 12 months in each group. There were no statistically significant differences in the risk of any renal complication between SR and IR fixation groups. The absolute RD between the SR and IR fixation groups was <1%, with no evidence of heterogeneity or publication bias for renal dysfunction, renal artery stenosis, renal artery occlusion or new need for hemodialysis after EVAR. Renal infarction occurred in 6.4% of SR patients and in 2.5% of IR patients (P = .09), with evidence of heterogeneity (I(2) = 85%) and publication bias (Egger P = .08). Subgroup analyses revealed that older studies (median treatment period before 2000) reported greater risks of renal infarction with SR fixation (RD, 6.2%; P = .01). However, more contemporary studies (median treatment period after 2000) demonstrated no difference between SR and IR fixation on renal infarction risk (RD, 0.2%; P = .75)., Conclusions: There is no difference in the risk of postoperative renal complications when comparing stent grafts using SR vs IR fixation, particularly with newer-generation devices. Contemporary comparative studies with longer-term follow-up are warranted to further elucidate the influence of SR and IR fixation on renal complications., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: The need for specialty devices to improve the technical outcome of endovascular interventions is dependent on the rate of early failure in such procedures. This meta-analysis assessed procedural outcomes of such interventions to elucidate the rate of early procedural failures and the need for such specialty devices., Materials and Methods: MEDLINE and EMBASE were searched for contemporary studies (2000-2012) reporting procedural or short-term outcomes for revascularization of infrapopliteal atherosclerotic lesions. A random-effects metaanalysis was performed, which included post hoc comparisons among treatment groups., Results: A total of 42 studies with 52 treatment arms representing 3,660 unique patients were included. Technical success rates were higher with bare metal stents (BMSs; 98.6%) than with atherectomy (92.2%; P < .05) or percutaneous transluminal angioplasty (PTA; 91.2%; P = .01), and higher with drug-eluting stents (DESs) than with PTA (P < .001). DES use had higher primary patency rates than atherectomy (P < .05), BMS use (P < .001), and PTA (P < .01). The 30-day rate of target lesion revascularization was significantly higher with PTA (8.1%) than with BMSs (2.2%; P < .05) and DESs (1.1%; P < .05). Thirty-day rates of major unplanned amputation (range, 1.5%-4.4%) and mortality (range, 0.9%-3.3%) were comparable among treatment groups. Significant heterogeneity among studies was noted for most PTA outcomes. Publication bias was evident for most PTA and DES outcomes., Conclusions: Early failure of percutaneous therapies in patients with infrapopliteal atherosclerotic lesions is device- and technique-dependent. Specialty devices designed to reduce technical failure rates may therefore be of benefit in this selected group of patients. Study results are confounded by inconsistent data reporting, heterogeneity of treatment effects, and publication bias., (Copyright © 2014 SIR. Published by Elsevier Inc. All rights reserved.)

The basic treatment of deep vein thrombosis (DVT) over the past several decades has consisted of anticoagulation only, with inferior vena cava filtration for those who either failed or could not tolerate anticoagulation. Until recently no randomized trials had studied the efficacy of thrombolysis in DVT despite advances in techniques and technologies for endovascular clot removal. This article is a review of the current evidence on catheter-based therapies for patients with DVT. Technical considerations to improve outcome as well as optimal patient selection are discussed.

Background: Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the postthrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life. Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has not been tested in a large multicenter randomized trial., Study Design: The ATTRACT Study is an ongoing National Institutes of Health-sponsored, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial. Approximately 692 patients with acute proximal DVT involving the femoral, common femoral, and/or iliac vein are being randomized to receive PCDT + standard therapy versus standard therapy alone. The primary study hypothesis is that PCDT will reduce the proportion of patients who develop PTS within 2 years by one-third, assessed using the Villalta Scale. Secondary outcomes include safety, general and venous disease-specific quality of life, relief of early pain and swelling, and cost-effectiveness., Conclusion: ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Acute procedural thromboembolic events are serious complications affecting both short- and long-term outcome. Patients at high risk include those undergoing catheter-based interventions for acute limb ischemia and long segment de novo or stented occlusions of the lower limb arteries. Additionally, debulking procedures and angioplasty/stenting of complex lesions in patients with advanced disease have also been associated with a higher risk of distal embolization and in situ thrombosis. This article includes a discussion of detection methods as well as preventive and treatment strategies., (Copyright © 2011 Elsevier Inc. All rights reserved.)

During normal breathing, the kidneys move up and down due to the diaphragm motion and the renal artery subsequently experiences bending at or close to its point of fixation to the aorta. The impact of this kidney motion on implanted stent fatigue performance was not well understood in the past. Previous study from the authors on an 18-mm long single cobalt-chromium stent showed that the change in bending angle was minor during simulated respiration-induced kidney motion on cadavers. Finite Element Analysis revealed excellent fatigue resistance of the studied cobalt-chromium stent under simulated respiratory motion for the single stent configuration. In this article, the study was extended further to the overlapped stent configuration where a physician deploys two stents overlapping at the stent ends to fully cover a long lesion. Fluoroscopic images showed that the change in bending angle during simulated respiration-induced kidney motion on cadavers was more significant when two cobalt-chromium stents were overlapped. Calculated data of the Goodman analysis for the overlapped stents migrated toward the Goodman diagram failure line, indicating lower fatigue resistance during respiration when compared to a single stent.

Purpose: To examine the effects of swallowing and side-to-side head turning on stents in the internal carotid artery., Methods: Seven patients (4 men; mean age 76.9 years) who underwent carotid artery stenting for the treatment of atherosclerotic cervical carotid artery disease were examined with cine fluoroscopy. Geometric processing techniques were used to quantify carotid stent deformations due to head turning and swallowing forces. The variables measured included radial, axial, and crush deformations, as well as radii of stent curvatures during tested maneuvers., Results: Radial deformations of the stented vessels were significantly less than axial and crush deformations, ranging from -10.2% to 15.5%. Axial deformations in response to both swallowing and head turning were positive (average 4.5%, range -14.5% to 14.1%), indicating a general lengthening of the stented vessel due to biomechanical motions. Crush strains exhibited the largest range of all of the deformation modes during both swallowing and head turning. Strain values ranged from -18.7% to 25.9% in the anteroposterior direction and from -25.6% to 21.9% in the lateral direction. Head turning produced fairly symmetrical crushing of the stent. Conversely, swallowing resulted in a preferential medial crush of the stented artery due to contraction of the pharyngeal constrictor muscles. Curvature measurements revealed a tightest radius of curvature of approximately 1.5 cm during ipsilateral head turning, with average values during both swallowing and head turning of approximately 10 cm., Conclusion: In general, head turning toward the stented artery produced greater deformation in the vessels than swallowing. Since patients are expected to undergo far more swallowing cycles than head turns, however, the accumulated deformations from swallowing may be more significant and should be considered in the design of fatigue resistant stents for carotid arteries.

Excessive shunting through transjugular intrahepatic portosystemic shunts (TIPS) can cause life-threatening hepatic encephalopathy and insufficiency. Intentional reduction of flow may be effective but difficult to control. The present report describes refinements of the parallel stent/stent-graft technique of flow reduction that is adjustable in either direction. Six patients underwent TIPS reduction with varying stent positioning and a variety of commercial products. Flow was adjusted by iterative balloon dilatation of the stent and stent-graft, resulting in a mean gradient increase of 8 mm Hg. All cases were technically successful, but 1-year survival was seen in only the patient who underwent liver transplantation.

Mycotic aneurysms are rare but are associated with a high risk of rupture if not treated promptly. The early mortality rate associated with traditional surgery depends on patients' condition and can be as high as 43%. The use of stent-grafts is less invasive but the outcome is unproven in the setting of infected aneurysms. In an attempt to better elucidate the role of stent-grafts in this setting, a literature search was performed to examine 52 articles describing 91 patients with mycotic aneurysms who were treated with stent-grafts. The early mortality rate was 5.6%. Incidences of late aneurysm-related mortality and complications were 12.2% and 7.8%, respectively. The most consistent predictor of poor outcome was development of aortoenteric fistula. Although the 30-day mortality rate associated with the use of stent-grafts appears to be lower than that associated with surgery, late aneurysm-related events are frequent and warrant a more vigilant follow-up regimen than used with noninfected aneurysms.

The aim of this study was to determine the feasibility of using a newly designed polytetrafluoroethylene (PTFE)-covered metallic stent in the ureter by comparing its effectiveness with that of the noncovered stent in a canine model. We placed 14 stents in the ureters of seven mongrel dogs that weighed 30-40 kg each. The covered and noncovered stents were deployed in the right and left ureters, respectively, of six dogs. In the seventh dog, a covered stent and a double-J catheter were inserted in the right ureter, and a covered stent only was inserted in the left ureter. The first six dogs were sacrificed at 5, 10, and 15 weeks after deployment of the stents (two for each follow-up period), and the seventh dog was sacrificed at 30 weeks. There was no migration or poor expansion of any of the stents observed on plain radiography. On intravenous pyelogram and retrograde pyelogram, all of the covered stents at each follow-up period had patent lumens at the stented segments without hydronephrosis, and the passage of contrast material through it was well preserved. The noncovered stents in the dogs sacrificed at 5 and 10 weeks and one of the two dogs sacrificed at 15 weeks showed near-complete occlusion of the stent lumen due to ingrowth of the soft tissue, and severe hydronephrosis was also noted. The noncovered stent in the other dog sacrificed at 15 weeks showed the passage of contrast material without hydronephrosis, but the lumen of the stent was still nearly occluded by the soft tissue. There was no evidence of hydronephrosis or passage disturbance of the contrast material in both ureters of the dog sacrificed at 30 weeks. We conclude that the newly designed PTFE-covered stent effectively prevented the luminal occlusion caused by urothelial hyperplasia compared to the near-total occlusion of the noncovered stents, and no migration of the covered stents was noted.

Purpose: To elucidate the mechanism of persistence or recurrence of varicoceles after surgical repair by examining the venographic anatomy, and to review the efficacy of treatment of these patients with n-butyl cyanoacrylate (NBCA) embolization., Materials and Methods: From 2001 to 2007, 17 patients with persistent or recurrent varicoceles were studied by retrograde venography 4 months to 18 years after open surgical repair. All patients were then treated with NBCA glue embolization of the entire gonadal vein and the venographically identified duplications and collateral vessels, with three patients undergoing bilateral procedures. Venographic anatomy and clinical success were retrospectively analyzed., Results: The majority of patients (65%) exhibited duplications draining into a single left gonadal vein. Duplications were most frequently found to be confined to the pelvis and inguinal canal. Communication with other retroperitoneal veins, including the renal hilar, lumbar, iliac, and circumaortic renal vein, was relatively uncommon. NBCA embolization effectively treated the main gonadal vein as well as the duplications and communications, with only one patient developing thrombophlebitic complications., Conclusions: Duplication of the gonadal vein in the pelvic or inguinal region with apparent incomplete ligation or resection is a common finding in patients with persistence or recurrence of varicocele after surgery. NBCA embolization effectively treats these duplicated vessels, resulting in a high rate of clinical success on short-term follow-up.

Purpose: To summarize the preliminary experience with the Trellis-8 infusion catheter (TIC) in the treatment of deep venous thrombosis (DVT) and compare the outcome to that with catheter-directed thrombolysis (CDT) by using a meta-analysis of published reports., Materials and Methods: Technical success, bleeding complications, and costs for patients treated with the TIC for DVT were reported through a voluntary, company-sponsored registry. Technical success was classified by using the National Venous Registry grading scale for DVT lysis (<50% lysis = grade I, 50%-99% lysis = grade II, and 100% lysis = grade III). The cost of treatment with the TIC was based on equipment (catheters) needed to perform the intervention, thrombolytic agents used, bleeding episodes, procedure time in the angiography and/or interventional suite, and monitoring time in a critical care unit. Outcomes with the TIC were compared against outcomes with CDT by using literature-derived outcomes derived from a meta-analysis., Results: Thrombolytic doses and infusion durations were less with TIC than with conventional CDT. Grade II and III lysis was achieved in 93% of patients treated with the TIC and 79% of patients treated with CDT (P = .03). Major hemorrhage was reported in none of the TIC patients and in 8.5% of patients treated with CDT (P < .001). The per-patient cost of therapy was $3,697 for TIC and $5,473 for CDT (P = .03)., Conclusions: Thrombolysis in DVT with the TIC is associated with a greater technical success rate, a lower rate of bleeding, and a lower cost than that reported for CDT. These preliminary results indicate that further evaluation of the TIC in the treatment of DVT is warranted.