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 pathogenesisnonthrombotic, 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.
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:URLhttps://www.clinicaltrials.gov. Unique identifierNCT02112877.
•Modeling of CZTS solar cells.•AZTS as buffer layer.•Effect of various parameters.•Efficiency enhanced.
This paper presents the use of AZTS, a non-toxic and earth abundant material as buffer layer in ...CZTS solar cells due to its good lattice match. We have performed simulation on the experimentally fabricated AZTS/CZTS hetero-junction device by adding CZTS as back surface field (BSF) layer. In this work, first we have reconstructed the AZTS/CZTS experimentally designed solar cell then BSF layer is added to boost the solar cell performance in SCAPS simulator. Several parametersof AZTS buffer layer such as generation/recombination rate and doping concentration are varied during simulationto enhance the performance of investigated solar cells structures. It has been noticed that addition ofBSF layer increasesthe efficiency of AZTS/CZTS solar cell from 4.51% to 5.05% along with improvement of both Voc and FF.
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.
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.
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.
BACKGROUND:The ATTRACT trial (Acute Venous ThrombosisThrombus 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 ulcer49% 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 ulcer18% versus 28%; risk ratio, 0.65; 95% CI, 0.45–0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32–1.01; P=0.048; and Venous Clinical Severity Score ≥86.6% 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:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00790335.
Autosomal recessive primary microcephaly (MCPH) is a neurodevelopmental disorder characterized by a congenitally reduced head circumference (-3 to -5 SD) and non-progressive intellectual disability. ...The objective of the study was to evaluate pathogenic mutations in the ASPM gene to understand etiology and molecular mechanism of primary microcephaly. Blood samples were collected from various families across different remote areas of Pakistan from February 2017 to May 2019 who were identified to be affected with primary microcephaly. DNA extraction was performed using the salting-out method; the quality and quantity of DNA were evaluated using spectrophotometry and 1% agarose gel electrophoresis, respectively in University of the Punjab. Mutation analysis was performed by whole exome sequencing from the Cologne Center for Genomics, University of Cologne. Sanger sequencing was done in University of the Punjab to confirm the pathogenic nature of mutation. A novel 4-bp deletion mutation c.3877_3880delGAGA was detected in exon 17 of the ASPM gene in two primary microcephaly affected families (A and B), which resulted in a frame shift mutation in the gene followed by truncated protein synthesis (p.Glu1293Lysfs*10), as well as the loss of the calmodulin-binding IQ domain and the Armadillo-like domain in the ASPM protein. Using the in-silico tools Mutation Taster, PROVEAN, and PolyPhen, the pathogenic effect of this novel mutation was tested; it was predicted to be "disease causing," with high pathogenicity scores. One previously reported mutation in exon 24 (c.9730C>T) of the ASPM gene resulting in protein truncation (p.Arg3244*) was also observed in family C. Mutations in the ASPM gene are the most common cause of MCPH in most cases. Therefore, enrolling additional affected families from remote areas of Pakistan would help in identifying or mapping novel mutations in the ASPM gene of primary microcephaly.
Field experiments were conducted on wheat to study the effects of foliar-applied iodine(I) alone, Zn (zinc) alone, and a micronutrient cocktail solution containing I, Zn, Se (selenium), and Fe ...(iron) on grain yield and grain concentrations of micronutrients. Plants were grown over 2 years in China, India, Mexico, Pakistan, South Africa, and Turkey. Grain-Zn was increased from 28.6 mg kg–1 to 46.0 mg–1 kg with Zn-spray and 47.1 mg–1 kg with micronutrient cocktail spray. Foliar-applied I and micronutrient cocktail increased grain I from 24 μg kg–1 to 361 μg kg–1 and 249 μg kg–1, respectively. Micronutrient cocktail also increased grain-Se from 90 μg kg–1 to 338 μg kg–1 in all countries. Average increase in grain-Fe by micronutrient cocktail solution was about 12%. The results obtained demonstrated that foliar application of a cocktail micronutrient solution represents an effective strategy to biofortify wheat simultaneously with Zn, I, Se and partly with Fe without yield trade-off in wheat.
To investigate the short-term results of single-session treatment of iliocaval and iliofemoral DVT using a single thrombectomy device.
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.
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.
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.
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.
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.
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.
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.
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