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Prakash Saha - One of the best experts on this subject based on the ideXlab platform.
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device profile of the vici Venous Stent for chronic iliofemoral Venous obstruction recanalization overview of its safety and efficacy
Expert Review of Medical Devices, 2020Co-Authors: Jack Kingdon, Stephen A Black, Adam M Gwozdz, Alberto Smith, Rachael Morris, Prakash SahaAbstract:Introduction: EndoVenous Stenting is being increasingly used for the management of iliofemoral Venous outflow obstruction due to thrombotic or non-thrombotic iliac vein lesions (NIVL). Dedicated ve...
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two year outcome after chronic iliac vein occlusion recanalisation using the vici Venous Stent
European Journal of Vascular and Endovascular Surgery, 2018Co-Authors: Stephen A Black, Adam M Gwozdz, Narayan Karunanithy, Justinas Silickas, Karen Breen, Beverley J Hunt, Alberto Smith, Ander Cohen, Prakash SahaAbstract:OBJECTIVE/BACKGROUND The aim was to assess two year outcomes with placement of the Vici Venous Stent® in patients with chronic iliofemoral Venous occlusions (complete blockage). METHODS This was a retrospective single centre study comprising patients treated with the Vici Venous Stent for venographically verified iliofemoral Venous occlusion and post-thrombotic syndrome (Villalta score ≥ 5 points) at least 12 months after acute deep vein thrombosis. Venography and intravascular ultrasound were used peri-operatively; duplex ultrasound was used to assess Stent patency during follow up. RESULTS Eighty-eight patients (101 limbs) had Stent placement between March 2014 and October 2016. Median pre-treatment Villalta score was 14 (range 5-33). Stenting extended across the inguinal ligament in 63 limbs (62%) in order to land in a healthy Venous segment. Six patients (7%) required endophlebectomy and fistula creation. Median imaging follow up was 21 months (range 0-41 months). Primary, assisted primary and secondary patency rates at one year were 59%, 78%, and 87%, respectively, and two years 51%, 73%, and 82%, respectively. Forty-three limbs (43%) had re-intervention (lysis, venoplasty, and/or placement of Stent) during follow up; median time to re-intervention was 32 days (range 0-520 days). At 24 months, 37 of 53 limbs (70%) with available Villalta assessment showed clinically significant improvement (>30% reduction of baseline score). Villalta scores at the 6, 12, and 24 month clinical follow up were significantly lower than before Stenting (p < .001, all time points). In a subset analyses of limbs with Stenting terminating above and below the inguinal ligament, secondary cumulative patency rates at 24 months were 90% and 79%, respectively; clinical outcome showed 58% vs. 73% of limbs with clinically significant improvement, respectively. There was no statistically significant difference in patency or clinical outcomes. CONCLUSION The Vici Venous Stent is associated with a good secondary patency rate and durable and substantial symptomatic resolution in patients with chronic post-thrombotic occlusions, regardless of whether Stents extended beneath the inguinal ligament.
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Two Year Outcome After Chronic Iliac Vein Occlusion Recanalisation Using the Vici Venous Stent
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery, 2018Co-Authors: Stephen A Black, Adam M Gwozdz, Narayan Karunanithy, Justinas Silickas, Karen Breen, Beverley J Hunt, Alberto Smith, Ander Cohen, Prakash SahaAbstract:OBJECTIVE/BACKGROUND The aim was to assess two year outcomes with placement of the Vici Venous Stent® in patients with chronic iliofemoral Venous occlusions (complete blockage). METHODS This was a retrospective single centre study comprising patients treated with the Vici Venous Stent for venographically verified iliofemoral Venous occlusion and post-thrombotic syndrome (Villalta score ≥ 5 points) at least 12 months after acute deep vein thrombosis. Venography and intravascular ultrasound were used peri-operatively; duplex ultrasound was used to assess Stent patency during follow up. RESULTS Eighty-eight patients (101 limbs) had Stent placement between March 2014 and October 2016. Median pre-treatment Villalta score was 14 (range 5-33). Stenting extended across the inguinal ligament in 63 limbs (62%) in order to land in a healthy Venous segment. Six patients (7%) required endophlebectomy and fistula creation. Median imaging follow up was 21 months (range 0-41 months). Primary, assisted primary and secondary patency rates at one year were 59%, 78%, and 87%, respectively, and two years 51%, 73%, and 82%, respectively. Forty-three limbs (43%) had re-intervention (lysis, venoplasty, and/or placement of Stent) during follow up; median time to re-intervention was 32 days (range 0-520 days). At 24 months, 37 of 53 limbs (70%) with available Villalta assessment showed clinically significant improvement (>30% reduction of baseline score). Villalta scores at the 6, 12, and 24 month clinical follow up were significantly lower than before Stenting (p
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410. Nitinol Venous Stent outcomes in peripartum women following treatment for acute ilio-femoral deep vein thrombosis
Pregnancy Hypertension, 2018Co-Authors: Katalin Lestak, Adam M Gwozdz, Justinas Silickas, Alberto Smith, Prakash Saha, Leslie Fiengo, Oscar Johnson, B J Hunt, Catherine Nelson-piercy, Susan RobinsonAbstract:Introduction Deep vein thrombosis (DVT) is the leading cause of morbidity and mortality within pregnant and post-partum women. Contemporary management of acute ilio-femoral DVT includes catheter-directed thrombolysis and Stenting of an obstructive lesion. Objective This study examines Venous Stent related outcomes of peripartum women (pregnant or within 6wks post-partum) with acute ilio-femoral DVT. Methods Peripartum women (2012–2017) treated for acute ilio-femoral DVT were included for analysis. Primary patency was defined as a patent Stent with Results Of 190 patients treated for acute ilio-femoral DVT, 81 (43%) were women. Cumulative patency was 88% (median follow-up 2.3 yrs; range 30–328 wks). From this group, 9 women were peripartum (11%). Onset of DVT was post-partum for all (mean 4 wks after birth; range 3–6 wks). Two women were treated with catheter-directed thrombolysis alone, and 7 women were also Stented. Median age at the time of Stent placement was 29yrs (range 22–41 yrs). Primary, primary-assisted, and secondary patency rates were 14%, 43%, and 43%, respectively. Re-intervention was required in 6/7 (86%) peripartum women, with mean time to re-intervention of 9 wks (range 1–33 wks). Venous Stenting in peripartum women was associated with a higher risk of re-intervention (HR 6.58; p = 0.0001, 95% CI [2.46, 17.60]), and was a strong predictor of cumulative patency loss (HR 10.71; p = 0.002, 95% CI [2.37, 48.51]). Discussion Peripartum women are significantly more likely to require re-intervention and experience patency loss compared with their non-peripartum counterpart. Thresholds for intervention may need to be higher and periprocedural anticoagulation strategies require more investigation if treatment is to be offered in the peripartum period.
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Outcomes Following Placement of Venous Stents for Treatment of Thrombotic Venous Disease
Blood, 2017Co-Authors: Karen Breen, Beverley J Hunt, Prakash Saha, Narayan Karanunithy, Alexander T. Cohen, Vickie Mcdonald, James Uprichard, Michael Fay, Stephen BlackAbstract:Background EndoVenous Stenting is a method to overcome Venous outflow obstruction in the treatment of patients with acute iliofemoral deep vein thrombosis (DVT) or in those with symptomatic post-thrombotic syndrome (PTS). These treatments allow maximal luminal expansion of the caval and/or iliac Venous segment leading to a reduction in Venous hypertension. While there is growing enthusiasm for their use, particularly as conventional treatments usually with anticoagulation are not always effective there is however little clinical data regarding efficacy in improving clinical outcome. Objectives To determine the outcomes in patients following placement of Venous Stents for treatment of obstruction in acute Venous thrombotic and post-thrombotic syndrome. Methods Consecutive patients with a history of DVT in whom a Venous Stent was inserted at two UK specialist tertiary referral centres between 2012-2015 were included. 9Acute9 patients consisted of those with a fresh symptomatic iliofemoral DVT; chronic patients were those with recalcitrant PTS unresponsive to conventional therapy. Patients planned for intervention were discussed by a multidisciplinary team made up from Haematology, Interventional Radiology and Vascular Surgery. Stents were placed under general anaesthesia. Venous access was obtained using ultrasound guidance. Intravascular ultrasound (IVUS) was used to size the Stent and to ensure it was fully expanded. Endophlebectomy with arterio-Venous fistula formation was carried out in selected patients. All patients were given therapeutic dose low molecular weight heparin (LMWH) post procedure before transition to oral anticoagulation. Ultrasound surveillance commenced the day after the procedure and at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and annually thereafter. Clinical follow-up was at 6 weeks, 6 monthly thereafter. Primary patency was defined as a patent Stent with Results 379 Venous Stents were placed in 148 patients. The median age of patients was 42yrs (range: 18-81yrs), and 86 (58%) patients were female. Symptoms in the left leg were most common (116 patients, 78%). There were 60 (41%) patients who had a Venous Stent placed to treat an underlying stenosis following catheter directed thrombolysis of an acute iliofemoral DVT. 88 (58%) patients had Stent placement to treat a post-thrombotic obstruction considered pathological for PTS. Primary, primary-assisted and secondary patency was 67%, 85% and 88% respectively at one-year in the acute DVT group (figure 1) and 64%, 86% and 86% respectively for the PTS group (figure 2). The median Villata score was 0 (range 0-14), 12 months after Stenting, though new ulceration was noted in three patients in the acute DVT group. Median Villalta scores in patients without ulceration decreased from 15 (range 6-23) to 5 (range 1-22) one-year following the procedure (P There was one death from cancer during follow-up, but no Stent related mortality or major bleeding complications. Conclusions This is the largest reported series of outcomes of Venous Stents placed in patients with acute iliofemoral Venous thrombosis or severe post-thrombotic syndrome. Patients had a minimum follow-up of one year Venous Stenting offer potential for the treatment of patients with obstruction related to thrombotic Venous disease with good clinical outcomes at one year. Further study on patient selection, outcomes and optimal anticoagulation is required. Disclosures Breen: Veniti: Speakers Bureau. Cohen: Bayer Healthcare: Employment, Speakers Bureau. Uprichard: Bayer Healthcare: Speakers Bureau. Black: Veniti: Speakers Bureau.
Khashayar Farsad - One of the best experts on this subject based on the ideXlab platform.
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early Venous Stent failure predicted by platelet count and neutrophil lymphocyte ratio
Circulation, 2019Co-Authors: Younes Jahangiri, Masayuki Endo, Ramsey Alhakim, John A Kaufman, Khashayar FarsadAbstract:BACKGROUND Inflammation and platelet activation have been shown to be involved in acute thromobogenicity following Venous occlusive conditions. The aim of this study was to identify the association of baseline platelet count and neutrophil/lymphocyte ratio (NLR) with Venous Stent failure. Methods and Results: Patients who underwent technically successful iliocaval Venous Stent placement with available baseline complete blood count and follow-up Stent patency data were selected (n=50). Stent failure was defined as >50% stenosis or occlusion at follow-up angiography, contrast-enhanced CT, MRI or duplex US. Median patient age was 49.5 years (range, 13-76 years), and 62% were female. Median follow-up time was 10.2 months (range, 0.1-76.4 months). Stent failure occurred in 13 patients (26%) after a median of 1.2 months (range, 1 day-76.4 months). On multivariable-adjusted Cox modeling, baseline platelets (HR, 2.28; P=0.004) and WBC count (HR, 2.03; P=0.013) were significantly associated with Stent failure on follow-up; neutrophils (HR, 16.10; P=0.050); and NLR (HR, 12.19; P=0.050) had borderline significance. Compared with patients without Stent failure, those with early, but not late, Stent failure had higher baseline platelets (P=0.031) and neutrophils (P=0.025), and NLR (P=0.026). CONCLUSIONS Baseline platelet count and NLR are associated with early but not late failure of iliocaval Venous Stents. This suggests different pathophysiologic mechanisms and a role for both platelet activation and inflammatory mechanisms in early rather than late Stent thrombosis. Future research is needed to better explain this novel finding.
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Early Venous Stent Failure Predicted by Platelet Count and Neutrophil/Lymphocyte Ratio.
Circulation journal : official journal of the Japanese Circulation Society, 2018Co-Authors: Younes Jahangiri, Masayuki Endo, John A Kaufman, Ramsey Al-hakim, Khashayar FarsadAbstract:BACKGROUND Inflammation and platelet activation have been shown to be involved in acute thromobogenicity following Venous occlusive conditions. The aim of this study was to identify the association of baseline platelet count and neutrophil/lymphocyte ratio (NLR) with Venous Stent failure. Methods and Results: Patients who underwent technically successful iliocaval Venous Stent placement with available baseline complete blood count and follow-up Stent patency data were selected (n=50). Stent failure was defined as >50% stenosis or occlusion at follow-up angiography, contrast-enhanced CT, MRI or duplex US. Median patient age was 49.5 years (range, 13-76 years), and 62% were female. Median follow-up time was 10.2 months (range, 0.1-76.4 months). Stent failure occurred in 13 patients (26%) after a median of 1.2 months (range, 1 day-76.4 months). On multivariable-adjusted Cox modeling, baseline platelets (HR, 2.28; P=0.004) and WBC count (HR, 2.03; P=0.013) were significantly associated with Stent failure on follow-up; neutrophils (HR, 16.10; P=0.050); and NLR (HR, 12.19; P=0.050) had borderline significance. Compared with patients without Stent failure, those with early, but not late, Stent failure had higher baseline platelets (P=0.031) and neutrophils (P=0.025), and NLR (P=0.026). CONCLUSIONS Baseline platelet count and NLR are associated with early but not late failure of iliocaval Venous Stents. This suggests different pathophysiologic mechanisms and a role for both platelet activation and inflammatory mechanisms in early rather than late Stent thrombosis. Future research is needed to better explain this novel finding.
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Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting
CardioVascular and Interventional Radiology, 2018Co-Authors: Masayuki Endo, Younes Jahangiri, John A Kaufman, Masahiro Horikawa, Ryan C. Schenning, Kenneth J. Kolbeck, Robert E. Barton, Yasufumi Ohuchi, Keng Wei Liang, Khashayar FarsadAbstract:Purpose To examine the effectiveness of antithrombotic medications to prevent Venous Stent malfunction for iliocaval occlusive disease. Materials and Methods A retrospective analysis was performed on 62 patients who underwent technically successful endovascular iliocaval Stent placement between May 2008 and April 2017. Clinical records were reviewed for demographic information, procedure details, post-Stenting antithrombotic prophylaxis and Stent patency on follow-up. Stent malfunction was defined as > 50% stenosis or occlusion at follow-up. Risk factors for Stent malfunction were assessed with univariable and multiple Cox proportional hazard models. Results The median follow-up period was 11.6 months (range 0.1–76.4). Overall primary and secondary cumulative patency rates at 12 months were 70.0% and 92.4%, respectively. After Stent placement, 97% of patients received anticoagulation with warfarin, enoxaparin or a factor Xa inhibitor. In addition, 61% received antiplatelet prophylaxis with aspirin, clopidogrel or a combination. In multiple Cox regression analysis, post-Stenting antiplatelet use remained significantly associated with primary Stent patency (HR = 0.28, P = 0.022). Conclusion After iliocaval Venous Stenting, Stent patency was best predicted by concomitant antiplatelet and anticoagulation therapy rather than anticoagulation alone. This novel finding warrants further research underlying mechanisms leading to Venous Stent thrombosis, and has implications for optimal medical management after Venous Stenting.
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Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting.
Cardiovascular and interventional radiology, 2018Co-Authors: Masayuki Endo, Younes Jahangiri, John A Kaufman, Masahiro Horikawa, Ryan C. Schenning, Kenneth J. Kolbeck, Robert E. Barton, Yasufumi Ohuchi, Keng Wei Liang, Khashayar FarsadAbstract:To examine the effectiveness of antithrombotic medications to prevent Venous Stent malfunction for iliocaval occlusive disease. A retrospective analysis was performed on 62 patients who underwent technically successful endovascular iliocaval Stent placement between May 2008 and April 2017. Clinical records were reviewed for demographic information, procedure details, post-Stenting antithrombotic prophylaxis and Stent patency on follow-up. Stent malfunction was defined as > 50% stenosis or occlusion at follow-up. Risk factors for Stent malfunction were assessed with univariable and multiple Cox proportional hazard models. The median follow-up period was 11.6 months (range 0.1–76.4). Overall primary and secondary cumulative patency rates at 12 months were 70.0% and 92.4%, respectively. After Stent placement, 97% of patients received anticoagulation with warfarin, enoxaparin or a factor Xa inhibitor. In addition, 61% received antiplatelet prophylaxis with aspirin, clopidogrel or a combination. In multiple Cox regression analysis, post-Stenting antiplatelet use remained significantly associated with primary Stent patency (HR = 0.28, P = 0.022). After iliocaval Venous Stenting, Stent patency was best predicted by concomitant antiplatelet and anticoagulation therapy rather than anticoagulation alone. This novel finding warrants further research underlying mechanisms leading to Venous Stent thrombosis, and has implications for optimal medical management after Venous Stenting.
Peter Neglén - One of the best experts on this subject based on the ideXlab platform.
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Placement of closed-cell designed Venous Stents in a mixed cohort of patients with chronic Venous outflow obstructions - short-term safety, patency, and clinical outcomes.
VASA. Zeitschrift fur Gefasskrankheiten, 2018Co-Authors: Michael Lichtenberg, Wilhelm Friedrich Stahlhoff, Frank Breuckmann, Peter Neglén, De Graaf RickAbstract:Abstract. Background: To evaluate the performance of a closed-cell designed Venous Stent for the treatment of chronic ilio-femoral Venous outflow obstruction (VOO) in the shortterm. Patients and me...
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The initial report on 1-year outcomes of the feasibility study of the VENITI VICI Venous Stent in symptomatic iliofemoral Venous obstruction.
Journal of vascular surgery. Venous and lymphatic disorders, 2017Co-Authors: Mahmood K. Razavi, William A. Marston, Stephen Black, Dana Bentley, Peter NeglénAbstract:Abstract Objective The objective of this study was to assess the safety and efficacy of a dedicated Venous Stent (the VICI Venous Stent; VENITI, Fremont, Calif) for treatment of symptomatic iliofemoral Venous outflow obstruction. Methods Thirty patients (24 female; median age, 43 years) were enrolled in the feasibility phase of an international, multicenter investigational device exemption trial from June 2014 to February 2015. All patients exhibited unilateral Venous disease with ≥50% stenosis in the iliofemoral veins. Patients within 3 months of acute deep Venous thrombosis or with prior surgical or endovascular intervention of the target vessel were excluded. Lesions were primarily of post-thrombotic causes (63%), with a left limb-right limb ratio of 5:1. Nine patients (30%) had lesions extending beneath the inguinal ligament. Median baseline stenosis was 91%; 11 patients (37%) had occlusions. Results Fifty-one Stents were implanted successfully in 30 patients. Median residual stenosis was 0%, as estimated by venography and intravascular ultrasound. Median follow-up was 701 days. At 12 months, primary, assisted-primary, and secondary patency was 93%, 96%, and 100%, respectively. The Stent occluded in two patients through the 12-month window (occurring at 19 and 385 days). Both occlusions occurred in patients presenting with post-thrombotic obstruction. No patients in this cohort exhibited Stent fracture at 12 months. Symptomatic improvement of ≥2 points on the Venous Clinical Severity Score was observed in 23 patients (85%) at 12 months (median score improvement, 5 points). There was a median 12-month pain reduction of 20 mm on the visual analog scale score and 15-point improvement on the Chronic Venous Insufficiency Questionnaire score. Scores improved significantly on all three clinical and quality of life scales at 6 and 12 months. Conclusions The VICI Venous Stent is safe and feasible for treatment of symptomatic iliofemoral Venous obstruction, with excellent 12-month patency rates and significant improvement seen in clinical symptoms and quality of life indices. The pivotal phase (170 patients, 22 centers) of this investigational device exemption trial is currently ongoing.
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Reinterventions for nonocclusive iliofemoral Venous Stent malfunctions
Journal of vascular surgery, 2008Co-Authors: Seshadri Raju, Paul Tackett, Peter NeglénAbstract:Background Percutaneous iliofemoral Venous Stenting has been shown to be effective, safe, and durable in both nonthrombotic iliac vein lesion (NIVL) and postthrombotic disease. A small fraction of Stented limbs require reintervention to correct Stent malfunction. This manuscript examines the reasons for reintervention, types of procedures performed, and outcome. Methods Femoro-ilio-caval Stenting was performed in 1085 limbs over a 10 year period from 1997 to 2007 (NIVL/postthrombotic limb ratio 1:1). Reinterventions were required in 137 limbs (13%) for non-occlusive Stent malfunction. Results Median time of reintervention after the initial procedure was 15 months. Primary indication for reintervention was Stent abnormalities discovered on routine surveillance imaging in 31% of the limbs and residual/recurrent symptoms after initial Stenting in 69% of the limbs. Prevalent symptoms before reintervention were swelling (45%), pain (18%), combination of pain and swelling (33%), and Venous dermatitis/ulcer (15%). Seventy-seven percent of limbs required only a single reintervention and 23% required two or more interventions. The type of reintervention could be broadly categorized into four types: (1) cephalad Stent extension to correct Stent outflow problems; (2) caudad Stent extension to correct inflow problems; (3) balloon dilatation of Stent stenoses; and (4) combinations. The types of Stent inflow/outflow lesions encountered were different in NIVL and postthrombotic limbs. In both groups, the external iliac vein segment had a greater incidence of pathology than other Stented Venous segments during reintervention. A denovo stenotic lesion of uncertain aetiology that occurred below an existing Stent was also exclusive to the external iliac vein segment. InStent restenosis (ISR) occurred in both subsets. Two types of ISR were encountered: (1) a ‘soft' lesion probably due to reduced flow channel lined by thrombus within the Stent from inflow/outflow problems and (2) a ‘hard' lesion that occurred independently, was resistant to dilatation and tended to recur unlike the ‘soft' lesion. Cumulative improvement in pain and swelling at 18 months following intervention was 67% and 72%, respectively. Complete cumulative healing of Venous dermatitis/ulcer was 90% at 12 months post reintervention. Conclusion Venous Stenting for chronic Venous disease is largely trouble-free with only a small fraction of the Stented limbs requiring reinterventions. Reinterventions were performed to correct previously overlooked or new defects in inflow, outflow and/or the Stent. Reinterventions are worthwhile since they improve residual/recurrent symptoms in a durable fashion.
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Reversal of abnormal lymphoscintigraphy after placement of Venous Stents for correction of associated Venous obstruction
Journal of vascular surgery, 2001Co-Authors: Seshadri Raju, Sam Owen, Peter NeglénAbstract:Abstract Purpose: The purpose of this study was to report improvement or normalization of abnormal lymphoscintigraphy in swollen lower limbs after correction of associated Venous stenosis by balloon dilatation and placement of Venous Stent of the iliac veins. Material: Twenty-six patients with lower-limb swelling underwent balloon dilatation and placement of Venous Stent of the iliac veins for correction of Venous stenosis. Technetium 99M-sulfur colloid lymphoscintigraphy was also abnormal (8 absent, 18 reduced) before Stent placement in all 26 limbs, suggesting combined Venous/lymphatic etiology for the limb swelling. Median age was 53 years. Male-to-female ratio was 1:8 and left-to-right ratio, 3:1. Fifteen patients had limb pain associated with the swelling. Severity of Venous stenosis was generally underestimated by preoperative transfemoral venography as compared with intravascular ultrasound, (mean, 50% versus 77%); in five limbs (19%), transfemoral venography altogether failed to identify the Venous lesion evident on intravascular ultrasound. The etiology of Venous obstruction was post-thrombotic in nine limbs and nonthrombotic (web, stricture, or May-Thurner syndrome) in 17 limbs. Results: PostStent lymphoscintigraphy completely normalized in 10 limbs, improved but remained abnormal in 9, and remained unchanged in 7. Clinical follow-up (mean, 1 year) showed improvement in swelling in 16 of 26 limbs ( P P Conclusion: These findings suggest that patients with a diagnosis of lymphedema made on the basis of lymphoscintigraphy alone and consigned to conservative therapy on that basis may benefit from additional Venous investigations regardless of clinical presentation suggestive of lymphedema. This report supports the practice of aggressively searching for a Venous basis of edema in these patients. Correction of the Venous lesion may result in normalization or improvement of the lymphoscintigraphic abnormality and in any case may yield significant symptom relief, even in some limbs where the lymphoscintigraphic abnormality failed to improve after placement of Venous Stent. (J Vasc Surg 2001;34:779-84.)
Nicolas W. Shammas - One of the best experts on this subject based on the ideXlab platform.
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Worsening Back and Lower Leg Pain Post Stenting of the Common Iliac Vein: Is There Evidence it is Related to Stent Size?
The Journal of invasive cardiology, 2020Co-Authors: Nicolas W. ShammasAbstract:Sizing of iliac vein Stents remains controversial. We present the first Venovo Venous Stent (BD/Bard) that was explanted because of worsening of back and leg pain post treatment and analyze data from the first 50 consecutive Venovo Venous Stents from our center. Stent size was obtained with intravascular ultrasound of the ipsilateral common iliac vein. The data indicate that there is no statistical relationship between the Stent size and worsening or emergence of low back and leg pain. Patient-specific factors may be contributing to this extremely rare and persiStent pain beyond the 30-day follow-up.
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The Venovo Venous Stent in Pregnancy.
The Journal of invasive cardiology, 2020Co-Authors: Andrew N. Shammas, Nicolas W. Shammas, Mary F Knowles, Lori ChristensenAbstract:We present the case of a young woman who became pregnant following placement of a Venovo Venous Stent (BD/Bard) in her left common iliac vein. Our case illustrates the safety of the Venovo Stent during pregnancy. This needs further validation with a larger registry.
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CRT-200.10 Venovo Venous Stent in Treating Iliac Vein Compression: A Single-Center Experience
JACC: Cardiovascular Interventions, 2020Co-Authors: Qais Radaideh, Nicolas W. Shammas, Gail A. Shammas, Shaddy Khalafallah, Amanda Abi Doumet, Rusina Karia, Rommy Khalafallah, W John ShammasAbstract:The Venovo Venous Stent (BD, Bard) was recently approved by the Food and Drug Administration to treat iliofemoral veno-occlusive disease. We present our own experience with the Venovo Venous Stent in treating iliac vein compression (ILVC). In this retrospective cohort, consecutive patients treated
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CRT-200.01 24-Month Results From the Prospective, Multicenter VERNACULAR Trial for the Treatment of Iliac and Femoral Vein Occlusive Disease With the Venovo Self-expanding Venous Stent
JACC: Cardiovascular Interventions, 2020Co-Authors: Nicolas W. ShammasAbstract:To assess the performance and safety of a dedicated Venous Stent (Venovo Venous Stent, Becton Dickinson) for the treatment of iliofemoral vein occlusive disease. 170 patients were enrolled in the intent-to-treat population, 93 post-thrombotic syndrome patients (PTS) and 77 non-thrombotic iliac vein
Waldemar E. Wysokinski - One of the best experts on this subject based on the ideXlab platform.
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Platelet recruitment to Venous Stent thrombi
Journal of Thrombosis and Thrombolysis, 2013Co-Authors: Robert D. Mcbane, Krzysztof Karnicki, Waldemar E. WysokinskiAbstract:Thrombosis following Venous Stent placement is a morbid clinical outcome. Whether to target platelets or coagulation factors for Venous Stent thromboprophylaxis remains unclear. We sought to determine whether integrin α_IIbβ_3 antagonism with lamifiban would inhibit platelet recruitment to Venous Stent thrombosis. Anti-thrombotic efficacy was compared between Venous and arterial circulations. Pigs received either lamifiban (0.2 mg/kg bolus plus 0.2 mg/kg/h infusion; n = 6) or saline ( n = 12). Carotid arteries were crush injured and then harvested 30 min later to provide an assessment of antithrombotic efficacy in the arterial circulation. Iliac Venous Stents were then deployed and thrombi allowed to propagate for 2 h before harvesting. Platelet deposition was measured by scintillation detection of autologous ^111In-platelets. Venous thrombi were quantified by weight and compared to platelet, Von Willebrand factor (VWF) and fibrinogen content. Arterial platelet deposition (×10^6/cm^2) was reduced >80 % by lamifiban (398 ± 437) compared to controls (1,540 ± 883; p
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Platelet recruitment to Venous Stent thrombi.
Journal of thrombosis and thrombolysis, 2013Co-Authors: Robert D. Mcbane, Krzysztof Karnicki, Waldemar E. WysokinskiAbstract:Thrombosis following Venous Stent placement is a morbid clinical outcome. Whether to target platelets or coagulation factors for Venous Stent thromboprophylaxis remains unclear. We sought to determine whether integrin αIIbβ3 antagonism with lamifiban would inhibit platelet recruitment to Venous Stent thrombosis. Anti-thrombotic efficacy was compared between Venous and arterial circulations. Pigs received either lamifiban (0.2 mg/kg bolus plus 0.2 mg/kg/h infusion; n = 6) or saline (n = 12). Carotid arteries were crush injured and then harvested 30 min later to provide an assessment of antithrombotic efficacy in the arterial circulation. Iliac Venous Stents were then deployed and thrombi allowed to propagate for 2 h before harvesting. Platelet deposition was measured by scintillation detection of autologous 111In-platelets. Venous thrombi were quantified by weight and compared to platelet, Von Willebrand factor (VWF) and fibrinogen content. Arterial platelet deposition (×106/cm2) was reduced >80 % by lamifiban (398 ± 437) compared to controls (1,540 ± 883; p < 0.005). Lamifiban also reduced Venous thrombus platelet deposition (139 ± 88 vs. 281 ± 167) however did not prevent thrombosis. In control animals, Venous Stent platelet deposition correlated with plasma fibrinogen content (R2 = 0.29; p = 0.03). Fibrinogen content correlated directly with Venous Stent platelet deposition (p = 0.03) but not thrombus weight. Neither Venous platelet deposition nor thrombus weights varied by VWF content. Platelet recruitment to Venous Stent thrombi occurs in part through the integrin αIIbβ3 receptor. Unlike arterial thrombosis, inhibition of this receptor is insufficient to prevent Venous Stent thrombosis.
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Iliac Venous Stenting. Antithrombotic Efficacy of PD0348292, an Oral Direct Factor Xa Inhibitor, Compared With Antiplatelet Agents in Pigs
Arteriosclerosis thrombosis and vascular biology, 2007Co-Authors: Robert D. Mcbane, Krzysztof Karnicki, Robert J. Leadley, Sangita M. Baxi, Waldemar E. WysokinskiAbstract:Objective— The clinical use of Venous Stents is increasing dramatically. Although antiplatelet agents are required for arterial Stent patency, optimal thrombo-prophylaxis after Venous Stenting remains undefined. To address this issue, PD0348292, a direct Factor Xa inhibitor, was compared with antiplatelet therapy in a porcine Venous Stent model. Methods and Results— Four hours before Stent deployment, pigs (n=5 to 6 per group) received oral PD0348292 at 0.4, 0.9, 4.3 mg/kg, or 0.4 mg/kg plus aspirin (325 mg). Aspirin, clopidogrel (75 mg), aspirin plus clopidogrel, or vehicle (n=10) were administered daily for 2 days before the procedure. Two hours after Stent placement, thrombi were quantified by autologous 111In-platelet content and weights. Thrombus weight and platelet deposition were significantly reduced by PD0348292 at 0.4 (49±79 mg and 110±145×106/cm2), 0.9 (5±6 mg and 107±128×106/cm2), 4.3 mg/kg (0±0 mg and 87±125×106/cm2), and PD348292 plus aspirin (20±40 mg and 157±70×106/cm2) compared with vehicle (402±226 mg; 584±454×106/cm2). Despite prolonging bleeding times and inhibiting platelet aggregation, neither aspirin (567±683 mg and 533±622×106/cm2), clopidogrel (404±349 mg and 178±101×106/cm2), nor aspirin plus clopidogrel (247±261 mg and 231±266×106/cm2) significantly decreased Stent thrombosis. Conclusions— PD0348292 completely inhibited thrombosis after Venous Stenting. Platelet accretion in these Venous thrombi appear to involve pathways distinct from arachidonate metabolism or ADP P2Y12 receptor activation.
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Immunohistochemistry of thrombi following iliac Venous Stenting: A novel model of Venous thrombosis
Thrombosis and Haemostasis, 2006Co-Authors: Bobby Burches, Waldemar E. Wysokinski, Krzysztof Karnicki, Robert D. McbaneAbstract:SummaryStenting has become a common intervention for Venous occlusive disease. Little is known regarding the composition of Venous thrombi complicating Stent placement. The optimal design of antithrombotic agents in this setting requires this knowledge. Quantitative immunohistochemistry was undertaken to define the platelet, fibrin(ogen) and leukocyte composition and spatial orientation of Venous thrombi following percutaneous iliac Stent placement in pigs. Venous Stent thrombus size was measured by weight and scintillation detection of autologous 111In-platelets. Thrombi were divided in segments (cephalad to caudad), sectioned and stained with monoclonal anti-platelet glycoprotein Ib or polyclonal anti-fibrin(ogen) fluorescent antibodies. Thrombus platelet content was 100-fold greater than paired whole blood samples. The caudal-most segments contained platelet-rich aggregates (p<0.05) with abundant leukocytes (p<0.0001) relative to more cephalad segments. Platelet and fibrin(ogen) content varied over an eight-fold range between segments but were directly correlated with each other (r=0.77; p<0.0001). The platelet co-localization with fibrin(ogen) is consiStent with the phospholipid dependence of prothrombin activation. The abundance and caudal distribution of platelet-leukocyte aggregates indicate their preferential accretion from flowing blood early in the genesis of Venous Stent thrombi. These may represent novel cellular targets for the prevention and treatment of Venous thrombosis.
