Mahmood Razavi, Michael Lichtenberg, Kush Desai, David Dexter, Peter Soukas, Nicolas Shammas, Ankur Lodha, Paul Gagne, Anna Nordell, Raghu Kolluri, Mark Garcia
{"title":"The VIVID Trial 12-month outcomes of the Venous stent for the Iliofemoral Vein using the Duo Venous Stent System.","authors":"Mahmood Razavi, Michael Lichtenberg, Kush Desai, David Dexter, Peter Soukas, Nicolas Shammas, Ankur Lodha, Paul Gagne, Anna Nordell, Raghu Kolluri, Mark Garcia","doi":"10.1016/j.jvsv.2024.101995","DOIUrl":"https://doi.org/10.1016/j.jvsv.2024.101995","url":null,"abstract":"<p><strong>Objective: </strong>There are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) study was to investigate the safety and efficacy of the Duo Venous Stent System for the treatment of patients with non-malignant iliofemoral venous obstructive disease.</p><p><strong>Methods: </strong>This was an international, prospective, multi-center, single-arm study that enrolled patients with symptomatic non-thrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety endpoint was freedom from major adverse events at 30 days post-index procedure. The primary efficacy endpoint was primary patency of stent-bearing segments at 12 months. Secondary and observational endpoints included symptom relief, primary assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months.</p><p><strong>Results: </strong>A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety endpoint was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P<0.0001). The primary safety endpoint was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy endpoint was met in 90.2% compared with the performance goal of 77.3% (P=0.0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline through 6 and 12 months.</p><p><strong>Conclusions: </strong>Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of non-malignant iliofemoral venous obstructive disease.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142546209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roman A Tauraginskii, Fedor Lurie, Sergei Simakov, Rishal Agalarov, Pavel Khramtsov, Maxim Babushkin, Tatiana Gurina, Denis Borsuk
{"title":"The human lower leg muscle pump functions as a flow diverter pump, maintaining low ambulatory venous pressures during locomotion.","authors":"Roman A Tauraginskii, Fedor Lurie, Sergei Simakov, Rishal Agalarov, Pavel Khramtsov, Maxim Babushkin, Tatiana Gurina, Denis Borsuk","doi":"10.1016/j.jvsv.2024.101996","DOIUrl":"https://doi.org/10.1016/j.jvsv.2024.101996","url":null,"abstract":"<p><strong>Objective: </strong>Ambulatory venous pressure (AVP) is the drop of pressure observed in the superficial veins of the lower leg during movement. This phenomenon has been linked to the function of the calf muscle pump (CMP) and the competence of venous valves. Nevertheless, the concept of the CMP function remains controversial. This study aimed to elucidate the association between lower leg muscles activity, changes in pressure in distinct venous segments, and lower extremity arterial blood supply in healthy subjects during various types and intensities of exercise.</p><p><strong>Methods: </strong>Twelve legs of nine healthy volunteers were enrolled in the study. Continuous pressure (intramuscular vein [IV] and three great saphenous vein [GSV] points) and surface electromyography data (gastrocnemius and anterior tibial [ATM] muscles) were recorded during treadmill walking, running, and plantar flexion exercises. The pressure gradient (ΔP, mmHg) between adjacent points of measurement was calculated. Minute unit power of muscle pump ejection and suction (N<sub>E</sub>, and N<sub>S</sub>, MPa/min) were calculated and compared with the arterial blood supply of the lower extremity (LBF, L/min).</p><p><strong>Results: </strong>ΔP demonstrated a consistent pattern of changes during walking and running. In GSV, the ΔP was observed to be directed from the thigh to the mid-calf (retrogradely) and from the ankle to the mid-calf (anterogradely) throughout the entire stride cycle. However, its value decreased with increasing stride cycle frequency. The dynamics of ΔP between the IV and GSV were as follows: It was directed from the IV to GSV during gastrocnemius contraction and was reversed during anterior tibial muscle contraction and gastrocnemius relaxation (swing phase). LBF, N<sub>E</sub>, and N<sub>S</sub> demonstrated similar exponential growth with increasing stride frequency during walking and running.</p><p><strong>Conclusions: </strong>During natural locomotion, the muscle pump acts as a flow diverter pump, redirecting the flow of blood from the superficial veins to the intramuscular veins via the perforating veins. During ambulation, the pressure in the superficial venous network depends upon the capacity of the muscle pump to provide output that matches the changes in arterial blood flow.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142502963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ania Trzesniowski, Gaurav Lakhanpal, Levan Sulakvelidze, Richard Kennedy, Sanjiv Lakhanpal, Peter Pappas
{"title":"Long-term follow-up for the treatment of symptomatic pelvic venous insufficiency secondary to combined iliac vein stenosis and ovarian vein reflux treated with iliac vein stenting alone.","authors":"Ania Trzesniowski, Gaurav Lakhanpal, Levan Sulakvelidze, Richard Kennedy, Sanjiv Lakhanpal, Peter Pappas","doi":"10.1016/j.jvsv.2024.101990","DOIUrl":"10.1016/j.jvsv.2024.101990","url":null,"abstract":"<p><strong>Background: </strong>We previously reported that in women with symptomatic pelvic venous insufficiency secondary to combined iliac vein stenosis (IVS) and ovarian vein reflux (OVR), treated with iliac vein stenting alone that 78% reported complete symptom resolution up to 6 months. The purpose of this investigation was to determine the long-term effectiveness of this treatment strategy, the poststent reintervention rate and the incidence of poststent ovarian vein embolization (OVE) for residual symptoms.</p><p><strong>Methods: </strong>A retrospective review of prospectively collected data at the Center for Vascular Medicine was performed. We investigated women with pelvic pain or dyspareunia secondary to combined IVS and OVR who were treated with stenting alone. Patients whose primary complaint was dysmenorrhea and/or leg symptoms were excluded from the analysis. Assessments and interventions consisted of an evaluation for other causes of pelvic venous disorder by a gynecologist, documentation of preintervention and 3-, 6-, 12-, 24-, and 36-month visual analog scale pain scores; transabdominal duplex ultrasound examination; stent type, diameter, and length; vein territory covered; and reintervention rates. All patients underwent diagnostic venography of their pelvic, left ovarian veins, and pelvic reservoirs, and intravascular ultrasound examination of their iliac veins.</p><p><strong>Results: </strong>From February 2018 to January 2023, 141 women with a pelvic venous disorder secondary to IVS and OVR were identified. The average age was 44.7 ± 10.5 years with 3.18 ± 1.82 pregnancies. The average follow-up time for the entire cohort was 12.0 ± 12.1 months (median, 10.65 months). Types of stents were Venovo 48 (34%), Wallstent 14 (10%), and Abre 79 (56%). The most common diameter and stent lengths used were 14 and 16 mm and 140 and 150 mm, respectively. The most common vein territories covered were the inferior vena cava to the left external iliac vein in 83% and inferior vena cava to right external iliac vein in 13%. Pelvic and dyspareunia VAS scores before the intervention and at 3, 6, 12, 24, and 36 months after the intervention were as follows: 6.4 ± 73 (n = 141), 2.6 ± 3.3 (n = 98), 1.71 ± 2.83 (n = 77), 2.04 ± 3.5 (n = 76), 2.4 ± 3.7 (n = 30), and 1.15 ± 3 (n = 13) (P ≤ .001). Of the entire cohort no patients required OVE and pelvic reservoir embolization. Pelvic reservoirs were present in 113 of 141 patients (83%). Stent reinterventions were required in 19 of 141 patients (13%).</p><p><strong>Conclusions: </strong>The majority of women with pelvic pain secondary to combined IVS and OVR achieved near complete symptom resolution with iliac vein stenting alone, despite the presence of a pelvic reservoir in 83% of patients. Although most women complained of some minimal residual pelvic pain or dyspareunia, the majority were satisfied with their outcomes and did not require further intervention. In this patient population, iliac vein","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Information for Readers","authors":"","doi":"10.1016/S2213-333X(24)00393-7","DOIUrl":"10.1016/S2213-333X(24)00393-7","url":null,"abstract":"","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142432371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Francisco J Melesio, Mariam Mesa-Damiano, Jailenne I Quinones-Rodriguez, Shawn M Staudaher, Cassius I Ochoa Chaar, Limael E Rodriguez
{"title":"Early experience with diclofenac topical gel for moderate to severe postablation phlebitis.","authors":"Francisco J Melesio, Mariam Mesa-Damiano, Jailenne I Quinones-Rodriguez, Shawn M Staudaher, Cassius I Ochoa Chaar, Limael E Rodriguez","doi":"10.1016/j.jvsv.2024.101994","DOIUrl":"10.1016/j.jvsv.2024.101994","url":null,"abstract":"<p><strong>Objective: </strong>Oral (PO) nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat phlebitis and thrombus extension postendovenous ablation. Few studies have evaluated diclofenac topical gel for treating postablation phlebitis. This study assesses diclofenac 1% topical gel as a first-line treatment for patients with moderate to severe phlebitis after ablation.</p><p><strong>Methods: </strong>From December 2021 to March 2024, a retrospective cohort study was performed to identify patients who developed postablation phlebitis and were treated with either diclofenac topical gel (with or without PO NSAIDs) vs PO NSAIDs alone. All patients were evaluated with a numeric pain rating scale (NPRS, 0-10) at four time intervals (1, 7, 14, and 30 days) after initiating treatment.</p><p><strong>Results: </strong>Overall, 45 patients were included in the study, with 38 in the diclofenac ± PO NSAIDs group (9 males and 29 females) and 7 in the PO NSAIDs alone group (all females). NPRS scores showed similar pain reduction trends at all time intervals. Topical diclofenac gel was noninferior to PO treatments and resulted in partial to complete relief in most patients at 30 days. At the 30-day follow-up interview, 57% of patients preferred the diclofenac topical gel owing to its ease of use and immediate local pain reduction.</p><p><strong>Conclusions: </strong>Patients with moderate to severe postablation phlebitis respond well to diclofenac topical gel with or without PO NSAIDs. Moreover, patients often had significant pain relief without additional need for PO NSAIDs. Longitudinal studies are needed to support the use of diclofenac topical gel for postablation phlebitis.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Events of Interest","authors":"","doi":"10.1016/S2213-333X(24)00394-9","DOIUrl":"10.1016/S2213-333X(24)00394-9","url":null,"abstract":"","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142432588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Iliac venous stenting provides long-term relief from chronic pelvic pain.","authors":"Laurencia Villalba, Theresa Larkin","doi":"10.1016/j.jvsv.2024.101993","DOIUrl":"10.1016/j.jvsv.2024.101993","url":null,"abstract":"<p><strong>Objective: </strong>Iliac venous obstruction has been reported as a cause of chronic pelvic pain (CPP), however, there is a paucity of data in the literature reporting outcomes of venous stenting in this population. This study reports on a group of women with CPP and evidence of iliac venous obstruction: (1) the long-term impact of iliac vein stenting on pain scores; (2) the associations of age, stenosis severity, and concurrent presence of ovarian vein reflux (OVR) on pain; and (3) the effect of pregnancy after stenting.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of prospectively collected data of women with chronic pelvic pain who subsequently underwent iliac vein stenting. Data analyzed included demographics, venous measures (iliac and ovarian veins), visual analog scales, and pregnancy after stenting.</p><p><strong>Results: </strong>A total of 113 female patients who had a history of chronic pelvic pain and underwent iliac venous stenting were included in analyses. The mean age at the time of stenting was 46.5 ± 15.7 years (range, 17-88 years). The baseline left common iliac vein diameter on duplex was 0.43 ± 0.18 cm and left common iliac vein area stenosis on intravascular ultrasound was 77.4 ± 9.4%. The baseline pain severity was correlated with younger age, degree of stenosis and presence of OVR. At a median follow-up of 5 years after stenting, 98% had improved pain scores and 73% had complete resolution of their pain despite the presence of residual OVR. Pregnancy after stenting did not result in the recurrence of pain and there were no stent-related complications with pregnancy.</p><p><strong>Conclusions: </strong>Iliac venous stenting provides long-term relief from CPP even with residual OVR and poststent pregnancy. With 73% of women having full pain resolution, and the rest having a mean residual pain score of <3, this study supports venous stenting for the treatment of CPP of venous origin, especially in young women.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The largest single-center report on intravenous leiomyomatosis and development of a classification to guide surgical management.","authors":"Yulin Wen, Guotao Ma, Qi Miao, Jiang Shao, Wei Lu, Xingrong Liu, Chaoji Zhang, Jianzhou Liu, Dongyan Cao, Ninghai Chen, Jinhui Wang","doi":"10.1016/j.jvsv.2024.101989","DOIUrl":"10.1016/j.jvsv.2024.101989","url":null,"abstract":"<p><strong>Background: </strong>Intravenous leiomyomatosis (IVL) is a rare neoplasm; the accumulated knowledge about the characteristics and prognosis of this tumor has been derived mainly from isolated case reports with no comprehensive research. In this study, we reviewed our institution's experience with IVL over a 20-year period and developed a classification system that can be used to guide surgical management.</p><p><strong>Methods: </strong>The study had a retrospective cohort design and included patients who underwent resection of IVL at our institution between January 2002 and December 2022. Perioperative parameters were then collected among four stages of our proposed classification. The long-term outcomes, oncologic prognosis, and factors associated with recurrence were analyzed.</p><p><strong>Results: </strong>A total of 216 patients were included (stage 1, n = 92; stage 2, n = 39; stage 3, n = 76; stage 4, n = 9). The mean follow-up duration was 26.34 months, during which 18 patients (9.7%) in the complete resection group had recurrence, and 12 (39.0%) in the incomplete resection group showed disease progression. Recurrence or progression of residual disease was associated with adjuvant aromatase inhibitor therapy and maximum tumor thrombus diameter but not with total hysterectomy and bilateral salpingo-oophorectomy, age, or postoperative treatment with a gonadotropin-releasing hormone agonist therapy.</p><p><strong>Conclusions: </strong>This is the largest single-center report on IVL published to date and provides valuable information on its clinical features and long-term outcomes, as well as surgical technique. Our classification system can be used to evaluate the extent of lesion involvement and guide surgical management.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yasser M ElKiran, Amr ElShafei, Ahmed M Morshed, Yasmin Y Elkiran, Ahmed M Elmetwally
{"title":"Hybrid approach of massive lipolymphedema of the thigh: A novel surgical technique.","authors":"Yasser M ElKiran, Amr ElShafei, Ahmed M Morshed, Yasmin Y Elkiran, Ahmed M Elmetwally","doi":"10.1016/j.jvsv.2024.101987","DOIUrl":"10.1016/j.jvsv.2024.101987","url":null,"abstract":"<p><strong>Objective: </strong>The goal of this study was to test the hybrid technique of combined tumescent liposuction and surgical excision in patients with advanced lipolymphedema of the thigh after compression therapy as a gold standard for treatment.</p><p><strong>Methods: </strong>Between January 2016 and April 2020, 18 female and 1 male patients with massive thigh lipolymphedema were treated with complete decongestive therapy for the whole thigh followed by selective decongestive therapy to the upper and lower thigh to make a lump on the midmedial region. Then, the patient was prepared for surgery. Skin is refashioned and sutured in a manner that leaves no furrows and a cosmetic contour is obtained. Compression therapy is maintained from the day of the surgery starting by compression bandage until full healing of the wound, followed by well-fitted garments.</p><p><strong>Results: </strong>This study was conducted on 18 female patients and 1 male patient who presented with massive lipolymphedema of the thigh. The age of the patients ranged from 46 to 65 years old with a mean age of 51.38 years. All patients in this study underwent compression therapy as a preparatory stage to turn the massive lipolymphedema into lumpedema, followed by hybrid technique which consisted of combined liposuction and surgical excision.</p><p><strong>Conclusions: </strong>Conversion of massive thigh lipolymphedema into lumpedema followed by tumescent liposuction and surgical excision has proven to be a safe and effective treatment option with a marvelous cosmetic result and low wound morbidity and should be considered as a solution for all patients with this disorder.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142406574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}