{"title":"Comparative study on the effectiveness and safety of simultaneous and staged bilateral saphenous vein radiofrequency ablation.","authors":"Ufuk Türkmen, Adnan Yalçınkaya","doi":"10.1016/j.jvsv.2024.102003","DOIUrl":"10.1016/j.jvsv.2024.102003","url":null,"abstract":"<p><strong>Objective: </strong>Chronic venous insufficiency (CVI) is a common condition affecting more than one-half of the general population, with approximately 20% of cases being bilateral. The high prevalence, diagnosis, and treatment costs, along with the negative impact on patients' quality of life, underscore its significance. This study evaluates the clinical outcomes, quality-of-life effects, and postoperative complications of simultaneous and staged bilateral radiofrequency ablation (RFA) in patients with bilateral CVI in the great saphenous vein at Clinical, Etiological, Anatomical, Pathophysiological stages 2 to 4.</p><p><strong>Methods: </strong>This retrospective study included 433 patients with bilateral CVI in the great saphenous vein at Clinical, Etiological, Anatomical, Pathophysiological stages 2 to 4, treated with RFA between January 2018 and December 2022. Patients were classified into two groups: group 1 (n = 257) underwent simultaneous bilateral RFA, and group 2 (n = 176) underwent staged bilateral RFA. Clinical outcomes and quality of life effects were evaluated using Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire, and Visual Analog Scale scores. Demographic data, type of anesthesia, surgery durations, and postoperative complications were analyzed.</p><p><strong>Results: </strong>Both groups showed significant improvements in Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score scores at 12 months postoperatively, with no significant differences between the groups in preoperative and postoperative scores. No significant difference was found in postoperative Visual Analog Scale scores. Postoperative complication rates were low and comparable. No pulmonary embolism was observed. Symptomatic deep vein thrombosis was detected in one patient from each group and treated successfully.</p><p><strong>Conclusions: </strong>Simultaneous bilateral RFA is as effective and safe as staged bilateral RFA for treating CVI, providing similar clinical outcomes and low complication rates. The simultaneous approach offers the advantage of a single treatment session, potentially improving patient satisfaction and operational efficiency. This study supports simultaneous bilateral RFA as a viable and effective option for treating bilateral CVI.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":" ","pages":"102003"},"PeriodicalIF":2.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621902","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}
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":"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 nonmalignant iliofemoral venous obstructive disease.</p><p><strong>Methods: </strong>This was an international, prospective, multicenter, single-arm study that enrolled patients with symptomatic nonthrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety end point was freedom from major adverse events at 30 days after the index procedure. The primary efficacy end point was primary patency of stent-bearing segments at 12 months. Secondary and observational end points 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 end point was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P < .0001). The primary safety end point was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy end point was met in 90.2% compared with the performance goal of 77.3% (P = .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 nonmalignant iliofemoral venous obstructive disease.</p><p><strong>Clinical relevance: </strong>The VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) investigational device exemption trial is the first study of a hybrid, venous stent specifically designed to address the anatomic challenges of the iliofemoral venous system. The Duo Venous Stent System consists of a self-expanding nitinol Duo Hybrid Stent used independently or in conjunction with the flexible extension Duo Extend Stent. This is the first report of primary outcomes from the VIVID Study, assessing the safety and efficacy of the Duo Venous Stent System to treat patients with nonmalignant, symptomatic iliofemoral venous outflow obstruction. The Duo Venous Stent System successfully met its 12-month safety and effectiveness performance goals.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":" ","pages":"101995"},"PeriodicalIF":2.8,"publicationDate":"2024-10-29","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}
{"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":"12 6","pages":"Article 101979"},"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}
{"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":"12 6","pages":"Article 101980"},"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":"Events of interest","authors":"","doi":"10.1016/S2213-333X(24)00316-0","DOIUrl":"10.1016/S2213-333X(24)00316-0","url":null,"abstract":"","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":"12 5","pages":"Article 101954"},"PeriodicalIF":2.8,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213333X24003160/pdfft?md5=09af76fa7dfd4850f1a3357fc0292553&pid=1-s2.0-S2213333X24003160-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997504","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":"Information for Readers","authors":"","doi":"10.1016/S2213-333X(24)00315-9","DOIUrl":"10.1016/S2213-333X(24)00315-9","url":null,"abstract":"","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":"12 5","pages":"Article 101953"},"PeriodicalIF":2.8,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213333X24003159/pdfft?md5=eb3721fdf554c6efa3e72daaa1b5fb83&pid=1-s2.0-S2213333X24003159-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997503","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}
Junji Tsukagoshi MD , Benjamin Wick BS , Abbas Karim BS , Kamil Khanipov PhD , Mitchell W. Cox MD
{"title":"Perioperative and intermediate outcomes of patients with pulmonary embolism undergoing catheter-directed thrombolysis vs percutaneous mechanical thrombectomy","authors":"Junji Tsukagoshi MD , Benjamin Wick BS , Abbas Karim BS , Kamil Khanipov PhD , Mitchell W. Cox MD","doi":"10.1016/j.jvsv.2024.101958","DOIUrl":"10.1016/j.jvsv.2024.101958","url":null,"abstract":"<div><h3>Objective</h3><div>Thrombolytic therapy has been a mainstay of treatment for massive or submassive pulmonary embolism (<em>PE</em>), a common and highly morbid pathology. New percutaneous mechanical thrombectomy (<em>PMT</em>) devices have recently become widely available and have been used increasingly for the treatment of acute PE, but evidence demonstrating its efficacy over standard catheter-directed lytic protocol remains limited.</div></div><div><h3>Methods</h3><div>Using TriNetX Data Network, a global federated database of >250 million patients, we conducted a retrospective cohort study of patients from January 2017 to August 2023 with a diagnosis of PE, treated with either PMT or catheter-directed thrombolysis (<em>CDT</em>). Eligible patients were 1:1 propensity score-matched for preoperative covariates including demographics and comorbidities. We calculated and compared the 30-day outcomes of all-cause mortality, bleeding complications (blood transfusion, gastrointestinal bleed, and intracranial hemorrhage), diagnosis of acute respiratory failure (<em>RF</em>), myocardial infarction (<em>MI</em>), and pulmonary hypertension (<em>PH</em>) using odds ratios (<em>OR</em>) with 95% confidence intervals (<em>CIs</em>). Also, the 5-year outcomes of all-cause mortality, a composite outcome of chronic PH (chronic PE, chronic cor pulmonale, chronic thromboembolic PH), right heart failure (<em>RHF</em>), RF, and emergency department visits, were compared using hazard ratios (<em>HRs</em>) with 95% CIs.</div></div><div><h3>Results</h3><div>We identified 2978 patients treated with PMT and 1137 patients treated with CDT. After matching, we compared 1102 patients in each cohort. For 30-day outcomes, all-cause mortality, acute RF, and blood transfusion were similar between the two groups. However, compared with CDT, PMT was associated with a better safety profile, including lower bleeding risk for both ICH (OR, 0.46; 95% CI, 0.24-0.890) and gastrointestinal bleed (OR, 0.42; 95% CI, 0.28-0.63). PMT also demonstrated better immediate functional outcomes, with less PH (OR, 0.53; 95% CI, 0.41-0.68) and MI (OR, 0.54; 95% CI, 0.41-0.76). At 5 years, the all-cause mortality and RF for both procedures were similar, but PMT was associated with lower rates of chronic PH (HR, 0.70; 95% CI, 0.55-0.90), RHF (HR 0.49; 95% CI, 0.37-0.65), and emergency department visits (348 for PMT vs 426 for CDT; <em>P</em> < .01).</div></div><div><h3>Conclusions</h3><div>In patients undergoing catheter-based therapy for PE, PMT has an improved procedural safety profile vs CDT and results in significantly fewer 30-day postoperative complications, with fewer bleeding events, and is also associated with fewer periprocedural MIs and less acute PH. Perhaps, more important, PMT also demonstrated improved long-term outcomes with significantly fewer chronic PH and RHF diagnoses with fewer emergency department visits.</div></div>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":"12 6","pages":"Article 101958"},"PeriodicalIF":2.8,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141902179","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}
Lucas Mota MD, John N. Tomeo BS, Sai Divya Yadavalli MD, Andy Lee MD, Patric Liang MD, Allen D. Hamdan MD, Mark C. Wyers MD, Marc L. Schermerhorn MD, Lars Stangenberg MD, PhD
{"title":"Management and outcomes of venous thoracic outlet decompression: A transition to the infraclavicular approach","authors":"Lucas Mota MD, John N. Tomeo BS, Sai Divya Yadavalli MD, Andy Lee MD, Patric Liang MD, Allen D. Hamdan MD, Mark C. Wyers MD, Marc L. Schermerhorn MD, Lars Stangenberg MD, PhD","doi":"10.1016/j.jvsv.2024.101959","DOIUrl":"10.1016/j.jvsv.2024.101959","url":null,"abstract":"<div><h3>Objective</h3><div>Venous thoracic outlet syndrome (vTOS) is caused by compression of the subclavian vein at the costoclavicular space, which may lead to vein thrombosis. Current treatment includes thoracic outlet decompression with or without venolysis. However, given its relatively low prevalence, the existing literature is limited. Here, we report our single-institution experience in the treatment of vTOS.</div></div><div><h3>Methods</h3><div>We performed a retrospective review of all patients who underwent rib resection for vTOS at our institution from 2007 to 2022. Demographic, procedural details, and perioperative and long-term outcomes were reviewed.</div></div><div><h3>Results</h3><div>A total of 76 patients were identified. The mean age was 36 years. Swelling was the most common symptom (93%), followed by pain (6.6%). Ninety percent of patients had associated deep vein thrombosis, with 99% of these patients starting anticoagulation preoperatively. A total of 91% of patients underwent rib resection via the infraclavicular approach, 2% via the paraclavicular approach (due to a neurogenic component), and 7% via the transaxillary approach. Eighty-three percent of patients had endovascular intervention before or at the time of the rib resection, with catheter-directed thrombolysis (87%), followed by angioplasty (71%) and rheolytic thrombectomy (57%) being the most common interventions. The median time from endovascular intervention to rib resection was 14 days, with 25% at the same admission. The median postoperative stay was 3 days (2-5 days). There was no perioperative mortality or nerve injury. Fourteen percent of patients had postoperative complications, with bleeding complications (12%) being the most common. Waiting more than 30 days between initial endovascular intervention and rib resection was not associated with decreased risk of bleeding complications. Patients were seen postoperatively at 1-month (physical examination) and 6-month (duplex) intervals or for any new or recurrent symptoms. Twenty-two percent of our overall patient population underwent reintervention, most commonly angioplasty (21%). At last follow-up, 97% of subclavian veins were patent, and 93% of patients were symptom free.</div></div><div><h3>Conclusions</h3><div>Over the last decade, we have transitioned to an infraclavicular approach for isolated vTOS, with low perioperative morbidity and good patency rates. These results support the adoption of the infraclavicular approach with adjunct endovascular techniques as a safe and efficacious treatment of vTOS.</div></div>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":"12 6","pages":"Article 101959"},"PeriodicalIF":2.8,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893712","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}
Ben Li MD , Naomi Eisenberg PT, MEd, CCRP , Derek Beaton PhD , Douglas S. Lee MD, PhD , Leen Al-Omran MD(c) , Duminda N. Wijeysundera MD, PhD , Mohamad A. Hussain MD, PhD , Ori D. Rotstein MD, MSc , Charles de Mestral MD, PhD , Muhammad Mamdani PharmD, MA, MPH , Graham Roche-Nagle MD, MBA , Mohammed Al-Omran MD, MSc
{"title":"Predicting inferior vena cava filter complications using machine learning","authors":"Ben Li MD , Naomi Eisenberg PT, MEd, CCRP , Derek Beaton PhD , Douglas S. Lee MD, PhD , Leen Al-Omran MD(c) , Duminda N. Wijeysundera MD, PhD , Mohamad A. Hussain MD, PhD , Ori D. Rotstein MD, MSc , Charles de Mestral MD, PhD , Muhammad Mamdani PharmD, MA, MPH , Graham Roche-Nagle MD, MBA , Mohammed Al-Omran MD, MSc","doi":"10.1016/j.jvsv.2024.101943","DOIUrl":"10.1016/j.jvsv.2024.101943","url":null,"abstract":"<div><h3>Objective</h3><div>Inferior vena cava (<em>IVC</em>) filter placement is associated with important long-term complications. Predictive models for filter-related complications may help guide clinical decision-making but remain limited. We developed machine learning (<em>ML</em>) algorithms that predict 1-year IVC filter complications using preoperative data.</div></div><div><h3>Methods</h3><div>The Vascular Quality Initiative database was used to identify patients who underwent IVC filter placement between 2013 and 2024. We identified 77 preoperative demographic and clinical features from the index hospitalization when the filter was placed. The primary outcome was 1-year filter-related complications (composite of filter thrombosis, migration, angulation, fracture, and embolization or fragmentation, vein perforation, new caval or iliac vein thrombosis, new pulmonary embolism, access site thrombosis, or failed retrieval). The data were divided into training (70%) and test (30%) sets. Six ML models were trained using preoperative features with 10-fold cross-validation (Extreme Gradient Boosting, random forest, Naïve Bayes classifier, support vector machine, artificial neural network, and logistic regression). The primary model evaluation metric was area under the receiver operating characteristic curve (<em>AUROC</em>). Model robustness was assessed using calibration plot and Brier score. Performance was evaluated across subgroups based on age, sex, race, ethnicity, rurality, median Area Deprivation Index, planned duration of filter, landing site of filter, and presence of prior IVC filter placement.</div></div><div><h3>Results</h3><div>Overall, 14,476 patients underwent IVC filter placement and 584 (4.0%) experienced 1-year filter-related complications. Patients with a primary outcome were younger (59.3 ± 16.7 years vs 63.8 ± 16.0 years; <em>P</em> < .001) and more likely to have thrombotic risk factors including thrombophilia, prior venous thromboembolism (<em>VTE</em>), and family history of VTE. The best prediction model was Extreme Gradient Boosting, achieving an AUROC of 0.93 (95% confidence interval, 0.92-0.94). In comparison, logistic regression had an AUROC of 0.63 (95% confidence interval, 0.61-0.65). Calibration plot showed good agreement between predicted/observed event probabilities with a Brier score of 0.07. The top 10 predictors of 1-year filter-related complications were (1) thrombophilia, (2) prior VTE, (3) antiphospholipid antibodies, (4) factor V Leiden mutation, (5) family history of VTE, (6) planned duration of IVC filter (temporary), (7) unable to maintain therapeutic anticoagulation, (8) malignancy, (9) recent or active bleeding, and (10) age. Model performance remained robust across all subgroups.</div></div><div><h3>Conclusions</h3><div>We developed ML models that can accurately predict 1-year IVC filter complications, performing better than logistic regression. These algorithms have potential to guide patient s","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. Venous and lymphatic disorders","volume":"12 6","pages":"Article 101943"},"PeriodicalIF":2.8,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141860215","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}