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1.
Ann Vasc Dis ; 17(1): 21-24, 2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38628936

ABSTRACT

Objective: Cyanoacrylate closure (CAC) is a minimally invasive technique for the treatment of varicose veins. A recent paper reported serious adverse events (AEs) associated with this use. This triggered an urgent survey to determine the incidence of AEs in Japan. Methods: The CAC-AE survey was sent to all 1,030 institutions authorized for CAC treatments. Cases performed between January 2020 and October 2023 were surveyed. Data on serious AEs and mortality were collected. Results: There were 623 surveys returned. There were 16 cases of proximal deep vein thrombosis, 3 cases of pulmonary embolism (PE), and 0 cases of stroke. Deep vein occlusion due to cyanoacrylate extension was observed in 1 case. Vein resection due to infection was observed in 4 cases. There were 299 cases of localized phlebitis and/or allergic reactions requiring steroid administration. Systemic allergic reactions requiring steroid administration were observed in 66 cases. There was no anaphylaxis associated with cyanoacrylate. There was one postoperative death from PE. Conclusion: This report's intent is to provide real world data on serious AEs following CAC from Japan given current concern over these events. An extensive report investigation of individual complications with analysis including causality will be provided following a full investigation separately.

2.
J Vasc Surg Venous Lymphat Disord ; : 101884, 2024 Mar 27.
Article in English | MEDLINE | ID: mdl-38552954

ABSTRACT

BACKGROUND: Insurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment. METHODS: We performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, "clinical improvement." The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom. RESULTS: A total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results. CONCLUSIONS: LCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed.

3.
Stem Cell Res ; 75: 103285, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38199067

ABSTRACT

Arterial calcification due to deficiency of CD73 (ACDC) is an adult onset, rare genetic vascular disorder signified by calcium deposition in lower extremity arteries and joints of hands and feet. Mutations in NT5E gene has been shown to be responsible for the inactivation of enzyme CD73 causing calcium buildup. Here, we report a iPSC line generated from a patient showing signs of ACDC and carrying a missense mutation in NT5E (c.1126A→G,p.T376A) gene. This iPSC line shows normal morphology, pluripotency, karyotype, and capability to differentiate into three germ layers, making it useful for disease modeling and investigating pathological mechanisms of ACDC.


Subject(s)
Calcinosis , Induced Pluripotent Stem Cells , Joint Diseases , Vascular Diseases , Adult , Humans , Calcium , Calcinosis/genetics , Mutation
4.
J Vasc Surg Venous Lymphat Disord ; 12(2): 101679, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37708939

ABSTRACT

OBJECTIVE: Varicose veins have a significant impact on quality of life and can commonly occur in the thigh and calves. However, there has been no large-scale investigation examining the relationship between anatomic distribution and outcomes after varicose vein treatment. This study sought to compare below-the-knee (BTK) and above-the-knee (ATK) varicose vein treatment outcomes. METHODS: Employing the Vascular Quality Initiative Varicose Vein Registry, 13,731 patients undergoing varicose vein ablation for either BTK or ATK lesions were identified. Outcomes were assessed using patient-reported outcomes (PROs) and the Venous Clinical Severity Score (VCSS). Continuous variables were compared using the t-test, and categorical variables were analyzed using the χ2 test. Multivariable logistic regression was used to estimate the odds of improvement after intervention. The multivariable model controlled for age, gender, race, preoperative VCSS composite score, and history of deep vein thrombosis. RESULTS: Patients who received below-knee treatment had a lower preoperative VCSS composite (7.0 ± 3.3 vs 7.7 ± 3.3; P < .001) and lower PROs composite scores (11.1 ± 6.4 vs 13.0 ± 6.6; P < .001) compared with those of patients receiving above-knee treatment. However, on follow-up, patients receiving below-knee intervention had a higher postoperative VCSS composite score (4.4 ± 3.3 vs 3.9 ± 3.5; P < .001) and PROs composite score (6.1 ± 4.4 vs 5.8 ± 4.5; P = .007), the latter approaching statistical significance. Patients receiving above-knee interventions also demonstrated more improvement in both composite VCSS (3.8 ± 4.0 vs 2.9 ± 3.7; P < .001) and PROs (7.1 ± 6.8 vs 4.8 ± 6.6; P < .001). Multivariable logistic regression analysis similarly revealed that patients receiving above-knee treatment had significantly higher odds of improvement in VCSS composite in both the unadjusted (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.28-1.65; P < .001 and adjusted (OR, 1.31; 95% CI, 1.14-1.50; P < .001) models. Patients receiving above-knee treatment also had a significantly higher odds of reporting improvement in PROs composite in both the unadjusted (OR, 1.85; 95% CI, 1.64-2.11; P < .001) and adjusted (OR, 1.65; 95% CI, 1.45-1.88; P < .001) models. CONCLUSIONS: Treatment region has a significant association with PROs and VCSS composite scores after varicose vein interventions. Preoperatively, there were significant differences in the composite scores of VCSS and PROs with patients receiving BTK treatment exhibiting less severe symptoms. Yet, the association appeared to reverse postoperatively, with those receiving BTK treatments exhibiting worse PROs, worse VCSS composites scores, and less improvement in VCSS composite scores. Therefore, BTK interventions pose a unique challenge compared with ATK interventions in ensuring commensurate clinical improvement after treatment.


Subject(s)
Ablation Techniques , Varicose Veins , Venous Insufficiency , Humans , Leg , Quality of Life , Saphenous Vein/surgery , Treatment Outcome , Varicose Veins/diagnostic imaging , Varicose Veins/surgery , Venous Insufficiency/therapy
5.
J Vasc Surg Venous Lymphat Disord ; 12(1): 101681, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37703943

ABSTRACT

OBJECTIVE: The aim of this study was to summarize the existing evidence for the treatment of saphenous veins >10 mm in diameter, to determine whether there were vein size limits for treatment modalities, and to determine if there are specific technical considerations for treatment of large veins. METHODS: We searched the literature for reports of treatment methods and outcomes for patients with large-diameter saphenous veins treated with various ablation methods between 1993 and 2023. These studies were evaluated for the size of the vein determined as "large diameter," type of ablation method, study type, outcomes, adverse events, and any technical considerations noted. A systematic review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. The COVIDENCE software was used for full-text screening and data extraction. Three reviewers reviewed the data, and the content expert served as the tiebreaker. RESULTS: Seventy-one records were identified, of which 24 studies were deemed appropriate for extraction. Most of the studies identified reported outcomes of endovenous thermal ablation modalities. There were fewer studies on non-thermal, non-tumescent techniques, and these studies reported an overall lower occlusion rate compared with endovenous thermal ablation techniques. CONCLUSIONS: Large head-to-head trials or randomized controlled that compare all the modalities over a long follow-up duration are yet to be performed. In the existing literature, there is considerable heterogeneity in terms of the study size, design, definition of large veins, site of vein measurement, and follow-up periods, making it challenging to make fair comparisons and draw firm conclusions. Currently available evidence supports the use of endothermal ablation techniques for the treatment of veins >10 mm in diameter as they have a more favorable efficacy and safety profile and have a larger body of evidence available compared with non-thermal, non-tumescent techniques or surgery.


Subject(s)
Ablation Techniques , Varicose Veins , Venous Insufficiency , Humans , Saphenous Vein/diagnostic imaging , Saphenous Vein/surgery , Ablation Techniques/adverse effects , Ablation Techniques/methods , Varicose Veins/diagnostic imaging , Varicose Veins/surgery , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/surgery , Femoral Vein , Treatment Outcome
6.
J Vasc Surg Venous Lymphat Disord ; 12(1): 101685, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37703944

ABSTRACT

BACKGROUND: Vein ablation is a common and effective treatment for patients with chronic venous insufficiency. The overuse of vein ablation despite the existence of evidence-based guidelines has resulted in insurance companies developing restrictive policies for coverage that create barriers to appropriate care. This study compares the insurance coverage by single-state carriers (SSCs) and multistate carriers (MSCs), highlighting the variations and inconsistencies in the various policies. METHODS: The American Venous Forum Venous Policy Navigator was reviewed for the various policies available in the United States. The policies were divided into SSCs and MSCs. The characteristics of the policies, including the anatomic and hemodynamic criteria for specific veins, duration of conservative treatment, disease severity, symptoms, and types of procedures covered, were compared between the two groups. SAS, version 9.4 (SAS Institute Inc) was used for statistical analysis. RESULTS: A total of 122 policies were analyzed and divided between SSCs (n = 85; 69.7%) and MSCs (n = 37; 30.3%). A significant variation was found in the size requirement for great saphenous vein ablation. Although 48% of the policies did not specify a size criterion, the remaining policies indicated a minimal size, ranging from 3 to 5.5 mm. However, no significant differences were found between SSCs and MSCs. Similar findings were encountered for the small and anterior accessory saphenous veins. MSCs were more likely to define a saphenous reflux time >500 ms compared with SSCs (81.1% vs 58.8%; P = .04). A significant difference was found between the SSCs and MSCs in the criteria for perforator ablation in terms of size and reflux time. MSCs were significantly more likely to provide coverage for mechanochemical ablation than were SSCs (24.3% vs 8.2%; P = .03). SSCs were more likely to require ≥12 weeks of compression stocking therapy than were MSCs (76.5% vs 48.7%; P = .01). No significant differences were found in the clinical indications between the two groups; however, MSCs were more likely to mention major hemorrhage than were SSCs. CONCLUSIONS: The results of this study highlight the variations in policies for venous ablation, in particular, the striking inconsistencies in size criteria. MSCs were more likely to cover mechanochemical ablation and require a shorter duration of conservative therapy before intervention compared with SSCs. Evidence-based guidance is needed to develop more coherent policies for venous ablation coverage.


Subject(s)
Catheter Ablation , Varicose Veins , Venous Insufficiency , Humans , United States , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/surgery , Treatment Outcome , Saphenous Vein/diagnostic imaging , Saphenous Vein/surgery , Femoral Vein/surgery , Catheter Ablation/adverse effects , Varicose Veins/surgery , Retrospective Studies
7.
J Vasc Surg Venous Lymphat Disord ; 12(1): 101670, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37652254

ABSTRACT

The Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society recently published Part I of the 2022 clinical practice guidelines on varicose veins. Recommendations were based on the latest scientific evidence researched following an independent systematic review and meta-analysis of five critical issues affecting the management of patients with lower extremity varicose veins, using the patients, interventions, comparators, and outcome system to answer critical questions. Part I discussed the role of duplex ultrasound scanning in the evaluation of varicose veins and treatment of superficial truncal reflux. Part II focuses on evidence supporting the prevention and management of varicose vein patients with compression, on treatment with drugs and nutritional supplements, on evaluation and treatment of varicose tributaries, on superficial venous aneurysms, and on the management of complications of varicose veins and their treatment. All guidelines were based on systematic reviews, and they were graded according to the level of evidence and the strength of recommendations, using the GRADE method. All ungraded Consensus Statements were supported by an extensive literature review and the unanimous agreement of an expert, multidisciplinary panel. Ungraded Good Practice Statements are recommendations that are supported only by indirect evidence. The topic, however, is usually noncontroversial and agreed upon by most stakeholders. The Implementation Remarks contain technical information that supports the implementation of specific recommendations. This comprehensive document includes a list of all recommendations (Parts I-II), ungraded consensus statements, implementation remarks, and best practice statements to aid practitioners with appropriate, up-to-date management of patients with lower extremity varicose veins.


Subject(s)
Cardiology , Varicose Veins , Venous Insufficiency , Humans , United States , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/therapy , Venous Insufficiency/etiology , Radiology, Interventional , Sclerotherapy/methods , Saphenous Vein/surgery , Treatment Outcome , Varicose Veins/diagnostic imaging , Varicose Veins/surgery , Vascular Surgical Procedures/adverse effects , Lower Extremity
9.
Article in English | MEDLINE | ID: mdl-37701430

ABSTRACT

Objective: Health care providers and recipients have been using artificial intelligence and its subfields, such as natural language processing and machine learning technologies, in the form of search engines to obtain medical information for some time now. Although a search engine returns a ranked list of webpages in response to a query and allows the user to obtain information from those links directly, ChatGPT has elevated the interface between humans with artificial intelligence by attempting to provide relevant information in a human-like textual conversation. This technology is being adopted rapidly and has enormous potential to impact various aspects of health care, including patient education, research, scientific writing, pre-visit/post-visit queries, documentation assistance, and more. The objective of this study is to assess whether chatbots could assist with answering patient questions and electronic health record inbox management. Methods: We devised two questionnaires: (1) administrative and non-complex medical questions (based on actual inbox questions); and (2) complex medical questions on the topic of chronic venous disease. We graded the performance of publicly available chatbots regarding their potential to assist with electronic health record inbox management. The study was graded by an internist and a vascular medicine specialist independently. Results: On administrative and non-complex medical questions, ChatGPT 4.0 performed better than ChatGPT 3.5. ChatGPT 4.0 received a grade of 1 on all the questions: 20 of 20 (100%). ChatGPT 3.5 received a grade of 1 on 14 of 20 questions (70%), grade 2 on 4 of 16 questions (20%), grade 3 on 0 questions (0%), and grade 4 on 2/20 questions (10%). On complex medical questions, ChatGPT 4.0 performed the best. ChatGPT 4.0 received a grade of 1 on 15 of 20 questions (75%), grade 2 on 2 of 20 questions (10%), grade 3 on 2 of 20 questions (10%), and grade 4 on 1 of 20 questions (5%). ChatGPT 3.5 received a grade of 1 on 9 of 20 questions (45%), grade 2 on 4 of 20 questions (20%), grade 3 on 4 of 20 questions (20%), and grade 4 on 3 of 20 questions (15%). Clinical Camel received a grade of 1 on 0 of 20 questions (0%), grade 2 on 5 of 20 questions (25%), grade 3 on 5 of 20 questions (25%), and grade 4 on 10 of 20 questions (50%). Conclusions: Based on our interactions with ChatGPT regarding the topic of chronic venous disease, it is plausible that in the future, this technology may be used to assist with electronic health record inbox management and offload medical staff. However, for this technology to receive regulatory approval to be used for that purpose, it will require extensive supervised training by subject experts, have guardrails to prevent "hallucinations" and maintain confidentiality, and prove that it can perform at a level comparable to (if not better than) humans. (JVS-Vascular Insights 2023;1:100019.).

10.
JMIR Form Res ; 7: e43258, 2023 Aug 23.
Article in English | MEDLINE | ID: mdl-37610798

ABSTRACT

BACKGROUND: Innovative solutions to nursing care are needed to address nurse, health system, patient, and caregiver concerns related to nursing wellness, work flexibility and control, workforce retention and pipeline, and access to patient care. One innovative approach includes a novel health care delivery model enabling nurse-led, off-hours wound care (PocketRN) to triage emergent concerns and provide additional patient health education via telehealth. OBJECTIVE: This pilot study aimed to evaluate the implementation of PocketRN from the perspective of nurses and patients. METHODS: Patients and part-time or per-diem, wound care-certified and generalist nurses were recruited through the Stanford Medicine Advanced Wound Care Center in 2021 and 2022. Qualitative data included semistructured interviews with nurses and patients and clinical documentation review. Quantitative data included app use and brief end-of-interaction in-app satisfaction surveys. RESULTS: This pilot study suggests that an app-based nursing care delivery model is acceptable, clinically appropriate, and feasible. Low technology literacy had a modest effect on initial patient adoption; this barrier was addressed with built-in outreach and by simplifying the patient experience (eg, via phone instead of video calls). This approach was acceptable for users, despite total patient enrollment and use numbers being lower than anticipated (N=49; 17/49, 35% of patients used the app at least once beyond the orientation call). We interviewed 10 patients: 7 who had used the app were satisfied with it and reported that real-time advice after hours reduced anxiety, and 3 who had not used the app after enrollment reported having other resources for health care advice and noted their perception that this tool was meant for urgent issues, which did not occur for them. Interviewed nurses (n=10) appreciated working from home, and they reported comfort with the scope of practice and added quality of care facilitated by video capabilities; there was interest in additional wound care-specific training for nonspecialized nurses. Nurses were able to provide direct patient care over the web, including the few participating nurses who were unable to perform in-person care (n=2). CONCLUSIONS: This evaluation provides insights into the integration of technology into standard health care services, such as in-clinic wound care. Using in-system nurses with access to electronic medical records and specialized knowledge facilitated app integration and continuity of care. This care delivery model satisfied nurse desires for flexible and remote work and reduced patient anxiety, potentially reducing postoperative wound care complications. Feasibility was negatively impacted by patients' technology literacy and few language options; additional patient training, education, and language support are needed to support equitable access. Adoption was impacted by a lack of perceived need for additional care; lower-touch or higher-acuity settings with a longer wait between visits could be a better fit for this type of nurse-led care.

11.
Med Clin North Am ; 107(5): 895-909, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37541715

ABSTRACT

Varicose veins are tortuous and dilated veins commonly seen in chronic venous disease. This article will review chronic venous disease, including its differential diagnosis, workup, and treatment.


Subject(s)
Varicose Veins , Venous Insufficiency , Humans , Venous Insufficiency/diagnosis , Venous Insufficiency/therapy , Varicose Veins/diagnosis , Varicose Veins/therapy , Chronic Disease
14.
J Vasc Surg Venous Lymphat Disord ; 11(4): 876-888.e1, 2023 07.
Article in English | MEDLINE | ID: mdl-37054883

ABSTRACT

OBJECTIVE: Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases. METHODS: We searched the literature for reports of reactions following cyanoacrylate glue use in patients with venous diseases between 2012 and 2022. The search was performed using MeSH (medical subject headings) terms. The terms included cyanoacrylate, venous insufficiency, chronic venous disorder, varicose veins, vein varicosities, venous ulcer, venous wound, CEAP (clinical, etiologic, anatomic, pathophysiologic), vein, adverse events, phlebitis, hypersensitivity, foreign body granuloma, giant cell, endovenous glue-induced thrombosis, and allergy. The search was limited to the literature reported in English. These studies were evaluated for the type of product used and the reactions noted. A systematic review, in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method, was performed. Covidence software (Melbourne, VC, Australia) was used for full-text screening and data extraction. Two reviewers reviewed the data, and the content expert served as the tiebreaker. RESULTS: We identified 102, of which, 37 reported on cyanoacrylate use other than in the context of chronic venous diseases and were excluded. Fifty-five reports were determined appropriate for data extraction. The adverse reactions to cyanoacrylate glue were phlebitis, hypersensitivity, foreign body granuloma, and endovenous glue-induced thrombosis. CONCLUSIONS: Although cyanoacrylate glue closure for venous reflux is generally a safe and clinically effective treatment choice for patients with symptomatic chronic venous disease and axial reflux, some adverse events could be specific to the properties of the cyanoacrylate product. We propose mechanisms for how such reactions can occur based on histologic changes, published reports, and case examples; however, further exploration is necessary to confirm these theories.


Subject(s)
Granuloma, Foreign-Body , Hypersensitivity , Phlebitis , Varicose Veins , Venous Insufficiency , Humans , Cyanoacrylates/adverse effects , Granuloma, Foreign-Body/chemically induced , Granuloma, Foreign-Body/pathology , Saphenous Vein , Varicose Veins/diagnostic imaging , Varicose Veins/therapy , Varicose Veins/pathology , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/therapy , Venous Insufficiency/pathology , Treatment Outcome , Phlebitis/chemically induced , Hypersensitivity/pathology
15.
N Engl J Med ; 388(14): 1318-1324, 2023 Apr 06.
Article in English | MEDLINE | ID: mdl-37018496
16.
J Vasc Surg Venous Lymphat Disord ; 11(4): 692-699.e1, 2023 07.
Article in English | MEDLINE | ID: mdl-36972751

ABSTRACT

OBJECTIVE: Chronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates. METHODS: The VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months. RESULTS: We enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points. CONCLUSIONS: Treatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.


Subject(s)
Ulcer , Varicose Ulcer , Humans , Female , Middle Aged , Aged , Infant , Male , Polidocanol , Sclerotherapy , Treatment Outcome , Varicose Ulcer/therapy , Varicose Ulcer/surgery , Wound Healing , Pain
18.
J Vasc Surg Venous Lymphat Disord ; 11(2): 270-279.e1, 2023 03.
Article in English | MEDLINE | ID: mdl-36410701

ABSTRACT

OBJECTIVE: The objective of this study was to assess patient, wound, care, and reflux characteristics of venous leg ulcers (VLUs) to update and improve knowledge of disease etiology, identify barriers to healing, and improve treatment. METHODS: Patients diagnosed with VLUs treated at the Stanford Advanced Wound Care Center between 2018 and 2019 were identified from the Healogics iHeal database. We identified 327 VLU entries, of which 133 were patients who had multiple or recurring wounds. An additional 27 patients were labeled as misdiagnosis, resulting in a final patient sample of 167. Patient demographics, wound, care, and ultrasound data for these patients were extracted from the Stanford electronic medical records regarding characteristics. The initial data analysis suggested possible differences in VLU characteristics depending on patient age and body mass index (BMI), which was then further analyzed. RESULTS: Of the 167 VLU patients assessed, 53.9% were male and 46.1% were female. The mean age was 74.7 years, and the average BMI was 30.2 kg/m2, including 41.1% of patients with a BMI over 30 kg/m2. Approximately 50% of wounds were presented in multiples, had cellulitis, or were recurring, and 39.5% were caused by trauma. Most common venous reflux patterns on duplex ultrasound examination were below-knee great saphenous vein reflux and calf perforator reflux, which was identified in 37.7% and 29.3% of the patients, respectively. Axial great saphenous vein reflux was detected in 14.4% of patients. When looking at the patient sample under 60 years of age, 67.7% were male, 61.3% presented with venous skin changes, and 51.6% had diabetes. In the patients older than 60, only 51.9% were male, 37.6% presented with venous skin changes, and 31.6% had diabetes. BMI was greater in the patients under age 60, with an average of 39.2 kg/m2, compared with 28.2 kg/m2 in those above 60. Of the patients with a BMI ≥30 kg/m2, 64.3% had multiple wounds, 61.4% had recurring wounds, and 56.5% had venous skin changes. In contrast, in patients with BMI <30 kg/m2, 47.4% had multiple wounds, 39.2% had recurring wounds, and 32.0% had venous skin changes. CONCLUSIONS: VLU pathology appears to differ depending on patient demographics and characteristics. Different drivers may influence disease cause, progression, and prognosis, making a standard approach to VLUs difficult. Our findings suggest that identifying different subtypes of VLUs and adapting an algorithm of care with a personalized treatment may help optimize management of these patients.


Subject(s)
Multiple Trauma , Varicose Ulcer , Humans , Male , Female , Aged , Middle Aged , Varicose Ulcer/therapy , Prognosis , Saphenous Vein/diagnostic imaging , Ultrasonography
19.
J Vasc Surg Venous Lymphat Disord ; 11(2): 231-261.e6, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36326210

ABSTRACT

The Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society collaborated to update the 2011 Society for Vascular Surgery/American Venous Forum clinical practice guidelines and provide new evidence-based recommendations on critical issues affecting the care of patients with varicose veins. Each recommendation is based on a recent, independent systematic review and meta-analysis of the diagnostic tests and treatments options for patients with lower extremity varicose veins. Part I of the guidelines includes evidence-based recommendations for the evaluation of patients with CEAP (Clinical Class, Etiology, Anatomy, Pathology) class 2 varicose vein using duplex ultrasound scanning and other diagnostic tests, open surgical treatment (ligation and stripping) vs endovenous ablation techniques, thermal vs nonthermal ablation of the superficial truncal veins, and management of incompetent perforating veins in CEAP class 2 disease. We have also made recommendations on the concomitant vs staged treatment of varicose tributaries using phlebectomy or liquid or foam sclerotherapy (with physician-compounded foam or commercially prepared polidocanol endovenous microfoam) for patients undergoing ablation of incompetent superficial truncal veins.


Subject(s)
Cardiology , Varicose Veins , Venous Insufficiency , Humans , United States , Venous Insufficiency/surgery , Treatment Outcome , Saphenous Vein/surgery , Varicose Veins/surgery , Sclerotherapy/adverse effects , Vascular Surgical Procedures/adverse effects , Lower Extremity
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