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• W2111118082 abstract "Perhaps more so than in other areas of medicine and surgery, the management of acute and chronic venous disease remain somewhat diffuse. A wide variety of medical and surgical specialties are responsible for the prevention, diagnosis, and treatment of acute deep venous thrombosis (DVT), and patients with chronic venous disease (CVD) may be managed by primary care physicians, dermatologists, interventional radiologists, phlebologists, general surgeons, vascular medicine specialists, and vascular surgeons. Each may have a different approach to venous disease depending on their practice demographics, experience, and training. Furthermore, although the standard of care for acute venous thromboembolism has been established by randomized clinical trials and evidence-based guidelines have been developed,1Buller H.R. Agnelli G. Hull R.D. Hyers T.M. Prins M.H. Raskob G.E. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126: 401S-428SCrossref PubMed Scopus (1150) Google Scholar outcomes such as the post-thrombotic syndrome have received inadequate attention, potential adjuncts such as thrombolytic therapy have not been adequately evaluated, and there remain problems with widespread dissemination of the guidelines. In the case of chronic venous disease, many treatment approaches are based on observational data and have not been subjected to rigorous trials. Furthermore, the current approaches to some problems, such as post-thrombotic deep venous incompetence and the prevention of ulcer recurrence, remain inadequate. Under the auspices of the American Venous Forum (AVF), the 5th Pacific Vascular Symposium was envisioned as a process to address many of the problems existing in our understanding and management of acute and chronic venous disease. The goals of the meeting were to define the current state of knowledge in acute and chronic venous disease, and using this information as a baseline, to identify areas of deficiency, establish priorities, and map the future of venous disease with respect to needed research, professional and patient education, organization of the field, and management of acute and chronic venous disease. This was accomplished through a process of professionally facilitated appreciative inquiry2Barrett F.J. Fry R.E. Appreciative inquiry: a positive approach to building cooperative capacity. Taos Institute Publications, Chagrin Falls, (OH)2005Google Scholar involving collaboration among experts from epidemiology and clinical trials, dermatology, hematology, interventional radiology, phlebology, and vascular medicine and surgery as well as representatives from industry and the National Institutes of Health. The assembled experts were organized into four groups addressing acute venous disease, the hemodynamic and diagnostic evaluation of venous disease, primary chronic venous disease, and secondary chronic venous disease. A final break-out group, the International Compression Club, evaluated the current status and future needs of medical compression hosiery. The current state of knowledge in each of these areas has been reviewed in the previous sections of this supplement and provided the basis for developing future priorities for the field. Several of the priorities crossed group designations and are discussed first below. These are followed by the individuals groups’ recommendations for advancing the future of venous disease, both in terms of overall priorities and specific initiatives that can be begun immediately. The American Venous Forum (AVF), with a few exceptions, is largely composed of vascular surgeons. However, physicians from several specialties participate in the care of patients with acute and chronic venous disease and more cooperative efforts across key specialties are needed. Such efforts need to include vascular surgeons, dermatologists, hematologists, interventional radiologists, cardiologists, and field specific scientific experts in areas such as basic science, epidemiology, and genetics. Unless the quality of scientific collaboration and functional infrastructure are comprehensively improved and promoted (designated “we” priorities), priorities referring to the delivery of medicine from the physician to the patient (“me” priorities) are unlikely to advance effectively. Consistent with these goals, there was consensus that the American Venous Forum should direct efforts towards becoming a more broadly inclusive organization. As part of its scientific mission, the forum should move to establish a clearinghouse for projects related to venous disease, allowing experts to collaborate on specific initiatives. Such measures could include development of a nonprofit foundation to consolidate funding from disparate sources. The focus should be on highest quality evidence and credibility; this could be best achieved by collaboration between healthcare organizations, government funding agencies, industry, and members of the AVF and associated groups. A more unified, broadly inclusive organization would build a culture of cooperation and common purpose among venous specialists. With the purpose of strengthening, consolidating, and coordinating the resources of existing organizations; raising awareness about venous disorders among physicians and the public; and fostering relationships among those with an interest in all aspects of venous disease; formation of a Joint Venous Council was recommended. Council members would include representatives from the major societies, industry, government, and the public. This group might be structured similar to the peripheral arterial disease (PAD) coalition that has focused on issues relating to peripheral arterial disease. A steering committee has been formed to implement this proposal and will develop an organizational framework, propose membership of the Joint Council, and plan an agenda for the first meeting. A second universal theme was the need to develop a new training paradigm to properly train physicians in the diagnosis, treatment, and investigation of the entire spectrum of venous disorders. There is a clear need for an organized, evidence-based postgraduate venous curriculum. The development of an “angiology” specialty was suggested as a long-term goal to be discussed at future meetings. Creation of dedicated venous clinics with accreditation standards and a focus on education would be part of this project. Significant resources should also be devoted to educating nonspecialists (especially in the primary care and hospital settings) in the prevention of deep venous thrombosis and leg ulcers. A global information system to facilitate reporting of venous disease was also considered important in advancing communication among investigators. Such a system could be used to develop and implement longitudinal epidemiologic studies characterizing the demographic, environmental, anthropomorphic, and social factors that lead to development of chronic venous disease in an international population. It would be useful in standardizing clinical trials of venous thrombosis, as well as evaluating drugs and devices for the treatment of venous disorders. Such a system could also improve the education of practicing physicians, private and governmental health care agencies, and the public. Finally, all groups agreed to the need for increased governmental recognition of the importance of venous disease and innovative approaches to research funding incorporating both private commercial investment and governmental funding. The therapy of venous disorders must become more organized and evidence-based and should include development of better drugs for acute and chronic venous disease, as well as refinement of existing surgical procedures and development of new procedures and devices. Potential new devices for the treatment of venous disease include improved stenting systems, biodegradable filters, venous conduits, angiogenesis factors, artificial valves, and skin replacements. A better understanding of the interaction among devices and the coagulation and inflammatory systems will be required to properly assess any new device. Quality of life assessments must also be part of the evaluation of any new drug, device, or therapeutic approach to venous disorders, and the associated psychosocial problems need to be more fully addressed. Finally, from a clinical perspective, the development of integrated, multidisciplinary teams is essential in the treatment of patients with more advanced manifestations of CVD. The acute venous disease study section was charged with developing global programs to promote the awareness and prophylaxis of venous thromboembolic disease (VTE) as well as developing specific scientific projects to improve present standards of care. Several sessions were devoted to the identification of projects that would advance the treatment of venous disease through emerging technologies in clinical and basic science. From these discussions came three specific research endeavors that could be implemented in the next funding cycle. Many other potential initiatives were discussed, with the goal of using this meeting to launch future projects. Several areas of need were identified and discussed in enough detail to initiate corrective measures and scientific studies in the near future. The need for a cooperative, interdisciplinary approach to venous disease; the advantages of a multidisciplinary, multicenter approach to research; and the need for a partnership between governmental funding agencies and industry has been discussed above. From an organizational standpoint a network of physicians interested in clinical protocols and basic research is also needed. This network should be internet-based and must be responsive to government-sponsored requests for proposals and industrial opportunities. Increased involvement of the AVF research committee in coordinating a web article repository, serving as a clearinghouse for Pacific Vascular V reports, and organizing lifeline venous research presentations is also needed. From a research perspective, the basic mechanisms of venous thrombosis initiation and resolution need to be further investigated with the goal of designing future clinical trials in a hypothesis driven manner. Crucial to further efforts is the integration of acute DVT outcomes research with therapies to improve and standardize patient care. Three specific research projects were identified as warranting immediate attention and planning. Despite encouraging results from large multicenter registries3Mewissen M.W. Seabrook G.R. Meissner M.H. Cynamon J. Labropoulos N. Haughton S.H. Catheter-directed thrombolysis of lower extremity deep venous thrombosis: Report of a national multicenter registry.Radiology. 1999; 211: 39-49Crossref PubMed Scopus (740) Google Scholar and small trials,4Plate G. Einarsson E. Ohlin P. Jensen R. Qvarfordt P. Eklof B. Thrombectomy with temporary arteriovenous fistula: the treatment of choice in acute iliofemoral venous thrombosis.J Vasc Surg. 1984; 1: 867-876PubMed Scopus (172) Google Scholar, 5Plate G. Ohlin P. Eklof B. Pulmonary embolism in acute ileofemoral venous thrombosis.Br J Surg. 1985; 72: 912-915Crossref PubMed Scopus (73) Google Scholar there is a lack of randomized clinical trial data supporting the use of early thrombus removal techniques in the treatment of acute DVT and such strategies are not routinely recommended by current consensus guidelines.1Buller H.R. Agnelli G. Hull R.D. Hyers T.M. Prins M.H. Raskob G.E. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126: 401S-428SCrossref PubMed Scopus (1150) Google Scholar There is a clear need for generalizeable, randomized clinical trials comparing standard anticoagulation with “open vein” strategies designed to remove thrombus early after presentation with mechanical or pharmacological catheter-based thrombolytic techniques. Such trials should be of an international, multicenter design with anatomic stratification (iliofemoral vs femoropopliteal thrombosis) of patients. The design should include a 1-year run-in period to bring all centers online and perform early harm analysis. There was consensus in allowing some latitude with respect to the specific technique of thrombus removal (mechanical, pharmacological, or combination) to accommodate improvements in technology. Emphasis was placed on 5-year as well as 1-year outcomes with respect to quality of life, rate of recurrent VTE, and objective development of the post-thrombotic syndrome. It is notable that a similar initiative, comparing best medical therapy vs best interventional strategy for thrombus removal, was recently designated the highest research priority at a multidisciplinary consensus panel arranged under the auspices of the Cooperative Alliance for Interventional Radiology Research (CAIRR) and the Society for Interventional Radiology (SIR).6Vedantham S. Rundback J.H. Comerota A.J. Hunter D.W. Meissner M.H. Hofmann L.V. et al.Development of a research agenda for endovascular treatment of venous thromboembolism: proceedings from a multidisciplinary consensus panel.J Vasc Interv Radiol. 2005; 16: 1567-1573Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar The trial proposed by this panel is currently in the initial development and funding stages. The participants at the Pacific Vascular Symposium broadly supported such a trial and agreed to assist in the design and implementation of a definitive study as needed. The safety of permanent filters, as well as the development of retrievable filters, has led to their expanded use for a number of perceived relative indications7Langan 3rd, E.M. Miller R.S. Casey 3rd, W.J. Carsten 3rd, C.G. Graham R.M. Taylor S.M. Prophylactic inferior vena cava filters in trauma patients at high risk: follow-up examination and risk/benefit assessment.J Vasc Surg. 1999; 30: 484-488Abstract Full Text Full Text PDF PubMed Scopus (99) Google Scholar, 8Sugerman H.J. Sugerman E.L. Wolfe L. Kellum Jr, J.M. Schweitzer M.A. DeMaria E.J. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease.Ann Surg. 2001; 234: 41-46Crossref PubMed Scopus (153) Google Scholar without substantial evidence to support such practices. Trials comparing the use of permanent and retrievable IVC filters with prophylaxis and DVT surveillance strategies in high-risk patients (eg, trauma and intracerebral hemorrhage) are desperately needed. The development and implementation of such a trial would optimally involve the participation of trauma surgeons and intensive care specialists. Trial endpoints should include survival, incidence of VTE, cost, length of ICU and hospital stay, and device specific complications such as IVC patency and filter migration. Preliminary data suggests that the levels of fibrinolytic inhibition and activated coagulation are related to the extent of recanalization.9Meissner M.H. Zierler B.K. Chandler W.L. Strandness D.E. Coagulation, fibrinolysis, and recanalization after acute deep venous thrombosis.J Vasc Surg. 2002; 35: 278-285Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar Furthermore, although the duration of anticoagulation is currently based on the risk of recurrent VTE, determined by randomized clinical trials,1Buller H.R. Agnelli G. Hull R.D. Hyers T.M. Prins M.H. Raskob G.E. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126: 401S-428SCrossref PubMed Scopus (1150) Google Scholar observational data suggests that incomplete recanalization documented by ultrasonography10Piovella F. Crippa L. Barone M. Vigano D’Angelo S. Serafini S. et al.Normalization rates of compression ultrasonography in patients with a first episode of deep vein thrombosis of the lower limbs: association with recurrence and new thrombosis.Haematologica. 2002; 87: 515-522PubMed Google Scholar, 11Prandoni P. Lensing A.W. Prins M.H. Bernardi E. Marchiori A. Bagatella P. et al.Residual venous thrombosis as a predictive factor of recurrent venous thromboembolism.Ann Intern Med. 2002; 137: 955-960Crossref PubMed Scopus (455) Google Scholar and persistently elevated D-Dimer levels12Palareti G. Legnani C. Cosmi B. Valdre L. Lunghi B. Bernardi F. et al.Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia.Circulation. 2003; 108: 313-318Crossref PubMed Scopus (255) Google Scholar after discontinuing oral anticoagulants are important risk factors for recurrence. There is a need for robust management trials of specific markers of coagulation (D-Dimer, thrombin-antithrombin complex, microparticles, prothrombin fragment 1 + 2) and fibrinolysis (t-plasminogen activator and plasminogen activator inhibitor-1) in determining the type and duration of therapy for acute VTE. Endpoints would include thrombus extension, recanalization, and recurrent VTE. Biomarkers would be quantified at presentation, 1 week prior to discontinuation of therapy and 4 weeks following the completion of therapy. Patients would be followed for at least 2 years to document endpoints. Other studies proposed, but not developed in detail, included development of a test or panel of tests (a “thrombochip”) to stratify the risk of VTE and predict outcomes after acute DVT. Such knowledge would permit interventions and duration of therapy to be individualized based on genomic, proteomic and serum biomarker profiles. Studies defining the true natural history and appropriate management of both secondary upper extremity DVT and proximal saphenous thrombophlebitis are also needed. There is clearly no consensus regarding the treatment of superficial thrombophlebitis and a registry may be more appropriate than a formal trial as an initial step. Projects including strategies to promote DVT awareness and improve compliance with established American College of Chest Physician (ACCP) guidelines13Geerts W.H. Pineo G.F. Heit J.A. Bergqvist D. Lassen M.R. Colwell C.W. et al.Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126: 338S-400SCrossref PubMed Scopus (2501) Google Scholar were also encouraged. Multicenter projects to generate support for young investigators and to assist with AVF sponsored submissions to the NIH were also proposed. This group focused on unresolved issues and future projects involving the diagnosis of acute and chronic venous disease. As venous diagnostic testing requires a thorough understanding of venous physiology and hemodynamics, this group was termed the diagnostics/hemodynamics group. After preliminary discussions in breakout groups, the diagnostics/hemodynamics group developed plans and recommendations for research projects relevant to venous diagnosis. The initial discussions of the diagnostics/hemodynamics group were broadly focused and several ideas were advanced. Future research should focus on the identification of molecular, serologic, and genetic markers that may be useful in detecting venous disease apriori, perhaps in conjunction with targeted thrombophilia testing and assessment of environmental risk factors. Such information might facilitate more individualized treatment of patients with acute venous thrombosis and chronic venous disease and aid in identifying the contribution of individual risk factors to the overall risk of venous thrombosis. Further work is needed to improve our understanding of venous physiology, pathophysiology, and natural history. This is fundamental to improving diagnostic tests and facilitating precise treatment of patients with venous disorders. The development of a quantitative test for venous obstruction and a global noninvasive surrogate measure of ambulatory venous pressure are particular priorities. In addition, there is a critical need to standardize existing venous tests with respect to indications, testing protocols, and normal ranges. A clear definition of what constitutes a significant change in a testing parameter is particularly needed in patients with advanced CVD who may undergo interventions. Based on these preliminary deliberations, the following projects have been identified as priorities in advancing our understanding of venous hemodynamics and improving diagnostic modalities. The goals of this project are to standardize noninvasive testing for acute and chronic venous disease; identify standard quality of life and hemodynamic outcomes; and develop uniform testing protocols. As initially proposed, this project involves three phases. First, the diagnostic modalities currently being utilized in vascular laboratories must be determined. Potential sources of data include the Intersocietal Commission for Accreditation of Vascular Laboratories (ICVAL) database, which can be used to identify tests actually being performed as well as the indications, protocols, and exam and interpretation standards of various vascular laboratories. The Center for Medicare and Medicaid Services (CMS) can also be queried for ICD-9 and CPT codes to define the range of tests performed, the indications for testing, and the demographics of those ordering examinations. Members of the venous societies can also be surveyed for their testing practices in patients with acute and chronic venous disease. Secondly, a comprehensive literature review should be undertaken to examine the tests and standards used in current venous research. Finally, appropriate societal representatives should evaluate the above data and a consensus statement developed regarding protocols for noninvasive venous testing, normal ranges, the definition of significant within patient change, and recommended examinations based upon common clinical presentations. These suggestions would be added to the existing reporting standards for venous disease.14Eklof B. Rutherford R.B. Bergan J.J. Carpentier P.H. Gloviczki P. Kistner R.L. et al.Revision of the CEAP classification for chronic venous disorders: consensus statement.J Vasc Surg. 2004; 40: 1248-1252Abstract Full Text Full Text PDF PubMed Scopus (1395) Google Scholar, 15Porter J. Moneta G. Reporting standards in venous disease: an update.J Vasc Surg. 1995; 21: 635-645Abstract Full Text Full Text PDF PubMed Scopus (1031) Google Scholar, 16Porter J. Rutherford R. Clagett G. Cranley J. O’Donnell T. Raju S. et al.Reporting standards in venous disease.J Vasc Surg. 1988; 8: 172-181PubMed Google Scholar Magnetic resonance venography (MRV) is among the most promising modalities in venous diagnostic testing. This project aims to explore the use of MRV in assessing venous obstruction. Potential methods of interest include CINE-gated MRV to quantify outflow obstruction. Soft tissue water content should also be evaluated as a potential diagnostic measure. Pre- and post-therapy testing will be performed along with blood tagging (eg, with gadolinium) studies to evaluate venous inflow and outflow. This study proposes to evaluate the anatomic patterns of reflux and hemodynamic parameters that most accurately identify individual CEAP categories, forecast disease progression to higher CEAP classes, and predict response to therapy (quality of life, ulcer healing). Reflux will be evaluated from the inguinal ligament to the ankle using duplex ultrasonography and standing cuff deflation methods.17van Bemmelen P.S. Bedford G. Beach K. Strandness D.E. Quantitative segmental evaluation of venous valvular reflux with duplex ultrasound scanning.J Vasc Surg. 1989; 10: 425-431PubMed Scopus (396) Google Scholar Diagnostic measurements will include duration of reflux, reflux velocity, reflux volume, reflux velocity index, and perhaps other as yet unknown parameters. An Incompetent Valvular Severity Score will be developed to quantify the overall severity of reflux. A multicenter design is required to provide adequate patient numbers and insure inclusion of patients with varying demographics. Subjects with lymphedema, recent trauma, BMI > 40, and previous vein surgery would be excluded. Most validated strategies for the diagnosis of acute DVT have limited examination to compression of the proximal veins and have required either serial examinations18Birdwell B. Raskob G. Whitsett T. Durica S. Comp P. George J. et al.The clinical validity of normal compression ultrasonography in outpatients suspected of having deep venous thrombosis.Ann Intern Med. 1998; 128: 1-7Crossref PubMed Scopus (253) Google Scholar, 19Cogo A. Lensing A.W.A. Koopman M.M.W. Piovella F. Siragusa S. Wells P. et al.Compression ultrasonography for diagnostic management of patients with clinically suspected deep vein thrombosis: prospective cohort study.BMJ. 1998; 316: 617-620Crossref Scopus (367) Google Scholar or combined algorithms including D-dimer measurement and clinical risk stratification.20Anderson D.R. Wells P.S. Stiell I. MacLeod B. Simms M. Gray L. et al.Management of patients with suspected deep vein thrombosis in the emergency department: combining use of a clinical diagnosis model with D-dimer testing.J Emerg Med. 2000; 19: 225-230Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar, 21Dryjski M. O’Brien-Irr M.S. Harris L.M. Hassett J. Janicke D. Evaluation of a screening protocol to exclude the diagnosis of deep venous thrombosis among emergency department patients.J Vasc Surg. 2001; 34: 1010-1015Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar, 22Wells P.S. Hirsh J. Anderson D.R. Lensing A.W.A. Foster G. Kearon C. et al.Accuracy of clinical assessment of deep-vein thrombosis.Lancet. 1995; 345: 1326-1330Abstract PubMed Scopus (447) Google Scholar, 23Wells P.S. Anderson D.R. Bormanis J. Guy F. Mitchell M. Gray L. et al.Value of assessment of pretest probability of deep-vein thrombosis in clinical management.Lancet. 1997; 350: 1795-1798Abstract Full Text Full Text PDF PubMed Scopus (922) Google Scholar Despite encouraging preliminary data,24Elias A. Mallard L. Elias M. Alquier C. Guidolin F. Gauthier B. et al.A single complete ultrasound investigation of the venous network for the diagnostic management of patients with a clinically suspected first episode of deep venous thrombosis of the lower limbs.Thromb Haemost. 2003; 89: 221-227PubMed Google Scholar, 25Schellong S.M. Schwarz T. Halbritter K. Beyer J. Siegert G. Oettler W. et al.Complete compression ultrasonography of the leg veins as a single test for the diagnosis of deep vein thrombosis.Thromb Haemost. 2003; 89: 228-234PubMed Google Scholar the accuracy of a single, technically adequate duplex scan, including the calf veins, has not yet been sufficiently validated. The purposes of this study are to evaluate the accuracy of a single color flow duplex examination, including the calf veins, in excluding acute DVT; to improve guidelines for the diagnosis of acute DVT; and to define an adequate scan technique. Subjects should have no prior history of DVT and be clinically symptomatic. In addition to clinical and demographic information, collected data will include physical examination (including calf circumference), clinical probability scores, and D-dimer and CRP levels. Complete, bilateral color flow duplex scans will be performed including measurement of thrombus location, length, volume, and echogenicity as well as venous diameter and wall thickness. Subjects with negative scans but a high clinical probability of DVT will undergo serial imaging. As comparison with venography would be difficult, this will be a management trial with endpoints including the results of clinical and ultrasound follow-up at 6 months. The purposes of this study are to evaluate the natural history of DVT, including the development of reflux, in relation to ultrasound characteristics of the thrombus. Thrombus specific measurements will include the extent and location of the thrombus, degree and length of time to recanalization, grey-scale characteristics of the thrombus, and the development of reflux and its timing. Analysis will include the effects of type of anticoagulation (low molecular heparin vs unfractionated heparin), the use of other adjuvant therapies, and serum markers of coagulation, fibrinolysis, and inflammation. The working framework for the primary chronic venous disease group was subdivided into topics including prevention, pathophysiology, diagnostics, research, and treatment and intervention. The combination of declining health care budgets and an increasing number of patients with CVD will soon render the issue of funding care for complications of primary CVD critical. Population screening for early disease will likely become indispensable in containing the socio-economic repercussions of primary CVD by enabling timely intervention and prevention of disease progression. Control of associated risk factors; genetic interventions in CVD-related aberrations; selective, safe and long-lasting suppression of inflammatory processes; and national awareness of primary CVD are also essential in disease prevention. Optimal treatment of CVD is currently hindered by insufficient knowledge of the pathophysiology, including the sentinel events preceding CVD progression and the effects of inflammation, re-epithelialization, matrix deposition, and tissue remodeling. An improved understanding of these pathophysiologic mechanisms, through clinical and basic research, is critical to further advancements in disease prevention and management. Comprehensive, cost-effective, and minimally invasive diagnostics must be developed to facilitate both early identification of CVD and quantification of the associated pathophysiology. Three-dimensional, lim" @default.
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• W2111118082 title "Mapping the future: Organizational, clinical, and research priorities in venous disease" @default.
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