Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries.

PURPOSE: To evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries. MATERIALS AND METHODS: All lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis. RESULTS: Among the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%-99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69-0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27-0.39; P < .001) composite end points. CONCLUSIONS: Intravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.

Optimal Medical Therapy Following Deep Venous Interventions: Proceedings from the Society of Interventional Radiology Foundation Research Consensus Panel.

The optimal medical management of patients following endovascular deep venous interventions remains ill-defined. As such, the Society of Interventional Radiology Foundation (SIRF) convened a multidisciplinary group of experts in a virtual Research Consensus Panel (RCP) to develop a prioritized research agenda regarding antithrombotic therapy following deep venous interventions. The panelists presented the gaps in knowledge followed by discussion and ranking of research priorities based on clinical relevance, overall impact, and technical feasibility. The following research topics were identified as high priority: 1) characterization of biological processes leading to in-stent stenosis/rethrombosis; 2) identification and validation of methods to assess venous flow dynamics and their effect on stent failure; 3) elucidation of the role of inflammation and anti-inflammatory therapies; and 4) clinical studies to compare antithrombotic strategies and improve venous outcome assessment. Collaborative, multicenter research is necessary to answer these questions and thereby enhance the care of patients with venous disease.

Qualitative study of patients with venous malformations: symptom experiences and content validity of patient-reported outcome measures.

PURPOSE: To determine important symptoms and functional effects of venous malformations (VMs) to assess the content validity of commonly used patient-reported outcome (PRO) measures for use with VM patients. METHODS: This cross-sectional, qualitative study involved cognitive interviews with participants with VM aged ≥ 14 years. From February to June 2016, 11 participants (8 female) with a mean (± standard deviation) age of 31 ± 15 years were recruited from three clinical sites. The following subgroups were evaluated: 5 adults (aged ≥ 18) with trunk/extremity VMs; 3 adolescents (aged 14-17) with trunk/extremity VMs; and 3 adults with head/neck VMs. We evaluated the content validity of the Worst Pain Numeric Rating Scale (NRS), Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference 8-item short form, and PROMIS Physical Function 8-item short form. RESULTS: The most common participant-reported VM symptoms were swelling (n = 10), skin discoloration (n = 8), acute episodic pain (n = 8), chronic pain (n = 7), numbness (n = 7), and tingling/burning (n = 6). Participants reported that VMs affected their physical function (n = 10), appearance (n = 10), relationships/social activities (n = 7), and emotional health (n = 3). The Worst Pain NRS and PROMIS Pain Interference measures were relevant to all participants' VM experience. Only adults with head/neck VMs found the PROMIS Physical Function measure to be irrelevant. The assessed PRO measures did not address several symptoms commonly reported by VM patients (swelling, skin discoloration, numbness, and appearance). CONCLUSION: These results suggest that several VM symptoms are not assessed fully by commonly used PRO measures, and that the relevance of functional limitation questions may vary by VM location.

Ultrasound for Lower Extremity Deep Venous Thrombosis: Multidisciplinary Recommendations From the Society of Radiologists in Ultrasound Consensus Conference.

Venous ultrasound is the standard imaging test for patients suspected of having acute deep venous thrombosis (DVT). There is variability and disagreement among authoritative groups regarding the necessary components of the test. Some protocols include scanning the entire lower extremity, whereas others recommend scans limited to the thigh and knee supplemented with serial testing. Some protocols use gray-scale ultrasound alone, whereas others include Doppler interrogation. Point-of-care ultrasound is recommended in some settings, and there is heterogeneity of these protocols as well. Heterogeneity of recommendations can lead to errors including incorrect application of guidelines, confusion among requesting physicians, and incorrect follow-up. In October 2016, the Society of Radiologists in Ultrasound convened a multidisciplinary panel of experts to evaluate the current evidence to develop recommendations regarding ultrasound protocols for DVT and the terminology used to communicate results to clinicians. Recommendations were made after open discussion and by unanimous consensus.The panel recommends a comprehensive duplex ultrasound protocol from thigh to ankle with Doppler at selected sites rather than a limited or complete compression-only examination. This protocol is currently performed in many facilities and is achievable with standard ultrasound equipment and personnel. The use of these recommendations will increase the diagnosis of calf DVT and provide better data to explain the presenting symptoms. The panel recommends a single point-of-care protocol that minimizes underdiagnoses of proximal DVT.The panel recommends the term chronic postthrombotic change to describe the residual material that persists after the acute presentation of DVT to avoid potential overtreatment of prior thrombus.Adoption of a single standardized comprehensive duplex ultrasound and a single point-of-care examination will enhance patient safety and clinicians' confidence.

Comparison of outcomes in women and men following carotid interventions in the Washington state's Vascular Interventional Surgical Care and Outcomes Assessment Program.

BACKGROUND: The benefit for carotid endarterectomy (CEA) to prevent a potential stroke has been shown to be less beneficial for women compared with men and the risk of carotid stenting (CAS) is higher in women than men. We hypothesized that a community-based Washington state registry data would also reveal increased morbidity and mortality for women undergoing carotid interventions. METHODS: Deidentified data for CEA and CAS between 2010 and 2015 were obtained from 19 hospitals participating in the Washington State Vascular-Interventional Surgical Care and Outcomes Assessment Program. Data analysis compared in-hospital composite outcome of stroke and mortality from CEA and CAS between women and men. RESULTS: Over the study period, 3704 individuals underwent CEA (n = 2759; 49.5% symptomatic) and CAS (n = 945; 60.9% symptomatic). Women accounted for 39.5% of the cohort. Women were slightly younger than men (70.0 ± 10.2 vs 71.0 ± 9.6 years respectively; P < .01), less likely to be smokers (70.1% vs 75.6%; P < .01), and less likely to have a diagnosis of coronary artery disease (32.9% vs 46.5%; P < .01). Fewer women underwent CEA for symptomatic carotid disease (46.1% vs 51.8%; P < .01). There were no statistically significant differences in the postoperative in-hospital stroke and mortality among women and men undergoing CEA (asymptomatic, 0.8% vs 1.4% [P = .36]; symptomatic, 1.8% vs 2.2% [P = .58]) and CAS (asymptomatic, 1.4% vs 2.2% [P = .56]; symptomatic, 4.6% vs 2.5% [P = .18]). Hospital duration of stay and discharge disposition were similar for women and men. A subanalysis of the octogenarian cohort undergoing CAS demonstrated a substantial increase in-hospital stroke and mortality among women and men (11.6% [CAS] vs 2.2% [CEA]; P = .024). CONCLUSIONS: In the Washington state Vascular-Interventional Surgical Care and Outcomes Assessment Program registry, hospital composite outcome of stroke and mortality following carotid interventions from 2010 to 2015 were noted to be similar for women and men. The notable exception to this finding was observed in subcohort of women undergoing CAS for symptomatic carotid disease at age 80 years or older. These findings should be taken into account when risk stratifying patients for carotid interventions.

Research Priorities in Pelvic Venous Disorders in Women: Recommendations from a Multidisciplinary Research Consensus Panel.

Pelvic venous disorders (PeVDs) in women can present with chronic pelvic pain, lower-extremity and vulvar varicosities, lower-extremity swelling and pain, and left-flank pain and hematuria. Multiple evidence gaps exist related to PeVDs with the consequence that nonvascular specialists rarely consider the diagnosis. Recognizing this, the Society of Interventional Radiology Foundation funded a Research Consensus Panel to prioritize a research agenda to address these gaps. This paper presents the proceedings and recommendations from that Panel.

Preliminary validation of the Claudication Symptom Instrument (CSI).

This article describes the development of the Claudication Symptom Instrument (CSI) and its measurement properties for evaluating the symptom experience of patients diagnosed with intermittent claudication (IC). We conducted semi-structured qualitative interviews with IC patients for item development and cognitive interviews in which patient comprehension of items was tested. We evaluated measurement properties using data collected and analyzed in the context of an observational comparative effectiveness study of IC treatments. Items measuring five symptom important to patients were developed and cognitively tested: Pain, Numbness, Heaviness, Cramping, and Tingling. Item means (higher means worse) ranged from 1.1 (Tingling) to 2.3 (Pain) (range: 0 'none' to 4 'extreme'). Rasch analysis yielded support for an overall score (χ2=26.5, df=20, p=0.15). The total CSI score differed by clinician-rated severity of mild versus moderate ( p<0.05), but not moderate versus severe. Re-administration of the CSI 5-10 days after baseline yielded an intra-class correlation coefficient of 0.86. Changes in CSI total score and VASCUQOL total score between baseline and 6 months post-treatment were correlated at -0.52 ( p<0.05). The CSI preliminarily meets accepted measurement standards for content validity, internal consistency and test-retest reliability, construct validity, and sensitivity for detecting change. Because of its high test-retest reliability, it may also be useful in clinical care with individual patients. It takes approximately 3 minutes to complete.

Influence of Gender on Abdominal Aortic Aneurysm Repair in the Community.

BACKGROUND: Women have been shown to experience inferior outcomes following intact and ruptured abdominal aortic aneurysm (AAA) treatment in endovascular aneurysm repair (EVAR) and open surgical repair (OSR) groups. The goal of our study was to compare gender-specific presentation, management, and early outcomes after AAA repair using a statewide registry. METHODS: We utilized the Washington State's Vascular Interventional Surgical Care and Outcomes Assessment Program registry data collected in 19 hospitals from July 2010 to September 2013. Demographics, presentation, procedural data, and outcomes in elective and emergent AAA repair groups were analyzed. RESULTS: We identified 1,231 patients (19.6% women) who underwent intact (86.4%) or ruptured AAA (13.6%) repairs. Nine thousand seventy-two (79.0%) patients had EVAR and 259 (21.0%) had OSR. Men and women were of equivalent age and had similar comorbidities, except that women had less coronary artery disease (P < 0.01) and were more likely to suffer from chronic obstructive pulmonary disease (P = 0.05). Women had smaller aneurysm diameters (5.8 ± 1.1 vs. 6.2 ± 1.8 cm, P < 0.01) at the time of presentation and men had slightly higher incidence of rupture at larger aneurysm size. Men were more likely to undergo EVAR, with significant differences in elective (82.1% vs. 74.1%, P = 0.01), but not ruptured repair. Women had significantly higher mortality rates following elective EVAR (3.1% vs. 0.6%, P = 0.01), but not after ruptured or elective open repair. Following elective EVAR, women were less likely to be discharged to home after longer hospital stays (3 vs. 2 days, P < 0.01). CONCLUSIONS: Despite presentation at a similar age, with a smaller aneurysm diameter, and similar medical comorbidities, women experience substantially worse hospital outcomes primarily driven by elective endovascular procedures. Utilization of endovascular techniques in women still remains lower compared with men. Improvement of elective outcomes in women will likely depend on technical advancements in repair techniques and management strategies that may differ between genders.

The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.

BACKGROUND: Diabetes mellitus continues to grow in global prevalence and to consume an increasing amount of health care resources. One of the key areas of morbidity associated with diabetes is the diabetic foot. To improve the care of patients with diabetic foot and to provide an evidence-based multidisciplinary management approach, the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine developed this clinical practice guideline. METHODS: The committee made specific practice recommendations using the Grades of Recommendation Assessment, Development, and Evaluation system. This was based on five systematic reviews of the literature. Specific areas of focus included (1) prevention of diabetic foot ulceration, (2) off-loading, (3) diagnosis of osteomyelitis, (4) wound care, and (5) peripheral arterial disease. RESULTS: Although we identified only limited high-quality evidence for many of the critical questions, we used the best available evidence and considered the patients' values and preferences and the clinical context to develop these guidelines. We include preventive recommendations such as those for adequate glycemic control, periodic foot inspection, and patient and family education. We recommend using custom therapeutic footwear in high-risk diabetic patients, including those with significant neuropathy, foot deformities, or previous amputation. In patients with plantar diabetic foot ulcer (DFU), we recommend off-loading with a total contact cast or irremovable fixed ankle walking boot. In patients with a new DFU, we recommend probe to bone test and plain films to be followed by magnetic resonance imaging if a soft tissue abscess or osteomyelitis is suspected. We provide recommendations on comprehensive wound care and various débridement methods. For DFUs that fail to improve (>50% wound area reduction) after a minimum of 4 weeks of standard wound therapy, we recommend adjunctive wound therapy options. In patients with DFU who have peripheral arterial disease, we recommend revascularization by either surgical bypass or endovascular therapy. CONCLUSIONS: Whereas these guidelines have addressed five key areas in the care of DFUs, they do not cover all the aspects of this complex condition. Going forward as future evidence accumulates, we plan to update our recommendations accordingly.

A comparison of Villalta-Prandoni scale and venous clinical severity score in the assessment of post thrombotic syndrome.

BACKGROUND: Post-thrombotic syndrome (PTS) is the most important late complication of acute deep venous thrombosis (DVT), with as many as two-thirds of patients developing symptoms of pain, edema, hyperpigmentation, or ulceration. Although several instruments are available for evaluation of the severity of PTS, including the Villalta-Prandoni scale (VPS) and Venous Clinical Severity Score (VCSS), no studies have yet compared the 2 instruments. The purpose of this study is to compare the 2 instruments as part of a larger randomized controlled study that assessed the impact of graduated compressive stockings in the prevention of PTS. METHODS: Sixty-nine consecutive patients with acute DVT documented by duplex ultrasonography were randomized to treatment with 30-40 mm Hg graduated compressive stockings (GCS) or no stockings. Patients were followed clinically at months 1, 3, 6, 12, 18, and 24 after the diagnosis of DVT. PTS as defined by the VPS and VCSS were assessed at these follow-up visits. Based upon the VPS, PTS was scored as absent (score <3 or 3 without objective criteria), mild to moderate (score ≥3 with 1 objective criteria), or severe (score ≥4). For the VCSS, PTS was considered to be absent (score ≤3), mild to moderate (score 4-7), or severe (score ≥8). The 2 instruments were compared for mild to moderate and severe disease using the Pearson chi-squared test and gamma statistic. RESULTS: Good correlation was detected in the ability of VPS and VCSS instruments to detect mild to moderate disease (gamma statistic = 0.71-0.98; P < 0.05). For severe disease, a statistically significant correlation was not found in the ability of the 2 instruments to detect disease (gamma statistic = 0.5-0.98; P > 0.05), especially at 12 and 24 months. CONCLUSION: Both VPS and the VCSS scoring systems are important tools in the identification and follow-up of PTS. There exists agreement between the 2 instruments for detecting mild to moderate disease. For severe disease however, VCSS may possibly be a more sensitive instrument.

Diagnosis and Management of Pelvic Venous Disorders in Women.

Pelvic venous reflux and obstruction can lead to chronic pelvic pain and extra-pelvic varicosities. This paper will discuss the contemporary understanding of this pathophysiology and its clinical manifestations. It will review evidence-based clinical and imaging criteria of pelvic venous disorders, data supporting benefit from venous interventions, criticisms of the available data and highlight evidence research gaps that exist. Finally, it will argue that comparative outcomes research utilizing standardized patient selection for embolization and stenting, embolization treatment strategies that eliminate the pelvic varices (at least to start), and clinically relevant outcome measures are necessary to establish the benefit of vascular treatments.

Diagnosis of post-thrombotic syndrome: International union of phlebology (UIP) survey of medical specialists.

OBJECTIVE: To review the current approaches to the diagnosis of Post-Thrombotic Syndrome (PTS) and to evaluate the potential need for a diagnostic tool. METHOD: Medical specialists were invited to participate in an online survey of their current approaches to the diagnosis and management of PTS, including the use of scoring systems, diagnostic imaging techniques and the extent the practitioner reviews the patient's venous history. RESULTS: 502 participants completed the survey. Over 80% obtained imaging reports to confirm a history of deep vein thrombosis (DVT). 72% of participants always obtained an up-to-date duplex ultrasound for PTS diagnosis. Over 50% did not use a scoring system for either PTS diagnosis or management. 65% of the participants agreed that a new system for PTS diagnosis should be devised. CONCLUSION: Heterogeneity was observed in methods of diagnosing PTS by medical practitioners with frequent use of medical imaging studies and moderate use of scoring systems. Development of a new diagnostic tool for PTS should be considered for future studies.

The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine.

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.

The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology.

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.

Early thrombus removal strategies for acute deep venous thrombosis: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.

BACKGROUND: The anticoagulant treatment of acute deep venous thrombosis (DVT) has been historically directed toward the prevention of recurrent venous thromboembolism. However, such treatment imperfectly protects against late manifestations of the postthrombotic syndrome. By restoring venous patency and preserving valvular function, early thrombus removal strategies can potentially decrease postthrombotic morbidity. OBJECTIVE: A committee of experts in venous disease was charged by the Society for Vascular Surgery and the American Venous Forum to develop evidence-based practice guidelines for early thrombus removal strategies, including catheter-directed pharmacologic thrombolysis, pharmacomechanical thrombolysis, and surgical thrombectomy. METHODS: Evidence-based recommendations are based on a systematic review and meta-analysis of the relevant literature, supplemented when necessary by less rigorous data. Recommendations are made according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, incorporating the strength of the recommendation (strong: 1; weak: 2) and an evaluation of the level of the evidence (A to C). RESULTS: On the basis of the best evidence currently available, we recommend against routine use of the term "proximal venous thrombosis" in favor of more precise characterization of thrombi as involving the iliofemoral or femoropopliteal venous segments (Grade 1A). We further suggest the use of early thrombus removal strategies in ambulatory patients with good functional capacity and a first episode of iliofemoral DVT of <14 days in duration (Grade 2C) and strongly recommend their use in patients with limb-threatening ischemia due to iliofemoral venous outflow obstruction (Grade 1A). We suggest pharmacomechanical strategies over catheter-directed pharmacologic thrombolysis alone if resources are available and that surgical thrombectomy be considered if thrombolytic therapy is contraindicated (Grade 2C). CONCLUSIONS: Most data regarding early thrombus removal strategies are of low quality but do suggest patient-important benefits with respect to reducing postthrombotic morbidity. We anticipate revision of these guidelines as additional evidence becomes available.

Development of an international standard set of outcome measures for patients with venous thromboembolism: an International Consortium for Health Outcomes Measurement consensus recommendation.

The International Consortium for Health Outcomes Measurement assembled an international working group of venous thromboembolism experts and patient representatives to develop a standardised minimum set of outcomes and outcome measurements for integration into clinical practice and potentially research to support clinical decision making and benchmarking of quality of care. 15 core outcomes important to patients and health-care professionals were selected and categorised into four domains: patient-reported outcomes, long term consequences of the disease, disease-specific complications, and treatment-related complications. The outcomes and outcome measures were designed to apply to all patients with venous thromboembolism aged 16 years or older. A measurement tool package was selected for inclusion in the core standard set, with a minimum number of items to be measured at predefined timepoints, which capture all core outcomes. Additional measures can be introduced to the user by a cascade opt-in system that allows for further assessment if required. This set of outcomes and measurement tools will facilitate the implementation of the use of patient-centred outcomes in daily practice.

Guideline methodology of the Society for Vascular Surgery including the experience with the GRADE framework.

In 2006, the Society for Vascular Surgery began development of clinical practice guidelines to assist clinicians in the process of decision making. The Society selects clinical questions of high impact and evaluates the totality of evidence by identifying and conducting rigorous systematic reviews. Multidisciplinary committees follow the Grading of Recommendations, Assessment, Development and Evaluation framework (GRADE), standard consensus, and voting procedures. Factors other than evidence, including patients' values and preferences and the availability of surgical expertise, are also considered. We describe, in the context of cumulative 4-years' experience, the methods and rigor of current procedures adopted by the Society for Vascular Surgery in developing practice guidelines. We also discuss potential future efforts needed to maximize the quality, adoption, and application of the clinical recommendations.

A systematic review of lower extremity arterial revascularization economic analyses.

OBJECTIVE: Economic evaluation remains an understudied aspect of lower extremity vascular reconstructions. This study reviewed the economic-based literature with respect to open and endovascular treatment of peripheral arterial disease. METHODS: This systematic review included economic analyses of open and endovascular treatment of lower extremity peripheral arterial disease, including claudication and critical limb ischemia. Studies were categorized as model-based, cost-consequences, or econometric cost-analyses. Clinical, financial, and time-based outcomes were examined. RESULTS: From a candidate list of 1351 studies, 19 were appropriate for the review, comprising 3 model-based, 12 cost-consequence, and 4 cost-analyses. Because of the small numbers, claudication and critical limb ischemia studies were analyzed together. There was a trend favoring initial cost-savings with endovascular therapy. Whether this benefit is sustained over time is unknown. We were prevented from drawing cost-efficacy inferences because of a noted lack of standardized patient-centric outcomes, longitudinal data, and reintervention data. CONCLUSIONS: The existing lower extremity arterial revascularization economic literature is inadequate for drawing cost-efficacy conclusions and cannot inform guidelines for open vs endovascular treatment. Overcoming this limitation will require the inclusion of cost (initial and reintervention) and patient-centric outcomes in future studies evaluating lower extremity revascularization technologies. All journals, particularly vascular journals, should enforce standard reporting guidelines of effectiveness and economic studies to enable appropriate comparative and cost-effectiveness analyses.