Thromboembolic outcomes are decreased with the use of a standardized venous thromboembolism risk assessment and prophylaxis protocol for patients undergoing superficial venous procedures.

OBJECTIVE: Patients with venous insufficiency can be treated with ablation or phlebectomy, or both. Patients undergoing superficial venous procedures have an elevated risk of deep vein thrombosis (DVT) and pulmonary embolism (PE). At our institution, we initiated a standardized protocol in which patients with a Caprini score (2005 version) of ≥8 are treated with 1 week of prophylactic anticoagulation after the procedure. Duplex ultrasound was performed at 1 week and then within 90 days after the procedure. This aim of the present study was to determine the thrombotic and clinical outcomes after superficial vein procedures using a standardized protocol for DVT/PE risk assessment and prophylaxis. METHODS: We performed a retrospective analysis of prospectively collected data of superficial vein procedures from 2015 to 2021 at a single center. The patient demographics, CEAP (Clinical-Etiology-Anatomy-Pathophysiology) clinical class, venous clinical severity score, patient-reported outcomes, treatment type, Caprini scores, pre- and postoperative anticoagulation use, and outcomes were collected. Descriptive statistics were used for the patient demographics, procedure details, and unadjusted surgical outcomes. Multivariable logistic regression was used to evaluate the relationship between procedure type and DVT and PE after adjusting for patient characteristics, disease severity, periprocedural anticoagulation, and Caprini score. RESULTS: A total of 1738 limbs were treated with ablation (n = 820), phlebectomy (n = 181), or ablation and phlebectomy (n = 737). More patients were women (67.1%) and White (90.9%). The overall incidence of DVT/PE was 1.4%. Patients undergoing ablation with phlebectomy had higher rates of DVT/PE (2.7%) than those undergoing ablation (0.2%) or phlebectomy alone (1.7%; P < .01). However, only 30% of DVTs were above the knee. On multivariate analysis, only the procedure type predicted for DVT/PE. However, patients undergoing ablation and phlebectomy achieved better patient-reported outcomes (Caprini score, 5.9) compared with those undergoing ablation (Caprini score, 7.2) or phlebectomy (Caprini score, 7.9) alone (P < .01). The best improvement in the venous clinical severity score was seen with phlebectomy alone. CONCLUSIONS: The expected difference in the DVT/PE rates between high- and low-risk groups did not materialize in our patients, perhaps secondary to the additional chemoprophylaxis prescribed for the high-risk cohort (Caprini score, ≥8). These results call for a randomized trial to assess the efficacy of a standardized protocol in the reduction of DVT/PE after superficial vein procedures.

Choosing a mouse model of venous thrombosis: a consensus assessment of utility and application.

Murine models are widely used valuable tools to study deep vein thrombosis (VT). Leading experts in VT research came together through the American Venous Forum to develop a consensus on maximizing the utility and application of available mouse models of VT. In this work, we provide an algorithm for model selection, with discussion of the advantages, disadvantages, and applications of the main mouse models of VT. Additionally, we provide a detailed surgical description of the models with guidelines to validate surgical technique.

Age is not a barrier to good outcomes after varicose vein procedures.

BACKGROUND: The Vascular Quality Initiative (VQI) Varicose Vein Registry (VVR) represents a patient-centered database launched in January 2015. Previous work describing overall trends and outcomes of varicose vein procedures across the United States demonstrates a benefit from these procedures. The existing gaps in evidence to support current and future Medicare coverage of varicose vein procedures necessitate further description of clinical outcomes in patients ≥65 years old compared with the population <65 years old. METHODS: This study analyzed prospectively captured anatomic, procedural, and outcome data for all patients in a national cohort of all VQI VVR-participating centers. The VQI VVR database was queried for all patients undergoing varicose vein procedures between January 2015 and July 2016. Preprocedural and postprocedural Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification, Venous Clinical Severity Score (VCSS), and patient-reported outcomes (PROs) were compared between patients <65 years and ≥65 years old. Univariate descriptive statistics of demographic and procedural data were performed. Student t-tests were then performed on change in CEAP classification, VCSS score, and PROs (heaviness, achiness, throbbing, swelling, itching, appearance, and impact on work) for each group. RESULTS: There were 4841 varicose vein procedures performed from January 2015 to May 2016. There were 3441 procedures performed in 2691 patients (3631 limbs) in the group <65 years old and 1400 procedures performed in 1068 patients (1467 limbs) in the group ≥65 years old. Truncal veins alone were the most common veins treated in both groups. The majority of patients were white and female in both groups. Most of the demographic characteristics were clinically similar (although statistically different) in both groups with the exception of a higher body mass index in the group <65 years old and a history of bilateral varicose vein treatment, and anticoagulation was more common among patients ≥65 years old. Patients in both groups experienced statistically significant improvement in VCSS, PROs, and CEAP class. There was no difference in overall complications between age groups. CONCLUSIONS: All patients demonstrated an associated improvement in both clinical outcomes (CEAP class, VCSS) and PROs. There was no significant difference in the improvement in CEAP class and VCSS between patients younger and older than 65 years, although the younger population reported greater improvement in PROs. Given these findings, patients older than 65 years appear to benefit from varicose vein procedures and should not be denied interventions on their varicose veins and venous insufficiency on the basis of their age only.

Report of the Society for Vascular Surgery and the American Venous Forum on the July 20, 2016 meeting of the Medicare Evidence Development and Coverage Advisory Committee panel on lower extremity chronic venous disease.

On July 20, 2016, a Medicare Evidence Development and Coverage Advisory Committee panel assessed the benefits and risks of currently used lower extremity chronic venous disease (CVD) treatments and their effects on health outcome of the American adult population. The main purpose of the meeting was to advise the Centers for Medicare & Medicaid Services on coverage determination for interventions used for treatment of CVD. A systematic review of the Agency for Healthcare Research and Quality was presented, followed by lectures of invited experts and a public hearing of representatives of professional societies and the industry. After discussing critical issues, the panel voted for key questions. This report summarizes the presented evidence to support recommendations of the Society for Vascular Surgery/American Venous Forum coalition and the presentations on selected discussion topics. These included important venous disease evidence gaps that have not been sufficiently addressed, venous disease treatment disparities and how they may affect the health outcomes of Medicare beneficiaries, and mechanisms that might be supported by the Centers for Medicare & Medicaid Services to improve the evidence base to optimize the care of patients with lower extremity CVD.

Program requirements for fellowship education in venous and lymphatic medicine.

Background In every field of medicine, comprehensive education should be delivered at the graduate level. Currently, no single specialty routinely provides a standardized comprehensive curriculum in venous and lymphatic disease. Method The American Board of Venous & Lymphatic Medicine formed a task force, made up of experts from the specialties of dermatology, family practice, interventional radiology, interventional cardiology, phlebology, vascular medicine, and vascular surgery, to develop a consensus document describing the program requirements for fellowship medical education in venous and lymphatic medicine. Result The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine identify the knowledge and skills that physicians must master through the course of fellowship training in venous and lymphatic medicine. They also specify the requirements for venous and lymphatic training programs. The document is based on the Core Content for Training in Venous and Lymphatic Medicine and follows the ACGME format that all subspecialties in the United States use to specify the requirements for training program accreditation. The American Board of Venous & Lymphatic Medicine Board of Directors approved this document in May 2016. Conclusion The pathway to a vein practice is diverse, and there is no standardized format available for physician education and training. The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine establishes educational standards for teaching programs in venous and lymphatic medicine and will facilitate graduation of physicians who have had comprehensive training in the field.

Validation of the Caprini Venous Thromboembolism Risk Assessment Model in Critically Ill Surgical Patients.

IMPORTANCE: Appropriate risk stratification for venous thromboembolism (VTE) is essential to providing appropriate thromboprophylaxis and avoiding morbidity and mortality. OBJECTIVE: To validate the Caprini VTE risk assessment model in a previously unstudied high-risk cohort: critically ill surgical patients. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective cohort study of 4844 adults (≥18 years old) admitted to a 20-bed surgical intensive care unit in a large tertiary care academic hospital during a 5-year period (July 1, 2007, through June 30, 2012). MAIN OUTCOMES AND MEASURES: The main study outcome was VTE (defined as patients with deep vein thrombosis or pulmonary embolism) that occurred during the patient's initial hospital admission. RESULTS: The study population was distributed among risk levels as follows: low, 5.3%; moderate, 19.9%; high, 31.6%; highest, 25.4%; and superhigh, 14.9%. The overall incidence of inpatient VTE was 7.5% and increased with risk level: 3.5% in low-risk patients, 5.5% in moderate-risk patients, 6.6% in high-risk patients, 8.6% in highest-risk patients, and 11.5% in superhigh-risk patients. Patients with Caprini scores greater than 8 were significantly more likely to develop inpatient VTE events when compared with patients with Caprini scores of 7 to 8 (odds ratio [OR], 1.37; 95% CI, 1.02-1.85; P = .04), 5 to 6 (OR, 1.35; 95% CI, 1.16-1.57; P < .001), 3 to 4 (OR, 1.30; 95% CI, 1.16-1.47; P < .001), or 0 to 2 (OR, 1.37; 95% CI, 1.16-1.64; P < .001). Similarly, patients with Caprini scores of 7 to 8 were significantly more likely to develop inpatient VTE when compared with patients with Caprini scores of 5 to 6 (OR, 1.33; 95% CI, 1.01-1.75; P = .04), 3 to 4 (OR, 1.27; 95% CI, 1.08-1.51; P = .005), or 0 to 2 (OR, 1.38; 95% CI, 1.10-1.74; P = .006). CONCLUSIONS AND RELEVANCE: The Caprini VTE risk assessment model is valid. This study supports the use of individual risk assessment in critically ill surgical patients.

Reliability of hospital readmission rates in vascular surgery.

OBJECTIVE: The Center for Medicare and Medicaid Services recently began assessing financial penalties to hospitals with high readmission rates for a narrow set of medical conditions. Because these penalties will be extended to surgical conditions in the near future, we sought to determine whether readmissions are a reliable predictor of hospital performance with vascular surgery. METHODS: We examined 4 years of national Medicare claims data from 1576 hospitals on beneficiaries undergoing three common vascular procedures: open or endovascular abdominal aortic aneurysm repair (n = 81,520) or lower extremity arterial bypass (n = 57,190). First, we divided our population into two groups on the basis of operative date (2005-2006 and 2007-2008) and generated hospital risk- and reliability-adjusted readmission rates for each time period. We evaluated reliability through the use of the "test-retest" method; highly reliable measures will show little variation in rates over time. Specifically, we evaluated the year-to-year reliability of readmissions by calculating Spearman rank correlation and weighted κ tests for readmission rates between the two time periods. RESULTS: The Spearman coefficient between 2005-2006 readmissions rankings and 2007-2008 readmissions rankings was 0.57 (P < .001) and weighted κ was 0.42 (P < .001), indicating a moderate correlation. However, only 32% of the variation in hospital readmission rates in 2007-2008 was explained by readmissions during the 2 prior years. There were major reclassifications of hospital rankings between years, with 63% of hospitals migrating among performance quintiles between 2005-2006 and 2007-2008. CONCLUSIONS: Risk-adjusted readmission rates for vascular surgery vary substantially year to year; this implies that much of the observed variation in readmission rates is either random or caused by unmeasured factors and not caused by changes in hospital quality that may be captured by administrative data.

Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS).

BACKGROUND: The Venous Clinical Severity Score (VCSS) was designed and validated as an objective measure of disease severity in patients with chronic venous disease (CVD). Recently, a revision of the VCSS (rVCSS) was performed to resolve ambiguity in the clinical descriptors and improve clarity and ease of use. This new revised VCSS requires validation to determine its repeatability and reproducibility in clinical evaluation of patients with varying levels of CVD. METHODS: A prospective multicenter protocol was designed to enroll patients undergoing evaluation for CVD at venous practices with experience using the original VCSS. At the time of initial evaluation, two clinicians independently assessed both lower extremities to determine the rVCSS and the CEAP clinical score. Between 1 and 6 weeks, patients returned and received repeat assessment of the rVCSS by the same two clinicians independently. Patients were excluded if any venous intervention occurred between the two separate evaluation visits. Scores were compared to determine inter- and intra-observer variability overall and within each CEAP clinical class. RESULTS: Seven centers enrolled a total of 136 limbs yielding 248 paired evaluations for interobserver variability and 258 paired evaluations for intraobserver variability. The mean interobserver rVCSS difference was 1.4 ± 1.7 and the mean intraobserver variability was 1.3 ± 1.6. Statistical assessment with weighted kappa yielded good repeatability (κ = 0.68; P < .0001) and good reproducibility (κ = 0.72; P < .000001) for the rVCSS. The rVCSS correlated well with the CEAP clinical class with significant differences between rVCSS in increasing classes. (P < .0001). CONCLUSIONS: In this multicenter evaluation, the rVCSS was demonstrated to be a reliable and reproducible instrument for documentation of the severity of symptoms in patients with lower extremity venous insufficiency.

A role for interleukin-10 in the assessment of venous thromboembolism risk in injured patients.

BACKGROUND: Management of patients with multiple trauma requires prophylaxis for venous thromboembolism (VTE). This involves recognition of the physiologic factors that are associated with VTE risk. Currently, there is no effective strategy for risk assessment. The purpose of this study is to investigate the relationship of serum P-selectin and interleuken-10 (IL-10) with VTE as a possible physiologic marker. METHODS: Patients admitted to two trauma centers with an Injury Severity Score >/=9 had blood samples drawn and underwent duplex ultrasound scanning of the lower extremities before initiating prophylaxis at admission, on days 3 and 7, and weekly until discharge. Patients were prophylaxed according to institutional protocols. RESULTS: One hundred eighty-six patients were enrolled with a VTE incidence of 17.8%. The population was predominantly male (60%), with a mean age of 48 years. sP-selectin levels were not statistically different between the groups (64.4 versus 74.8 pg/mL). However, IL-10 was significantly lower in the VTE group at both the initial and subsequent blood draws (21 versus 165 ng/mL, p = 0.012). Further, the ratio of sP-selectin to IL-10 (3.92 versus 0.92, p = 0.014) was statistically higher in the VTE group at admission. CONCLUSION: An elevated sP-selectin to IL-10 ratio appears to be associated with the development of VTE in patients at high risk and may prove to be a useful clinical marker for this dreaded complication among trauma patients. Early recognition of this high-risk group improves the accuracy of the risk/benefit determination for prophylaxis and identifies a group in whom routine ultrasound screening would be cost-effective.

Venous thromboembolism: regional differences in the nationwide inpatient sample, 1993 to 2000.

Venous thromboembolism (VTE) is a costly complication of hospitalization. The sequelae make it a concern for public health planners. The Nationwide Inpatient Sample (NIS) contains data for hospital discharges in the United States. These data were reviewed to determine their suitability for health policy planning. International Classification of Diseases, Ninth Revision, Clinical Modification codes for VTE were applied to the NIS data. The sample was queried for demographic information, mortality, length of hospital stay, diagnosis, and treatment. The rates were standardized for geographic region and disease acuity. Statistical analysis included descriptive reporting of means and event rates; analysis of variance and logistic regression were used for regional effects and modeling of mortality. Between 1993 and 2000, 636,814 discharges involved VTE (1.2%). This rate was consistent over time and within regions. Regional differences existed in the acceptance of new technology and hospital charges. Mortality varied from 6.3% (Midwest) to 7.9% (Northeast) and was associated with admission type, comorbidities, pulmonary embolism, and discharge from the Northeast region. White race, chronic venous insufficiency, and female gender were protective variables. The NIS data report a consistent mortality rate despite improved therapy. Regional diagnostic, treatment, and economic differences exist. The data are useful for the purposes of public health care planning and stimulating clinical trial questions.

Cost of routine screening for carotid and lower extremity occlusive disease in patients with abdominal aortic aneurysms.

OBJECTIVE: The burden of clinically relevant noncoronary atherosclerotic occlusive disease in patients with abdominal aortic aneurysms (AAAs) is poorly defined. Furthermore, the cost-effectiveness of routine versus selective preoperative noninvasive examination of the carotid and lower extremity arterial beds has not been established in patients who undergo elective AAA repair. METHODS: Diagnostic vascular laboratory study results were reviewed in 206 patients who underwent evaluation before AAA repair from 1994 to 1998. The patients underwent routine preoperative carotid duplex scan examinations and lower extremity Doppler scan arterial studies with ankle-brachial index (ABI) determinations. The medical records were reviewed for the identification of clinical evidence consistent with cerebrovascular or lower extremity arterial occlusive disease. The costs of routine screening and selective screening were determined with Medicare reimbursement schedules. RESULTS: The prevalence rate of advanced (80% to 100%) carotid artery stenosis (CAS) was 3.4%, and 18% of the patients had CAS between 60% and 100%. Advanced peripheral vascular occlusive disease (PVOD; ABI, <0.3) was found in 3% of the patients, and 12% of the patients had an ABI of less than 0.6. Most patients with advanced CAS (71%) or advanced PVOD (83%) had clinical indications of their disease. The absence of clinical evidence of disease had a negative predictive value of 99% for both advanced CAS and PVOD. The cost of routine screening for all patients for advanced CAS was $5445 per case. Routine screening for severe PVOD costs were $3732 per case discovered. In contrast, the costs for selective screening for advanced CAS or PVOD in patients with appropriate history or symptoms were $1258 and $785 per case found, respectively. CONCLUSION: Routine noninvasive diagnostic testing for the identification of asymptomatic CAS and PVOD in patients with AAA may not be justified. Preoperative screening is more clearly indicated for patients with AAAs who have clinical evidence suggestive of CAS or PVOD.