Lymphoscintigraphy is frequently recommended but seldom used in a "real world setting".

OBJECTIVE: Lymphedema (LED) lacks a standard, simple, guiding noninvasive diagnostic test, unlike the two other circulatory disorders-arterial or venous disease. Lymphoscintigraphy (LSG) has been recommended by several guidelines as the diagnostic test of choice for LED. Several recent expert panels, however, have suggested from anecdotal experience that LSG was used infrequently, and that the diagnosis of LED is usually based on clinical examination. METHODS: To determine the use of LSG in a large real-world LED population, the International Business Machines MarketScan Research Database was examined from April 2012 to March 2020 for patients with a new diagnosis of LED (the index date). Use of LSG (LSG+) was ascertained during the period beginning 12 months prior to the initial coding of a LED diagnosis and ending 12 months after the index date based on the corresponding Current Procedural Terminology code; LSG use for sentinel node mapping at the time of oncologic surgery was excluded. Demographic profiles, comorbidities, and causes of LED among patients with and without evidence of LSG were characterized. RESULTS: We identified 57,674 patients, aged ≥18 years, who had a new diagnosis of LED and health care coverage for ≥12 months before and after this index date. Only a small number (1429; 2.5%) of these patients underwent LSG during the study period. The LSG + cohort was younger (53.7 vs 60.7 years), had a higher proportion of women (91.3% vs 73.4%), but a lower percentage of diabetes (12.8% vs 27.5%), heart failure (2.2% vs 8.7%), hypertension (32.4% vs 51.0%), and obesity (15.1% vs 22.2%) compared with the LED population who did not undergo LSG (all P < .001). Most importantly, the use of LSG for diagnosis varied with the etiology of LED (LSG was most frequently utilized among patients with melanoma-LED (9.5%) and patients with breast cancer-LED (6.7%), in contrast to patients with advanced venous disease-related LED (1.1%; P < .05 for both comparisons). CONCLUSIONS: Despite four guidelines recommending LSG, including the Guidelines of the American Venous Forum (Handbook of Venous and Lymphatic Disease-4th edition), which recommended LSG "for the initial evaluation of patients with LED" with a 1B recommendation, LSG plays a minor role in establishing the diagnosis of LED in the United States. This underlines the need for a better, simple diagnostic test for LED to complement clinical examination.

Impact of lymphedema in the management of venous leg ulcers.

INTRODUCTION: Lymphedema (LED) in patients with venous leg ulcers (VLU) [VLU+LED] can impair ulcer healing and predispose to cellulitis. There is little data, however, demonstrating how lymphatic dysfunction may impact the clinical course, treatment, and healthcare expenditures for VLU+LED versus VLU-LED patients. OBJECTIVE: To determine how lymphatic dysfunction might influence treatment and expenditures among VLU patients in a large deidentified healthcare claims database. METHODS: A retrospective cohort design and data from the IBM MarketScan Database (April 2013 to March 2019) were employed. Study population comprised VLU patients, and was stratified into two subgroups: VLU+LED (index date = date of first LED diagnosis) and VLU-LED (index dates randomly assigned to match distribution of index dates for VLU+LED). Within each subgroup, patients with <1 year of healthcare claims information before and after their index dates were excluded. Demographics, comorbidities, procedures/treatments, as well as all-cause post-index medical resource utilization and expenditures ($/patient/year) of the two groups were compared. Stabilized inverse probability treatment weights (IPTWs) were employed to adjust for differences between groups in baseline characteristics. RESULTS: A total of 5466 VLU patients were identified (VLU+LED: N = 299; VLU-LED: N = 5167). Overall ambulatory encounters (AMB ENC) and their components were higher in VLU+LED, which were reflected in increased expenditures for this group (Table 1). Treatment with endovenous ablation (EVA) or stenting for venous hypertension as well as for specific measures for LED were higher in the 1-year post-index period for VLU+LED. The use of LED specific therapy was low for both groups, but a greater percentage of VLU+LED patients received therapy, which was predominantly manual lymphatic drainage (17.4%) rather than pneumatic compression (10.7%). CONCLUSIONS: The clinical presence of LED in patients with VLU is a marker for a more complex disease process with more episodes of cellulitis and expenditures, but a surprisingly low specific treatment for LED.

Safety and Efficacy of Percutaneous Translumbar Inferior Vena Cava Catheters: A Systematic Review and Meta-Analysis.

PURPOSE: To examine the reported adverse events associated with inferior vena cava (IVC) catheterization and investigate the reasons for discrepancies between reports. MATERIALS AND METHODS: Cochrane Library trials register, PubMed, Embase, and Scopus databases were systematically searched for studies that included any terms of IVC and phrases related to catheters or central access. Of the 5,075 searched studies, 137 were included in the full-text evaluation. Of these, 37 studies were included in the systematic review, and the adverse events reported in 16 of these 37 identified studies were analyzed. An inverse-variance random-effects model was used to conduct the meta-analysis. Outcomes were summarized by the incidence rate (IR) and 95% CI. RESULTS: Compared with that of catheters <10 F in size (IR, 0.08; 95% CI, 0.03-0.12), the incidence of catheter-related infections per 100 catheter days was 0.2 more for catheters ≥10 F in size (IR, 0.28; 95% CI, 0.25-0.31). In addition, dual-lumen catheters showed 0.13 more malfunction per 100 catheter days (IR, 0.27; 95% CI, 0.16-0.37) than that shown by single-lumen catheters (IR, 0.14; 95% CI, 0.09-0.19). Both differences were statistically significant. Other adverse events were malposition (IR, 0.04; 95% CI, 0.04-0.05), fracture (IR, 0.01; 95% CI, 0.00-0.02), kinking (IR, 0.01; 95% CI, 0.00-0.01), replaced catheter (IR, 0.2; 95% CI, 0.1-0.31), removal (IR, 0.13; 95% CI, 0.1-0.16), IVC thrombosis (IR, 0.01; 95% CI, 0.00-0.03), and retroperitoneal hematoma (IR, 0.01; 95% CI, 0.00-0.01), all per 100 catheter days. CONCLUSIONS: Translumbar IVC access is an option for patients with exhausted central veins. Small-caliber catheters cause fewer catheter-related infections, and single-lumen catheters function longer.

A systematic review of routine post operative screening duplex ultrasound after thermal and non-thermal endovenous ablation.

OBJECTIVE: The Society of Vascular Surgery and the American Venous Forum recommend duplex ultrasound (DUS) following endovenous ablation. However, this screening may not be cost-effective or clinically indicated. The most common abnormal finding, endovenous heat-induced thrombosis (EHIT level 1-2), represents extension of thrombus from the saphenous <50% across the femoral or popliteal vein, which is thought to have a benign course regardless of intervention. The likelihood of venous thromboembolism (VTE) after thermal and non-thermal ablations was explored to determine the utility of routine postoperative DUS. METHODS: This is an updated and expanded systematic review including data from randomized trials and large observational studies (≥150 patients) of thermal and non-thermal ablations, examining the incidence of VTE. Using PubMed and EMBASE, 4584 publications were screened from 2000 through 2020. After applying inclusion and exclusion criteria, 72 studies were included. Random effects DerSimonian-Laird method was conducted to obtain the pooled incidence. We calculated the number of tests needed to detect one VTE, and the cost was derived from Center for Medicare Services tables. RESULTS: A total of 31,663 patients were included. The pooled incidence of EHIT II-IV, deep venous thrombosis (DVT), and pulmonary embolism (PE) was 1.32% (95% confidence interval [CI], 0.75%-2.02%); DVT (excluding EHIT), 0.20% (95% CI, 0.0%-0.2%); EHIT (I-IV), 2.51% (95% CI, 1.54%-3.68%); and EHIT (II-IV), 1.00% (95% CI, 0.51%-1.61%). There was no mortality. There was a lower DVT rate in thermal vs non-thermal ablations (0.23% vs 0.43%; P = .02); however, for all VTE (EHIT I-IV + DVT + PE), thermal techniques had more thrombosis (2.5% vs 0.5%; P <.001). When clinical significance is defined as DVT + EHIT (II-IV), 175 studies are needed to identify one VTE, costing $21,813 per "significant VTE." Patients receiving pharmacological prophylaxis had less EHIT I-IV compared with those who did not (3.04% vs 1.63%; P < .001); those who received DUS during the first post-op week had three times higher EHIT incidence compared with those whose first DUS was >7 days postoperative (6.6% vs 2.4%; P < .001). CONCLUSIONS: For thermal and non-thermal endovenous ablations, the incidence of VTE diagnosed with routine DUS is small and without clear clinical significance but caries a high cost. The Society of Vascular Surgery and the American Venous Forum recommendation to perform DUS within 72 hours is not justified by these data. We recommend a more targeted post-ablation scanning protocol including symptomatic patients and those at high risk.

Preoperative Depression is Associated with Worse Outcomes after The Lower Extremity Revascularization.

OBJECTIVE: This retrospective study sought to describe the association between preoperative diagnosis of depression and major adverse events after infrainguinal bypass surgery or peripheral vascular intervention (PVI). METHODS: We retrospectively analyzed a consecutive series of all patients undergoing PVI and/or infrainguinal bypass surgery at a single tertiary institution between 2010 and 2019. Propensity matching and Cox regression analysis were conducted to examine the impact of comorbid depression on the incidence of major adverse events (MAEs), defined as re-intervention, major amputation, or death, within 2 years of surgery. RESULTS: Of all patients (n = 512) undergoing intervention at our institution, 166 (32.4%) suffered an MAE and 169 (33.0%) patients had a preoperative diagnosis of depression. After propensity score matching, univariate (HR, 1.7; 95% CI, 1.1-2.7) and multivariable hazard analyses (aHR, 1.50; [1.1-2.2]) demonstrate that there is a statistically significant relationship between the diagnosis of depression and increased MAE. CONCLUSION: Over one-third of our lower extremity revascularization patients were noted to have a preoperative diagnosis of depression. After intervention, these patients had worse outcomes compared to patients without depression; this finding was more evident in patients who underwent PVI mainly due to high overall mortality rate. Prospective studies are necessary to better understand this association and to ascertain if early intervention can improve post-procedure vascular outcomes.

The American Venous Forum, American Vein and Lymphatic Society and the Society for Vascular Medicine expert opinion consensus on lymphedema diagnosis and treatment.

BACKGROUND: Lymphedema imposes a significant economic and social burden in modern societies. Controversies about its risk factors, diagnosis, and treatment permeate the literature. The goal of this study was to assess experts' opinions on the available literature on lymphedema while following the Delphi methodology. METHODS: In December of 2019, the American Venous Forum created a working group tasked to develop a consensus statement regarding current practices for the diagnosis and treatment of lymphedema. A panel of experts was identified by the working group. The working group then compiled a list of clinical questions, risk factors, diagnosis and evaluation, and treatment of lymphedema. Fifteen questions that met the criteria for consensus were included in the list. Using a modified Delphi methodology, six questions that received between 60% and 80% of the votes were included in the list for the second round of analysis. Consensus was reached whenever >70% agreement was achieved. RESULTS: The panel of experts reached consensus that cancer, infection, chronic venous disease, and surgery are risk factors for secondary lymphedema. Consensus was also reached that clinical examination is adequate for diagnosing lymphedema and that all patients with chronic venous insufficiency (C3-C6) should be treated as lymphedema patients. No consensus was reached regarding routine clinical practice use of radionuclide lymphoscintigraphy as a mandatory diagnostic tool. However, the panel came to consensus regarding the importance of quantifying edema in all patients (93.6% in favor). In terms of treatment, consensus was reached favoring the regular use of compression garments to reduce lymphedema progression (89.4% in favor, 10.6% against; mean score of 79), but the use of Velcro devices as the first line of compression therapy did not reach consensus (59.6% in favor vs 40.4% against; total score of 15). There was agreement that sequential pneumatic compression should be considered as adjuvant therapy in the maintenance phase of treatment (91.5% in favor vs. 8.5% against; mean score of 85), but less so in its initial phases (61.7% in favor vs. 38.3% against; mean score of 27). Most of the panel agreed that manual lymphatic drainage should be a mandatory treatment modality (70.2% in favor), but the panel was split in half regarding the proposal that reductive surgery should be considered for patients with failed conservative treatment. CONCLUSION: This consensus process demonstrated that lymphedema experts agree on the majority of the statements related to risk factors for lymphedema, and the diagnostic workup for lymphedema patients. Less agreement was demonstrated on statements related to treatment of lymphedema. This consensus suggests that variability in lymphedema care is high even among the experts. Developers of future practice guidelines for lymphedema should consider this information, especially in cases of low-level evidence that supports practice patterns with which the majority of experts disagree.

Outcomes of Thoracic Endovascular Aortic Repair in Octogenarians.

OBJECTIVE: The aim of this study is to compare outcomes between octogenarians and non-octogenarians undergoing thoracic endovascular aortic repair (TEVAR). METHODS: Using the National Inpatient Sample database, we identified octogenarians (≥80 years) and non-octogenarians (<80 years) who had undergone thoracic endovascular aortic repair between 2012 and 2017. We compared patients' demographic, socioeconomic, comorbidity data between the two groups as well as the procedure indications and perioperative outcomes. A multivariable logistic regression analysis was conducted to evaluate the impact of advanced age (≥80 years) on the in-hospital mortality rates in patients who underwent TEVAR. This analysis was also performed for a separate cohort which included only patients who underwent TEVAR for ruptured thoracic aortic aneurysm. RESULTS: A total of 4108 patients were included in our study; 3432 (83.5%) patients were <80 years (37.9% female; median age, 64 years; 34.3% non-white) and 676 (16.5%) patients were ≥80 years (50.7% female; median age, 83 years; 20.4% non-white). Non-ruptured thoracic aortic aneurysm was the most common indication for TEVAR in older patients (61.4%), whereas type B aortic dissection was the most common indication in younger patients (36.4%). In-hospital complications were comparable between the two groups except for respiratory complications that were higher in the younger patients (21.2% vs. 15.2%; P <.001). The multivariable analysis demonstrated that advanced age had no association with increased in-hospital mortality rates (adjusted odds ratio [aOR], 1.41; 95% confidence interval [CI], .97-2.05), However, in ruptured thoracic aortic aneurysm cohort, octogenarians had higher in-hospital mortality rates (aOR, 1.86; 95% CI, 1.04-3.32). CONCLUSIONS: Octogenarians have acceptable rates of perioperative morbidity and mortality compared to the younger group and should be considered for TEVAR. Octogenarians are at higher risk for in-hospital mortality in the setting of ruptured thoracic aortic aneurysm, supporting the appropriateness of elective TEVAR in selected Octogenarians.

Outcomes of Infrainguinal Bypass in Patients with Cannabis vs Opioid Use Disorder.

BACKGROUND: Marijuana and opioids are commonly used illicit drugs in the United States and their use continues to rise. Cannabis use disorder (CUD) and Opioid use disorder (OUD) are associated with adverse effects on public health and postoperative outcomes. However, their impact on vascular surgery, specifically infrainguinal bypass repair (IIB). is not well described in the literature. Therefore, our study aimed to assess perioperative outcomes in patients with CUD and OUD who underwent IIB. METHODS: A retrospective analysis of the National Inpatient Sample database for the years 2005 to 2018 was performed. Using the International Classification of Diseases Clinical Modification, Ninth and Tenth revisions, patients who were diagnosed with peripheral artery disease and underwent IIB repair.were identified. Our primary outcome was the comparison of rates of in-hospital complications between the groups, and the secondary outcomes included analysis of total hospital charges and length of stay. A 1:1 propensity score matching (PSM) CUD and OUD patients to their control groups without the disease was conducted using the nearest-neighbor method. The matching was based on select patient demographics and comorbidities included in our analyses. RESULTS: A total of 190,794 patients were identified: 972 patients with CUD and 682 patients with OUD. In the matched cohorts, patients with a diagnosis of CUD had a higher incidence of in-hospital cardiac complications (adjusted Odds Ratio [aOR], 1.76; 95% Confidence Interval [CI], 0.99-3.12) and acute kidney injury (AKI) (aOR, 1.51; CI, 1.09-2.08). Additionally, total hospital charges and mean length of stay were higher in the CUD group (P < 0.001). Those with OUD had a higher incidence of postoperative respiratory complications (aOR, 1.92; CI, 1.23-2.99), sepsis (aOR, 2.39; CI, 1.32-4.34), infection (aOR, 3.55; CI, 1.16-10.84), AKI (aOR, 2.11; CI,1.47-3.04), major amputations (aOR, 1.69; CI, 1.07-2.69), along with higher total charges and mean length of stay (P < 0.001). CONCLUSIONS: Both CUD and OUD have increased incidence of postoperative complications following IIB. The OUD group had generally worse outcomes compared to patients with CUD. Both were associated with a substantial increase in total hospital charges and length of hospital stay. A further prospective study is warranted to provide better insight on the effects of substance use disorders on the procedure's short- and long-term outcomes.

An Analysis of Guideline Consensus for the Prevention, Diagnosis, and Management of Diabetic Foot Ulcers.

BACKGROUND: Multiple organizations have issued guidelines to address the prevention, diagnosis, and management of diabetic foot ulcers (DFUs) based on evidence review and expert opinion. We reviewed these guidelines to identify consensus (or lack thereof) on the nature of these recommendations, the strength of the recommendations, and the level of evidence. METHODS: Ovid, PubMed, Web of Science, Cochrane Library, and Embase were searched in October 2018 using the MESH term diabetic foot, the key word diabetic foot, and the filters guideline or practice guideline. To minimize recommendations based on older literature, guidelines published before 2012 were excluded. Articles without recommendations characterized by strength of recommendation and level of evidence related specifically to DFU were also excluded. A manual search for societal recommendations yielded no further documents. Recommendations were ultimately extracted from 12 articles. Strength of evidence and strength of recommendation were noted for each guideline recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system or the Centre for Evidence-Based Medicine system. To address disparate grading systems, we mapped the perceived level of evidence and strength of recommendations onto the American Heart Association guideline classification schema. RESULTS: Recommendations found in two or more guidelines were collected into a clinical checklist characterized by strength of evidence and strength of recommendation. Areas for future research were identified among recommendations based on minimal evidence, areas of controversy, or areas of clinical care without recommendations. CONCLUSIONS: Through this work we developed a multidisciplinary set of DFU guidelines stratified by strength of recommendation and quality of evidence, created a clinical checklist for busy practitioners, and identified areas for future focused research. This work should be of value to clinicians, guideline-issuing bodies, and researchers. We also formulated a method for the review and integration of guidelines issued by multiple professional bodies.

Reporting of Financial Conflicts of Interest in Studies of Placental Membrane Allografts.

Objective: To systematically review the accuracy of self-reported financial conflicts of interest (COI) by authors of placental membrane allograft product studies. Approach: A PubMed search identified placental membrane allograft studies published between 2015 and 2019. Industry payments were collected using the Centers for Medicare & Medicaid Services Open Payments database. Self-declared COI were compared with recorded payments. Risk factors for positive product recommendation were determined at study and author levels. Results: Eighty-nine studies (417 authors) were identified. Seventy-five studies (84%) had at least one author receive undisclosed payments. From 2015 to 2019, 5,841 general payments (totaling $15,558,026) and 1,234 research payments (totaling $18,290,062) were made by 46 companies. Travel/lodging was the most commonly reported transaction (34%). Authors were comprised mostly of podiatrists (27%), plastic surgeons (15%), and orthopedic surgeons (15%). Comparative studies were less likely to have a positive product recommendation compared to noncomparative studies (odds ratio [OR] 0.204, 95% confidence interval 0.06-0.066, p = 0.02). Multivariate analysis showed no association between COI discrepancy and product recommendation. Innovation: The accuracy of self-reported financial COI in placental membrane studies is evaluated for the first time. Conclusion: The majority of placental membrane product studies did not declare all industry payments. Whether these payments represent "relevant COI" remains unclear. In addition, not all placental product companies report to the Open Payments database, suggesting that the issue may be even more significant. This study highlights the need for improved definitions of "relevant COI," a standardized reporting system across journals, and the uniform participation of all medical product vendors.

The economic impact of infection requiring hospitalization on venous leg ulcers.

OBJECTIVE: To determine the impact of infection (INF) on medical resource utilization (MRU) and cost of care in patients with venous leg ulcers (VLU). METHODS: We performed a retrospective case-control study of 78 patients followed for a minimum of 12 months with C6 VLUs treated by vascular surgeons, at our wound center. To eliminate minor episodes of INF or incorrectly diagnosed episodes, only patients who had an inpatient admission specifically for INF comprised the INF group, whereas all other admissions were excluded for this group. MRU was defined as the number of clinic visits, Visiting Nurse Association (VNA) visits, and inpatient admissions. The actual cost for treatment was determined using financial data provided by both the hospital and physician organization billing units. The total cost over the 1-year follow-up period comprised individual cost centers: inpatient and outpatient facility fees, physician fees, and visiting nurse services. Mean MRU and cost data were compared using the two-sample t-test between INF and NON-INF. RESULTS: Of the 78 patients with C6 VLU, 9 (11.5%) had at least one inpatient admission for INF related to their VLU in the 1-year treatment period, with an additional five recurrent admissions for a total of 14 admissions, whereas 69 NON-INF had three NON-INF-related admissions. There was no difference between INF and NON-INF for usual risk factors, but INF had a greater proportion of congestive heart failure (44%; 13%, P < .02). Regarding MRU, both the number of outpatient wound center visits (INF 16.89 ± 6.41; NON-INF 9.46 ± 7.7, P = .008) and VNA blocks (INF 3.89 ± 2.93; NON-INF 1.94 ± 2.24, P < .02) were greater for INF. Total costs for INF ($27,408 ± $10,859) were threefold higher than those for NON-INF ($11,088 ± $9343, P < .0001) and subsequent VNA costs were doubled for INF ($9956 ± $4657) vs NON-INF ($4657 ± $5486, P = .01). CONCLUSIONS: INFs in patients with VLU led to an overall increase in MRU and cost of care, with the INF cohort requiring more inpatient admissions, outpatient visits, and VNA services than NON-INF. Given the major impact INF has on cost and MRU, better treatment modalities that prevent INF as well as identifying risk factors for INF in patients with VLU are needed.

Correlation between Restless Leg Syndrome and Superficial Venous Reflux.

Restless leg syndrome (RLS) is a common cause of lower extremity discomfort. We hypothesized that patients with RLS symptoms have higher rates of deep and superficial venous reflux (SVR). Retrospective review of patients ≥18 years of age evaluated in a venous center from December 2018 to February 2019. Differences in rates of RLS symptoms, demographics, comorbidities, and clinical and radiologic presence of venous disease were analyzed. Overall, 207 patients were analyzed; 140 (67.6%) reported RLS symptoms ( n = 25 with prior RLS diagnosis). RLS symptoms were more common with superficial or combined superficial and deep venous reflux (DVR) compared with those without reflux ( p < 0.001). Patients with RLS symptoms as opposed to those without had similar demographics and comorbidities (all p > 0.05) but increased rates of venous pain, phlebitis, family history of venous disease, lower extremity swelling and SVR, and combined SVR and DVR (all p < 0.05). Our multivariable logistic regression found presence of SVR, and family history of venous reflux was associated with RLS symptomatology (all p < 0.001). Ninety-nine patients with RLS underwent ablation; of them, 93 had duplex-proven reflux resolution of which 81 (87%) reported RLS symptom improvement. This included 13 of 16 (81.3%) with prior RLS diagnosis. SVR is associated with increased rates of RLS symptoms in a vein center population. Therefore, RLS symptoms should trigger a targeted venous evaluation. Our results suggest that venous ablation may lead to resolution of RLS symptoms in patients with SVR, but randomized prospective trials with strict RLS definition criteria are warranted to confirm these outcomes.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Private payers' varicose vein policies are inaccurate, disparate, and not evidence based, which mandates a proposal for a reasonable and responsible policy for the treatment of venous disease.

Varicose veins afflict more than one in five Americans, and although varicose veins may be an asymptomatic cosmetic concern in some, many others experience symptoms of pain, aching, heaviness, itching, and swelling. More advanced venous disease can result from untreated venous insufficiency. The complications of chronic venous disease, including bleeding, thrombosis, and ulceration, are seen in up to 2 million Americans annually. Numerous reports have documented venous disease adversely affects quality of life and that treatment of venous disease can improve quality of life. It has previously been documented that private insurers, and Centers for Medicare & Medicaid Services subcontractors for that matter, have disparate policies that in many instances are self-serving, contain mistakes, use outdated evidence, and disregard evidence-based guidelines. The two leading venous medical societies, the American Venous Forum and the American Venous and Lymphatic Society, have come together to review the varicose vein coverage policies of seven major U.S. private medical insurance carriers whose policies cover more than 150 million Americans. The authors reviewed the policies for venous disease and, if significant gaps or inconsistencies are found, we hope to point them out, and, finally, to propose a thoughtful and reasonable policy based on the best available evidence.

A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database.

OBJECTIVE: To investigate opportunities and limitations of using the Manufacturer and User Facility Device Experience (MAUDE) database for cardiovascular surgery research, we analyzed the quality of studies having ever used MAUDE, in the field of cardiovascular surgery. METHODS: We systematically searched the Cochrane Library, PubMed, EMBASE, and Google Scholar for randomized and nonrandomized studies, from inception to July 2019. Two authors evaluated the quality of the retrieved observational studies, according to the National Institutes of Health quality assessment tool for either case series or cross-sectional studies. These tools quantify the quality of case series and cohorts/cross-sectional studies, respectively, with nine and 14 queries. RESULTS: Fifty-eight studies were included in the final qualitative review. Of 58 identified studies, 32 were case series, 8 were abstracts of case series, and 13 were reviews or case discussion with an included series from MAUDE. Also, five articles were cross-sectional studies. Of the 32 formal case series, 26 (81%) were found to have poor quality. The most common reasons for a poor quality designation included a lack of consecutive participants, undetermined comparability of participants, and undetermined follow-up adequacy. Only one out of five cross-sectional studies had fair quality; four others were evaluated as poor quality studies. CONCLUSIONS: Cardiovascular surgery studies using the MAUDE database, whether case series or cross-sectional design, are mostly of poor quality. Their low quality is partly caused by poor study design, but mainly by intrinsic limitations to the MAUDE database: cases recruited are not consecutive; patient characteristics are not detailed enough to allow a meaningful comparison of patient characteristics between different patient entries; outcome measures are unclear; there is a limited follow-up; and time-to-event data are lacking. We conclude that the quality of cardiovascular surgery publications that rely on data from MAUDE could be improved if investigators were to extract all relevant data points from MAUDE entries, then apply standard quality assessment tools in compiling and reporting the data. MAUDE might be improved if it used medical case report standards during the process of reporting and indexing adverse events. To calculate the incidence rate of any adverse event, all event-free cases, as well as all adverse events in patients using a device, are required. Neither of these two variables is available in the MAUDE at the time of writing.

Distal perfusion cannulae reduce extracorporeal membrane oxygenation-related limb ischemia.

BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a means of providing cardiopulmonary support that is being increasingly used in patients with acute heart failure. When ECMO cannulae are placed peripherally, their large diameters pose a risk of limb ischemia. Distal perfusion cannulae (DPC) have been proposed as means to reduce risk, but their use is not recommended by the most recent ECMO guidelines. We sought to establish their utility at our institution. METHODS: We performed a retrospective review of of all patients treated with peripheral VA-ECMO at our institution from 2013-2018. During the first 2 years, DPC were not routinely placed, whereas in the final 4 years, DPC were recommended as part of the ECMO cannulation routine. RESULTS: One hundred and one patients were treated with peripheral VA-ECMO, with an overall mortality of 61%. By univariate analysis, obesity (47% vs. 75%, P<0.01) and limb ischemia (57% vs. 83%, P<0.05) were associated with increased mortality. DPC were placed prophylactically in 49% of patients. Prophylactic placement of a DPC at the time of cannulation significantly reduced the incidence of limb ischemia (2% vs. 32%, P<0.05), but did not impact mortality (53% vs. 69%, P=0.0953). In patients who did not have a DPC placed during ECMO cannulation and subsequently developed limb ischemia, late DPC placement for limb salvage did not impact mortality. CONCLUSIONS: Limb ischemia portends a poor outcome in VA-ECMO patients, and prophylactic DPC placement significantly reduces the risk of limb ischemia. We propose prophylactic DPC placement be considered in patients requiring peripheral VA-ECMO.

The Dynamic Platelet Transcriptome in Obesity and Weight Loss.

OBJECTIVE: Adiposity is associated with oxidative stress, inflammation, and glucose intolerance. Previous data suggest that platelet gene expression is associated with key cardiometabolic phenotypes, including body mass index but stable in healthy individuals over time. However, modulation of gene expression in platelets in response to metabolic shifts (eg, weight reduction) is unknown and may be important to defining mechanism. Approach and Results: Platelet RNA sequencing and aggregation were performed from 21 individuals with massive weight loss (>45 kg) following bariatric surgery. Based on RNA sequencing data, we measured the expression of 67 genes from isolated platelet RNA using high-throughput quantitative reverse transcription quantitative PCR in 1864 FHS (Framingham Heart Study) participants. Many transcripts not previously studied in platelets were differentially expressed with bariatric surgical weight loss, appeared specific to platelets (eg, not differentially expressed in leukocytes), and were enriched for a nonalcoholic fatty liver disease pathway. Platelet aggregation studies did not detect alteration in platelet function after significant weight loss. Linear regression models demonstrated several platelet genes modestly associated with cross-sectional cardiometabolic phenotypes, including body mass index. There were no associations between studied transcripts and incident diabetes or cardiovascular end points. CONCLUSIONS: In summary, while there is no change in platelet aggregation function after significant weight loss, the human platelet experiences a dramatic transcriptional shift that implicates pathways potentially relevant to improved cardiometabolic risk postweight loss (eg, nonalcoholic fatty liver disease). Further studies are needed to determine the mechanistic importance of these observations.

Lessons learned during a 30-year experience with simultaneous carotid endarterectomy and coronary artery bypass grafting.

OBJECTIVE: A simultaneous operative approach to patients with significant carotid and coronary disease has been suggested as a safe, lower cost, and more convenient alternative to a staged approach. During the last three decades, spanning the career of our senior author, our group has pursued simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) in limited circumstances. We previously reported on our results in series from 1984 to 1994 and 1994 to 1999. Based on these prior results and the current literature, we liberalized our inclusion criteria. We are now reporting on a contemporary cohort of 91 patients operated on from 2006 to 2018. METHODS: All patients who underwent combined CEA/CABG in 2006 to 2018 were entered into the Vascular Quality Initiative database. We compared the current series of 91 patients (group 3) with the 74 patients (group 2) from 1994 to 1999 and the 100 patients (group 1) from 1984 to 1994 who also underwent combined CEA/CABG. We examined demographic and comorbid factors, presence of cerebrovascular symptoms, degree of contralateral carotid stenosis, perioperative stroke, and death. Statistical comparison was made with χ2 analysis. RESULTS: The groups had similar demographics and comorbidities. Significant differences were noted in the preoperative diagnosis of hyperlipidemia (42%, 51%, 75%; P = .005) and the proportion of patients requiring urgent operations (24%, 47%, 56%; P = .002) during successive time periods. Patients in group 3 were much less likely to have preoperative symptoms from carotid stenosis before operation (55%, 31%, 4.4%; P < .001). Correspondingly, patients in group 3 were more likely to have asymptomatic unilateral carotid stenosis (20%, 55%, 78%; P < .001). The 30-day mortality rate remained stable compared with the first interval (8%, 3%, 2.2%; P = .11). Likewise, the overall stroke rate decreased in the later periods compared with the first series (9%, 1.4%, 2.2%; P = .016). Of the two perioperative strokes recorded for group 3, only one event was ipsilateral to the carotid artery operated on compared with the four ipsilateral strokes of nine total reported in group 1 and no ipsilateral stroke reported in group 2. CONCLUSIONS: Based on the favorable results of the previously reported series of CEA/CABG from our group, we continued to liberalize selection criteria for the combined procedure to essentially mirror the standard recommendations for CEA in patients without coronary disease. The current series using this treatment algorithm demonstrates the safety of this approach, with stroke and death rates equivalent to those of CABG alone. These excellent results were achieved in the face of increasingly urgent cardiac procedures. The fact that the majority of the perioperative strokes were contralateral to the carotid artery operated on reinforces the safety of our approach but underscores the significant burden of atherosclerosis in these patients.

Correlation of disease comorbidity with prescribed treatment among insured U.S. lymphedema patients.

OBJECTIVE: The objective of this study was to define the current forms of treatment in a contemporary population of lymphedema (LED) patients for LED related to breast cancer, the most prevalently diagnosed LED comorbidity in Western countries, and phlebolymphedema with venous leg ulcer (PLEDU), a sequela of chronic venous disease. The goals of LED therapy are to reduce edema, thereby improving function and related symptoms, and to improve skin integrity to prevent development of infection. Treatment is generally nonsurgical: conservative care, including complex physical therapy, manual lymphatic drainage, and compression bandaging; or pneumatic compression device (PCD) therapy by a simple nonprogrammable device or an advanced programmable device. METHODS: To determine the frequency of individual types of treatment for LED and their relationship to breast cancer-related lymphedema (BCRL) and PLEDU, we queried claims from a deidentified Health Insurance Portability and Accountability Act-compliant commercial administrative insurance database with >165 million members. A total of 26,902 patients identified with LED who had been enrolled with continuous medical benefits for 12 months before and after the index date for the complete years 2012 through 2016 were separated into four treatment categories: no treatment, conservative care, simple PCD (SPCD), and advanced PCD. LED treatment was related to the BCRL and PLEDU comorbidities. RESULTS: BCRL patients, who represented 32.1% of all study patients, made up 41% of all patients receiving conservative care and 24% of patients receiving PCD therapy. By contrast, PLEDU patients (9.6% of study patients) were proportionally under-represented in the conservative care group (7.8%) but composed a disproportionately high share of the PCD therapy group (17.7%). PLEDU patients represented 23.5% of all LED patients prescribed SPCD therapy, whereas BCRL patients composed 10.3% of total LED patient SPCD prescriptions (P < .001). CONCLUSIONS: Our analysis of a large health care administrative database showed clear differences between the way BCRL and PLEDU patients are treated. Compared with BCRL patients, PLEDU patients were less likely to receive conservative care and more likely to be prescribed SPCDs for pneumatic compression therapy. These differences suggest that lymphatic therapy may be undervalued for treatment of chronic venous swelling and prevention and treatment of PLEDU.

A systematic review of guidelines for lymphedema and the need for contemporary intersocietal guidelines for the management of lymphedema.

OBJECTIVE: Lymphedema (LED) affects an estimated 35 million patients in the United States and a staggering 140,200 million people worldwide, yet LED is the forgotten vascular disease. Whereas the diagnosis and treatment of arterial and venous diseases have been strengthened by the development of clinical practice guidelines (CPGs), few CPGs are available for LED. Moreover, for CPGs to have their greatest impact, they should be both of high quality and developed using the most rigorous evidence-based methods. We performed a systematic review of the available CPGs for LED, which were assessed for breadth of content and methodologic strength. METHODS: A literature search was conducted from National Guideline Clearinghouse (www. GUIDELINES: gov), BMJ Clinical Evidence (http://clinicalevidence.bmj.com), and National Institute for Health and Care Excellence (http://www.nice.org.uk) as well as from MEDLINE and Google, which selected 245 documents. After a horizon scan that identified 13 potential CPGs, 4 satisfied the criteria for LED. These were analyzed for inclusion of key elements of diagnosis and treatment. RESULTS: A horizon scan (abstract review) of the 245 documents identified 10 potential CPGs. Of the 10 documents, 6 claimed to be CPGs, but 2 were limited in scope (rehabilitation or compression only), 2 were consensus statements, 1 was a position statement, and 1 was a systematic review. This process yielded four CPGs: Lymphedema Framework Best Practice for the Management of Lymphedema; Japanese Lymphedema Study Group-A Practice Guideline for the Management of Lymphedema; Clinical Resource Efficiency Support Team Guidelines for the Diagnosis, Assessment and Management of Lymphedema; and Guidelines of the American Venous Forum. Only one of four CPGs was based on a contemporary systematic review (2016 end date of references), whereas the remainder had older systematic reviews (end dates of 2005, 2007, and 2007). Several areas of contemporary diagnosis, treatment, and monitoring of LED were absent. CONCLUSIONS: This systematic review of available LED CPGs demonstrates a limited number of guidelines. The four CPGs identified lack contemporary references while demonstrating low overall study quality. Therefore, it is imperative for our vascular societies to develop contemporary high-quality evidence-based CPGs for LED, as they have for other vascular diseases.