MicroRNA-409-3p/BTG2 signaling axis improves impaired angiogenesis and wound healing in obese mice.

Wound healing is facilitated by neoangiogenesis, a complex process that is essential to tissue repair in response to injury. MicroRNAs are small, noncoding RNAs that can regulate the wound healing process including stimulation of impaired angiogenesis that is associated with type-2 diabetes (T2D). Expression of miR-409-3p was significantly increased in the nonhealing skin wounds of patients with T2D compared to the non-wounded normal skin, and in the skin of a murine model with T2D. In response to high glucose, neutralization of miR-409-3p markedly improved EC growth and migration in human umbilical vein endothelial cells (HUVECs), promoted wound closure and angiogenesis as measured by increased CD31 in human skin organoids, while overexpression attenuated EC angiogenic responses. Bulk mRNA-Seq transcriptomic profiling revealed BTG2 as a target of miR-409-3p, where overexpression of miR-409-3p significantly decreased BTG2 mRNA and protein expression. A 3' untranslated region (3'-UTR) luciferase assay of BTG2 revealed decreased luciferase activity with overexpression of miR-409-3p, while inhibition had opposite effects. Mechanistically, in response to high glucose, miR-409-3p deficiency in ECs resulted in increased mTOR phosphorylation, meanwhile BTG-anti-proliferation factor 2 (BTG2) silencing significantly decreased mTOR phosphorylation. Endothelial-specific and tamoxifen-inducible miR-409-3p knockout mice (MiR-409IndECKO ) with hyperglycemia that underwent dorsal skin wounding showed significant improvement of wound closure, increased blood flow, granulation tissue thickness (GTT), and CD31 that correlated with increased BTG2 expression. Taken together, our results show that miR-409-3p is a critical mediator of impaired angiogenesis in diabetic skin wound healing.

The Benefit of Cost-Transparency Calculators Does Not Extend to Vascular Surgery Patients.

BACKGROUND: In 2021, the Centers for Medicare & Medicaid Services (CMS) mandated that every hospital create a publicly available webtool for pricing various medical services in an effort to give patients transparency in regard to their health care expenses and allow patients to "shop around" to receive the care most fitting their budget. Our objective is to investigate the utility this mandate provides for vascular surgery patients. METHODS: Standardized searches were performed to find patient cost calculators for Newsweek's Top 50 Hospitals in the United States. If the webtool was found, a list of standardized searches were performed to investigate whether the tool listed prices for the following vascular procedures: Arteriovenous fistula (AVF), varicose vein procedures, and Endovascular Aneurysm Repair (EVAR). RESULTS: Of the 50 hospitals included, all had an easily accessible web-based cost estimator tool. The average time to find the cost estimator was 33.27 sec. Of these 50 hospitals, 10% provided cost information on AVF surgery, 12% provided cost information on varicose vein procedures, and 0% provided information on EVAR. There was no difference in the hospital's likelihood to report a price based on region of the United States. Average preinsurance price for AVF surgery was $11,933.61 and $22,191 for vein procedures. CONCLUSIONS: In conclusion, despite good adherence to the CMS mandate requiring a publicly available pricing tool, these tools provide little to no information for vascular surgery patients. Overall, this discrepancy places vascular surgery patients at a significant disadvantage. As such, vascular patients do not have access to the knowledge necessary to financially prepare for surgery, and furthermore, they are not afforded the luxury to choose where to have procedures performed based on price variability. Hopefully this research will encourage hospitals to broaden the scope of their cost calculators to allow it to benefit all patients.

Comparison of academic productivity and funding support between United States and international medical graduate vascular surgeons.

OBJECTIVE: The demand for vascular surgeons in the United States stands to far exceed the current supply. International medical graduates (IMGs) are not only vital to meeting the country's growing health care needs, but also help to advance clinical research and medical education in the field of vascular surgery. Nearly 17% of practicing vascular surgeons in the United States are IMGs, yet little is known about their relative contributions to academic vascular surgery. Our study aims to compare the academic profiles and funding support for IMG vascular surgeons to that of their US medical graduate (USMG) counterparts. METHODS: A cross-sectional study was performed on all IMG and USMG academic vascular surgeons practicing in US-based hospitals with vascular surgery residency and/or fellowship programs. In addition to the baseline surgeon characteristics, academic profiles and research output were also collected. Furthermore, the National Institutes of Health (NIH) research reporting tool and open payments database were queried for any funding/payments to surgeons in both groups. Matching for year of vascular surgery training program graduation was performed where appropriate. RESULTS: A total of 908 academic vascular surgeons were included; 759 (83.6%) were USMGs and 149 (16.4%) were IMGs. The median year of graduation was comparable between the two groups, but USMGs had a significantly higher proportion of female surgeons (23.6% vs 10.7%; P = .0003). There were no significant differences in the academic profiles and leadership positions between the two groups. Although research productivity is similar between the two groups, IMG surgeons were more likely to have first or senior-authorship papers (47.1% vs 37.5%; P < .001). Additionally, faculty departments chaired/cheifed by a USMG were less likely to be staffed with IMG vascular surgeons (1.6 surgeons vs 3.1 surgeons; P < .0001). Following grant analysis, USMG surgeons received more NIH R01 grants (5.7% vs 1.3%; P = .026). R01-funded surgeons had significantly greater research output by number of publications (121.0 vs 47.5), citations (3872 vs 938), H-index (32.0 vs 17.5), and average journal impact factor (>10: 86.7% vs 33.3%) (all P < .001). CONCLUSIONS: The efforts to further diversify vascular surgery are vital to better serving an increasingly diverse US population, amid growing disparities in health care. Although IMGs account for a minority of academic vascular surgeons, and contribute significantly to their published research, they had less NIH R01 funding, warranting further investigation.

Assessment of Conflicts of Interest in the Transcarotid Artery Revascularization Literature.

INTRODUCTION: To systematically review the accuracy of self-reported conflicts of interest (COIs) among transcarotid artery revascularization (TCAR) studies and evaluate factors associated with increased discrepancies. MATERIALS AND METHODS: A literature search identified all TCAR-related studies with at least one American author published between January 2017 and December 2020. Industry payments from Silk Road Medical, Inc. were collected using the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior (24-mo period). Risk factors for COI discrepancy were evaluated at both the study and author level. RESULTS: A total of 79 studies (472 authors) were identified. Sixty four studies (81%) had at least one author who received payments from Silk Road Medical, Inc. Fifty eight (73%) studies had at least one author who received an undeclared payment. Consulting fees represented the majority of general payment subtype (60%). Authors who accurately disclosed payments received significantly higher median payments compared to authors who did not accurately disclose payments ($37,222 [interquartile range: $28,203-$132,589] versus $1748 [interquartile range $257-$35,041], P < 0.0001). Senior authors were significantly more likely to have a COI discrepancy compared to first authors (P = 0.0219). CONCLUSIONS: The majority of TCAR-related studies did not accurately declare COI. A multivariate analysis demonstrated no effect of sponsorship on study recommendations or impact factor. This study highlights the need for increased efforts in accountability to improve the transparency of industry sponsorship, especially when consulting authors are reporting their results on patient outcomes.

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.

Median Arcuate Ligament Syndrome: Comparing the Safety of Open and Laparoscopic Management in a Large Cohort.

BACKGROUND: Open surgery has been the traditional approach for Median Arcuate Ligament Syndrome (MALS) management. However, there has been a recent rise in laparoscopic management for MALS. In this study we used a large-scale database to compare perioperative complications between open and laparoscopic approaches for MALS. METHODS: Using the National Inpatient Sampling database, we identified all patients surgically treated for MALS between 2008 and 2018 through conventional open and laparoscopic approaches. International Classification of Diseases (ICD)-9 and ICD-10 codes were used to identify patients and their specific surgical interventions. Statistical analyses were conducted to compare the perioperative complications between the 2 MALS surgical approaches, as well as and length of hospital stays and total charges. The complications include postoperative bleeding, accidental operative laceration/puncture, surgical wound infection, ileus, hemothorax/pneumothorax, and cardiac and respiratory complications. RESULTS: A total of 630 patients were identified: 487 (77.3%) patients underwent open surgery while 143 (22.7%) patients underwent laparoscopic decompression. The majority of the study population consisted of female patients (74.8%) with a mean age of 40.6 ± 19 years. Patients who underwent laparoscopic decompression had significantly less all-cause perioperative complications compared to their open surgery counterparts (0.7% vs. 9.9%; P = 0.001). Additionally, prolonged hospitalization was noted in the open group compared to the laparoscopic 1 (5.8 days vs. 3.5; P < 0.001, respectively) with a significantly higher mean of total hospital charges ($70,095.8 vs. 56,113.5; P = 0.016). CONCLUSIONS: Laparoscopic management of MALS has significantly less perioperative complications than open surgical decompression with shorter hospitalization and lower total charges. Given that, laparoscopic technique could be a safe option in treating select MALS patients.

Peripheral artery disease and extracorporeal membrane oxygenation: Examining a high-risk cohort over time.

OBJECTIVE: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a resource-intensive approach for the management of refractory cardiogenic shock. Within this population exists a substantial cohort of patients with peripheral artery disease (PAD), which independently increases the risk of complications and all-cause mortality. We studied 10-year national trends of the impact of PAD among VA-ECMO recipients to better understand the prevalence of PAD and implications on outcomes in this vulnerable population. METHODS: This 10-year retrospective, propensity score-matched study identified all adult patients (≥18) who underwent VA-ECMO between 2009 and 2018, from a large US database (National Inpatient Sample). Patients with an ICD diagnosis of PAD were identified. The primary endpoints of in-hospital mortality, bleeding complications and major limb loss (above- or below-knee amputation) were compared between patients with PAD to those without. RESULTS: A total of 6768 patients were identified, of which 342 (5.3%) had PAD. The median age at admission was significantly higher in PAD patients [64 years vs. 55 years; p < .01], as was male gender [71% vs. 64%; p < .01]. Patients with PAD had higher rates of smoking (38.9% vs. 23.3%), hypertension (71.1% vs. 50%), diabetes (37.4% vs. 27.0%), chronic kidney disease (30.1% vs. 18.0%), coronary artery disease (76.0% vs. 35.0%) and dyslipidemia (76.0% vs. 35.0); all p < .01. After propensity-matching 2:1 for comorbidities, PAD patients were found to have significantly greater overall complications, including in-hospital mortality, bleeding, surgical wound infections, pseudoaneurysms, and major adverse limb events [71.9% vs. 63.9%; p < .01]. Subgroup analysis revealed greater in-hospital mortality [62.2% vs. 55.3%; p < .05], major amputations [4.1% vs. 0.3%; p < .01] and blood transfusions [32.2% vs. 26.2%; p < .05] in PAD patients. Over 2014-2018, the non-PAD group demonstrated statistically discernable trends in a 51.1% decrease in overall complications and a 28.1% increase in survival to discharge (all p < .01). Over the same time period the PAD cohort experienced a modest, nonsignificant, decrease in complications [7.0%, p = .40] and a decrease in those surviving to discharge [47.1% vs. 40.5%, p = .91]. CONCLUSION: Patients with PAD on VA-ECMO are sicker at baseline and experience significantly greater major amputations and higher in-hospital mortality. They have not benefitted from the considerable decrease in complication rates and increase in survival to discharge over time as compared to their non-PAD counterparts. These findings demonstrate the substantial frailty of the PAD population within an already high-risk cohort, and highlight the need for better procedural approaches and innovative technologies.

The effects of major depression disorder on neurogenic thoracic outlet syndrome surgery outcomes.

OBJECTIVES: Thoracic outlet syndrome (TOS) is a group of disorders caused by impingement of the neurovascular structures at the thoracic outlet. Neurogenic TOS (nTOS), which is thought to be caused by a compression of the brachial plexus, accounts for more than 90% of the cases. Although treatment for nTOS is successful through physiotherapy and/or surgical decompression, little is known about the impact of psychosocial factors, namely, major depressive disorder (MDD), on postoperative outcomes such as non-routine discharge (NRD). Here, we assess whether MDD predicts the type of discharge following nTOS surgical intervention. METHODS: A retrospective analysis of the National Inpatient Sample database from the years 2005-2018 was performed. Using the International Classification of Diseases Clinical Modification, Ninth and Tenth revisions, patients who underwent a surgical intervention for nTOS were identified. Our primary outcome was to investigate the effects of MDD on nTOS patient disposition status after surgical management; secondary outcomes included analysis of total hospital charges and length of stay. NRD was defined as anything beyond discharge home without healthcare services. Univariate and multivariable logistic regression analyses were conducted to assess MDD and other potential independent predictors of NRD and prolonged hospital stay (> 2 days) following surgical intervention. RESULTS: A total of 6099 patients were identified: 596 (9.77%) patients with MDD and 5503 (90.23%) without MDD. On average, patients with MDD were older (39.6 ± 12.0 years vs. 36.0 ± 13.0 years; p < 0.001), female (80.7% vs. 63.5%; p < 0.001), white (89.6% vs. 85.6%; p = 0.030), and on Medicare (9.6% vs 5.2%; p < 0.001). Univariate and multivariable logistic regression models identified MDD as an independent risk factor associated with a higher risk of NRD (adjusted odds ratio [aOR], 1.50; 95% confidence interval [CI], 1.0-2.2). Additionally, chronic kidney disease (aOR, 2.60; 95% CI, 1.2-5.4), postoperative complications (aOR, 1.87; 95% CI, 1.2-2.9), and Medicare (aOR, 2.95; 95% CI, 1.9-4.7) were statistically significant predictors for higher risk of NRD. However, MDD was not associated with prolonged hospital stay (aOR, 1.00; 95% CI, 0.8-1.2) or higher median of total charges (MDD group: $27,867 vs. non-MDD group: $28,123; p = 0.799). CONCLUSION: Comorbid MDD was strongly associated with higher NRD rates following nTOS surgical intervention. MDD had no significant impact on length of hospital stay or total hospital charges. Additional prospective research is necessary in order to better evaluate the impact of MDD in patients with nTOS.

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.

Prevalence of abdominal aortic aneurysms in patients with lung cancer.

OBJECTIVE: Concomitance of abdominal aortic aneurysm (AAA) and primary lung cancer (LC) is not uncommon due to several shared risk factors. To evaluate the incidence of this association, analysis of the National Inpatient Sample database was utilized. METHODS: A retrospective analysis of the National Inpatient Sample database between 2014 and 2018 for all patients diagnosed with primary LC was performed. The differences in the reported findings between the LC and control groups were assessed using the Pearson χ2, Fisher exact, Student t, and/or Mann-Whitney U tests where appropriate. Multivariable logistic regression analysis was conducted to determine independent predictors of the presence of documented AAA. RESULTS: A total of 158,904 patients were identified. Of these, 2430 patients (1.53%) were diagnosed with AAA and 156,474 (98.47%) without AAA. In the multivariable model, LC patients had higher odds of AAA compared with the general population (odds ratio, 1.43; 95% confidence interval, 1.35-1.51). In all age groups, female smokers had a higher rate of AAA compared with female nonsmokers (age <60 years, 0.13% vs 0.04%; 60-69 years, 0.77% vs 0.34%; 70-79 years, 1.65% vs 0.69%; and >80 years, 2.63% vs 1.31%; all P < .001). CONCLUSIONS: LC and AAA share similar risk factors, which may explain the higher AAA prevalence among patients with LC. Given the higher prevalence of AAA in smokers compared with nonsmokers across all age groups in both male and female patients with LC, further sex-based studies investigating the overall mortality and morbidity benefits of AAA screening among patients with LC are highly warranted. This consideration would potentially address the sex disparity in outcomes for AAA management.

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.

Transcarotid transcatheter aortic valve replacement with cerebral embolic protection.

There remains concern about the risk of stroke with transcarotid transcatheter aortic valve replacement (TAVR). We describe the use of the Sentinel cerebral protection device with transcarotid TAVR in a patient at high risk for embolic complications. Deployment of the Sentinel filter in the innominate artery accommodated the insertion of the TAVR device through the bovine aortic arch via the contralateral carotid artery. By adapting the "flip-n-flex" technique from our previous transaxillary TAVR experience, we performed left transcarotid TAVR with the Sentinel device in an ergonomic manner and achieved coaxial placement of the transcatheter valve. Inspection of the Sentinel filter after the case revealed captured embolic debris.

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.

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.

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.

Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock.

BACKGROUND: Bleeding complications and acute limb ischemia (ALI) are devastating vascular complications in patients with ST-segment elevation myocardial infarction (STEMI). Cardiogenic shock (CS) can further increase this risk due to multiorgan failure. In the contemporary era, percutaneous mechanical circulatory support is commonly used for management of CS. We hypothesized that vascular complications may be an important determinant of clinical outcomes for CS due to STEMI (CS-STEMI). OBJECTIVE: We evaluated 10-year national trends, resource utilization and outcomes of bleeding complications, and ALI in CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database (National Inpatient Sample) between 2005 and 2014. Events were then divided into four different groups: no MCS, with intra-aortic balloon pump, percutaneous ventricular assist device includes Impella or Tandem Heart or extracorporeal membrane oxygenation. RESULTS: Bleeding complications and ALI were observed in 31,389 (18.2%) and 1,628 (0.9%) out of 172,491 admissions with CS-STEMI, respectively. Between 2005 and 2014, overall trends increased for ALI; however, the number of bleeding events decreased. ALI was associated with increased in-hospital mortality in comparison to those without any ALI. However, bleeding complications were not associated with increased in-hospital mortality. Compared to patients without complications, both bleeding and ALI were associated with increased length of stay (LOS) and hospitalization costs. CONCLUSIONS: Bleeding and ALI are common complications associated with CS-STEMI in the contemporary era. Both complications are associated with increased hospital costs and LOS. These findings highlight the need to develop algorithms focused on vascular safety in CS-STEMI.

Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock.

OBJECTIVE: The authors sought to evaluate 10-year national trends, incidence and clinical outcomes of stroke in CS-STEMI. BACKGROUND: Stroke is a devastating complication among patients with ST-elevation myocardial infarction (STEMI). Concomitant cardiogenic shock (CS) may further increase the risk of stroke. Use of percutaneous mechanical circulatory support (pMCS) devices may further increase stroke risk in CS-STEMI. No studies have evaluated the risk of stroke in contemporary CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database between 2005 and 2014. Previously validated codes for stroke were used to identify events of ischemic or hemorrhagic stroke. They were then divided into different groups: without MCS, with intra-aortic balloon pump, percutaneous ventricular assist device (PVAD, includes Impella or TandemHeart devices), or extracorporeal membrane oxygenation. RESULTS: In 172,491 admissions, stroke was noted in 5,613 (3.2%). Between 2005 and 2014, we observed an increase in the events of overall stroke from 3.1% in 2005 to 5.0% in 2014 (p for the trend <.001). The number of ischemic stroke events (2.4%) was higher than hemorrhagic stroke (0.1%) during the study period. Presence of stroke was associated with higher in-hospital mortality (40.6 vs. 29.8%, 95% CI adjusted odds ratio: 1.57, 1.44-1.67; p < .0001 among stroke vs. without stroke). CONCLUSIONS: The incidence of stroke events in CS-STEMI patients increased between 2005 and 2014, and is associated with higher in-hospital mortality, length of stay, and cost of hospitalization. The incidence of both hemorrhagic and ischemic stroke was higher with pMCS device use. Stroke prevention is a priority for CS-STEMI patients.

A systematic review and meta-analysis of predilation and postdilation in transfemoral carotid artery stenting.

OBJECTIVE: In this review, we evaluate the short-term impact of different ballooning combinations on hemodynamic instability neurologic events, and mortality associated with carotid artery stenting. METHODS: We used a search strategy to identify studies in the Cochrane Library trials register, PubMed, EMBASE, Google Scholar, and the US National Library of Medicine clinical trial databases up to May 2019. Studies reporting either hemodynamic instability, neurologic events, or mortality were included according to the recommendations of the Preferred Reporting Items for Systematic reviews and Meta-analysis. Fixed and random models were used to summarize the effects. RESULTS: Of seven included cohort studies for qualitative review, six were selected for meta-analysis. Patients without postdilation had significantly less hemodynamic instability in the random effects model (risk ratio, 0.53; 95% confidence interval, 0.37-0.77; P = .001). Regardless of the dilation type, the overall summary effect in the fixed model showed a significant decrease in the risk of developing short-term neurologic events (risk ratio, 0.67; 95% confidence interval, 0.47-0.97; P = .03). Last, the exclusion of either of the two dilation techniques had no significant effect on mortality. CONCLUSIONS: Avoiding postdilation reduces perioperative hemodynamic instability and this benefit lasts at least up to 30 days. Regardless of the type, fewer dilations during carotid artery stenting possibly decreases the neurologic events during and 30 days after the procedure. The data also suggest that the residual stenoses above current practiced standard may provide a safer threshold to prompt postdilation. Statements about the long-term effects of dilation techniques requires more study.

Right Axillary Artery Conduit Is a Safe and Reliable Access for Implantation of Impella 5.0 Microaxial Pump.

BACKGROUND: Impella 5.0 is a powerful mechanical circulatory support device placed into the left ventricle of patients in cardiogenic shock not responding to pharmacologic support alone. This therapy can support patient hemodynamics from weeks to several months, and patients can potentially ambulate with the device implanted while awaiting destination therapy. METHODS: From July 2012 to September 2017, 22 Impella 5.0 devices (Abiomed Inc., Danvers, MA) were implanted via right axillary artery at our center. All devices were implanted under fluoroscopic and transesophageal echocardiographic guidance. RESULTS: Eighty-one percent of patients were male, and average age was 61 years (range 27-73). A 10- or 12-mm graft was used in 96% of the cases, most commonly Hemashield (Maquet, Rastatt, Germany; 46%) or Dacron (DuPont, Wilmington, DE; 23%). The graft was tunneled laterally in a subcutaneous plane in 91% of the cases. All attempts at right axillary artery conduit creation and device implantation were successful. The angle of end-to-side anastomosis was 45-60°. The average duration of therapy was 8.8 days (range 1-19). There were no brachial plexus injuries, patients with upper extremity ischemia, or bleeding requiring intervention in the postoperative period. One patient was coagulopathic and developed a hemorrhagic stroke. Concurrent use of mechanical circulatory support for the right heart was present in 27% of the cases. Twenty-seven percent of patients bridged successfully to ventricular assist devices, 18% recovered to have the device explanted, and 55% of patients died within 30 days of device implantation. CONCLUSIONS: Right axillary artery conduit is a safe and reliable access for implantation of Impella 5.0. This technique appears to be associated with low complication rates when implanted with a standardized technique.