Association between Asian race and perioperative outcomes after carotid revascularization varies with Asian procedure density.

OBJECTIVE: Postoperative outcomes following carotid revascularization are understudied in Asian patients. We aimed to assess whether disease severity and postoperative outcomes following carotid revascularization differ between Asian and White patients, and whether this varies with Asian procedure density. METHODS: We analyzed the Vascular Quality Initiative Carotid Endarterectomy and Carotid Artery Stenting datasets from 2003 to 2021. Regions were divided into tertiles based on Asian procedure density. Propensity scores were used to match Asian and White patients based on patient factors and procedure type. The primary outcome variable was a collapsed composite of in-hospital ipsilateral stroke/death/myocardial infarction. χ2 tests were used to assess association between Asian race and disease severity, center and surgeon volume, and 1-year outcomes. Logistic and Cox regressions were performed between the matched cohorts. RESULTS: A total of 1766 Asian and 159,608 White patients underwent carotid revascularization, and we identified 2704 patients (1352 Asian and 1352 White) in the matched cohorts. Among propensity matched patients, all-comer Asian patients more commonly had >80% ipsilateral stenosis (63% vs 52%; P < .001) and a moderate/severe preoperative Rankin score (7.6% vs 5.1%; P = .007). The rate of in-hospital stroke/death/myocardial infarction was higher in Asian patients (2.6% vs 1.3%; P = .012), and this disparity was more pronounced in the lowest tertile of Asian procedure density (4.3% vs 0.5%; P < .001). Logistic regression in the propensity-matched cohort demonstrated Asian race was associated with lower odds of intervention at highest volume centers (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.2-0.3; P < .001) and by highest volume surgeons (OR, 0.3; 95% CI, 0.3-0.4; P < .001). Asian race was associated with higher odds of in-hospital stroke/death/myocardial infarction (OR, 2.0; 95% CI, 1.1-3.8; P = .031), and there was a significant interaction between Asian procedure density and the relationship between Asian race and this outcome (interaction P = .001). After accounting for center and surgeon volume, the association of Asian race and the composite outcome was mitigated (OR, 1.5; 95% CI, 0.7-3.3; P = .300). Cox regression between the matched cohorts demonstrated that Asian race was associated with lower 1-year mortality (hazard ratio, 0.5; 95% CI, 0.3-0.7; P = .001) and higher risk of 1-year reintervention (hazard ratio, 16; 95% CI, 1.8-142; P = .013). CONCLUSIONS: Asian patients are more likely to present with a higher degree of carotid stenosis, higher preoperative risk, and experience worse perioperative outcomes. The association of Asian race with perioperative stroke/death/myocardial infarction varies with Asian procedure density and is also confounded by center and surgeon volume. These results highlight the importance of understanding referral patterns and cultural effects on outcomes disparities in Asian patients.

Practice patterns in utilization of atherectomy and embolic protection devices in inpatient and outpatient treatment settings.

OBJECTIVE: The frequency of atherectomy in lower extremity arterial disease has increased substantially over the past several years, specifically in the office-based laboratory (OBL) setting, yet the efficacy compared with other interventions and the consequences of distal embolization remain unknown. Embolic protection devices (EPDs) have been used at varying rates depending on physician and practice setting. Previous studies have described lesion characteristics to consider when weighing the benefits and drawbacks associated with device use. Our study focuses on the use of atherectomy and EPDs in femoropopliteal arterial disease to better characterize resource use trends and postoperative outcomes in the inpatient and OBL interventional settings. METHODS: We conducted a retrospective analysis on endovascular interventions performed for femoral-popliteal occlusive disease that were entered into the Vascular Quality Initiative data registry between 2017 and 2021. A one:one greedy match, adjusted analysis based on inpatient or OBL location of procedure was used to compare the groups. Hierarchical logistical regression with selective use of principal component analysis was used to further explore the differences in EPD use and immediate postoperative outcomes. A proportional hazard model was used to demonstrate differences in reintervention rates up to 2 years postoperatively between patients who underwent atherectomy in the inpatient vs OBL treatment setting. RESULTS: Were included 2849 matched pairs in the final analysis. In our cohort, there was 22% EPD use overall, 40% in the hospital setting and 4.4% in the OBL setting (P < .001). Among the patients with available follow-up information, OBL intervention setting increased probability of reintervention by 18% at 2 years postoperatively compared with the inpatient setting; however, there was no difference associated with EPD placement and rate of reintervention. CONCLUSIONS: Use of EPDs in the OBL setting compared with the hospital setting is dramatically decreased; however, no increased incidence of postoperative complications was seen compared with procedures performed in the hospital setting when controlling for patient and lesion characteristics. Patients with available follow-up data were more likely to undergo ipsilateral reintervention between 6 months and 2 years postoperatively if atherectomy was done in the OBL setting. Dedicated studies are encouraged to ensure patient safety, effective resource allocation, and long-term efficacy of OBL atherectomy as an ever-growing number of peripheral arterial procedures are transitioned to the OBL setting.

Insurance status is associated with urgent carotid endarterectomy and worse postoperative outcomes.

OBJECTIVE: Underinsured patients can experience worse preoperative medical optimization. We aimed to determine whether insurance status was associated with carotid endarterectomy (CEA) urgency and postoperative outcomes. METHODS: We analyzed the Society for Vascular Surgery Vascular Quality Initiative Carotid Endarterectomy dataset from January 2012 to January 2021. Univariable and multivariable methods were used to analyze the differences across the insurance types for the primary outcome variable: CEA urgency. The analyses were limited to patients aged <65 years to minimize age confounding across insurers. We also examined differences in preoperative medical optimization and symptomatic disease and postoperative outcomes. A secondary analysis was performed to examine the effect of CEA urgency on the postoperative outcomes. RESULTS: A total of 27,331 patients had undergone first-time CEA. Of these patients, 4600 (17%) had Medicare, 3440 (13%) had Medicaid, 17,917 (65%) had commercial insurance, and 1374 (5%) were uninsured. The Medicaid and uninsured patients had higher rates of urgent operation compared with Medicare (20.0% and 34.7% vs 14.4%; P < .001), with no differences in the commercial group vs the Medicare group. Additionally, Medicaid and uninsured patients had lower rates of aspirin, statin, and/or antiplatelet use (93.6% and 93.5% vs 95.8%; P < .001) and higher rates of symptomatic disease (42.1% and 57.6% vs 36.2%; P < .001) compared with Medicare patients. The rate of perioperative stroke/death was higher for the Medicaid and uninsured patients than for the Medicare patients (1.63% and 1.89% vs 1.02%; P = .017 and P = .01, respectively), with no differences in the commercial group. Multivariable analysis demonstrated that compared with Medicare, Medicaid and uninsured status were associated with increased odds of an urgent operation (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.1-1.5; and OR, 2.3; 95% CI, 2.0-2.7, respectively), symptomatic disease (OR, 1.2; 95% CI, 1.1-1.4; and OR, 2.2; 95% CI, 1.9-2.5, respectively), and perioperative stroke/death (OR, 1.6; 95% CI, 1.1-2.4; and OR, 1.8; 95% CI, 1.1-3.0, respectively) and a decreased odds of aspirin, statin, and/or antiplatelet use (OR, 0.71; 95% CI, 0.6-0.9; and OR, 0.76; 95% CI, 0.6-0.99, respectively). Additionally, the rates of perioperative stroke/death were higher for patients who had required urgent surgery compared with elective surgery (2.8% vs 1.0%; P < .001). Multivariable analysis demonstrated increased odds of perioperative stroke/death for patients who had required urgent surgery (OR, 2.4; 95% CI, 1.9-3.1). CONCLUSIONS: Medicaid and uninsured patients were more likely to require urgent CEA, in part because of poor preoperative medical optimization. Additionally, urgent operation was independently associated with worse postoperative outcomes. These results highlight the need for improved preoperative follow-up for underinsured populations.

Asian race is associated with peripheral arterial disease severity and postoperative outcomes.

OBJECTIVE: The nature of peripheral arterial disease and postoperative outcomes are understudied in Asian patients. We aimed to determine if there are disparities in disease severity at the time of presentation and postoperative outcomes with regard to Asian race. METHODS: We analyzed the Society for Vascular Surgery Vascular Quality Initiative Peripheral Vascular Intervention dataset from 2017 to 2021, which includes endovascular lower extremity interventions. Propensity scores were used to match White and Asian patients based on age, sex, comorbidities, ambulatory/functional status, and intervention level. Differences were examined with regard to Asian race across all patients in the United States, Canada, and Singapore, and separately in the United States and Canada only. The primary outcome was emergent intervention. We also examined differences in severity of disease and postoperative outcomes. RESULTS: A total of 80,312 White and 1689 Asian patients underwent peripheral vascular intervention. After propensity score matching, we identified 1669 matched pairs of patients across all centers including Singapore and 1072 matched pairs in the United States and Canada only. Among the matched cohort consisting of all centers, Asian patients had a higher rate of emergent intervention to prevent limb loss (5.6% vs 1.7%, P < .001). The majority of Asian patients presented with chronic limb threatening ischemia at a higher rate than White patients within the cohort including Singapore (71% vs 66%, P = .005). Within both propensity-matched cohorts, the rate of in-hospital death was higher in Asian patients (all centers: 3.1% vs 1.2%, P < .001; United States and Canada only: 2.1% vs 0.8%, P = .010). Logistic regression demonstrated greater odds of emergent intervention in Asian patients from all centers including Singapore (odds ratio [OR], 3.3; 95% confidence interval [CI], 2.2-5.1, P < .001) but not in the United States and Canada only (OR, 1.4; 95% CI, 0.8-2.8, P = .261). In addition, Asian patients had greater odds of in-hospital death in both matched cohorts (all centers: OR, 2.6; 95% CI, 1.5-4.4, P < .001; United States and Canada: OR, 2.5; 95% CI, 1.1-5.8, P = .026). Asian race was associated with a greater risk of loss of primary patency at 18 months (all centers: hazard ratio, 1.5; CI, 1.2-1.8, P = .001; United States and Canada only: hazard ratio, 1.5; CI, 1.2-1.9, P = .002). CONCLUSIONS: Asian patients are more likely to present with advanced peripheral arterial disease and undergo emergent intervention to prevent limb loss, in addition to having worse postoperative outcomes and long-term patency. These results highlight the need for improved screening and postoperative follow-up in this understudied population.

The impact of neighborhood social disadvantage on presentation and management of first-time hemodialysis access surgery patients.

OBJECTIVES: The impact of social determinants of health on the presentation, management, and outcomes of patients requiring hemodialysis (HD) arteriovenous (AV) access creation have not been well-characterized. The Area Deprivation Index (ADI) is a validated measure of aggregate community-level social determinants of health disparities experienced by members living within a community. Our goal was to examine the effect of ADI on health outcomes for first-time AV access patients. METHODS: We identified patients who underwent first-time HD access surgery in the Vascular Quality Initiative between July 2011 to May 2022. Patient zip codes were correlated with an ADI quintile, defined as quintile 1 (Q1) to quintile 5 (Q5) from least to most disadvantaged. Patients without ADI were excluded. Preoperative, perioperative, and postoperative outcomes considering ADI were analyzed. RESULTS: There were 43,292 patients analyzed. The average age was 63 years, 43% were female, 60% were of White race, 34% were of Black race, 10% were of Hispanic ethnicity, and 85% received autogenous AV access. Patient distribution by ADI quintile was as follows: Q1 (16%), Q2 (18%), Q3 (21%), Q4 (23%), and Q5 (22%). On multivariable analysis, the most disadvantaged quintile (Q5) was associated with lower rates of autogenous AV access creation (OR, 0.82; 95% confidence interval [CI], 0.74-0.90; P < .001), preoperative vein mapping (OR, 0.57; 95% CI, 0.45-0.71; P < .001), access maturation (OR, 0.82; 95% CI, 0.71-0.95; P = .007), and 1-year survival (OR, 0.81; 95% CI, 0.71-0.91; P = .001) compared with Q1. Q5 was associated with higher 1-year intervention rates than Q1 on univariable analysis, but not on multivariable analysis. CONCLUSIONS: The patients undergoing AV access creation who were most socially disadvantaged (Q5) were more likely to experience lower rates of autogenous access creation, obtaining vein mapping, access maturation, and 1-year survival compared with the most socially advantaged (Q1). Improvement in preoperative planning and long-term follow-up may be an opportunity for advancing health equity in this population.

Malpractice allegations against vascular surgeons: Prevalence, risk factors, and impact on surgeon wellness.

OBJECTIVE: The contemporary medicolegal environment has been linked to procedure overuse, health care variation, and higher costs. For physicians accused of malpractice, there is also a personal toll. The objective of this study was to evaluate the prevalence of and risk factors for involvement in medical malpractice lawsuits among United States vascular surgeons, and to examine the association between these allegations with surgeon wellness. METHODS: In 2018, the Society of Vascular Surgery (SVS) Wellness Task Force conducted a confidential survey of active members using a validated burnout assessment (Maslach Burnout Index) embedded into a questionnaire. This survey included questions related to medical errors and malpractice litigation. De-identified demographic, personal, and practice-related characteristics were assessed in respondents who reported malpractice allegations in the preceding 2 years, then compared with those without recent medicolegal litigation. Risk factors for malpractice allegations were identified (χ2, Kruskal-Wallis tests), and the association between malpractice allegations with wellness was examined. Multivariate logistic regression models were developed to identify independent risk factors for malpractice accusations. RESULTS: Of 2905 active SVS members, 871 responses from practicing vascular surgeons were analyzed. A total of 161 (18.5%) were named in a malpractice lawsuit within 2 years. Malpractice allegations were significantly associated with surgeon burnout (odds ratio, 1.47; 95% confidence interval, 1.01-2.15; P = .041), but not with self-reported depression or suicidal ideation. The nature of malpractice claims included procedural errors (23.1%), failure to treat (18.8%), and error/delay in diagnosis (16.9%). Twenty percent of claims were settled prior to trial, and 19% were dismissed. Defendant vascular surgeons reported a "fair" resolution in 26.4% of closed cases. By unadjusted analysis, factors significantly associated with recent malpractice claims included mean age (51.7 ± 10.0 vs 49.3 ± 11.2 years; P = .0044) and mean years in practice (18.0 ± 10.7 vs 15.2 ± 11.8; P = .0007). Multivariate analysis revealed independent variables associated with malpractice allegations, including on-call frequency (P = .0178), recent medical errors (P = .0189), and male surgeons (P = .045). CONCLUSIONS: Malpractice allegations are common for vascular surgeons and are significantly associated with surgeon burnout. Nearly 20% of survey respondents reported being named in a lawsuit within the preceding 2 years. Our findings underscore the need for SVS initiatives to provide counseling and peer support for vascular surgeons facing litigation.

Association of insurance status with timing of hemodialysis access placement.

OBJECTIVE: Patients without adequate outpatient follow-up often present requiring emergency hemodialysis and then undergo permanent dialysis access placement at a later time. We sought to examine the relationship between type of insurance and whether a patient was already on dialysis at time of surgery. METHODS: The Vascular Quality Initiative Hemodialysis Access registry was queried for all adult patients undergoing first time permanent hemodialysis access between January 2015 and September 2019. Patient and procedural characteristics were examined in patients split by private insurance-Medicare more than 65 years of age, Medicare less than 65 years of age, and Medicaid. The primary outcome was whether patients were on dialysis at the time of surgery. RESULTS: There were 19,307 adult patients that underwent first time placement of an arteriovenous fistula or graft. Of these patients, 9729 (50%) had Medicare, 7179 (37%) had private insurance, and 2399 (12%) had Medicaid. The patients with Medicare were subgrouped by age with 2968 (31%) being less than 65 years of age and 6761 (69%) being more than 65 years of age. Patients with Medicare and less than 65 were the most likely to be on dialysis at the time of surgical access placement at 67%, whereas 59% of Medicaid patients were on dialysis, and 53% each group of patients with Medicare and more than 65 years of age and private insurance were on dialysis. After adjustment for patient characteristics, patients with Medicare who were less than 65 and more than 65 years of age were both significantly more likely to be on dialysis at time of surgery compared with private insurance with odds ratio (OR) of 1.64 (95% confidence interval [CI], 1.49-1.80; P < .001) and an OR of 1.11 (95% CI, 1.03-1.20; P = .007), respectively. After adjustment, patients with Medicaid were no longer significantly more likely to be on dialysis. Secondary outcomes demonstrated, after adjustment, no difference in the association between a surgical fistula vs graft in any insurance groups; however, patients with Medicare and who were less than 65 years of age were more likely to have a nonradial artery used for anastomosis with an OR of 1.18 (95% CI, 1.04-1.34; P = .011). CONCLUSIONS: Certain types of insurance are correlated with being on dialysis at the time of access placement. Although associations were seen between insurance type and surgical access characteristics, these were associations predominantly insignificant when patient demographics and status of dialysis were controlled for. These potential gaps in care represent an area for improvement that deserves further exploration.

Transcarotid artery revascularization versus carotid endarterectomy and transfemoral stenting in octogenarians.

OBJECTIVE: Transfemoral carotid artery stenting (TFCAS) has higher combined stroke and death rates in elderly patients with carotid artery stenosis compared with carotid endarterectomy (CEA). However, transcarotid artery revascularization (TCAR) may have similar outcomes to CEA. This study compared outcomes after TCARs relative to those after CEAs and TFCAS, focusing on elderly patients. METHODS: We included all patients with carotid artery stenosis and no prior endarterectomy or stenting who underwent either a CEA, TFCAS, or TCAR in the Vascular Quality Initiative from September 2016 (TCAR commercially available) to December 2019. We categorized patients into age decades: 60 to 69 years, 70 to 79 years, and 80 to 90 years. Outcomes included 30-day and 1-year composite rates of stroke or death. Cox proportional hazards models evaluated both outcomes after adjusting for patient demographics, clinical factors, symptomatology, hospital CEA volume, and clustering. RESULTS: We identified 33,115 patients who underwent either a CEA, TFCAS, or TCAR for carotid artery stenosis (35% in their 60s, 44% in their 70s, and 21% in their 80s), where one-half (50%) were symptomatic. The majority of patients had CEAs (80%), followed by TFCAS (11%) and TCARs (9.1%). The overall rate of 30-day stroke/death was 1.5% and of 1-year stroke/death was 4.4%. Octogenarians had the highest 30-day and 1-year stroke/death rates relative to their peers (2.3% and 6.3%, respectively). Among all patients, the adjusted hazards of TCARs relative to CEAs was similar for 30-day stroke/death (hazard ratio [HR] 1.10; 95% confidence interval [CI], 0.75-1.62) and slightly higher for 1-year stroke/death (HR, 1.34; 95% CI, 1.02-1.76). Among octogenarians, however, the adjusted hazards of TCARs relative to CEAs was similar for both 30-day stroke/death (HR, 1.12; 95% CI, 0.59-2.13) and 1-year stroke/death (HR, 1.28; 95% CI, 0.85-1.94). TFCAS relative to CEAs had higher hazards of both 30-day stroke/death (HR, 1.78; 95% CI, 1.10-2.89) and 1-year stroke/death (HR, 1.85; 95% CI, 1.35-2.54) in octogenarians. CONCLUSIONS: TCARs had similar outcomes relative to CEAs among octogenarians with respect to 30-day and 1-year rates of stroke/death. TCAR may serve as a promising less invasive treatment for carotid disease in older patients who are deemed high anatomic, surgical, or clinical risk for CEAs.

The variable impact of aneurysm size on outcomes after open abdominal aortic aneurysm repairs.

OBJECTIVE: Previous studies evaluating the association between abdominal aortic aneurysm (AAA) size with postoperative outcomes after open repairs seldom accounted for renal or visceral artery involvement, proximal clamp site, intraoperative renal ischemia time, and hospital volume. This study examined the association between aneurysm size with outcomes after open repairs. METHODS: We identified patients who underwent open repairs of infrarenal versus juxtarenal nonruptured AAAs, defined by proximal clamp site, in the 2004-2019 Vascular Quality Initiative. Outcomes included 30-day mortality, postoperative complications, failure to rescue, and 1-year mortality. Multivariable logistic regressions adjusted for patient characteristics, operative factors, hospital volume, and hospital clustering. RESULTS: We identified 8011 patients (54% infrarenal, 46% juxtarenal). The median aneurysm size did not differ between infrarenal versus juxtarenal aneurysms (5.7 cm vs 5.9 cm; P = .12). For infrarenal aneurysms, every 1-cm increase in size increase the adjusted odds ratio (OR) or hazard ratio (HR) of 30-day mortality by 18% (OR, 1.18; 95% CI, 1.06-1.31), failure to rescue by 20% (OR, 1.20; 95% CI, 1.06-1.34), 1-year mortality by 18% (HR, 1.18; 95% CI, 1.10-1.26), but not complications (OR, 1.03; 95% CI, 0.98-1.07). For juxtarenal aneurysm, larger aneurysm sizes were not associated with any outcome. Proximal clamp site, ischemia time, and volume were associated with outcomes. CONCLUSIONS: The association between AAA size and outcomes matters less with renal and visceral artery aneurysmal involvement, having important implications for surgical decision-making, operative planning, and patient counseling.

Incidence and risk factors of groin lymphocele formation after venoarterial extracorporeal membrane oxygenation in cardiogenic shock patients.

OBJECTIVE: Venous-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established therapy for refractory cardiopulmonary failure. Femoral cannulation offers a quick and effective means of providing circulatory support but is not without complication. Inflammation or lymphatic disruption at the site of cannulation can cause the formation of lymphoceles, leading to the patient's discomfort and possibly necessitating intervention. The purpose of this study was to evaluate the incidence of in-hospital lymphocele formation in VA-ECMO patients and to identify predictors for their development. METHODS: We conducted a single-center retrospective review of 192 patients who underwent femoral VA-ECMO insertion and subsequent decannulation from March 2007 to August 2016 for cardiogenic shock. Baseline demographics, risk factors, and cannulation strategies were examined. Groin lymphocele formation was assessed as the primary outcome. RESULTS: Median age was 58 years (interquartile range, 48-67 years) with a median duration of support of 4 days (interquartile range, 2-6 days). Lymphocele formation was identified in 31 patients (16%). Patients who developed lymphoceles were more likely to have post-heart transplantation primary graft dysfunction (PGD) as an indication for ECMO support compared with those who did not (54.2% vs 8%; P < .001). ECMO duration was similar between groups, but lymphocele patients were more likely to have undergone femoral cutdown procedures (68% vs 42%; P = .010). Compared with those PGD patients who did not develop lymphoceles, PGD lymphocele patients had higher rates of diabetes mellitus preoperatively (62% vs 8%; P = .006). Thirteen (42%) patients required surgical incision and drainage, and 4 of these patients (31%) required repeated surgical intervention. CONCLUSIONS: Lymphocele formation is relatively common after femoral VA-ECMO. There was a significantly higher incidence of lymphocele formation in diabetic patients requiring support for PGD after heart transplantation.

Routine Use of Distal Arterial Perfusion in Pediatric Femoral Venoarterial Extracorporeal Membrane Oxygenation.

Lower-extremity ischemia is a significant complication in children on femoral venoarterial extracorporeal membrane oxygenation (VA ECMO). Our institution currently routinely uses distal perfusion catheters (DPCs) in all femoral arterial cannulations in attempts to reduce ischemia. We performed a single-center, retrospective review of pediatric patients supported with femoral VA ECMO from January 2005 to November 2015. The outcomes of patients with prophylactic DPC placement at cannulation (prophylactic DPC) were compared to a historical group with DPCs placed in response only to clinically evident ischemic changes (reactive DPC). Ischemic complication requiring invasive intervention (fasciotomy or amputation) was the primary outcome. Twenty-nine patients underwent a total of 31 femoral arterial cannulations, 17 with prophylactic DPC and 14 with reactive DPC. Ischemic complications requiring invasive intervention developed in 2 of 17 (12%) prophylactic DPC patients versus 4 of 14 (29%) reactive DPC. In the reactive DPC group, 7 of 14 (50%) had ischemic changes postcannulation, six underwent DPC placement, and three out of six of these patients still required invasive intervention. One of the seven patients had ischemic changes, did not undergo DPC, and required amputation. While a greater percentage of patients in the prophylactic group was cannulated during extracorporeal cardiopulmonary resuscitation (ECPR), statistical significance was not otherwise demonstrated. We demonstrate feasibility of superficial femoral artery (SFA) access in pediatric patients. We note fewer ischemic complications with prophylactic DPC placement, and observe that salvaging a limb with a reactive DPC was only successful 50% of the time. Although there was no statistical difference in the primary outcome between the two groups, limitations and confounding factors include small sample size and a greater percentage of patients in the prophylactic DPC group cannulated with ECPR in progress.

Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass.

OBJECTIVE: Despite improvements in endovascular therapy for lower extremity arterial disease, open surgical revascularization is still required when the disease is extensive. Although autogenous vein is the conduit of choice for open femoropopliteal bypass, prosthetic grafts can be an acceptable alternative when adequate vein is not available. The FUSION BIOLINE heparin-coated vascular graft (Maquet Endovascular, Wayne, NJ) was developed to improve the patency rate associated with standard prosthetic grafts. The current study, the FINEST Trial (Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE), was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective, randomized, controlled, multicenter trial. METHODS: During a 25-month period ending in June 2012, 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene (ePTFE) graft or the heparin-coated FUSION BIOLINE vascular graft. Among 203 patients in the efficacy analysis, claudication was the presenting symptom in 147 (72.4%), and the site of the distal anastomosis was at the above-knee level in 174 (85.7%). Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days, 6 months, and 12 months. The primary efficacy end point was primary patency of the study graft. The primary safety end point was the composite of major adverse events and periprocedural death. Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency. RESULTS: The primary patency rates at 6 months were 86.4% for the FUSION BIOLINE heparin-coated vascular graft group compared with 70.0% for the standard ePTFE group, a difference of 16.4% (95% confidence interval, 2.7%-29.9%; P = .006), and the respective rates at 12 months were 76.5% and 67.0% (95% confidence interval, -4.8% to 23.0%; P = .05). The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group (P < .0001). Major adverse events were significantly lower in the FUSION BIOLINE group, occurring in 17.1%, compared with 30.7% in the standard ePTFE group (P = .033), principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group (16.2% vs 30.7%). CONCLUSIONS: Data from this randomized multicenter study demonstrated improved midterm patency, less bleeding at the suture hole, and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts. Although the ultimate long-term benefit of the graft cannot be ascertained with the data currently available, the utility of the FUSION BIOLINE vascular graft appears promising.

External carotid artery stenosis after internal and common carotid stenting.

BACKGROUND: The external carotid artery (ECA) can be an important collateral for cerebral perfusion in the presence of severe internal carotid artery (ICA) disease. ICA stenting that covers the ECA origin may put the ECA at increased risk of stenosis. Our objective was to determine the rate of ECA stenosis secondary to ICA stenting, determine predictive factors, and describe any subsequent associated symptoms. METHODS: We retrospectively reviewed clinical data on all ICA stents crossing the origin of the ECA placed by vascular surgeons at our institution. We analyzed patient demographics, comorbidities, stent type and sizes, as well as medication profile to determine predictors of ECA stenosis. RESULTS: Between 2005 and 2013, there were 72 (out of 119 total ICA stenting) patients (mean age 71, 68% male) who underwent placement of ICA stents that also crossed the origin of the ECA. Six patients (8.3%) had a significantly increased ECA stenosis postprocedure. There were no occlusions. All patients with ECA stenosis maintained patency of their ICA stent and were asymptomatic. Age, gender, comorbidities, stent type and size, and medication profile were not associated with ECA stenosis after stenting. CONCLUSIONS: ECA stenosis after ICA stenting covering the ECA origin is uncommon and not clinically significant in patients with patent ICA stents. The clinical significance of concurrent ECA and ICA stenosis after stenting is unclear as it is not captured here. The potential for ECA stenosis should not deter stenting across the ECA origin if necessary. Patient and stent factors are not predictive of ECA stenosis.

The vascular surgeon's experience with adrenal venous sampling for the diagnosis of primary hyperaldosteronism.

BACKGROUND: Adrenal venous sampling (AVS) is used to distinguish between bilateral idiopathic hyperplasia and a functional adrenal tumor in patients with hyperaldosteronism. Successful sampling from both adrenal veins is necessary for lateralization and may require more than 1 procedure. AVS has traditionally been performed by interventional radiologists; however, our goal was to examine the outcomes when performed by a vascular surgeon. METHODS: All patients with a diagnosis of hyperaldosteronism were referred for AVS regardless of imaging findings. Cortisol and aldosterone levels were measured in blood samples from both adrenal veins. Postoperative analysis of intraoperative laboratory values before and after cosyntropin administration determined successful cannulation and sampling of each vein. RESULTS: Between 2007 and 2012, 53 patients underwent AVS by one vascular surgeon. The average age was 54 and 63% were men. Our success rate increased with experience, because during the earlier years (2007-2010) primary and secondary success rates were 58% and 68%, respectively compared with later years (2011-2012) when primary and secondary success rates were 82% and 95%, respectively (P<0.05). Results of AVS altered localization of disease compared with what had been anticipated based on preoperative imaging and thus influenced surgical decision making in 47% of cases. CONCLUSIONS: AVS is an important procedure in the work up of hyperaldosteronism to help identify and localize metabolically active tumors. It is an additional area in medicine where a vascular surgeon can lend expertise. Success with the procedure improves with experience and should be performed by high volume surgeons.

Effect of race and insurance status on outcomes after vascular access placement for hemodialysis.

BACKGROUND: Race and insurance status are seen as potential barriers to health care access and maintenance. Our goal was to see how these, as well as other patient and procedural characteristics, affected our populations' upper extremity vascular access outcomes. METHODS: We retrospectively reviewed 601 vascular access patients from 2004 through 2012 in our urban university hospital. We recorded patient demographics, insurance status, comorbidities, and complications. Primary outcomes were reintervention, long-term mortality, and transplantation. RESULTS: Median age was 62 ± 15.8 years, and 58% were male. Most operations were arteriovenous fistulas (66%). The majority of patients identified themselves as Hispanic (50%), followed by white (22%), and black (19%). Most patients had Medicare only (42%), 31% had private insurance, and 27% had Medicaid as their insurance. Black/African American patients were more likely to receive an arteriovenous graft (AVG) compared with white and Hispanic patients (44% vs. 28% and 33%, P < 0.05). White patients were significantly older (68) than Hispanics (61) or blacks (58). Freedom from reintervention at 5 years was 55% with previous tunneled catheter use predictive. Mortality at 5 years was 35% and predicted by age, AVG placement, white race, and not receiving a kidney transplant. Predictors of not receiving a transplant included older age, lower albumin, AVG placement, and coronary artery disease. CONCLUSIONS: There were no disparities with insurance status in long-term outcomes in our population. Race was not a factor for reintervention or transplantation; however, black/African American patients were more likely have an AVG placed, and white patients had a lower long-term survival after access placement.

Small apolipoprotein(a) isoforms may predict primary patency following peripheral arterial revascularization.

Background: High lipoprotein (a) [Lp(a)] is associated with adverse limb events in patients undergoing lower extremity revascularization. Lp(a) levels are genetically pre-determined, with LPA gene encoding for two apolipoprotein (a) [apo(a)] isoforms. Isoform size variations are driven by the number of kringle IV type 2 (KIV-2) repeats. Lp(a) levels are inversely correlated with isoform size. In this study, we examined the role of Lp(a) levels, apo(a) size and inflammatory markers with lower extremity revascularization outcomes. Methods: 25 subjects with chronic peripheral arterial disease (PAD), underwent open or endovascular lower extremity revascularization (mean age of 66.7±9.7 years; F=12, M=13; Black=8, Hispanic=5, and White=12). Pre- and post-operative medical history, self-reported symptoms, ankle brachial indices (ABIs), and lower extremity duplex ultrasounds were obtained. Plasma Lp(a), apoB100, lipid panel, and pro-inflammatory markers (IL-6, IL-18, hs-CRP, TNFα) were assayed preoperatively. Isoform size was estimated using gel electrophoresis and weighted isoform size ( wIS ) calculated based on % isoform expression. Firth logistic regression was used to examine the relationship between Lp(a) levels, and wIS with procedural outcomes: symptoms (better/worse), primary patency at 2-4 weeks, ABIs, and re-intervention within 3-6 months. We controlled for age, sex, history of diabetes, smoking, statin, antiplatelet and anticoagulation use. Results: Median plasma Lp(a) level was 108 (44, 301) nmol/L. The mean apoB100 level was 168.0 ± 65.8 mg/dL. These values were not statistically different among races. We found no association between Lp(a) levels and w IS with measured plasma pro-inflammatory markers. However, smaller apo(a) wIS was associated with occlusion of the treated lesion(s) in the postoperative period [OR=1.97 (95% CI 1.01 - 3.86, p<0.05)]. The relationship of smaller apo(a) wIS with re-intervention was not as strong [OR=1.57 (95% CI 0.96 - 2.56), p=0.07]. We observed no association between wIS with patient reported symptoms or change in ABIs. Conclusions: In this small study, subjects with smaller apo(a) isoform size undergoing peripheral arterial revascularization were more likely to experience occlusion in the perioperative period and/or require re-intervention. Larger cohort studies identifying the mechanism and validating these preliminary data are needed to improve understanding of long-term peripheral vascular outcomes. Key Findings: 25 subjects with symptomatic PAD underwent open or endovascular lower extremity revascularization in a small cohort. Smaller apo(a) isoforms were associated with occlusion of the treated lesion(s) within 2-4 weeks [OR=1.97 (95% CI 1.01 - 3.86, p<0.05)], suggesting apo(a) isoform size as a predictor of primary patency in the early period after lower extremity intervention. Take Home Message: Subjects with high Lp(a) levels, generally have smaller apo(a) isoform sizes. We find that, in this small cohort, patients undergoing peripheral arterial revascularization subjects with small isoforms are at an increased risk of treated vessel occlusion in the perioperative period. Table of Contents Summary: Subjects with symptomatic PAD requiring lower extremity revascularization have high median Lp(a) levels. Individuals with smaller apo(a) weighted isoform size (wIS) have lower primary patency rates and/or require re-intervention.

Small apolipoprotein(a) isoforms may predict primary patency following peripheral arterial revascularization.

Background: High lipoprotein (a) [Lp(a)] is associated with adverse limb events in patients undergoing lower extremity revascularization. Lp(a) levels are genetically pre-determined, with LPA gene encoding for two apolipoprotein (a) [apo(a)] isoforms. Isoform size variations are driven by the number of kringle IV type 2 (KIV-2) repeats. Lp(a) levels are inversely correlated with isoform size. In this study, we examined the role of Lp(a) levels, apo(a) size, and inflammatory markers with lower extremity revascularization outcomes. Methods: Twenty-five subjects with chronic peripheral arterial disease (PAD) underwent open or endovascular lower extremity revascularization (mean age, 66.7 ± 9.7 years; Female = 12; Male = 13; Black = 8; Hispanic = 5; and White = 12). Pre- and postoperative medical history, self-reported symptoms, ankle-brachial indices (ABIs), and lower extremity duplex ultrasounds were obtained. Plasma Lp(a), apoB100, lipid panel, and pro-inflammatory markers (IL-6, IL-18, hs-CRP, TNFα) were assayed preoperatively. Isoform size was estimated using gel electrophoresis and weighted isoform size (wIS) calculated based on % isoform expression. Firth logistic regression was used to examine the relationship between Lp(a) levels and wIS with procedural outcomes: symptoms (better/worse), early primary patency at 2 to 4 weeks, ABIs, and reintervention within 3 to 6 months. We controlled for age, sex, history of diabetes, smoking, statin, antiplatelet, and anticoagulation use. Results: Median plasma Lp(a) level was 108 (interrquartile range, 44-301) nmol/L. The mean apoB100 level was 168.0 ± 65.8 mg/dL. These values were not statistically different among races. We found no association between Lp(a) levels and wIS with measured plasma pro-inflammatory markers. However, smaller apo(a) wIS was associated with occlusion of the treated lesion(s) in the postoperative period (odds ratio, 1.97; 95% confidence interval, 1.01-3.86; P < .05). The relationship of smaller apo(a) wIS with reintervention was not as strong (odds ratio, 1.57; 95% confidence interval, 0.96-2.56; P = .07). We observed no association between wIS with patient reported symptoms or change in ABIs. Conclusions: In this small study, subjects with smaller apo(a) isoform size undergoing peripheral arterial revascularization were more likely to experience occlusion in the postoperative period and/or require reintervention. Larger cohort studies identifying the mechanism and validating these preliminary data are needed to improve understanding of long-term peripheral vascular outcomes.

Statins reduce neurologic injury in asymptomatic carotid endarterectomy patients.

BACKGROUND AND PURPOSE: Statins are neuroprotective in a variety of experimental models of cerebral injury. We sought to determine whether patients taking statins before asymptomatic carotid endarterectomy exhibit a lower incidence of neurological injury (clinical stroke and cognitive dysfunction). METHODS: A total of 328 patients with asymptomatic carotid stenosis scheduled for elective carotid endarterectomy consented to participate in this observational study of perioperative neurological injury. RESULTS: Patients taking statins had a lower incidence of clinical stroke (0.0% vs 3.1%; P=0.02) and cognitive dysfunction (11.0% vs 20.2%; P=0.03). In a multivariate regression model, statin use was significantly associated with decreased odds of cognitive dysfunction (odds ratio, 0.51 [95% CI, 0.27-0.96]; P=0.04). CONCLUSIONS: Preoperative statin use was associated with less neurological injury after asymptomatic carotid endarterectomy. These observations suggest that it may be possible to further reduce the perioperative morbidity of carotid endarterectomy. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00597883.

Endovascular management of superior mesenteric artery pseudoaneurysm.

A 31-year-old man underwent a Whipple procedure for a pancreatic neuroendocrine tumor, which consists of a pancreaticoduodenectomy and reconstruction to restore intestinal continuity. Six weeks after the operation, he presented with severe mid-epigastric pain radiating to his back. Imaging studies revealed a large pseudoaneurysm arising from the superior mesenteric artery. Selective superior mesenteric angiography confirmed the presence of the pseudoaneurysm. A 6 mm × 2.5 cm stent graft (Viabhan; W.L. Gore, Flagstaff, Ariz) was deployed across the pseudoaneurysm origin with preservation of the mesenteric branches. The patient had immediate resolution of symptoms and follow-up imaging showed patency of the stent graft and exclusion of the pseudoaneurysm.