Objectives Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Though well-studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized-control trials (RCT) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCT and analyzes whether these studies adequately represent our diverse patient population. Methods We conducted a retrospective review of US-based RCT from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population. Results Seventy-seven studies were reviewed and 52 met our inclusion criteria. Of these, only 85% reported gender and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 subjects), multi-center, government-funded trials (P<0.001 for all). Women are disproportionately under-represented in RCT for all procedure categories (AAR: 9.0% vs 21.5%, CR: 30.0% vs 42.9%, LER: 22.4% vs 41.3%) while minorities are underrepresented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) while they are over represented in LER studies (26.0% vs 21.8%, P<.001 for all). Conclusions Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCT, particularly in small, non-government funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCT may yield more broadly applicable results.

Background Practice guidelines regarding management of the left subclavian artery (LSA) during thoracic endovascular aortic repair (TEVAR) are based on low quality evidence and there is limited literature that addresses optimal revascularization techniques. The purpose of this study is to compare outcomes of LSA coverage during TEVAR and revascularization techniques. Study Design We performed a single-center retrospective cohort study from 2001–2013. Patients were categorized by LSA revascularization and by revascularization technique, carotid-subclavian bypass (CSB) or subclavian-carotid transposition (SCT). Thirty-day and mid-term stroke, spinal cord ischemia, vocal cord paralysis, upper extremity ischemia, primary patency of revascularization, and mortality were compared. Results Eighty patients underwent TEVAR with LSA coverage, 25% (n=20) were unrevascularized and the remaining patients underwent CSB (n=22, 27.5%) or SCT (n=38, 47.5%). Mean follow-up time was 24.9 months. Comparisons between unrevascularized and revascularized patients were significant for a higher rate of 30-day stroke (25% vs. 2%, p=0.003) and upper extremity ischemia (15% vs. 0%, p=0.014). However, there was no difference in 30-day or mid-term rates of spinal cord ischemia, vocal cord paralysis, or mortality. There were no statistically significant differences in 30-day or midterm outcomes for CSB vs. SCT. Primary patency of revascularizations was 100%. Survival analysis comparing unrevascularized vs. revascularized LSA, was statistically significant for freedom from stroke and upper extremity ischemia, p=0.02 and p=0.003, respectively. After adjustment for advanced age, urgency and coronary artery disease, LSA revascularization was associated with lower rates of peri-operative adverse events (OR 0.23, p=0.034). Conclusions During TEVAR, LSA coverage without revascularization is associated with an increased risk of stroke and upper extremity ischemia. When LSA coverage is required during TEVAR, CSB and SCT are equally acceptable options.

Chart review after EVAR demonstrated a 6% 1-year and 16% 3-year reintervention rate, and almost all (92%) of these events were accurately captured using VQI-Medicare data. Linking VQI data with Medicare claims allows an accurate assessment of reintervention rates after EVAR without labor-intensive physician chart review.

Objective Accurate and complete long-term post-operative outcome data is critical to improving value in healthcare delivery. The Society for Vascular Surgery – Vascular Quality Initiative (VQI) is an important tool to achieve this goal in vascular surgery. To improve on the capture of long term outcomes after vascular surgery procedures for patients in the VQI, we sought to match VQI data to Medicare Claims for comprehensive capture of major clinical outcomes in the first several years following vascular procedures. Methods Patient and procedure characteristics for abdominal aortic aneurysm procedures captured in the SVS-VQI between January 1, 2002, and December 31, 2013 were matched to Medicare claims data using an indirect identifier methodology. Late outcomes captured in the VQI and in Medicare claims were compared. Results Matching procedures yielded 9,895 endovascular aneurysm repair (EVAR) patients (82.4% of eligible VQI patients) and 3,405 open aneurysm repair (OAR) patients (74.4% of eligible). Comparison of patients that did and did-not match to a Medicare claim demonstrated similar patient and procedure characteristics. Evaluation of late outcomes revealed good patient-level agreement on mortality for both EVAR (kappa 0.64) and OAR (kappa 0.82). Post-operative reintervention rates demonstrated lower agreement for both EVAR (kappa 0.26) and OAR (kappa 0.16). Conclusions This work demonstrates the feasibility of an algorithm using indirect identifiers to match VQI patients and procedures to Medicare claims data. The refinement of this strategy will focus on establishing and improving algorithms related to identifying and categorizing late events after EVAR, and may serve as a mechanism to ensure the best quality follow-up information is achieved within the Vascular Quality Initiative.

In this series, TCCE for treatment of aneurysm enlargement due to type II endoleaks was safe and relatively effective despite prior failed interventions in nearly half of the cases. TCCE is a useful alternative in cases in which the anatomy makes other approaches difficult or impossible.