Faculty Bibliography

IMPORTANCE:Venous leg ulcers (VLU) are the most common cause of lower extremity ulceration that commonly occur among older individuals and are characterized by a slow healing trajectory and frequent recurrence; in the United States, VLUs affect more than 600 000 people per year with an estimated cost of $3.5 billion. Clinical trial data show that early intervention with endovenous ablation substantially improves the healing rate and reduces recurrence among patients with VLUs, but there is a need to assess the cost-effectiveness of early endovenous ablation in the US context. OBJECTIVES:To evaluate the cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with VLU from the US Medicare perspective. DESIGN, SETTING, AND PARTICIPANTS:This economic evaluation used a Markov model to simulate the disease progression of VLU for patients receiving compression therapy with early vs deferred ablation over 3 years. The simulated cohort included patients with VLU aged 65 years and older who had clinical characteristics similar to those in the randomized Early Venous Reflux Ablation trial in the United Kingdom. Data were analyzed from September 2021 to June 2022. MAIN OUTCOMES AND MEASURES:Direct medical costs, quality-adjusted life years (QALYs), and the incremental monetary benefits at a willingness-to-pay threshold of $100 000/QALY. Univariate and probabilistic sensitivity analyses were performed to test uncertainty of model results. RESULTS:This model used a simulated cohort of patients with VLU aged 65 years and older enrolled in Medicare. Early ablation dominated, with a lower per-patient cost of $12 527 and an increase of 2.011 QALYs, whereas compression therapy with deferred ablation yielded a per-patient cost of $15 208 and 1.985 QALYs gained. At a $100 000/QALY cost-effectiveness threshold, the incremental net monetary benefit was $5226 per patient in favor of early ablation. Probability of healing, followed by the probability of recurrence, was the parameter with greatest impact on model uncertainty. The probabilistic sensitivity analysis showed that early ablation was cost-effective in 59.2% of simulations at the $100 000/QALY threshold. CONCLUSIONS AND RELEVANCE:In this economic evaluation of compression therapy with early endovenous ablation, early intervention was dominant, as it was cost saving and generated greater QALYs over 3 years from the US Medicare perspective. Payers should prioritize coverage for early ablation to prevent VLU complications rather than treat a costly outcome that also reduces patient well-being.

OBJECTIVE:Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients. METHODS:All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL. RESULTS:Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001). CONCLUSIONS:For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings.

BACKGROUND:Concomitant iliac artery aneurysms can pose challenges during repair of complex abdominal and thoracoabdominal aortic aneurysms. In fenestrated aortic aneurysm repairs (FEVAR), preservation of internal iliac perfusion is important to minimize risk of spinal cord ischemia. Currently, most commonly used fenestrated stent grafts and the only approved iliac branch devices are manufactured by different companies in the United States. We report our experience with combining Iliac Branch Endoprosthesis (IBE) (W.L. Gore and Associates, Flagstaff, AZ) and fenestrated stent grafts, using the Zenith platform (Cook Medical, Bloomington, IN). METHODS:Retrospective review of consecutive patients who underwent FEVAR at a single institution from September, 2015 to June, 2020 was performed. Patients were deemed high-risk for open repair. Fenestrated aortic components implanted were either physician-modified or custom manufactured. Cases in which IBEs were deployed during FEVAR were specifically reviewed. Anatomic details were obtained from preoperative CT scans. Postoperative outcomes such as mortality, technical success, major adverse events, limb patency, limb-related endoleaks and re-intervention rates were assessed. RESULTS:During the study period, 171 patients underwent FEVAR at our institution. Among those, 15 patients had unilateral IBE implantation during FEVAR, while one received bilateral IBE implantation. Fourteen cases involved physician-modified fenestrated endograft, and Zenith Fenestrated (Cook Medical, Bloomington, IN) in combination with Excluder bifurcated main body and IBE (W.L. Gore and Associates, Flagstaff, AZ). Mean operative, and fluoroscopy times were 340.2 minutes, and 65.4 minutes respectively. A total of 67 viscerorenal target vessels (mean = 3.9, range =_3-5) and 15 internal iliac arteries were incorporated, with a mean of 160 cc contrast used. Completion angiograms were free of type 1 and type 3 endoleaks. Technical success was 100%. There was no perioperative mortality. One patient developed spinal cord ischemia post-operative day two with neurological recovery. At mean follow-up of 430 days, overall survival was 100% with no aneurysm-related mortalities. Limb patency remained 100%. There were no type 3 endoleaks while one patient had a type 1B endoleak that is currently being monitored. There was one re-intervention for type 1C renal branch graft endoleak. CONCLUSION/CONCLUSIONS:Combining IBE with FEVAR allows internal iliac preservation during endovascular repair of complex abdominal aortic aneurysms, with encouraging early results.

BACKGROUND:Penetrating carotid injuries are associated with an up to 20% risk of stroke. This study evaluated patients in the American Association for Surgery of Trauma PROspective Observational Vascular Injury Trial, with the aim of determining factors associated with stroke and stroke or death. METHODS:Penetrating extracranial carotid injuries in the American Association for Surgery of Trauma PROspective Observational Vascular Injury Trial registry from 2012 to 2020 were queried. Isolated external carotid injuries were excluded. Patients with documented postinjury in-hospital stroke were compared with those without. Significant predictors (p < 0.1) for stroke and stroke or death on univariate analysis were included in multivariate analyses. RESULTS:One hundred two patients from 17 institutions were included. Mean age was 35 ± 18 years, and 80% were male. Average Glasgow Coma Scale (GCS) score on presentation was 9 ± 5, with an Injury Severity Score [ISS] of 22 ± 13. Operative management occurred in 51% of patients who were significantly more hypotensive (systolic blood pressure: 109 vs. 131 mm Hg; p = 0.015) with a lower initial pH (7.17 vs. 7.31; p = 0.001) and presented with hard signs of vascular injury (74% vs. 26%; p < 0.001). Overall stroke rate was 17% (23% operative vs. 10% nonoperative, p = 0.076). Rate of stroke or death was 27% (64% operative and 36% nonoperative). On multivariate analysis, lower GCS (p = 0.05) and completion angiography (p = 0.04) were associated with stroke. Likewise lower GCS (p = 0.015) and ISS (p = 0.04) were associated with stroke or death. CONCLUSION:Penetrating carotid trauma undergoing operative management had a stroke rate of 23%. Low GCS on arrival and need for completion angiography are independently associated with postinjury in-hospital stroke, whereas low GCS on arrival and ISS were associated with stroke or death. The ideal treatment strategy remains elusive, thus a dedicated multicenter study may help to achieve higher fidelity data on this rare but devastating injury. LEVEL OF EVIDENCE:Prognostic and Epidemiological, Level III.

OBJECTIVE:We sought to determine trends in percutaneous transluminal angioplasty (PTA) versus non-PTA interventions over time, as well as factors that influence the decision for non-PTA intervention. BACKGROUND:Although the optimal strategy for revascularization in patients with below-the-knee (BTK) chronic limb-threatening ischemia (CLTI) remains under investigation, PTA has been the preferred endovascular approach. Recently, there has been an increase in the use of non-PTA approaches for revascularization. METHODS:We performed a retrospective analysis of the Vascular Quality Initiative. Between 2011 and 2020, a total of 23,850 procedures corresponding to 33,098 arteries in 19,404 patients with CLTI were included. After application of exclusion criteria and removal of missing variables, 18,644 arteries were included in the study cohort. The primary analysis was factors associated with receiving non-PTA intervention. Secondary analysis included trends in PTA versus non-PTA intervention over time. RESULTS:Throughout the study period, the majority of interventions (72%) were PTA alone. The percentage of non-PTA interventions, on a per-artery basis, increased over the study period from 18% to 33%, p < 0.01. Advanced age, increasing TransAtlantic Inter-Society Consensus classification, and concomitant above-the-knee disease were associated with an increased likelihood for non-PTA intervention. In contrast, longer lesion length, insulin-dependent diabetes mellitus, bilateral disease, and discharge to location other than home were associated with an increased likelihood of PTA. CONCLUSIONS:We observed a significant increase in the percentage of non-PTA interventions for patients with CLTI requiring BTK interventions over the last decade, with lesion- and patient-specific characteristics associated with the type of endovascular approach.

BACKGROUND:Anatomic remodeling within the thoracic aorta following thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) has been well documented. However, less is known about the response of the untreated visceral aorta. In the present study, we investigated the visceral aortic behavior after TEVAR for acute or subacute TBAD to identify any associations with the clinical outcomes. METHODS:A multicenter retrospective review was performed of all imaging studies for all patients who had undergone TEVAR for acute (0-14 days) and subacute (14-90 days) nontraumatic TBAD from 2006 to 2020. The cohort was inclusive of those with uncomplicated, high-risk, and complicated (defined in accordance with the Society for Vascular Surgery reporting guidelines) dissections. Centerline aortic measurements of the true and false lumen and total aortic diameter (TAD) were taken at standardized locations relative to the aortic anatomy within each aortic zone (the zones were defined by the Society for Vascular Surgery reporting guidelines). Diameter changes over time were evaluated using repeated measures mixed effects linear growth modeling. Visceral segment instability (VSI) was defined as any growth in the TAD of ≥5 mm within aortic zones 5 through 9. RESULTS:A total of 82 patients were identified. The median length of imaging follow-up was 2.1 years (interquartile range, 0.75-4.5 years), with 15% of the cohort having follow-up >5 years. VSI was present in 55% of the cohort, with an average maximal increase in the TAD of 10.4 ± 6.3 mm during a median follow-up of 2.1 years (interquartile range, 0.75-4.5 years). Approximately one third of the cohort had experienced rapid VSI (growth ≥5 mm in the first year), and 4.8% of the cohort had developed a large paravisceral aortic aneurysm (TAD ≥5 cm) secondary to VSI. Linear growth modeling identified significant predictable growth in the TAD across all visceral zones. Zone 7 had the highest rate of TAD dilation, with a fixed effect estimated rate of 1.3 mm/y (95% confidence interval [CI], 0.23-2.1; P = .022). The preoperative factor most strongly associated with VSI was a cumulative number of zones dissected of six or more (odds ratio, 6.4; 95% CI, 1.07-8.6; P = .041). The odds for aortic reintervention were significantly increased for cases in which VSI led to the development of a paravisceral aortic aneurysm of ≥5 cm (odds ratio, 3.7; 95% CI, 1.1-13; P = .038). CONCLUSIONS:VSI was identified in most patients who had undergone TEVAR for management of acute and subacute TBAD. The preoperative anatomic features such as the dissection extent, rather than the procedural details of graft coverage, might play a more significant role in VSI occurrence. Significant TAD growth had occurred in all visceral segments. These results highlight the importance of lifelong surveillance following TEVAR and identified a subset of patients who might have an increased risk of reintervention.