Faculty Bibliography

INTRODUCTION/BACKGROUND:The natural history of penetrating aortic ulcers (PAU) and intramural hematomas (IMH) of the aorta is not well described. While repair is warranted for rupture, unremitting chest pain or growth, there is no established threshold for treating incidental findings. Thoracic endovascular aortic repair (TEVAR) offers an attractive approach in treating these pathologies, however, peri-procedural and post-operative outcomes are not well defined. METHODS:Patients 18 or older identified in the VQI database who underwent TEVAR for PAU and/or IMH between 1/2011-2/2020 were included. We identified 1042 patients, of whom 809 had available follow-up data. Patient demographics and comorbidities were analyzed to identify risk factors for major adverse events (MAE), as well as postoperative and late mortality. RESULTS:The cohort was 54.8% female and 69.9% former smokers with a mean age of 71.1 years. Comorbidities were prevalent with 57.8% classified ASA IV; 89.8% had hypertension, 28.3% chronic obstructive pulmonary disease (COPD), 17.9% coronary artery disease, and 12.2% congestive heart failure (CHF). Patients were predominately symptomatic (74%) and 44.5% underwent non-elective repair. MAE incidence was 17%. Independent predictors of MAE were history of CAD, non-Caucasian race, emergent procedural indication, ruptured presentation, and deployment of two or more endografts. In-hospital mortality was 4.3%. Seventy-three percent of index hospitalization mortalities were treatment-related. Of 809 patients with follow-up (mean 25.1 months±19 months), all-cause mortality was 10.6%. Predictors of late mortality in follow-up included age greater than 70 years, ruptured presentation, and history of COPD and ESRD. Subset analysis comparing symptomatic (74%) vs. asymptomatic (26%) patients demonstrated the former were frequently female (58.2% vs. 45.3%, p<.001) with a higher incidence of MAE (20.6% vs. 6.9%, p<.001), notably higher in-hospital reintervention rates (5.9% vs. 1.5%, p=.002) and mortality (5.6% vs. 0.7%, log-rank p=.015), and prolonged length of stay (6.9 vs. 3.7 days, p<.0001) despite similar procedural risks. In follow-up, late mortality was higher in the symptomatic cohort (12.2% vs. 6.5%, log-rank p=.025), with all treatment-related mortalities limited to the symptomatic group. CONCLUSIONS:We demonstrate significantly higher morbidity and mortality in symptomatic patients undergoing repair compared to asymptomatic patients, despite similar baseline characteristics. Asymptomatic patients treated with TEVAR had no treatment-related mortality in follow-up, with overall prognosis largely dependent on pre-existing comorbidities. These findings, in conjunction with growing evidence highlighting the risk of disease progression and attendant morbidity associated with these aortic entities, suggest a need for natural history studies and definitive guidelines on the elective repair of IMH and PAU.

OBJECTIVE:Endovascular abdominal aortic aneurysm repair (EVAR) is preferred to open surgical repair (OSR) for the treatment of abdominal aortic aneurysm (AAA) in high-risk patients. We sought to compare perioperative and long-term outcomes for EVAR in patients designated as unfit for OSR using a large national dataset. METHODS:The Vascular Quality Initiative database collected from 2013 to 2019 was queried for patients undergoing elective EVARs for AAA > 5cm. The patients were stratified into two cohorts based on the suitability for OSR (FIT vs. UNFIT). Primary outcomes included perioperative (in-hospital) major adverse events, perioperative mortality, and mortality at 1 and 5 years. Patient demographics and postoperative outcomes were analyzed to identify predictors of perioperative and long-term mortality. RESULTS:Of 16,183 EVARs, 1,782 patients were deemed unfit for OSR. The UNFIT cohort was more likely to be older and female, with higher proportions of HTN, CAD, CHF, COPD, and larger aneurysm diameter. Postoperatively, the UNFIT cohort was more likely to have cardiopulmonary complications (6.5% vs. 3%; P<.001), with higher perioperative mortality (1.7% vs. 0.6%; P<.001) and 1 and 5-year mortality (13% and 29% UNFIT vs. 5% and 14% FIT; P<.001). Subgroup analysis within the UNFIT cohort revealed those deemed unfit due to hostile abdomen had significantly lower 1 and 5-year mortality (6% and 20%) compared to those unfit due to cardiopulmonary compromise and frailty (14% and 30%; P=.451). Reintervention-free survival at 1 and 5-years was significantly higher in the FIT cohort (93% and 82%) as compared to the UNFIT cohort (85% and 68%; P<.001). Designation as unfit for OSR was an independent predictor of both perioperative (OR 1.59; 95% CI, 1.03-2.46; P=.038) and long-term mortality (HR 1.92; 95% CI, 1.69-2.17; P<.001). Advanced age (OR 2.91; 95% CI, 1.28-6.66; P=.011) was the strongest determinant of perioperative mortality while ESRD (HR 2.51; 95% CI, 1.78-3.55; P<.001) was the strongest predictor of long-term mortality. Statin (HR 0.77; 95% CI, 0.69-0.87; P<.001) and ACE inhibitor (HR 0.83; 95% CI, 0.75-0.93; P<.001) were protective of long-term mortality. CONCLUSION/CONCLUSIONS:Despite low perioperative mortality, long-term mortality of those designated by the operating surgeons as unfit for OSR was rather high in patients undergoing elective EVARs, likely due to the competing risk of death from their medical frailty. Unfit designation due to hostile abdomen did not confer any additional risks after EVAR. Judicious estimation of the patient's life expectancy is essential when considering treatment options in this subset of patients deemed unfit for OSR.

OBJECTIVES/OBJECTIVE:Chronic limb threatening ischemia (CLTI) in patients with end-stage renal disease (ESRD) confers a significant survival disadvantage and is associated with a high major amputation rate. Moreover, diabetes mellitus (DM) is an independent risk factor for developing CLTI. However, the interplay between end stage renal disease (ESRD) and DM on outcomes after peripheral revascularization for CLTI is not well established. Our goal was to assess the effect of DM on outcomes after an infrainguinal bypass for CLTI in patients with ESRD. METHODS:Using the Vascular Quality Initiative dataset from January 2003 to March 2020, records for all primary infrainguinal bypasses for CLTI in patients with ESRD were included for analysis. One-year and perioperative outcomes of all-cause mortality, reintervention, amputation-free survival (AFS) and major adverse limb event (MALE) were compared for patients with DM versus those without DM. RESULTS:Of a total of 1,058 patients (66% male) with ESRD, 726 (69%) patients had DM, and 332 patients did not have DM. The DM group was younger (median age, 65 years vs. 68 years; P=.002), with higher proportions of obesity (body-mass index>30kg/m2; 34% vs. 19%; P<.001) and current smokers (26% vs. 19%; P=.013). The DM group presented more frequently with tissue loss (76% vs. 66%; P<.001). A distal bypass anastomosis to tibial vessels was more frequently performed in the DM group compared to the non-DM group (57% vs. 45%; P<.001). DM was independently associated with higher perioperative MALE (OR 1.34; 95% CI, 1.06-1.68; P=.013), without increased risks of loss of primary patency and composite outcomes of amputation or death. On the mean follow-up of 11.4 ± 5.5 months, DM patients had a significantly higher rate of one-year MALEs (43% vs. 32%; P=.001). However, the one-year primary patency and AFS, did not differ significantly. After adjusting for confounders, the risk-adjusted hazards for MALE (HR 1.34; 95% CI, 1.06-1.68; P=.013) were significantly increased in patients with DM. However, DM was not associated with increased risk of AFS (HR 1.16; 95% CI, 0.91-1.47; P=.238), or loss of primary patency (HR 1.04; 95% CI, 0.79-1.37; P=.767). CONCLUSION/CONCLUSIONS:DM and ESRD each independently predict early and late major adverse limb events after an infrainguinal bypass in patients presenting with CLTI. However, in the presence of ESRD, DM may increase perioperative adverse events, but does not influence primary patency and AFS at one-year. The risk profile associated with ESRD appears to supersede that of DM, with no additive effect.

INTRODUCTION/BACKGROUND:Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation and contrast required with contralateral common femoral access (CFA). Yet, this technique remains underutilized in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and effectiveness of antegrade SFA access in the outpatient setting. METHODS:A retrospective review of lower extremity peripheral arterial interventions in our office-based endovascular suite was conducted from 2013 to 2018. Interventions necessitating CFA access such as iliac, common femoral or deep femoral artery revascularization were excluded (n = 206). In addition, interventions potentially requiring large sheaths not amenable to SFA access (e.g. popliteal aneurysm) were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. RESULTS:We identified 718 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in 448 patients (62.4%) with the remaining 270 patients having retrograde CFA access. Antegrade SFA access was achieved primarily with a 4 French sheath, while a majority of retrograde CFA interventions utilized a 6 French sheath for access (87.7% vs. 69.5%, p <0.001). Significantly less fluoroscopy (9.5 min vs 16.4 min, p <0.001) and contrast (25.4 mL vs. 38.5 mL, p <0.001) were used during SFA access compared with retrograde access. Technical success was achieved in 93.2% with antegrade SFA versus 94.8% retrograde CFA access (p 0.42). The overall rate of complications was low for both cohorts (2.7% vs. 3.7%, p 0.78) and there were no statistical differences in access-site complications (1.1% vs. 1.5%, p 0.94), hematoma (0.7% vs. 1.1%, p 0.84) and pseudoaneurysm (0.4% vs. 0%, p 0.98) between techniques. CONCLUSIONS:Percutaneous antegrade SFA access can be performed safely in the outpatient setting, and remains an effective alternative to retrograde CFA access with significantly less utilization of fluoroscopy and contrast.

OBJECTIVE:Wound complications after major lower extremity amputations are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are limited data on its use in major lower extremity amputations. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would reduce the risk of complications as compared to a standard dressing in patients with peripheral vascular disease undergoing major lower extremity amputation. METHODS:system (Acelity L.P. Inc., San Antonio, TX, USA) was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a non-adherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value < .05 was considered statistically significant. RESULTS:For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared to the standard group (44% vs. 13%; P = .011), as well as trends towards increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared to the standard group (52% vs. 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared to the standard group (13% vs. 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI and one incision line necrosis. In the standard group, there were 4 wound dehiscences with deep SSI, 3 superficial SSIs, 4 incision line necroses and 1 stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard group (3% vs. 4% and 4.3% vs. 10%, respectively). CONCLUSIONS:Closed incision negative pressure wound therapy may decrease the incidence of wound complications in vascular patients undergoing major lower extremity amputation. This held true even amongst a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.

Introduction and Objectives: Adjunctive false lumen embolization (FLE) with thoracic endovascular aortic repair (TEVAR) in patients with chronic aortic dissection is thought to induce FL thrombosis and favorable aortic remodeling. However, evidence is limited and the potential benefit of FLE remains unproven.
Method(s): Patients 18+ who underwent TEVAR for chronic aortic dissection with known FLE status in the SVS VQI database 1/2010-2/2020 were included. Ruptured patients and emergent procedures were excluded. Primary outcomes were in-hospital post-operative complications and all-cause mortality. Secondary outcomes included follow-up maximum aortic diameter change, re-intervention rates, and mortality.
Result(s): 884 patients were included: 46 had TEVAR/FLE and 838 had TEVAR alone. There was no significant difference between groups in terms of age, gender, comorbidities, maximum pre-operative aortic diameter, presentation symptomatology, or intervention indication. FLE was associated with significantly longer procedural times (178min vs. 146min, p=0.0002), increased contrast use (134mL vs. 113mL, p=0.02), and prolonged fluoroscopy time (34min vs. 21min, p<0.0001), but not associated with a significant difference in post-operative complications (17.4% vs. 13.8%, p=0.51), length of stay (6.5 vs. 5.7 days, p=0.18), or in-hospital all-cause mortality (0% vs. 1.3%, p=1). In mid-term follow-up (median 15.5months), all-cause mortality trended lower, but was not significant (2.2% vs. 7.8%); Kaplan-Meier analysis demonstrated no difference in overall survival between groups (p=0.23). Post-operative complications had the strongest independent association with all-cause mortality (HR 2.65, 95% CI 1.56-4.5, p<0.001). In patients with available follow-up imaging and re-intervention status, mean aortic diameter change (n=337, -0.71cm vs. -0.69cm, p=0.64) and re-intervention rates (n=487, 10% vs. 11.4%, p=1) were similar.
Conclusion(s): Adjunctive FLE can be performed safely in chronic thoracic aortic dissections without significantly higher perioperative morbidity or mortality. However, given lack of reduction in re-intervention rates, induction of significant favorable aortic remodeling, or definitive survival benefit compared to TEVAR alone, FLE utility remains unclear.
Copyright

Objective: Whereas clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease, a substantial number of events continue to occur. This study investigated the variability in response to clopidogrel and its relationship with clinical outcomes.
Method(s): There were 300 patients enrolled in the Platelet Activity in Vascular Surgery and Cardiovascular Events (PACE) study before lower extremity revascularization, of whom 119 were receiving clopidogrel. Platelet aggregation was measured in response to adenosine diphosphate (ADP) 2M immediately before revascularization. Patients were observed longitudinally for a median follow-up of 18 months. The primary end point was major adverse limb events (MALEs), defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to the percentage ADP-induced aggregation at 300 seconds (<50% aggregation, normal responder; >=50% aggregation, poor responder).
Result(s): Overall, the median age was 70 years (62-76 years), and 39.5% were female. Thirty-six (30.3%) patients had a MALE event (15 major amputation and 25 major reoperation); 60 patients underwent open or hybrid operations, and 50 patients underwent endovascular procedures. The remaining nine patients had no interventions. Of the group of 119 patients, 97 patients were taking aspirin. Overall, median aggregation to ADP 2M was 22.5% (Q1-Q3, 10%-50%), and 27 patients (26%) were clopidogrel nonresponders. Baseline aggregation was higher in patients who went on to develop a MALE than in those without a MALE (43% vs 20%; P =.018). Patients with aggregation > median (22.5%) were more likely to experience a MALE than were patients with aggregation < median (69% vs 31%; hazard ratio [HR], 2.71; 95% confidence interval [CI], 1.23-5.98; P =.013). After multivariable adjustment for age, sex, race/ethnicity, body mass index, diabetes, coronary artery disease, and aspirin, aggregation > median was associated with MALEs (adjusted HR, 2.67; 95% CI, 1.18-6.01; P =.018). When stratified by established cutoffs for responsiveness to clopidogrel (50% aggregation), 27 (26%) patients were poor responders. Poor responders were more likely to experience MALEs than normal responders (59% vs 41%; HR, 2.33; 95% CI, 1.11-4.89; P =.026). After multivariable adjustment, poor responder status trended toward an increased risk of MALE compared with a normal responder (adjusted HR, 2.18; 95% CI, 1.00-4.78; P =.051).
Conclusion(s): Among patients undergoing lower extremity revascularization, poor response to clopidogrel is associated with increased risk for major adverse limb events. Preoperative screening to ensure therapeutic clopidogrel response should be considered in these patients.
Copyright

Objective: Aortic neck dilation (AND) can occur in nearly 25% of patients after EVAR, resulting in loss of proximal seal and aortic rupture. Fenestrated endovascular aneurysm repair (FEVAR) affords increased treatment options for patients with shorter infrarenal aortic necks; however, AND has not been well characterized in these patients. This study sought to compare AND in patients undergoing FEVAR vs standard endovascular aneurysm repair (EVAR).
Method(s): Retrospective review was conducted of prospectively collected data of 20 consecutive FEVAR patients (Cook Zenith fenestrated; Cook Medical, Bloomington, Ind) and 20 EVAR patients (Cook Zenith). Demographic and anatomic characteristics, procedural details, and clinical outcome were analyzed. Preoperative, 1-month postoperative, and longest follow-up computed tomography scans were analyzed using a dedicated three-dimensional workstation. Abdominal aortic aneurysm (AAA) neck diameter was measured in 5-mm increments from the lowest renal artery. Standard statistical analysis was performed.
Result(s): Demographic characteristics did not differ significantly between the two cohorts. The FEVAR group had larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length (Table). On follow-up imaging, the suprarenal aortic segment dilated significantly more at all suprarenal locations in the FEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared with the EVAR group (Table). The FEVAR group demonstrated significantly greater sac regression vs the EVAR group. Positive aortic remodeling, as evidenced by increased distance from the celiac axis to the most cephalad margin of the AAA, occurred to a more significant degree in the FEVAR cohort. Device migration, endoleak occurrence, and need for reintervention were similar in both groups.
Conclusion(s): Compared with EVAR, patients undergoing FEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in FEVAR patients, appears more stable in the postoperative period compared with EVAR cases. Moreover, the FEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in FEVAR may confer a previously undescribed increased level of protection against infrarenal neck dilation and lessen endotension, resulting in more rapid and dramatic sac shrinkage and contributing to a more durable aortic repair. [Formula presented]
Copyright

The novel coronavirus 2019 (SARS-CoV-2) was first identified in January 2020 and has since evolved into a pandemic affecting >200 countries. The severity of presentation is variable and carries a mortality between 1% and 3%. We continue to learn about the virus and the resulting acute respiratory illness and hypercoagulability; however, much remains unknown. In our early experience in a high-volume center, we report a series of four cases of acute peripheral artery ischemia in patients with COVID-19 in the setting of elevated D-dimer levels.