Faculty Bibliography

Complex abdominal aortic aneurysms (AAAs) can preclude endovascular aortic repair. In patients unable to undergo open surgical repair (OSR), using endografts outside the Instructions for Use (IFU) may be the only option. We present the case of a woman with a highly angulated infrarenal AAA neck who was unsuitable for OSR and successfully treated using a Gore TAG Conformable Thoracic Stent Graft with Active Control, Medtronic Heli-FX EndoAnchors, and bifurcated Gore Excluder endoprosthesis. The repair was successful without evidence of endoleak. Using a thoracic endograft off IFU to treat infrarenal AAAs may be feasible for patients unable to undergo OSR.

OBJECTIVE:Transcarotid artery revascularization (TCAR) seems to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant decrease in periprocedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low-frequency events, and to provide guidelines for avoiding them. METHODS:The U.S. Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA. RESULTS:A total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. CONCLUSIONS:In high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.

OBJECTIVES/OBJECTIVE:The pandemic of Coronavirus disease 2019 (COVID-19) has caused devastating morbidity and mortality worldwide. In particular, thromboembolic complications have emerged as a key threat in COVID-19. We assessed our experience with deep venous thrombosis (DVT) in patients with COVID-19. METHODS:We performed a retrospective analysis of all patients with COVID-19 undergoing upper or lower extremity venous duplex ultrasonography at an academic health system in New York City between March 3 2020 and April 12 2020 with follow-up through May 12 2020. A cohort of hospitalized patients without COVID-19 (non-COVID-19) undergoing venous duplex ultrasonography from December 1 2019 to December 31 2019 was used for comparison. The primary outcome was DVT. Secondary outcomes included pulmonary embolism (PE), in-hospital mortality, admission to intensive care unit, and antithrombotic therapy. Multivariable logistic regression was performed to identify risk factors for DVT and mortality. RESULTS:Of 443 patients (188 COVID-19 and 255 non-COVID-19) undergoing venous duplex ultrasonography, patients with COVID-19 had higher incidence of DVT (31% vs. 19%; P=0.005), compared to the non-COVID-19 cohort. The incidence of PE was not statistically different between the COVID-19 and non-COVID-19 cohorts (8% vs. 4%; P=.105). The DVTs in the COVID-19 group were more distal (63% vs. 29%; P<.001) and bilateral (15% vs. 4%; P<.001). The result of duplex ultrasonography had a significant impact on the antithrombotic plan; 42 (72%) patients with COVID-19 in the DVT group had their therapies escalated while 49 (38%) and 3 (2%) patients had their therapies escalated and de-escalated in the non-DVT group, respectively (P<.001). Within the COVID-19 cohort, the D-dimer was significantly higher in the DVT group at the time of admission (2,746 ng/mL vs 1,481 ng/mL; P=.004) and at the time of the duplex exam (6,068 ng/mL vs. 3,049 ng/mL; P<0.01). At multivariable analysis, male sex (odd ratio (OR) 2.27; 95% confidence interval (CI), 1.06-4.87; P=.035), ICU admission (OR 3.42; 95% CI, 1.02-11.44; P=.046) and extracorporeal membrane oxygenation (OR 5.5; 95% CI, 1.01-30.13; P=.049) were independently associated with DVT. CONCLUSION/CONCLUSIONS:Given the high incidence of venous thromboembolic events in this population, we support the decision to empirically initiate therapeutic anticoagulation in patients with low bleeding risk and severe COVID-19 infection, with duplex ultrasonography reserved for patients with high clinical suspicion of VTE in which anticoagulation may pose a life-threatening consequence. Further study is warranted in patients with COVID-19 to elucidate the etiology of vascular thromboembolic events and guide prophylactic and therapeutic interventions in these patients.

OBJECTIVE:Although inferior vena cava (IVC) thrombosis is infrequently encountered, it carries a significant risk of post-thrombotic syndrome and pulmonary embolus. Recent studies show no difference in the incidence of post-thrombotic syndrome in patients with iliofemoral deep venous thrombosis (DVT) treated with pharmacothrombolysis vs anticoagulation alone; however, there is an associated increased risk of bleeding. The treatment of IVC thrombosis is less well-studied and the hemodynamic changes may be more significant with pharmacothrombolysis, although the bleeding risk remains. The ClotTriever and FlowTriever systems remove thrombus from veins without the use of thrombolytics. Our study evaluates outcomes of patients undergoing mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and FlowTriever devices. METHODS:A retrospective chart review was performed to identify consecutive patients who underwent mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and/or FlowTriever systems from November 2018 to January 2020 at four data-sharing institutions. The decision of which device(s) to use was at the discretion of the surgeon. Patient demographics, symptomatology, and imaging characteristics were captured at presentation and follow-up. RESULTS:A total of 15 patients met the inclusion criteria; 10 were male, and the average age was 59 years. The majority of patients were symptomatic at presentation (n = 14), had a prior history of DVT (n = 13), and had a preexisting IVC filter (n = 8). Eleven patients presented with acute onset (<1 week) of symptoms, whereas three patients had subacute (1-4 weeks) symptoms. Most patients had an associated iliofemoral DVT (n = 13) and were treated with both ClotTriever and FlowTriever (n = 8); others were treated with either ClotTriever or FlowTriever alone (n = 5 and n = 2, respectively). Technical success was achieved in all but two patients, one who had a nonocclusive thrombus densely adherent to a preexisting IVC filter and another who had a chronic rubbery clot in the IVC that could not be cleared. No patient required concomitant lytic therapy or a postoperative stay in the intensive care unit. Furthermore, there were no postoperative bleeding events, myocardial infarctions, pulmonary emboli, renal impairments, or deaths. The median length of stay was 3 days (range, 1-37 days). Patients underwent postoperative follow-up (n = 7) as well as extended follow-up (>6 months; n = 8). All patients who achieved technical success were asymptomatic without evidence of reocclusion of the IVC on follow-up imaging. CONCLUSIONS:In our multicenter series of 15 patients, The ClotTriever and FlowTriever showed promise in the treatment of IVC thrombosis without the use of fibrinolytic drugs, with no bleeding events and no requirement for intensive care unit stay.

OBJECTIVE:Lymphedema is associated with significant morbidity and healthcare resource usage. Conventional therapy efficacy is limited with poor surgical salvage options. Preliminary studies demonstrated advanced pneumatic compression devices (APCD) improve clinical outcomes, however limited evidence regarding their role in healthcare cost mitigation or health-related quality of life (QOL) is available. METHODS:) between February 2016 and March 2019. Patients were assessed at baseline, 12, 24, and 52 weeks from enrollment by limb circumference, QOL assessments (Short Form-36 [SF-36] and Lymphedema Quality of Life [LYMQOL]), device compliance, cellulitic episodes and lymphedema-related health care use since the previous visit. Primary endpoints of interest were QOL at baseline compared to 12 weeks as well as unscheduled lymphedema-related clinic visits and hospital admissions at 52 weeks. Secondary endpoints included change in limb girth and QOL at 52 weeks compared to baseline. RESULTS:178 patients with LE lymphedema were prospectively enrolled; this interim report represents the first 74 subjects to complete 52 weeks of APCD treatment. The cohort was predominately male (94.6%), elderly (mean 67 years), obese (median BMI 32), and most commonly enrolled for treatment of phlebolymphedema (71.6%) with largely bilateral LE involvement (91.9%). There was no significant difference in QOL at 12 weeks. However, at 52 weeks, LYMQOL was significantly improved from baseline (6.3 vs. 7.4, p<0.0001) and SF-36 demonstrated significant improvement from baseline in the Physical Component (38.6 vs. 40.8; p=0.035) with an effect towards overall improvement as well in the Mental Component (49.9 vs. 51.3; p=0.549). Limb circumference was significantly reduced at 12 weeks from baseline (28.5cm vs. 27.7cm; p=0.0005) in the most affected LE, and this reduction remained stable for the study duration. APCD treatment was associated with a significant reduction in cellulitic incidence (24.3% vs. 8.1%, p=0.005), lymphedema-related clinic visits (2.2 vs. 0.7; p=0.02), urgent care visits (1.2 vs. 0.3; p=0.004), and hospital admissions (0.5 vs. 0.1; p=0.047) per patient. CONCLUSIONS:The FLX APCD results in initial significant limb girth reduction as early as 12 weeks and a steady sustained improvement in health-related QOL up to one year. The latter is likely reflective of a decrease in cellulitis episodes and fewer associated lymphedema-related clinic, urgent care visits and hospital admissions.

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.

Background: Severe presentations of chronic venous insufficiency may result from reflux or obstruction at the deep venous, perforator or superficial venous levels. Iliofemoral venous stenting may be used to address central venous obstruction, but its effect on deep venous reflux remains unclear. The purpose of this study was to evaluate the effect of iliac vein stenting on femoropopliteal deep vein reflux with the hypothesis that sonographic evidence of deep vein reflux would remain absent or improve following iliac vein stenting.
Method(s): This study was a retrospective review of patients undergoing iliofemoral venous stenting from 2013-2020. Patients were divided into two cohorts based on the preprocedural presence (Group A) or absence (Group B) of femoropopliteal reflux. Baseline patient variables were collected including age, gender, CEAP, presence of concomitant superficial or perforator reflux, DVT history, and additional venous intervention(s). The primary outcome evaluated was the persistent absence or the resolution of deep vein reflux on the latest venous duplex ultrasound follow-up. Other outcomes included follow-up CEAP classification as well as need for secondary deep venous interventions.
Result(s): There were 275 consecutive patients who underwent iliofemoral venous stenting. Of those, 58 presented with deep vein reflux (Group A), and the remaining did not (Group B). When comparing Group A and Group B, patients in Group A had a higher likelihood of prior DVT (P =.0001) as well as higher frequency of venous ablation (Table). The remaining demographics did not differ significantly between the two groups. In Group A, deep vein reflux resolved in follow-up in 17/51 patients (P =.0001). In Group B, deep vein reflux developed on follow-up in 6/217 patients. CEAP appeared to improve from preintervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; and C6, 24.5%) to latest follow-up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; and C6, 13.3%).
Conclusion(s): For patients who undergo iliofemoral vein stenting, deep vein reflux may improve if present initially, and is unlikely to develop if not present prior to intervention. A cohort of patients maintained persistent deep vein reflux, and these warrant further evaluation. Prospective studies are required to corroborate the safety, efficacy and durability of iliofemoral venous stenting in patients with deep vein reflux. [Formula presented]
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Aortic mural thrombus in the absence of underlying aortic disease is rare and results in a risk of distant arterial embolization that can result in limb loss or other end organ damage. Current management involves open surgery, anticoagulation, and systemic thrombolysis; however, each carries inherent risks. We report the case of aortic thrombus with distal emboli in two patients, a 56-year-old man and a 68-year-old man, neither with underlying aortic pathology and both presenting with limb threatening ischemia. We performed percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, Calif) with successful removal of the aortic thrombus in both patients.

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.

Thrombosis is a major concern in respiratory infections. Our aim was to investigate the magnitude and duration of risk for arterial and venous thrombosis following discharge after respiratory infection. Patients with respiratory infections were identified using the United States Nationwide Readmission Database from 2012 to 2014. Patients admitted with asthma or cellulitis served as comparators. Readmissions for acute myocardial infarction (MI) and venous thromboembolism (VTE) were evaluated at 30 to 180 days. The likelihood of a first thrombotic event after discharge was compared with a 30-day period prior to hospitalization. Among 5,271,068 patients discharged after a respiratory infection, 0.56% and 0.78% were readmitted within 30-days with MI and VTE, respectively. Relative to asthma and cellulitis, respiratory infection was associated with a greater age and sex-adjusted hazard of 30-day readmission for MI (adjusted HR [aHR] 1.48 [95% CI 1.42-1.54] vs. asthma; aHR 1.36 [95% CI 1.31-1.41] vs. cellulitis) and VTE (aHR 1.28 [95% CI 1.24-1.33] vs. asthma; aHR 1.26, [95% CI 1.22-1.30] vs. cellulitis). Risks of MI and VTE attenuated over time. In a crossover-cohort analysis, the odds of MI (OR 1.68 [95% CI 1.62-1.73]) and VTE (OR 3.30 [95% 3.19-3.41]) were higher in the 30 days following discharge after respiratory infection than during the 30-day baseline period. Hospitalization for respiratory infection was associated with increased risks of thrombosis that were highest in the first 30-days after discharge and declined over time.