Direct oral anticoagulants over warfarin at discharge associated with improved survival and patency in infra-geniculate bypasses with prosthetic conduits.

OBJECTIVE: There is no consensus on the optimal anticoagulant regimen following lower extremity bypass. Historically, warfarin has been utilized for prosthetic or compromised vein bypasses. Direct-acting oral anticoagulants (DOACs) are increasingly replacing warfarin in this context, but their efficacy in bypass preservation has not been well-studied. Recent studies have shown that DOACs may improve outcomes following bypasses; however, it is unclear if this is dependent upon type of bypass conduit. The goal of this study was to evaluate whether a difference exists between vein and prosthetic infra-geniculate bypasses outcomes based on the anticoagulant utilized on discharge, warfarin or DOAC. METHODS: The Vascular Quality Initiative infra-inguinal bypass database was queried for all patients who underwent an infra-geniculate bypass and were anticoagulation-naive at baseline but were discharged on either warfarin or DOACs. A survival analysis was performed for patients up to 1 year to determine whether the choice of discharge anticoagulation was associated with differences between those with vein vs prosthetic conduits in overall survival, primary patency, risk of amputation, or risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in baseline demographic factors between the groups. RESULTS: During the study period (2003-2020), 57,887 patients underwent infra-geniculate bypass. Of these, 3230 (5.5%) were anticoagulated on discharge. There was a similar distribution of anticoagulation between vein (n = 1659; 51.4%) and prosthetic conduits (n = 1571; 48.6%). Thirty-two percent were discharged on DOACs, and 68.0% were discharged on warfarin. For prosthetic conduits, being discharged on a DOAC was associated with improved outcomes on univariate and multivariable analyses revealing lower risk of overall mortality (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.41-0.93; P = .021), loss of primary patency (HR, 0.70; 95% CI, 0.55-0.89; P = .003), risk of amputation (HR, 0.71; 95% CI, 0.54-0.93; P = .013), and risk of MALE (HR, 0.80; 95% CI, 0.64-1.00; P = .048). Patients with a vein bypass had improved univariate outcomes for survival and primary patency; however, with multivariable analysis, there were no significant differences in outcomes between DOAC and warfarin. CONCLUSIONS: Anticoagulation-naive patients who underwent an infra-geniculate prosthetic bypass had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged on a DOAC compared with warfarin. Those with vein bypasses had similar outcomes regardless of the choice of anticoagulation.

Anatomic Utility of Single Branched Thoracic Endograft During Thoracic Endovascular Aortic Repair.

INTRODUCTION: Single branched thoracic endografts (SBTEs) have been designed for pathology requiring zone 2 seal during thoracic endovascular aortic repair (TEVAR). Numerous criteria must be met to allow for their implantation. Our aim was to analyze anatomic suitability for a next generation SBTE. METHODS: We reviewed 150 TEVAR procedures between 2015 and 2019. Proximal seal was: zone 0 in 21 (16%), zone 1 in 4 (3%), zone 2 in 52 (40%), zone 3 in 45 (35%), and zone 4 or distal in 7 (5%). We analyzed the Zone 2 patient's angiograms and CT angiograms using centerline software to measure arterial diameters and length in relation to the left common carotid artery (LCCA), left subclavian artery (LSA) and proximal extent of aortic disease to determine if patients met anatomic criteria of a novel SBTE. RESULTS: Zone 2 average age was 64.4 ± 16.3 years; 34 patients were male (65%). Indications for repair were aneurysm (N = 9, 17%), acute dissection (N = 14, 27%), chronic dissection with aneurysmal degeneration (N = 7, 13%), intramural hematoma (N = 9, 17%), penetrating aortic ulcer (N = 5, 10%), and blunt traumatic aortic injury (BTAI, N = 8, 15%). LSA revascularization occurred in 27 patients (52%). Overall, 20 (38.5%) of the zone 2 patients met anatomic criteria. Patients with dissection met anatomic criteria less frequently than aneurysm (33% [10 of 30] vs 64% [9 of 14]). Patients treated for BTAI rarely met the anatomic criteria (1 of 8, 13%). The main anatomic constraints were an inadequate distance from the LCCA to the LSA takeoff and from the LCCA to the start of the aortic disease process. CONCLUSION: Less than half of patients who require seal in zone 2 met criteria for this SBTE. Patients with aneurysms met anatomic criteria more often than those with dissection. The device would have little applicability in treating patients with BTAI.

Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia.

OBJECTIVE: Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. METHODS: We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). CONCLUSIONS: FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome.

Management and Outcome of Non-Aneurysmal Primary Aortic Infection.

INTRODUCTION: Aortic infection without prior intervention or aneurysm is exceedingly rare. We report the presentation, diagnosis, management, and outcome of patients with this unusual entity. METHODS: Retrospective chart and imaging review of patients with primary aortic infection. RESULTS: 5 patients (3 male, mean age 71.2 years) presented between 2014 and 2022. All had abdominal, back, or flank pain. Four had constitutional symptoms. All were evaluated with a complete blood count; 3 had leukocytosis. Both serum C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were elevated in the 4 patients evaluated with these tests. All were studied with peripheral blood culture on the first hospital day prior to any antibiotic administration. Blood culture was positive in only 1 patient. Computed tomography (CT) scan showed periaortic inflammation without aneurysm in all. Fluorodeoxyglucose positron emission tomography (PET) was obtained in 3 and a radiolabeled leukocyte single-photon emission CT (SPECT) scan was performed in 2. All demonstrated periaortic concentration of the radioisotope consistent with inflammation or infection. Intraoperative cultures were positive in 3. One patient who had a negative intraoperative culture was examined with broad range polymerase chain reaction (PCR) and DNA sequencing which identified a causative bacterium. The other patient with a negative intraoperative culture had periaortic abscess but was on antibiotics preoperatively, potentially confounding the culture. All patients underwent in-situ repair with rifampin impregnated polyester (N = 2), cryopreserved aortic allograft (N = 2), or autogenous femoral vein (N = 1). No patient developed recurrent infection or aortic related complications following surgery with an average follow up of 31.8 months (range 8-88 months). CONCLUSIONS: Patients with primary aortic infection present similarly with the triad of abdominal or back pain, laboratory markers of infection, and imaging demonstrating periaortic inflammation. Patients were treated successfully with in-situ repair. Preoperative identification of a causative organism was difficult, and PCR may be useful to help identify an organism.

Use of direct-acting oral anticoagulants associated with improved survival and bypass graft patency compared with warfarin after infrageniculate bypass.

OBJECTIVE: No consensus has yet been reached regarding the optimal antiplatelet and anticoagulant regimen for patients after lower extremity bypass. Usually, patients who have undergone below-the-knee bypass will begin oral anticoagulation therapy. Historically, the bypass has been with prosthetic conduits and the anticoagulation therapy has been warfarin. However, the use of direct-acting oral anticoagulants (DOACs) has been increasing owing to their relative ease of dosing. The goal of the present study was to evaluate whether a difference exists in the postoperative outcomes for patients who have undergone infrageniculate bypass stratified by the use of on DOACs vs warfarin. METHODS: The Vascular Quality Initiative infrainguinal bypass database was queried for all patients who had undergone infrageniculate bypass, been anticoagulation naive at baseline, and been discharged with anticoagulation therapy. A survival analysis was performed for patients for ≤2 years postoperatively to determine whether discharge with warfarin vs DOACs was associated with differences in overall mortality, loss of primary patency, risk of amputation, and risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in the baseline demographic factors between the two groups. RESULTS: During the study period (2007-2020) 57,887 patients had undergone infrageniculate bypass. Of these patients, 2786 had been anticoagulation naive and discharged with either warfarin (n = 1889) or DOACs (n = 897). Discharge with a DOAC was associated with a lower risk of overall mortality (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.47-0.83; P = .001), loss of primary patency (HR, 0.74; 95% CI, 0.62-0.87; P < .001), risk of amputation (HR, 0.70; 95% CI, 0.57-0.86; P = .001), and risk of MALE (HR, 0.83; 95% CI, 0.71-0.97; P = .017). CONCLUSIONS: Anticoagulation-naive patients who had undergone infrageniculate bypass had had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged with a DOAC than with warfarin.

Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials.

OBJECTIVE: Patients can be considered at high risk for carotid endarterectomy (CEA) because of either anatomic or physiologic factors and will often undergo transcarotid artery revascularization (TCAR). Patients with physiologic criteria will be considered to have a higher overall surgical risk because of more significant comorbidities. Our aim was to study the incidence of stroke, myocardial infarction (MI), death, and combined end points for patients who had undergone TCAR stratified by the risk factors (anatomic vs physiologic). METHODS: An analysis of prospectively collected data from the ROADSTER (pivotal; safety and efficacy study for reverse flow used during carotid artery stenting procedure), ROADSTER 2 (Food and Drug Administration indicated postmarket trial; postapproval study of transcarotid artery revascularization in patients with significant carotid artery disease), and ROADSTER extended access TCAR trials was performed. All 851 patients were considered to be at high risk for CEA and were included and stratified using high-risk anatomic criteria (ie, contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stenting, hostile neck anatomy with previous neck irradiation, neck dissection, cervical spine immobility) or high-risk physiologic criteria (ie, age >75 years, multivessel coronary artery disease, history of angina, congestive heart failure New York Heart Association class III/IV, left ventricular ejection fraction <30%, recent MI, severe chronic obstructive pulmonary disease, permanent contralateral cranial nerve injury, chronic renal insufficiency). For trial inclusion, asymptomatic patients were required to have had ≥80% carotid stenosis and symptomatic patients to have had ≥50% stenosis. The primary outcome measures were stroke, death, and MI at 30 days. The data were statistically analyzed using the χ2 test, as appropriate. RESULTS: A total of 851 high surgical risk patients were categorized into two groups: those with anatomic-only risk factors (n = 372) or at least one physiologic risk factor present (n = 479). Of the 851 patients, 74.5% of those in the anatomic subset were asymptomatic, and 76.6% in the physiologic subset were asymptomatic. General anesthesia was used similarly in both groups (67.7% anatomic vs 68.1% physiologic). MI had occurred in eight patients in the physiologic group (1.7%), all of whom had been asymptomatic and in none of the anatomic patients (P = .01). The combined stroke, death, and MI rate was 2.1% in the anatomic cohort and 4.2% in the physiologic cohort (P = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any further differences. CONCLUSIONS: The patients who had undergone TCAR in the present prospective, neurologically adjudicated trial because of high-risk physiologic factors had had a higher rate of MI compared with the patients who had qualified for TCAR using anatomic criteria only. These patients had experienced comparable rates of combined stroke, death, and MI rates. The anatomic patients represented a healthier and younger subset of patients, with notably low overall event rates.

Outcomes of great vessel debranching to facilitate thoracic endovascular aortic repair.

OBJECTIVE: With the expanding application of endovascular technology, the need to deploy into zone 0 has been encountered on occasion. In the present study, we evaluated the outcomes of great vessel debranching (GVD) as a method of extending the proximal landing zone to facilitate thoracic endovascular aortic repair (TEVAR). METHODS: We performed a single-center retrospective review of all patients who had undergone GVD followed by TEVAR between May 2013 and December 2020. The primary outcome was primary patency of all targeted vessels, with all-cause perioperative mortality as a secondary outcome. Kaplan-Meier analysis was used to account for censoring of mortality and primary patency. The extent of hybrid aortic repairs was characterized into type I (GVD plus TEVAR without ascending aorta or aortic arch reconstruction, type II (GVD plus TEVAR with ascending aorta reconstruction), and type III (GVD plus TEVAR with ascending aorta and aortic arch reconstruction with an elephant trunk (soft [surgical] or frozen [endovascular]]). RESULTS: A total of 42 patients (23 men [54.8%]; mean age, 62.2 ± 11.2 years) had undergone GVD, with 122 vessels revascularized (42 innominate, 42 left common carotid, and 38 left subclavian arteries). The indication for TEVAR was aneurysmal degeneration from aortic dissection in 32 patients (76.2%), a thoracic aneurysm in 9 patients (21.4%), and a perforated aortic ulcer in 1 patient (2.4%). The median duration between GVD and TEVAR was 82 days. The mean follow-up period was 25.7 ± 23.5 months. Type I repair was performed in 4, type II in 16, and type III in 22 patients. The perioperative mortality, stroke, and paraplegia rates were 9.5%, 7.1%, and 2.4%, respectively. Neither the extent of repair (P = .80) nor a history of aortic repair (P = .90) was associated with early mortality. Of the 38 patients who had survived the perioperative period, 6 had died >30 days postoperatively. At 36 months, the survival estimate was 68.6% (95% confidence interval, 45.7%-83.4%). The overall primary patency of the innominate artery, left common carotid artery, and left subclavian artery was 100%, 89.5%, and 94.1%, respectively. The primary-assisted patency rate was 100% for all the vessels. CONCLUSIONS: We found GVD to be a safe and effective method of extending the proximal landing zone into zone 0 with outstanding primary patency rates. Further studies are required to confirm the safety and longer term durability for these patients.

Balloon dilation strategy does not affect outcomes for transcarotid artery revascularization in prospective trials.

OBJECTIVES: Strategies of balloon dilation during transfemoral carotid artery stenting include prestent dilation only (PRE), post-stent dilation only (POST), or both predilation and postdilation (PRE+POST). Concerns over higher neurological risk have been raised with POST and PRE+POST during transfemoral carotid artery stenting. Whether these concerns are applicable to transcarotid artery revascularization (TCAR), which uses proximal clamping and cerebral blood flow reversal during stent deployment and balloon angioplasty remains unknown. Our aim is to analyze outcomes of PRE, POST, or PRE+POST balloon dilation strategies during TCAR. METHODS: We analyzed the prospectively collected data from the ROADSTER1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All trial patients had a high risk anatomic or clinical factors for carotid endarterectomy and were included, unless they did not undergo stent deployment or balloon dilation. For trial inclusion, asymptomatic patients had a carotid stenosis of more than 80%, and symptomatic patients had stenosis of more than 50%. Primary outcome measures were stroke, death, and myocardial infarction (MI) at 30 days. Data were statistically analyzed with χ2, analysis of variance, and multivariable analysis, as appropriate. RESULTS: There were 851 patients (566 male) who underwent dilation by PRE (n = 216), POST (n = 249), or PRE+POST (n = 386). Patients had carotid stenosis of greater than 70% (n = 828, 97%), and 207 (24%) were symptomatic. Flow reversal times were longer in the PRE+POST group (PRE 10.2 minutes, POST 9.8 minutes, and PRE+POST 13.3 minutes; P < .001). The 30-day stroke rate for the whole cohort was 1.9%, mortality was 0.5%, and MI rate was 0.94%. Stroke rates for the PRE cohort (1.9%), POST cohort (2.0%), and PRE+POST cohort (1.8%; P = .98) were similar. Also, death rates at 30 days, and composite stroke, death, and MI rates were similar in the three cohorts. No significant differences in adverse outcomes were noted among the various dilation strategies for both symptomatic and asymptomatic patients. CONCLUSIONS: Based on these prospective trial data, there is no difference in neurological complications owing to balloon dilation strategy during TCAR. The balloon dilation technique best suited to the patient's specific lesion morphology should be used. Further studies are needed to evaluate the relationship of these dilation strategies to long-term outcomes, including stent patency, restenosis, and reintervention.

Elevated Neutrophil to Lymphocyte Ratio is Associated with Worse Outcomes after Carotid Endarterectomy in Asymptomatic Patients.

OBJECTIVE: Management of carotid artery stenosis (CAS) remains controversial and proper patient selection critical. Elevated neutrophil to lymphocyte ratio (NLR) has been associated with poor outcomes after vascular procedures. The effect of NLR on outcomes after carotid endarterectomy (CEA) in asymptomatic and symptomatic patients is assessed. MATERIALS AND METHODS: A retrospective review was conducted of all patients between 2010 and 2018 with carotid stenosis >70% as defined by CREST 2 criteria. A total of 922 patients were identified, of whom 806 were treated with CEA and 116 non-operatively with best medical therapy (BMT). Of patients undergoing CEA, 401 patients (290 asymptomatic [aCEA], 111 symptomatic [sCEA]) also had an available NLR calculated from a complete blood count with differential. All patients treated with BMT were asymptomatic and had a baseline NLR available. Kaplan-Meier analysis assessed composite ipsilateral stroke or death over 3 years. RESULTS: In sCEA group, the 3-year composite stroke/death rates did not differ between NLR < 3.0 (22.9%) vs NLR > 3.0 (38.1%) (P=.10). In aCEA group, patients with a baseline NLR >3.0 had an increased risk of 3-year stroke/death (42.6%) compared to both those with NLR <3.0 (9.3%, P<.0001) and those treated with BMT (23.6%, P=.003). In patients with NLR <3.0, aCEA showed a superior benefit over BMT with regard to stroke or death (9.3% vs. 26.2%, P=.02). However, in patients with NLR >3.0, there was no longer a benefit to prophylactic CEA compared to BMT (42.6% vs. 22.2%, P=.05). Multivariable analysis identified NLR >3.0 (HR, 3.23; 95% CI, 1.93-5.42; P<.001) and congestive heart failure (HR, 2.18; 95% CI, 1.33-3.58; P=.002) as independent risk factors for stroke/death in patients with asymptomatic carotid artery stenosis. CONCLUSIONS: NLR >3.0 is associated with an increased risk of late stroke/death after prophylactic CEA for asymptomatic carotid artery stenosis, with benefits not superior to BMT. NLR may be used to help with selecting asymptomatic patients for CEA. The effect of NLR and outcomes in symptomatic patients requires further study. Better understanding of the mechanism(s) for NLR elevation and medical intervention strategies are needed to modulate outcome risk in these patients.

Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia.

OBJECTIVE: Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX. METHODS: We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR. CONCLUSIONS: In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.

Elevated neutrophil to lymphocyte ratio is associated with decreased amputation-free survival after femoropopliteal percutaneous revascularization.

BACKGROUND: An elevated neutrophil-lymphocyte ratio (NLR) is a biomarker associated with adverse outcomes after cardiovascular surgery. This study evaluates the association of preoperative NLR with clinical outcomes after peripheral vascular intervention (PVI) of the femoropopliteal segments. METHODS: A retrospective review identified 488 patients who underwent percutaneous interventions of femoropopliteal arteries between 2011 and 2018 and had a pre-procedural complete blood count with differential with normal white blood cell count within 30 days prior to intervention. Amputation-free survival (AFS), survival, and freedom from major amputation were assessed using Kaplan-Meier methods. Cohorts of patients with NLR <3 (Low), 3-4 (Mid), and >4 (High) were compared using univariate and multivariable statistical models. In these analyses NLR was analyzed as a continuous variable to correlate with clinical outcomes. RESULTS: Mean age was 71.7±12.8 years and males constituted 55.5%. The majority of patients presented with chronic limb threatening ischemia (CLTI, 78.5%). Increasing NLR was correlated with increasing rates of comorbidities, except for smoking history. The 30-day mortality rates increased with increasing NLR: 1.4%, 4.3%, and 7.0% for low (<3), mid (3-4) and high (>4) NLR groups, respectively (P=0.005). Patients with a lower pre-operative NLR achieved significantly greater amputation-free survival at 4-year follow-up: low NLR, 65.5%; mid NLR, 37.5%; and high NLR, 17.6% (P<0.0001). By multivariable analysis, increasing NLR, advanced age, CLTI, and dialysis-dependent renal failure reduced AFS. CONCLUSIONS: Elevated NLR is an independent predictor of decreased AFS following percutaneous interventions of femoropopliteal segments. Further research on identification and modulation of risk factors for high NLR are warranted.

Computer-based video training is effective in teaching basic surgical skills to novices without faculty involvement using a self-directed, sequential and incremental program.

INTRODUCTION: Computer-based video training (CBVT) of surgical skills overcomes limitations of 1:1 instruction. We hypothesized that a self-directed CBVT program could teach novices by dividing basic surgical skills into sequential, easily-mastered steps. METHODS: We developed a 12 video program teaching basic knot tying and suturing skills introduced in discrete, incremental steps. Students were evaluated pre- and post-course with a self-assessment, a written exam and a skill assessment. RESULTS: Students (n = 221) who completed the course demonstrated significant improvement. Their average pre-course product quality score and assessment of technique using standard Global Rating Scale (GRS) were <0.4 for 6 measured skills (scale 0-5) and increased post-course to ≥3.25 except for the skill tying on tension whose GRS = 2.51. Average speed increased for all skills. Students' self-ratings (scale 1-5) increased from an average of 1.4 ± 0.7 pre-elective to 3.9 ± 0.9 post-elective across all skills (P < 0.01). CONCLUSION: Self-directed, incremental and sequential video training is effective teaching basic surgical skills and may be a model to teach other skills or to play a larger role in remote learning.

Systematic review of hemostatic agents used in vascular surgery.

BACKGROUND: Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of perioperative bleeding. A relative lack of comparative research studies have left surgeons with the option of choosing hemostatic agents based on their personal experience. The present review has highlighted the efficacy and safety of hemostatic agents and categorized them according to their primary mechanism of action and cost. METHODS: A systematic search strategy encompassing hemostatic agent products was deployed in the PubMed database. Single-center and multicenter, randomized, controlled trials with >10 patients were included in the present study. RESULTS: We reviewed 12 studies on the efficacy and safety of hemostatic agents compared with manual compression or other hemostatic agents. Using the time to hemostasis as the primary end point, all studies had found hemostatic agents to be significantly more efficient than manual compression. Likewise, adhesives (high pressure sealants) and dual agents (containing biologically active and absorbable components) were found to be more efficient, but costlier, than agents with either biologically active or absorbable components only. Agents with porcine or bovine constituents were found to trigger anaphylactic reactions in rare cases. Additionally, the absence of fibrin stabilizing factor XIII in a brand of fibrin sealant was speculated to reduce the affinity of the fibrin sealant for the expanded polytetrafluoroethylene graft. The cost of agents varied greatly depending on their active ingredient. CONCLUSIONS: Hemostatic agents appear to be highly effective at decreasing the risk of bleeding during surgical procedures. Although some hemostatic agents were demonstrated to achieve hemostasis faster than others, most are able to control bleeding within <10 minutes. Based on the limited data, the least expensive agents might suffice for limited suture lines used in routine procedures.

Paclitaxel-Coated Peripheral Arterial Devices are Associated with Reduced Mortality in Younger Patients.

BACKGROUND: Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices. METHODS: We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure: <60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and >80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models. RESULTS: Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (<60 years old, 56.2%; 60-80 years old, 57.0%; >80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the <60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the >80-year-old group treated with paclitaxel. In patients <60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years: <60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the >80-year-old group (46.6% vs. 32.8%; P = 0.65). CONCLUSIONS: Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.

Learning curve and proficiency of transcarotid artery revascularization compared to transfemoral carotid artery stenting.

Both transfemoral carotid artery stenting (TF-CAS) and transcarotid artery revascularization (TCAR) are competing endovascular alternatives to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis. TF-CAS is an endovascular procedure associated with a long learning curve and higher periprocedural stroke and death rates during an operator's early experience. Estimates suggest that more than 50 cases are required to achieve outcomes similar to carotid endarterectomy. TCAR is a novel hybrid procedure combining direct common carotid artery access and cerebral blood flow reversal with carotid stent placement. In distinction from TF-CAS, TCAR has a rather short learning curve. A multi-institutional analysis showed that operators achieved technical proficiency after approximately 10 to 15 cases. This was reinforced by a large Society for Vascular Surgery, Vascular Quality Initiative Transcarotid Artery Revascularization Surveillance Project analysis that demonstrated that expertise peaked after approximately 20 cases. Both studies found that TCAR was not associated with an increased rate of stroke or death during operator's early experience. These data suggest that TCAR is readily learned and patients are not at increased risk during a surgeon's early experience.

Anatomic criteria in the selection of treatment modality for atherosclerotic carotid artery disease.

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Elevated neutrophil-lymphocyte ratio predicts mortality following elective endovascular aneurysm repair.

OBJECTIVE: The neutrophil-lymphocyte ratio (NLR) is an inexpensive and useful inflammatory marker that incorporates the balance of the innate (neutrophil) and adaptive (lymphocyte) immune responses. Data exist on the association between NLR and mortality in various coronary diseases and in cancer surgery, but there is a paucity of data on the impact of preoperative NLR on vascular surgical outcomes. The aim of this study was to evaluate the relationship between preoperative NLR and elective endovascular aortic aneurysm repair (EVAR) outcome. METHODS: A retrospective review of all patients who underwent elective EVAR at a single institution between 2010 and 2018 was conducted (n = 373). Only patients who had a preoperative complete blood count with differential within 30 days of their operation were included. The NLR was computed by dividing the absolute neutrophil count by the absolute lymphocyte count. A receiver operating characteristic curve was used to determine the optimal cutoff value of NLR with the strongest association with mortality. NLR was dichotomized so that patients with NLR above the threshold were at increased risk of mortality compared with those below it. Continuous variables were analyzed using Wilcoxon nonparametric signed-rank test and categorical variables with the Fisher exact test. A comparison of NLR and mortality was completed using Kaplan-Meier survival analysis. Cox regression analysis was used to evaluate factors associated with mortality through 5-year follow-up. RESULTS: Overall, 108 patients were included in this study. An NLR ≥ 4.0 was found to be associated with mortality (P < .0001). Thirty-two patients composed the High-NLR (NLR ≥ 4.0) group and the remaining 76 patients formed the Low-NLR (NLR < 4.0) group. Baseline characteristics were similar between groups, except that the High-NLR group was older (77.9 vs 74.4; P = .047). At a mean of 36.4 months follow-up, the overall mortality rate was 32.4%. Although there were no differences in the perioperative period, the Kaplan-Meier estimates of mortality were significantly greater in the High-NLR group at 1, 2, and 5 years postoperatively (P < .0001). The mean preoperative NLR of the deceased was higher (5.94 ± 5.20; median, 4.75; interquartile range, 3.17-7.83) than those who survived (2.87 ± 1.61; median, 2.53; interquartile range, 1.97-3.49) (P < .0001). Secondary interventions and sac enlargement rates were similar between groups. On univariable analysis, NLR (hazard ratio [HR], 1.17; 95% confidence interval [CI], 1.10-1.23; P < .0001), age (HR, 1.06; 95% CI, 1.02-1.11; P = .004), and aneurysm diameter (HR, 1.04; 95% CI, 1.01-1.07; P = .003) were associated with mortality. On multivariable analysis, NLR (HR, 1.19; 95% CI, 1.12-1.27; P < .0001), age (HR, 1.06; 95% CI, 1.01-1.11; P = .026), and aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.07; P = .003) were associated with mortality. CONCLUSIONS: Patients with an elevated preoperative NLR, irrespective of other comorbidities, may represent a previously unrecognized subset of patients who are at heightened risk of mortality after elective EVAR. A complete blood count with differential is an inexpensive test that may be used as a prognostic indicator for outcome after EVAR. Further research is warranted to identify clinical, pathological, or anatomical factors associated with an elevated NLR and to determine modifiable factors, which may help improve long-term survival.

Frequency of perigraft hygroma after open aortic reconstruction.

OBJECTIVE: The incidence of perigraft hygroma (PGH) development after aortic reconstruction remains poorly defined and its clinical relevance is questionable. This study was designed to establish the incidence of and determine the risk factors associated with PGH formation and its outcomes. METHODS: Patients who underwent open aortic reconstruction for either aneurysmal or occlusive disease with an expanded polytetrafluoroethylene (ePTFE) or polyester graft from 2004 to 2018 were retrospectively reviewed (n = 262). Only those who had follow-up imaging 3 or more months after repair were included. Patients with mixed graft types were excluded. PGH was defined as a perigraft fluid collection of 30 mm or greater in diameter with a radiodensity of 30 or fewer Hounsfield units on computed tomography at a minimum of 3 postoperative months. Analysis was conducted between patients with and without PGH. RESULTS: One hundred forty patients met the inclusion criteria: 88 were treated with ePTFE and 52 with polyester grafts. Twenty-three patients (16.4%) were found to have radiologic evidence of PGH. PGH developed more frequently in patients with ePTFE (21/88 [23.9%]) compared with those with polyester grafts (2/52 [3.8%]) (P = .002). Mean PGH size was 63.5 ± 36.4 mm (range, 33-153 mm) and the average time to PGH detection 27.7 months (range, 3-112 months). Baseline characteristics were similar between the groups. Patients who developed PGH had larger aneurysms, more often received ePTFE grafts, had larger graft diameters, and had bifurcated grafts. The overall mortality was 32.1% at a mean follow-up of 5.2 years. The 5-year mortality rates were similar between patients with and without PGH (26.1% vs 18.8%; P = .41). Of the 23 patients with PGH, 4 (all with ePTFE) presented with symptoms related to the PGH. The average size of symptomatic and asymptomatic PGH were 11.5 and 4.8 cm, respectively. Mortality rates overall were similar between those with and without symptoms (50.0% vs 36.8%; P = .99). CONCLUSIONS: Nearly one-quarter of aortic reconstructions with ePTFE are associated with PGH formation compared with 4% with polyester. Clinically significant PGH-related symptom development occurs in 20%. Patient education and close surveillance are warranted. Manufacturer's device modification is needed.

Duration of blood flow reversal during transcarotid artery revascularization does not affect outcome.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has become an increasingly popular alternative for the treatment of carotid bifurcation stenosis. TCAR employs carotid blood flow reversal through an ex vivo common carotid artery to femoral vein shunt for neuroprotection during the placement and angioplasty of the carotid artery stent. There is a lack of data regarding an association between the duration of flow reversal and neurologic complications or other adverse events. We analyzed TCAR flow reversal time in relation to major adverse events. METHODS: There were 307 patients who underwent TCAR at four high-volume academic institutions. Patients were separated on the basis of the duration of carotid flow reversal as follows: group I, ≤8 minutes (n = 138); group II, 9-13 minutes (n = 105); group III, 14-20 minutes (n = 42); and group IV, >20 minutes (n = 22). Adverse events including stroke (assessed by a National Institute of Health Stroke Scale-certified examiner), myocardial infarction (MI), and death at discharge and 30 days were collected in all patients and were compared between groups using one-way analysis of variance and χ2 analysis. RESULTS: There were four strokes in the total cohort, yielding an overall stroke rate of 1.3%. All strokes were minor in nature; two were ipsilateral and two were contralateral. All patients demonstrated full recovery at 30 days. We found no significant difference in the stroke rate between any of the groups: I, 1.5% (2/138); II, 1.9% (2/105); III, 0% (0/42); and IV, 0% (0/22; P = .76). The four strokes occurred in patients with flow reversal time of 6, 7, 11, and 12 minutes. There was also no difference in the 30-day composite stroke/death or stroke/death/MI rates among the groups. CONCLUSIONS: The length of flow reversal during TCAR does not affect rates of stroke, MI, or death. These data suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than on its duration.