Safety and Efficacy of Stent-Graft in the Treatment of Aortoiliac Artery Occlusive Disease: A Multicenter Study of Short-Term and Medium-Term Outcomes.

BACKGROUND: To evaluate the short-term and mid-term safety and efficacy of stent-graft compared with bare stents for treatment of aortoiliac occlusive disease (AIOD). METHODS: One hundred eighty three patients diagnosed with AIOD who received stent implantation at 3 vascular centers in north China between January 2019 and December 2021 were enrolled. Patients were divided into those undergoing stent-graft (Group A; n = 67) or bare stent (Group B; n = 116) implantation for retrospective cohort analysis. Efficacy was assessed as surgical success rate and rate of freedom from clinically driven target lesion reintervention at each follow-up time point. Safety was assessed by the rate of perioperative complication, major limb amputation, and aortoiliac artery-related mortality. RESULTS: There were no preoperative baseline differences between the 2 groups (P > 0.05). The surgical success was 91.04% for Group A, significantly higher than that for Group B (79.31%; P < 0.05). Incidence of perioperative complications was 2.98% for Group A, significantly lower than that for Group B (9.48%, P < 0.05), as was the rate of major limb amputation (A: 1.49% vs. B: 5.17%) and aortoiliac artery-related mortality (A: 1.49% vs. B: 4.31%), although these 2 indicators were not significantly different (P > 0.05). Follow-up rates were 91.8% for the total follow-up time of 3 years. Kaplan-Meier survival curve analysis gave significantly higher 1-year and 2-year freedom from clinically driven target lesion reintervention for Group A (98.51% and 95.52%) than for Group B (95.69% and 89.66%, P < 0.05). CONCLUSIONS: Stent-graft is more effective and safer than bare stent in the treatment of AIOD.

Outcome Analysis Using the Modified Frailty Index-5 in Patients With Complex Aortoiliac Disease.

OBJECTIVES: Vascular surgery patients commonly have several comorbidities that cumulatively lead to a frailty status. The cumulative comorbidities disproportionately increase the risk of adverse events and are also associated with worsened long-term prognosis. In recent years, several tools have been elaborated with the objective of quantifying a patient's frailty. One of them is the modified frailty index-5 (mFI-5), a simplified and easy to use index. There is scarce data regarding its value as a prognostic factor in aortoiliac occlusive disease. The aim of this work is to validate mFI-5 as a potential postoperative prognostic indicator in this population. METHODS: From January 2013 to January 2020, 109 patients who underwent elective revascularizations, either endovascular or open surgery, having Trans-Atlantic Inter-Society Consensus II type D aortoiliac lesions in a tertiary and a regional hospital were selected from a prospective vascular registry. Demographic data was collected including diabetes mellitus, chronic heart failure, chronic obstructive pulmonary disease, arterial hypertension requiring medication and functional status. The 30-d and subsequent long-term surveillance outcomes were also collected including major adverse cardiovascular events (MACE), major adverse limb events (MALE) and all-cause mortality were assessed in the 30-d post-procedure and in the subsequent long-term surveillance period. The mFI-5 was applied to this population to evaluate the prognostic impact of this frailty marker on mortality and morbidity. RESULTS: In the long-term follow-up, mFI-5 was significantly associated with MACE (hazard ratio [HR] 2.469; 95% confidence interval [CI]: 1.267-4.811; P = .008) and all-cause mortality (HR 2.585; 95% CI: 1.270-5.260; P = .009). However, there was no significant association with 30-day outcomes. Along with the presence of chronic kidney disease, mFI-5 was the prognostic factor better able of predicting MACE. No prognostic value was found regarding short-term outcomes. CONCLUSION: The mFI-5 index may have a role in predicting long term outcomes, namely MACE and all-cause mortality, in the subset of patients with extensive aortoiliac occlusive disease. Its ease of use can foster its application in risk stratification and contribute for the decision-making process.

Acute abdominal aortic occlusion: A 16-year single-center experience.

BACKGROUND: Acute abdominal aortic occlusion (AAO) is a rare vascular emergency associated with high morbidity and mortality. In the present study, we analyzed the clinical management and outcomes for a consecutive patient series during a 16-year period. METHODS: We included all patients with an acute AAO and bilateral acute limb ischemia who had been treated between 2004 and 2019. Patients with dissection, aneurysm rupture, or chronic occlusive disease were excluded. The patient characteristics, surgical procedures, and outcomes were extracted retrospectively from a prospective aortic database, electronic patient files, and outpatient examination records. The extent of ischemia was classified according to the TASC II (Inter-Society Consensus for the Management of Peripheral Arterial Disease) section on acute limb ischemia. The primary endpoints were 30-day mortality (safety endpoint) and the combined 6-month amputation and/or death rate (efficacy endpoint). The follow-up outcomes, amputation rates, and 30-day complications were evaluated as secondary endpoints. The patient cohort was divided into four 4-year groups (2004-2007, 2008-2011, 2012-2015, 2016-2019) to assess the outcome changes over time. Statistical analysis included χ2 tests and univariate and linear regression analyses. RESULTS: A total of 74 patients (57% male; median age, 64.5 years) with an acute AAO were identified. Arterial thrombosis was the most common etiology (66%). The extent of ischemia was TASC I, IIa, IIb, and III in 7%, 39%, 40%, and 14%, respectively. The patient numbers had increased significantly over time (P = .016). Of the patients, 42% had undergone open transfemoral recanalization (including hybrid procedures), 35% open aortic surgery, 15% extra-anatomic bypass surgery, and 5% (four patients) endovascular therapy alone. The overall 30-day mortality rate was 23%, and the 6-month amputation and/or death rate was 43%. The 30-day mortality rate had declined significantly from 54% for 2004 to 2007 to 10% for 2011 to 2015 (odds ratio [OR], 0.10; 95% confidence interval [CI], 0.001-0.52) and 20% for 2016 to 2019 (OR, 0.21; 95% CI, 0.05-0.90), a statistically nonsignificant trend showing that the relative decline in the use of open aortic procedures was associated with decreased 30-day mortality (P = .06). Univariate analysis indicated that elevated serum lactate on admission (OR, 3.33; 95% CI, 1.06-10.48) and an advanced stage of limb ischemia (OR, 4.33), were strongly associated with an increased 30-day mortality rate. The incidence of severe postoperative systemic complications also indicated a greater incidence of both primary endpoints. The 6-month amputation and/or mortality rates were also affected by the presence of atrial fibrillation (OR, 3.63; 95% CI, 1.34-9.79) and increased patient age (OR, 3.96; 95% CI, 1.49-10.53). CONCLUSIONS: Acute AAO remains a life-threatening emergency. Immediate transfemoral open or endovascular techniques should be preferred, if technically possible and proper intraoperative imaging is available.

Thoracofemoral bypass outcomes in the Vascular Quality Initiative.

OBJECTIVE: Thoracofemoral bypass (TFB) has been used infrequently but is an alternative for select patients with aortoiliac occlusive disease. Limited data are available in the reported data regarding TFB, with all studies small, single-center series. We aimed to describe the perioperative and long-term survival, patency, and rate of major perioperative complications after TFB in a large national registry. METHODS: The Vascular Quality Initiative suprainguinal bypass module was used to identify patients who had undergone TFB for occlusive disease from 2009 to 2019. A descriptive analysis was performed to provide the rates of survival, patency, major complications, and freedom from major amputation in the perioperative period and at 1 year of follow-up. Major complications were compared by procedure indication, with categorical variables analyzed using χ2 tests and continuous variables using analysis of variance. Kaplan-Meier curve analysis was used to estimate survival at the 1- and 5-year follow-up intervals and freedom from major amputation at 1 year. RESULTS: A total of 154 TFB procedures were identified. Of the 154 patients, 59 (38.3%) had undergone previous inflow bypass and 22 (14.2%) had undergone previous leg bypass. The procedure indications included claudication (n = 66; 42.9%), rest pain (n = 59; 38.3%), tissue loss (n = 19; 12.3%), and acute limb ischemia (n = 10; 6.5%). Major complications (eg, wound infection, respiratory, major stroke, new dialysis, cardiac, embolic, major amputation, occlusion) occurred in 31.2% of the cohort. When examined by indication, the acute limb ischemia and claudication cohorts had an increased rate of major complications (acute limb ischemia, 60.0%; claudication, 34.8%; critical limb ischemia, 24.4%; P = .05). The survival rate at 30 days was 95.5%, with a Kaplan-Meier estimated 1-year survival rate of 92.7% ± 2.2%. Primary patency at discharge from the index hospitalization was 92.9% and 89.0% at 1 year. Postoperative major amputation was required for 1 patient during the index hospitalization, for a Kaplan-Meier estimated freedom from major amputation at 1 year of 97.1% ± 2.2%. Two patients developed in-hospital bypass occlusion and three patients developed occlusion within 1 year, for an overall freedom from occlusion rate of 96.8% at 1 year. CONCLUSIONS: TFB is associated with a high rate of perioperative major complications; however, the long-term survival and patency after TFB remained acceptable when performed for limb salvage. The high perioperative complication rates of TFB procedures performed for claudication suggest TFB should be used rarely in this population. These data can be used to counsel patients and aid in decision making before operative intervention.

Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.

BACKGROUND: Peripheral vascular devices (stents and balloons) coated with paclitaxel were developed to address suboptimal outcomes associated with percutaneous revascularization procedures of the femoral-popliteal arteries. In randomized controlled trials (RCT), paclitaxel-coated devices (PCD) provided increased long-term patency and a decreased need for repeat revascularization procedures compared with uncoated devices. This finding resulted in the adoption of their use for endovascular lower extremity revascularization procedures. However, in late 2018 a study-level meta-analysis showed increased all-cause mortality at 2 years or more after the procedure in patients treated with PCDs. This review examines the subsequent data evaluation following the publication of the meta-analysis. METHODS: We review the published responses of physicians, regulatory agencies, and patient advocates during 15-month period after the meta-analysis. We present the additional data gathered from RCTs that comprised the meta-analysis and safety outcomes from large insurance databases in both the United States and Europe. RESULTS: Immediately after the publication of the meta-analysis, concern for patient safety resulted in less PCD use, the suspension of large RCTs evaluating their use, and the publication of a letter from the U.S. Food and Drug Administration informing physicians that there was uncertainty in the benefit-risk profile of these devices for indicated patients and that the potential risk should be assessed before the use of PCDs. Review of the meta-analysis found that a mortality signal was present, but criticisms included that the evaluation was performed on study-level, not patient-level data, and the studies in the analysis were heterogenous in device type, paclitaxel doses, and patient characteristics. Further, the studies were not designed to be pooled nor were they powered for evaluating long-term safety. Clinical characteristics associated with a drug effect or causal relationship were also absent. Specifically, there was no dose response, no clustering of causes of death, and a lack of signal consistency across geographic regions. As more long-term data became available in the RCTs the strength of the mortality signal diminished and analysis of real-world use in large insurance databases, showed that there was no significant increase in all-cause mortality associated with PCD use. CONCLUSIONS: The available data do not provide definitive proof for increased mortality with PCD use. A key observation is that trial design improvements will be necessary to better evaluate the risk-benefit profile of PCDs.

Propensity-Matched Comparison of Endovascular versus Open Reconstruction for TASC-II C/D AortoIliac Occlusive Disease. A Ten-Year Single-Center Experience with Self-Expanding Covered Stents.

BACKGROUND: To compare endovascular therapy (EVT) using kissing self-expanding covered stents, with open repair (OR) with aortobifemoral bypass (ABF), for reconstruction of the aortic bifurcation in Trans-Atlantic Inter-Society Consensus II (TASC-II) C/D aortoiliac occlusive disease (AIOD). METHODS: A single-center retrospective analysis of patients treated by EVT or ABF for TASC-II C/D AIOD (2009-2018) was carried out. The perioperative risk was quantified by the Society for Vascular Surgery (SVS) and American Society of Anesthesiologists (ASA) scores. Outcomes of interest were early (30 days) mortality and complication rates, length of hospitalization, and midterm patency that were compared between EVT and OR after propensity score matching. Follow-up results were analyzed with Kaplan-Meier curves. Cox proportional hazards were used to identify predictors of patency. RESULTS: Sixty-three EVT and 55 OR patients were treated; the EVT group had higher perioperative risk (ASA score, P = 0.012. SVS score, P = 0.012) and less advanced disease (TASC D lesions, 52.3% vs. 72.7%; P = 0.036. Iliac occlusion, 46.8% vs. 87.2%; P = 0.024). After propensity score matching, 148 limbs were selected (74 EVT and 74 OR), resulting in well-balanced groups regarding risk (ASA score, P = 0.514. SVS score, P = 0.373) and anatomical complexity (TASC D lesions, 60.4% vs. 63.0%; P = 0.516. Iliac occlusion, 47.3% vs. 59.5%; P = 0.187). Mortality was 0%. The EVT group showed significantly shorter hospital (4.5 ± 7.6 days vs. 9.9 ± 6.8 days; P < 0.001) and intensive care unit stay (0 ± 0.1 days vs. 1.7 ± 1.5 days; P = 0.046) and less surgical complications (4% vs. 14.8%; P = 0.046). Five-year primary patency was similar between EVT and OR (84.1% vs. 88.3%; P = 0.454); multivariate analysis showed that Rutherford category was the only predictor of primary patency (HR 4.1, P = 0.023). CONCLUSIONS: The endovascular kissing self-expanding covered stent technique for TASC-II C/D AIOD presented a primary patency equal to ABF at 5 years, with the advantage of less surgical complications and shorter hospitalization. Therefore, it may be considered as a valid option for complex atherosclerotic lesions involving the aortic bifurcation.

Predictors of in-hospital mortality and complications in acute aortic occlusion: a comparative analysis of patients with embolism and in-situ thrombosis.

BACKGROUND: Acute aortic occlusion (AAO) represents potentially fatal acute vascular emergency that requires prompt diagnosis and intervention. Clinical condition of patients with AAO is frequently severely devastated when surgical intervention is questionable. Our objective was to retrospectively review our institutional experience with AAO and assess predictors of intrahospital mortality and morbidity. METHODS: This is a retrospective single-center cohort study with prospectively collected data between January 1, 2005 and January 1, 2018. The total number of 28 consecutive patients with AAO were included in our analysis. Patients with acute aortic thrombosis manifested by bilateral acute limb ischemia were divided in two groups based on potential caues of AAO (embolism or in-situ thrombosis) differentiated according to condition of aortoilical segment. RESULTS: We identified 28 patients with AAO. All of them underwent either aortobifemoral bypass (N.=20, 71%) or bilateral trans-femoral thrombectomy (N.=8, 29%). The overall in-hospital mortality was 36%. Factors that influenced in-hospital mortality were: paralysis (OR=4.41, 95% CI: 1.88-21.78) and higher lactate values on admission (OR=1.23, 95% CI: 1.09-1.83), postoperative development of severe acute kidney injury (OR=3.08, 95% CI: 1.42-14.66), hemodialysis (OR=10.74, 95% CI: 1.64-109.78) and bowel ischemia (OR=5.19, 95% CI: 1.58-55.63). CONCLUSIONS: Paralysis, higher lactate values, development of acute kidney injury, hemodialysis and bowel ischemia are predictors of worse outcome and may be used for risk stratification of patients with acute aortic occlusion and improve counseling patients and their families about expected postoperative outcomes. Patients with embolism and malignant disease have worse outcome; however, this should be tested in future studies on larger sample.

Arterial Thrombosis in Coronavirus Disease 2019 Patients: A Rapid Systematic Review.

BACKGROUND: Emerging evidence suggests that severe form of coronavirus disease 2019 (COVID-19) is mediated, in part, by a hypercoagulable state characterized by micro- and macro-vascular thrombotic angiopathy. Although venous thrombotic events in COVID-19 patients have been well described, data on arterial thrombosis (AT) in these patients is still limited. We, therefore, conducted a rapid systematic review of current scientific literature to identify and consolidate evidence of AT in COVID-19 patients. METHODS: A systematic search of literature was conducted between November 1, 2019, and June 9, 2020, on PubMed and China National Knowledge Infrastructure to identify potentially eligible studies. RESULTS: A total of 27 studies (5 cohort, 5 case series, and 17 case reports) describing arterial thrombotic events in 90 COVID-19 patients were included. The pooled incidence of AT in severe/critically ill intensive care unit-admitted COVID-19 patients across the 5 cohort studies was 4.4% (95% confidence interval 2.8-6.4). Most of the patients were male, elderly, and had comorbidities. AT was symptomatic in >95% of these patients and involved multiple arteries in approximately 18% of patients. The anatomical distribution of arterial thrombotic events was wide, occurring in limb arteries (39%), cerebral arteries (24%), great vessels (aorta, common iliac, common carotid, and brachiocephalic trunk; 19%), coronary arteries (9%), and superior mesenteric artery (8%). The mortality rate in these patients is approximately 20%. CONCLUSIONS: AT occurs in approximately 4% of critically ill COVID-19 patients. It often presents symptomatically and can affect multiple arteries. Further investigation of the underlying mechanism of AT in COVID-19 would be needed to clarify possible therapeutic targets.

Acute Arterial Thromboembolism in Patients with COVID-19 in the New York City Area.

BACKGROUND: Coronavirus disease 2019 (COVID-19) predisposes to arterial and venous thromboembolic complications. We describe the clinical presentation, management, and outcomes of acute arterial ischemia and concomitant infection at the epicenter of cases in the United States. METHODS: Patients with confirmed COVID-19 infection between March 1, 2020 and May 15, 2020 with an acute arterial thromboembolic event were reviewed. Data collected included demographics, anatomical location of the thromboembolism, treatments, and outcomes. RESULTS: Over the 11-week period, the Northwell Health System cared for 12,630 hospitalized patients with COVID-19. A total of 49 patients with arterial thromboembolism and confirmed COVID-19 were identified. The median age was 67 years (58-75) and 37 (76%) were men. The most common preexisting conditions were hypertension (53%) and diabetes (35%). The median D-dimer level was 2,673 ng/mL (723-7,139). The distribution of thromboembolic events included upper 7 (14%) and lower 35 (71%) extremity ischemia, bowel ischemia 2 (4%), and cerebral ischemia 5 (10%). Six patients (12%) had thrombus in multiple locations. Concomitant deep vein thrombosis was found in 8 patients (16%). Twenty-two (45%) patients presented with signs of acute arterial ischemia and were subsequently diagnosed with COVID-19. The remaining 27 (55%) developed ischemia during hospitalization. Revascularization was performed in 13 (27%) patients, primary amputation in 5 (10%), administration of systemic tissue- plasminogen activator in 3 (6%), and 28 (57%) were treated with systemic anticoagulation only. The rate of limb loss was 18%. Twenty-one patients (46%) died in the hospital. Twenty-five (51%) were successfully discharged, and 3 patients are still in the hospital. CONCLUSIONS: While the mechanism of thromboembolic events in patients with COVID-19 remains unclear, the occurrence of such complication is associated with acute arterial ischemia which results in a high limb loss and mortality.

An Endovascular-First Approach for Aortoiliac Occlusive Disease is Safe: Prior Endovascular Intervention is Not Associated with Inferior Outcomes after Aortofemoral Bypass.

BACKGROUND: Although prior endovascular intervention is a risk factor for inferior outcomes after infrainguinal bypass, there are few studies evaluating the effect of prior aortoiliac endovascular intervention (AIEI) on outcomes after aortofemoral bypass (AFB). We sought to determine if prior AIEI was predictive of adverse events after AFB. METHODS: The Vascular Quality Initiative was queried for all patients who underwent AFB form 2009 to 2019. Urgent/emergent cases and repeat procedures were excluded. Primary outcomes were major perioperative complications, major adverse limb event (MALE)-free survival, and long-term survival. Multivariable logistic regression identified predictors of major complications. Predictors of MALE-free survival were identified with Cox proportional hazards modeling. RESULTS: There were 3,056 patients who underwent AFB; 618 had a prior AIEI. Mean age was 60.3 ± 8.7 years, and 58.7% of patients were men. There was no difference in major complications between the 2 groups (AIEI: 23.8%, no AIEI: 24.5%; P-value = 0.70). Factors associated with major complications were chronic obstructive pulmonary disease (odds ratio [OR]: 1.28, 95% confidence interval [CI]: 1.07-1.54; P = 0.008), simultaneous lower extremity intervention (endarterectomy, bypass, or transluminal intervention, OR 1.41, 95% CI: 1.18-1.69; P < 0.001), congestive heart failure (CHF) (OR 1.58, 95% CI: 1.15-2.16; P = 0.004), increased age (OR 1.03 per year, 95% CI: 1.02-1.04; P < 0.001), increasing operative blood loss (OR 1.35 per liter, 95% CI: 1.21-1.50; P < 0.001), increasing operative time (OR 1.07 per hour, 95% CI: 1.02-1.13; P = 0.008), and end-to-side proximal anastomosis (OR 1.23, 95% CI: 1.03-1.46; P = 0.022). One-year MALE-Free survival was 88.2% (95% CI: 85.2-90.7%) for the prior AIEI group and 89.7% (95% CI: 88.3-90.7%) for the group without prior AIEI (logrank P-value = 0.201). Predictors of MALEs/death were history of a bypass (hazard ratio [HR] 1.51, 95% CI: 1.16-1.96; P = 0.002), increasing degree of ischemia on presentation (HR 1.28 per increasing level of ischemia, 95% CI: 1.16-1.41; P < 0.001), diabetes (HR 1.29, 95% CI: 1.05-1.59; P = 0.014), simultaneous peripheral vascular intervention (HR 2.06, 95% CI: 1.02-4.15; P = 0.044), CHF (HR 1.60, 95% CI: 1.18-2.18; P = 0.002), end-stage renal disease on hemodialysis (HR 5.07, 95% CI: 2.45-10.48; P < 0.001), and presenting hemoglobin<9 g/dl (HR 1.76, 95% CI: 1.02-3.02; P = 0.041). One-year survival for the prior AIEI group was 94.5% (95% CI: 92.2-96.1%) and 94.0% (95% CI: 92.9-94.9%) for the group with no prior AIEI (logrank P = 0.486). Prior AIEI did not predict any of the primary outcomes in multivariable analysis. CONCLUSIONS: An endovascular-first approach for aortoiliac occlusive disease appears to be safe and does not portend to inferior results after AFB.

Long-term results of extensive aortoiliac occlusive disease (EAIOD) treated by endovascular therapy and risk factors for loss of primary patency.

BACKGROUND: Although endovascular therapy has been widely used for focal aortoiliac occlusive disease (AIOD), its performance for extensive AIOD (EAIOD) is not fully evaluated. We aimed to demonstrate the long-term results of EAIOD treated by endovascular therapy and to identify the potential risk factors for the loss of primary patency. METHODS: Between January 2008 and June 2018, patients with a clinical diagnosis of the 2007 TransAtlantic Inter-Society Consensus II (TASC II) C and D AIOD lesions who underwent endovascular treatment in our institution were enrolled. Demographic, diagnosis, procedure characteristics, and follow-up information were reviewed. Univariate analysis was used to identify the correlation between the variables and the primary patency. A multivariate logistic regression model was used to identify the independent risk factors associated with primary patency. Five- and 10-year primary and secondary patency, as well as survival rates, were calculated by Kaplan-Meier analysis. RESULTS: A total of 148 patients underwent endovascular treatment in our center. Of these, 39.2% were classified as having TASC II C lesions and 60.8% as having TASC II D lesions. The technical success rate was 88.5%. The mean follow-up time was 79.2 ±â€Š29.2 months. Primary and secondary patency was 82.1% and 89.4% at 5 years, and 74.8% and 83.1% at 10 years, respectively. The 5-year survival rate was 84.2%. Compared with patients without loss of primary patency, patients with this condition showed significant differences in age, TASC II classification, infrainguinal lesions, critical limb ischemia (CLI), and smoking. Multivariate logistic regression analysis showed age <61 years (adjusted odds ratio [aOR]: 6.47; 95% CI: 1.47-28.36; P = 0.01), CLI (aOR: 7.81; 95% CI: 1.92-31.89; P = 0.04), and smoking (aOR: 10.15; 95% CI: 2.79-36.90; P < 0.01) were independent risk factors for the loss of primary patency. CONCLUSION: Endovascular therapy was an effective treatment for EAIOD with encouraging patency and survival rate. Age <61 years, CLI, and smoking were independent risk factors for the loss of primary patency.

Predictors of mortality for patients with COVID-19 and large vessel occlusion.

BACKGROUND: This study evaluates the mortality risk of patients with emergent large vessel occlusion (ELVO) and COVID-19 during the pandemic. METHODS: We performed a retrospective cohort study of two cohorts of consecutive patients with ELVO admitted to a quaternary hospital from March 1 to April 17, 2020. We abstracted data from electronic health records on baseline, biomarker profiles, key time points, quality measures and radiographic data. RESULTS: Of 179 patients admitted with ischemic stroke, 36 had ELVO. Patients with COVID-19 and ELVO had a higher risk of mortality during the pandemic versus patients without COVID-19 (OR 16.63, p = 0.004). An age-based sub-analysis showed in-hospital mortality in 60% of COVID-19 positive patients between 61-70 years-old, 66.7% in between 51-60 years-old, 50% in between 41-50 years-old and 33.3% in between 31-40 years old. Patients that presented with pulmonary symptoms at time of stroke presentation had 71.4% mortality rate. 27.3% of COVID-19 patients presenting with ELVO had a good outcome at discharge (mRS 0-2). Patients with a history of cigarette smoking (p = 0.003), elevated d-dimer (p = 0.007), failure to recanalize (p = 0.007), and elevated ferritin levels (p = 0.006) had an increased risk of mortality. CONCLUSION: Patients with COVID-19 and ELVO had a significantly higher risk for mortality compared to COVID-19 negative patients with ELVO. A small percentage of COVID-19 ELVO patients had good outcomes. Age greater than 60 and pulmonary symptoms at presentation have higher risk for mortality. Other risk factors for mortality were a history of cigarette smoking, elevated, failure to recanalize, elevated d-dimer and ferritin levels.

Do Surgical Site Infections in Open Aortoiliac Surgery Differ Between Occlusive and Aneurysmal Arterial Disease?

BACKGROUND: Surgical site infections (SSI) are frequently seen after aortoiliac vascular surgery (2%-14%). Deep SSIs are associated with graft infection, sepsis, and mortality. This study evaluates the difference in incidence and nature of SSI following open aortoiliac surgery for aneurysmal disease compared to occlusive arterial disease. METHODS: A retrospective cohort study was conducted, including all consecutive patients who underwent open aortoiliac vascular surgery between January 2005 and December 2016 in the Amphia Hospital, Breda, the Netherlands. Patients were grouped by disease type, either aneurysmal or occlusive arterial disease. Data were gathered, including patient characteristics, potential risk factors, and development of SSI. Surgical site infections were defined in accordance with the criteria of the Centers for Disease Control. RESULTS: Between January 2005 and December 2016, a total of 756 patients underwent open aortoiliac surgery of which 517 had aortoiliac aneurysms and 225 had aortoiliac occlusive disease. The group with occlusive disease was younger, predominantly male, and had more smokers. After exclusion of 228 patients undergoing acute surgery, the SSI rate after elective surgery was 6.2%, with 10 of 301 SSIs in the aneurysmal group (3.0%) and 22 of 213 SSIs in the group with occlusive disease (10.3%, P < .001). Also, infection-related readmission and reintervention were higher after occlusive surgery, 6.6% versus 0.9% (P < .001) and 4.2% versus 0.9% (P = .003), respectively. Staphylococcus aureus was found as the most common pathogen, causing 64% of SSI in occlusive disease versus 10% in aneurysmal disease (P = .005). Logistic regression showed occlusive arterial disease and chronic renal disease were associated with SSI. CONCLUSION: Our study presents evidence for a higher rate of SSI in patients with aortoiliac occlusive disease compared to aortoiliac aneurysmal disease, in part due to inherent use of inguinal incision in patients with occlusive disease. All precautions to prevent SSI should be taken in patients undergoing vascular surgery for arterial occlusive disease.

Impact of Adding Carotid Endarterectomy to Supra-aortic Trunk Surgical Reconstruction.

BACKGROUND: Up to 20% of patients requiring open supra-aortic trunk (SAT) reconstruction have significant carotid artery stenosis. The addition of carotid endarterectomy (CEA) to SAT has been described. Yet, additive risks are not well defined and controversy remains as to whether concomitant CEA increases stroke risk. This study assessed the perioperative effects of adding CEA to SAT. METHODS: Using the National Surgical Quality Improvement Program (NSQIP), patients who underwent SAT from 2005 to 2015 were evaluated. SAT + CEA were identified. An isolated SAT (ISAT) cohort was created by removing patients who underwent concurrent secondary procedures. Nonocclusive indications were excluded. SAT + CEA were compared with ISAT as well as a propensity-matched ISAT cohort. Primary outcomes were 30-day stroke, death, and composite stroke/death/myocardial infarction (SDM). Univariate and logistic regression analyses were performed. RESULTS: After review, 1,515 patients were identified: 1,245 ISAT (82%) and 270 SAT + CEA (18%). Most were women (56%), 86% were Caucasian, and 24% were symptomatic. Average age was 65 ± 12 years and SAT + CEA were older (69 vs. 64 years, P < 0.001). CEA + SAT were more likely to be men (53% vs. 42%, P < 0.001), have hypertension (86% vs. 75%, P < 0.001) and diabetes (26% vs. 20%, P = 0.04). SAT procedures included the following: carotid-subclavian bypass (68%), carotid-carotid bypass (16%), aorta-great vessel bypass (9%), and carotid-subclavian transposition (7%). ISAT were more likely to undergo carotid-subclavian bypass than SAT + CEA (71% vs. 54%, P < 0.001). Overall stroke was 2.3%, death 1.4%, and SDM 4.6%. There were no differences in 30-day stroke (ISAT 2.0% vs. SAT + CEA 3.7%, P = 0.09) or mortality (1.4% vs. 1.5%, P = 0.88). SAT + CEA had higher rates of SDM (7% vs. 4%, P = 0.03). On logistic regression, urgency was a predictor of SDM (operating room [OR] 3.6, 95% confidence interval [CI] 1.5-8.4, P = 0.003); addition of CEA was not predictive of stroke (OR 1.4, 95% CI 0.5-4.2, P = 0.52) or SDM (OR 1.5, 95% CI 0.6-3.6, P = 0.40). After propensity matching, there were no longer differences in demographics or primary end points between the 2 cohorts. CONCLUSIONS: Addition of CEA does not confer increased perioperative stroke or SDM risk over ISAT. Perioperative outcomes appear to be more affected by disseminated disease risk factors than the addition of CEA. In patients undergoing SAT, it is reasonable to consider performing combined CEA in populations with tandem carotid bifurcation disease and appropriate operative risk profile.

A Retrospective Comparison Between Hybrid Treatment and Prosthetic Above-the-Knee Femoro-Popliteal Bypass in the Management of the Obstructive Disease of the Superficial Femoral Artery.

OBJECTIVE: We assessed early and late outcomes following hybrid intervention (common femoral artery endarterectomy and superficial femoral artery (SFA) stenting) versus above-the-knee (AK) femoro-popliteal bypass performed for peripheral artery occlusive disease (PAOD) in a double-center retrospective comparative cohort study. MATERIALS AND METHODS: From January 2006 to December 2017, 82 hybrid revascularizations with femoral endarterectomy and SFA stenting (HY Group) and 98 AK femoro-popliteal bypasses with femoral endarterectomy (BP Group) were performed at two academic vascular centers. The two groups were compared in terms of preoperative and intraoperative details and of perioperative (<30 days) outcomes with χ2 test. Long-term results were compared using Kaplan-Meier curves and log-rank test. RESULTS: No differences were found in demographics variables, risk factors, comorbidities and clinical presentation between the two groups. Also perioperative outcomes were similar between the two groups. Median duration of follow-up was 38 months. At five years, the estimated survival rate was 60% in HY Group and 77.5% in BP Group (p = 0.002) Five-year primary patency rates were 46% in HY Group and 64% in BP Group (p = 0.005). Overall, 13 patients in HY Group required conversion to open surgery and 6 patients in BP Group underwent below-knee (n = 4) or distal (n = 2) bypass. The 5-year rate of limb maintenance was 85% in HY Group and 94% in BP Group (p = 0.1) and was not significantly different regardless of presentation, claudication or critical limb ischemia. CONCLUSIONS: In patients with PAOD due to complex long lesions of the infrainguinal arteries, open-surgical treatment with AK bypass provided better long-term survival and patency rates compared to a hybrid approach.

The Comparison of Long-Term Results between Aortofemoral and Axillofemoral Bypass for Patients with Aortoiliac Occlusive Disease.

PURPOSE: We evaluated the clinical outcomes of aortofemoral bypass (AoFB) and axillofemoral bypass (AxFB) surgeries for complex aortoiliac occlusive disease (AIOD) and compared them from the perspectives of safety and efficacy. METHODS: We retrospectively reviewed 21 patients with AoFB grafting and 9 patients with AxFB grafting. The demographic information of the patients was examined, and the intra-, peri-, and postoperative results as well as long-term outcomes were evaluated. RESULTS: In the AoFB, 2 of 21 (9.5%) cases had intra- and perioperative complications, and 4 of 21 (19.0%) cases had postoperative complications; however, there were no postoperative mortalities. In the AxFB, two of nine (22.2%) cases had postoperative graft thrombosis; however, again there were no postoperative mortalities. According to Kaplan-Meier analysis, the primary patency rates in the AoFB and AxFB groups at 5 years were 94.8% and 53.6%, respectively (P = 0.001), while the limb salvage rates at 5 years were 96.4% and 92.9%, respectively (P = 0.320). CONCLUSIONS: Even though the patency rates with AxFB grafting were inferior to those with AoFB grafting, AxFB was able to achieve equivalent limb salvage rates and should thus be considered as an alternative treatment method, especially when limb salvage is a goal.

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass.

OBJECTIVE: The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease. METHODS: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR. RESULTS: During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism. CONCLUSIONS: The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions.

Meta-analysis of direct surgical versus endovascular revascularization for aortoiliac occlusive disease.

OBJECTIVE: There is a paucity of good-quality evidence comparing direct surgical (DS) with endovascular/hybrid (EVH) revascularization for aortoiliac occlusive disease (AIOD). We aimed to perform a meta-analysis of studies comparing DS and EVH revascularization for AIOD. METHODS: PubMed, Ovid MEDLINE, Cochrane, and Embase databases were searched for studies comparing DS and EVH revascularization for AIOD from 2000 to 2018. Risk of bias assessment was performed using the Methodological Index for Non-Randomized Studies. Demographics, clinical presentation, and comorbidities of the two groups were compared. Kaplan-Meier curves from selected studies were digitized with WebPlotDigitizer. Meta-analysis was conducted using Review Manager, and outcome measures were compared. Subgroup analysis was performed for primary patency in the EVH group. RESULTS: Eleven observational studies were identified comparing a sample of 4030 patients. The median Methodological Index for Non-Randomized Studies score was 19 of 24. A total of 1679 and 2351 patients underwent DS and EVH techniques, respectively. No significant difference was found between means for sex, claudication, rest pain, tissue loss, preoperative ankle-brachial pressure index, and TransAtlantic Inter-Society Consensus C and D lesions in the two groups averaged across studies. However, the DS group had significantly younger patients (average age, 61.83 vs 66.77; P = .0011). The risk factors of the two groups, such as smoking, diabetes, ischemic heart disease, hypertension, hyperlipidemia, renal failure, and chronic lung disease, were comparable. Average hospital stay was significantly higher for the DS group (7.76 days vs 3.12 days; P = .025). Change in ankle-brachial pressure index, 30-day mortality, and 30-day graft/stent thrombosis were not significantly different for the groups. Overall, primary patency for a median follow-up of 50 months favored the DS group (hazard ratio [HR], 0.51; confidence interval [CI], 0.36-0.73; P = .0002). There was moderate heterogeneity among studies (I2 = 46%). The HR for the subgroup for which endovascular procedures were combined with common femoral endarterectomy was 0.43 compared with 0.88 for endovascular revascularization alone. Limb salvage was similar in both groups (HR, 1.10; CI, 0.74-1.64; P = .63), but overall survival after the procedure favored the DS group (HR, 0.75; CI, 0.60-0.94; P = .01; I2 = 0%). CONCLUSIONS: Moderate-quality studies showed that DS revascularization had significantly better primary patency than EVH revascularization for AIOD, although DS patients were younger and may have differed on other confounding variables. Both techniques had similar limb salvage rates, and the primary patency was better for endovascular revascularization combined with common femoral endarterectomy than for endovascular revascularization alone.

A single-center experience in the eversion femoral endarterectomy.

OBJECTIVES: Endarterectomy is the treatment of choice for arterial occlusive disease of the femoral bifurcation. Longitudinal arteriotomy and prosthetic patch angioplasty is the standard technique but, due to the increasing concerns with prosthetic-related infections and multidrug-resistant pathogens our group adopted an alternative approach. We present our experience with eversion femoral endarterectomy. METHODS: All patients submitted to eversion femoral endarterectomy in a single institution during 2016-2019 were retrospectively analyzed. Patient demographics, surgical data, and complications were captured from medical records. RESULTS: Nineteen patients, 84.2% male and a median age of 67 years (IQR 62-78) were submitted to eversion femoral endarterectomy with a median follow-up of 180 days (IQR 71-395). Seventeen (89.4%) patients were treated for chronic limb ischemia and the other two were submitted to femoral endarterectomy during endovascular aortic aneurysm repair. Most of the patients had smoking history (84.2%), followed by hypertension (68.4%), dyslipidemia (63.2%), coronary heart disease (29.4%), and diabetes (26.3%). Only 3 patients (15.8%) were submitted exclusively to endarterectomy, 13 (68.4%) were submitted to endarterectomy as an adjuvant for peripheral endovascular treatment, 2 (10.5%) as a concomitant procedure to endovascular repair of aortic aneurysm, and 1 (5.3%) was complemented with thrombectomy of the femoro-popliteal sector. Primary patency rates were 100% and 87.5% (CI (38.7-98.1)) at 6 and 12 months, respectively. Primary-assisted and secondary patency rates were 100%. The 30-day mortality rate was 5.3% (n = 1) and complication rate 10.5% (n = 2). One patient complicated with acute renal disease related to rhabdomyolysis. Another patient developed a wound-related hematoma treated with surgical drainage, but died three days after consequent to ischemia-reperfusion injury. CONCLUSIONS: Eversion femoral endarterectomy is a safe and feasible technique, with good patency results and respecting the concept of leaving nothing behind. A careful control of the proximal and distal endpoints is essential for the success of the technique.

Effect of Intra-operative Intra-arterial Thrombolysis on Long Term Clinical Outcomes in Patients with Acute Popliteal Artery Aneurysm Thrombosis.

OBJECTIVE: Acute lower limb ischaemia (ALI) as a result of popliteal artery aneurysm (PAA) thrombosis represents a significant problem. The aim of this study was to investigate outcome of intra-operative intra-arterial thrombolysis in the treatment of acute ischaemia due to PAA thrombosis in terms of major adverse limb events (MALE), overall survival, and intrahospital complications, especially those associated with bleeding. METHODS: A total of 156 patients with Rutherford grade IIa and IIb acute ischaemia resulting from PAA thrombosis were admitted between 1 January 2011 and 1 January 2017. The patients were divided into two groups, those who underwent additional treatment with intra-operative intra-arterial thrombolysis (20 patients), and those who did not (136 patients). By using covariables from baseline and angiographic characteristics, a propensity score was calculated for each patient. Each patient who underwent intra-operative thrombolysis was matched to four patients from the non-thrombolysis group. Thus, comparable patient cohorts (20 in the thrombolysis and 80 in the non-thrombolysis group) were identified for further analysis. The primary end point was MALE and the secondary endpoint all cause mortality. RESULTS: After a median follow up of 55 months, the estimated MALE rate was significantly lower in the thrombolysis group (30% vs. 65%, chi square = 10.86, p < .001, log rank test). Also, patients in the thrombolysis group had a significantly lower mortality rate (20% vs. 42.65%, chi square = 3.65, p = .05, log rank test). The thrombolysis group had wound/haematoma related interventions performed more commonly (25% in thrombolysis vs 8%, in non-thrombolysis group), but the difference was not significant (p=.013). There were no cases of major (intracranial and gastrointestinal) bleeding in either group. CONCLUSION: The data suggest that intra-operative thrombolysis in the treatment of selected patients with ALI due to PAA thrombosis has long term MALE and overall survival benefits, without a significant risk of major, life threatening bleeding complications.