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.

Association of neutrophil-to-lymphocyte ratio with thirty-day mortality in acute peripheral arterial ischemia.

BACKGROUND: Acute peripheral arterial ischemia (APAI) is an acute ischemic condition that develops as a result of embolism or thrombosis, and its morbidity and mortality are still high today. The objective of this study is to determine the effect of preoperative Neutrophil-to-Lymphocyte ratio (NLR) on mortality in patients admitted with the diagnosis of APAI. METHODS: 178 patients who were diagnosed with acute peripheral arterial occlusion and underwent emergency embolectomy were evaluated retrospectively over a 7-year period. Patient demographics, clinical history, risk factors, comorbidity, and hemogram sub-parameters were documented. The endpoint of the patients was determined as death. RESULTS: A total of 178 patients were identified with a mean age 74.29±14.71 (range 28-111) years; among them, 105 (59%) were female. 18% patients (32/178) died within 30 days. Lower extremity involvement was present in 124 (69.7%) of the patients. A statistically significant difference was found between the mortality rates and blood parameters of the patients included in the study in terms of white blood count C-reactive protein (CRP), and age among those with normal distribution. Neutrophil, NLR, procalcitonin, lactate, aspartate aminotransferase, and urea; It was statistically significant in terms of mortality in our patients with APAI. NLR values of the deceased were determined as 7.98 ± 6.85. CONCLUSIONS: APAI patients with high NLRs had significantly higher risks of 30-day mortality. The NLR can be used as a prognostic marker in these patients and warrants further investigation.

Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion.

BACKGROUND: Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited. METHODS: We conducted a multicenter, prospective, randomized, controlled trial of endovascular thrombectomy for basilar-artery occlusion at 36 centers in China. Patients were assigned, in a 2:1 ratio, within 12 hours after the estimated time of basilar-artery occlusion to receive endovascular thrombectomy or best medical care (control). The primary outcome was good functional status, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]), at 90 days. Secondary outcomes included a modified Rankin scale score of 0 to 2, distribution across the modified Rankin scale score categories, and quality of life. Safety outcomes included symptomatic intracranial hemorrhage at 24 to 72 hours, 90-day mortality, and procedural complications. RESULTS: Of the 507 patients who underwent screening, 340 were in the intention-to-treat population, with 226 assigned to the thrombectomy group and 114 to the control group. Intravenous thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of those in the control group. Good functional status at 90 days occurred in 104 patients (46%) in the thrombectomy group and in 26 (23%) in the control group (adjusted rate ratio, 2.06; 95% confidence interval [CI], 1.46 to 2.91, P<0.001). Symptomatic intracranial hemorrhage occurred in 12 patients (5%) in the thrombectomy group and in none in the control group. Results for the secondary clinical and imaging outcomes were generally in the same direction as those for the primary outcome. Mortality at 90 days was 37% in the thrombectomy group and 55% in the control group (adjusted risk ratio, 0.66; 95% CI, 0.52 to 0.82). Procedural complications occurred in 14% of the patients in the thrombectomy group, including one death due to arterial perforation. CONCLUSIONS: In a trial involving Chinese patients with basilar-artery occlusion, approximately one third of whom received intravenous thrombolysis, endovascular thrombectomy within 12 hours after stroke onset led to better functional outcomes at 90 days than best medical care but was associated with procedural complications and intracerebral hemorrhage. (Funded by the Program for Innovative Research Team of the First Affiliated Hospital of USTC and others; ATTENTION ClinicalTrials.gov number, NCT04751708.).

Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion.

BACKGROUND: The effects and risks of endovascular thrombectomy 6 to 24 hours after stroke onset due to basilar-artery occlusion have not been extensively studied. METHODS: In a trial conducted over a 5-year period in China, we randomly assigned, in a 1:1 ratio, patients with basilar-artery stroke who presented between 6 to 24 hours after symptom onset to receive either medical therapy plus thrombectomy or medical therapy only (control). The original primary outcome, a score of 0 to 4 on the modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 4 moderately severe disability, and 6 death) at 90 days, was changed to a good functional status (a modified Rankin scale score of 0 to 3, with a score of 3 indicating moderate disability). Primary safety outcomes were symptomatic intracranial hemorrhage at 24 hours and 90-day mortality. RESULTS: A total of 217 patients (110 in the thrombectomy group and 107 in the control group) were included in the analysis; randomization occurred at a median of 663 minutes after symptom onset. Enrollment was halted at a prespecified interim analysis because of the superiority of thrombectomy. Thrombolysis was used in 14% of the patients in the thrombectomy group and in 21% of those in the control group. A modified Rankin scale score of 0 to 3 (primary outcome) occurred in 51 patients (46%) in the thrombectomy group and in 26 (24%) in the control group (adjusted rate ratio, 1.81; 95% confidence interval [CI], 1.26 to 2.60; P<0.001). The results for the original primary outcome of a modified Rankin scale score of 0 to 4 were 55% and 43%, respectively (adjusted rate ratio, 1.21; 95% CI, 0.95 to 1.54). Symptomatic intracranial hemorrhage occurred in 6 of 102 patients (6%) in the thrombectomy group and in 1 of 88 (1%) in the control group (risk ratio, 5.18; 95% CI, 0.64 to 42.18). Mortality at 90 days was 31% in the thrombectomy group and 42% in the control group (adjusted risk ratio, 0.75; 95% CI, 0.54 to 1.04). Procedural complications occurred in 11% of the patients who underwent thrombectomy. CONCLUSIONS: Among patients with stroke due to basilar-artery occlusion who presented 6 to 24 hours after symptom onset, thrombectomy led to a higher percentage with good functional status at 90 days than medical therapy but was associated with procedural complications and more cerebral hemorrhages. (Funded by the Chinese National Ministry of Science and Technology; BAOCHE ClinicalTrials.gov number, NCT02737189.).

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.

Direct to Angiography vs Repeated Imaging Approaches in Transferred Patients Undergoing Endovascular Thrombectomy.

Importance: A direct to angiography (DTA) treatment paradigm without repeated imaging for transferred patients with large vessel occlusion (LVO) may reduce time to endovascular thrombectomy (EVT). Whether DTA is safe and associated with better outcomes in the late (>6 hours) window is unknown. Also, DTA feasibility and effectiveness in reducing time to EVT during on-call vs regular-work hours and the association of interfacility transfer times with DTA outcomes have not been established. Objective: To evaluate the functional and safety outcomes of DTA vs repeated imaging in the different treatment windows and on-call hours vs regular hours. Design, Setting, and Participants: This pooled retrospective cohort study at 6 US and European comprehensive stroke centers enrolled adults (aged ≥18 years) with anterior circulation LVO (internal cerebral artery or middle cerebral artery subdivisions M1/M2) and transferred for EVT within 24 hours of the last-known-well time from January 1, 2014, to February 29, 2020. Exposures: Repeated imaging (computed tomography with or without computed tomographic angiography or computed tomography perfusion) before EVT vs DTA. Main Outcomes and Measures: Functional independence (90-day modified Rankin Scale score, 0-2) was the primary outcome. Symptomatic intracerebral hemorrhage, mortality, and time metrics were also compared between the DTA and repeated imaging groups. Results: A total of 1140 patients with LVO received EVT after transfer, including 327 (28.7%) in the DTA group and 813 (71.3%) in the repeated imaging group. The median age was 69 (interquartile range [IQR], 59-78) years; 529 were female (46.4%) and 609 (53.4%) were male. Patients undergoing DTA had greater use of intravenous alteplase (200 of 327 [61.2%] vs 412 of 808 [51.0%]; P = .002), but otherwise groups were similar. Median time from EVT center arrival to groin puncture was faster with DTA (34 [IQR, 20-62] vs 60 [IQR, 37-95] minutes; P < .001), overall and in both regular and on-call hours. Three-month functional independence was higher with DTA overall (164 of 312 [52.6%] vs 282 of 763 [37.0%]; adjusted odds ratio [aOR], 1.85 [95% CI, 1.33-2.57]; P < .001) and during regular (77 of 143 [53.8%] vs 118 of 292 [40.4%]; P = .008) and on-call (87 of 169 [51.5%] vs 164 of 471 [34.8%]; P < .001) hours. The results did not vary by time window (0-6 vs >6 to 24 hours; P = .88 for interaction). Three-month mortality was lower with DTA (53 of 312 [17.0%] vs 186 of 763 [24.4%]; P = .008). A 10-minute increase in EVT-center arrival to groin puncture in the repeated imaging group correlated with 5% reduction in the functional independence odds (aOR, 0.95 [95% CI, 0.91-0.99]; P = .01). The rates of modified Rankin Scale score of 0 to 2 decreased with interfacility transfer times of greater than 3 hours in the DTA group (96 of 161 [59.6%] vs 15 of 42 [35.7%]; P = .006), but not in the repeated imaging group (75 of 208 [36.1%] vs 71 of 192 [37.0%]; P = .85). Conclusions and Relevance: The DTA approach may be associated with faster treatment and better functional outcomes during all hours and treatment windows, and repeated imaging may be reasonable with prolonged transfer times. Optimal EVT workflow in transfers may be associated with faster, safe reperfusion with improved outcomes.

Midterm Outcomes on Primary Endovascular Treatment of 395 Aortoiliac Occlusive Disease Patients: A Single-Center Experience.

We report the results of endovascular treatment of Trans-Atlantic Inter-Society Consensus II (TASC) A&B, TASC C, and TASC D aortoiliac lesions in a single vascular center. In this retrospective, observational cohort study, we analyzed 395 patients (mean age 61.2 ± 9.0; 359 men) between January 2015 and December 2017. Technical success was achieved in 96.5%; in-hospital mortality was 1.2% (n = 5). Median follow-up was 36 months (range 24-49 months). After 1 and 5 years, the primary patency rates were 99% and 85% for TASC A&B, 90%, and 78% for TASC C, and 90% and 74% for TASC D. Secondary patency rates were 99% and 90% for TASC A&B, 98% and 65% for TASC C, and 97% and 65% for TASC D. Previous peripheral revascularization (hazard ratio: 1.76, 95% CI: 1.01-3.08, P = .04) was associated with decreased primary patency along with lower age, TASC C, and TASC D class. This analysis reported the acceptable effectiveness and safety of stenting for all types of aortoiliac occlusive disease in a modern setting, with few complications and excellent long-term primary and secondary patency rates.

Thrombotic Lesions are Associated with Poor Outcomes after Endovascular Treatment in Patients with Non-Acute Aortoiliac Total Occlusions.

AIM: The post-endovascular treatment outcomes of thrombotic lesions remain unclear. This study aimed to investigate the effects of thrombotic lesions on post-endovascular treatment outcomes in patients with non-acute aortoiliac total occlusions. METHODS: This subanalysis of a multicenter prospective observational registry study included patients from 64 institutions in Japan between April 2014 and April 2016. A total of 346 patients (394 limbs; median age, 72 years), including 186 men, underwent endovascular treatment for non-acute aortoiliac total occlusions and were included. The patients were classified as having thrombotic or non-thrombotic lesions. The primary (1-year primary patency rate) and secondary (1-year overall survival rate) endpoints were evaluated. RESULTS: Thrombotic lesions were identified in 18.5% (64/346) of the patients. The 1-year primary patency (85.9% versus 95.4%, log-rank p＜.001) and overall survival (90.6% versus 97.9%, log-rank p=.003) rates were significantly lower in the thrombotic group than in the non-thrombotic group. Thrombotic lesions had significant effects on the post-endovascular treatment outcomes, with adjusted hazard ratios of 3.91 (95% confidence interval, 1.64-9.34, p=.002) for primary patency and 4.93 (95% confidence interval, 1.59-15.3, p=.006) for all-cause mortality. CONCLUSIONS: Thrombotic lesions were associated with 1-year restenosis and all-cause mortality after endovascular treatment for non-acute aortoiliac total occlusions. Endovascular treatment strategies should be carefully planned for patients with thrombotic lesions.

Revised Injury Severity Classification II (RISC II) is a predictor of mortality in REBOA-managed severe trauma patients.

The evidence supporting the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in severely injured patients is still debatable. Using the ABOTrauma Registry, we aimed to define factors affecting mortality in trauma REBOA patients. Data from the ABOTrauma Registry collected between 2014 and 2020 from 22 centers in 13 countries globally were analysed. Of 189 patients, 93 died (49%) and 96 survived (51%). The demographic, clinical, REBOA criteria, and laboratory variables of these two groups were compared using non-parametric methods. Significant factors were then entered into a backward logistic regression model. The univariate analysis showed numerous significant factors that predicted death including mechanism of injury, ongoing cardiopulmonary resuscitation, GCS, dilated pupils, systolic blood pressure, SPO2, ISS, serum lactate level and Revised Injury Severity Classification (RISCII). RISCII was the only significant factor in the backward logistic regression model (p < 0.0001). The odds of survival increased by 4% for each increase of 1% in the RISCII. The best RISCII that predicted 30-day survival in the REBOA treated patients was 53.7%, having a sensitivity of 82.3%, specificity of 64.5%, positive predictive value of 70.5%, negative predictive value of 77.9%, and usefulness index of 0.385. Although there are multiple significant factors shown in the univariate analysis, the only factor that predicted 30-day mortality in REBOA trauma patients in a logistic regression model was RISCII. Our results clearly demonstrate that single variables may not do well in predicting mortality in severe trauma patients and that a complex score such as the RISC II is needed. Although a complex score may be useful for benchmarking, its clinical utility can be hindered by its complexity.

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.

COVID-19 and Major Organ Thromboembolism: Manifestations in Neurovascular and Cardiovascular Systems.

COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been shown to cause multisystemic damage. We undertook a systematic literature review and comprehensive analysis of a total of 55 articles on arterial and venous thromboembolism in COVID-19 and articles on previous pandemics with respect to thromboembolism and compared the similarities and differences between them. The presence of thrombosis in multiple organ systems points to thromboembolism being an integral component in the pathogenesis of this disease. Thromboembolism is likely to be the main player in the morbidity and mortality of COVID -19 in which the pulmonary system is most severely affected. We also hypothesize that D-dimer values could be used as an early marker for prognostication of disease as it has been seen to be raised even in the pre-symptomatic stage. This further strengthens the notion that thromboembolism prevention is necessary. We also examined literature on the neurovascular and cardiovascular systems, as the manifestation of thromboembolic phenomenon in these two systems varied, suggesting different pathophysiology of damage. Further research into the role of thromboembolism in COVID-19 is important to advance the understanding of the virus, its effects and to tailor treatment accordingly to prevent further casualties from this pandemic.

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.

Long-Term Effectiveness and Safety of Initiating Statin Therapy After Index Revascularization In Patients With Peripheral Arterial Occlusive Disease.

Background An increasing number of patients with a peripheral arterial occlusive disease were put on statins during the past years. This study assessed whether statin therapy was effective and safe for these new users. Methods and Results Using health insurance claims data from Germany's second-largest insurance fund, BARMER, we identified patients with peripheral arterial occlusive disease who had index revascularization between 2008 and 2018 without prior statin therapy. We compared patients with and without statin therapy in addition to antithrombotics during the first quarter after discharge (new users versus nonusers). Outcomes were all-cause mortality, cardiovascular events, and incident major amputation for effectiveness and incident diabetes mellitus and incident myopathy for safety. Propensity score matching was used to balance the study groups. All analyses were stratified into patients with chronic limb-threatening ischemia and intermittent claudication. A total of 22 208 patients (mean age 71.1 years and 50.3% women) were included in the study. In 10 922 matched patients, statin initiation was associated with lower all-cause mortality (chronic limb-threatening ischemia: hazard ratio [HR], 0.75 [95% CI, 0.68-0.84]; intermittent claudication: HR, 0.80 [95% CI, 0.70-0.92]), lower risk of major amputation in patients with chronic limb-threatening ischemia (HR, 0.73; 95% CI, 0.58-0.93) and lower risk of cardiovascular events (hazard ratio, 0.80; 95% CI, 0.70-0.92) in patients with intermittent claudication during 5 years of follow-up. Safety outcomes did not differ among the study groups. Conclusions Initiating statin therapy in patients with peripheral arterial occlusive disease after index revascularization is efficient and safe with an effect size comparable to earlier studies. Awareness campaigns for evidence-based optimal pharmacological treatment among patients are recommended.