Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.

OBJECTIVE: Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS: The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS: Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS: In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.

One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia.

OBJECTIVE: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. METHODS: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. RESULTS: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. CONCLUSIONS: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes.

OBJECTIVE: To compare thrombus removal and residual venous symptoms and signs of disease following interventional treatment of iliofemoral deep vein thrombosis (DVT) with mechanical thrombectomy (MT) and pharmacomechanical catheter directed thrombolysis (PCDT). METHODS: Retrospective cohort analysis of propensity score matched subgroups from the multicentre prospective MT ClotTriever Outcomes registry and the PCDT arm of the randomised Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter Directed Thrombolysis trial. Patients with bilateral DVT, symptom duration greater than four weeks, isolated femoral-popliteal disease, or incomplete case data were excluded. Patients with iliofemoral DVT were propensity score matched (1:1) on 10 baseline covariables, including race, sex, age, body mass index, leg treated, prior thromboembolism, Marder score, symptom duration, provoked deep vein thrombosis status, and Villalta score. Reduction in post-procedure thrombus burden (i.e., Marder scores), assessment of venous symptoms and signs (i.e., Villalta scores) at 12 months, and healthcare resource utilisation were compared between subgroups. RESULTS: Propensity score matching resulted in 130 patient pairs with no significant differences in baseline characteristics between the MT and PCDT groups. MT was associated with a greater reduction in Marder scores (91.0% vs. 67.7%, p < .001), and a greater proportion of patients at 12 months with no post-thrombotic syndrome (83.1% vs. 63.6%, p = .007) compared with matched patients receiving PCDT. No differences in rates of adjunctive stenting or venoplasty were identified (p = .27). Higher rates of single session treatment were seen with MT (97.7% vs. 26.9%, p < .001), which also showed shorter mean post-procedure hospital stays (1.81 vs. 3.46 overnights, p < .001), and less post-procedure intensive care unit utilisation (2.3% vs. 52.8%, p < .001). CONCLUSION: Compared with PCDT, MT was associated with greater peri-procedural thrombus reduction, more efficient post-procedure care, and improved symptoms and signs of iliofemoral vein disease at 12 months.

A more proximal landing zone is preferred for thoracic endovascular repair of acute type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has become first-line therapy for complicated acute type B aortic dissection (aTBAD). However, the strategy for optimal proximal landing zone remains to be determined. We compared early outcomes and late aortic-related adverse events in patients undergoing TEVAR for complicated aTBAD with endograft deployment in proximal landing zone 2 vs 3. METHODS: We performed a retrospective chart review of adult patients undergoing TEVAR for complicated aTBAD within 6 weeks of diagnosis from January 2008 to December 2018. We excluded patients with connective tissue disorders and prior type A repair. Patients were divided into landing zone 2 TEVAR (Z2T) and zone 3 TEVAR (Z3T) groups. Z2 patients were divided between left subclavian artery (LSA) revascularization (Z2R) vs LSA coverage without revascularization (Z2C). Groups were compared for the need for aortic reintervention within 36 months of initial admission and freedom from aortic-related adverse events and mortality (AREM), defined as the need for aortic reintervention, aortic-related death, or rupture. RESULTS: Eighty-three patients underwent TEVAR for complicated aTBAD within a mean of 4.1 ± 7.8 days; 89.5% of patients had less than 2 cm of healthy proximal descending thoracic aorta. The landing zone was Z3T in 35 patients and 48 underwent Z2T: 10 Z2C and 38 Z2R. There were no differences between Z2T and Z3T in time from diagnosis to TEVAR, demographics, comorbidities, and diameter aortic measurements. The 30-day survival was 87.8%-89.5% for Z2R, 88.6% for Z3, and 80.0% for Z2C (P = .610). The postoperative spinal cord ischemia rate was 3.7%-2.7% for Z2R, 0% for Z3T, and 20.0% for Z2C (P = .012). The postoperative thoracic aortic rupture was 2.2% in Z2 and 0 in Z3. The need for aortic reintervention at 36 months after TEVAR was lower for Z2T (10.4%) vs Z3T (31.4%; P = .025). Freedom from AREM at 36 months was higher in Z2T vs Z3T (87.5% vs 68.6%; P = .048). The freedom from proximal reintervention was higher in Z2T (95.8%) compared with Z3T (80.0%; P = .019). Z3T deployment was predictive for AREM (odd ratio, 3.648; 95% confidence interval, 1.161-11.465; P = .027) and need for proximal reintervention (odds ratio, 5.542; 95% confidence interval, 1.062-28.927; P = .042). CONCLUSIONS: Most patients with aTBAD have less than 2 cm of proximal healthy descending thoracic aorta. In patients treated for complicated aTBAD, Z2T is associated with a lower need for aortic reintervention and aortic-related adverse events than Z3T. Patients may benefit from a more aggressive proximal landing zone with similar perioperative morbidity when Z2T is done with LSA revascularization.

Impact of thoracic endovascular aortic repair timing on aortic remodeling in acute type B aortic intramural hematoma.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) is increasingly utilized in the management of acute type B aortic intramural hematoma (TBIMH). Optimal timing for intervention has not been described. The aim of this study was to evaluate TEVAR timing on postoperative aortic remodeling. METHODS: A retrospective chart review was performed on patients who underwent TEVAR for TBIMH from January 2008 to September 2018. Imaging was reviewed pre- and postoperatively. Primary data points included true lumen diameter (TLD) and total aortic diameter (TAD) at the site of maximal pathology. Primary endpoint was aortic remodeling evidenced by a TAD/TLD ratio closest to 1.0. Secondary outcome was occurrence of aortic-related adverse events and mortality (AREM): aortic rupture, aortic-related death, progression to dissection, or need for aortic reintervention within 12 months. Patients undergoing emergent TEVAR (within 24 hours, 'eTEVAR') were compared with the remainder - delayed TEVAR ('dTEVAR'). RESULTS: We analyzed 71 patients that underwent TEVAR for TBIMH; 25 underwent emergent TEVAR and 46 patients underwent dTEVAR (median, 5.5 days; range, 2-120 days). There were no differences in demographics and comorbidities, and patients did not differ in presenting IMH thickness (12.6 ± 3.1 vs 11.3 ± 4.1 mm; P = .186) nor presenting TAD/TLD ratio (1.535 ± 0.471 vs 1.525 ± 0.397; P = .928) for eTEVAR and dTEVAR groups, respectively. eTEVAR patients had larger average presenting maximal descending aortic diameter (45.8 ± 14.3 vs 38.2 ± 7.5 mm; P = .018) and higher incidence of penetrating aortic ulcer on presenting computed tomography angiography (52.0% vs 21.7%; P = .033). Thirty-day mortality was 2 of 25 (8.0%) for eTEVAR and 2 of 45 (4.4%) for dTEVAR (P = .602). Postoperative aortic remodeling was more complete in the dTEVAR group (1.23 ± 0.12 vs 1.33 ± 0.15; P = .004). Case-control matching (controlling for presenting descending aortic diameter and penetrating aortic ulcer) on 30 patients still showed better aortic remodeling in the dTEVAR group (1.125 ± 0.100 vs 1.348 ± 0.42; P < .001). The incidence of AREM was higher in the eTEVAR (6/25; 24.0%) group compared with the dTEVAR group (2/46; 4.3%). At 12 months, freedom from AREM was higher in the dTEVAR group (95.7% vs 76.0%; P = .011). Postoperative TAD/TLD ratio was the best predictor for late aortic-related adverse events (area under the receiver operator characteristic = 0.825; P = .003). CONCLUSIONS: TEVAR for acute TBIMH within 24 hours of admission is associated with lower aortic remodeling and higher occurrence of late AREM. Delaying TEVAR when clinically possible could improve aortic remodeling and aortic-related outcomes.

Continuous mechanical aspiration thrombectomy performs equally well in main versus branch pulmonary emboli: A subgroup analysis of the EXTRACT-PE trial.

INTRODUCTION: The EXTRACT-PE trial evaluated the safety and performance of the Indigo Aspiration System (Penumbra Inc.) with an 8F continuous mechanical aspiration thrombectomy system for the treatment of pulmonary embolism (PE). This subgroup analysis evaluates performance outcomes of patients with main pulmonary artery (PA) emboli versus discrete unilateral or bilateral PA emboli without main PA involvement. METHODS: The EXTRACT-PE trial was a prospective, single-arm, multicenter trial that enrolled 119 patients with acute submassive PE. Emboli location was collected at the time of enrollment, CT obstruction was measured and assessed by a Core Lab, and patients were grouped on whether emboli involved the main PA (with or without branch vessels) or not (branch vessels alone). Procedural device time, changes in the right ventricle to left ventricle (RV/LV) ratio, and systolic PA pressure from pre-and posttreatment were compared between the two groups. RESULTS: Out of the 119 patients enrolled, 118 had core lab-assessed clot locations. Forty-five (38.1%) had emboli that involved the main PA and 73 (61.9%) had only branch emboli. No significant difference was observed between these groups for 30-day mortality, procedural device time, changes in RV/LV ratio, reduction in CT Obstruction Index, or for systolic PA pressure from pre-and posttreatment. The mean absolute reduction in clot burden was significant in both groups. CONCLUSION: Continuous mechanical aspiration thrombectomy with the 8F Indigo Aspiration System was effective at improving clinical outcomes for submassive PE patients regardless of emboli location, and clot burden was significantly reduced in both groups.

Endovascular Removal of Thrombus and Right Heart Masses Using the AngioVac System: Results of 234 Patients from the Prospective, Multicenter Registry of AngioVac Procedures in Detail (RAPID).

PURPOSE: To assess device and procedural safety and technical success associated with the use of the AngioVac System to remove vascular thrombi and cardiac masses. MATERIALS AND METHODS: The Registry of AngioVac Procedures in Detail (RAPID) study prospectively collected data for 234 patients receiving treatment with AngioVac at 21 sites between March 2016 and August 2019: 84 (35.9%) with caval thromboemboli (CTEs), 113 (48.3%) with right heart masses (RHMs), 20 (8.5%) with catheter-related thrombi (CRTs), and 4 (1.7%) with pulmonary emboli (PEs). Thirteen patients had a combination of procedures during the same admission. RESULTS: Using the AngioVac system, 70%-100% thrombus or mass removal was achieved in 73.6% of patients with CTEs, 58.5% of patients with RHMs, 60% of patients with CRTs, and 57.1% of patients with PEs. Extracorporeal bypass time was < 1 hour for 176 (75.2%) procedures. Estimated blood loss was < 250 mL for 179 procedures (76.5%). Mean hemoglobin decreased from 10.4 g/dL ± 2.9 preoperatively to 9.4 g/dL ± 2.6 postoperatively. Transfusions were administered in 59 procedures (25.2%) with 47 transfusions (78.2%) being ≤ 2 U. There were 36 procedure-related complications, including 1 death. CONCLUSIONS: The RAPID registry data demonstrate that the AngioVac System can be safely and effectively used to remove vascular thrombi and cardiac masses across a broad range of patient populations. The limited use of the device to remove pulmonary emboli in the present series precludes recommending the use of the AngioVac device for this indication.

Distal Revascularization and Interval Ligation for the Management of Dialysis Access Steal Syndrome.

BACKGROUND: Treatment options for dialysis access steal syndrome (DASS) include distal revascularization with interval ligation (DRIL), proximalization of arterial inflow (PAI), access banding, and access ligation. This study examines the efficacy of DRIL in treating DASS and reports short-term bypass patency, access patency, and wound infection rates. METHODS: A retrospective analysis was performed on adults diagnosed with DASS following hemo-dialysis access creation who underwent DRIL procedures between January 1, 2009 and May 11, 2017. Patients <18 years and those with lower extremity accesses or HeRO grafts that developed DASS were excluded. Data was obtained using electronic medical records and analyzed using SPSS software. Residual steal was defined as reintervention for DASS within 60 days of DRIL. Recurrent steal was defined as reintervention beyond 60 days. RESULTS: Eighty-nine DRIL procedures were performed for correction of DASS. Population included 59.6% female (n = 53), 47.2% current/former smokers (n = 42), 76.4% diabetic (n = 68), and 79.8% AVF (n = 71). Symptom resolution was complete for 69.7% (n = 62), and partial for 25.8% (n = 23), with no improvement in 4.5% (n = 4). Following DRIL, mean DBI improved from 0.43 to 0.67 (P= 0.002). Mean steal classification improved from 3.04 to 0.64 (P< 0.001). Five patients required a subsequent procedure for DASS symptoms - 3 for residual steal and 2 for recurrent steal. Bypass patency at 6 months post DRIL was 93.3% (n = 83) primary, 97.8% (n = 87) primary-assisted, and 100% (n = 89) secondary patency. Access patency at 6 months post DRIL was 78.7% (n = 70) primary, 91% (n = 81) primary-assisted, and 94.4% (n = 84) secondary. Twenty-one patients (23.5%) had 24 cases of surgical site infections, with 70.8% (n = 17) occurring at the saphenectomy site. Wound infections re-solved within 60 days postoperatively in 23 out of 24 patients. CONCLUSIONS: DRIL is highly effective in relieving symptoms of DASS and has excellent rates of short-term access and bypass patency. However, consideration must be given to the high wound infection rate and the potential need for subsequent procedures.

Medical therapy in type B aortic intramural hematoma is associated with a high failure rate.

OBJECTIVE: Intramural hematoma (IMH) is on the spectrum of acute aortic syndrome, but optimal management is poorly understood. The aim of this study was to evaluate outcomes of patients with type B IMH (TBIMH) after best medical therapy (BMT) and to assess for risk factors associated with failure of BMT. METHODS: This is a single-institution retrospective chart review of all patients with TBIMH between January 2008 and December 2017. Failure of BMT was defined as any of the following end points: aortic rupture, aorta-related death, aortic enlargement to at least 55 mm or growth of >10 mm within 12 months, or need for surgical aortic intervention for failed BMT. RESULTS: We identified 92 patients, of whom 25 received emergent thoracic endovascular aortic repair; 67 patients were initially managed with BMT, and of these, 32 underwent thoracic endovascular aortic repair within 14 days for early BMT failure. Two additional patients had early BMT failure; one died of aortic rupture due to retrograde type A dissection, and one patient was advised to undergo repair but did not comply and was lost to follow-up. Fourteen patients (20.9%) received endovascular therapy for late failure of BMT after the initial hospitalization. Medical management was successful in 19 patients (28.4%), although 5 patients had aortic enlargement but below the threshold for elective repair (maximal aortic diameter of 55 mm). On univariate analysis, presenting IMH thickness and growth of IMH thickness were risk factors for BMT failure. On multivariate analysis, presenting IMH thickness was the sole predictive risk factor for medical therapy failure (odds ratio, 1.083; 95% confidence interval, 1.021-1.149; P = .008), with an odds ratio of 6.810 (95% confidence interval, 1.921-24.146; P = .002) with a presenting IMH thickness of ≥8.0 mm, which was the calculated IMH thickness cutoff value with highest sensitivity and specificity to predict failure of BMT (area under the receiver operating characteristic curve = 0.795; P = .001; J = 0.62). CONCLUSIONS: BMT for TBIMH is associated with a high failure rate and need for interventions. IMH thickness on admission is the most reliable factor to predict failure of BMT.

Vascular interventions in head and neck cancer patients as a marker of poor survival.

OBJECTIVE: Head and neck cancer can involve the surrounding vasculature and require technically challenging vascular interventions. These interventions can be complicated by tumor invasion, history of prior surgery, and history of radiation therapy. Our aim was to examine patients with vascular interventions in association with head and neck cancer to determine outcomes and best practice. METHODS: We performed a retrospective review of cancer patients treated by head and neck surgery and vascular surgery between 2007 and 2014. Data concerning previous cancer treatment, operative details of head and neck surgery and vascular surgery, perioperative outcomes, and survival data were collected. Statistical analyses were performed using the χ2 test, Student t-test, and binomial regression. Patency and survival data were determined by Kaplan-Meier analysis. RESULTS: A total of 57 patients with head and neck cancer requiring vascular interventions were identified. Of these, 44 patients had squamous cell carcinoma, 4 had thyroid cancer, 3 had sarcoma, 2 had Merkel and basal cell carcinoma, and 1 each had a parotid tumor, paraganglioma, extrarenal rhomboid tumor, and malignant spindle cell neoplasm. The majority of the interventions (n = 36 [63%]) were performed on patients with recurrent or persistent malignancy despite prior treatment. The most common previous treatment was radiation therapy (n = 44 [77%]). Tumor resection and vascular intervention were performed concurrently in 26 patients (46%). The mean time between cancer treatment and vascular intervention was 37 months (range, 18 days-18 years). The most common indication for vascular intervention was bleeding (n = 21 [37%]), which included vessel rupture (n = 14), tumor bleeding (n = 5), and intraoperative bleeding (n = 2). The remaining indications for intervention included invasion/encasement of major vasculature (n = 25), stenosis/occlusion (n = 12), and aneurysm (n = 1). The most common intervention was stenting (n = 22 [41%]), followed by resection (n = 20 [35%]), exposure/dissection (n = 12 [22%]), bypass (n = 8 [15%]), and embolization (n = 3 [6%]). Of the 22 patients who were stented, 12 (55%) were placed electively (11 for stenosis and 1 for aneurysm) and 10 (45%) were placed emergently (6 for blowout and 4 for tumor bleeding). A total of six patients (11%) required reintervention after their index vascular procedure. There were no intraoperative mortalities. The 30-day mortality was 9% (n = 5). The 30-day stroke rate was 7% (n = 4; one s/p common carotid artery-internal carotid artery bypass and three with emergent intervention for vessel rupture). Primary patency at 1 year was 66% for stents and 71% for bypass (P = .604). Survival in those patients operated on emergently for bleeding at 1 year was 38%, with a trend toward worse survival compared with the 77% survival at 1 year for all other indications (P = .109). The overall survival in the cohort at 1 and 2 years was 62% and 44%, respectively. CONCLUSIONS: Vascular involvement in head and neck cancer is a marker for poor survival. Any intervention performed in light of mass resection, persistent disease, and previous radiation complicates management. Minimally invasive techniques can be used with emergent bleeding but the survival benefits are marginal. Vascular interventions, including reconstruction, are feasible but should be approached with adequate expectations and multidisciplinary support.

Determining patient risk factors associated with accelerated growth of popliteal artery aneurysms.

OBJECTIVE: The objective of this study was to determine the natural progression of popliteal artery aneurysms (PAAs) and clinical variables associated with their accelerated growth. METHODS: Retrospective chart review of 224 patients with encounters between January 2008 and May 2016 and with at least one PAA was conducted. From this group, 65 asymptomatic patients had either unilateral (n = 43) or bilateral (n = 22) PAAs that were observed for at least 1 year of medical management before intervention. We divided these aneurysms into two groups based on whether their overall growth rate was above or below the eventual mean. Aneurysm diameter was taken from duplex ultrasound and computed tomography angiography. RESULTS: There were 87 aneurysms evaluated among 65 patients. Mean age at diagnosis was 70.9 years (standard deviation [SD], 9.39 years), and 64 patients were male (98%); 50 (77%) were white and 7 (11%) were African American. The average body mass index was 27.69 (SD, 4.90). At or before initial diagnosis, 61 (94%) patients had a concomitant lower extremity or abdominal aortic aneurysm; 51 (78%) patients were current or former smokers; and 16 (25%) had atrial fibrillation. The average growth rate of all aneurysms was 1.22 mm/y (SD, 1.93 mm). The mean surveillance time from initial diagnosis to last follow-up or intervention was 3.12 years (SD, 1.66 years). Of 87 aneurysms, 25 (29%) were repaired; 18 (21%) were repaired because of size criteria, 2 (2%) because of symptom criteria (claudication or acute limb ischemia), and 5 (6%) because of both criteria. During our study window, 62 aneurysms (71%) remained asymptomatic or did not undergo an intervention. The mean initial diameter at diagnosis was 16.9 mm (SD, 5.32 mm). Within the study, 50 (57%) aneurysms presented with or developed mural thrombus. Univariate analysis identified larger initial diameter (19.2 vs 14.7 mm; P = .020), atrial fibrillation (35% vs 16%; P = .042), and mural thrombus (38% vs 20%; P < .001) as predictors of diameter expansion greater than the mean. Multivariable analysis of the significant univariate factors determined that only initial diameter (odds ratio, 5.53; P = .007) and the presence or development of mural thrombus (odds ratio, 4.00; P = .008) maintained significance. CONCLUSIONS: Patients presenting with a PAA at 20 mm or >20 mm in diameter, presence of luminal thrombus, or atrial fibrillation may need to be observed at more frequent scanning intervals than those without these risk factors. Further studies are required to validate these predictive growth factors.

Outpatient Endovascular Tibial Artery Intervention in an Office-Based Setting Is as Safe and Effective as in a Hospital Setting.

PURPOSE: To compare outcomes of outpatient tibial artery procedures between an office endovascular center and a hospital angiography suite. METHODS: A retrospective review was conducted of 204 outpatient tibial interventions performed on 161 patients (mean age 72±11.5 years; 81 men) in either an office (n=100) or hospital (n=104) angiography suite from April 2011 through September 2013. Patients who had an existing ipsilateral bypass that was completely proximal to the tibial trifurcation were eligible, as were patients with prior proximal endovascular interventions. Exclusion criteria included previous ipsilateral bypass involving the infrapopliteal vessels, in-patient status at the time of the procedure, planned admission after the procedure, and infrapopliteal stenting. Treatment included percutaneous transluminal angioplasty (PTA) or PTA with atherectomy. Primary outcomes were unplanned admission, emergency room visits, acute complications, and patency. RESULTS: There were no significant differences in demographics or baseline Rutherford category between patients treated in an office endovascular suite vs a hospital angiography suite. Factors more prevalent in the hospital group included chronic obstructive pulmonary disease (16% vs 8%, p=0.045), renal insufficiency (37% vs 25%, p=0.017), and previous proximal bypass (12% vs 4%, p=0.045). Of the 100 office procedures, 25 involved PTA and 75 were PTA with atherectomy, while in the 104 hospital procedures, PTA was applied in 68 patients and PTA with atherectomy in 36. Thirty-day local complication rates (7% vs 11%, p=0.368), systemic complication rates (4% vs 8%, p=0.263), and mortality (1% vs 2%, p=0.596) in the office vs hospital setting were not statistically different. Unplanned postprocedure hospital admission rates for medical reasons were lower in the office group (2% vs 11%, p=0.01). Kaplan-Meier estimates of the 1-year follow-up data were better in the office group for primary patency (69% vs 53%, p=0.050), assisted primary patency (90% vs 89%, p=0.646), and amputation-free survival (89% vs 83%, p=0.476), but the differences were not statistically significant. CONCLUSION: Efficacy and safety of outpatient endovascular tibial artery interventions between office and hospital settings were similar, with lower unplanned admission rates and better patency. With appropriate patient selection, the office endovascular suite can be a safe alternative to the hospital angiography suite.

Anatomic severity grading score for primary descending thoracic aneurysms predicts procedural difficulty and aortic-related reinterventions after thoracic endovascular aortic repair.

BACKGROUND: An anatomic severity grading (ASG) score for primary descending thoracic aortic aneurysms (DTAs) was developed. The objective of this study was to determine if an ASG score cutoff value for DTAs is predictive of procedural complexity, aortic-related reinterventions, and mortality in patients who undergo thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective review from 2008 to 2013 of patient records was conducted of all consecutive patients who underwent TEVAR for a primary DTA. A comprehensive scoring system of preoperative DTA morphology on the basis of computed tomography angiography images was established to identify and classify anatomic features that might influence outcome after TEVAR. ASG score calculations were achieved using preoperative computed tomography angiography images. Primary outcomes included primary technical success, aortic-related reinterventions, aneurysm-related mortality, and all-cause mortality. Secondary outcomes included procedural complexity (unplanned adjunctive procedures, number of endografts implanted, contrast volume, and procedure time), endoleak formation, endoleak requiring reintervention, stroke and paraplegia, and conversion to open repair. RESULTS: Of 469 patients with a diagnosis of a thoracic aortic aneurysm, 62 patients (13%) underwent TEVAR and had adequate preoperative imaging (mean age, 71 years). Applying the ASG score, we identified 39 patients (63%) with a score ≥24 (high-score group) and 23 patients (37%) with a score <24 (low-score group). Mean follow-up was 15.3 months (range, 4 days to 3.7 years; standard deviation, 1 year) for both groups. Freedom from all-cause mortality was significantly different in the high-score (87% at 1 year, 79% at 2 years, and 57% at 3 years) vs the low-score group (100% at 1, 2, and 3-years; log-rank test, P < .021). There was no significant difference between mortality in the high-score (97% at 1 year, 87% at 2 years, and 69% at 3 years) compared with the low-score group (100% at 1, 2, and 3 years; log-rank test, P = .162). Freedom from aortic-related reinterventions was significantly lower in the high-score (82% at 1 year, 68% at 2 years, and 35% at 3 years) compared with the low-score group (100% at 1, 2, and 3 years; log-rank test, P = .002). Operative difficulty in the form of intraoperative adjunct procedures, number of endografts implanted, and procedural time had significant differences between groups (18% vs 0%, P = .038; 79% vs 39%, P = .004; 120 vs 79 minutes, P = .005, respectively). No significant difference in 30-day combined stroke and paraplegia (16%) was present between groups, and no patient had a conversion to open repair during the follow-up period. CONCLUSIONS: Preoperative ASG score for primary DTAs predicted procedure complexity and aortic-related reinterventions after TEVAR.

Patient compliance limits the efforts of quality improvement initiatives on arteriovenous fistula maturation.

OBJECTIVE: Our institutional quality-improvement (QI) initiative instituted a well-defined office follow-up schedule after arteriovenous fistula (AVF) creation, including an office visit within 30 days, fistulogram within 40 days, if indicated, and a second office visit within 55 days. In addition, a patient liaison contacted patients and dialysis units to improve follow-up. The purpose of this study was to determine the effect of the QI initiative on patient compliance and overall time to AVF permission to cannulate. METHODS: We performed a retrospective review of patients undergoing first-time radiocephalic, brachiocephalic, and basilic vein transposition creation before the QI initiative (pre-QI group: January to April 2012) and during the QI period (QI group: January to April 2013). Categoric data were compared using χ(2) analysis, and nominal data were compared using the Student t-test. RESULTS: We reviewed 198 first-time AVF creations in patients (57% male) with a mean age of 61 years. Demographics and comorbidities between the pre-QI and QI groups were similar. Compliance with the first 30-day postoperative appointment increased significantly after the QI initiative, from 48% in the pre-QI group to 65% in the QI group (P = .015). Yet, the QI initiative did not maintain an effect on the subsequent follow-up checkpoints. No statistical difference was identified for compliance with fistulogram within 40 days of access creation (pre-QI, 12% vs QI, 25%; P = .093) or for compliance with the 55-day postoperative appointment (pre-QI, 33% vs QI, 23%; P = .457). Both checkpoints demonstrated a very high noncompliance rate. Accordingly, the mean time to permission to cannulate was 88 days for both the pre-QI and QI groups, with a failure to mature rate of 22% for the pre-QI group and 21% for the QI group (P = .816). CONCLUSIONS: The QI initiative significantly increased the number of patients complying with the first 30-day follow-up appointment after AVF access creation. However, patient compliance with a timely fistulogram and the second follow-up appointment was poor and not influenced by the QI initiative, limiting the functional effect of the QI initiative on the time to AVF permission to cannulate.

Volumetric analysis of the initial index computed tomography scan can predict the natural history of acute uncomplicated type B dissections.

OBJECTIVE: Our objective was to characterize the predictive impact of computed tomography (CT) scan volumetric analysis on the natural history of acute uncomplicated type B aortic dissections (ADs). METHODS: We conducted a retrospective review of patients with acute type B ADs from 2009 to 2014. On an iNtuition workstation (TeraRecon, Foster City, Calif), volume measurements were obtained using the true lumen volume (TLV), false lumen volume (FLV), and total aortic volume from the left subclavian artery to the celiac artery. Growth rate was calculated as the change in maximal diameter between first and last available CT scans during the time interval. The primary outcome of the study was delayed aortic intervention. P < .05 was considered statistically significant. RESULTS: During a 5-year period, 164 patients had CT scan evidence of acute type B ADs; 11 patients were excluded for lack of subsequent follow-up imaging; 36 patients who underwent urgent repair (<14 days from presentation) were also excluded. We evaluated a total of 117 patients: 85 patients who did not require intervention and 32 who underwent delayed (>14 days) thoracic endovascular aneurysm repair (29) or open repair (3). Mean age was 66 ± 12 years. Mean TLV/FLV ratio on initial CT scan was significantly higher in patients who did not eventually require an operation (1.55 vs 0.82; P = .02). The mean growth rate was higher in those eventually requiring operation (2.47 vs 0.42 mm/mo; P = .003). Patients were divided into three subgroups on the basis of their initial imaging TLV/FLV ratios (<0.8, 0.8-1.6, and >1.6). There was a significant difference in the growth rates between these three groups (4.6 vs 2.4 vs 0.8 mm/mo; P < .025). Area under the receiver operating characteristic curve analysis revealed that a TLV/FLV ratio <0.8 was highly predictive for requiring an intervention (area = 0.8; sensitivity, 69%; specificity, 84%: positive predictive value, 71%; negative predictive value, 81%), with an odds ratio of 12.2 (confidence interval, 5-26; P < .001). Conversely, a TLV/FLV ratio of >1.6 was highly predictive for freedom from delayed operation (sensitivity, 91%; specificity, 42%; positive predictive value, 61%; negative predictive value, 86%). After Kaplan-Meier analysis, 1-year and 2-year survival free of aortic interventions was 60% and 42% with a TLV/FLV ratio <0.8 and 92% and 82% with a ratio >1.6 (P = .001). CONCLUSIONS: Initial CT scan volumetric analysis in patients presenting with uncomplicated acute type B ADs is a useful tool to predict growth and need for future intervention.

The effect of demographic factors and lesion severity on iliac stent patency.

OBJECTIVE: The aim of our study was to perform a large multivariate analysis to identify demographic, anatomic, or procedural factors that affect iliac artery stent primary patency (PP). METHODS: Patients receiving iliac stents from 2007 to 2013 were retrospectively reviewed. Univariate analysis assessed cohort characteristics and their effect on PP. Variables considered significant (P < .05) were brought forward in the multivariate analysis. RESULTS: A total of 213 patients underwent primary iliac artery stenting, and 307 limbs were analyzed. The average age was 66 years (range, 38-93 years), 54% were male, and 55% were Caucasian. Indications for procedure were claudication in 68%, rest pain in 20%, and tissue loss in 12%. All TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classifications were included: 51% TASC II A, 25% TASC II B, 13% TASC II C, and 11% TASC II D. The treated anatomic locations were 27% isolated external iliac artery (EIA), 56% isolated common iliac artery, and 17% combined common iliac artery and EIA. Multivariate analysis found three factors were correlated with decreased PP: non-Caucasian race (hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.08-3.13; P = .025), younger age (HR, 1.04; 95% CI, 1.01-1.08; P = .006), and presence of EIA occlusion (HR, 2.02; 95% CI, 1.05-3.89; P = .036). Overall, Kaplan-Meier analysis at 1 and 3 years revealed a PP of 86% and 53%, assisted PP of 98% and 89%, and secondary patency of 99% of 98%. Kaplan-Meier analysis showed PP at 1 year for was 91% Caucasian patients vs 77% for non-Caucasian (P = .001). PP was 75% in patients aged <60 years, 86% in patients aged 60-70 years, and 96% in patients aged >70 years, with a significant difference between all groups (P < .001). PP was significantly different for those with and without EIA occlusion (P = .002), with 1-year PP of 71% and 88%, respectively. CONCLUSIONS: In our experience with a large number of iliac interventions, younger age, non-Caucasian race, and EIA occlusion were strong predictors for loss of PP.

Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis.

OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.

A case-matched validation study of anatomic severity grade score in predicting reinterventions after endovascular aortic aneurysm repair.

BACKGROUND: In 2002, the Society for Vascular Surgery created the anatomic severity grading (ASG) score to classify abdominal aortic aneurysms (AAAs). Our objective was to identify the predictive capability and cutoff value of preoperative ASG score for reintervention after endovascular aneurysm repair (EVAR). METHODS: We completed a retrospective review of AAA patients treated with elective EVAR from 2007 through 2011. Patients who had reinterventions as well as preoperative M2S (M2S Inc, West Lebanon, NH) three-dimensional reconstructions were identified and compared with a case-matched control group of patients without reintervention. ASG component scores (neck, aortic, and iliac) and total ASG scores were calculated using M2S software. RESULTS: Of the 623 patients treated with EVAR, 79 (13%) had reinterventions of which 45 had preoperative M2S three-dimensional reconstructions available for ASG score calculation. The reintervention group (mean age, 74 ± 8; 80% male) had a mean ASG score of 18 ± 5 (range, 8-30) compared with a cohort of 45 EVAR patients (mean age, 74 ± 7; 80% male) who had a mean ASG score of 13 ± 4 (range, 6-21; P < .0001). The mean AAA diameter for all patients was 52 mm ± 14 and was not significantly different between the groups. After area under the receiver-operating curve analysis, an ASG score of 17 was highly predictive for reintervention (area = 0.8; sensitivity = 60%; specificity = 78%; positive predictive value = 73%; negative predictive value = 66%). An ASG score of 13 was highly predictive for freedom from reintervention (sensitivity = 93%; specificity = 47%; positive predictive value = 64%; negative predictive value = 88%). The lowest ASG score that yielded a 100% reintervention rate was 22. The majority of reinterventions fell into three categories: proximal extension cuff (n = 18; 40%), distal extension limb (n = 7; 16%), and type II endoleak embolization (n = 13; 29%). Those that received proximal extensions had significantly higher mean total ASG score (19 vs 15; P = .0005), mean neck score (3.28 vs 2.36; P = .047), and mean aorta score (7.39 vs 2.36; P = .004). Those that received distal extensions had a significantly higher mean iliac score (9.00 vs 6.86; P = .013), and those that required an embolization had a significantly higher mean aorta branch score (1.92 vs 1.19; P = .017). CONCLUSIONS: Preoperative total ASG score strongly predicts reintervention after EVAR. Use of a cutoff ASG value predictive of prohibitive reintervention rates could help guide the decision between endovascular vs open AAA repair.