Stent Diameter,Not Cephalic Arch Anatomy,Predicts Stent Graft Patency in Cephalic Arch Stenosis

PurposeTo investigate the relationship between anatomic factors and primary patency of brachiocephalic arteriovenous fistulae (AVFs) after stent graft (SG) placement for cephalic arch stenosis (CAS).Materials and MethodsThis retrospective study reviewed all cephalic arch SGs placed in brachiocephalic AVFs in a tertiary academic medical center between 2014 and 2017. Sixty-three patients were included in the study. The mean patient age at the time of SG placement was 62.6 years ± 19, and the mean patient follow-up was 1,994 days ± 353. A cohort of patients (n = 31) who underwent brachiocephalic fistulograms for CAS but only received percutaneous transluminal angioplasty (PTA) was the control group. Patient demographic characteristics, AVF anatomy, SG type, and clinical outcomes were reviewed. The duration of primary cephalic arch patency after SG placement was compared with that after previous PTA.ResultsThe median AVF age at the time of data retrieval was 345 days. The primary patency of CAS after SG placement at 6 months, 12 months, and 3 years was 64%, 49.9%, and 23.5%, respectively. Primary cephalic arch patency was significantly associated with the SG diameter (P = .007) but not with cephalic vein–axillary vein junction anatomy, size of feeding artery, or SG length (P > .05). The primary patency of CAS in patients treated with PTA only (n = 31) at 6 months, 12 months, and 3 years was 61%, 35%, and 0%, respectively, which was significantly lower than that in patients treated with SG placement (P = .01).ConclusionsThis study showed that the primary patency of CAS after SG placement was significantly higher than that of PTA-only treatment. Moreover, primary cephalic arch patency after SG placement was significantly associated with the SG diameter.     

Vascular Pathology and Impact of Stent Eccentricity for Stent Restenosis in Femoropopliteal Endovascular Therapy

PurposeTo explore the clinical features associated with stent eccentricity and reveal the impact of stent eccentricity on the risk of 1-year restenosis after femoropopliteal stent implantation for symptomatic atherosclerotic peripheral artery disease (PAD).Materials and MethodsThe clinical database of a multicenter prospective study was used. It registered 2,018 limbs of 1,766 patients in whom intravascular ultrasound (IVUS)-supported femoropopliteal endovascular therapy (EVT) for symptomatic atherosclerotic PAD was planned from November 2015 to June 2017. The study included 1,233 limbs of 1,088 patients implanted with a bare nitinol stent, drug-eluting stent (DES), or stent graft and administered ≥2 antithrombotic drugs. The stent eccentricity was evaluated using IVUS, calculated as [(maximum diameter) / (minimum diameter) ? 1] at the cross-sectional segment with the lowest lumen area after stent implantation.ResultsChronic total occlusion and bilateral arterial calcification (peripheral artery calcification scoring system Grades 3 and 4) were positively associated with stent eccentricity, whereas renal failure while receiving dialysis, DES use, and stent graft use were negatively associated with stent eccentricity (all P < .05). Stent eccentricity was associated with an increased risk of 1-year restenosis (odds ratio [OR], 1.18; 95% CI, 1.01–1.37; P = .034). However, after adjustment for lesion severity and implanted stent types, the association was no longer significant (OR, 1.07; 95% CI, 0.91–1.24; P = .43).ConclusionsStent eccentricity was not significantly associated with the risk of 1-year restenosis after femoropopliteal EVT.     

The Effects of Protrusion into the Outflow Vein on Outcomes of Stent Grafts Used to Treat Cephalic Arch Stenoses in Dysfunctional Brachiocephalic Fistulae

PurposeTo assess long-term patency rates of cephalic arch stent grafts in brachiocephalic fistulae and the importance of device position.Materials and MethodsThis retrospective study reviewed 152 patients with dysfunctional brachiocephalic fistulae and cephalic arch stenosis treated with stent grafts (Viabahn; W. L. Gore) at a single tertiary center between 2012 and 2021. The median age was 67.5 years (range, 25–91 years), and the median follow-up period was 637 days (range, 3–3,368 days). A grading system of protrusion was applied: (a) Grade 0, no protrusion; (b) Grade 1, perpendicular; and (c) Grade 2, in-line protrusion. Subsequent fistulograms were available in 133 (88%) of the 152 patients and were assessed for central vein stenosis within 10 mm of the stent graft. Clinical records were assessed for sequelae of stent graft protrusion. Stent graft primary and cumulative circuit patencies were calculated using the Kaplan-Meier method.ResultsProtrusion was documented in 106 (70%) stent grafts—56 Grade 1 and 50 Grade 2. Central vein stenosis was seen in 1 (2%) case of no protrusion (Grade 0) and 38 (40%) cases of protrusion (P < .0001). There was no significant difference in stenosis between Grade 1 and 2 protrusion (P = .15). No adverse clinical sequelae occurred in 147 (97%) patients. Eight patients had a new access subsequently formed in the same arm, and 3 of these 8 patients developed symptoms due to the previous stent graft protrusion (all Grade 2). The primary patency rates of the stent-grafts at 6 and 12 months were 73% and 50%, respectively. The cumulative access circuit patency rates at 1, 2, and 5 years were 84%, 72%, and 54%, respectively.ConclusionsThis study demonstrated that protrusion of a cephalic arch stent graft into the central vein is safe and only clinically relevant when a subsequent ipsilateral access is created.     

Endovascular Treatment of Malignant Superior Vena Cava Syndrome through Upper-Limb Access: A Comparison between Venous-Dedicated and Conventional Stents

PurposeTo retrospectively evaluate the technical and clinical outcomes of superior vena cava (SVC) stent placement through upper-limb venous access in malignant SVC syndrome (SVCS) and compare the efficacy of different nitinol stent types.Materials and MethodsBetween 2006 and 2018, 156 patients (132 male; mean age, 62 y; age range, 33–81 y) underwent SVC stent placement for malignant obstructions through upper-limb venous access with 1 of 3 types of nitinol stent: 1 venous-dedicated (Sinus-XL stent) and 2 non–venous-dedicated (E-Luminexx Vascular Stent and Protégé GPS). Cases of common femoral vein access or non-nitinol stents were excluded from further analysis. The mean duration of follow-up was 8 mo.ResultsTechnical success was achieved in 99.3% of cases. One patient died during the procedure as a result of cardiac tamponade. Balloon predilation was performed in 10 patients and postdilation in 126. Mean procedural time was 34.4 min (range, 18–80 min). Overall survival rates were 92.3%, 57.3%, and 26.8%, and overall primary patency rates were 94.5%, 84.8% and 79.6%, at 1, 6, and 12 mo, respectively. There were no statistically significant differences in primary patency rates between venous- and non–venous-dedicated stents or among different Stanford SVCS grading groups (P > .05).ConclusionsSVC stent placement through an upper-limb approach is a safe, fast, and effective technique. There is no evident benefit of venous-dedicated vs non–venous-dedicated stents in the treatment of malignant SVCS.     

Percutaneous Cystic Duct Interventions and Drain Internalization for Calculous Cholecystitis in Patients Ineligible for Surgery

PurposeTo evaluate the feasibility, effectiveness, and outcomes of percutaneous cholecystostomy drain internalization in patients with calculous cholecystitis who were not surgical candidates.Materials and MethodsPercutaneous cystic duct interventions were attempted in 17 patients (with the intent to place dual cholecystoduodenal stents) who were deemed unfit for surgery and had previously undergone percutaneous cholecystostomies for acute calculous cholecystitis. Baseline demographics, technical success, time from percutaneous cholecystostomy to internalization (dual cholecystoduodenal stent placement), stent patency duration, and adverse event rates were evaluated.ResultsFifteen (88%) of 17 procedures to cross the cystic duct were technically successful. Of these 17 patients, 13 (76%) underwent successful placement of dual cholecystoduodenal stents. Two of these 13 patients (who had successful dual cholecystoduodenal stent placement) needed repeat percutaneous cholecystostomy drains (1 patient had stent migration leading to recurrent cholecystitis, and the other had a perihepatic biloma). The 1-year patency rate was 77% (95% CI, 47%–100%).ConclusionsDual cholecystoduodenal stent placement in nonsurgical patients is a technically feasible treatment option with the goal to remove percutaneous cholecystostomy drains.     

Treatment of Arm Swelling in Hemodialysis Patients with Ipsilateral Arteriovenous Access and Central Vein Stenosis: Conversion to the Hemodialysis Reliable Outflow Graft versus Stent Deployment

PurposeTo compare outcomes after conversion of arteriovenous (AV) access to Hemodialysis Reliable Outflow (HeRO) graft vs stent deployment in patients with arm swelling owing to ipsilateral central vein stenosis.Materials and MethodsThis single-center retrospective study comprised 48 patients (19 men, mean age 58 y) with arm swelling ipsilateral to AV access and central vein stenosis over a 13-year period who had clinical follow-up and without prior central stents. Twenty-one patients underwent placement of a HeRO graft with anastomosis of the HeRO graft to the existing graft or fistula, and 27 patients underwent central venous stent deployment. Symptomatic improvement in arm swelling and access patency rates after intervention were ascertained from medical records.ResultsImprovement in swelling within 1 month after HeRO conversion and stent deployment was found in 95% and 89%, respectively (P = .62). Swelling eventually recurred in 16 patients (59%) treated with stents compared with 1 patient (5%) who underwent HeRO conversion (P < .001). Primary access patency was statistically significantly longer after HeRO conversions than stent deployments, with 6- and 12-month primary patency rates of 89% and 72% vs 47% and 11% (P < .001). HeRO conversions also resulted in longer 6- and 12-month secondary access patency rates (95% and 95% vs 79% and 58%, P = .006). Mean number of interventions per 1,000 access days to maintain secondary patency was 2.7 for the HeRO group vs 6.3 for the stent group.ConclusionsAlthough stent deployment and HeRO graft conversion are effective for alleviating arm swelling in the short term in patients receiving hemodialysis with clinically significant arm swelling and functioning AV access, the HeRO graft has more durable results.     

Factors Affecting Recurrent Deep Vein Thrombosis after Pharmacomechanical Thrombolysis and Left Iliac Vein Stent Placement in Patients with Iliac Vein Compression Syndrome

PurposeThis study evaluated the factors affecting contralateral and ipsilateral recurrent deep vein thrombosis (DVT) after iliac vein stent placement in patients with iliac vein compression syndrome (IVCS).Materials and MethodsData from 130 patients (95 female patients) who underwent catheter-directed thrombolysis and stent placement for IVCS with left lower leg thrombosis at a single institution were retrospectively analyzed. Mean patient age was 69.0 ± 14.0 years old. Median follow-up was 14 months (range, 3–164 months). Anticoagulation therapy was prescribed for 6 months, followed by lifelong antiplatelet therapy. Multivariate logistic regression analysis was performed to evaluate the factors affecting the development of contralateral and ipsilateral recurrent DVT.ResultsSeven patients (5.4%) developed contralateral DVT (median, 26 months; range, 2–61 months), and 11 patients (8.5%) developed ipsilateral DVT (median, 1 month; range, 0–53 months). Stent location (odds ratio [OR], 11.564; 95% confidence interval [CI], 1.159–115.417) and in-stent thrombosis during follow-up (OR, 15.142; 95% CI, 1.406–163.119) were predictors of recurrent contralateral DVT. Thrombophilia (OR, 47.560; 95% CI, 2.369–954.711), remaining inferior vena cava filter (OR, 30.552; 95% CI, 3.495–267.122), and in-stent thrombosis during follow-up (OR, 82.057; 95% CI, 2.915–2309.848) were predictors of ipsilateral DVT.ConclusionsContralateral DVT occurs late and is associated with extension of the iliac vein stent to the inferior vena cava and in-stent thrombosis. Ipsilateral DVT occurs relatively early and is associated with thrombophilia, remaining inferior vena cava filter, and in-stent thrombosis.     

Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries

PurposeTo evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries.Materials and MethodsAll lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis.ResultsAmong the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%–99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69–0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27–0.39; P < .001) composite end points.ConclusionsIntravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.     

No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene–Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial

PurposeTo prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.Materials and MethodsAfter failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene–covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.ResultsThree patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178–438 d) for covered and 442 d (95% CI, 172–712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68–124 d) with covered stents and 75 days (95% CI, 42–108 d) with uncovered stents (P = .6).ConclusionsIn malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.     

Lower Extremity Venous Stent Placement: A Large Retrospective Single-Center Analysis

PurposeTo study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement.Materials and MethodsA database of all patients who received lower extremity venous stents between 1996 and 2018 revealed 1,094 stents were placed in 406 patients (172 men, 234 women; median age, 49 y) in 513 limbs, including patients with iliocaval stents (9.4% acute thrombosis, 65.3% chronic thrombosis, 25.3% nonthrombotic lesions). Primary, primary assisted, and secondary patency rates were assessed for lower extremity venous stents at 1, 3, and 5 years using Kaplan-Meier analyses and summary statistics. Subset analyses and Cox regression were performed to identify risk factors for patency loss. Vein diameters and Villalta scores before and up to 12 months after stent placement were compared. Complication and mortality rates were calculated.ResultsPrimary, primary assisted, and secondary patency rates at 5 years were 57.3%, 77.2%, and 80.9% by Kaplan-Meier methods and 78.6%, 90.3%, and 92.8% by summary statistics. Median follow-up was 199 days (interquartile range, 35.2–712.0 d). Patency rates for the subset of patients (n = 46) with ≥ 5 years of follow-up (mean ± SD 9.1 y ± 3.4) were nearly identical to cohort patency rates at 5 years. Patients with inferior vena cava stent placement (hazard ratio 2.11, P < .0001) or acute thrombosis (hazard ratio 3.65, P < .0001) during the index procedure had significantly increased risk of losing primary patency status. Vein diameters were significantly greater after stent placement. There were no instances of stent fracture, migration, or structural deformities. In patients with chronic deep vein thrombosis, Villalta scores significantly decreased after stent placement (from 15.7 to 7.4, P < .0001). Perioperative mortality was < 1%, and major perioperative complication rate was 3.7%.ConclusionsCavo-ilio-femoral stent placement for venous occlusive disease achieves improvement of vein disease severity scores, increase in treated vein diameters, and satisfactory long-term patency rates.     

Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model

PurposeTo evaluate the patency, cellular response, and thrombogenicity of a novel vascular stent graft.Materials and MethodsTest stent grafts, incorporating luminal spun polytetrafluoroethylene and a nonpermeable fluoropolymer layer, and control stent grafts, constructed of permeable expanded polytetrafluoroethylene, were implanted in the external iliac arteries of 14 adult sheep with a median weight of 73.4 kg ranging from 60.6–86.8 kg for 30 (n = 4), 90 (n = 4), and 180 (n = 6) days. Angiographic patency and percent diameter stenosis (%DS) were assessed at termination. Excised stent grafts were fixed and stained for histopathologic analysis, including neointimal coverage (NC) assessment.ResultsTest and control device migration occurred in 1 animal, resulting in test device thrombosis. Both devices were excluded from analysis. Mean %DS in test and control implants was 4.6% and 8.2% (P = .563), 2.0% and 10.9% (P = .363), and 2.1% and 10.3% (P = .009) at 30, 90, and 180 days, respectively. Median NC scores at 30, 90, and 180 days were significantly lower in middle test device sections (P < .05). Proximal and distal test and control sections exhibited similar median NC scores at all time periods (P > .05). When present, test and control devices exhibited no neointimal detachment from the graft surface. Except for the migrated test device, no thrombus was observed. Transgraft cellular migration was absent in test devices but present in control devices with tissue accumulation around the stent struts.ConclusionsTest and control devices demonstrated excellent patency in an ovine model. Compared to the control, test devices exhibited significantly lower %DS values at 180 days and significantly lower mid-device NC scores at 30, 90, and 180 days.     

Transjugular Intrahepatic Portosystemic Shunts in Pediatric Portal Hypertension: A Systematic Review and Meta-Analysis

PurposeTo investigate the technical outcome, clinical outcome, and patency of transjugular intrahepatic portosystemic shunt (TIPS) in pediatric portal hypertension (PHT).MethodsA systematic search of MEDLINE/PubMed, EMBASE, Cochrane databases, ClinicalTrials.gov, and WHO ICTRP registries was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An a priori protocol was registered at the PROSPERO database. Original full-text articles on pediatric patients (sample size of ≥5 patients with upper age limit of 21 years) with PHT who underwent TIPS creation for any indication were included.ResultsSeventeen studies with 284 patients (average-weighted age of 10.1 years) were included, with an average-weighted follow-up of 3.6 years. TIPS was technically successful in 93.3% (95% confidence interval [CI], 88.5%–97.1%) of patients, with a major adverse event rate of 3.2% (95% CI, 0.7–6.9) and adjusted hepatic encephalopathy rate of 2.9% (95% CI, 0.6–6.3). The pooled 2-year primary and secondary patency rates were 61.8% (95% CI, 50.0–72.4) and 99.8% (95% CI, 96.2%–100.0%), respectively. Stent type (P = .002) and age (P = .04) were identified as a significant source of heterogeneity for clinical success. In subgroup analysis, the clinical success rate was 85.9% (95% CI, 77.8–91.4) in studies with a majority of covered stents, and 87.6% (95% CI, 74.1–94.6) in studies with a median age of 12 years or older.ConclusionsThis systematic review and meta-analysis demonstrates that a TIPS is a feasible and safe treatment for pediatric PHT. To improve clinical outcome and patency on the long term, the use of covered stents should be encouraged.     

Five-Year Outcomes of the Bioresorbable Peripheral Remedy Stent in the Treatment of Iliac Artery Disease

PurposeTo evaluate the 5-year performance of a bioresorbable vascular scaffold, the Remedy stent, for the treatment of iliac artery atherosclerotic disease.Materials and MethodsThis prospective, multicenter, single-arm clinical study evaluated 97 patients (97 lesions) with symptomatic TransAtlantic Inter-Society Consensus II A/B iliac artery lesions for 5 years after stent placement. The primary efficacy end point was 12-month primary patency compared with the prespecified standard derived from historical data with metallic stents, and the primary safety end point was the occurrence of major adverse clinical events within 5 years. All angiographic and computed tomography angiographic findings were evaluated by an independent core laboratory for quantitative vessel analysis.ResultsThe 12-month primary patency rate was 88.6% (95% CI, 80.1%–94.4%), which was lower than the prespecified standard. No significant difference was noted between the diameter stenosis at 9 and 12 months. There were no device- or procedure-related deaths, major amputation, or distal embolization during the follow-up period. The ankle-brachial index maintained significant improvement through the 5-year period compared with that at baseline. The Kaplan–Meier estimates of freedom from target lesion revascularization (TLR), major adverse cardiovascular events, and major adverse cardiovascular and limb events were 95.8%, 91.7%, and 87.5% at 12 months and 85.4%, 72.1%, and 62.5% at 5 years, respectively.ConclusionsThe 5-year follow-up outcomes, including freedom from TLR, of the Remedy stent in iliac artery lesions were satisfactory, with a good safety profile. Nevertheless, the 12-month primary patency did not meet the expected standard compared with that of contemporary metallic stents.     

Comparison between Suprapapillary and Transpapillary Uncovered Self-Expandable Metallic Stent Placement for Perihilar Cholangiocarcinoma

PurposeTo compare the effectiveness, adverse events (AEs), stent patency, and patient survival with suprapapillary and transpapillary uncovered self-expandable metallic stent placement for perihilar cholangiocarcinoma.Materials and MethodsA single-center retrospective study of 54 patients with inoperable perihilar cholangiocarcinoma who underwent percutaneous transhepatic biliary stent placement between January 1, 2019, and August 31, 2021, was conducted. According to stent location, the patients were classified into 2 groups: suprapapillary (S) and transpapillary (T). Demographic data, Bismuth-Corlette classification, type and location of the stent, laboratory data, postprocedural AEs, procedural success, stent occlusion, reintervention rate, and mortality were compared between the groups.ResultsStent placement was suprapapillary in 13 (24.1%) patients and transpapillary in 41 (75.9%) patients. Mean age was higher in Group T (78 vs 70.5 years; P = .046). Stent occlusion rates were similar in the 2 groups (Group S, 23.8%; Group T, 19.5%), as were AE rates, the most common being cholangitis (Group S, 23.1%; Group T, 24.4%). There were no significant differences in revision rate (Group S, 7.7%; Group T, 12.2%) and 30-day mortality rate (Group S, 15.4%; Group T, 19.5%). Ninety-day mortality rate was statistically significantly higher in Group T (46.3% vs 15.4%; P = .046). Preprocedural bilirubin level was higher in Group T, as were postprocedural leukocyte and C-reactive protein (CRP) levels.ConclusionsSuprapapillary and transpapillary stent placement procedures were similar in terms of procedural success, occlusion rate, revision rate, postprocedural AEs, and 30-day mortality. Ninety-day mortality rate and postprocedural leukocyte and CRP levels were higher in Group T, although these patients were also older and had higher preprocedural bilirubin levels.     

Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial

PurposeThis study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication.Materials and MethodsThis was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture.ResultsA total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%–83.0%) at 24 months and 75.4% (95% CI, 69.6%–80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (−0.1 ± 0.2) and 1.5 (−0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients).ConclusionsOSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.     

Use of the Covera Stent Graft for the Treatment of Dysfunctional or Thrombosed Arteriovenous Grafts: A Retrospective Analysis of 64 Patients

PurposeTo retrospectively evaluate the safety and effectiveness of the Covera stent graft (SG) for the treatment of dysfunctional or thrombosed arteriovenous grafts (AVGs).Materials and MethodsWithin 29 months (February 2016–August 2018), 79 patients underwent Covera SG placement in the authors’ department for the treatment of dysfunctional AVGs. Data were available for 64 patients who underwent 64 procedures, using 64 devices. Minimum follow-up was 6 months, unless reintervention occurred. Mean follow-up was 277 days (6–923 days). Treatment characteristics were 51 cases with venous-graft anastomosis (VGA) stenosis (79.7%), 13 cases of puncture zone stenosis (20.3%), 14 cases of in SG stenosis (21.9%), 8 cases of pseudoaneurysm treatment (12.5%) (1 treatment area might have had more than 1 characteristic). Thirty-six patients presented with thrombosis (56.2%), and 31 of 64 case were de novo treatment areas (48.4%). Primary outcome measurements were technical success and post-intervention primary patency (PIPP) at 6 months, whereas secondary outcome measurements included factors influencing primary outcome.ResultsTechnical success was 100%. Median PIPP was 336 days, and 73.6% of treatment areas were patent at 6 months. There were no significant differences in terms of PIPP when de novo treatment areas were compared with restenotic areas (519 vs. 320 days, respectively; P = .1); patients who presented with versus those who presented without thrombosis (320 vs. 583 days, respectively; P = .07); puncture zone stenosis or elsewhere (329 vs. 686 days, respectively; P = .52); and VGA stenosis or elsewhere (336 vs. 335 days, respectively; P = .9).ConclusionsUse of the Covera SG for AVG treatment was safe and effective in every type of treatment area presented in this retrospective analysis.     

Percutaneous Treatment of Benign Biliary Anastomotic Strictures: Retrievable Covered Self-Expandable Metal Stent with Fixation String Versus Large-Bore Catheters

PurposeTo retrospectively compare the safety and efficacy of a covered self-expandable metal stent (CSEMS) with a transhepatic fixation string and a large-bore catheter for benign biliary anastomotic stricture after hepatobiliary surgery.Materials and MethodsFrom March 2012 to June 2017, 49 patients with benign biliary anastomotic strictures, untreatable with endoscopy, were included. Twenty-three patients (catheter group) were treated with a large-bore catheter (with progressive catheter upsizing to 16–18 Fr), whereas 26 patients (stent group) were treated by CSEMS (10-mm stent) placement. Technical success, clinical success, primary patency, recurrent strictures, complication rate, and catheter or stent indwelling time were compared between the groups.ResultsTechnical success and clinical success were achieved in all patients. In the stent group, stent retrieval was successful in all patients. The overall complication rate was 24.5% (catheter group vs. stent group, 30.4% vs. 19.2%; P = .363). Stent migration occurred in 1 patient during follow-up (1/26, 3.8%). The mean indwelling time was 10.3 ± 3.0 months (range, 8–16 months; median, 10 months) in the catheter group and 4.0 ± 1.2 months (range, 3–7 months; median, 4 months) in the stent group (P < .001). Recurrent strictures occurred in 10 (43.5%) patients in the catheter group and 4 (15.4%) patients in the stent group (P = .030). The 1- and 3-year primary patency rates were 82.6% and 69.3% in the catheter group and 92.3% and 84.4% in the stent group (P = .042).ConclusionsPercutaneous placement of a retrievable CSEMS showed superior intermediate-term outcomes over a large-bore catheter in patients with benign biliary anastomotic strictures.     

Endovascular Recanalization of the Chronically Occluded Native Superficial Artery After Failed Bypass Graft: Midterm Results

PurposeTo evaluate the safety, effectiveness, and outcomes of endovascular recanalization of chronic total occlusion (CTO) of the superficial femoral artery (SFA) in patients with critical limb ischemia (CLI) after failed surgical bypass graft.MethodsEndovascular recanalization of SFA CTO was performed for 26 consecutive CLI patients with failed bypass grafts from 2016 to 2020. Patient demographics, bypass and lesion characteristics, procedural data, technical, and clinical outcomes were evaluated.ResultsThe technical success rate was 96.2% (25/26). Retrograde arterial access was used in 16 (61.6%) patients. Additional tibial and iliac angioplasty was performed in 15 and 2 patients, respectively. Fifteen complications occurred in 10 patients, including thrombosis, embolism, vessel rupture, dissection, arteriovenous fistula, and pseudoaneurysm. Pain relief and wound healing were achieved in 22 patients. The primary, assisted primary, and secondary patency rates were 95.5%, 100%, and 100% at 6 months, 81.8%, 95.5%, and 100% at 12 months, and 76.7%, 82.7%, and 87.5% at 24 months, respectively. By univariate analysis, hyperlipidemia (hazard ratio = 7.82; 95% CI: 1.27–48.04, P = .026) was found to be the only significant risk factor related to primary patency loss. Amputation-free survival and limb salvage rates were 100% and 100% at 6 months, 100% and 100% at 12 months, and 87.1% and 93.8% at 24 months, respectively.ConclusionsEndovascular recanalization of SFA CTO in CLI patients with graft failures is effective with high technical success rates. Acceptable limb salvage and amputation-free survival rates make this technique a reasonable alternative to repeat surgery for high-risk patients.     

Assessment of 3-Year Patency after Endoluminal versus Surgical Bypass Therapy for Complex Femoropopliteal Artery Disease

PurposeTo compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass for complex femoropopliteal (FP) arterial lesions.Materials and MethodsIn this retrospective multicenter study, 530 patients with symptomatic peripheral artery disease (Rutherford classification 1–3, 66.0%; 4–6, 34.0%) who underwent either endoluminal bypass with Viabahn stent grafts (n = 276) or surgical bypass (n = 254) (with saphenous vein grafts, 74.4%; prosthetic grafts, 25.6%) for FP arterial lesions between 2010 and 2018 were analyzed. The propensity score-matched analysis was performed to compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, freedom from target lesion revascularization (TLR), limb salvage, and overall survival. The interaction effect of baseline characteristics on the association of the revascularization strategy with the risk of restenosis was analyzed using the Poisson mixed-effect model.ResultsThe propensity score-matched analysis extracted 107 pairs. After propensity score matching, the primary patency rate at 1, 2, and 3 years was 84.5%, 75.1%, and 70.9%, respectively, for the endoluminal bypass group versus 78.6%, 73.3%, and 72.0%, respectively, for the surgical bypass group (P = .65). There was no significant difference in secondary patency, freedom from TLR, limb salvage, and overall survival (all P > .05). The subsequent interaction analysis revealed that the involvement of popliteal lesions, small distal reference vessel diameters, and long lesions favored surgical bypass over endoluminal bypass because of improved primary patency (all P for interaction < .05).ConclusionsThe 3-year clinical outcomes after endoluminal bypass or surgical bypass for FP arterial lesions were similar.     

In Situ Laser Stent Graft Fenestration of the Left Subclavian Artery during Thoracic Endovascular Repair of Type B Aortic Dissection with Limited Proximal Landing Zones: 5-Year Outcomes

PurposeTo assess safety and feasibility of in situ laser stent graft fenestration to revascularize the left subclavian artery (LSA) during thoracic endovascular repair (TEVAR) of type B aortic dissection (TBAD) with limited proximal landing zones with 5 years of follow-up.Materials and MethodsIn a single-center retrospective study, 130 patients with TBAD with limited proximal landing zones (≤ 1.5 cm) underwent in situ laser stent graft fenestration revascularizing the LSA during TEVAR from April 2014 to April 2019. Outcomes were assessed by CT angiography and clinic visits, including technical success rate, operative time, LSA patency, ischemic events, and late aorta-related complications during follow-up.ResultsMean age of patients was 53 y (range, 33–73 y). Primary technical success rate was 96.9% (126/130). Three chimney stents were placed instead of fenestration, and 1 LSA fenestration was combined with a left common carotid artery (LCCA) chimney stent. Mean operative time was 53 min ± 28 with fluoroscopy time of 40 min ± 15. There were no neurologic complications and no deaths, with a mean duration of hospital stay of 9 d (range, 5–21 d). At a mean follow-up of 42 mo (range, 5–60 mo), there was a 97% primary LSA patency. Four patients had a type I endoleak, which disappeared during follow-up. One LCCA became occluded after 6 months. No type II or III endoleaks were found. Retrograde type A aortic dissection and stent graft–induced new distal entry were not found during follow-up.ConclusionsIn situ laser fenestration to revascularize the LSA during TEVAR of TBAD with limited proximal landing zones was efficient, safe, and feasible based on 5-year follow-up.