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.     

Predictive Factors for Restenosis Following Stent-Supported Endovascular Therapy with Intravascular Ultrasound Evaluation for Femoropopliteal Chronic Total Occlusion

PurposeTo determine the predictive factors for in-stent restenosis (ISR) following stent-supported endovascular therapy (EVT) with intravascular ultrasound (US) evaluation for femoropopliteal chronic total occlusion.Materials and MethodsThis was a single-center, retrospective, observational study. The study included 276 lesions in 251 patients who underwent stent-supported EVT with intravascular ultrasound evaluation for femoropopliteal chronic total occlusion from July 2012 to June 2019. The wire passage route was assessed using intravascular US, and lesions were classified accordingly into 2 groups: intraluminal and subintimal passage. In this study, the intraluminal group was further divided into 3 subgroups by severity of calcification: none, <180°, and ≥180° circumferential. The subintimal group was further divided into 2 subgroups: subintimal passage without or with calcification. The primary outcome measure was ISR. Cox proportional hazards regression was used to determine the association of clinical characteristics with ISR rates.ResultsThe mean follow-up period was 19 months ±16, during which time ISR was observed in 31% of lesions. After multivariate analysis, an increased degree of plaque burden (hazard ratio [HR] = 1.101) and subintimal passage with calcification (HR = 3.408) were associated with an increased risk of ISR; a larger distal external elastic membrane area (HR = 0.898) and use of a stent graft (HR = 0.130) were significantly associated with a reduced risk of ISR.ConclusionsThis study revealed that factors associated with ISR after stent-supported EVT with intravascular US evaluation were distal external elastic membrane area, plaque burden, subintimal passage with calcification, and use of a stent graft.     

Evaluation of Technical Success,Efficacy, and Safety of Portomesenteric Venous Intervention following Nontransplant Hepatobiliary or Pancreatic Surgery

PurposeTo evaluate technical success, efficacy and safety of portomesenteric venous (PMV) intervention for PMV stenosis or occlusion following nontransplant hepatobiliary or pancreatic (HPB) surgery.Materials and MethodsA retrospective review identified 42 patients (mean age 60 y) with PMV stenosis (n = 33; 79%) or occlusion (n = 9; 21%) who underwent attempted PMV intervention following HPB surgery between June 1, 2011, and April 1, 2018. Main outcomes were technical success, primary patency rates, and complications. Technical success was compared by venous pathology and primary PMV patency based on anticoagulation status after the procedure using Fisher exact test. Rates of primary patency by stent group were estimated using Kaplan-Meier method.ResultsTechnical success was 91% (n = 38/42) and significantly higher in patients with stenosis (n = 33/33; 100%) vs occlusion (n = 5/9; 56%) (P = .001). Primary presenting symptom resolved in 28 (87%) patients, including 6 (100%) patients with gastrointestinal bleeding. At mean imaging follow-up of 8.6 months ± 8.8, primary stent patency was 76%. There was no significant difference in primary stent patency based on anticoagulation status after the procedure (P = .48). There were 2 (4.8%) periprocedural complications.ConclusionsPortomesenteric venoplasty and stent placement following nontransplant HPB surgery is safe with a high rate of technical success if performed before chronic occlusion.     

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.     

Predictors of Disease Recurrence after Venoplasty and Stent Placement for May–Thurner Syndrome

PurposeTo identify factors independently associated with disease recurrence after venoplasty and stent placement for May–Thurner syndrome (MTS).Materials and MethodsFifty-nine consecutive patients (age, 47 y ± 15; 93% female) were identified who had undergone endovascular stent placement for MTS. Patient charts were reviewed for demographic data, risk factors for venous thrombosis, comorbidities, and venous inflow or outflow at first follow-up (3 wk to 6 mo after treatment). Logistic regression was used to identify independent predictors of symptom recurrence or repeat intervention, and multivariate analysis of variance and receiver operator characteristic curve analysis were used to assess relationships between degrees of in-stent stenosis and other variables in the 73% of patients with available cross-sectional imaging. Median follow up was 20.7 months (interquartile range, 4.7–49.5 mo).ResultsAll procedures were technically successful. Disease recurrence, defined as symptom recurrence following initial postprocedural resolution, was observed in 38% of patients. No preprocedural variable was found to be independently predictive of disease recurrence; however, poor venous inflow or outflow were both strongly associated with recurrent disease, with adjusted odds ratios and 95% confidence intervals of 38.02 (3.76–384.20; P = .002) and 7.00 (1.15–42.71; P = .04), respectively. Higher degrees of in-stent stenosis were also associated with symptom recurrence, with an area under the curve of 0.93 (P = .000002) and 39%–41% stenosis being 78%–83% sensitive and 88%–92% specific for symptom recurrence.ConclusionsThese results suggest that cross-sectional imaging can help differentiate patients in whom closer follow-up may be warranted after venoplasty and stent placement for MTS and also guide counseling regarding prognosis.     

Stent Graft Placement for the Treatment of Hepatic Artery Injury in Patients with Cancer: Primary Patency and Clinical Outcomes

PurposeTo evaluate the safety, primary patency, and clinical outcomes of hepatic artery stent graft (SG) placement for vascular injuries.Materials and MethodsPatients treated with hepatic arterial SG placement for vascular injuries between September 2018 and September 2021 were reviewed. Data on demographic characteristics, indication, stent graft characteristics, antiplatelet/anticoagulant use, clinical success rate, complications, and type of follow-up imaging were collected. Follow-up images were reviewed by 2 independent reviewers to assess primary patency. A time-to-event analysis was performed. The median duration of stent graft patency was estimated using Kaplan-Meier curves. A Cox proportional hazard model was used to evaluate factors related to stent graft patency.ResultsThirty-five patients were treated with hepatic arterial SG placement, 11 for postoperative bleeds and 24 for hepatic artery infusion pump catheter–related complications. Clinical success was achieved in 32 (91%) patients (95% CI, 77–98). The median primary patency was 87 days (95% CI, 73–293). Stent grafts of ≥6-mm diameter retained patency for a longer duration than that with stent grafts of smaller diameters (6 mm vs 5 mm; hazard ratio, 0.35; 95% CI, 0.14–0.88; P = .026; and 7+ mm vs 5 mm; hazard ratio, 0.27; 95% CI, 0.09–0.83; P = .023). Anticoagulation/antiplatelet regimen was not associated with increased stent graft patency duration (P > .05). Only minor complications were reported in 2 (5.7%) patients.ConclusionsStent grafts can be used safely and effectively to treat injuries of the hepatic artery. Stent graft diameters of ≥6 mm seem to provide more durable patency.     

Impact of Renal Function Trajectory on Renal Replacement Therapy and Mortality Risk after Renal Artery Revascularization

PurposeTo determine the impact of renal function trajectory, defined as the change in renal function over time before and after renal artery stent placement, on long-term risk for renal replacement therapy (RRT) and mortality.Materials and MethodsEstimated glomerular filtration rates (eGFRs) 6–12 months before renal artery stent placement, at the time of intervention, and 6–12 months after intervention were determined in 398 patients. The effect of eGFR change before and after renal artery stent placement was calculated. Cox proportional-hazards ratio was used to determine the risks for RRT and all-cause mortality.ResultsThe risk for RRT was significantly influenced by eGFR change from the time of intervention to follow-up at 6–12 month after treatment (P = .02). In addition, among patients with a postintervention eGFR ≤ 40 mL/min/1.73 m², for every 1 unit of eGFR increase, there was a significant decrease in RRT and all-cause mortality (P < .001 and P < .001, respectively). Secondary parameters that increased RRT risk included diabetes at the time of intervention (P = .03), increased baseline proteinuria (P < .001), and stage 4 or 5 chronic kidney disease (CKD; P = .01 and P = .003, respectively). Multivariate analysis demonstrated higher all-cause mortality rates among patients with diabetes at the time of intervention (P = .009).ConclusionsPostintervention eGFR trajectory improvement approaching 40 mL/min/1.73 m² was associated with decreased RRT and mortality risk. These findings suggest that patients with advanced CKD and renal artery stenosis may benefit from revascularization regardless of their preinterventional renal function measurement.     

Comparison of Anticoagulation Regimens Following Stent Placement for Nonthrombotic Lower Extremity Venous Disease

PurposeTo determine whether subtherapeutic anticoagulation regimens are noninferior to therapeutic anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease.Materials and MethodsFifty-one consecutive patients (88% women; mean age, 44 years) who underwent stent placement for nonthrombotic lower extremity venous disease between 2002 and 2016 were retrospectively identified. The patients were divided into 2 cohorts: those who received prophylactic enoxaparin or no anticoagulation (subtherapeutic) after the procedure and those who received therapeutic doses of anticoagulation with enoxaparin, warfarin, and/or rivaroxaban (therapeutic) after the procedure. Baseline demographic characteristics, procedure characteristics, and outcomes were compared between the 2 groups using the Student t test, Fisher exact test, and χ² test. The subtherapeutic and therapeutic anticoagulation groups did not differ significantly in the baseline demographic characteristics (eg, sex, race, and age) or procedure characteristics (eg, number of stents placed, stent brand, stent diameter, etc).ResultsThe mean clinical follow-up time was 4.4 years (range, 0–16.3 years). There were no thrombotic adverse events or luminal obstructions due to in-stent restenosis in either group. There were 5 minor bleeding adverse effects in the therapeutic group and no bleeding adverse effects in the subtherapeutic group (P = .051). There were no statistically significant differences in subjective symptom improvement (P = .75).ConclusionsIn this retrospective cohort, the subtherapeutic and therapeutic anticoagulation regimens produced equivalent outcomes in terms of adverse event rates, reintervention rates, and symptomatic improvement, suggesting that therapeutic doses of anticoagulation do not improve outcomes compared with subtherapeutic anticoagulation regimens following nonthrombotic venous stent placement.     

Imaging-Guided De Novo Retrograde Ureteral Access and Stent Placement without Cystoscopy in Women

PurposeTo evaluate the feasibility of a new technique for imaging-guided de novo retrograde ureteral double J (DJ) stent placement without cystoscopy in women.Materials and MethodsEighty-four women referred for ureteral stent placement between April 2019 and January 2022 were included. In all the patients, the initial attempt for stent placement was performed in a retrograde fashion. Successful ureteral catheterization and DJ stent placement were considered as technical success. The fluoroscopy time required to catheterize the ureter and that for the entire procedure were recorded. Factors affecting the technical success rate and fluoroscopy time were examined.ResultsA total of 108 ureteral stent placement procedures in 84 women, with a mean age of 57.5 years (range, 19–85 years), were performed. The most common underlying pathologies were cervical (n = 33, 31%) and ovarian (n = 32, 30%) carcinomas. The most commonly involved segments of the ureter were the lower half (n = 44, 40%) and trigone (n = 39, 36%). The technical success rate was 81.5%, and it reached 93% in the case of lower-half ureteral obstruction. Distorted trigonal anatomy caused by external compression of the bladder wall by a mass was associated with a higher rate of technical failure (90.6% vs 47.8%; P < .001). The use of ultrasound guidance to guide the sheath to the ureteral orifice allowed for a significant decrease in the fluoroscopy time for ureteral catheterization (4.6 minutes ± 3.91 vs 2.26 minutes ± 2.32; P = .003) and that for the entire procedure (9.42 minutes ± 4.95 vs 5.93 minutes ± 4.06; P = .001).ConclusionsImaging-guided de novo retrograde ureteral catheterization and stent placement can be successfully performed in a high percentage of patients within a reasonable fluoroscopy time without the need for cystoscopy in women.     

Percutaneous Gastrostomy Compared with Esophageal Stent Placement for the Treatment of Esophageal Cancer with Dysphagia

PurposeTo compare the outcomes of self-expandable metal stent placement and percutaneous gastrostomy (PG) for the treatment of patients with esophageal cancer (EC) and dysphagia.Materials and MethodsThis retrospective observational study consisted of 113 patients with EC and dysphagia who underwent either stent placement (n = 47) or PG (n = 66) at a single center between June 2014 and June 2018.ResultsThere were 63 men and 50 women, with a mean age of 76.5 years (standard deviation 4.9 years). The 2 groups had similar baseline characteristics, except that the PG group had a higher percentage of patients with cervical EC (22.7% vs 2.1%, P < .001). The PG group had better maintenance of nutritional status in terms of reduction in serum albumin level (P = .039) and weight loss (P = .041). Compared with the stent group, the PG group demonstrated a lower incidence of local severe pain (0% vs 21.3%, P < .001) and lower incidence of dislodgment of device (1.5% vs 19.1%, P = .002). The PG group demonstrated longer overall survival compared with the stent group for Stages II and III (201 vs 185 days, P = .034) and Stage IV (122 vs 86 days, P = .001).ConclusionsCompared with stent insertion, PG is associated with better maintenance of nutritional status, fewer complications, and better survival. Thus, PG may be the preferred choice for treating malnutrition in patients with EC and dysphagia.     

Angioscopic Ulcerated Plaques in the Femoropopliteal Artery Associated with Impaired Infrapopliteal Runoff

PurposeTo determine the correlation between upstream atherosclerosis in the femoropopliteal arteries, assessed using angioscopy, and impaired infrapopliteal runoff.Materials and MethodsThirty-one patients with peripheral arterial disease who underwent endovascular therapy and angioscopy were prospectively included. Yellow plaque color scores were semiquantitatively determined as 0, 1, 2, or 3. Irregular plaques with rough surfaces, similar to gastric ulcers, were defined as ulcerated plaques (UPs). Angioscopic data were correlated with angiographic runoff scores (ARS).ResultsUPs were detected in 74.2% of enrolled diseased legs using angioscopy. Mural thrombi were more commonly observed in the femoropopliteal artery in patients with UPs than in those without UPs (91.3% vs 37.5%, respectively; P = .006) and were frequently found on the UPs (21/23 patients with UPs). Univariate and multivariate linear regression analyses revealed that the presence of UPs was positively and independently associated with a poor ARS and that oral anticoagulant use was independently associated with a preferable ARS (standardized β = 0.462, P = .004 and standardized β = ?0.411, P = .009, respectively, in the multivariate analysis).ConclusionsUPs, associated with mural thrombi and diagnosed by angioscopic examination, were demonstrated to be one of the factors associated with poor infrapopliteal runoff.     

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.     

Portal Vein Recanalization for Noncirrhotic Portal Vein Cavernous Transformation: Transjugular Intrahepatic Portosystemic Shunt Creation versus Portal Vein Stent Placement

PurposeTo compare the clinical outcomes of transjugular intrahepatic portosystemic shunt (TIPS) creation versus portal vein stent placement (PVS) in patients with noncirrhotic cavernous transformation of the portal vein (CTPV).Materials and MethodsIn this retrospective study, clinical data from patients with noncirrhotic CTPV who underwent TIPS creation or PVS were compared. A total of 54 patients (mean age, 43.8 years ± 15.8; 31 men and 23 women) were included from January 2013 to January 2021; 29 patients underwent TIPS creation, and 25 patients underwent PVS. Stent occlusion, variceal rebleeding, survival, and postprocedural complications were compared between the 2 groups.ResultsThe mean follow-up time was 40.2 months ± 26.2 in the TIPS group and 35.3 months ± 21.1 in the PVS group. The stent occlusion rate in the PVS group (16%, 4 of 25) was significantly lower than that in the TIPS group (41.4%, 12 of 29) during the follow-up (P = .042). The cumulative variceal rebleeding rates in the TIPS group were significantly higher than those in the PVS group (28% vs 4%; P = .027). The procedural success rate was 69% in the TIPS group and 86% in the PVS group (P = .156). There was a higher number of severe adverse events after TIPS than after PVS (0% vs 24%; P = .012).ConclusionsPortal vein recanalization with PVS may be a preferable alternative to TIPS creation in the treatment of noncirrhotic CTPV because of higher stent patency rates, lower risk of variceal rebleeding, and fewer adverse events.     

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis

PurposeTo evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).Materials and MethodsA post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]).ResultsIn the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes.ConclusionsIn both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.     

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.     

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.     

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.     

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.     

Independent Predictors of Major Adverse Cardiovascular Events at 3 Years after Aortoiliac Stent Implantation

PurposeTo identify the risk factors for major adverse cardiovascular events (MACEs) in real-world practice for symptomatic peripheral artery disease in Japan.Materials and MethodsData on Japanese patients (N = 880) from the Observational Prospective Multicenter Registry Study on Outcomes of Peripheral Arterial Disease Patients Treated by Angioplasty Therapy for Aortoiliac Artery who underwent de novo aortoiliac stent placement. The 3-year risk of incident MACEs was investigated.ResultsThe median age of the patients was 72.6 years (range, 34–97 years), and 83.1% of the patients were men. The patients had the following conditions: smoking (35.6%), hypertension (94.1%), dyslipidemia (81.7%), diabetes (48.0%), renal failure on dialysis (12.6%), myocardial infarction (12.7%), stroke (15.8%), and chronic limb-threatening ischemia (7.1%). Femoropopliteal lesions were present in 38.8% of the limbs with aortoiliac lesions. The 3-year rate of freedom from MACEs was 89.1%. Baseline characteristics, such as age, renal failure on dialysis, myocardial infarction, stroke, and femoropopliteal lesions, were independently associated with the risk of incident MACEs. When the study population was stratified according to these risk factors, the rate of MACEs was highest in patients with at least 3 risk factors (32.9% at 3 years).ConclusionsThe 3-year rate of freedom from MACEs was reported. Baseline characteristics, such as age, renal failure on dialysis, myocardial infarction, stroke, and femoropopliteal lesions, are independent risk factors for MACEs after aortoiliac stent placement.     

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.