Self-expanding Stent Implantation Research Articles

Evaluation of short and mid-term clinical outcomes in patients with aortic coarctation treated with self-expandable stents

The present study aimed to evaluate the outcomes of percutaneous treatment of aortic coarctation using self-expandable uncovered Nitinol stents. We conducted a retrospective clinical data review of all patients with aortic coarctation and treated with self-expandable uncovered Nitinol stents at our institution between 2009 and 2019. The gradient pressure across the coarctation site was measured using aortography. Follow-up echocardiography and computed tomography angiography were performed to assess possible stent complications. A total of 127 stents were successfully implanted in 125 patients (64.8% males) with a mean age of 35.36 ± 11.9 years. The gradient across the coarctation site decreased significantly from 67.48 ± 14.79 to 5.04 ± 3.01 mmHg (P < 0.001) after self-expandable stent implantation. Systolic blood pressure (SBP) decreased significantly from 175.53 ± 15.99 to 147.22 ± 12.83 mmHg (P < 0.001) after self-expandable stenting. There were no major technical or clinical complications, including balloon rupture, aneurysmal formation, infection, secondary stent migration, thrombosis, death during the procedure, and in-hospital mortality. On a mean follow-up of 48 ± 23.6 months (12–120 months), the gradient [from 59.43 ± 15.42 to 3.72 ± 1.38 mmHg (P < 0.001)] and SBP [from 175.53 ± 15.99 to 127.99 ± 7.82 mmHg (P < 0.001)] decreased significantly. There was no mortality, aneurysmal formation in the stent site, dislocation, or aortic re-stenosis requiring intervention during mid-term follow-up. Treatment of aortic coarctation using a self-expandable uncovered nitinol stent is safe and effective with promising mid-term outcomes.

X-ray-guided self-expandable metal stent (SEMS) implantation in oesophageal malignancy as an alternative treatment.

&lt;b&gt;&lt;br&gt;Indroduction:&lt;/b&gt; Significant dysphagia, aspiration pneumonia, and impossible oral nutrition in patients with unresectable or recurrent gastroesophageal malignancy or bronchial cancer invading the oesophagus with a tracheoesophageal fistula lead to cachexia. Dehiscence of the esophago-jejunal or gastroesophageal anastomosis may cause severe oesophageal haemorrhage. We believe that X-ray-guided oesophageal stent implantation (SEMS) is an alternative palliative method for microjejunostomy or full parenteral nutrition.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Aim:&lt;/b&gt; The aim of this paper was to assess the safety and efficacy of a novel X-ray-guided oesophageal stent implantation technique.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Materials and methods:&lt;/b&gt; This retrospective analysis included 54 patients (35 men and 19 women) treated for malignant dysphagia, gastroesophageal/gastrointestinal anastomotic fistula or bronchoesophageal fistula in two Surgical Units between 2010 and 2019, using a modified intravascular approach to oesophageal stent implantation.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Results:&lt;/b&gt; The presented modified intravascular method of oesophageal stent implantation was successfully performed in all described patients requiring oral nutrition restoration immediately following oesophageal stent implantation. Two patients with oesophageal anastomotic dehiscence died on postoperative days 7 and 9 due to circulatory and respiratory failure. One patient was reimplanted due to a recurrent fistula. Two patients with ruptured thoracic aneurysm and thoracic stent graft implantation due to oesophageal haemorrhage, who were implanted with an oesophageal stent, died on postoperative days 4 and 14.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Conclusions:&lt;/b&gt; The modified intravascular X-ray-guided SEMS technique may be a palliative treatment for patients with unresectable oesophageal malignancies.&lt;/br&gt.

Colonic stent as a bridge to surgery versus emergency rection for malignant left-sided colorectal obstruction: A systematic review and meta-analysis of randomized controlled trials.

The role of self-expanding metal stent (SEMS) implantation as a bridge to surgery in malignant left-sided colorectal obstruction (MLCO) remains controversial. To evaluate the safety of SEMS implantation versus emergency surgery (ER) in the treatment of MLCO. Four major literature databases (Cochrane Library, Embase, PubMed, and Web of Science) were searched to collect articles published before April 20, 2023. After determining random or fixed-effect models based on heterogeneity tests, odds ratios (RR) or standardized mean differences (SMD) with their respective 95% confidence intervals (CI) were calculated. Nineteen randomized controlled studies were included. The main outcomes included overall tumor recurrence rate, 30-day mortality rate, and overall incidence of complications. Secondary outcomes included mortality-related indicators, tumor recurrence-related indicators, surgery-related indicators, and other relevant indicators. The study found that there was no significant difference in the 30-day mortality rate between the SEMS group and the er group. However, the SEMS group had a lower overall incidence of complications (RR = 0.787, P = .004), lower incision infection rate (RR = 0.472, P = .003), shorter operation time (SMD = -0.591, P = .000), lower intraoperative blood loss (SMD = -1.046, P = .000), lower intraoperative transfusion rate (RR = 0.624, P = .021), lower permanent stoma rate (RR = 0.499, P = .000), lower overall stoma rate (RR = 0.520,P = .000), shorter hospital stay (SMD = -0.643, P = .014), and more lymph node dissections during surgery (SMD = 0.222, 95% CI: 0.021-0.423, P = .031), as well as a higher primary anastomosis rate (RR = 0.472, 95% CI: 0.286-0.7 77, P = .003), among other advantages. However, the SEMS group had a higher overall tumor recurrence rate (RR = 1.339, P = .048). SEMS has significant advantages over er in relieving clinical symptoms and facilitating postoperative recovery in MLCO, but does not reduce the tumor recurrence rate. Neoadjuvant chemotherapy combined with SEMS may provide a new approach to the treatment of MLCO.

Impact of residual stenosis on clinical outcomes when performing carotid artery stenting without postdilation.

Many centers consider postdilation if the final angiography after carotid artery stenting (CAS) shows residual stenosis of >30% to 40%. Postdilation has been demonstrated to potentially increase the risk of developing neurologic events. This study aimed to investigate the safety of CAS without postdilation regardless of the degree of residual stenosis. We retrospectively investigated 191 patients who underwent transfemoral CAS without postdilation intendedly. All cases underwent mild predilation and self-expanding stent implantation. We divided the patients into a residual stenosis of ≥40% group (n= 69 [36.1%]) and a residual stenosis of<40% group (n= 122 [63.9%]) according to their final angiography. We compared the procedural (within 30days after CAS) and nonprocedural (afterward) adverse cardiovascular events and in-stent restenosis between the two groups. We also investigated the incidence of perioperative hemodynamic depression between the groups and the changes in residual stenosis over the follow-up time. Patients in the residual stenosis of ≥40% group had a higher preoperative stenosis rate and a greater proportion of severely calcified lesions than those in the<40% group. There was one procedural cardiac death (0.5%), five strokes (2.6%), and four myocardial infarctions (2.1%). A total of 2.9% had stroke or death procedurally in the residual stenosis of ≥40% group and 3.2% in the residual stenosis of<40% group (P> .950). The median nonprocedural follow-up time was 22months, with a total of six deaths and four strokes. The cumulative 2-year death or stroke rate was 6.2%, with 5.9% in the residual stenosis of ≥40% group versus 6.7% in the residual stenosis of<40% group (P= .507). There were two cases of in-stent restenosis in the residual stenosis of ≥40% group and three in the residual stenosis of<40% group (P= .927). The difference in the peak systolic velocity of the target lesion between groups at 3months after CAS was no longer present, and residual stenosis stabilized at 10% to 20% at 6months in both groups. The patients showed an association between increasing hemodynamic depression incidence and residual stenosis in a significantly graded response (P=.021). Residual stenosis after carotid stenting without postdilation is not associated with a risk of postoperative adverse events. This study provides evidence for the feasibility of a no postdilation strategy for CAS.

Conservative management of Boerhaave’s syndrome: a case report

The management of esophageal perforation has evolved. The underlying principles of drainage of sepsis, adequate nutrition and repair, or defunctioning of the esophagus remain. We are presenting a case of Boerhaave syndrome, where we have successfully managed conservatively with endoscopic stenting. Endoscopic therapy and VATS are used with increasing frequency and in appropriately selected patients with good results. Careful selection of patients for such procedures are important. Implantation of self-expanding metallic stent in patients with esophageal leak or perforation is a safe and feasible alternative to operative treatment and can lower the interventional morbidity rate.

Heterogeneous vascular response after implantation of bare nitinol self-expanding stents in the swine femoropopliteal artery

BackgroundMechanism of femoropopliteal in-stent restenosis has been underappreciated.AimThe aim of this animal study was to elucidate vascular response after femoropopliteal bare nitinol self-expanding stents (SESs) implantation.MethodsMisago, Smart Flex, or Innova stent was randomly implanted in 36 swine femoropopliteal arteries. At week 4, quantitative vessel analysis (QVA) was performed on 36 legs, of which 18 underwent histological evaluation after angiography. The remaining 18 legs underwent QVA and histological evaluation at week 13.ResultsFibrin deposition was excessive at week 4. Internal elastic lamina (IEL) progressively enlarged over time, and vessel injury developed from mild level at week 4 to moderate level at week 13. Vessel inflammatory reaction was mild to moderate at week 4, and was moderate to severe at week 13. Increased fibrin deposition was an early-acting, IEL enlargement and increased vessel inflammation were long-acting, and increased vessel injury and giant cells infiltration were late-acting contributors to neointimal hyperplasia (NIH). Stent type altered time-dependent process of vessel injury, vessel inflammation, eosinophils and giant cells infiltration. Misago had less fibrin deposition and vessel enlargement, and less progressive vessel injury, vessel inflammation, and eosinophils and giant cells infiltration. Net lumen as assessed by percent diameter stenosis or minimum lumen diameter was preserved with Misago, but was not preserved with the other stents.ConclusionsIn the context of bare nitinol SES platform with less progressive mechanical stress and inflammatory reaction, the advantage of less NIH outweighed the disadvantage of less vessel enlargement, leading to net lumen preservation.

Intracranial stenting as a bail-out option for posthemorrhagic cerebral vasospasm: a single-center experience with long-term follow-up

BackgroundCerebral vasospasm (CVS) is a leading cause of morbidity and mortality in patients after aneurysmal subarachnoid hemorrhage (aSAH). Endovascular treatment, including intraarterial infusion of drugs with vasodilation effects, and balloon- and stentriever angioplasty, are helpful but may achieve only short-term effects. There is a clinical need for long-lasting treatment of refractory recurrent vasospasm. We report our experience in stent implantation as a treatment for recurrent severe post-SAH vasospasm.MethodsA retrospective analysis of our institutional database of 883 patients with SAH, managed between January 2010 and December 2021, was performed. Six patients were identified as having received intracranial stenting in the context of post-SAH cerebral vasospasm. All patients were initially treated with intra-arterial infusion of nimodipine and/or milrinone. Self-expanding intracranial stents were implanted during endovascular aneurysm treatment to enable access despite impaired perfusion (Group 1) or as a bail-out strategy after failed intraarterial drug infusion or mechanical treatment (Group 2). All stented patients received dual antiplatelet therapy (DAPT) for 6 months.ResultsNine vessels in six patients with severe post-SAH vasospasm were stented. The stents were deployed in 16 vessel segments. All attempted implantations were technically successful. All patients demonstrated radiographic and clinical improvement of the vessel narrowing. No recurrent vasospasm or permanent vessel occlusion of the stented vessels was encountered. A thrombus formation in a Group 1 patient resolved under 4 mg eptifibatide IA infusion. During long-term angiographic follow-up, neither in-stent stenosis nor stent occlusion was found.ConclusionsEndovascular implantation of self-expanding stents is a potential ultima ratio strategy for patients with severe refractory post-SAH cerebral vasospasm. Stents with reduced thrombogenicity (avoiding DAPT) and bioabsorbable self-expanding stents might further advance this concept.

Self-Expandable Metallic Stent Implantation Combined With Bronchial Artery Infusion Chemoembolization in the Treatment of Lung Cancer With Complete Atelectasis.

BackgroundAtelectasis is a common complication of lung cancer, and there are few reports about the treatment methods. This study retrospectively analyzed the safety and effectiveness of endotracheal metal stent implantation combined with arterial infusion chemoembolization in the treatment of non-small cell lung cancer with complete atelectasis.MethodsThe clinical data of patients with non-small cell lung cancer and complete atelectasis treated by self-expandable metallic stent implantation combined with arterial infusion chemotherapy were retrospectively analyzed. The clinical efficacy was evaluated and postoperative adverse reactions were observed. Progression-free survival and overall survival were analyzed by Kaplan-Meier method.ResultsIn all, 42 endotracheal metallic stents were implanted in 42 patients under fluoroscopy. 5–7 days after stent implantation, CT showed that 24 patients (57.1%) had complete lung recruitment, and that 13 (31.0%) had partial lung recruitment. The technical success rate was 100%, and the clinical success rate was 88.1% (37/42). 5–7 days after stent implantation, bronchial artery infusion chemoembolization was performed in all patients. The median progression-free survival and overall survival were 6 months (95% CI: 2.04-9.66) and 10 months (95% CI: 7.22-12.79), respectively.ConclusionSelf-expandable metallic stent implantation combined with arterial infusion chemoembolization may be an effective and safe strategy in the treatment of lung cancer with atelectasis clinically.

Сравнительный анализ стентирования и гастростомии у больных со злокачественной патологией пищевода и пищеводно-желудочного перехода

Objective — to analyze the results of esophageal stenting in comparison with gastrostomy in patients with malignant dysphagia. Material and methods. The first group consists of 100 men and 42 women with malignant dysphagia, who underwent stenting of the esophagus and cardia with self-expanding metal stents. The group consists of 142 people aged 43 to 90 years. Stenting of the esophagus in this group was performed with the aim of resolving malignant stenosis of the esophagus in 71 patients: malignant stenosis of the esophageal-gastric junction in 59 patients and extraorgan compression of the esophagus from the outside in 12 patients. The second group consisted of 164 people in the age group from 33 to 89 years — 140 men and 24 women who underwent gastrostomy by the laparotor method according to Topprover in order to resolve malignant dysphagia. Gastrostomy was imposed on 110 patients due to malignant stenosis of the esophagus: with malignant stenosis of the esophageal-gastric junction in 44 patients and as a result of external compression in 10 patients. Results. Complications in patients after stenting in the remote period occurred in 17 cases. In the group of patients who underwent gastrostomy, complications requiring gastrostomy replacement occurred in 23 patients. Death occurred in one patient as a result of specific complications after gastrostomy. Life expectancy as a percentage, regardless of the pathology of the disease, does not have a large spread in the comparison groups and is approximately the same. The results of studies on life expectancy depending on the type of treatment (stenting-gastrostomy) and the location of the tumor lesion did not reveal statistically significant differences. Conclusions. Comparison of the results of implantation of self-expanding metal esophageal stents and gastrostomy by the laparotomic method in malignant dysphagia of the esophagus and esophagogastric junction was performed for the first time. In the course of the study, it was revealed that in the studied groups of patients, life expectancy in percentage terms, regardless of the pathology of the disease, does not have a wide spread and is approximately the same. There are no statistically significant differences in life expectancy depending on the type of treatment (stenting-gastrostomy) and the location of the tumor lesion in the analysis of variance according to the criterion of the least significant difference. Esophageal stenting with self-expanding metal stents is the least traumatic and effective method of choosing the resolution of malignant dysphagia of the esophagus and gastroesophageal junction with low complication rates, which allows to restore adequate nutrition, thereby improving the quality of life in incurable patients.

Endovascular Treatment of Subclavian Artery Stenosis: Single-Center Experience

Introduction The aetiology of subclavian artery stenosis can be very different, but typically the most common form is due to atherosclerotic disease. Interventional treatment is generally indicated for upper limb ischemia, vertebrobasilar symptoms and subclavian steal syndrome, coronary steal syndrome. Endovascular stenting is preferred over surgery because of its high success rate, less invasive nature, and minimal complication rate. In this study the characteristics of patients treated endovascularly due to subclavian artery stenosis in our centre and their procedural details will be examined. Methods: We retrospectively analyzed patients with subclavian artery stenosis treated by endovascular techniques in our centre between January 2019 and January 2021. Result Twelve (80%) of 15 patients with stenotic subclavian arteries were successfully treated with endovascular techniques. In 3 patients, the procedure was terminated with failure.The mean age of the patients was 64.66 years old and 3(20%) of the patients were female. All of the patients were receiving antihypertensive treatment with the diagnosis of hypertension, and 4 (26.66%) patients had Diabetes mellitus, 13 (86.66%) patients had hyperlipidemia, 13 (86.66%) patients had coronary artery disease. In 2 patients, the lesion was diagnosed in the right subclavian artery. In 7 patients, the procedure was performed with the telescopic method from a transfemoral approach. In 5 patients, the transradial approach was used. In 3 patients, the procedure was performed directly over the transbrachial approach. Balloon expandable stent implantation was performed in 10 (66.66%) patients at the end of the procedure, and self-expandable stent implantation was performed in 1 patient. Conclusion In conclusion, signs and symptoms can be managed effectively with endovascular techniques in patients with significant subclavian artery disease. In this study, we shared our real-life data on subclavian artery endovascular treatment.

Three-Year Clinical Outcomes of the Innova™ Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions.

To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting. This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1-6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events. Restenosis following Innova™ implantation was found in 61% of the cases at 3years. At the end of 3years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1year, no predictive factors for restenosis at 3years could be determined. The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

Three-Year Clinical Outcomes Following Implantation of LifeStent Self-Expanding Nitinol Stents in Patients With Femoropopliteal Artery Lesions.

The aim of this study was to evaluate midterm clinical outcomes after implantation of LifeStent self-expanding nitinol stents for the treatment of femoropopliteal lesions. This retrospective, multicenter, non-randomized study examined 260 femoropopliteal lesions in 250 consecutive patients with peripheral artery disease implanted with LifeStents from April 2016 to April 2017. The prevalence of chronic total occlusion (CTO), lesion length ≥25cm, and distal reference vessel diameter (RVD) <5mm was 58%, 35%, and 50%, respectively. The 3-year restenosis rate in the overall population was estimated to be 72.9% and a major adverse limb event was observed in 36.9%. Multivariate analysis revealed that chronic limb-threatening ischemia (CLTI) (odds ratio [OR]: 8.04; 95% confidence interval [CI]: 1.86-34.7), CTO (OR: 4.87; 95% CI: 1.43-16.6), lesion length ≥25cm (OR: 5.95; 95% CI: 1.11-32.0), and distal RVD <5mm (OR: 4.43; 95% CI: 1.34-14.6) were independent risk factors for 3-year restenosis. The present study demonstrated the midterm clinical outcomes and risk factors for restenosis after implantation of the LifeStent in femoropopliteal artery lesions. CLTI, CTO, lesion length ≥25cm, and distal RVD <5mm predicted decreased patency after a 3-year follow-up.

Long-term Outcomes After Self-Expanding Nitinol Stent Implantation for the Treatment of Lesions in the Superficial Femoral Artery And Proximal Popliteal Artery: 3-Year Results From the BIOFLEX-I Trial

Long-term Outcomes After Self-Expanding Nitinol Stent Implantation for the Treatment of Lesions in the Superficial Femoral Artery And Proximal Popliteal Artery: 3-Year Results From the BIOFLEX-I Trial

Direct cholangioscopic visualization of gallbladder cancer ingrowth into an open-cell, laser-cut hilar stent

An 84-year-old woman presented with severe jaundice. Imaging studies and ERCP indicated advanced gallbladder cancer with hilar infiltration and preserved left-right communication (Bismuth-Corlette II) (A). After adequate counseling, the surgically unfit patient opted for self-expandable metal stent (SEMS) implantation without adjunctive radiofrequency ablation. Therefore, tissue diagnosis was not pursued, and an 80- × 10-mm open-cell, laser-cut SEMS (Zilver635, Cook Medical, Bloomington, Ind, USA) with an ultra-slim 6F applicator was placed through the 30-mm high-grade stricture without difficulties.

ANALYSIS OF THE RESULTS OF ENDOSCOPIC STENT IMPLANTATION IN MALIGNANT EXTRINSIC ESOPHAGEAL СOMPRESSIONS AND ESOPHAGEAL ANASTOMOSES

Background . Malignant dysphagia caused by the extrinsic compression of the esophagus and esophageal anastomoses is a rare complication of malignant neoplasms. Studies on the safety and efficacy of esophageal stenting for extra-organ esophageal compression have contradictory results. The aim of the study was to analyze the life expectancy and complications after stenting in patients with malignant extra-organ compression of the esophagus and esophageal anastomoses. Material and Methods. From 2011 to 2019, 19 patients with extrinsic compression of the esophagus and esophageal anastomoses caused by malignant neoplasms underwent ultrasound-guided implantation of self-expandable metallic stents. Results . No complications were observed during stent implantation procedure. The mean dysphagia score decreased by 1.9 points. Short-and long-term complications, such as stent migration, profuse esophageal bleeding with lethal outcome, dysphagia relapse, tracheo-esophageal fistula, pronounced and granulation growth causing recurrent dysphagia, were observed in 5 patients. The median survival time was 55.9 days. Conclusion. placement of metal stents in patients with malignant dysphagia due to extrinsic esophageal compression was shown to be safe and effective in relieving the symptoms of dysphagia.

Adaptation of endovascular technique of self-expandable metal esophageal stent implantation in palliative treatment of malignant dysphagia in the course of esophageal and bronchial cancers: A one-center study.

Esophageal stent implantation is an alternative for microjejunostomy or total parenteral nutrition in the palliative treatment of malignant dysphagia in the course of esophageal and advanced bronchial cancers infiltrating the esophagus. The procedure of implanting an esophageal self-expanding metal stent (SEMS) is performed with gastroscopic guidance under general anesthesia. To analyze the efficacy and safety of a simplified technique (without gastroscopic guidance in local anesthesia) of esophageal SEMS implantation in patients with malignant dysphagia in the course of esophageal and bronchial cancers. This is a retrospective analysis of consecutive procedures of uncovered esophageal SEMS implantation performed with a simplified adaptation of the endovascular technique (Seldinger wire) in patients with esophageal and bronchial cancers and poor performance status. The procedures were done in a single surgical center over an 8-year period in 27 patients who were referred from oncology departments with esophageal stenosis confirmed using gastroscopy and who were being treated for malignant dysphagia. The study endpoints were effectiveness (a decrease in dysphagia from grade 3 or 4 to grade 1 after the procedure) and complications related to the procedures (including restenosis and stent migration). In all 27 patients, the SEMS were effectively implanted, enabling enteral nutrition after the procedure. No early complications related to the procedure were observed. A single patient developed restenosis 14 days after the procedure, which required re-stenting. The simplified method for SEMS implantation described herein may be considered an option in the palliative treatment of patients with malignant dysphagia in the course of esophageal and bronchial cancers and poor performance status, especially in facilities with limited access to endoscopy.

Long term clinical outcome after self-expandable nitinol stent implantation for femoropopliteal occlusive disease in hemodialysis patients

Abstract Background Endovascular therapy (EVT) using self-expandable bare nitinol stent (BNS) has been commonly accepted in patients with symptomatic femoropopliteal (FP) occlusive disease. However, poor clinical outcomes in hemodialysis (HD) patients are major problems. We investigated the impact of HD on clinical outcome after EVT in patients with FP disease. Methods A total of 427 consecutive HD patients undergoing successful EVT with BNS for FP disease were enrolled with 157 non-HD patients as a control group. They were followed-up for 5 years. We collected data on target lesion revascularization (TLR) rate, and limb salvage rate as well as survival rate. Propensity-score matching analysis was performed to investigate the true impact of HD on the outcome. Results Critical limb ischemia was observed in 44.0% of overall population (43.0% in HD group vs. 46.8% in non-HD group, p=0.42). Rates of diabetes (67.1% vs. 58.1%, p=0.045) and coronary artery disease (73.5% vs. 58.3%, p=0.0008) were higher, while age (70±10 years old vs. 76±10 years old, p&amp;lt;0.0001) and TASC2 C/D lesion (27.9% vs. 44.6%, p=0.0002) were lower in HD group compared to non-HD group. Pre-procedural C-reactive protein level (0.4mg/l vs. 0.3mg/l, p=0.045) was higher and serum albumin level (3.6g/dl vs. 3.8g/dl, p=0.0045) was lower in HD group than those in non-HD group. The freedom rate from TLR at 5 years was significantly lower in HD group than in non-HD group [47.2% vs. 65.2%, hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.23–2.64, p=0.0017]. The limb salvage rate was comparable between the groups (93.3% vs. 97.1%, HR 1.57, 95% CI 0.58–5.47, p=0.41), while the survival rate was significantly lower in HD group compared to non-HD group (60.6% vs. 86.0%, HR 2.53, 95% CI 1.56–4.36, p=0.0002). After propensity-score analysis, 250 patients (125 in each group) were matched without any difference of clinical characteristics in both groups. In the matched cohort, the freedom rate from TLR was still lower in HD group compared to non-HD group (46.7% vs. 66.6%, HR 2.25, 95% CI 1.35–3.87, p=0.0019). The adjusted limb salvage rate was consistently similar between the groups (95.4% vs. 97.3%, HR 1.10, 95% CI 0.20–5.94, p=0.91). Also, the adjusted survival rate was lower in HD group than in non-HD group (47.6% vs. 89.9%, HR 3.60, 95% CI 1.89–7.44, p&amp;lt;0.0001). Conclusion The freedom rate from TLR at 5 years after BNS implantation for FP disease were significantly lower in HD group than in non-HD group, though the limb salvage rate was similar between the groups. The survival rate was consistently lower in HD group compared to non-HD group. HD status had a great impact on TLR and mortality after EVT with BNS in patients with FP disease. Funding Acknowledgement Type of funding source: None

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

Intravascular Ultrasound Imaging During Aortoiliac Stenting: No Impact on Outcomes at 1 Year

Purpose To investigate the effect of intravascular ultrasound (IVUS) imaging use on clinical outcomes after aortoiliac stenting in patients with peripheral artery disease (PAD). Materials and Methods Subjects for this retrospective analysis were derived from the OMOTENASHI registry database, which contained 803 symptomatic PAD patients (Rutherford categories 2–4) who were treated with self-expanding stent implantation for aortoiliac atherosclerotic lesions at 61 centers in Japan between January 2014 and April 2016. Of the 803 patients, 545 (67.9%) patients (mean age 73±9 years; 453 men) underwent IVUS-supported stent implantation and were compared with the 258 patients (mean age 73±8 years; 217 men) treated without IVUS. A propensity score analysis of 138 matched pairs was conducted to compare treatment strategies and clinical outcomes between patients having IVUS-supported endovascular therapy and those treated without IVUS. Results Endovascular strategies and postoperative medications were not significantly different between the IVUS and no-IVUS groups. A procedure time under 1 hour was less frequent in the IVUS group, which had a longer fluoroscopy time. The 12-month restenosis rate was not significantly different between the 2 groups [10.2% (95% CI 6.9 to 14.9%) vs 10.3% (95% CI 5.4 to 18.6%), p=0.99]. There was no interaction between baseline characteristics and the association of IVUS use with restenosis risk. Conclusion Propensity score matching analysis revealed that duration and fluoroscopy time during IVUS-supported procedures were significantly longer than in cases without IVUS use, whereas the 12-month restenosis rate was not significantly different between the groups. IVUS use in aortoiliac lesions may be unnecessary.

Self-expandable metal stent of esophagogastric junction versus pyloric area obstruction in advanced gastric cancer patients

Upper gastrointestinal stenting is a palliative treatment for relieving symptoms such as nausea, vomiting, and dietary intake in patients with obstruction due to inoperable advanced stomach cancer. Self-expandable metal stent (SEMS) implantation for malignant obstruction has recently become more effective, safer, and less expensive than operative modality. It also has better short-term outcomes, particularly a shorter hospital stay and a more rapid return to oral intake, than surgical treatment. However, there is no comparative analysis regarding the efficacy, side effects, and survival rate of stenting between the esophagogastric junction (EGJ) and pyloric obstructions.To compare the prognoses and complications after SEMS implantation between EGJ and pyloric obstructions in advanced gastric cancer.Among advanced gastric cancer patients with gastrointestinal obstruction diagnosed from January 2008 to December 2017 at the Gastroenterology Department of Chungnam National University Hospital, 42 and 76 patients presented with EGJ (EGJ obstruction group) and gastric pyloric obstructions (pyloric obstruction group), respectively. We retrospectively reviewed the survival period, changes in food intake, and complications of these patients before and after SEMS placement.The prevalences of aspiration pneumonia were 11.9% (5/42) and 2.6% (2/76) in the EGJ and pyloric obstruction groups, respectively, before SEMS placement (P value: .041). Other symptoms associated with gastric malignant obstruction were not statistically different between the groups. Success rate and adverse events did not significantly differ between the EGJ and pyloric obstruction groups. There was no difference in frequency of stent reinsertion procedures performed owing to reobstruction, but the reprocedure average period was statistically significantly longer in the EGJ obstruction group [EGJ obstruction: 158.3 days (±42.4); pyloric obstruction: 86.0 days (±29.1)] (P value: .022). As an index of improved dietary status, the Gastric Outlet Obstruction Scoring System score was not significantly different between the groups before and after SEMS placement.The EGJ and pyloric obstruction groups did not significantly differ in prognosis or complication rates. However, EGJ stent was more stable than pyloric stent when reobstruction was considered.