Stent System Research Articles

Five-Year Clinical Outcomes After XIENCE PRIME Everolimus Elution Coronary Stent System (EECSS) Implantation

Background/aim: This study was aimed at evaluating 5-year effectiveness and safety in participants after XIENCE PRIME Everolimus Elution Coronary Stent System (EECSS) implantation. Materials and methods: From December 2013 to May 2014, 108 patients (127 lesions) were treated with the XIENCE PRIME EECSS. The entire follow-up included annual assessments for 5 years after treatment or until one of the clinical endpoints was reached. We evaluated the 5-year clinical outcomes with Kaplan-Meier analysis and the Cox regression model. Results: Nearly three-quarters of the participants were men (76.8%), and the average age was 65.6 ± 10.8 years. Bifurcation lesions accounted for 96.1% (122 lesions), and left main lesions accounted for 3.9% (five lesions), with a total count of 127 lesions. The cumulative rate of major adverse cardiac events was as follows: 1 year, 1.9%; 2 year, 4.0%; and 5 year, 10.0%. No definite or probable stent thrombosis was observed, and the rate of target lesion failure was only 3.3% over 5 years. The cumulative rate of major bleeding eventually increased to only 4.4%. Conclusions: The 5-year clinical outcomes were favorable in patients treated with XIENCE PRIME EECSS, and the incidence of stent thrombosis and target lesion failure was relatively low. The incidence of major bleeding gradually increased but remained moderate.

Post market surveillance registry (PIONEER) of the Yukon Choice PC-Elite Coronary Stent System for percutaneous coronary intervention in Indian acute coronary syndrome population

AimThe aim of this study was to assess the safety and efficacy profile of a newer generation biodegradable DES, the Yukon Choice PC Elite with a temperature controlling mechanism, in patients with acute coronary syndrome (ACS). MethodsThis prospective multi-center study (PIONEER Registry) was conducted in an Indian ACS population, therefore providing data in real world clinical practice. Patients with ACS underwent DES implantation in de novo native-vessel coronary lesions with the Yukon Choice PC Elite biodegradable polymer DES and were followed up for a year. ResultsA total 999 patients were evaluated. The majority of patients were male (79.2%). A total of 6.7% of the patients had a history of prior myocardial infarction (MI) and 2.7% of patients had a history of previous coronary artery bypass graft. The clinical presentations of the patients included: unstable angina pectoris (UA) (46.4%), ST-segment elevation MI (STEMI) (38.1%), and Non-ST-segment elevation MI (NSTEMI) (15.4%). Implantation of the device was successful in 99.9% of cases. The median stent length and stent size were 21.0 mm (Range: 8.0–40.0 mm) and 2.8 mm (Range 2.0–4.0 mm), respectively. Through to one-year clinical follow-up after percutaneous coronary intervention, all-cause death occurred in 4 of 999 patients (Crude Percentage: 0.4%). Cardiac death, MI, TLR, and stent thrombosis were occurred in 1 (0.1%), 8 (0.8%), 12 (1.2%) and 1 (0.1%) patients, respectively. ConclusionThe results of this post marketing surveillance registry suggest favorable safety and efficacy outcomes associated with the Yukon Choice PC Elite biodegradable DES in a real world Indian ACS population.

Investigation on forced vibration characteristics of Nitinol tracheal stent.

Tracheal stents can be placed in a narrow position in the human trachea to ensure smooth breathing. And the stent will deform during service by the influence of the physiological environment or random excitations, such as coughing. This paper divides the vibration into periodic and random vibrations according to the different pressures. And a coupling vibration model was established by analyzing the contact relationship between the stent and the trachea tissue. And this study discusses the influence of tracheal diameter, respiratory pressure, and frequency on the stent vibration characteristics through Ansys simulation. In addition, the nonlinear equations were solved by the Matlab numerical analysis method, which could help analyze the influence of cough intensity on the stability of the tracheal stent system. The results showed that when tracheal stenosis occurred in the trachea's more significant grade, the trachea stent was more likely to fall off when treated with a tracheal stent. With the increase in respiratory frequency and pressure, the deformation of the tracheal stent is more considerable. Moreover, the frequency of normal cough hardly affects the stability of the stent system, while the excitation force and damping coefficient value greatly influence the system. When the excitation force of the cough exceeds the critical importance of 20N, the tracheal stent is prone to fall off. This study comprehensively obtained the forced vibration characteristics of the stent under service conditions, which could make up for the shortage of the vibration theory of the stent. The results can provide a theoretical basis for predicting the possibility of stent loss in clinical treatment.

A Randomized Controlled Trial of a Biodegradable Polymer, Microcrystalline Sirolimus-Eluting Stent (MiStent) versus Another Biodegradable Polymer Sirolimus-Eluting Stent (TIVOLI): The DESSOLVE-C Trial

Objective: Data comparing the outcomes of MiStent (Micell Technologies, Durham, North Carolina, USA) microcrystalline biodegradable polymer (BP) drug-eluting stent (DES) and those of another post-marketing BP-DES, TIVOLI (EssenTech, Beijing, China) are rare. This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent (SES) system MiStent and those of TIVOLI BP-SES. Methods: The DESSOLVE-C trial was a prospective, single-blinded, multicenter, randomized trial (NCT02448524), which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio. The primary endpoint was a non-inferiority comparison of in-stent late lumen loss (LLL) by quantitative coronary angiography at 9 months. The secondary endpoint was device-related clinical cardiovascular composite events (target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization) and 1-year outcomes. Results: A total of 428 patients (216 patients in the MiStent group and 212 patients in the TIVOLI group) were enrolled and included in an intention-to-treat analysis. MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months ((0.23 ± 0.37) mm vs. (0.34 ± 0.48) mm, P for non-inferiority <0.001, P for superiority = 0.02). Although without significant difference, the rate of TLF in MiStent was quantitatively lower than that in TIVOLI (3.70% vs. 6.60%; P = 0.17). Conclusion: Compared with TIVOLI BP-SES, the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.

Controversies in the management of proximal deep vein thrombosis.

Controversies in the management of proximal deep vein thrombosis.

Dual strengthened corrosion control of biodegradable coating on magnesium alloy for vascular stent application

Recently, magnesium alloy vascular stents have aroused great attraction because of their biodegradability and good mechanical properties. However, the rapid degradation of magnesium alloy stents causes their premature collapse in clinical application. So far, there have been few magnesium alloy stent systems that achieved sufficient support time by using biodegradable coating. In this paper, a dual strengthened biodegradable coating on a AZ31b magnesium alloy stent was suggested to achieve stronger adhesion and lower water permeability. The composite coating consisted of a magnesium hydrate - magnesium fluoride (Mg(OH)2-MgF2) inorganic base layer constructed by a simple two-step solution immersion and a graphene oxide - poly(trimethylene carbonate) outer layer prepared by ultrasonic spraying. The biodegradable composite coating modified magnesium alloy exhibited an extremely low corrosion current density of 4.3 × 10−10 A·cm−2, which is five orders of magnitude lower than the unmodified magnesium alloy. In vitro immersion tests revealed that the modification can effectively reduce the corrosion rate of the magnesium alloy stent, and the modified magnesium alloy stent can support at least 8 weeks. Furthermore, in vitro biological experiment revealed the modification of the composite coating improved the biocompatibility and ensured good microenvironment for vascular repair. These results suggest that the biodegradable composite coating has great potential for application in vascular stent.

Enhanced stent visualization system for percutaneous coronary intervention in patients with chronic kidney disease: effects on contrast media volume and radiation exposure

ObjectiveWe aimed to assess the impact of using enhanced stent visualization (ESV) systems on contrast media volume and radiation dose in percutaneous coronary intervention (PCI), especially for patients with chronic kidney disease (CKD).BackgroundCoronary heart disease (CHD) is associated with chronic kidney disease (CKD), as they share a similar pathological pathway. In addition, the iodinated contrast media used for angiography is a risk factor for contrast-associated acute kidney injury (CA-AKI), which could aggravate the progression of CKD. We hypothesized that ESV systems have the potential to reduce the use of contrast media as well as the radiation dose; however, few studies have reported the impact on contrast media with the use of ESV systems.MethodsWe retrospectively collected 124 patients with acute coronary syndrome who underwent PCI from May 2020 to July 2021. The patients were divided into the ESV-guided group (n = 64) and angiography-guided group (n = 60). Procedural parameters, including contrast media volume, radiation exposure (in Air Kerma-AK and Dose Area Product-DAP), number of cines, cine frames, fluoroscopy and procedure time, were recorded and analysed.ResultsThe groups were comparable regarding the patient characteristics. There was a significant reduction in contrast media volume (174.7 ± 29.6 ml vs.132.6 ± 22.3 ml, p = 0.0001), radiation exposure (776 (499 - 1200) mGy vs. 1065 (791 - 1603) mGy, p = 0.002 in AK; 43 (37 - 73) Gycm2 vs. 80 (64 - 133) Gycm2, p = 0.030 in DAP) and procedure time (53.06 ± 21.20 min vs. 72.00 ± 30.55 min, p = 0.01) with the use of ESV systems. Similar results were observed in the subgroup analysis for the patients with CKD.ConclusionThis study suggested that the use of ESV is associated with reduced contrast media usage, radiation dose and procedure time during PCI. The same results were observed in a subgroup analysis in patients with CKD, and this shows that ESV-guided PCI has the potential to reduce renal impairment and mitigate the progression of CKD for those CHD patients with CKD.

A Fenestrated Balloon Expandable Stent System for the Treatment of Aortoiliac Occlusive Disease.

In aortoiliac occlusive disease, atherosclerotic plaques can occlude the distal aortic bifurcation and proximal bilateral iliac artery and thus cause ischemia in the lower extremity. This is typically treated by restoring patency with balloon expandable stents. Stents are typically deployed in a "kissing stent" configuration into the bilateral iliac arteries and into the distal aortic bifurcation lumen to restore antegrade arterial flow. However, these stents typically become re-occluded by plaques. To understand the reasons for this and look for solutions, we simulated flow dynamics in the aortic bifurcation in the presence and absence of stents using computational fluid dynamics. Results demonstrated that the kissing stent configuration was associated with high levels of vorticity and flow constriction. These prothrombotic variables were alleviated in an alternative, aortoiliac fenestrated (AIFEN), tapered, and balloon-expandable stent design. Our findings suggest that stent design can be tailored to improve flow fields for aortoiliac stenting.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

Patient-related adverse events and device failures associated with commercially available enteral or duodenal self-expanding metal stents: an analysis of the MAUDE database

Duodenal stents are widely used to treat patients with malignant gastric outlet obstruction (MGOO), most commonly from pancreatic cancer. The WallFlex (Boston Scientific, Natick, Mass, USA) and Evolution (Cook Endoscopy, Winston-Salem, NC, USA) duodenal stents are in widespread use for treating MGOO. The objective of this study was to analyze device failures and patient-related adverse events reported to the U.S. Food and Drug Administration (FDA) for these 2 stents. We analyzed postmarketing surveillance data on the WallFlex and Evolution duodenal stents from January 2000 to January 2022 through the FDA's Manufacturer and User Facility Device Experience (MAUDE) database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). One hundred fifty-four MAUDE reports were identified and analyzed, from which 176 device failures and 186 patient-related adverse events were identified. Device-related failures for the WallFlex stent were delivery system failure (15.4%) and failure to activate the stent (13.2%). Device failures for the Evolution stent were failure to activate the stent (16.5%) and delivery system failure (15.3%). Patient-related adverse events for the WallFlex stent were perforation (18.9%), death (6.6%), and hemorrhage (3.8%), whereas patient-related adverse events for the Evolution duodenal stent were obstruction (16.3%), perforation (6.3%), aspiration (3.8%), and fragments of broken delivery system left in the patient (3.8%). Both stents are associated with device failures such as failure to activate the stent, stent migration, and occlusion by tumor growth. Despite high success rates, duodenal stents can be associated with serious device failures and patient-related adverse events.

S348 Creating Your Own Paths: EUS-Guided Transjejunal Gallbladder Drainage and ERCP, Cholecystoscopy, and Electrohydraulic Lithotripsy for Choledocholithiasis and Cholelithiasis in a Patient With Roux-en-Y Gastric Bypass

Introduction: Treating choledocholithiasis and cholelithiasis in patients with altered gastrointestinal anatomy is a challenge given the difficulty in accessing the biliary tract using conventional endoscopic techniques. Endoscopic ultrasound (EUS) directed transgastric ERCP (EDGE) represents a novel solution to this challenge. It allows access to the excluded stomach allowing safe performance of ERCP and interventional EUS procedures including gallbladder drainage. Case Description/Methods: A 61-year-old man with a history of morbid obesity, Roux-en-Y gastric bypass, and bowel perforation complicated by extensive resection and short gut syndrome, as well as rheumatoid arthritis and chronic kidney disease, presented to clinic for intermittent right upper quadrant pain, nausea, and vomiting. Imaging revealed large cholelithiasis, choledocholithiasis, and biliary dilatation with gallbladder distention. Given his high surgical risk and symptomatic biliary disease, EDGE and EUS-guided management of the large gallstone was planned. The first step was to create a jejunogastrostomy (JG) which was performed using EUS-guided 15mmx10mm lumen-apposing metal stent (LAMS) deployment through the Roux limb into the excluded stomach. ERCP was performed 4 weeks later finding choledocholithiasis, and complete removal of two stones was accomplished. This was followed by EUS-guided gallbladder drainage via JG and successful creation of a cholecystoduodenostomy (CDS) using the 15mmx10mm AXIOS stent system. Direct cholecystoscopy, electrohydraulic lithotripsy and removal of a large gallstone were then performed. Both LAMS from JG and CDS were removed at the end of the procedure. Follow-up upper GI series at 6 weeks showed complete closure of the jejunogastrostomy fistula. Discussion: The EDGE approach provides access to the excluded remnant stomach enabling ERCP and interventional EUS procedures such as gall bladder drainage. In this case, we demonstrate the utility of this procedure in enabling access to the gallbladder and permitting direct cholecystoscopy, electrohydraulic lithotripsy, and removal of a large symptomatic gallstone, thus avoiding long-term percutaneous drains and recurrent symptoms, in addition to the risk of cholecystitis or Mirizzi syndrome from a large gallstone. Watch the video at https://tinyurl.com/ACGAbstractS348

S2901 Afferent Limb Syndrome Treated With Non-Cautery-Enhanced Lumen Apposing Metal Stent: An Alternate Approach

Introduction: Afferent limb syndrome (ALS) is a known complication after gastrojejunostomies from mechanical obstruction of the afferent limb (AL). Recently endoscopic ultrasound (EUS) guided gastroenterostomy placement has provided an alternate to surgical correction. However this approach is not always technically possible. We describe a case successfully treated with endoluminal non-cautery enhanced lumen apposing metal stent (LAMS) placement. Case Description/Methods: A 63 year old woman with a history of ileocolonic Crohns disease (diagnosed at age 25), status post multiple surgeries including ileocolic resections and Billroth II gastrectomy, was referred with persistent abdominal pain. She was recently diagnosed with acute pancreatitis with CT concerning for dilated afferent jejunal limb, a luminal stricture near the biliary anastomosis and dilated intra and extra hepatic bile ducts (Figure a). She underwent two deep enteroscopies revealing a stricture in the AL from intra-abdominal adhesion. This was dilated with minimal improvement in symptoms and imaging. After multi-disciplinary discussion it was decided to attempt EUS guided drainage of the AL to promote drainage of pancreatico- biliary secretions. During the procedure a significant amount of food residue was identified in the gastric remnant. The dilated afferent limb was visualized endosonographically adjacent to the posterior stomach at an acute angle. Considering large amount of food in the stomach, difficult angulation to deploy the AXIOS stent and concern for food entering the already obstructed limb after stent deployment it was decided to reconsider this approach. The AL was then explored with a therapeutic upper endoscope with stenosis at 10 cm from the anastomosis. A wire was passed through the stenosis under fluoroscopy. It was decided to place a stent using the 15 x 10 mm LAMS stent system considering short (< 1 cm) stricture. Using non cautery technique both flanges were deployed successfully across the stricture under fluoroscopic and endoscopic guidance with decompression of the AL (Figure b,c). 1 month follow up imaging demonstrated continued decompression of the AL. Discussion: EUS guided gastrojejunostomy has been increasingly used for ALS. However it can be challenging in situations where a good window cannot be identified. In such settings using a traditional luminal route to reach the stenosis and placing a non-cautery enhanced LAMS can provide a viable alternative.Figure 1.: (a) Dilated afferent limb with stricture (arrows), (b) post non-cautery enhanced LAMS deployment, (c) Fluoroscopy image post LAMS deployment

Sensors-based monitoring and treatment approaches for in-stent restenosis.

Cardiovascular disease (CVD) can progressively narrow arteries due to plaque accumulation on the inner walls of the blood vessels, which results in an obstructed blood flow, leading to heart attack, stroke, and even death if the obstruction is severe. A popular treatment for the disease is to use an intravascular mechanical device called the stent to achieve an immediate restoration of blood flow. However, the physical stimulation induced by the stent expansion can cause inflammation of the vessel tissue. As one of the most common post-stenting complications, re-narrowing of the vessel is the main pathology that leads to in-stent restenosis (ISR), induced by the excess growth of the tissue over the deployed stent. The ISR is widely recognized as a significant cause of death globally if early symptoms are not detected. Hence, monitoring and early diagnosis indeed matter when it comes to treatment. The latest technologies for monitoring and treatments of ISR were reviewed in this work, and the potential issues and suggestions related to the reported technologies were presented. The target of this review aims to positively prompt researchers to develop an advanced stent system in terms of its electromechanical performance, size, functional feature, feasibility, and reliability.

Solitaire™ Stent Thrombectomy System in the Treatment of Acute Lower-Limb Ischemia: Comparisons in Safety and Effectiveness with Conventional Catheter-Directed Thrombolysis Therapy.

Objective The study aimed to investigate the safety and efficacy of the Solitaire™ AB Stent System (ev3 Inc., Plymouth, MN, USA) for the treatment of acute lower extremity ischemia (ALLI) compared with conventional catheter-directed thrombolytic therapy. Methods Retrospective analysis of patients with ALLI treated in the Department of Interventional Radiology at the First Hospital of Nanjing from January 2017 to April 2020 divided into a conventional (CDT) group (n = 106) and a percutaneous mechanical thrombectomy (PMT) group (n = 55) according to the procedure. PMT was performed using the Solitaire™ AB stent system. The combined clinical outcomes of mortality, major amputation, recurrent ischemia, and major morbidity were compared between the two groups. Results Of the 161 patients, 128 (79.5%) did not have a composite clinical outcome after 12 months of follow-up, namely, 78 CDT patients and 50 PMT patients, with significant differences in composite clinical outcome (26.4% vs. 9.1%, P = 0.010) and mortality (19.8% vs. 7.3%, P = 0.037) between them. Thrombolytic drug dose (19.34 ± 5.93 vs. 13.55 ± 6.54 mg, P < 0.001) and length of hospital stay (8.29 ± 3.91 vs. 5.49 ± 1.18 days, P = 0.003) were significantly lower in the PMT group. Conclusion PMT with the Solitaire™ AB Stent System is safer and more effective in treating patients with Rutherford stage I-IIB ALLI, with the advantage of rapid opening of obstructed vessels, shorter thrombolysis time, reduced thrombolytic dose, and improved blood flow to the infrapopliteal vessels.

Midterm and Long-Term Outcomes following Dedicated Endovenous Nitinol Stent Placement for Symptomatic Iliofemoral Venous Obstruction: Three- to 5-Year Results of the VIRTUS Study

PurposeTo assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract. Materials and MethodsPatients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed. ResultsA total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture. ConclusionsThe results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents: BIOFLOW V Final 5-Year Outcomes.

Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain. This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES). BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P=0.495) for BP SES and DP EES, respectively. In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.

Y‐Stent–Assisted Coiling of Wide‐Necked Intracranial Aneurysms With the Neuroform Atlas Stent System

Background Endovascular management of wide‐necked bifurcation aneurysms poses a therapeutic challenge, as coiling often requires the use of multiple adjunctive stent constructs to achieve successful embolization without compromising parent vessel integrity. The Neuroform Atlas Stent System is a novel low‐profile, intraluminal remodeling device. The study aims to investigate the safety and efficacy of Y‐stent–assisted coiling configuration constructs using the next generation stent for aneurysm coil embolization. Methods Subjects undergoing Y‐stent–assisted coiling in the ATLAS IDE (Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas Stent System Investigational Device Exception) trial were identified for subgroup analysis. Enrollment in the trial was not stratified on the basis of the procedural stenting technique used. The primary efficacy end point was complete aneurysm occlusion (Raymond–Roy class 1) on 12‐month angiography, in the absence of re‐treatment or parent artery stenosis (&gt;50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent imaging core laboratory and the clinical events committee. Results A total of 60 subjects were identified. The mean age was 59, and 28.3% were men. The median aneurysm size was 6.7 mm, with a median neck size of 4.3 mm. Frequently reported aneurysm locations included the basilar apex (56.7%), anterior communicating artery (20.0%), and middle cerebral artery bifurcation (11.7%). The composite primary efficacy end point was achieved in 81.1% of subjects. Overall, 1.7% of subjects experienced a primary safety endpoint of major ipsilateral stroke or neurological death. Conclusion In the ATLAS IDE aneurysm cohort premarket approval study, Y‐stent–assisted coiling with Neuroform demonstrated high rates of complete aneurysm occlusion at 12 months, with low rates of morbidity.

A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems

The first two Food and Drug Administration (FDA)-approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's Vici and BD's Venovo venous stent systems, were both recalled in early 2021 within years of entering the market. Given the recent addition of patient issues as a publicly reported variable by the FDA Manufacturer and User Facility Device Experience (MAUDE) database, we set forth to analyze adverse event reports in MAUDE to better characterize issues reported for each system. MAUDE was queried for all adverse event reports for brands "Vici" and "Venovo" from their respective US FDA market approval dates to August 19, 2021. Reported device issues, patient issues, and interventions performed for each adverse event were compiled and compared using Fisher's exact test. A total of 50 unique adverse event reports were compiled for the Vici system and 341 for the Venovo system. The most common device issue reported for the Vici system was migration (48% vs. 0%; P=0.0001) versus activation failure in Venovo (85% vs. 4%; P=0.0001). A significantly higher proportion of Venovo reports specified no patient complications or symptoms (90% vs. 26%; P=0.0001), with no intervention performed (89% vs. 32%; P=0.001). A significantly higher proportion of Vici devices were extracted (8% vs. 2%; P=0.01), required use of a new device (26% vs. 5%; P=0.0001), and required application of a second stent within the venous stent initially placed (28% vs. 2%; P=0.0001). The rate of intervention with balloon expansion was not significantly different between the Vici and Venovo systems (6% vs. 2%; P=0.08). While 2 venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved and well described. Our data suggest that despite recent improvements to MAUDE reporting, additional standardization with specificity regarding patient issues and interventions is needed to assist vascular surgeons monitoring real-time adverse event trends for vascular devices.

Long-term results of wide-necked intracranial bifurcation aneurysms treated with stent-assisted coiling using low-profile acandis acclino stents.

Little data exists on endovascular treatment of complex intracranial aneurysms with the Acandis Acclino low-profile self-expanding closed-cell stent systems and is mainly limited to short- or midterm results. We report our long-term, single-centre experience with three generations of Acclino stents treating complex intracranial aneurysms. 62 wide-necked intracranial aneurysms were treated electively using 88 Acclino stent systems. Single stent-assisted coiling was the preferred treatment in 38 cases and the kissing-Y stenting technique in 24 cases. We analysed demographic data and long-term follow-up results. All stents were successfully deployed with immediate complete (Raymond Roy occlusion classification, RROC I) or near-complete occlusion (RROC II) achieved in 93,5%. Follow-up was available in 55 cases with a mean follow-up of 36 months (range 9-80 months). Long-term RROC I or II was achieved in 49 cases (89,1%). Three cases of stable residual aneurysmal filling were observed (5,5%). Seven aneurysms (12,7%) demonstrated a worsening on follow-up leading either to a neck remnant (4 cases, 7,3%) or to an aneurysm recurrence (3 cases, 5,5%). One recurrent aneurysm was retreated with coilembolization (1,8%). The directly procedural-related complication rate was 4,8%. Seven cases of clinically silent in-stent stenosis (12,7%; morbidity n = 0) were detected on long-term follow-up, six of them using the kissing-Y stenting technique. Endovascular treatment of various intracranial aneurysms using the Acandis Acclino stent systems is safe and efficient with high aneurysm occlusion rates combined with low complication rates on long-term follow-up. Overall, rates of in-stent stenosis are low but may depend on the treatment technique (single stent-assisted coiling versus kissing-Y stenting with coiling).

Supera stent implantation for the treatment of isolated popliteal artery disease systematic review and evaluation of current endovascular strategies.

&lt;b&gt;Introduction:&lt;/b&gt; The anatomical location of the popliteal artery is one of the greatest challenges for percutaneous interventions. The biomechanical attributes of the vessel lead to higher rates of restenosis, stent fracture, and occlusion. Some surgeons consider the popliteal artery as a no stenting zone. Many specialists favor percutaneous transluminal angioplasty to be the first line of endovascular treatment in the popliteal artery with bail-out stent implantation if the results are suboptimal. The Supera peripheral stent system is a novel stent that has been manufactured with a high degree of flexibility and supposedly might be appropriate for implantation in the popliteal artery. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Aim:&lt;/b&gt; Evaluation of the performance of Supera stent in isolated popliteal artery disease in comparison to other methods of treatment. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Methods:&lt;/b&gt; As many as 92 articles were found in the databases and after full-text review, 4 studies matched the inclusion criteria and were evaluated. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Results:&lt;/b&gt; Primary patency rates of Supera implantation in an isolated popliteal artery at 12 months ranged from 68% to 90%. In all four studies, no stent fractures were observed. Only one study provided longer follow-up than 12 months and evaluated the performance of the Supera stent 36 months after implantation. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Conclusion:&lt;/b&gt; In conclusion, mentioned studies show promising and superior to other stent patency rates of the Supera stent regarding popliteal artery lesions. What is more, no stent fracture is promising regarding longer follow-up. However, more studies with longer follow-ups and direct comparison to other methods are required to fully evaluate Supera&apos;s performance in the popliteal artery.