Stent System Research Articles

A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).

Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy. The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate. BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up. Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration. The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.

Resolute onyx stent more effective than wingspan stent at preventing procedural complications and long-term restenosis.

Angioplasty and stenting is a treatment option for patients with medically refractory symptomatic intracranial atherosclerotic disease (sICAD). Currently the Wingspan Stent System (WSS) is the only FDA approved device for this indication. We find the Resolute (R) Onyx Stent, a drug-eluting balloon mounted stent (DES), a better alternative to the WSS for treatment of sICAD. Herein, we present our findings comparing the two stents based on our single center experience. A prospectively maintained neuro-endovascular databased was queried for patients between January 2013 to June 2021. Inclusion criteria for patients included sICAD with failed medical management, and intracranial stenting with either R-Onyx DES or WSS, including patients treated within 7 days of their last stroke. Primary outcomes were assessed via the occurrence of ischemic or hemorrhagic stroke or death within 72 h of the procedure. Secondary outcomes consisted of recurrent stroke or significant in-stent restenosis evaluated by a clinical or angiographic follow-up at 6 months. A total of 184 patients, average age 61.26 (SD = 12.53) (44% women), were eligible for analysis with 58 having R-onyx DES and 126 having WSS. Within 72 h, the primary outcome was observed in 1.7% (n = 1) of patients in the R-onyx DES group and 6.3% (n = 8) of patients in the WSS group (p = 0.089). Among 41 angiographic and clinical follow-ups in the R-onyx DES group, none had a recurrent stroke, while among 101 patients who had follow-up in the WSS group, 8.9% (n = 9) had a stroke (p = 0.024). At a 6-month angiographic follow-up, there was a significantly lower rate of symptomatic in-stent restenosis among the R-onyx DES group with 1.7% (n = 1) compared with 21.4% (n = 27) in the WSS group (p = 0.0003). R-onyx DES is more effective than WSS in treating sICAD with low rates of periprocedural complications and long-term strokes and symptomatic in-stent restenosis. Future prospective randomized multicenter trials are needed.

Device Complications and Outcomes Before and After FDA Recall of the VICI and Venovo Venous Stent Systems

The first two Food and Drug Administration (FDA) approved stents specific for iliofemoral vein obstruction, the VICI (Boston Scientific, Marlborough, MA) and Venovo (Becton, Dickinson and Co, Franklin Lakes, NJ) venous stent systems, were recalled on April 12, 2021 and May 12, 2021, respectively, within years of entering the market. We analyzed the publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize the predominant device and patient issues reported for each system over their recall timelines.

Fluid-Structure Interaction Analysis on the Influence of the Aortic Valve Stent Leaflet Structure in Hemodynamics.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical treatment for heart valve disease. At present, personalized TAVR valves are not available for some patients. This study adopts the fluid-structure interaction (FSI) model of the research object that has a three-disc leaflet form and structural design in the valve leaflet area. The valve opening shape, orifice area, stress-strain, and distribution of hemodynamic flow and pressure were compared under the condition of equal contact area between valve and blood. The FSI method was used to simulate the complex three dimensional characteristics of the flow field more accurately around the valve after TAVR stent implantation. Three personalized stent systems were established to study the performance of the leaflet design based on computational fluid dynamics. By comparing the different leaflet geometries, the maximum stress on leaflets and stents of model B was relatively reduced, which effectively improved the reliability of the stent design. Such valve design also causes the opening area of the valve leaflet to increase and the low-velocity area of the flow field to decrease during the working process of the valve, thus reducing the possibility of thrombosis. These findings can underpin breakthroughs in product design, and provide important theoretical support and technical guidance for clinical research.

Bifurcated Aneurysm Location Predicts In-Stent Stenosis After Neuroform-EZ Stent-Assisted Coiling for Intracranial Aneurysm.

Background and PurposeThe Neuroform EZ stent system (Boston Scientific Corporation, Fremont, CA, United States) is a fourth-generation intracranial aneurysm stent designed specifically for the cerebrovasculature to support aneurysm treatment. In this study, we analyzed our consecutive series of patients with aneurysm treated with the Neuroform EZ stent, with special attention to the occurrence of in-stent stenosis (ISS).MethodsA retrospective review of our center's electronic database was conducted to identify all patients with intracranial aneurysms who underwent aneurysm treatment with the Neuroform EZ stent between January 2016 and October 2018. Patients with at least one digital subtraction angiography (DSA) follow-up in our hospital were enrolled in this study. In-stent stenosis (ISS) was graded as mild (<2–5%), moderate (25–50%), or severe (>50%).ResultsThe study included 114 patients (78 women, 68.4%; median age 57.2 ± 9 years) with a total of 116 aneurysms. Of the 116 lesions, 20 were identified with ISS (17.2%) at a mean follow-up of 6.9 ± 1.7 months, and ISS was mild in 30% (6/20), moderate in 50% (10/20), and severe in 20% (4/20). No patients were symptomatic or required further intervention. Patients who developed ISS were younger than those without ISS (52.6 ± 7.8 vs. 57.9 ± 9; p = 0.016). The proportion of aneurysms located at the artery bifurcation was significantly higher in patients with stenosis than located at the sidewall artery (37.9 vs. 10.3%; p = 0.002). In the multivariable analysis, the patients' age (OR = 0.94; 95% CI 0.88–0.998; p = 0.02) and bifurcated aneurysm location (OR = 4.59; 95% CI 1.54–13.67; p = 0.006) were independent predictors of ISS.ConclusionsIn this retrospective study, the incidence of ISS after Neuroform EZ stent placement was 17.2%, and all the ISS cases were asymptomatic. Patients with younger age and bifurcated aneurysm location are more likely to develop ISS. Although Neuroform EZ stent is particularly suitable for bifurcated aneurysms, the ISS for this location should be focused upon.

Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System®

Purpose The excellent performance of the Supera Peripheral Stent System ® by Abbott Vascular in femoropopliteal interventions has already been proven through several trials. This retrospective study aims to evaluate the durability and long-term patency of the Supera stent for the treatment of severe femoropopliteal lesions in a real-world population. Methods A retrospective analysis was conducted of 136 consecutive limbs from 128 patients with atherosclerotic disease in the femoropopliteal region, treated with Supera stents between September 2010 and September 2017. As primary endpoints patency rates and freedom from target lesion revascularization (TLR) were calculated and presented using Kaplan-Meier analysis. Results Fifty-five percent were treated for claudication (IC), 45% for chronical limb threatening ischemia (CLTI). The mean treated lesion length was 143 mm (±77.8). The majority of lesions (63%) were Trans-Atlantic Inter-Society Consensus Criteria II (TASC II) C/D lesions. The overall primary patency rates at 12 and 24 months of follow-up were 72.6% and 60.8% respectively. The primary patency at 12 and 24 months for TASC II A/B lesions was respectively 86% and 75.4%. For TASC II C/D lesions primary patency at 12 and 24 months was 64% and 51.1% respectively (p = 0.001). Overall freedom from TLR after 12 and 24 months was 73.8% and 62.8% respectively. No significant patency differences were observed based on calcification rate. Conclusion Endovascular treatment of femoropopliteal disease with Supera Stent is safe, even in extensive, highly calcified lesions. Patency rates and freedom from TLR are acceptable in a real-life population.

Clinical Experience of the PK Papyrus Covered Stent in Patients With Coronary Artery Perforations: Results From a Multi-Center Humanitarian Device Exemption Survey

Background/purposeThe PK Papyrus covered coronary stent system (Biotronik AG, Bülach, Switzerland) is intended for treatment of coronary artery perforation (CAP) and is approved for use under a Humanitarian Device Exemption (HDE) in the United States (US). Methods/materialsThe retrospective data analysis includes cases reported from the US PK Papyrus HDE post-market surveillance clinical dataset with CAP cited as the reason for PK Papyrus stent use. ResultsFrom April 2019 to July 2021, PK Papyrus device registration forms citing CAP as the reason for use were received for 1094 cases from 335 US hospital programs. Ellis classification was assessed as: type III cavity spilling/IV, 11.0%; type III, 57.9%; type II, 23.8%; type I, 7.3%. Mechanisms of perforation included: balloon angioplasty (42.3%), stent placement (31.3%), atherectomy (13.9%), and guidewire (10.9%). The majority (72.6%) of cases involved single covered stent placement. Successful PK Papyrus delivery was reported in 97.7% of cases with successful perforation sealing in 92.1%. Emergency cardiac surgery and in-hospital death occurred in 6.3% and 12.4% of cases, respectively. Pericardiocentesis was performed in 30.2% of patients. Acute/subacute stent thrombosis occurred in 10 patients (1.1%). ConclusionAs the largest dataset of patients treated with a covered stent for CAP, these data provide significant insight into patient characteristics, procedural outcome, and in-hospital clinical events associated with this life-threatening complication. These results demonstrate that the PK Papyrus stent is a safe and effective method to seal CAP and with the potential to reduce high morbidity and mortality associated with this event.

The resolute Onyx drug eluting stent for neurointervention: A technical series.

Current methods for angioplasty and stenting of the intracranial vasculature for neurointervention are limited. The Wingspan Stent System is Food and Drug Administration (FDA) approved with human device exemption for a limited patient group and despite numerous prospective registries and trials demonstrating reasonable safety, still carries warnings from the FDA for its use. Given these limitations, we present the technical nuances and outcomes of the off-label use of the Resolute Onyx drug-eluting stent (DES) for neurointerventional purposes. Retrospective chart review of all patients undergoing a neurointerventional procedure with the Resolute Onyx DES was done from January 2017-2021. The Resolute Onyx is a coronary balloon-mounted drug-eluting (zotarolimus) single wire laser cut stent. Technical details and procedural outcomes were collected. In total 40 patients had attempted placement of the Resolute Onyx DES with procedural success in 95% of patients. The most common vessel stented was the basilar artery, 30% (12/40). The most common indication was intracranial atherosclerotic disease in 62.5% (25/40) patients, followed by acute stroke in 17.5% (7/40) of patients. The technical and procedural outcomes were excellent with only one technical complication (2.5%). This series describes the initial technical safety and utility of utilizing a new generation balloon-mounted drug-eluting stent for neurointerventional purposes. This stent offers the potential for improved navigability, delivery, and outcomes compared to current neurointerventional options and warrants further study.

One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial

ObjectivesTranscarotid artery revascularization (TCAR) is a carotid stenting technique that utilizes reversal of cerebral arterial flow to confer cerebral protection. Although carotid endarterectomy (CEA) remains the standard for treatment of symptomatic and asymptomatic carotid stenosis, the search for the optimal minimally invasive option for the high-risk surgical patient continues. The goal of the current study is to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial. MethodsROADSTER 2 is a prospective, open-label, single-arm, multicenter, post-approval registry for patients undergoing TCAR. All patients were considered high risk for CEA and underwent independent neurological assessments preoperatively, postoperatively, and had long-term clinical follow-up. The primary end point was incidence of ipsilateral stroke after treatment with the ENROUTE Transcarotid Stent System. Secondary end points included individual/composite rates of stroke, death, and perioperative myocardial infarction. ResultsBetween June 2016 and November 2018, 155 patients at 21 centers in the United States and one in the European Union were enrolled and represented a subset of the overall trial. Asymptomatic (n = 119; 77%) and symptomatic patients (n = 36; 23%) with high-risk anatomic (ie, high lesion, restenosis, radiation injury; 43%), physiologic (32%), or combined factors (25%) were enrolled. No patient suffered a perioperative myocardial infarction or stroke. Over the year, no patient had an ipsilateral stroke, but four patients died (2.6%), all from non-neurological causes. Additionally, a technical success rate of 98.7% with a low cranial nerve deficit rate of 1.3% was achieved. ConclusionsIn patients with high risk factors, TCAR yields high technical success with a low stroke and death rate at 1 year. Further comparative studies with CEA are warranted.

Feasibility evaluation of the transapical saddle-shaped valved stent for transcatheter mitral valve implantation.

Background and Aims of StudyTranscatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high‐risk mitral regurgitation. We aimed to investigate the feasibility of a novel self‐expanding valved stent for TMVI via apical access.MethodsWe designed a novel self‐expanding mitral valve stent system consisting of an atrial flange and saddle‐shaped ventricular body connected by two opposing anchors and two opposing extensions. During valve deployment, each anchor was controlled by a recurrent string. TMVI was performed in 10 pigs using the valve prosthesis through apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. Surviving pigs were killed 4 weeks later to confirm stent deployment.ResultsTen animals underwent TMVI using the novel mitral valve stent. Optimal valve deployment and accurate anatomical adjustments were obtained in nine animals. Implantation failed in one case, and the animal died 1 day later due to stent mismatch. After stent implantation, the hemodynamic parameters of the other animals were stable, and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract were 2.98 ± 0.91 mmHg and 3.42 ± 0.66 mmHg, respectively. Macroscopic evaluation confirmed the stable and secure positioning of the stents. No obvious valve displacement, embolism, or paravalvular leakage was observed 4 weeks postvalve implantation.ConclusionsThis study demonstrated that the novel mitral valve is technically feasible in animals. However, the long‐term feasibility and durability of this valved stent must be improved and verified.

Abre Venous Self-expanding Stent System

Abre Venous Self-expanding Stent System

Accelerated Endothelialization of Nanofibrous Scaffolds for Biomimetic Cardiovascular Implants.

Nanofiber nonwovens are highly promising to serve as biomimetic scaffolds for pioneering cardiac implants such as drug-eluting stent systems or heart valve prosthetics. For successful implant integration, rapid and homogeneous endothelialization is of utmost importance as it forms a hemocompatible surface. This study aims at physicochemical and biological evaluation of various electrospun polymer scaffolds, made of FDA approved medical-grade plastics. Human endothelial cells (EA.hy926) were examined for cell attachment, morphology, viability, as well as actin and PECAM 1 expression. The appraisal of the untreated poly-L-lactide (PLLA L210), poly-ε-caprolactone (PCL) and polyamide-6 (PA-6) nonwovens shows that the hydrophilicity (water contact angle > 80°) and surface free energy (<60 mN/m) is mostly insufficient for rapid cell colonization. Therefore, modification of the surface tension of nonpolar polymer scaffolds by plasma energy was initiated, leading to more than 60% increased wettability and improved colonization. Additionally, NH3-plasma surface functionalization resulted in a more physiological localization of cell–cell contact markers, promoting endothelialization on all polymeric surfaces, while fiber diameter remained unaltered. Our data indicates that hydrophobic nonwovens are often insufficient to mimic the native extracellular matrix but also that they can be easily adapted by targeted post-processing steps such as plasma treatment. The results achieved increase the understanding of cell–implant interactions of nanostructured polymer-based biomaterial surfaces in blood contact while also advocating for plasma technology to increase the surface energy of nonpolar biostable, as well as biodegradable polymer scaffolds. Thus, we highlight the potential of plasma-activated electrospun polymer scaffolds for the development of advanced cardiac implants.

Total Endovascular Aortic Arch Repair: From Dream to Reality.

The gold-standard therapy for the treatment of aortic arch pathologies is conventional open surgery. Recently, total endovascular aortic arch replacement with branched stent-grafts has been introduced into clinical practice with the aim of reducing invasiveness especially in selected high-risk patients. The aim of this review is to describe the two most commonly used branched devices for endovascular arch stent-grafting: Nexus (Endospan, Herzlia, Israle) and RelayBranch (Terumo Aortic, Glasgow, United Kingdom). Nexus is a CE-certified off-the-shelf, single branch, double stent graft system. It consists of two different components: a main module for the aortic arch and the descending aorta with a side-branch for the brachiocephalic artery (BCA), and a curved module for the ascending aorta that lands into the sino-tubular junction and connects to the main module through a side-facing self-protecting sleeve. Nexus may be used in urgent-emergency cases and also in patients with only one suitable supra-aortic target vessel but, on the other hand, it makes cerebral blood flow dependent on one source vessel only. The RelayBranch Thoracic Stent-Graft System is a custom made, double branched endograft with a wide window on its superior portion to accommodate two inner tunnels for BCA and left common carotid artery connection; bilateral cervical accesses are generally used to advance guidewires for catheterization of the inner tunnels in a retrograde fashion. RelayBranch can be customized on every patient’s specific anatomy and provides a double blood source for the brain, but it cannot be used in urgent-emergency conditions. Therefore, in order to optimize outcomes, the choice of the most appropriate device should be made considering pros and cons of each system and patient’s anatomy by an experienced aortic team. In conclusion, total endovascular aortic arch exclusion is a promising reality in selected high-risk patients.

A Novel Development of Endovascular Aortic Stent System Featuring Promising Antenna Characteristics

This article presents a deeply implanted stent antenna system for endovascular aneurysm repair (EVAR) to treat abdominal aortic aneurysm (AAA). The stent antenna is composed of multiple helical wires connected to form meshed rings incorporating a single feed wire, thereby precluding the random distribution of currents on the stent-struts. In addition to EVAR application, the key features of the proposed stent system are its better antenna characteristics, including an omnidirectional radiation pattern, high gain, and perfect impedance matching. The proposed stent antenna exhibits wide-band characteristics covering the frequency range from 850 to 950 MHz, including industrial, scientific, and medical bands (i.e., ISM 868 and 915 MHz). Moreover, the stent offers peak gain values of −20.75 and −19.04 dBi at the 868 and 915 MHz bands, respectively. Simulations were performed using the finite-element method and finite-difference time domain to evaluate the properties of the EVAR stent system. For validation, measurements were conducted with a 3-D printed AAA placed in a saline-filled American Society for Testing and Materials phantom and in minced pork. Good agreement between simulation and measured results was observed, thereby serving a first validation of the EVAR stent antenna attributes. A link budget analysis was performed to analyze the biotelemetry capabilities.

Clinical Results and Aortic Remodeling After Endovascular Treatment for Complicated Type B Aortic Dissection With the "Fabulous" Stent System.

ObjectiveTo report the clinical outcomes and aortic remodeling after the implantation of a self-developed, biomechanically optimized, two-stage thoracic stent system named Fabulous.BackgroundGiven the efficacy of the PETTICOAT concept, the benefits of Fabulous and the behavior of remodeling in different segments need further investigation.MethodsThis is a prospective and multicenter study. From 2017 to 2019, 145 patients (mean age, 56.6 years; 88.3% male) from 14 centers were included in this cohort. The clinical results and core laboratory results were from a central electronic data capture system. Computed tomographic angiography was performed preoperatively, 1 month, 6 months and yearly thereafter and was used for volumetric analysis by 3mensio (Bilthoven, The Netherlands). After the 1-year follow-up, 97.2 and 87.6% of the clinical and imaging results of the eligible patients were available.ResultsBoth stent grafts and bare stents were successfully delivered in place in 100% of the patients. The 30-day mortality and 1-year freedom from all-cause mortality were 2.1 and 96.6%, respectively. The incidence of entry flow was 11.7% at 30 days and 6.2% at 365 days. No cases of stent-induced new entry (SINE) or reintervention were observed. After the 1-year follow-up, the true lumen/overall volume ratio reached 88%. The following subdivided segment volume changes were recorded: stent graft segment TL +56%; FL −92%, bare stent segment TL +32%; FL −75%, and there were no significant changes in the visceral segment.ConclusionsThese outcomes indicated that there were favorable clinical benefits of Fabulous stent system. This device achieved a low short-term mortality and a low incidence of reintervention. In addition, patients undergoing Fabulous stent system implantation showed remodeling both on descending aorta and on the distal aorta. The volume changes in the TL and FL varied in the different segments. The long-term follow-up is still ongoing.

Abstract TP162: Long-term Experience With Resolute Onyx Balloon Mounted Stent For Medically Refractory Intracranial Atherosclerotic Disease Evaluated By Wingspan Stent System Post Market Surveillance (WEAVE) Methodology

Background and Purpose: Angioplasty and stenting is a therapeutic option for patients with medically refractory intracranial atherosclerotic disease (ICAD). We previously demonstrated the feasibility of using Resolute (R) Onyx Stent, a drug-eluting balloon mounted coronary stent (DES), for ICAD patients. WEAVE (Wingspan Stent System Post Market Surveillance) trial assessed the periprocedural safety of Wingspan Stents in ICAD patients. We present our on-going experience with R-Onyx in ICAD patients integrating WEAVE styled methodology to assess outcomes in our cohort. Methods: A prospectively maintained neuro-endovascular database was queried for intracranial angioplasty and stenting cases from October 2019 to June 2021. Patients with symptomatic ICAD despite maximum medical management with &gt;70% stenosis who were treated with R-Onyx DES were included. Primary outcomes were assessed according to WEAVE trial criteria (ischemic or hemorrhagic stroke or death within 72 h of the procedure). Secondary outcomes were assessed by occurrence of stroke and/or in-stent restenosis evaluated 30 days post-procedure clinically or angiographically. Results: A total of 58 patients were eligible for analysis with a mean age of 63.66 years, and 63.8% (n=37) were males. A total of 42 patients had an indication for treatment consisting of recurrent stroke while 16 had recurrent transient ischemic attacks. A total of 62 R-onyx DES stents were used to treat 58 patients with symptomatic lesions with an average stenosis of 84.7%. All procedures were completed successfully with &lt;30% residual stenosis and 1.7% (n=1) of patients having hemorrhage and death within 72 h. Out of 41 patients who had a long-term follow-up, 0 had a stroke. In terms of 6-month angiographic follow-ups, 1 patient had in-stent restenosis treated via angioplasty. Conclusion: Our study reinforces the feasibility of R-Onyx DES for treatment of ICAD refractory to maximal medical management by reporting low periprocedural complication rates (1.7%) according to WEAVE methodology, which itself had a periprocedural complication rate of 2.6%, and low long-term frequencies of indications such as strokes and restenosis. These findings perhaps warrant randomized comparative studies between the stents.

Mechanical characteristics of venous stents to overcome challenges of venous outflow obstruction.

Many challenges posed by the venous outflow obstruction (VOO) are unique to the venous system which require specific mechanical characteristics of stents to overcome them. Therefore, this article aims to review and discuss these challenges and the stent mechanical characteristics required to overcome them. A literature search was performed with Pubmed with the terms "mechanical characteristics of venous stents" and "mechanical properties of venous stents". The venous system poses unique anatomical, physiological and pathological challenges when compared to the arterial counterpart. Several mechanical characteristics specific to venous stents which include the size, inherent forces, and flexibility are important to overcome these unique challenges when treating VOO. The most important stent inherent forces for venous stents include the chronic outward force, radial resistive force, and crush resistance. Various stent materials and designs, particularly laser-cut versus braided-structure stents, and open-cell versus closed-cell stents, determine the mechanical characteristics including the inherent forces of the venous stents. The desired mechanical characteristics of stents needed to overcome the venous system challenges often in conflict or with opposing effects. Therefore, it is important to fine adjust and optimize these characteristics. There are many anatomical, physiological, and pathological challenges unique to the venous system which need to be overcome by the stent system mechanically when treating VOO. Therefore, dedicated venous stents with optimal mechanical characteristics are being developed with different designs and properties to treat VOO. Further research and innovations are needed to improve the stent technology that targets the venous system specifically.

Abstract 133: Resolute Stents Less Likely Than Wingspan To Have Periprocedural Complications With A Significant Improvement In Long Term Restenosis Rates

Background and Purpose: Angioplasty and stenting is a treatment option for patients with medically refractory symptomatic intracranial atherosclerotic disease (sICAD). Currently the Wingspan Stent System (WSS) is the only FDA approved device for that indication. Nonetheless, our group has shown the Resolute (R) Onyx Stent, a drug-eluting balloon mounted stent (DES), can be feasibly used to treat lesions in this population at lower cost. Herein, we compare the two stents based on our single center experience. Methods: A prospectively maintained neuro-endovascular databased was queried for patients between January 2013 to June 2021. Inclusion criteria for patients included sICAD (≥70% stenosis) with failed medical management, and intracranial stenting with either the R-onyx DES or WSS, including patients treated within 7 days of last stroke. Primary outcomes were assessed via the occurrence of ischemic or hemorrhagic stroke or death within 72 h of the procedure while secondary outcomes consisted of stroke or angiographic reoccurrence (in-stent restenosis) evaluated by a clinical or angiographic follow-up at 6 months. Results: A total of 184 patients, average age 61.26 (SD=12.53) ( 44% women), were eligible for analysis with 58 having R-onyx DES and 126 having WSS. There was no significant difference in age or premorbid risk factors between the two groups. Within 72 h, 1.7% (n=1) of patients had a primary event of ischemic or hemorrhagic stroke or death in the R-onyx DES group while 6.3% (n=8) of patients had those indications in the WSS group (p = 0.089). Among 41 angiographic and clinical follow-ups in the R-onyx DES group, none had a stroke, while among 101 of those follow-ups in the WSS group, 8.9% (n=9) had a stroke (p=0.024). In terms of 6-month angiographic follow-ups, there was a significantly lower rate of symptomatic in-stent restenosis among the R-onyx DES group with 1.7% (n=1) experiencing symptomatic in-stent restenosis, and 21.4% (n=27) in the WSS group having that indication (p=0.0003). Conclusion: Our experience has been that R-onyx DES is more effective at treating sICAD with low rates of periprocedural complications within 72 h, long-term strokes, and symptomatic in-stent restenosis. Future prospective randomized multicenter trials are needed.

Analysis of Publicly Reported Adverse Events In The Vici And Venovo Venous Stent Systems

<h3>INTRODUCTION AND OBJECTIVES</h3> The first two FDA approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's VICI and BD's Venovo Venous Stent Systems, were both recalled early 2021, within years of entering market. We set forth to analyze publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize predominant device and patient issues reported for each system. <h3>METHODS</h3> 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, device return status, and intervention performed for each adverse event were compiled and compared utilizing Fisher's exact test. <h3>RESULTS</h3> A total of 50 adverse event reports were compiled for the VICI system and 341 for the Venovo system. The most common device issue reported was migration in VICI (48% vs 0%; p=0.0001) versus activation failure in Venovo (85% vs 4%; p=0.0001). A higher proportion of Venovo adverse event reports specified no patient complications or symptoms (90% vs 26%; p=0.0001) and device return to manufacturer (13% vs 2%, p=0.07). There were several significant differences between interventions reported following adverse events for each respective device (Table) <h3>CONCLUSIONS</h3> While two venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved. Our data suggests that despite recent addition of patient issues to MAUDE reporting, standardized inclusion of reporting specific interventions would greatly assist vascular surgeons monitoring real-time adverse event trends for vascular devices.

Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction.

Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction. The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) is a single-arm, multicenter, prospective study that included 200 subjects from 24 global sites. The primary end points were 12-month primary patency and major adverse events within 30 days. Secondary end points included lesion and procedure success, primary-assisted and secondary patency, major adverse events, stent migration, stent fracture, and quality of life changes. End point-related adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. Venous obstruction cause was classified as acute deep vein thrombosis (16.5%, 33/200), post-thrombotic syndrome (47.5%, 95/200), or nonthrombotic iliac vein lesion (36.0%, 72/200). The common iliac and external iliac veins were stented in 96.0% (192/200), 80.5% (161/200) of subjects, respectively. Stent implant into the common femoral vein was required in 44.0% (88/200). Primary patency at 12 months was 88.0% (162/184). Four (2.0%) major adverse events occurred within 30 days. Twelve-month primary-assisted and secondary patency were 91.8% (169/184) and 92.9% (171/184), respectively. No stent fractures or migrations were reported. Mean target limb Villalta score decreased from 11.2±5.6 at baseline to 4.1±4.8 at 12 months, and the mean target limb revised Venous Clinical Severity Score decreased from 8.8±4.7 at baseline to 4.3±3.6 at 12 months. Clinically meaningful improvements in quality of life and venous functional assessment scores from baseline were demonstrated through 12 months in all measures. Symptomatic iliofemoral venous obstruction can be successfully treated with an Abre venous stent. Study outcomes demonstrated a high patency rate with a good safety profile. Patients demonstrated a significant reduction in clinical symptoms and improvement in quality of life that was maintained through 12-month follow-up. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03038438.