Removal of Partially Deployed Supera Stents: Case-Based Review and Technical Considerations

Purpose: Maldeployment of the Supera stent system can result in primary technical failure, inferior primary patency, and poorer patient outcomes. The purpose of this article is to present a case series illustrating the conditions required to perform optimal stent deployment, and if necessary, undertake successful stent removal following maldeployment. Technique: Two key failures of effective Supera deployment are elongation and invagination. Several technical factors should be considered to reduce the risk of maldeployment: aggressive target vessel predilation, the use of multiple fluoroscopic views, slow deployment with controlled forward pressure applied on the delivery device, “sandwich packing” of the stent above and below target lesions, and the “pulling back” of invagination. To successfully retrieve a partially deployed stent, 3 factors should be considered: the percentage of the stent already deployed, the distance from the distal tip of the introducing sheath to the proximal extent of the deployed stent, and the severity of proximal vessel disease. The higher these factors, the greater the risk of stent detachment and failed retrieval. Conclusion: In this series of 6 cases of maldeployment, the removal of a partially deployed Supera stent appeared to be feasible and safe, with success dependent on selected technical and anatomical considerations.

BioMimics 3D vascular stent system for femoropopliteal interventions

Summary: Background: The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Patients and methods: Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. Results: A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%–93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%–2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%–86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%–82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Conclusions: Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.

CLINICAL EVALUATION OF THE INDIGENOUSLY MANUFACTURED REJUVENATE® BARE METAL STENT SYSTEM IN PAKISTANI PATIENTS WITH CORONARY ARTERY DISEASE

Objectives: The aim of this pilot study was the first-in-man evaluation of the safety, feasibility, deliverability, and efficiency of the newly developed REJUVENATE® bare metal stent system in coronary artery disease. Methodology: Current study was a pilot non-randomized, multi-centric and prospective study which was intended to study the safety of the REJUVENATE® bare metal stent in Pakistani population over 10 months. Study endpoints included target vessel related myocardial infarction, stent thrombosis, in-stent restenosis, stroke and death. The diameter of the target lesions selected was between 3-4mm with length no more than 22mm. Only one BMS was implanted per patient. These patients had well defined regular clinical follow-ups and CT scan coronary angiography at the end of 10 months. Results: 20 patients suffering from coronary artery disease (CAD) including15 male subjects and 5 female subjects were enrolled in this study and were treated with REJUVENATE® BMS. 65% patients were hypertensive, 25% diabetics and 25% were active smokers. Out of the 20 stents implanted, 14 stents were implanted in the right coronary artery and 6 were implanted in the left circumflex artery. During this 10-month study period there was 10.65% of cases in which late lumen loss (lumen stenosis <70%) was observed, however no cases of in stent restenosis and stent thrombosis were observed. There was no target vessel related myocardial infarction or stroke as well. One patient died of pneumonia during the follow up period. Conclusion: The current study demonstrated the deliverability and clinical safety of REJUVENATE® bare metal stent over a period of 10 months.

Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results

BackgroundFew prospective series have described the safety and effectiveness of the Neuroform Atlas Stent System. We aimed to investigate the efficacy and safety of the device in patients treated for unruptured aneurysm.MethodsATLAS EU PMCF is a consecutive, prospective, multicentric study that included patients with unruptured saccular aneurysm of all sizes. Follow-up visits were scheduled at 3–6 months and 12–16 months with digital subtraction angiography (DSA) or MRI imaging follow-up as per the site standard of care. The primary efficacy endpoint was adequate aneurysm occlusion (Raymond Roy occlusion grade I and II) on 12 month angiography. The primary safety endpoint was any major stroke or ipsilateral stroke or neurological death within 12 months.ResultsOf the 106 patients consented, 105 were treated with at least one Neuroform Atlas stent. There was a failed implantation attempt in 1 patient, 85 patients received lateral stenting, and 19 patients received Y-stenting. Mean aneurysm neck size was 4.2 mm (range 1.9–33 mm). Adequate occlusion was observed in 95.1% immediately after the procedure and in 98.9% of cases at 1 year DSA follow-up. Overall, 1.0% (1/102; 95% CI 0.0% to 5.3%) of patients experienced a primary safety endpoint of major stroke. Three minor strokes resulted in a modified Rankin Scale score of 2.ConclusionsIn this multicentric, prospective study, stent-assisted coiling of medium size unruptured aneurysms with the Neuroform Atlas stent resulted in a favorable rate of satisfactory occlusion. In our findings, the use of the Y-stenting technique was associated with increased rates of procedural complications.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02783339.

Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial

ObjectiveTo evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.Methods145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed.Results145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%)ConclusionAs compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms.Clinical registration numberNCT01801007

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Background: Drug penetration into the deeper arterial wall of heavily calcified lesions is one of the limitations of drug-coated balloons and drug-eluting stents in vascular interventions. The Temporary Spur Stent (TSS) system is characterized by a self-expanding nitinol stent that is uniformly covered in radialspikes, which, when coated, should allow a deeper penetration and longer retention of the drug into the diseased artery walls by penetrating through the calcified plaques. Materials and Methods and Results: Uncoated TSS and paclitaxel (PTX)-coated TSS systems have been deployed in porcine peripheral arteries. Four weeks after the deployment of uncoated TSS systems, no adverse vascular remodeling or neointimal formation in the treated vessel segments were noticed. PTX-coated TSS systems transferred 9%±7% of the drug that was on the device to the targeted vessel area (196±163 ng PTX/mg arterial tissue) and the addition of the fluorescent dye Nile red to the coating showed that the spikes promote the transfer of the coating to the deeper layers of the vessel wall. The PTX-coated TSS systems showed a significant reduction in neointimal proliferation compared to the uncoated TSS systems: quantitative angiography showed a vessel diameter stenosis of 37.2%±11.0% and 16.4%±8.8% 4 weeks after the treatment with uncoated and PTX-coated TSS systems, respectively. Conclusion: The treatment with the TSS system was well tolerated and the spikesfacilitate the transfer of the coating into deeper layers of the vessel wall. Moreover, the PTX-coated TSS systems effectively inhibit neointimal proliferation.