Carotid artery stenting with flow inversion cerebral protection and MicroNet-covered stent.

BACKGROUND: The study aims to evaluate the association of proximal flow-inversion cerebral protection and MicroNet-covered CGuard stents in reducing early and late embolic events in carotid artery stenting procedures. METHODS: From 2018 to 2023, we performed 204 procedures in 180 patients with flow inversion cerebral protection and CGuard stents at the Vascular Surgery Unit of Sant'Eugenio Hospital in Rome. Cerebral protection was achieved with a Flow-Gate2 catheter connected to a peripheral vein. The tip balloon is inflated in the CCA to obtain an effective endoclamping, the pressure difference between the carotid bifurcation and the venous compartment ensures a constant back flow with wash-out in the venous compartment. Inclusion criteria were: life expectancy of >12 months, target lesions indicating treatment according to ESVS Guidelines, increased surgical risk due to comorbidities or anatomic issues. ECD follow-up was performed immediately postoperatively, at 30 days, 6 and 12 months, and subsequently annually. RESULTS: The treatment protocol was successfully implemented in 99% of cases. No major strokes occurred, while one minor stroke (0.5%) occurred within 8 hours of the procedure, regressing in the following months. One perioperative death (0.5%) due to cerebral hemorrhage occurred three hours after the procedure. All patients remained asymptomatic, with no short or medium-term neurological score deterioration. One hemodynamically significant restenosis (0.5%) was detected at the 6-month follow-up. All patients completed the 6 months follow-up, though 6 (3%) were lost at the 12-month appointment. CONCLUSIONS: Our prospective monocentric study has demonstrated the effectiveness and safety of the FlowGate2 flow inversion cerebral protection system in association with MicroNet covered CGuard stent.

Percutaneous Retrieval of a Left Atrial Appendage Closure Device: The Device Waltz.

Embolization of a device in patients undergoing percutaneous left atrial appendage closure is an uncommon complication. We present an illustrative case of successful percutaneous retrieval of an embolized LAmbre device (Lifetech Scientific, Shenzhen, China) that was achieved with a combination of a snaring technique and forceps grasping and by using a steerable guiding catheter. (Level of Difficulty: Advanced.).

Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Vascular Access: Results From a European, Multicenter, Single-Arm Retrospective Analysis.

INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.

Common carotid artery endovascular clamping for neuroprotection during carotid stenting: Flow-gate system as an innovative treatment approach.

OBJECTIVES: We here report our clinical experience in CAS management through common carotid artery endovascular clamping with FlowGate2 system. METHODS: Forty-five patients were enrolled with de novo asymptomatic internal carotid artery stenosis ≥70%. Cerebral protection during the stenting procedure was achieved using a unique endovascular clamping technique developed in our Institution which includes: (a) the occlusion of the common carotid artery only, through inflatable balloons integrated in the FlowGate2 Balloon Guide Catheter system; (b) flow inversion connecting catheter to 16 G blood cannula previously placed in arm vein; (c) after the placement of the stent, the flow inversion is maintained for 30 s to allow debris washout. The related primary end-point was the rate of Diffusion-weighted imaging magnetic resonance (DWI) micro-embolic scattering of infarction. The patient's clinical and the neurological status were assessed prior, during and after intervention, at discharge. RESULTS: Transient clamping intolerance was observed in two patients (2/45; 4%). One minor stroke (1/45; 2%) occurred 8 hr the procedure with DWI ipsilateral micro-embolic lesions. No major strokes or deaths were observed at 3 months follow-up. DWI demonstrated ipsilateral micro-embolic scattering of infarction, in one asymptomatic patient. In all patients, no worst changes in NIHSS scale assessment were recorded at 1, 3, and 6 months. CONCLUSIONS: Our data confirmed the efficacy of FlowGate2 in terms of neuroprotection during CAS. To our knowledge, these are the first published data on this innovative approach developed in our institution. A large controlled trial is ongoing to confirm preliminary evidences.