Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery:A prospective,multicenter,single-arm clinical trial

Objective:To evaluate the safety and efficacy of the SeparGateballoon-guiding catheter(BGC)for blocking flow and delivering devices in neurointerventional surgery.Method:This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy.The primary endpoint was immediate procedural success rate in flow arrest,device delivery,and withdrawal.The efficacy endpoints were intraoperative product performance,including rigidity,smoothness,fracture resistance of the catheter wall,catheter push performance,compatibility and radiopaque display,integrity,adhesion thrombus after withdrawal and balloon rupture.The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration.Result:A total of 129 patients were included;of them,128 were analyzed in the full analysis set(FAS)and per protocol set(PPS).Immediate procedural success was achieved in 97.7%of patients with FAS and PPS.The lower bound of the 95%confidence interval was 94.6%,higher than the preset efficacy margin of 94%.Device-related adverse events occurred in 2(1.6%)cases.One was mild adverse event of vasospasm,which resolved spontaneously.The other was serious adverse event of dissection aggravation,which was treated with stenting angioplasty.No device defects were observed.Conclusion:In neurointerventional surgery,the SeparGateBGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.

Hepatic artery stenosis angioplasty and implantation of Wingspan neurovascular stent: A case report and discussion of stenting in tortuous vessels

BACKGROUND Hepatic artery stenosis is a complication of orthotopic liver transplant occurring in 3.1%-7.4%of patients that can result in graft failure and need for retransplantation.Endovascular therapy with angioplasty and stenting has been used with a high degree of technical success and good clinical outcomes,but tortuous hepatic arteries present a unique challenge for intervention.Suitable stents for this application should be maneuverable and conformable while also exerting adequate radial force to maintain a patent lumen.CASE SUMMARY Herein we report our experience with a neurovascular Wingspan stent system in a challenging case of recurrent hepatic artery stenosis and discuss the literature of stenting in tortuous transplant hepatic arteries.CONCLUSION Wingspan neurovascular stent is self-expanding,has good conformability,and adequate radial resistance and as such it could be added to the armamentarium of interventionalists in the setting of a tortuous and stenotic transplant hepatic artery.

Stroke and Left Ventricular Assist Device (LVAD)

Treatment of ischemic stroke for a patient on left ventricular assist device (LVAD) by neurointerventional means is rare and many anesthesia providers are unfamiliar with both LVAD and neurointerventional protocols. Examples of this include: 1) filling for continuous-flow LVAD depend on preload and the flow is inversely related to afterload;as mean arterial pressure (MAP) increases above 80 to90 mmHg, flow decreases;2) there may be no palpable pulse in patients with continuous flow LVADs;3) pulse oximetry may not work when pump flow is high and native myocardial function is minimal;4) increasing MAP above80 mmHg potentially will maintain ischemic brain tissue—the penumbra—until flow is restored. This latter example creates a paradoxical management goal: increasing the mean arterial pressure (MAP) above80 mmHg while maintaining ischemic brain tissue, may decrease flow to the LVAD. Finally, there is controversy regarding which type of anesthesia is most efficacious for neuro interventional procedures. We describe three patients on LVAD suffering ischemic stroke requiring anesthesia for embolectomy and angioplasty during neruointeventioal radiology procedures.