Proximal Balloon Protection Research Articles

In vitro testing of a funnel-tip catheter with different clot types to decrease clot migration in mechanical thrombectomy.

Mechanical thrombectomy is the standard treatment for acute ischemic stroke in patients with large vessel occlusion and can be performed up to 24h after symptom onset. Despite high recanalization rates, embolism in new territories has been reported in 8.6% of the cases. Causes for this could be clot abruption during stent retrieval into the smaller opening of a standard distal access catheter, and antegrade blood flow via collaterals despite proximal balloon protection. A funnel-shaped tip with a larger internal diameter was developed to increase the rate of first-pass recanalization and to improve the safety and efficacy of mechanical thrombectomy. This in vitro study compared the efficacy of a funnel-shaped tip with a standard tip in combination with different clot compositions. Mechanical thrombectomy was performed 80 times for each tip, using two stent retrievers (Trevo XP ProVue 3/20 mm, 4/20 mm) and four different clot types (hard vs. soft clots, 0-24h vs. 72h aged clots). Significantly higher first-pass recanalization rates (mTICI 3) were observed for the funnel-shaped tip, 70.0% versus 30.0% for the standard tip (absolute difference, 32; relative difference 57.1%; P < .001), regardless of the clot type and stent retriever. Recanalization could be increased using harder Chandler loop clots versus softer statically generated clots, as well as 0-24h versus 72h aged clots, respectively. The funnel-shaped tip achieved higher first-pass recanalization rates than the smaller standard tip and lower rates of clot abruption at the tip. Clot compositions and aging times impacted recanalization rates.

Real-time angiography in endovascular revascularization of intracranial atherosclerotic internal carotid artery stenosis under proximal balloon protection: “Retrograde suction-injection” technique and literature review

Intracranial angioplasty/stenting is a treatment option for patients with symptomatic intracranial atherosclerotic disease refractory to aggressive medical treatment. However, it carries a risk of procedure-related embolism as well as reperfusion hemorrhage and in-stent thrombosis. We have devised a new embolic protection system which can achieve both total ipsilateral internal carotid artery (ICA) embolic protection and real-time visualization of the target lesion during endovascular revascularization of intracranial atherosclerotic disease below the carotid T junction. Herein, we describe a case of medically refractory symptomatic intracranial atherosclerotic ICA stenosis successfully treated with this method.

Carotid Angioplasty and Stenting for Occlusive Diseases.

Stenting for carotid artery stenosis (CAS) was once denied 15years ago because it failed to prove the non-inferiority to carotid endarterectomy (CEA). However, it is now reevaluated and is thought better due to higher safety and efficacy thanks to the development of devices, strategies, and various protection methods. To achieve the safe CAS, protection methods and stents should be properly selected based on the vessel course and plaque components on the preoperative plaque images. Particularly multiple protection methods including proximal balloon protection and double-layer micromesh stents are useful for the cases with high-risk and fragile plaque. Perioperative anti-platelet management and the control of blood pressure are also important to avoid the ischemic complications and hyperperfusion. Properly protected and tailored CAS based on the risk management has dramatically improved the clinical results and contributed to extend the indication for more difficult lesions.

Subclavian Artery Stenting Under Cerebral Protection by Balloon-Guiding Catheter Inflation Inside the Aortic Arch at the Left Subclavian Artery Origin

We describe a simple and novel technique for cerebral protection during left subclavian artery (SA) stenting by inflation of a balloon-guiding catheter inside the aortic arch at the SA origin. A total of 12 patients with left SA stenosis underwent SA stenting with inflation of a balloon-guiding catheter inside the aortic arch at the left SA origin between January 2020 and December 2020. The SA stenting procedures under proximal protection were retrospectively reviewed to assess ischemic complications, hyperintense spots on diffusion-weighted imaging (DWI), and flow direction of left vertebral artery (VA) during balloon-guiding catheter inflation using ultrasonography (US). The success rate of the SA stenting procedure was 100% with no symptomatic ischemic complications. None of the 12 patients showed small hyperintense spots in DWI. In all patients, the left VA on US during balloon inflation showed retrograde blood flow. The left VA on US had retrograde blood flow during inflation of the balloon-guiding catheter inside the aortic arch at the SA origin. Therefore, the proximal balloon protection inside the aortic arch at the SA origin is a simple and maybe a safe technique for cerebral protection during SA stenting.

Endovascular revascularization of symptomatic chronic total occlusions of the internal carotid artery using a proximal balloon protection device.

To investigate the feasibility, efficacy, and safety of endovascular recanalization for symptomatic chronic internal carotid artery occlusions (ICAO). Thirty patients with symptomatic chronic ICAO were treated using the endovascular recanalization method. Proximal balloon protection devices were used to prevent embolic migration by completely blocking the blood flow. The morphology of the internal carotid artery (ICA) at the occluded segment based on catheter angiography was analyzed. Recanalization of symptomatic chronic internal carotid artery occlusion (CICAO) was successful in 20 of the 30 patients (66.7%). The time required for successful revascularization ranged from 120 to 180 min (mean, 150 min). Of the 20 successful patients, 14 were at the cervical ICAs, and six were at the intracranial ICAs. No permanent complications occurred in our study. Ischemic symptoms related to chronic ICAO did not occur during the 18.3 month follow-up period (range, 12-24 months) in the 20 successful patients. Endovascular revascularization can improve hemodynamic compromise. The treated sites of all 20 successfully recanalized patients were patent on computed tomographic angiography or carotid duplex sonography, and no case with >50% restenosis was observed during the follow-up period. Three patients with failed recanalization had a stroke during the follow-up period. Endovascular revascularization of symptomatic CICAO using a proximal balloon protection device is technically feasible in selected patients, and the outcomes are favorable for patients who benefit from revascularization.

Safety and efficacy of an open-cell stent and double-balloon protection for unstable plaques: analysis of 184 consecutive carotid artery stentings

IntroductionIn our institute, most cases of carotid artery stenosis are treated by carotid artery stenting (CAS) with an open-cell stent and double-balloon protection, even if plaques are unstable. This study...

Proximal Balloon Protection during Carotid Artery Stenting via the Transradial Approach

Proximal Balloon Protection during Carotid Artery Stenting via the Transradial Approach

経上腕動脈の頚動脈ステント留置術で応用できる protection 法の工夫〜7Fr ガイディングシースを用いて proximal balloon protection から total distal balloon protection へ切り替える方法〜

経上腕動脈の頚動脈ステント留置術で応用できる protection 法の工夫〜7Fr ガイディングシースを用いて proximal balloon protection から total distal balloon protection へ切り替える方法〜

近赤外線スペクトロスコピーを用いて頚動脈ステント留置術後過灌流現象を評価する妥当性についての検証

Hyperperfusion syndrome is a complication of carotid artery stenting (CAS) that leads to a poor outcome. Therefore, prevention of hyperperfusion syndrome is important in the perioperative management of CAS. We performed CAS under general anesthesia with both proximal balloon protection and distal filter protection. We used the Invos system to monitor regional cerebral oxygen saturation (rSO2) for 2 days after CAS. Although the Invos system provides continuous and less-invasive monitoring, rSO2 values may be influenced by the patient's respiratory or circulatory conditions. In this study, we compared perioperative rSO2 monitoring and single-photon emission computed tomography (SPECT) imaging, and report the efficacy of rSO2 monitoring in predicting hyperperfusion syndrome.Methods: SPECT was performed before and one day after CAS; rSO2 monitoring was continuously performed from immediately before induction of general anesthesia until two days after CAS.Results: In total, 44 patients underwent 49 CAS operations at our institution between January 2012 and December 2013. One patient who did not undergo SPECT imaging 1 day after CAS was excluded. The median age of all patients was 74 years and 88% patients were male. One patient experienced asymptomatic subarachnoid hemorrhage after CAS. According to the SPECT imaging results, hyperperfusion phenomenon was diagnosed in 4 patients, in 3 of whom the increase in the ratio of rSO2 on balloon deflation was above 0.2 and the decrease in ratio of rSO2 on balloon inflation was below 0.15. In one of these 4 patients, compared to the preoperative status, the difference between ipsilateral rSO2 and contralateral rSO2 increased by more than 5% after CAS.Conclusion: A change in the rSO2 ratio by proximal balloon protection could be one of the indices of hyperperfusion phenomenon. In some cases, rSO2 monitoring alone may not detect hyperperfusion. Therefore, another method such as SPECT imaging may be used in combination with rSO2 to detect hyperperfusion syndrome after CAS.

Transfemoral Carotid Artery Stenting Using Proximal Balloon Protection for Patients with Severe Elongation of the Aortic Arch: Inner-catheter Exchange with the Balloon Guide Catheter Anchored (“BGA Exchange”)

Transfemoral Carotid Artery Stenting Using Proximal Balloon Protection for Patients with Severe Elongation of the Aortic Arch: Inner-catheter Exchange with the Balloon Guide Catheter Anchored (“BGA Exchange”)

慢性期内頚動脈完全閉塞に対する脳血管内治療

EC-IC bypass based on the inclusion criteria of Japanese EC-IC Bypass Trial (JET study) is recommended for chronic total occlusion (CTO) of the internal carotid artery (ICA). But patients who do not meet the inclusion criteria of the JET study are also entitled to the best possible medical treatment. Recently several authors have reported the successful endovascular recanalization of CTO of the ICA. We report 10 cases of symptomatic CTO of the ICA that did not meet the inclusion criteria of the JET study that were treated by endovascular recanalization. Cerebral angiogram showed complete occlusion of the ICA and opacification of the cavernous segment of ICA or the more proximal portion of the ICA via collateral channels. Xenon CT (Xe-CT) showed hemodynamic compromise in all cases. The endovascular procedure was performed by proximal balloon protection of the common carotid arery and the external carotid artery via transfemoral route under local anesthesia. The occlusion of the ICA was recanalized successfully in all cases. Carotid artery stenting (CAS) was performed in eight cases identified as occlusion at the cervical ICA, and percutaneous transluminal angioplasty (PTA) with stenting using coronary stents was performed in two cases identified as occlusion at the cavernous or petrous ICA. Neither new ischemic symptoms nor hyperperfusion syndrome appeared after treatment. Endovascular recanalization of symptomatic CTO of the ICA can be considered as an alternative treatment for patients who do not meet the inclusion criteria of the JET study.

Carotid artery stenting using the proximal or dual protection method for near occlusion of the cervical internal carotid artery

The treatment for patients with near occlusion of the cervical internal carotid artery (ICA) is controversial. The aim of this study was to examine the results of carotid artery stenting (CAS) as a surgical treatment for ICA near occlusion. Between April 2008 and September 2012, 14 patients (all men; mean age, 75.4 years) with ICA near occlusion were treated with CAS. This represents 5.2% of a total of 267 patients treated with CAS during the study period. All patients were treated with CAS using an embolic protection device. The proximal balloon protection method was performed in five patients, and the dual protection method using a proximal balloon and distal filter protection was used in nine patients. We examined the change of stenotic lesion, hyperintensity spot in diffusion-weighted imaging (DWI), and perioperative complications after CAS. All near occlusions were successfully dilated. Among 2 of 14 patients, DWI showed 1 and 4 hyperintensity spots. Transient and persistent complications, including neurological deficits, did not occur in any patients. In this small number of cases, CAS using the proximal or dual embolic protection method seems to be a safe and beneficial treatment for ICA near occlusion.

Comparison of anti-embolic protection with proximal balloon occlusion and filter devices during carotid artery stenting: clinical and procedural outcomes.

AimThe objective of this study was to compare the periprocedural and clinical outcomes after carotid artery stenting (CAS) with proximal protection devices versus with distal protection devices.Material and methodsPatients with internal carotid artery (ICA) stenosis undergoing CAS with cerebral embolic protection were randomly assigned to proximal balloon occlusion or distal filter protection. Adverse events were defined as death, major stroke, minor stroke, transient ischemic attack (TIA) and myocardial infarction (MI). Periprocedural and 30-day adverse events and ICA vasospasm rates were compared between the two embolic protection groups.ResultsEighty-eight consecutive patients were randomized: 48 patients with proximal protection (mean age 68.8 ±13.6, 66% male) and 40 patients with a distal protection device (mean age 65.4 ±12.3; 70% male). There was no significant difference in periprocedural or 30-day adverse event rates between the two groups (p > 0.05). However, there was a higher periprocedural ICA vasospasm rate in the distal filter protection group (9 patients, 23%) compared with the proximal balloon occlusion group (1 patient, 2%) (p = 0.019).ConclusionsThere was no difference between the clinical periprocedural and 30-day adverse event rates of distal filter and proximal balloon protection systems. However, distal filter protection systems showed higher rates of periprocedural ICA vasospasm.

Transvenous balloon-protected embolization of a scalp arteriovenous fistula using Onyx liquid embolic

Scalp arteriovenous fistulas (AVFs) are rare and potentially complex lesions that can be treated in a multimodal fashion. We present here the first successful treatment of a Stage Ib scalp AVF using a balloon-protected, retrograde transvenous embolization with the liquid embolic Onyx. We describe the case of a 60-year-old man with a scalp AVF that had a fine, diffuse, serpiginous arterial supply, precluding a transarterial approach, and multiple venous drainage paths, including the external jugular vein (EJV). The lesion was successfully embolized exclusively via a femoral transvenous retrograde approach using Onyx with balloon-protection of the EJV to simultaneously prevent pulmonary embolism and enable improved retrograde casting of the fistula-outflow zone. The combined use of Onyx with proximal balloon-protection in a transvenous retrograde femoral approach is a novel method that can be used to definitively treat scalp AVFs with a defined catheter-accessible venous outflow. This technique may be useful when transarterial embolization, direct puncture, or surgical excision are not practical or possible.

Percutaneous angioplasty of a chronic total occlusion of the intracranial internal carotid artery. Case report

Background A CTO of the intracranial ICA is usually managed medically and rarely by EC-IC bypass in selected patients. Percutaneous transluminal angioplasty has not been used. Case Description A 73-year-old man presented with frequent temporary blindness of the left eye and dizziness due to thrombotic occlusion of the left intracranial ICA, causing hemodynamic compromise. This patient was successfully treated by percutaneous angioplasty (balloon angioplasty and stent placement) under proximal balloon protection at 7 weeks from the ictus. Ischemic symptoms had not recurred during the 6-month follow-up period. Conclusion Percutaneous angioplasty for a CTO of the intracranial ICA is technically feasible and can be an alternative to EC-IC bypass in a selected group of patients with symptomatic hemodynamic compromise, which is refractory to the best medical treatment.

Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients

Purpose To evaluate the short-term outcome of patients who underwent carotid stenting with the routine use of cerebral protection devices. Methods In five centers, 808 successful stent procedures (of 815 attempted) were performed in 753 patients (557 [74%] men; mean [± SD] age, 70 ± 8 years). Cerebral protection involved distal filter devices (n = 640), occlusive distal balloons (n = 144), or proximal balloon protection (n = 24). Results The protection device was positioned successfully in 793 (98.2%) of the 808 attempted vessels. Neurologic complications occurred within 30 days after 46 procedures (5.6%), including seven major strokes, 17 minor strokes, and 22 transient ischemic attacks. There were four deaths (one following a major stroke). The 30-day incidence of stroke and death was 3.3% (27/815). The rate of stroke or death was 3.8% (8/213) for symptomatic lesions and 3.2% (19/602) for asymptomatic lesions ( P = 0.87), and 3.4% (25/729) in patients aged <80 years and 2% (2/86) in those aged ≥80 years ( P = 0.81). Protection device–related vascular complications, none of which led to neurologic symptoms, occurred after nine procedures (1.1%). Conclusion In this uncontrolled study, routine cerebral protection during carotid artery stenting was technically feasible and clinically safe. The incidence of major neurologic complications in this study was lower than in previous reports of carotid artery stenting without cerebral protection.