Distal Balloon Protection Research Articles

Tumor Embolization via the Meningohypophyseal and Inferolateral Trunk in Patients with Skull Base Tumors Using the Distal Balloon Protection Technique.

Tumor embolization through the meningohypophyseal trunk and inferolateral trunk is known to be effective in skull base tumors; however, microcatheter cannulation into these arteries is difficult, and the number of cases that can be safely embolized is limited. In this study, we present a novel embolization procedure for the meningohypophyseal trunk and inferolateral trunk using the distal balloon protection technique and detail its clinical efficacy and complication risks. We developed this procedure to allow safe embolization in patients who cannot be adequately cannulated with microcatheters into these arteries. Patients who underwent meningohypophyseal trunk or inferolateral trunk embolization using the distal balloon protection technique for skull base tumors at our institution between 2010 and 2023 were included. In this procedure, the ICA was temporarily occluded with a balloon at the ophthalmic artery bifurcation, the microcatheter was guided to the meningohypophyseal trunk or inferolateral trunk vicinity, and embolic particles were injected into the arteries. The balloon was deflated after the embolic particles that had refluxed into the ICA were aspirated. A total of 25 meningohypophyseal trunks and inferolateral trunks were embolized during 21 operations. Of these 25 arteries, only 9 (36.0%) were successfully cannulated with microcatheters. Nevertheless, effective embolization was achieved in all cases. Permanent complications occurred in only 1 case (4.8%) in which the central retinal artery was occluded during inferolateral trunk embolization, resulting in a visual field defect. No permanent complications resulting from the embolic cerebral infarction were observed. Of 16 cases that underwent MR imaging within a week after embolization, however, 11 (68.8%) demonstrated embolic cerebral infarctions. In patients with skull base tumors with meningohypophyseal trunk or inferolateral trunk feeders that cannot be catheterized directly, embolization using the distal balloon protection technique for tumor supply can be considered as a salvage technique.

New Distal Balloon Protection System for Transradial Carotid Artery Stenting After Percusurge Guardwire Withdrawal: Jailbreak Technique

Embolic protection devices are commonly used to prevent cerebral embolism during carotid artery stenting (CAS). However, the PercuSurge Guardwire device, a distal balloon protection device, was discontinued in April 2021. We present a case of successful CAS using a new distal balloon protection system. The procedure, referred to as the jailbreak technique, was performed via transradial access. A 67-year-old man underwent CAS, using the jailbreak technique, for right carotid stenosis with a vulnerable plaque. 6-French (Fr) and 4-Fr Simmons guiding sheaths were delivered into the right common carotid artery via the right and left transradial access, respectively. Distal balloon protection was provided using a 2.6-Fr dual-lumen balloon microcatheter (Pinnacle Blue 20, Tokai Medical Products, Aichi, Japan) via the 4-Fr Simmons guiding sheath. A 4.2-Fr catheter was coaxially delivered proximal to the balloon and distal to the lesion. After CAS was successfully performed via the 6-Fr Simmons guiding sheath, the Pinnacle Blue 20 was retrieved through the 4.2-Fr catheter without interfering with the distal stent flare and stent struts. Postprocedural neuroimaging revealed no evidence of ischemic stroke. The jailbreak technique allows distal balloon protection during transradial CAS. This is a useful treatment option for patients with carotid stenosis.

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...

Retrograde three-dimensional rotational angiography: A novel method for the detection of plaque protrusion during carotid artery stenting under continuous distal balloon protection.

To prevent ischemic complications during carotid artery stenting, accurate detection of plaque protrusion and appropriate additional treatment are essential. Here, we introduce a novel method for the detection of plaque protrusion under distal balloon protection using three-dimensional rotation angiography-"retrograde 3DRA." We evaluated the safety and efficacy of this method. We retrospectively analyzed 28 consecutive carotid artery stenting procedures under distal balloon protection at our hospital between July 2017 and August 2019. The first line of protection was dual balloon protection (proximal and distal balloon). After stent deployment, balloon dilatation, and subsequent blood aspiration, 3DRA was performed with the injection of diluted contrast medium from the aspiration catheter positioned just proximal to the distal protection balloon. The stent lumen was analyzed by obtaining the reconstruction maximum intensity projection image. Among the 28 cases, all cases could be assessed for in-stent plaque protrusion using "retrograde 3DRA." We were able to evaluate the stent lumen clearly. There were three cases (10.7%) in which plaque protrusion could be confirmed. Since additional balloon dilatation was performed for all protrusion cases under continuing balloon protection, no ischemic complications occurred. Retrograde 3DRA could be safe and useful for the detection of plaque protrusions and to avoid ischemic complication for tolerable cases of internal carotid artery transient balloon protection.

Effects of Aspiration and Re-transfusion Technique with Carotid Artery Stenting.

Embolic stroke is the most serious complication after carotid artery stenting (CAS). The incidence rate of embolic stroke is reduced by the use of embolic protection devices (EPDs); however, there is no consensus on which EPD is the most effective. The aspiration and re-transfusion technique (ART) with CAS under distal balloon protection was adopted at our center to reduce the incidence of embolic complications. This retrospective study investigated the effects of ART. From November 2010, 243 consecutive patients treated by CAS under distal balloon protection were included. ART was performed on 202 patients (ART group) and the other 40 patients only received distal balloon protection (non-ART group). In ART, the blood from the aspiration catheter was continuously returned through a filter to the femoral vein. The amount of debris was assessed intermittently using a small blood sample and the rest was returned. We investigated the diffusion-weighted imaging (DWI)-positive rate and symptomatic ischemic stroke one day after CAS. Compared with the non-ART group, the incidence of DWI-positive lesions (22.7% vs 37.5%, P = 0.07) and frequency of symptomatic ischemic stroke (0.9% vs 5.0%, P = 0.12) were reduced in the ART group. The hemoglobin reduction rate was significantly reduced by ART (11.1% vs 14.9%, P <0.01). In the ART group, the frequency of multiple lesions (more than 5) and large lesions (more than 10 mm) was lower than that in the non-ART group (P <0.01, P = 0.14). CAS under distal balloon protection with ART was effective at reducing the incidence of DWI-positive lesions and may be useful to reduce the incidence of symptomatic ischemic stroke.

Open Retrograde Stenting with a Sheathless Method Using a Balloon-guiding Catheter for Proximal Common Carotid Artery Stenosis.

Carotid artery stenting (CAS) and carotid endarterectomy are relatively difficult for proximal common carotid artery (CCA) stenosis because of the difficulty in anatomical approach. We treated proximal CCA stenosis by retrograde stenting using a 9Fr Optimo for peripheral intervention with a sheathless method. A 60-year-old woman was scheduled for total arch replacement (TAR) for an aortic arch aneurysm. Preoperative cervical MRI incidentally revealed tandem stenosis in the left CCA. We intended to treat CCA stenosis prior to aortic arch replacement. Under general anesthesia, distal left CCA was exposed. A 9Fr Optimo was introduced into CCA by retrograde with a sheathless method. The retrograde CAS was performed under distal balloon protection. Her postoperative course was uneventful. Retrograde stenting using a 9Fr Optimo for peripheral intervention with a sheathless method was safe and useful for proximal CCA stenosis.

Postoperative ischemic events in patients undergoing carotid artery stenting using algorithmic selection for embolic protection.

Carotid artery stenting (CAS) is a valuable alternative to carotid endarterectomy, especially in high-risk patients. However, the reported incidences of perioperative stroke and death remain higher than for carotid endarterectomy, even when using embolic protection devices (EPDs) during CAS. Our purpose was to evaluate 30-day major adverse events after CAS when selecting the most appropriate EPD. We reviewed the clinical outcomes of 61 patients with 64 lesions who underwent CAS with EPDs. Patients who underwent CAS associated with thrombectomy and who had a preoperative modified Rankin scale score >3 were excluded from the analysis. The EPD was selected based on symptoms, carotid wall magnetic resonance imaging and lesion length, and we analyzed combined 30-day complication rates (transient ischemic attack, minor stroke, major stroke or death). Forty-nine patients were men and 12 were women. The median age was 72 years (range: 59-89 years) and 44 lesions were asymptomatic. A filter-type EPD was selected in 23 procedures, distal-balloon protection in 14 procedures and proximal-occlusive protection in 27 procedures. Two patients (3.1%) experienced a transient ischemic attack and one patient (1.6%) had a minor stroke within 30 days of the procedure. No patients experienced procedure-related morbidities (modified Rankin score >2) or death. The perioperative stoke rate was low when we selected a proximal-occlusive-type EPD in high-risk patients with vulnerable carotid artery disease. Our algorithm for EPD selection was an effective tool in the perioperative management of carotid artery stenosis.

Ultrasound-guided carotid artery stenting through distal balloon protection

Ultrasound-guided carotid artery stenting through distal balloon protection

Navigation of a 6-French guiding sheath into the common carotid artery using a tri-axial catheter system in transbrachial carotid artery stenting.

Placement of a large-bore guiding sheath or catheter into the common carotid artery (CCA) is crucial in transbrachial carotid artery stenting (CAS). Herein, we describe technical tips for the navigation of a 6-French guiding sheath into the CCA using a tri-axial catheter system in transbrachial CAS. A total of 27 patients underwent transbrachial CAS. For the right side, a 6-French straight guiding sheath was navigated directly into the CCA using a tri-axial catheter system, with a 4-French Simmons catheter placed through a 6-French straight guiding catheter. For the left side, a 6-French Simmons guiding sheath was navigated into the CCA using a tri-axial catheter system, with a 4-French Simmons catheter placed through a 6-French Simmons guiding catheter. After the placement of a 6-French guiding sheath into the CCA, CAS was performed under distal filter or balloon protection. Fifteen patients had a right carotid stenosis and 12 patients had a left carotid stenosis. The 6-French guiding sheath was safely placed with ease and provided adequate stabilization for CAS. All procedures were successfully performed without any complications. The use of a tri-axial catheter system for the navigation of a 6-French guiding sheath into the CCA appears safe and efficient, allowing transbrachial CAS, with 6-French guiding sheath stabilization, to be performed without any complication.

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〜

血流遮断による虚血症状が遷延した頸部内頸動脈狭窄症の1 治療例

要旨：症例は78 歳男性で，左中心前回の皮質梗塞による右上肢の単麻痺で発症．頸部MRA で左頸部内頸動脈狭窄を指摘．狭窄部は内出血を伴う脆弱性プラークが示唆された．発症約2 カ月後に頸動脈ステント留置術を施行．バルーンによる遠位プロテクションを選択．左内頸動脈を遮断すると直後より右片麻痺，失語，意識障害が出現．鎮静下に速やかにステントを留置し，遮断時間は8分50 秒．血流再開後の撮影で末梢塞栓はみられなかったが，遮断解除後も虚血症状は改善しなかった．治療3 時間後には右片麻痺は改善したが失語が続き，完全に改善したのが治療翌々日であった．バルーン遠位プロテクションでは虚血耐性が問題となるが，血流再開後虚血症状は多くは速やかに改善するとされる．本症例は片麻痺が約3 時間，失語が30 時間程度遷延したが，新たな脳梗塞はみられず，その後完全回復し，純粋に虚血不耐性による症状が遷延したものと考えられた．

Multiple device時代の頚動脈ステント治療の変遷と吸引血自己輸血の導入

Multiple device時代の頚動脈ステント治療の変遷と吸引血自己輸血の導入

Endovascular stenting of symptomatic innominate artery stenosis under distal balloon protection of the internal carotid and vertebral artery for cerebral protection: a technical case report

The use of cerebral protection devices in endovascular treatment for innominate artery (IA) stenosis is not well established. We describe a novel technique for cerebral protection during endovascular stenting of symptomatic IA stenosis. An 82-year-old man presented with acutely scattered brain infarction by artery-to-artery embolism due to IA stenosis. Endovascular treatment for symptomatic IA stenosis was planned to prevent recurrent attacks. Endovascular stenting for IA stenosis via the right femoral artery approach was performed under simultaneous distal balloon protection of the right internal carotid artery (ICA) and vertebral artery (VA) via the right brachial artery approach. Successful treatment of symptomatic IA stenosis was achieved with no complications. The technique with simultaneous distal balloon protection of the ICA and VA provided excellent cerebral protection in stenting of IA stenosis.

Distal protection filter device efficacy with carotid artery stenting: comparison between a distal protection filter and a distal protection balloon

This retrospective study aimed to compare the effectiveness of the embolization prevention mechanism of two types of embolic protection device (EPD)-a distal protection balloon (DPB) and a distal protection filter (DPF). Subjects were 164 patients scheduled to undergo carotid artery stenting: a DPB was used in 82 cases (DPB group) from April 2007 until June 2010, and a DPF was used in 82 cases (DPF group) from July 2010 to July 2011. Rates of positive findings on postoperative diffusion-weighted imaging (DWI) and stroke incidence were compared. Positive postoperative DWI results were found in 34 cases in the DPB group (41.4 %), but in only 22 cases in the DPF group (26.8 %), and there was only a small significant difference within the DPF group. In the DPB group, there was one case of transient ischemic attack (TIA) (1.2 %) and four cases of brain infarction (2 minor strokes, 2 major strokes; 4.9 %), compared to the DFP group with one case of TIA (1.2 %) and no cases of minor or major strokes. In this study, significantly lower rates of occurrence of DWI ischemic lesions and intraoperative embolization were associated with use of the DPF compared to the DPB.

Neuroprotection during carotid angioplasty and stenting: Comparison of no protection, occlusion, or filters

A variety of distal emboli protection systems are in development for carotid angioplasty and stenting, each of which may be associated with its own unique capability to capture emboli. This retrospective study was undertaken to compare the incidence and type of peri-procedural (1-month) neurological events using a variety of microembolization protection strategies. This is a retrospective review of 127 consecutive procedures performed over a period of 4 years solely by vascular surgeons. This analysis was restricted to outcomes associated with the treatment of carotid bifurcation lesions. Overall, angioplasty and stenting was performed without distal protection in 32 patients. Of the remaining 95 patients, protection devices included a distal occlusion balloon (n = 18), a Filterwire (n = 54), an Accunet filter (n = 22), and a Sci-pro device (n = l). Patients were considered at high risk for open surgery due to prior endarterectomy (n = 43), radiation (n = 9), high lesion (n = 3), or cardiopulmonary comorbididity (n = 37). A majority of patients (n = 92; 73%) had an asymptomatic >80% stenosis. All procedures were done without sedation and with continuous neurological monitoring. Periprocedural neurological events were classified as a transient ischemic attack (TIA), minor or major stroke, or seizure. In the absence of distal protection, TIAs lasting fewer than 10 min were observed in four patients with an additional patient suffering a minor stroke. Seizure-like activity was observed in two patients during balloon inflation. Among those in whom a filter-based embolization protection device was utilized, TIAs were noted in three patients and none developed either a minor or major stroke. Periprocedural events were not observed with the use of distal balloon protection, although one patient had a TIA 3 weeks after intervention. All neurological events occurred during post-stent dilatation and only among patients with prior neurological symptoms and de novo lesion. Intra-operative neurological events were significantly more common in the absence of protected stenting (n = 7, 21.8%), when compared to filter protection (n = 3, 4%) or complete distal occlusion (n = 0, 0%) (p = 0.0025). However, the majority of these events were transient without permanent neurological deficit. The overall incidence of major stroke/mortality rate was 0.8%. Carotid angioplasty and stenting is a safe and effective procedure when undertaken with adequate distal protection. Adverse neurological events can be minimized by avoiding aggressive post-stent dilatation.

Cerebrospinal Fluid Enhancement on Fluid Attenuated Inversion Recovery Images After Carotid Artery Stenting with Neuroprotective Balloon Occlusions: Hemodynamic Instability and Blood–Brain Barrier Disruption

A rare complication of carotid artery stenting (CAS), prolonged reversible neurological symptoms with delayed cerebrospinal fluid (CSF) space enhancement on fluid attenuated inversion recovery (FLAIR) images, is associated with blood-brain barrier (BBB) disruption. We prospectively identified patients who showed CSF space enhancement on FLAIR images. Nineteen patients-5 acute-phase and 14 scheduled-underwent 21 CAS procedures. Balloon catheters were navigated across stenoses, angioplasty was performed using a neuroprotective balloon, and stents were placed with after dilation under distal balloon protection. CSF space hyperintensity or obscuration on FLAIR after versus before CAS indicated CSF space enhancement. Correlations with clinical factors were examined. CSF space was enhanced on FLAIR in 12 (57.1%) cases. Postprocedural CSF space enhancement was significantly related to age, stenosis rate, acute-stage procedure, and total occlusion time. All acute-stage CAS patients showed delayed enhancement. Only age was associated with delayed CSF space enhancement in scheduled CAS patients. Ischemic intolerance for severe carotid artery stenosis and temporary neuroprotective balloon occlusion, causing reperfusion injury, seem to be the main factors that underlie BBB disruption with delayed CSF space enhancement shortly after CAS, rather than sudden poststenting hemodynamic change. Our results suggest that factors related to hemodynamic instability or ischemic intolerance seem to be associated with post-CAS BBB vulnerability. Patients at risk for hemodynamic instability or with ischemic intolerance, which decrease BBB integrity, require careful management to prevent intracranial hemorrhagic and other post-CAS complications.

Angiographic impact of the GuardWire system on inflated coronary segments after six months: does the distal protection balloon of the GuardWire Plus™ lead to restenosis?

To investigate the consequences of inflating low-pressure balloon occlusion devices in native coronary arteries.One hundred eighteen segments of 118 patients who were enrolled in the ASPARAGUS study were analysed post-procedure and at six months by means of quantitative coronary angiography. ASPARAGUS was a randomised study to assess the efficacy of the PercuSurge GuardWire system in acute myocardial infarction. Patients were divided into two groups; protection group (group P, n=53) and control group (group C, n=65). Matched 15 mm segments were selected for quantitative coronary angiographies using anatomical landmarks post-procedure and at six months. There were 118 matched QCA analysis (Group P 53, Group C 65). Baseline characteristics were similar between groups. The mean minimal lumen diameter (MLD) post procedure was 1.94+/-0.57 mm in group P and 1.92+/-0.57 mm in group C. The MLD at six months was 1.98+/-0.54 mm in group P and 1.92+/-0.54 mm in group C. There was virtually no late loss in both group (P: -0.04+/-0.38 mm, C: 0.00+/-0.38 mm, p=0.561).The inflation of the low-pressure PercuSurge balloon in native coronary arteries was not associated with angiographic vascular response during the 6-month follow-up. This finding may suggest the safety of using similar technology such as the low-pressure balloon system in human native coronary arteries.

Fibro-Fatty Volume of Culprit Lesions in Virtual Histology™ Intravascular Ultrasound Is Associated with the Amount of Debris during Carotid Artery Stenting

Objectives: This study aimed to evaluate the relationship between the amount of aspirated debris during distal balloon-protected carotid artery stenting (CAS) and the pre-intervention plaque composition, as assessed by Virtual Histology™ (VH) intravascular ultrasound (IVUS). Methods: The study subjects were 25 consecutive patients (mean age, 73.0 ± 5.2 years; 20 males and 5 females) who underwent CAS under distal balloon protection. The average rate of carotid stenosis was 74.6 ± 12.9% by North American Symptomatic Carotid Endarterectomy Trial criteria. We assessed culprit plaque components by VH-IVUS before CAS. Aspirated debris was filtered, stained with HE and mounted onto glass slides. The quantity of debris was evaluated by measuring its surface area. We evaluated the relationship between the quantity of aspirated debris and VH-IVUS measurements before CAS. Results: The amount of debris during CAS was positively correlated with the total plaque volume in grayscale IVUS (Rs = 0.480, p = 0.015) and fibro-fatty volumes over the entire lesion length in VH-IVUS (Rs = 0.561, p = 0.001). Conclusions: Culprit lesions with large plaque volumes, especially larger fibro-fatty volumes, as imaged by VH-IVUS, are associated with large amounts of debris during balloon-protected CAS.

Carotid Artery Stenting in a Patient With Internal Carotid Artery Stenosis and Ipsilateral Persistent Primitive Hypoglossal Artery Presenting With Transient Ischemia of the Vertebrobasilar System -Case Report-

A 62-year-old man experienced transient episodes of vertigo associated with left upper extremity weakness. Cerebral angiography showed 75% right internal carotid artery (ICA) stenosis and divergence of a persistent primitive hypoglossal artery (PPHA) distal to the stenosis. The area of stenosis was at a high position and he had a past medical history of congestive heart failure, which contraindicated carotid endarterectomy (CEA). Therefore, carotid artery stenting (CAS) was performed with single distal balloon protection. The stenotic area was restored and he was discharged without suffering recurrent attacks. CAS may be an effective alternative treatment to CEA to prevent further ischemic attacks in the posterior circulation in patients with PPHA. CAS using simple embolic protection devices is possible if the distance between the distal end of the ICA stenosis and the origin of the PPHA is sufficiently long.

The Results of a New Distal Protection Method in Intervention for Chronic Total Occlusion of the Superficial Femoral Artery

Aims. To determine the efficacy of a new distal protection method in SFA CTO interventions. Methods and Results. From June 2003 to February 2009, ninety-two consecutive, chronic total occlusions of superficial femoral arteries were treated with catheter-based intervention using a bidirectional approach. Nine of these cases were managed with our original, distal protection method, based on symptoms, angiographic images, wire resistance, and intravascular ultrasound images. The average age was 73 years; eight patients were male. The mean occlusion length was 17.1 cm. A distal protection balloon was inserted from the retrograde sheath in the popliteal artery and placed distal to the occluded lesion after successful wire crossing. Lesion dilatation with a balloon was performed antegradely and debris was removed by 6Fr. guiding catheter. Debris was retrieved from all lesions, consisting mainly of thrombus. Where we decided not to use the distal protection method, there was no distal thromboembolism. Conclusion. In SFA-CTO intervention, the risk of distal embolization is 10%, which can be anticipated and eliminated by the distal protection method.