Distal Balloon Protection Research Articles

Clinical Predictors of Transient Ischemic Attack, Stroke, or Death within 30 Days of Carotid Artery Stent Placement with Distal Balloon Protection

Carotid artery stent placement has been accepted as an effective alternative to carotid endarterectomy (CEA), especially in patients at high risk in the setting of CEA. The purpose of this study was to determine potential clinical risk factors for the development of postprocedural neurologic deficits after carotid artery stent placement. The clinical characteristics of 58 patients (49 men, nine women; 41 at high risk with CEA, 17 at low risk; median age, 70 years) who underwent carotid artery stent placement with distal balloon protection for 65 hemispheres/arteries (31 asymptomatic lesions and 34 symptomatic lesions) and the combined 30-day complication rates (transient ischemic attack [TIA], minor stroke, major stroke, or death) were analyzed. Six patients (9.0%) experienced a TIA and one patient (1.5%) had a major stroke (1.5%) within 30 days of the procedure. There were no deaths, so the overall 30-day combined stroke and death rate was 1.5%. The chi(2) test revealed that advanced age (>75 years) was a significant clinical predictor of 30-day combined neurologic complications and major adverse effects (P < .01). In addition, a symptomatic lesion was marginally associated with the 30-day incidence of neurologic ischemia on the ipsilateral side (P = .049). Our data suggest that carotid artery stent placement with distal balloon protection can be performed with similar periprocedural complication rates as CEA. CEA should be the first-line treatment in the management of patients older than 75 years of age.

Carotid angioplasty and stenting under protection: advantages and drawbacks

Carotid stenosis is responsible for approximately 30% of strokes, and carotid endarterectomy is considered to be the gold-standard treatment. Carotid angioplasty and stenting (CAS) has been proposed as an alternative to surgery but the risk of neurological complications and brain embolism remains the major drawback to this procedure. Embolic protection devices (EPDs), which retain particles and debris generated during the procedure, have been proposed to reduce the frequency of neurological complications. Three types of EPD have been developed: distal occlusion balloon, distal filters and proximal protection devices. Preliminary clinical results indicate that the routine use of an EPD along with specifically designed flexible stents, increasing skills of the interventionist and appropriate drugs combine to reduce ischemic neurological complications and can achieve similar results to the best surgical series, particularly in high surgical risk patients. Recent prospective, multicenter controlled trials and registries evaluating CAS with EPD have demonstrated that the CAS results are, at least, not inferior to surgery for patients at high risk for surgery (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy study) and in symptomatic patients (Stent Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy study). However, all protection devices are not equivalent and have some drawbacks. Advantages and disadvantages of each EPD will be analyzed in this review, allowing a good choice of the EPD depending on the patient and the lesion. Nevertheless, there is now a consensus among specialists to perform all CAS with EPD. EPDs have become an integral part of CAS and the routine use of EPDs seems beneficial, leading to a 60% reduction of brain embolisms.

Outcome of carotid endarterectomy and stent insertion based on grading of carotid endarterectomy risk: a 7-year prospective study

The authors of this study prospectively compared periprocedural neurological morbidity and the appearance of lesions on diffusion-weighted (DW) magnetic resonance (MR) imaging in patients who had undergone carotid endarterectomy (CEA) or carotid artery stent placement (CASP) with distal balloon protection, based on a CEA risk grading scale. Patients undergoing CEA (139 patients) and CASP (92 patients) were classified into Grades I to IV, based on the presence of angiographic (Grade II), medical (Grade III), and neurological (Grade IV) risks. Although not randomized, the CEA and CASP groups were well matched in terms of the graded risk factors except for a greater proportion of neurologically unstable patients in the CEA group (11 compared with 3%, p = 0.037). There were greater proportions of asymptomatic (64 compared with 34%, p = 0.006) and North American Symptomatic Carotid Endarterectomy Trial-ineligible patients (29 compared with 14%, p < 0.0001) in the CASP group. The overall rates of neurological morbidity with ischemic origin and the appearance of lesions on DW MR imaging after CEA were 2.2 and 9.3%, and those after CASP were 7.6 and 35.9% (nondisabling stroke only), respectively. The only disabling stroke was caused by an intracerebral hemorrhage attributable to hyperperfusion in one case (0.7%) of CEA. There were no deaths. There was no significant association between neurological morbidity and the risk grade in patients who had undergone CEA, although the incidence of lesions on DW imaging was significantly greater in the Grade IV risk group compared with that in the other risk groups combined (42.1 compared with 4.2%, p < 0.0001). After CASP, a higher incidence of neurological morbidity and lesions on DW imaging was noted for the Grade II and III risk groups combined as compared with that in the Grade I risk group, regardless of a symptomatic or an asymptomatic presentation (neurological morbidity: 10.5 compared with 3.1%, respectively, p = 0.41; and DW imaging lesions: 47.4 compared with 19.4%, p = 0.01). The incidence of lesions on DW imaging after CEA was significantly lower than that after CASP except for the Grade IV risk groups. Despite a higher incidence of DW imaging-demonstrated lesions in the Grade IV risk group, there was no significant association between the risk group and neurological morbidity rates after CEA. The presence of vascular and medical risk profiles conferred higher rates of neurological morbidity and an increased incidence of lesions on DW imaging after CASP. Considering that no serious nonneurological complications were noted, CEA and CASP appear to be complementary methods of revascularization for carotid artery stenosis with various risk profiles.

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.

Synergism of rheolytic thrombectomy and embolic distal protection using the percusurge guardwire for fresh thrombus removal: An in vitro study

To test the effectiveness of Rheolytic Thrombectomy (RT) and distal protection balloon wires when used synergistically in an in vitro model. Although effective, currently available technologies may not be individually ideal for fresh clots removal. Fourteen, fresh blood samples were placed in 14 plastic tubes and left to clot for 6 h. A Percusurge Guardwire balloon was inflated distal to the clot and aspiration was performed using RT in seven tubes and manual aspiration (MA) with the Export catheter in seven tubes. The residual clot in each tube was dried and weighed. Both aspiration systems were advanced over the Guardwire. During RT, none of the protection balloons ruptured and no retrograde clot embolization were observed. MA was most effective when the Export catheter tip was not in direct contact with the clot. The residual clot mass post RT was significantly less than post MA (9.7+/-2.2 versus 59.2+/-45.9, P = 0.01). RT is compatible with Distal Protection Balloon Wires and results in more complete clot removal than manual aspiration with the export catheter. Although manual aspiration results in a large variation in extraction efficacy, it is most effective when direct catheter-clot contact is kept to a minimum.

Inflammatory and vasoactive factors in the aspirate from the culprit coronary artery of patients with acute myocardial infarction

Background Besides distal embolization of thrombus and plaque debris, locally increased inflammatory markers at the site of ruptured plaque in acute myocardial infarction (AMI) are thought to have an adverse impact on myocardial reperfusion during primary percutaneous coronary intervention (PCI). However, there is lack of data on such factors. Therefore, we investigated the presence of locally increased inflammatory and vasoactive factors in culprit coronary artery. Methods We performed primary PCI with PercuSurge GuideWire system in 18 AMI patients. We collected blood samples from the femoral artery before PCI and from culprit coronary artery after first predilation while inflating the distal protection balloon and after completing PCI. We determined concentrations of C-reactive protein, soluble CD40 ligand, Interleukin (IL-6), serotonin, tissue factor, and factor VIIa. Results While the concentrations of soluble CD40 ligand (2.84 ± 3.74 vs 0.98 ± 0.63 ng/mL, p = 0.004), IL-6 (33.67 ± 32.63 vs 17.08 ± 21.41 pg/mL, p < 0.001), serotonin (2.05 ± 0.76 vs 0.92 ± 0.60 ng/mL, p < 0.001), tissue factor (257.17 ± 84.34 vs 154.60 ± 87.99 pg/mL, p < 0.001) and factor VIIa (34.30 ± 27.30 vs 24.19 ± 28.00 ng/mL, p = 0.016) were significantly higher in the culprit coronary artery than in the femoral artery, CRP levels did not differ. The locally elevated concentrations of various factors were successfully reduced after multiple aspirations of blood using the PercuSurge GuideWire system. Conclusions We found increased levels of soluble CD40 ligand, IL-6, serotonin, tissue factor and factor VII in the culprit coronary artery compared to those in peripheral blood. The clinical impact of such locally increased soluble factors in the culprit coronary artery needs to be investigated in further studies.

Nonsurgical Carotid Revascularization

Carotid endarterectomy is a well-established treatment of improving the carotid luminal diameter and preventing strokes, and the indications and complications are well-defined. Carotid angioplasty and stent placements are relatively newer ways of treating carotid artery stenosis. In certain contexts, they may have some advantages over carotid endarterectomy. However, the success rates, morbidity, and mortality associated with these procedures are less well characterized. In earlier comparative studies, the incidence of ipsilateral stroke rate was higher with angioplasty, but in later studies, this trend is reversing. Angioplasty may also have an edge in specific situations like patients with coexisting significant coronary arterial disease, contralateral carotid artery occlusion, and in instances when the narrowing is long and at multiple sites. Protective devices like distal occlusion balloon and filter protection devices may reduce the incidence of stroke. We are still awaiting the results of some major randomized head-to-head trials comparing carotid endarterectomy and stenting.

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Purpose: We experimentally assessed the pitfalls of distal balloon protection systems to learn technique tips for safe procedures. Materials and methods: Silicone carotid artery models were connected to a circulatory system to simulate carotid bifurcation. A distal balloon protection device, PercuSurge GuardWire Plus (PSGWP, Medtronic Vascular) was navigated to the internal carotid artery (ICA) and inflated to occlude ICA flow temporarily. A debris aspiration catheter (Thrombuster, Kaneka Medics) was navigated just proximal to the PSGWP coaxially to introduce and diffuse particulate debris (200-500 micro meter in diameter) in the ICA stump. After debris in the stump was aspirated, the PSGWP was deflated. We recorded all the processes of our simulation experiments on a digital video and observed the movements of debris during these experiments. Exp 1) We simulated the movements of debris in the ICA stump when the PSGWP balloon was gradually deflated to produce a gap between the balloon and vessel wall, simulating accidental movement of the PSGWP balloon during the procedure. Exp 2) To assess the optimal placement of the tip of aspiration catheter, the debris in the ICA stump was aspirated from 3 different sites (from just below the GuardWire balloon, from 5 cm below it, and at the ICA orifice). Exp 3) To assess the capacity of the aspiration catheters (7F, 6F Thrombusters (Kaneka Medics), 5.4F Export catheter (Medtronic Vascular), we compared the time to aspirate 20 cc of normal saline. Results: Exp 1) When the gap appeared between PSGWP balloon and silicone tube, simulated debris began to concentrate just below the balloon. Then, some debris migrated distally from the gap, and other debris crowded in the gap so that it was impossible to aspirate and migrated. Exp 2) Debris aspiration was most effective from immediately below the PSGWP, and the aspiration ability declined as the distance between the balloon and aspiration catheter became longer. Exp 3) The aspiration time for 20 cc of normal saline is 8.4+/-0.2 sec, 12.8+/-0.5 sec, 13.3+/-0.1 sec. in case of 7F Thrombuster, 5.4F Export catheter, 6F Thrombuster, respectively. Conclusion: Our simulation studies show that when the PSGWP was moved accidentally during CAS procedures, or when the aspiration catheter was not delivered all the way to the PSGWP balloon, distal embolization might still occur, even when care is taken. So to protect the distal embolism, the PSGWP balloon should be fully dilated and fixed to the arterial wall during procedures, and the aspiration catheter should be navigated just proximal to the PSGWP balloon.

Observing the carotid debris aspirated during carotid stenting: technical note

Objectives: Elective carotid stent implantation using a distal protection is increasing. In this article we describe an observation method for carotid plaque debris collection during carotid stenting.Methods: Endovascular stenting for the right internal carotid artery (ICA) stenosis was performed nder distal balloon protection. During balloon protection, 30 ml of blood containing debris was aspirated followed by vigorous saline irrigation flushing any residual debris out into the ipsilateral external carotid circulation. Post-operatively, the aspirated blood was filtered and the debris remained on the membrane. The membrane was stained with hematoxylin–eosin (HE) solution and then mounted onto a glass slide for visualization.Results: Microscopic observation of the slide revealed several debris such as atheromatous plaques and intimal strips. HE staining facilitates the characterization of the debris composition. In addition to the histological evaluation, this technique revealed the particle size as well as the quantity of debris. The resulting HE slide is also suitable for permanent storage. In addition to the qualitative and quantitative qualities, this simple technique requires neither specific instrumentation nor equipment.Discussion: Carotid plaque debris aspirated during carotid artery stenting under distal protection can be filtered and visualized on a permanent glass slide. This simple method allows us to better understand quantity, particle size, and composition of debris.

Simulation Study of Distal Balloon Protection Systems during Carotid Artery Stenting

The purpose of our experimental study was to assess the pitfalls of distal balloon protection systems and to learn any technique tips to increase safety. Silicone carotid artery models were connected to a circulatory system to simulate arterial flow. A distal balloon protection device, PercuSurge GuardWire Plus (GWP, Medtronic Vascular) was delivered to the internal carotid artery (ICA), then was inflated to occlude ICA flow temporarily. A debris aspiration catheter (Export catheter) was delivered just proximal to the GuardWire Plus balloon coaxially, in order to introduce and diffuse particulate debris (20-500micro meter in diameter) in the ICA stump. Then, after debris in the stump was aspirated, the GWP balloon was deflated. We recorded all the processes of our simulation experiments on a digital video and observed the movements of debris during these experiments. Exp 1) We simulated the movements of debris in the ICA stump when the GWP balloon was gradually deflated to produce a crevice between the balloon and vessel wall, simulating accidental movement of the GWP balloon during the procedure. Exp 2) In order to assess the optimal placement of the tip of aspiration catheter, the debris in the ICA stump was aspirated from three different sites(from just below the GuardWire balloon, from 2cm below it, and from 5cm below it). Exp 1) When the crevice appeared between GuardWire balloon and silicone tube, simulated debris began to concentrate just below the balloon. Then, some debris migrated distally from the crevice, and another part crowded in the crevice so that was impossible to aspirate and migrated in the end. Exp. 2) Debris aspiration was most effective from immediately below the GuardWire balloon, and the aspiration ability declined as the distance between the balloon and aspiration catheter became longer. According to our simulation studies, when the GWP balloon was moved accidentally during CAS procedures, or when the aspiration catheter was not delivered all the way to the GuardWire Plus balloon, distal embolization might still occur, even under protection.

Effects and Safety of Intracoronary Thrombectomy Using Transradial Application of the PercuSurge Distal Balloon Protection System in Patients with Early or Recent Myocardial Infarction

Background: Distal embolization and no reflow are likely during primary percutaneous coronary intervention (PCI) on the large infarct-related artery (IRA), which mostly contains high-burden thrombus formation (HBTF) and plaque burden. Mechanical devices to prevent distal atheroembolism may be of importance for preserving reperfusion and microvascular integrity in IRA. Methods and Results: Between May 2002 and December 2002, transradial application (TRA) of the PercuSurge GuardWire™ device with 7-french arterial sheath was performed in 39 consecutive patients who experienced early (>12 h and ≤7 days) or recent (>7 days and <14 days) myocardial infarction (MI) associated with large IRA (vessel size ≧3.5 mm with HBTF; group 1). Between January 2001 and April 2002, 64 consecutive patients who had early or recent MI associated with HBTF in IRA of a vessel size ≧3.5 mm received TRA of PCI with adjunctive tirofiban therapy but without using the adjunctive PercuSurge GuardWire device (group 2). The angiographic and clinical outcomes of both groups were compared in a chronologically consecutive manner. The procedural success rate and post-PCI myocardial blush grades were significantly higher in group 1 than in group 2 patients (all p values <0.05), whereas a combined incidence of vascular and bleeding complications and 30-day major adverse cardiac events (defined as death, reinfarction and repeated PCI of IRA) were significantly higher in group 2 than in group 1 patients (all p values <0.05). Conclusions: Our data suggested that TRA using the PercuSurge GuardWire device during PCI for patients with early or recent MI and HBTF in IRA was safe and feasible. This mechanical device provided more additional benefit to patients in this clinical setting than a combination of conventional PCI and tirofiban therapy.

Endovascular stenting for stenoses in surgically reconstructed brachiocephalic bypass grafts: immediate and midterm outcomes.

To report the use of endovascular stenting for treatment of patients with symptomatic obstruction of brachiocephalic surgical reconstructions. Twenty-two patients (17 men; mean age 65+/-6 years) with 24 symptomatic obstructions of brachiocephalic Dacron bypass grafts (2 aorto-innominate, 9 subclavian-carotid, and 11 carotid-subclavian) were treated with balloon-expandable stents delivered via a percutaneous brachial access or surgical exposure of the common carotid artery. A distal protection device was utilized in the 9 patients with subclavian-carotid bypass grafts. All patients were followed by clinical and Doppler examinations. Procedural success was 100%; 1 (4.5%) patient developed transient intraprocedural aphasia owing to intolerance to the distal protection balloon occlusion. All 22 patients reported complete relief of their presenting symptoms. Over a 29-month follow-up, 3 (13.6%) restenoses were found, but none was due to stent compression. Stenting for obstructed brachiocephalic reconstructions appears to be a safe, effective, and durable therapeutic strategy.

Direct percutaneous carotid artery stenting with distal protection: technical case report

We describe the technique of percutaneous carotid artery stent placement with distal protection in a patient in whom marked innominate artery ectasia prevented transfemoral access to the right common carotid artery. After induction of general anesthesia, ultrasound was used to guide direct puncture of the common carotid artery followed by the introduction of a 5 French sheath. A GuardWire distal protection balloon (Medtronic, Santa Rosa, CA) was placed distal to the lesion and deployed at nominal diameter. A balloon-expandable stent was deployed without difficulty. Following stent placement, angiography demonstrated improved flow in the entire right carotid artery territory. There were no complications related to cervical soft tissue damage or clinical embolism. The patient tolerated the procedure well and was discharged in 24 hours. Direct carotid access is acceptable in select patients in whom a transfemoral, brachial, or transradial approach is technically difficult. The use of distal cerebral protection devices may reduce cerebral embolism associated with these procedures.

Formation of a coronary artery aneurysm after inflation of a PercuSurge GuardWire distal protection balloon

Formation of aneurysms in the coronary arteries with the use of the PercuSurge distal protection system has not been reported. We describe a 54-year-old man with acute myocardial infarction who was treated with the PercuSurge system. Angiography performed 2 weeks later revealed an aneurysm in the area of inflation of the distal protection balloon.

Six-month angiographic results of primary angioplasty with adjunctive PercuSurge GuardWire device support: Evaluation of the restenotic rate of the target lesion and the fate of the distal balloon occlusion site

Recently, the combination of primary percutaneous coronary intervention (PCI) and adjunctive PercuSurge device support has been reported to be superior to conventional primary PCI in terms of immediate angiographic results. However, there are no data regarding 6-month angiographic results for either the treatment site or the site of the distal protection balloon. The purpose of this study was to address these two issues. Between May and November 2002, a total of 74 patients who had experienced acute myocardial infarction (AMI) underwent either primary PCI (48 patients within 12 hr of AMI) or elective PCI (26 patients with AMI of > 12 hr and < 72 hr) using the PercuSurge device through a transradial approach. The final TIMI 3 flow and myocardial blush grade > or = 2 achieved were 94% and 93%, respectively. Of these patients, three died in the hospital, two died in the third month after discharge, and the remainder of the patients were followed up in our outpatient department for a mean of 13 +/- 2.9 months. Six-month angiographic follow-up was performed in 85.5% (59/69) of patients. The angiographic restenotic rate (defined as > or = 50% restenosis at the target lesion site) was 22.0% (13/59) of patients. However, only 11.9% (7/59) of patients required repeat target vessel revascularization. Moderate obstruction at the site of the distal protection balloon was found in 5.1% (n = 3) of patients during PCI. Six-month angiographic results demonstrated that all three patients had significant stenosis at the site of the distal protection balloon that required PCI. PercuSurge device utilization during PCI in the clinical setting of AMI yielded a substantially higher rate of immediate final TIMI 3 flow in epicardial vessels and increased the integrity of the microvasculature. Combined therapy of PCI with the PercuSurge device appeared to have favorable late angiographic results at the target site. Late significant stenosis occurred at the site of the distal protection balloon if a preexisting moderate or more advanced atherosclerotic lesion was present there.

Use of a Large Angioplasty Balloon for Predilation is a Risk Factor for Embolic Complications in Protected Carotid Stenting

Periprocedural neurological complications (PNCs) after carotid stenting were retrospectively analyzed to determine the risk factors with the use of various protective devices. Forty-three lesions in 40 patients were treated by carotid stenting with distal balloon protection for nearly all postdilation procedures and some predilation procedures. The following variables were statistically analyzed for association with PNCs: diameter of the angioplasty balloon used for predilation, use of a distal protection balloon during predilation, use of a protection balloon during postdilation, lesion-bifurcation distance, length of the lesion, age, clinical presentation of the lesion (symptomatic or asymptomatic), and hypercholesterolemia. PNCs occurred in five patients, four with minor deficits and one with major deficits. Univariate analysis showed large diameter of the predilation angioplasty balloon (p = 0.0026), use of a protection balloon during predilation (p = 0.0075), lesion length (p = 0.0003), and lesion-bifurcation distance (p = 0.0006) were significantly associated with PNCs. Multivariate analysis of these four variables showed that use of a large angioplasty balloon for predilation was the only independent predictor (p = 0.004, odds ratio 34.00) for the occurrence of PNCs. Use of a large angioplasty balloon for predilation carries the risk of periprocedural embolic complications. Therefore, even when a protection device is used, predilation should be performed with a small balloon.

頚動脈ステントに対する新しいｄｉｓｔａｌ ｐｒｏｔｅｃｔｉｏｎ ｓｙｓｔｅｍ−ＰｅｒｃｕＳｕｒｇｅ ＧｕａｒｄＷｉｒｅ Ｓｙｓｔｅｍの使用経験−

Carotid artery stenting (CAS) has emerged as an endovascular treatment for obstructive extracranial carotid artery disease. Despite advanced stenting techniques, neurological events linked to embolization of the particulate material in cerebral circulation occur in 5% of cases. A distal balloon protection system is increasingly being used to prevent cerebral atheroembolism during CAS procedures. In this study, we examined the possible beneficial effect of a new cerebral protection device (PercuSurge occlusion balloon) based on balloon occlusion of the distal internal carotid artery (ICA) and debris aspiration for patients undergoing postdilation. Eight patients underwent CAS using the PercuSurge GuardWire system. SMART stents were employed after predilation. The protective balloon was then introduced into the carotid artery, and advanced across the lesion. After postdilation, the PercuSurge Export aspiration catheter with proximal vacuum syringe was advanced toward the occlusion balloon. With suction applied, this catheter was advanced and retracted several times. In the 8 patients, the mean stenosis rate before stenting, 82.6%, markedly decreased to 8.8% after the procedure. The debris containing atheromatous emboli was removed by aspiration. On diffusion-weighted MRI, hyperintense areas were detected in 3 of the 8 patients. No complication related to the procedures occurred. Stenting with the PercuSurge GuardWire system for cervical ICA stenosis is an effective therapeutic modality. Protection devices may play an important role in future carotid interventions and expand the applicability of the procedure.

Effect of the PercuSurge GuardWire device on the integrity of microvasculature and clinical outcomes during primary transradial coronary intervention in acute myocardial infarction

The present study investigates whether preintervention thrombectomy with a PercuSurge distal balloon protection device can improve final angiographic results compared with adjunctive tirofiban therapy during primary percutaneous coronary intervention (PCI) in large infarct-related arteries (IRAs) (vessel size ≥3.5 mm) with high-burden thrombus formation (HBTF). Results indicate that this mechanical device is superior to adjunctive tirofiban therapy during primary PCI in large IRAs with HBTF in terms of final epicardial flow, microvasculature integrity, and 30-day clinical outcomes.

Retinal Embolization and Cerebellar Asymptomatic Embolization after Carotid Stenting Using Distal Balloon Protection

We describe a rare case of having both symptomatic ipsilateral retinal embolization and asymptomatic cerebellar embolization occurring after carotid stenting with use of distal protect device. In this case, external carotid angiograms revealed accessory meningeal arteryophthalmic artery and occipital artery-vertebral artery anastomoses. This case suggested that the protection for external carotid artery should be considered during carotid stenting to avoid retinal embolization and cerebellar or cerebral embolization in cases showing angiographical anastomoses between external carotid artery and ophthalmic artery or intracranial arteries.

The use of a distal occlusion balloon protection device in acute coronary syndrome

We report our early experience in using the PercuSurge GuardWire Plus system as a distal protection device in patients with acute coronary syndrome and acute myocardial infarction. Forty-three patients received percutaneous coronary intervention with the GuardWire Plus system. Thirteen had unstable angina, five had non-Q myocardial infarction and 25 had ST segment elevation myocardial infarction. Forty-one target lesions were in native coronary vessels and two were in saphenous vein grafts. Total occlusion occurred in 18 patients. The mean occlusion time by the distal protective balloon was 262.8±114.1 s. Preoperatively, TIMI 0 flow was present in 18, TIMI II flow in two and TIMI III flow in 23 patients. Post-operatively, TIMI II and TIMI III flow were established in two and 41 patients, respectively. All procedures were successful and the GuardWire Plus system was successfully deployed in all but two patients. There was no procedure-related major adverse clinical event. There was no major adverse clinical event at 30 days. There was no device-related complication. We believe that the GuardWire Plus system is safe and feasible in patients with acute coronary syndrome and acute myocardial infarction.