Flow Reversal System Research Articles

An evolution in carotid care: Contemporary TCAR data and optimization techniques

ObjectiveCarotid endarterectomy (CEA) is the gold standard for revascularization of atherosclerotic extra-cranial carotid artery lesions. The introduction of transfemoral carotid artery stenting (TFCAS) led to multiple randomized controlled trials to compare the safety and efficacy of an endovascular approach against traditional CEA in the management of carotid artery stenosis. The operative management of carotid artery stenosis continues to evolve, with the more recent introduction of TransCarotid artery revascularization (TCAR) and a novel flow-reversal neuroprotection system. This manuscript reviews a brief history regarding carotid artery revascularization, as well as the indications, technical considerations, and clinical outcomes of the TCAR procedure. Technical considerationsThe preoperative, intraoperative, and postoperative medical and technical considerations are explored. Topics of discussion will include the indications and contraindications for TCAR, anatomic requirements, instructions for use (IFU) and off-label utility, optimal pharmacologic regimen with carotid stent placement, standard deployment and suggestions for hostile anatomy, as well as recommended postoperative management and surveillance imaging. DiscussionThe Society for Vascular Surgery (SVS) has published a consensus statement on the pathways available to obtain clinical competency and maintain technical proficiency with TCAR. Meta-analyses reviewing the contemporary technical success and clinical outcomes of TCAR have demonstrated high rates of procedural success and low rates of stroke, myocardial infarction, and death. Studies have further illustrated comparable one-year rates of peri‑procedural stroke between TCAR and CEA, for asymptomatic and symptomatic carotid lesions, with both outperforming TFCAS. ConclusionManagement of extra-cranial carotid artery stenosis utilizing TCAR with the ENROUTE flow-reversal neuroprotection system has been widely adopted, yielding clinical outcomes and stroke prevention similar to traditional CEA and superior to TFCAS.

Transcarotid artery revascularization for in-stent restenosis complicated by flow reversal occlusion

We report a case of symptomatic high grade in-stent restenosis of a prior placed transradial carotid artery stent. We performed a Transcarotid Artery Revascularization (TCAR) to treat this symptomatic restenosis. The TCAR was complicated by occlusion of our flow reversal system by a large atherosclerotic embolus. We performed a distal common carotid cutdown to retrieve the occlusive embolus and restored flow reversal. Completion neck and cerebral angiogram showed no filling defect, and our patient showed no neurologic deficit, and resolution of pre-operative symptoms.

A case of subsequent no-reflow phenomenon following mechanical thrombectomy under flow reversal system for isolated ICA occlusion

A case of subsequent no-reflow phenomenon following mechanical thrombectomy under flow reversal system for isolated ICA occlusion

Carotid Artery Stenting via Radial Access with Modified Flow Reversal Method: Case Series

ObjectiveNeuroendovascular treatment via transradial access (TRA) has gained popularity as a minimally invasive technique. However, the flow reversal (FR) system, reported useful in carotid artery stenting (CAS), cannot be applied via TRA because it requires an access route of more than 8 F. Herein, we report the utility of a modified FR system applied via TRA using a sheathless 8-F balloon guide catheter and a 2.6-F balloon catheter. MethodsIn a retrospective analysis of a single-center consecutive case series, patients with carotid artery stenosis and vulnerable plaques who were treated with CAS via TRA using a modified FR system from June 2022 to August 2022 were examined. High-intensity spots were assessed on postprocedural diffusion-weighted magnetic resonance images. Puncture site complications at discharge and cardiovascular events for 1 year after CAS were also evaluated. ResultsTen patients were included in this study. There were no high-intensity spots on diffusion-weighted magnetic resonance images after CAS. No procedure-related complications, including radial artery occlusion or cardiovascular events, were observed. ConclusionsThis study suggests that CAS with FR using our modified system is feasible via TRA and may be an effective technique with a low rate of vascular complications.

Rescue of immediate post-transcarotid artery revascularization carotid stent thrombosis due to clopidogrel resistance using flow-reversal and aspiration thrombectomy

An 84-year-old patient developed immediate thrombosis of his carotid stent in recovery after transcarotid artery revascularization. In the present report, the technical details about intraoperative management for neurovascular rescue using the transcarotid artery revascularization flow-reversal system are described. The patient was determined to have clopidogrel resistance. Intraoperative medical management is also discussed. The current alternative intravenous and oral antiplatelet therapies such as glycoprotein IIb/IIIa and P2Y12 inhibitors are explored. The debate regarding preoperative antiplatelet resistance testing remains ambiguous, and increasing studies have demonstrated the safety and efficacy of alternatives to clopidogrel. Despite an unpredictable and devastating complication, the patient's outcome was successful using contemporary strategies.

Is transcarotid artery revascularization training translatable to all new procedures?

In 2015, the U.S. Food and Drug Administration cleared the Enroute flow-reversal system (Silk Road Medical, Inc, Sunnyvale, Calif) through the 510(k) pathway on the condition that the manufacturer developed a physician training program. To the credit of the manufacturer, they embraced this model and have refined it over time. Lal et al1 used this natural experiment to compare the outcomes of transcarotid artery revascularization (TCAR) stratified by the type of training physicians received and found no differences.

Outcomes of transfemoral carotid artery stenting and transcarotid artery revascularization for restenosis after prior ipsilateral carotid endarterectomy

ObjectiveRestenosis after carotid endarterectomy (CEA) poses unique therapeutic challenges, with no specific guidelines available on the operative approach. Traditionally, transfemoral carotid artery stenting (TfCAS) has been regarded as the preferred approach to treating restenosis after CEA. Recently, transcarotid artery revascularization with a flow-reversal neuroprotection system (TCAR) has gained popularity as an effective alternative treatment modality for de novo carotid artery stenosis. The aim of the present study was to compare the contemporary perioperative outcomes of TfCAS and TCAR in patients with prior ipsilateral CEA. MethodsThe Vascular Quality Initiative database was reviewed for patients who had undergone TfCAS and TCAR for restenosis after prior ipsilateral CEA between January 2016 and August 2020. The primary outcome was the 30-day composite outcome of stroke and death. The secondary outcomes included 30-day stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and composite 30-day outcomes of stroke, death, and TIA, stroke and TIA, and stroke, death, and MI. Multivariable logistic regression models were used to evaluate the outcomes of interest after adjustment for potential confounders and baseline differences between cohorts. ResultsOf 3508 patients, 1834 and 1674 had undergone TfCAS and TCAR, respectively. The TCAR cohort was older (mean age, 71.6 years vs 70.2 years; P < .001) and less likely to be symptomatic (27% vs 46%; P < .001), with a greater proportion taking aspirin (92% vs 88%; P = .001), a P2Y12 inhibitor (89% vs 80%; P < .001), and a statin (91% vs 87%; P = .002) compared with the TfCAS cohort. Perioperatively, the TCAR cohort had had lower 30-day composite outcomes of stroke/death (1.6% vs 2.7%; P = .025), stroke/death/TIA (1.8% vs 3.3%; P = .004), and stroke/death/MI (2.1% vs 3.2%; P = .048), primarily driven by lower rates of stroke (1.3% vs 2.3%; P = .031) and TIA (0.2% vs 0.7%; P = .031). Among asymptomatic patients, the incidence of stroke (0.6% vs 1.4%; P = .042) and the composite of stroke/TIA (0.8% vs 1.8%; P = .036) was significantly lower after TCAR than TfCAS, and TCAR was associated with a lower incidence of TIA (0% vs 1%; P = .038) among symptomatic patients. On adjusted analysis, the TCAR cohort had lower odds of TIA (adjusted odds ratio, 0.17; 95% confidence interval, 0.04-0.74; P = .019). ConclusionsAmong patients undergoing carotid revascularization for restenosis after prior ipsilateral CEA, TCAR was associated with decreased odds of 30-day TIA compared with TfCAS. However, the two treatment approaches were similarly safe in terms of the remaining perioperative outcomes, including stroke and death and stroke, death, and MI. Our results support the safety and efficacy of TCAR in this subset of patients deemed at high risk of reintervention.

Primary mechanism of stroke reduction in transcarotid artery revascularization is dynamic flow reversal

ObjectiveRecent studies have suggested that the low risk of stroke and death associated with transcarotid artery revascularization (TCAR) is partially attributable to a robust dynamic flow reversal system and the avoidance of the atherosclerotic aortic arch during stenting. However, the benefits of flow reversal compared with distal embolic protection (DEP) in reducing stroke or death in TCAR have not been studied. MethodsAll patients undergoing carotid artery stenting (CAS) via the transcarotid route with either dynamic flow reversal (TCAR) or DEP (TCAS-DEP) in the Vascular Quality Initiative from September 2016 to November 2019 were analyzed. Both multivariable logistic regression and nearest neighbor propensity score-matched analysis were performed to explore the differences in outcomes between the two procedures. The primary outcome was in-hospital stroke or death. The secondary outcomes were stroke, death, myocardial infarction (MI), and the composite of stroke, death, and MI. A secondary analysis was performed to compare transcarotid stenting with DEP vs transfemoral CAS with DEP to evaluate the effects of crossing the aortic arch. ResultsA total of 8426 patients were identified (TCAS-DEP, n = 287; 3.4%). TCAR was associated with a lower risk of in-hospital stroke or death (1.6% vs 5.2%; odds ratio [OR], 0.35; 95% confidence interval [CI], 0.20-0.64; P = .001), stroke (1.4% vs 4.2%; OR, 0.37; 95% CI, 0.20-0.68; P = .002), and stroke/death/MI (2.0% vs 5.2%; OR, 0.41; 95% CI, 0.23-0.71; P = .001) compared with TCAS-DEP. Among the 274 pairs of patients identified with propensity score matching, TCAR was associated with a lower risk of stroke/death (1.1% vs 4.7%; risk ratio [RR], 0.23; 95% CI, 0.06-0.81; P = .021) and stroke (0.4% vs 4.0%; RR, 0.09; 95% CI, 0.01-0.70; P = .006) compared with TCAS-DEP but no differences in stroke/death/MI (1.8% vs 4.7%; RR, 0.38; 95% CI, 0.15-1.02; P = .077). The secondary analysis found no differences in stroke between TCAS-DEP and transfemoral CAS with DEP (4.9% vs 3.7%; RR, 1.3; 95% CI, 0.36-1.63; P = .65). ConclusionsCompared with TCAS-DEP, TCAR was associated with a lower risk of perioperative stroke or death and stroke. This finding implies that dynamic flow reversal might provide better neuroprotection than does a distal embolic filter in reducing the perioperative risk of stroke. Avoiding the aortic arch did not confer any reduction in the stroke rate. The present findings serve to separate the clinical benefit of dynamic flow reversal from that of avoiding the aortic arch during TCAR.

Vascular Quality Initiative risk score for 30-day stroke or death following transcarotid artery revascularization

ObjectiveTranscarotid artery revascularization (TCAR) using a flow-reversal neuroprotection system has gained popularity for the endovascular treatment of carotid artery atherosclerotic disease owing to its lower risk of stroke or death compared with transfemoral carotid artery stenting. However, specific risk factors associated with stroke or death complications after TCAR have yet to be defined. MethodsAll patients undergoing TCAR for the treatment of asymptomatic or symptomatic atherosclerotic carotid disease were identified between September 2016 and September 2019 in the Vascular Quality Initiative TCAR Surveillance Project. Our primary outcome was 30-day stroke or death. We created a risk model for 30-day stroke or death using multivariable fractional polynomials and internally validated the model using bootstrapping. ResultsDuring the study period 7633 patients underwent TCAR, of which 4089 (53.6%) were treated for symptomatic and 3544 (46.4%) for asymptomatic disease. The average age of patients undergoing TCAR was 73.3 ± 9.1 years and 63.7% were male. Stroke or death events within 30 days of the index operation occurred in 153 patients (2.0%). Factors independently associated with a higher odds of 30-day stroke or death included the severity of presenting stroke symptoms (cortical transient ischemic attack, odds ratio [OR], 2.17 [95% confidence interval (CI), 1.21-3.90; P = .009]; stroke, OR, 3.30; 95% CI, 2.25-4.85; P < .001), advancing age (OR, 1.03 per year; 95% CI, 1.01-1.06; P = .003), and history of unstable angina or myocardial infarction within the past 6 months (OR, 2.20; 95% CI, 1.29-3.77; P = .004), moderate or severe congestive heart failure (OR, 2.44; 95% CI, 1.31-4.55; P = .005), chronic obstructive pulmonary disease (on medications, OR, 1.61 [95% CI, 1.06-2.43; P = .024]; on home oxygen, OR, 2.52 [95% CI, 1.44-4.41; P = .001]), and prior ipsilateral carotid endarterectomy (OR, 1.56; 95% CI, 1.09-2.25; P = .016), whereas preoperative P2Y12 use was associated with a lower odds of 30-day stroke or death (OR, 0.57; 95% CI, 0.39-0.85; P = .005). A 30-point risk prediction model created based on these criteria produced a C statistic of 0.72 and Hosmer-Lemeshow goodness of fit of 0.97. Internal validation demonstrated good discrimination with a bias corrected area under the receiver operating characteristic curve of 0.70 with a calibration slope of 1.00. ConclusionsThis Vascular Quality Initiative TCAR risk score calculator can be used to estimate the risk of stroke or death within 30 days of the procedure. Because TCAR is commonly used to treat patients with high surgical risk for carotid endarterectomy, this risk score will help to guide treatment decisions in patients being considered for TCAR.

In-Hospital Outcomes of Transcarotid Artery Revascularization With Dynamic Flow Reversal Versus Transcarotid Artery Stenting With Distal Embolic Protection

Recent studies have suggested that the low risk of stroke and death associated with transcarotid artery revascularization (TCAR) is partially attributable to a robust dynamic flow reversal system as well as the avoidance of the atherosclerotic aortic arch during the stenting procedure. However, the performance of flow reversal against distal embolic protection (DEP) in terms of clinical end points among patients who undergo transcarotid revascularization has not been studied.

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis

ObjectiveRecent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described. MethodsWe performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019. We assessed in-hospital outcomes in propensity score-matched cohorts of patients using tfCAS with proximal balloon occlusion as the comparison cohort. The primary outcome was stroke or death. Secondary end points included the individual outcomes of stroke, death, transient ischemic attack (TIA), and myocardial infarction. ResultsOf the 24,232 patients undergoing carotid artery stenting, 561 (2.3%) procedures were performed through tfCAS with proximal balloon occlusion, 18,126 (74%) through tfCAS with distal embolic protection, and 5545 (22.9%) through TCAR with flow reversal. After matching, 463 pairs of patients undergoing tfCAS with proximal balloon occlusion and tfCAS with distal embolic protection were identified. There were no differences in stroke or death (proximal balloon, 3.2%; distal embolic protection, 3.7%; relative risk [RR], 0.88; 95% confidence interval [CI], 0.45-1.73; P = .73), stroke (2.4% vs 2.6%; RR, 0.92; 95% CI, 0.42-2.00; P = .83), death (1.1% vs 1.5%; RR, 0.71; 95% CI, 0.41-3.15; P = .80), TIA (1.7% vs 1.5%; RR, 1.14; 95% CI, 0.41-3.15; P = .80), or myocardial infarction (0.4% vs 0.6%; RR, 0.67; 95% CI, 0.11-3.99; P = .65). However, after matching 357 pairs of patients undergoing tfCAS with proximal balloon occlusion and TCAR with flow reversal, tfCAS with proximal balloon occlusion was associated with higher rates of stroke or death (3.1% vs 0.8%; RR, 3.67; 95% CI, 1.02-13.14; P = .03) and a trend toward higher rates of stroke (2.5% vs 0.8%; RR, 3.00; 95% CI, 0.81-11.08; P = .08) and death (0.8% vs 0.0%; P = .08), but no statistically significant differences in TIA (0.8% vs 0.8%; P > .99) or myocardial infarction (0.6% vs 0.3%; RR, 2.00; 95% CI, 0.18-22.06; P = .56). ConclusionsCompared with tfCAS with distal embolic protection, tfCAS with proximal balloon occlusion has similar major outcomes. However, tfCAS with proximal balloon occlusion does not offer the same degree of embolic protection compared with TCAR with flow reversal, given the significantly higher risk of perioperative stroke or death.

IP095. Simultaneous Transcarotid Revascularization With Flow Reversal and Coronary Artery Bypass Grafting

The optimal surgical management for patients with concomitant carotid and coronary disease remains unknown. We sought to investigate the safety of simultaneous transcarotid artery revascularization (TCAR) with the ENROUTE transcarotid neuroprotection and stent system (Silk Road Medical Inc, Sunnyvale, Calif) and coronary artery bypass grafting (CABG). We retrospectively reviewed our experience with synchronous TCAR-CABG performed between February 2018 and January 2019. All patients first underwent a median sternotomy and harvesting of the left internal mammary artery before dissection of the common carotid artery (CCA) and placement of a venous sheath in the right femoral vein. The patients were then heparinized and the proximal CCA cannulated. Arteriography was first performed to demonstrate the extent and exact location of the stenosis before exchanging the arterial sheath and connecting to the flow reversal system. Active flow reversal was achieved by clamping the CCA. Access to the carotid artery was obtained in the mediastinum. The lesions were then crossed, predilated and stented. All sheaths were removed and arteriotomies closed before three-vessel CABG was performed by the cardiac surgery team. Plavix load was administered at the completion of the CABG. Primary end points included perioperative stroke and death. Secondary end points were technical success and postoperative hemorrhage. Three male patients (mean age, 63 years) underwent simultaneous TCAR-CABG. All 3 patients had symptomatic coronary artery disease. Regarding carotid artery disease, one patient had symptomatic disease; the other two patients were asymptomatic, but had critical (>75%) internal carotid stenosis. The procedural success rate was 100%. The average flow reversal time during TCAR was 11 minutes. There were no perioperative strokes or deaths. There were no re-explorations for hemorrhage (Table). Concomitant coronary and carotid artery disease is a challenging clinical scenario. Outcomes from this small patient cohort reveal that simultaneous TCAR-CABG is technically feasible and safe. This novel approach has the potential to provide the morbidity benefits of an EVR strategy while mitigating the risk of stroke by avoiding manipulation of the aortic arch. However, further investigation with larger patient groups is required before widespread adoption of this innovative technique.TableOutcomesAdverse outcomes Ipsilateral stroke (n = 3)0 (0%) Death (n = 3)0 (0%) Re-exploration hemorrhage (n = 3)0 (0%)Procedural parameters Flow reversal time, minutes (n = 3)11.3 (±1.9) Technical success (n = 3)3 (100%) Open table in a new tab

Recent advances in the treatment of carotid artery disease.

Transfemoral carotid stenting has struggled to become a suitable alternative to carotid endarterectomy for the treatment of carotid disease because of higher perioperative stroke risks, even with use of embolic protection devices. To reduce the perioperative stroke rates associated with carotid stenting, several advancements in stent design, embolic protection systems, and technical approaches have been developed. Transcarotid artery revascularization (TCAR) was also recently introduced as a novel carotid artery stenting option which circumvents several of the high embolic-risk maneuvers found in transfemoral carotid stenting and employs a flow reversal system that provides continuous embolic protection throughout the procedure. Early results from this technique have shown low stroke/death rates comparable to carotid endarterectomy while maintaining the minimally invasive benefits of carotid stenting. TCAR has a strong potential to become the preferred method of carotid stenting in the near future and may challenge carotid endarterectomy as the preferred carotid artery revascularization method.

Early results of endovascular treatment of patients with bilateral stenoses of the internal carotid arteries using proximal protection systems at 30-day follow-up

BackgroundAlthough surgical endarterectomy remains the treatment of choice for carotid artery stenosis, carotid artery stenting (CAS) with use of proximal protection systems (PPS) plays an very important role as alternative treatment modality, especially in patients with critical, symptomatic lesions.This study was single-centre study to evaluate the technical and clinical success of proximal protection devices as the first choice for embolic protection in symptomatic and asymptomatic carotid stenosis in patients with bilateral, advanced lesions of carotid arteries (bilateral stenoses or stenosis and occlusion). MethodsThis was a post hoc analysis, with 30-day follow up. We analyzed results of treatment of 38 patients who underwent 38 CAS with PPS, 17 such procedures in asymptomatic (group A), and 21 in symptomatic individuals (group B). The GORE® Flow Reversal System (W.L. Gore, Flagstaff, AZ, USA) was used in 2 patients, and the Mo.Ma Ultra device (Medtronic, Minneapolis, MN, USA) in 36 patients. Mean age was 68±7 years, 65% percent of patient were male. ResultsThere were no procedural and during 30-day follow-up neurologic events. Intolerance of occlusion system occurred in 4 patients (11%) in both groups with any later symptoms. Risk factors of this adverse event comprised: lesions of the left internal carotid lesion and coexisiting diabetes mellitus. ConclusionsCAS in high risk patients with bilateral lesions of carotid arteries with the use of PPS seems to be a relatively very safe procedure.

Initial experience with a reversal-of-flow cerebral protection device in carotid angioplasty

PURPOSE: To report initial findings with the GORE Flow Reversal System®, with a focus on major/minor adverse events in the 30 first postoperative days. METHODS: The first 24 patients submitted to carotid angioplasty using the GORE system, from June 2010 to May 2012, were retrospectively assessed with regard to indications, anatomic details, technical difficulties, and early clinical outcomes, including major (stroke, death, acute myocardial infarction) and minor (hematoma) adverse events. RESULTS: Systemic hypertension was present in 100% of the patients, diabetes mellitus in 58.3%, and coronary disease in 37.5%. Type II aortic arch was encountered in 62.5% of the patients and atherosclerotic lesion predominantly at the carotid bifurcation affecting the internal and common carotid arteries in 79.2%. Angiographic data revealed contralateral carotid arteries with &lt;50% stenosis in 95.8% of cases and preservation of cerebral blood flow in 95.8%. All procedures but one were technically successful. Mean cerebral flow reversal time was 14.9 minutes, with a statistically significant difference between the first 12 (17.9 minutes) and the last 12 patients treated (11.6 minutes) (p&lt;0.001). Intolerance to flow reversal was observed in 17.4% of the cases. Technical difficulties were experienced in 1 patient (4.2%). Clinical outcomes included 4.2% of stroke and 12.5% of hematomas at arterial puncture sites. CONCLUSION: The system was technically effective. A significant reduction in cerebral flow reversal time was observed, and the rates of early major/minor adverse events were within acceptable limits, suggesting that the device is safe and effective.

Acute and long-term results of carotid stenting under proximal embolic protection using the gore flow reversal system

This study evaluates short- and long-term results of CAS with the Gore Flow Reversal System (GFRS). Embolic protection devices are of fundamental importance in carotid artery stenting (CAS). Proximal protection has potential advantages compared with distal protection. Limited data are available regarding the safety of the proximal GFRS. CAS was performed with the GFRS. Patients' neurological status was assessed during the intervention and at follow-up. Results of patients treated before 2006 were also compared to those of patients treated after 2006 because of changes in device design. CAS was performed in 86 patients with 87 stenoses (symptomatic in 37%). The procedure was technically successful in all cases. In 11 patients a transient periprocedural neurologic deficit occurred related to temporary cerebral flow compromise during balloon occlusion with complete resolution at completion of the procedure. The stroke/death rate at one month was 2.3% with a combined ipsilateral stroke and death rate at one year of 4.6%. There was no significant difference in event rates between the newer and older device version. Overall follow-up time was 484 ± 3.4 patient years with a range of 0 to 119 months. The average yearly ipsilateral stroke rate including the first 30 days was 0.96%. Our results demonstrate that CAS using the GFRS is safe whether the original or new device versions were used. The periprocedural stroke rate is at least as low as the stroke rate reported using distal protection. The long-term stroke rate after CAS is low.

Carotid artery stenting performed with a flow-reversal technique: Improved technical performance

To report our experience in carotid artery stenting (CAS) with GORE flow reversal system, focusing the assessment of its efficacy, security and practice procedure evolution. Twelve patients treated for atherosclerotic carotid stenosis were prospectively evaluated. All patients were symptomatic. Carotid symptoms were embolic stroke in eight, watershed stroke in two and transient ischemic attack (TIA) in two patients. All patients underwent carotid ultrasound, brain magnetic resonance image and magnetic resonance angiography before CAS procedure. The procedure time and the flow reversal time were registered. Neurological outcome was evaluated before treatment, during the first 48 hours post-treatment and after 3 months. CAS was successful in all cases. Mean procedure time was 33.8 minutes. Mean flow reversal time was 7.3 minutes. Temporary bradycardia occurred with six patients without associated hemodynamic instability. NIHSS patients' scores ranged from 0 to 5 (average 1.1) on admission and remained unchanged during 48 hours after treatment. mRS patients' scores ranged from 0 to 3 (average 1.6) on admission and remained unchanged during the follow-up of 3 months. There were no complications concerning groin puncture, or general anesthesia, or myocardial infarct or death. In our present selected subjects, the CAS procedure using the GORE flow reversal system appeared to be safe and effective, with improved technical performance of the procedure. This was observed in particular with the flow-reversal times achieved. Thus, studies comparing the GORE system and other protection devices are suggested to ascertain all of the benefits of flow reversal during CAS.

P-022 Endovascular revascularization of carotid artery using a flow reversal device

IntroductionSurgical carotid revascularization has been described with various degrees of technical and clinical success. Currently, carotid revascularization is not recommended, based on the high potential for embolic stroke during the...

E-022 Tandem symptomatic internal carotid artery and persistent hypoglossal artery stenosis treated by endovascular stenting and flow reversal: case report

The persistence of the hypoglossal artery (PHA) into adulthood is a very rare vascular anomaly and, when present, provides the only vascular supply to the posterior circulation. We describe a...

Prospective, multicenter European study of the GORE flow reversal system for providing neuroprotection during carotid artery stenting

Embolic protection devices (EPDs) are used to provide protection against brain embolization during carotid artery stenting (CAS) to treat carotid artery stenosis, but the optimal type of EPD has not been determined. Distally positioned filters are commonly used but do not provide protection during crossing of the lesion. This prospective, multicenter study investigated a proximally placed device (GORE Flow Reversal System) that reverses blood flow in the internal carotid artery during CAS, thereby directing emboli away from the brain. Outcomes in 122 patients (28% symptomatic), who underwent CAS using the flow reversal system were assessed (intention-to-treat analysis). The primary endpoint was a major adverse event (MAE; defined as death or stroke) within 30 days of CAS. The secondary endpoint was a myocardial infarction (MI) or nonstroke-related neurologic event within 30 days. The flow reversal system could not be used in one patient because of severe vessel tortuosity and in two patients (1.6%) because of intolerance. The 30-day MAE rate and the secondary endpoint rate were each 1.6%. No patient in the series died or had an MI within 30 days. No patient who was symptomatic before CAS had an MAE. One symptomatic and one asymptomatic patient had a transient ischemic attack. Use of the GORE Flow Reversal System during CAS had a high rate of technical success and low 30-day rates of adverse neurologic and cardiac events.