Filter Embolic Protection Research Articles

Carotid artery stenting in unfavorable vascular anatomy: Effect of embolic protection filter use on periprocedural complications

ObjectiveTo investigate the effect of embolic protection device (EPD) use on periprocedural complications in patients with carotid artery stenosis with anatomical variations. MethodThe study retrospectively evaluated 185 patients who consecutively underwent carotid artery stenting between November 2020 and December 2023. Forty-four patients with difficult anatomical structures, anatomical variations in the common carotid artery (CCA) and internal carotid artery (ICA) (tortuosity, kinking, or coiling), and a CCA-ICA angle of >60 degrees were included in the sample. The patients were divided into two groups according to the use of EPD filters during the procedure and compared in terms of periprocedural events. ResultsOf the 44 patients included in the study, 24 (54.5 %) were male, and the mean age of all patients was 68.7 ± 8.7 years. Comorbidities were present in 93.2 % (n = 41) of the patients. The most common comorbidity was hypertension (n = 32, 72.8 %). The CCA-ICA angle was ≥60 degrees in 45.4 % (n = 20) of all patients. ICA tortuosity was detected in 27.2 % (n = 12) of the patients, ICA kinking in 13.6 % (n = 6), ICA coiling in 6.8 % (n = 3), and CCA tortuosity in 6.8 % (n = 3). Procedure-related periprocedural events developed in 38.6 % (n = 17) of the patients. Postprocedural mortality occurred in two patients, secondary to myocardial infarction in one and COVID-19 pneumonia in the other. There was no significant difference between the filter and non-filter groups in relation to periprocedural events (p = 0.638). Major stroke did not occur in either group. Minor neurological events occurred in 15 % (n = 3/20) of the patients in the filter group and 16.7 % (n = 4/24) of those in the non-filter group. The incidence of vasospasm was statistically higher in patients using filters compared to those without filters (30 % vs. 0 %; P = 0.005, respectively). ConclusionEvaluation of vascular anatomy before carotid artery stenting is important to decide on the technical procedure to be applied in the procedure. The use of EPD in unfavorable anatomy does not reduce periprocedural neurological events. Instead, it results in technical difficulties, prolongs the duration of procedure, and leads to arterial vasospasm. Considering the high periprocedural events in this study, carotid endarterectomy may be a better alternative to endovascular treatment in patients with unfavorable carotid artery anatomy.

Successful Retrieval of Filter Embolic Protection Device Fragment Trapped by a Carotid Stent: A Case Report.

Embolic protection devices are useful for preventing distal embolism during carotid artery stenting (CAS); however, complications have been reported. The successful removal of a filter fragment trapped at the distal edge of a carotid stent during the retrieval procedure is described. CAS was performed for internal carotid artery stenosis in a patient in his 70s, and the carotid stent was successfully placed. During the retrieval procedure, the tip of the filter was trapped at the distal edge of the stent and detached from the filter. Using a snare kit, the filter tip was successfully retrieved, and no postoperative neurological symptoms occurred. The edge of a carotid stent can potentially trap devices. When trapping or fragmentation of a device is suspected, it is necessary to evaluate the situation and cause, and the device should be appropriately retrieved without using force.

Head-to-head comparison of two embolic protection devices in carotid artery stenting

Abstract Introduction Embolic protection devices (EPD) have been developed to reduce the risk of distal embolization and have become ubiquitous in carotid interventions. There are two classes of EPD: distal filter EPD (f-EPD) and proximal EPD (p-EPD). However, the best device for carotid artery stenting (CAS) has yet to be established. Purpose We aimed to assess and compare the early prognosis between the f-EPD and p-EPD groups in patients undergoing CAS. Methods Single-center, retrospective study. Patients who underwent CAS from 2000 to 2022 were included. The composite of transient ischemic attack(TIA)/stroke and death at 24 hours and 30 days were evaluated. Statistical analysis was performed using SPSS 28.0.1.1 software. Results A total of 436 patients were included (380 and 56 patients used f-EPD and p-EPD, respectively). The population's mean age (±SD) was 71,8 (±8,2) years, 74,8% men. There was a significant prevalence of arterial hypertension (88,3%), dyslipidemia (75,9%), diabetes (33,9%), and smoking background (25,9%). Regarding baseline clinical characteristics, arterial hypertension was more prevalent in the f-EPD group, with statistical significance (91,7% vs. 78,8%; p=0,003). Concerning the indications for carotid intervention, 16,1% of patients were asymptomatic but had severe stenosis, and 39,4% had neurological symptoms. In 41,9% of patients, the procedure was accomplished before cardiac surgery (coronary artery bypass graft or valvular surgery). Regarding the first 24 hours after the procedure, the combined endpoint of TIA/stroke or death occurred in 3,4% of patients in the f-EPD group and 3,6% in the p-EPD group, with no statistically significant difference (p=1,000). The incidence of TIA/stroke was also similar in both groups (3,2% and 3,6% in the f-EPD and p-EPD groups, respectively; no statistical difference was found; p=0,694). The early mortality rate was slightly lower in the f-EPD group (0,8%) compared with the p-EPD group (1,8%), though this difference did not reach statistical significance (p=0,424). During the 30-day follow-up, the combined endpoint of TIA/stroke or death occurred in 1,6% of patients in the f-EPD group and 1,8% in the p-EPD group, with no statistically significant difference (p=1,000). The incidence of TIA/stroke was lower in the f-EPD group (1,1%) compared to the p-EPD group (1,8%), however, no statistical difference was found (p=0,499). Regarding mortality rate, the incidence in the f-EPD group was 0,5%, in contrast with no events in the p-EPD group (statistical analysis not possible to compute). Conclusion In this cohort, no significant differences were found between the distal filter and proximal embolic protection devices in the risk of TIA/stroke and death at 24 hours and 30 days after carotid artery stenting. However, conclusions should be carefully drawn since the distal filter EPD was used more often than the proximal EPD, making direct comparisons challenging.

Entrapment of an embolic protection device within stent during carotid artery stenting: a case report

BackgroundDistal embolic protection devices have been widely used to reduce the incidence of embolic events during carotid artery stenting. Entrapment of an embolic protection device is an extremely rare complication, and most cases are resolved by surgical removal.Case presentationA 67-year-old male underwent carotid artery stenting with an embolic protection device. During the procedure, the embolic protection filter became entrapped within the stent. The complication was resolved endovascularly without sequelae.ConclusionThe most important step in stenting is to be careful until the procedure is completed. However, if complications occur during the operation, in-depth knowledge of the catheters, wires, and devices will help the operator resolve the problem using endovascular techniques.

Carotid stenting in Nepal: Our experience with two cases of carotid stenosis

Carotid artery stenosis is one of the important risk factors for stroke. Carotid endarterectomy and carotid artery stenting are the available treatment options for managing carotid artery stenosis patients. The technology shift towards carotid artery stenting is promising due to its less invasive approach. Carotid artery stenting has become an alternative for surgically high-risk patients and high carotid lesions (lesions located at or above the second cervical vertebra). Here, we present two cases with carotid artery stenosis who were successfully treated with open-cell type carotid stent with distal filter embolic protection device.

Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions.

Objective To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. Materials and Methods Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. Results The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (p=0.434). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (p < 0.0008). Conclusions There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.

Embolic Protection in Complex Femoropopliteal Interventions: Safety, Efficacy and Predictors of Filter Macroembolization

ObjectivesTo evaluate the safety and efficacy of a filter embolic protection device (FEPD) in endovascular interventions of the femoropopliteal arteries.MethodsPatients who underwent endovascular interventions of the femoropopliteal arteries between 2008 and 2016 and in whom the SpiderFXTM FEPD was applied were included in this retrospective study. Clinical and angiographic characteristics, filter macroembolization (FME), device-related complications, distal embolization, as well as the early clinical and hemodynamic outcome, were assessed. Potential risk factors for FME were evaluated by multivariate analysis.ResultsA total of 244 cases were identified (203 patients, claudication 60.4%, critical limb ischaemia 39.6%, mean lesion length 13.2 ± 12.9 cm, complete occlusions in 72.7%). Balloon angioplasty ± stenting (BAP), directional atherectomy ± balloon angioplasty ± stenting (DA) and rotational thrombectomy ± balloon angioplasty ± stenting (RT) were performed in 141, 61 and 42 cases, respectively. FEPD placement and retrieval were successful in all but one case each. Permanent filter-related vessel damage was not observed. The rate of FME was 37.3% (BAP 36.2%, DA 32.8%, RT 47.7%). Risk factors for FME in the BAP- and DA-group were total occlusion, lesion length > 19 cm, visible thrombus and diabetes mellitus. The distal embolization rate despite filter protection was 4.1 % (BAP 4.9%, DA 1.6%, RT 4.8%) and was higher in cases with FME compared with those without FME (8.7% vs. 1.5%, p = 0.02).ConclusionThe Spider FXTM device is safe and effective in capturing embolic debris during femoropopliteal interventions. A residual risk of peripheral embolization remains.Level of Evidence III, Cohort study

Heterogeneity of debris captured by cerebral embolic protection filters during TAVI.

The aim of this study was to investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning. A total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with the SENTINEL cerebral embolic protection (CEP) at our centre were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data were entered into our prospective database. TAVI was performed with either the Evolut R/PRO (N=123), SAPIEN 3 (N=113) or Lotus valve (N=92). Capture of debris occurred in 98% of patients. Lotus TAVI resulted in more frequent foreign body material (62% vs 40% vs 47%, p=0.006), endothelium (49% vs 30% vs 16%, p<0.0005), calcified material (33% vs 12% vs 24%, p=0.001) and myocardial tissue (19% vs 11% vs 2%, p<0.0005) compared to SAPIEN 3 or Evolut R/PRO. Native (functional) bicuspid valves (OR 2.91, 95% CI: 1.20-7.03, p=0.02) and Lotus (OR 2.44, 95% CI: 1.14-5.24, p=0.02) were associated with the highest risk for dislodging particles ≥1,000 um. Valve repositioning was independently associated with larger amounts of debris (OR 2.96, 95% CI: 1.42-6.16, p=0.004). All THV platforms had similar amounts of captured debris. THV repositioning seemed to be associated with a higher risk for dislodging greater amounts of debris to the brain.

Outcomes of Innominate Artery Revascularization Through Endovascular, Hybrid, or Open Approach

Atherosclerotic disease of the innominate artery (IA) is rare and can lead to cerebral, upper extremity, and vertebral steal symptoms. Nonocclusive lesions can be treated with endovascular interventions, often with a hybrid approach while performing a right carotid endarterectomy (RCEA). Calcified IA lesions have a high risk of embolization to bilateral cerebral hemispheres. Occlusive lesions may require treatment through a median sternotomy and bypass. The purpose of our study is to review our short-term and long-term outcomes of IA revascularization. Our operative database was used to identify patients who underwent IA revascularization between January 1998 and December 2018. Patients who underwent innominate artery stenting (IAS), combined with RCEA and IAS as well as aortoinnominate bypass (AIB), were identified. Our primary end points were freedom from neurologic event, all-cause mortality, and need for reintervention. Thirty-three patients (18 females [55%]) who underwent IA revascularization were identified. Average age was 67±8years, and mean clinical follow-up was 51±21months. Most patients (30 [91%]) were on a statin and antiplatelet therapy. Twenty-one patients (64%) were symptomatic. Twelve patients (36%) were asymptomatic and underwent combined RCEA with retrograde IAS for critical right carotid stenosis and IA stenosis. Preoperative imaging included a carotid duplex and computed tomography angiography. Eighteen patients (55%) underwent RCEA+IAS, 11 patients (33%) underwent isolated IAS, and 4 patients (12%) underwent AIB. In our attempt to protect bilateral hemispheres during IAS for heavily calcified lesions, we used right common carotid artery (CCA) clamping although open exposure and left CCA embolic protection filter was placed through transfemoral approach. Patients who underwent AIB had chronic heavily calcified IA occlusions or occluded IA stents with failed endovascular interventions. Perioperative stroke rate was 3%, involving 1 patient who developed reperfusion syndrome after RCEA+IAS. Perioperative mortality was 0%. Long-term stroke rate was 0%, and long-term mortality was 15% (5 of 33) because of cardiac disease. Overall restenosis rate was 9%, involving 3 patients who required secondary interventions for IA in-stent restenosis. IA interventions through a hybrid approach or an open approach are safe, with acceptable perioperative stroke and mortality rates. Long-term patency of these interventions is acceptable. Bilateral cerebral embolic protection can be accomplished by clamping the right CCA through an open exposure and placing a filter in the left CCA through a transfemoral approach. Patients undergoing IAS appear to have a higher rate of restenosis compared with AIB, and therefore, close follow-up with noninvasive imaging is recommended.

TCT-23 Heterogeneity of Debris Captured by Cerebral Embolic Protection Filters During Transcatheter Aortic Valve Replacement With Different Transcatheter Heart Valves

The role of cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR) is still under debate. Histopathological analysis of captured debris may provide important information regarding histopathogenesis of (peri-) procedural stroke. All patients who underwent TAVR with

Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection

ObjectivesThis study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation. BackgroundThe risk of major adverse events during carotid artery stenting (CAS) is equivalent to carotid endarterectomy. However, the risk of minor stroke remains higher with CAS. Much of this risk occurs during post-stent dilation. MethodsA total of 106 patients were enrolled in 5 centers in Germany. The study’s primary endpoint was all-cause death, myocardial infarction, and stroke at 30 days post-procedure. Pre- and post-procedural diffusion-weighted magnetic resonance imaging evaluated new ischemic lesions in 30 subjects. Filter histomorphometric analysis was performed in 23 patients. Retrospective analyses compared outcome rates to historical controls. ResultsDevice and procedural success rates were 100%. The combined major adverse event rate (death, myocardial infarction, and stroke) at discharge and at 30 days was 0% and 1.0%, respectively. The single adverse event was a stroke, which occurred at day 12 and was believed unrelated to the device or procedure. New ischemic lesions were found in 11 (36.7%) patients in the diffusion-weighted magnetic resonance imaging subset. New ipsilateral lesions were seen in 9 (30.0%) patients. Mean lesion volume per patient was 0.010 cm3. Debris was present in all filters, and approximately 90% of captured particles were <100 μm. ConclusionsUse of the Paladin System for post–stent dilation during CAS appears safe, and it may effectively decrease the number of embolic particles reaching the brain, which may help reduce the risk of procedure-related stroke. (A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection; NCT02501148)

Effectiveness of embolic protection filter devices in stroke prevention during endovascular aortic arch repair in significant aortic atheroma patients.

The objective of this study was to evaluate the effectiveness of embolic protection filter device in stroke prevention during hybrid endovascular arch repair in patients with significant aortic atheroma. Twenty-two patients (20 men, mean age 79.0 years, mean logistic EuroSCORE 23.9%) with aortic arch/proximal descending aortic diseases and significant aortic atheroma (atheroma grade ≥ II) who were deemed unfit for conventional open surgery underwent endovascular aortic arch repair with protection of the supra-arch vessels using a balloon catheter and filter devices. The effectiveness in preventing stroke was evaluated by a postoperative neurological examination protocol, which was followed by neuroimaging with computed tomography/DW-magnetic resonance imaging (MRI) study in cases with neurological deficits. The atheroma grades of the aortic arch were II, III and IV in 36%, 14% and 50% of the patients, respectively. In total, 37 filter devices were placed in the supra-aortic vessels (5 brachiocephalic arteries, 23 carotid arteries, 5 subclavian arteries and 4 vertebral arteries). Technical success was achieved in all patients, and 30-day mortality was 4.5% (1/22 cases). Two (9.1%) cases showed neurological symptomatic stroke postoperatively. With DW-MRI examination, a major new region was detected in the filter-protected left carotid artery in one case and in the balloon-protected left vertebral artery in another case. In high-risk patients with significant aortic arch atheroma, hybrid endovascular aortic arch repair with embolic protection using a filter device showed satisfactory early results. Filter protection could be an attractive adjunct manoeuvre for preventing critical stroke during endovascular arch repair.

Proximal embolic protection versus distal filter protection versus combined protection in carotid artery stenting: A systematic review and meta-analysis.

Proximal embolic protection devices (P-EPD) and distal filters (DF) are used to prevent distal cerebral embolizations during carotid artery stenting (CAS). We compared their comparative effectiveness in regards to prevention of intraprocedural and periprocedural adverse events, including ischemic lesions (ipsilateral and contralateral), stroke, transient ischemic attacks (TIA) and death. We also compared the combination of the two neuroprotection strategies vs. a single strategy in regards to ischemic lesions and stroke. This study was performed according to the PRISMA and MOOSE guidelines and eligible studies were identified through search of PubMed, Scopus and Cochrane Central. A meta-analysis was conducted with the use of a random effects model. The I-square statistic was used to assess for heterogeneity. Twenty-nine studies involving 16,307 patients were included. There was a significant reduction in ischemic lesions with the use of P-EPD among observational studies (RR: 0.66 [0.45-0.97]). There were no statistically significant differences for the other outcomes between the two treatment groups. There is a number of studies reporting outcomes on the comparison between P-EPD and DF for CAS. P-EDP can reduce distal embolization phenomena resulting into ischemic lesions when compared to DF based on the results from real-world studies. P-EPD was not superior however, in regards to periprocedural stroke, TIA and death. Further studies are anticipated to provide a clear answer to this debate.

A novel guidewire-integrated embolic protection filter device with a handy-folding system: In vitro and in vivo performance assessment.

We developed a novel guidewire-integrated filter device with a handy-folding system (IFD: Inoue filter device). In vitro and in vivo studies were conducted to evaluate the feasibilityof the IFD. Although distal atheromatous and thrombotic embolizations remain unresolved critical issues during catheter interventions, distal protection devices are infrequently used partly because of reduced lower maneuverability. In the in vitro experiment, we created an experimental circulation model composed of silicone latex tubes, a reservoir, and a roller pump. After the filter device was deployed in the tube, polystyrene fluorescent microspheres were injected and the capture rate was calculated. Ten trials were performed using the IFD and Spider FX. In the in vivo study, five independent operators deployed, and they retrieved the IFD in swine common iliac and internal carotid arteries. The procedural success rate as well as the delivery and retrieval time was evaluated. In the in vitro study, the mean capture rate was 94% and 35% in the IFD and Spider groups, respectively. In the in vivo study, all procedures were successful, with no complications. The mean delivery time was 281 ± 87 s and 194 ± 67 s and the mean retrieval time was 24 ± 9 and 13 ±1 s in the left internal carotid and the left common iliac arteries, respectively. Although further studies and improvements are required, the study results indicate that the IFD is feasible.

Evidence for polymicrobial communities in explanted vascular filters and atheroma debris

RationaleMicrobial communities have been implicated in a variety of disease processes and have been intermittently observed in arterial disease; however, no comprehensive unbiased community analysis has been performed. We hypothesize that complex microbial communities may be involved in chronic vascular diseases as well and may be effectively characterized by molecular assays. ObjectiveThe main objective is to survey vascular debris, atheroma, and vascular filters for polymicrobial communities consisting of prokaryotic and eukaryotic microbes, specifically eukaryotic microbes. Methods and resultsWe examined vascular aspirates of atheromatous debris or embolic protection filters in addition to matched peripheral blood samples, from fifteen patients, as well as three cadaveric coronary arteries from two separate patients, for microbial communities. General fluorescence microscopy by Höechst and ethidium bromide DNA stains, prokaryotic and eukaryotic community analysis by Next Generation DNA Sequencing (NGS), and a eukaryotic microbial 9 probe multiplexed quantitative PCR were used to detect and characterize the presence of putative polymicrobial communities. No prokaryotes were detected in peripheral blood; however, in 4 of 9 sequenced filters and in 2 of 7 sequenced atheroma debris samples, prokaryotic populations were identified. By DNA sequencing, eukaryotic microbes were detected in 4 of 15 blood samples, 5 of the 9 sequenced filters, and 3 of the 7 atheroma debris samples. The quantitative multiplex PCR detected sequences consistent with eukaryotic microbes in all 9 analyzed filter samples as well as 5 of the 7 atheroma debris samples. Microscopy reveals putative polymicrobial communities within filters and atheroma debris. The main contributing prokaryotic species in atheroma debris suggest a diverse and novel composition. Additionally, Funneliformis mosseae, an arbuscular mycorrhizal fungus in the Glomeraceae family, was detected in the coronary hard plaque from two patients. Well studied biofilm forming bacteria were not detectable in circulating peripheral blood and were not universally present in atheroma or filters. Analyses of the sequenced eukaryotes are consistent with a diverse of array poorly studied environmental eukaryotes. In summary, out of 15 patients, 6 exhibited molecular evidence of prokaryotes and 14 had molecular evidence of eukaryotic and/or polymicrobial communities in vivo, while 2 post-mortem coronary plaque samples displayed evidence of fungi. ConclusionProkaryotes are not consistently observed in atheroma debris or filter samples; however, detection of protozoa and fungi in these samples suggests that they may play a role in arterial vascular disease or atheroma formation.

Ubiquitous Nature of Distal Athero/Thromboembolic Events during Lower Extremity Atherectomy Procedures Involving the Superficial Femoral Artery

This study aims to evaluate occurrence, size, composition, and clinical significance of embolized debris during superficial femoral artery atherectomy using all commercially available atherectomy devices. Distal athero/thromboembolic events (DATE) are a universal phenomenon in lower extremity atherectomy procedures (LEAPs) due to the sheer volume of atheroma and the thrombus burden in peripheral arterial disease. Some of these events can be clinically significant. We prospectively gathered clinical and histopathological data on all commercially available atherectomy devices by using embolic protection devices (EPD) in every case. After intervention, the contents of EPD were examined both microscopically and macroscopically. Data from 59 consecutive patients undergoing LEAP were analyzed. DATE occurred 100% of the time. The composition of particulate debris varied with the device used. Grossly visible agglomerated debris was captured by the filter in the majority of patients 54/59 (91.5%). Clinically significant debris, defined by the Preventing Lower Extremity Distal Embolization Using Embolic Filter Protection registry as particle diameter > 0.2 cm, was found in 33/59 (56%) patients. The size of captured debris particles ranged from 0.1 to 2.4 mm. While DATE occurred in all patients, clinically significant DATE occurred in 56% patients undergoing LEAP regardless of the atherectomy device. In spite of a large fraction of the clinically significant debris occurring on our routine dual antiplatelet regimen, no patient suffered an amputation. Although DATE was prevented by the use of EPD in all 59 cases, more data are needed to determine whether the use of EPD translates into a long-term clinical benefit. Use of EPD and optimal thromboprophylaxis should be considered in patients, especially in the setting of compromised distal runoff.

Clinical Effectiveness of Endovascular Therapy for Total Occlusion of the Subclavian Arteries: A Study of 67 Patients

Endovascular therapy is a feasible option for total occlusion of the subclavian artery. The purpose of this study was to evaluate the effectiveness of stenting therapy bycomparing it with that of surgical treatment in patients with total subclavian artery occlusion. Between May 2007 and October 2013, 52 stents were placed in 67 patients who underwent endovascular therapy for the treatment of total atherosclerosis subclavian artery occlusion. During the same period, 21 patients underwent bypass surgery. All patients were followed at 3, 6, and 12months after treatment and annually thereafter. Technical success was achieved in 77.6% patients in the endovascular group, while clinical success was achieved in 74.6%. Technical failure was noted in 15 patients, while the symptoms failed to resolve in 2. The rate of primary patency was 98.2% at 12months, 94.3% at 24months, and 92.1% at 3years. Significant recurrent obstruction developed in 5 patients. No complications were observed in 5 patients with right side occlusion in whom embolic protection filters were used. Meanwhile, the technical success rate was 100% in the surgery group. One patient developed a major ischemic stroke during surgery (4.8%). The rate of primary patency was 100% at 12months, 96.3% at 24months, and 93.1% at 3years. When performed by skilled surgeons, percutaneous revascularization with primary stenting is a safe and effective therapy for symptomatic total occlusion of the proximal subclavian artery. However, we recommend the use of embolic protection devices during the treatment of right side occlusions. Otherwise, surgery may be the best choice.

JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries

Purpose: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment. Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9±11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4±13.1 cm. The primary effectiveness outcome was acute success (≤30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory. Results: Treated length was 19.5±12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6±3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months. Conclusion: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results.

CRT-300.14 Impact of Aspiration Thrombectomy During Carotid Artery Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging: A Randomized Controlled Trial

To determine whether routine aspiration, from the distal filter embolic protection device (EPD) back through the stent, during carotid artery stenting (CAS) would result in fewer clinical neurologic events and/or lesions on diffusion-weighted magnetic resonance imaging (DW-MRI) compared to CAS with

Carotid artery stenting may be performed safely in patients with radiation therapy-associated carotid stenosis without increased restenosis or target lesion revascularization

Neck radiation therapy (XRT) can induce carotid artery stenosis and may increase the technical difficulty of endarterectomy. It is considered a relative indication for carotid angioplasty and carotid artery stenting (CAS). This study sought to evaluate differences in CAS embolic potential and restenosis performed on XRT and non-XRT patients. At three institutions, 366 CAS procedures were performed on 321 patients (XRT, n = 43; non-XRT, n = 323). Mean follow-up was 410 days (median, 282 days; range, 7-1920 days). Patients were observed with duplex ultrasound to assess for restenosis. Additional end points included target lesion revascularization (TLR), myocardial and cerebrovascular events, and perioperative complications. Captured particulate from embolic protection filters was analyzed with photomicroscopy and image analysis software for 27 XRT and 214 non-XRT filters. XRT patients were more likely to be male and had lower rates of hypertension, coronary artery disease, and diabetes mellitus, although the mean age at procedure did not differ. There was no increase in severe internal carotid tortuosity among XRT patients (XRT: 50% vs non-XRT: 34.7%; P = .06). Indication for CAS did not differ between the two groups, including the number of CAS procedures performed for symptomatic carotid stenosis (XRT: 39.7% vs non-XRT: 39.0%; P = NS). Perioperative outcomes, including the composite 30-day stroke, myocardial infarction, and mortality, were not significantly different (XRT: 2.6% vs non-XRT: 3.9%; P = NS.) There were no significant differences in restenosis rate at the 50% (XRT: 9.4% vs non-XRT: 8.6%; P = NS) or 70% (XRT: 3.5% vs non-XRT: 8.6%; P = NS) threshold. Filter particle analysis revealed that filters from XRT patients had more numerous large particles per filter (1.4 vs 0.7; P < .05) and larger mean particle size (464.1 μm vs 320.0 μm; P < .05). TLR did not differ significantly between the groups. In contrast to earlier studies, this analysis reveals that there are significant differences in XRT and non-XRT patients undergoing CAS in terms of medical comorbidities and embolic material captured in embolic protection filters. The decreased incidence of atherosclerotic risk factors was observed in XRT patients probably because XRT was the primary factor responsible for carotid stenosis. Despite increased embolic particle size, CAS can be performed safely with no increased morbidity, TLR, or restenosis in XRT patients.