Filter Embolic Protection Device Research Articles

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.

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.

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

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

Use of Spider Filter Embolic Protection Device During Endovascular Revascularization of Acute Thromboembolic Occlusion of Superficial Femoral Artery

To retrospectively evaluate the safety and efficacy of the Spider filter embolic protection device (EPD) in protecting patients from distal migration of thromboemboli during revascularization of acute superficial femoral artery (SFA) occlusion secondary to thromboemboli. Data from all patients at our institution who had EPD placement for embolic protection during endovascular revascularization for acute thromboembolic occlusion of the SFA were analyzed. From April 2007 to June 2014, a total of 14 patients had EPD placement during endovascular revascularization for acute SFA occlusion secondary to thromboemboli. All patients presented with acute onset of limb ischemia, and further work-up with imaging studies demonstrated thromboembolic occlusions. The duration from onset of symptoms to revascularization was 7.0 ± 2.7 h (range 2-14 h). An aspiration technique for thrombectomy was used in all 14 cases (aspiration alone, 6 cases; aspiration plus urokinase, 7 cases; additional angioplasty after urokinase, 1 case). Spider filter EPDs were successfully placed at the target in all 14 cases, and the thromboemboli were captured in 13/14 (92.9%) cases. Successful reestablishment of the SFA flow without distal branch embolism occurred in all 14 cases. There were no EPD-related complications. During a mean 32.2 ± 20.2 months of follow-up, 13 patients remained asymptomatic; one patient who underwent PTA during the procedure reported limb coolness and fatigue 6 months later because of recurrent atherosclerotic stenosis. The Spider filter EPD can be safe and effective in protecting patients from distal branch embolism when they undergo an endovascular thrombectomy procedure.

Unprotected carotid artery stenting in modern practice

Embolic protection devices (EPD) may provide a mechanism to reduce peri-procedural strokes. They are advocated by consensus guidelines and mandated for Medicare reimbursement. However, outcomes data remain mixed. We aimed to characterize the population of patients undergoing unprotected carotid artery stenting (CAS) and assess the utility of distal filter EPD (F-EPD) in elective CAS. We analyzed patients enrolled in the CARE Registry® undergoing CAS between May, 2005 and January, 2012. We assessed the relationship between distal F-EPD use versus no use (No-EPD) and the composite of in-hospital death or stroke (MAE) in unadjusted and 1:3 propensity-matched analyses. Embolic protection was not attempted in a total of 579 out of 13,263 cases performed (4.4%). Patients in the No-EPD group had worse preprocedure neurologic risk factors including higher rates of acute evolving stroke, prior TIA/stroke, symptomatic lesion status, spontaneous carotid artery dissection, and use of general anesthesia intraprocedurally (all Standardized Differences{sd} >10). After exclusion of nonelective cases there was no significant difference in MAE between the No-EPD and F-EPD groups (1.6% vs. 2.3%, sd = 4.72). Additionally, after propensity matching, rates of MAE did not differ between the No-EPD (n = 355) and F-EPD (n = 1065) groups (1.7% vs. 2.5%, sd = 5.87). Patients selected to undergo unprotected CAS in contemporary practice have high rates of adverse preprocedure neurologic risk factors. Our propensity-matched analysis did not demonstrate evidence of significant benefit or harm associated with use of F-EPD in elective CAS patients.

Proximal protectionとdistal filter protectionを併用した頚動脈ステント留置術

Proximal protectionとdistal filter protectionを併用した頚動脈ステント留置術

Association between Plaque Echogenicity and Embolic Material Captured in Filter during Protected Carotid Angioplasty and Stenting

Objectives/design: The aim of the study was to investigate debris captured in filter embolic protection devices (EPDs) during carotid artery stenting (CAS) and its possible correlation with plaque echogenicity and other risk factors. Materials/methods: Between June 2010 and March 2011, 51 consecutive CAS patients (11 females, mean age 71.2 ± 7, 10 symptomatic) who underwent 53 procedures were included in this prospective study. Ultrasonographic Gray-Weale plaque type (I–V, echolucent to echogenic) characterisation was obtained in all cases. The same type of stent and filter EPD was used. Filters were collected and, after macroscopic evaluation, they were examined using the Thin-Prep® liquid-based cytology (LBC) technique. Results: Technical success was 100%. Thirty-day stroke and death rates were 1.8% (1/53) and 0%, respectively. Visible debris was detected in eight (15%) filters, whereas LBC revealed the presence of embolic material particles in 30 filters (56.6%). The presence of embolic material into the filter EPD was 2.38-fold increased for every category change from type IV to type I carotid plaques (OR = 2.38, 95% CI = 1.15-4.93). This association remained robust even after adjustment for age, gender and known atherosclerotic disease risk factors (OR = 2.26, 95% CI = 1.02–5.02). In multivariate analysis for risk factors, hypertension was associated with increased presence of embolic material detection in filter EPD (OR = 20.4, 95% CI = 1.28–326.1). The time distance from symptom to CAS was inversely correlated with debris quantity in EPD (Spearman rho −0.716; P = 0.02). Conclusions: Echolucent plaques, smaller time frame from last symptom and hypertension were associated with increased presence of embolic material.

Association between Plaque Echogenicity and Embolic Material Captured in Filter during Protected Carotid Angioplasty and Stenting

Objectives/designThe aim of the study was to investigate debris captured in filter embolic protection devices (EPDs) during carotid artery stenting (CAS) and its possible correlation with plaque echogenicity and other risk factors. Materials/methodsBetween June 2010 and March 2011, 51 consecutive CAS patients (11 females, mean age 71.2 ± 7, 10 symptomatic) who underwent 53 procedures were included in this prospective study. Ultrasonographic Gray-Weale plaque type (I–V, echolucent to echogenic) characterisation was obtained in all cases. The same type of stent and filter EPD was used. Filters were collected and, after macroscopic evaluation, they were examined using the Thin-Prep® liquid-based cytology (LBC) technique. ResultsTechnical success was 100%. Thirty-day stroke and death rates were 1.8% (1/53) and 0%, respectively. Visible debris was detected in eight (15%) filters, whereas LBC revealed the presence of embolic material particles in 30 filters (56.6%). The presence of embolic material into the filter EPD was 2.38-fold increased for every category change from type IV to type I carotid plaques (OR = 2.38, 95%CI = 1.15–4.93). This association remained robust even after adjustment for age, gender and known atherosclerotic disease risk factors (OR = 2.26, 95%CI = 1.02–5.02). In multivariate analysis for risk factors, hypertension was associated with increased presence of embolic material detection in filter EPD (OR = 20.4, 95%CI = 1.28–326.1). The time distance from symptom to CAS was inversely correlated with debris quantity in EPD (Spearman rho −0.716; p = 0.02). ConclusionsEcholucent plaques, smaller time frame from last symptom and hypertension were associated with increased presence of embolic material.

Expanding the use of the filter embolic protection devices in difficult to protect lesions

Expanding the use of the filter embolic protection devices in difficult to protect lesions

Systematic review: comparative effectiveness of adjunctive devices in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention of native vessels.

BackgroundDuring percutaneous coronary intervention (PCI), dislodgement of atherothrombotic material from coronary lesions can result in distal embolization, and may lead to increased major adverse cardiovascular events (MACE) and mortality. We sought to systematically review the comparative effectiveness of adjunctive devices to remove thrombi or protect against distal embolization in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI of native vessels.MethodsWe conducted a systematic literature search of Medline, the Cochrane Database, and Web of Science (January 1996-March 2011), http://www.clinicaltrials.gov, abstracts from major cardiology meetings, TCTMD, and CardioSource Plus. Two investigators independently screened citations and extracted data from randomized controlled trials (RCTs) that compared the use of adjunctive devices plus PCI to PCI alone, evaluated patients with STEMI, enrolled a population with 95% of target lesion(s) in native vessels, and reported data on at least one pre-specified outcome. Quality was graded as good, fair or poor and the strength of evidence was rated as high, moderate, low or insufficient. Disagreement was resolved through consensus.Results37 trials met inclusion criteria. At the maximal duration of follow-up, catheter aspiration devices plus PCI significantly decreased the risk of MACE by 27% compared to PCI alone. Catheter aspiration devices also significantly increased the achievement of ST-segment resolution by 49%, myocardial blush grade of 3 (MBG-3) by 39%, and thrombolysis in myocardial infarction (TIMI) 3 flow by 8%, while reducing the risk of distal embolization by 44%, no reflow by 48% and coronary dissection by 70% versus standard PCI alone. In a majority of trials, the use of catheter aspiration devices increased procedural time upon qualitative assessment.Distal filter embolic protection devices significantly increased the risk of target revascularization by 39% although the use of mechanical thrombectomy or embolic protection devices did not significantly impact other final health outcomes. Distal balloon or any embolic protection device increased the achievement of MBG-3 by 61% and 20% and TIMI3 flow by 11% and 6% but did not significantly impact other intermediate outcomes versus control. Upon qualitative analysis, all device categories, with exception of catheter aspiration devices, appear to significantly prolong procedure time compared to PCI alone while none appear to significantly impact ejection fraction. Many of the final health outcome and adverse event evaluations were underpowered and the safety of devices overall is unclear due to insufficient amounts of data.ConclusionsIn patients with STEMI, for most devices, few RCTs evaluated final health outcomes over a long period of follow-up. Due to insufficient data, the safety of these devices is unclear.

Simple immersion of filter devices into an urokinase solution prevents fibrin net formation during carotid artery stenting

Slow-flow phenomenon is frequently observed during carotid artery stenting (CAS) with a filter embolic protection device. It results in technical difficulties and can lead to adverse neurological events. Flow impairment is thought to be caused by plaque entrapped by the filter and/or blood coagulation on the filter. Characteristics of heparin- or urokinase-treated polyurethanes were analyzed by surface plasmon resonance, and the fibrinolytic activity of the urokinase-treated filter of Angioguard XP was estimated by the fibrin plate assay. A filter membrane of Angioguard XP protection device was treated with a heparin or urokinase solution. In clinical studies, six and nine patients were treated by CAS using Angioguard XP modified with heparin and urokinase, respectively. Filter membranes were examined by scanning electron microscopy (SEM). From in vitro studies, it appeared that urokinase adsorbed and remained on the Angioguard XP filter, and its fibrinolytic activity was demonstrated even after washing with saline; heparin, however, was easily washed out from the surface. From clinical study, some filter pores were obstructed in all six patients in the heparin group and in three patients in the urokinase group. Fibrin net was found on the filter in five of six patients in the heparin group and in one of nine patients in the urokinase group. Treatment of an Angioguard XP filter with a urokinase solution is effective in preventing pore occlusion and may reduce occurrence of the slow-flow phenomenon.

O-003 Prediction of periprocedual ischemic complication in carotid artery stenting with filter embolic protection device: feasibility of MR plaque imaging

PurposeOur purpose is to investigate the feasibility of MR plaque imaging to predict the high risk lesion for ischemic complication during carotid artery stenting (CAS) using a filter embolic protection...

Technical Limitations of Carotid Filter Embolic Protection Devices

Improved carotid artery stenting (CAS) results are credited to the development of embolic protection devices (EPDs). Reported are outcomes and technical failures of two classes of EPDs: distal balloon occlusion and distal filtration. We present a retrospective review of 206 CAS procedures from April 2001-September 2005. Filters (AccuNet, Angioguard, Filterwire, or Emboshield) were used in 98 cases (48%), distal balloon occlusion (PercuSurge) in 94 (46%), and no protection in 14. Data include demographics and procedural records. Mean age was 70 years (76% men, 24% women). At 30 days, there were no deaths, no myocardial infarctions, two major ipsilateral strokes (1%), two minor posterior strokes (1%), four transient ischemic attacks (2%), and one major access site complication (0.5%). Major neurologic events were equally divided between balloon occlusion and filters. Mean balloon occlusion time was 12 min, with only two patients (2%) manifesting reversible neurologic intolerance during flow arrest. In the last 100 cases, filter devices were preferentially used due to preserved antegrade flow. However, 11 cases (11%) necessitated intraoperative switching to balloon occlusion because of either extreme tortuosity or severe stenosis of the target lesion precluding passage of the filter element. CAS-specific equipment has improved procedural results. Despite theoretic advantages of filter EPDs, up to 10% of lesions are either too narrow or tortuous to allow safe passage of the filter element. Switching to a distal balloon occlusion system, which is well tolerated, may be preferred to unprotected predilation. Practitioners of CAS should be versed in both.

Comparison of embolization protection device-specific technical difficulties during carotid artery stenting

Embolic protection devices (EPDs) consisting of an internal carotid artery (ICA) filter or balloon occlusion are typically used during carotid artery stenting (CAS). This study compares the technical difficulties encountered using these two types of EPD. A retrospective review was conducted of patients undergoing CAS using a balloon occlusion EPD (balloon group: PercuSurge GuardWire) or filter EPD (filter group: Accunet, AngioGuard, or FilterWire). Complications were defined as minor stroke, National Institutes of Health (NIH) stroke scale <3; major stroke, NIH stroke scale > or =3; transient ischemic attack (TIA), reversible focal neurologic impairment; technical, reversible neurologic compromise during EPD deployment, inability to cross lesion, ICA spasm requiring treatment, EPD-related factors that prolonged CAS. CAS (n = 141) was performed in 133 patients (82% men) with a mean age of 72 of years. Comorbidities included diabetes, 35%; coronary artery disease, 75%; hypertension, 82%; and renal insufficiency, 15%. Indication was previous cerebrovascular accident in 10%, TIA in 29%, and asymptomatic >80% stenosis in 61%. Primary lesions were treated in 83% vs restenosis in 17%. The 30-day event rate was 1.4% major stroke, 2.1% minor stoke, 1.4% myocardial infarction, and 0.7% death. The overall combined 30-day stroke, death, and myocardial infarction rate was 5.6%. The 30-day stroke and death rate was 4.0% in the balloon group (n = 99) and 4.6% in the filter group (n = 42, P = .51). EPD-related technical difficulties occurred in 15% of the balloon group and 31% of the filter group (P < .05). Technical difficulties included a 10% incidence of reversible neurologic compromise during balloon deployment compared with 0% in the filter group (P = .002) and 12% incidence of inability to cross the lesion before predilation in the filter group compared with 0% in the balloon group (P = .001). During CAS, both balloon occlusion and filter devices provide acceptable results and appear complimentary. Filters can be used preferentially to avoid a 10% incidence of reversible neurologic compromise associated with balloon occlusion, except in critically narrowed or tortuous lesions when balloon occlusion may be preferred because of a 12% need for unprotected predilatation with filters.

European Carotid PROCAR Trial: Prospective Multicenter Trial to Evaluate the Safety and Performance of the ev3 Protégé™ Stent in the Treatment of Carotid Artery Stenosis—1‐ and 6‐Month Follow‐Up

The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. The Protégé GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018'' (6-9 mm stent) or 7 Fr 0.035'' (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA).

Embolic Protection Devices for Carotid Artery Stenting: Is There a Difference Between Filter and Distal Occlusive Devices?

We sought to compare the efficacy of a filter embolic protection device (F-EPD) and a distal occlusive embolic protection device (DO-EPD) in patients undergoing carotid artery stenting (CAS). The embolic protection device (EPD) may lower the periprocedural rate of cerebral ischemic events during CAS. However, it is unclear whether there is a difference in effectiveness between the different types of EPD. We analyzed data from the Carotid Artery Stent (CAS) Registry. From July 1996 to July 2003, 1,734 patients were included in the prospective CAS Registry. Of these patients, 729 patients were treated with an EPD, 553 (75.9%) with F-EPD, and 176 (24.1%) with DO-EPD. Patients treated with DO-EPD were more likely to be treated for symptomatic stenosis (64.5% vs. 53.4%, p = 0.011). The carotid lesions in patients treated under DO-EPD seemed to be more complicated, as expressed by a higher proportion of ulcers (p = 0.035), severe calcification (p = 0.039), a longer lesion length (p = 0.025), and a higher pre-interventional grade of stenosis (p < 0.001). The median duration of the CAS intervention was 30 min in the DO-EPD group, compared with 48 min in the filter group (p < 0.001). No differences in clinical events rate between the two groups of protection devices were observed. Multivariate analysis on the occurrence of the combined end point of in-hospital death or stroke found no difference between filter- and DO-EPD (4 of 176 [2.3%] for DO-EPD vs. 10 of 551 [1.8%] for F-EPD; adjusted odds ratio = 1.04, 95% confidence interval 0.24 to 4.44; p = 0.958). Filter EPD is the currently preferred method of EPD in clinical practice. Both F-EPD and DO-EPD seem to be equally effective during CAS.

A novel, low-profile filter-wire (Interceptor) embolic protection device during saphenous vein graft stenting

A novel, low-profile filter embolic protection device was deployed in 26 patients who underwent stent deployment for saphenous vein graft stenoses in a multicenter trial. Major adverse cardiovascular events were observed in only 2 patients (7.7%) and angiographic flow grades were improved.