Complication with an embolic protection device during carotid angioplasty.

A case of carotid artery stenting with an AngioGuard cerebral protection device is described in a patient with tight internal carotid stenosis. Deployment of AngioGuard induced sudden severe vasospasm, with subsequent minor stroke. According to our observations, AngioGuard may cause a vasospastic response with adverse neurologic effects.     

Robotic‐assisted balloon angioplasty and stent placement with distal embolic protection device for severe carotid artery stenosis in a high‐risk surgical patient

The use of robotic assistance in endovascular interventions may facilitate smoother procedures with fewer device manipulations, improve precision and accuracy of device deployment, and reduce exposure to fluoroscopic radiation. We used the CorPath GRX Robotic System for carotid balloon angioplasty and stent placement in a patient with limited surgical options.     

Initial multicenter experience with a novel distal protection filter during carotid artery stent implantation.

Atheroembolization resulting in transient or permanent neurologic impairment is the most common complication of catheter-based percutaneous carotid artery intervention. Protection of the distal cerebral vasculature during carotid stent implantation may enhance procedural safety. Carotid stent implantation with distal cerebral protection using the FilterWire EX was performed in 35 consecutive patients undergoing 36 procedures at six centers. The FilterWire was delivered and deployed successfully in all 36 cases, and embolic material was retrieved from 74% of procedures. The 30-day rate of major adverse events (death, major or minor stroke) was 0%. Transient ipsilateral periprocedural neurologic ischemia developed in two patients (5.7%), both resolving within 30 min. Distal cerebral protection with the FilterWire during carotid stenting is feasible and safe, results in capture and extraction of atheroembolic debris in the majority of patients while affording uninterrupted cerebral perfusion, and in this initial multicenter experience was associated with a high rate of procedural success without major complications.     

FilterWire distal embolic protection device for vein graft stenting: initial single-center experience

BACKGROUND: Saphenous vein graft (SVG) intervention is associated with a significant incidence of major adverse cardiac events (MACE) related to distal vessel embolization. The FilterWire distal embolic protection device has recently been approved as an adjunct to SVG intervention. We report here our initial experience in a single center in 30 consecutive patients using this device in SVG stenting. HYPOTHESIS: This study examined the outcomes and complications associated with these devices, as well as whether proficiency with the devices increased with greater experience and whether there were measurable outcome differences between devices. METHODS: We retrospectively identified all patients in whom a FilterWire device was placed at our hospital between June 2001 and June 2004. RESULTS: The device was successfully deployed in 29 of 30 patients, and all patients were stented successfully. Overall MACE rate was 6.6%, consistent with reports in larger multicenter clinical trials. Transient decreases in flow were noted while the device was in place in six patients, but improved in five patients with device removal. CONCLUSIONS: This early experience in a single center using FilterWire embolic protection indicates that excellent clinical results can be obtained by the adoption of filter protection for SVG intervention, without evidence for a detrimental learning curve.     

Approaches to difficult filter retrieval in carotid stenting.

The treatment of carotid disease continues to evolve with an increasing number of the lesions being successfully treated percutaneously. A large part of the success of percutaneous therapy has resulted from the use of distal protection devices and their ability to reduce embolization and subsequent strokes. However, device retrieval through implanted stents can be problematic. We describe situations in which difficulty was encountered advancing the distal protection filter retrieval device through the stent, as well as the different approaches to solve this potential problem.     

Subarachnoidal hemorrhage following carotid stenting with the distal-balloon protection.

A 61-year-old man underwent carotid stenting with the distal-balloon protection system for symptomatic carotid artery stenosis. During the procedure, progressive elevation of the systolic blood pressure occurred, reaching a peak of 220 mm Hg immediately following deflation of the distal balloon. This was associated with severe headaches and progressive deterioration in the mental status to a coma. Head CT scan showed massive subarachnoidal hemorrhage contralateral to the stented side and a secondary intracerebral hemorrhage. Despite immediate successful blood pressure control, his condition deteriorated and he died 2 days later.     

Carotid stenting in patients older than 65 years with inoperable carotid artery disease: A single‐center experience

Carotid angioplasty and stenting to treat extracranial carotid stenosis is an alternative (as yet not widely accepted) to high‐risk surgery, but its safety and efficacy are little known, especially in elderly patients. We reviewed our 3‐year experience of treating 100 elderly patients (> 65 years old) considered to be inoperable (76 men, 24 women, mean age 76 ± 10 years, mean follow‐up 18 ± 9.2 months) and present two case histories. Most (85%) were symptomatic (transient ischemic attacks in 60, stroke in 25); 80 had concomitant coronary artery disease (severe in 30 [defined by > 70% stenosis in two or more epicardial coronary arteries or the left main coronary artery]) and 25 had severe left ventricular dysfunction (ejection fraction ≤ 20%). The procedure was technically successful in all patients; there was one major stroke and no patient died. Postprocedure, 15% had minor complications: reversible neurological deficit (5%), pulmonary edema (3%), prolonged hypotension (3%), vascular access complications (3%), and neck hematoma (1%). Over 90% of patients were discharged home within 24 hr. Cathet. Cardiovasc. Intervent. 50:1–8, 2000. © 2000 Wiley‐Liss, Inc.     

Carotid artery stenting in high surgical risk patients using the FiberNet® embolic protection system: The EPIC trial results

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single‐arm trial evaluated the 30‐day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Background: Embolic protection filters available for use during CAS include fixed and over‐the‐wire systems that rely on embolic material capture within a “basket” structure. The FiberNet® Embolic Protection System (EPS), which features a very low crossing profile, consists of a three‐dimensional fiber‐based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30‐day follow‐up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30‐day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30‐day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). © 2009 Wiley‐Liss, Inc.     

Intravascular ultrasound identification of intraluminal embolic plaque material during carotid angioplasty with stenting.

INTRODUCTION: Carotid angioplasty with stenting (CAS) has evolved as a viable method for treating patients at high risk for carotid endarterectomy. Strokes complicating CAS are most commonly caused by the liberation and distal embolization of embolic material from plaque during the procedure. METHODS: CAS with distal embolic protection (DEP) was performed using the assistance of intravascular ultrasound (IVUS) in a 68-year-old man with asymptomatic carotid artery stenosis. Evaluation of the plaque pretreatment was performed using virtual histology software. IVUS evaluation was also performed after prestent angioplasty, stenting, and poststent angioplasty. RESULTS: Initial degree of angiographic stenosis was 78.9%. Final degree of stenosis was 15.7%. By IVUS, stenosis by minimum lumen diameter and minimum lumen area were 75.6% and 93.4% pretreatment, respectively, and 42.2% and 47.1% posttreatment, respectively. An intraluminal lesion was noted in the distal aspect of the stent after poststent angioplasty but before DEP device removal. Ultrasonographic characteristics of the intraluminal defect were consistent with ruptured plaque material. Angiographic runs failed to demonstrate the lesion. A repeat IVUS run performed approximately 10 min later failed to depict the lesion, suggesting that distal embolization had occurred. Embolic material was noticed in the DEP device after removal. The patient did not experience any ischemic neurological symptoms. CONCLUSIONS: IVUS can identify intraluminal plaque material, which may be a precursor for embolism and delayed ischemic events after CAS. IVUS may allow for treatment before distal embolization of plaque material. Virtual histology IVUS software may help to identify carotid lesions at higher risk for significant embolization during CAS.     

Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid revascularization with ev3 arterial technology evolution (CREATE) feasibility trial.

The purpose of this study was to evaluate the feasibility of carotid artery revascularization using a new system for carotid stenting and distal embolic protection in 30 patients with severe carotid stenosis and high risk for carotid endarterectomy (Carotid Revascularization With ev3 Arterial Technology Evolution, or CREATE). Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. All patients underwent percutaneous revascularization using the Protégé GPS self-expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). In-hospital and 30-day outcomes were analyzed. High-risk features included age > 75 years (63%), left ventricular ejection fraction < 35% (20%), and restenosis after prior carotid endarterectomy (53%). Procedural success was 100%. In-hospital complications included severe vasovagal reactions in six patients (20%) and a popliteal embolus in one patient (3.3%), treated by successful embolectomy. During 30 days of follow-up, two patients (6.6%) experienced minor neurological deficits, including transient expressive aphasia that resolved without therapy in one patient and homonymous hemianopsia due to contralateral posterior circulation stroke in one patient. This study supports the feasibility of percutaneous carotid artery revascularization with the Protégé GPS self-expanding stent and Spider distal embolic protection system, which will be evaluated in a large multicenter pivotal trial (CREATE Pivotal Trial).     

Carotid artery stenting in octogenarians using a proximal endovascular occlusion cerebral protection device: A multicenter registry

Background : Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians. Purpose : The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high‐volume centers by experienced operators. Methods : From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days. Results : 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In‐hospital complications: Two minor and two major strokes (2.02%) occurred. No device‐related complications and no serious access site complication were noted. Between discharge and 30‐day follow‐up, one patient died due to a cardiac arrest. The overall 30‐day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender. Conclusion : This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines. © 2010 Wiley‐Liss, Inc.     

A "mouse in a trap" method for cerebral protection during carotid stenting: Technical note.

Carotid artery angioplasty and stenting (CAS) is now used as an alternative to surgical endarterectomy. The introduction of cerebral protection systems during stenting has improved carotid artery stenosis treatment, with less periprocedural complications. A "mouse in a trap" method was conceived and used in three patients. This involved an emboli entrapment-aspiration system using one proximal occluder in the common carotid artery and two distal occluders in the internal carotid artery or external carotid artery, followed by serial inflation-deflation cycles during each carotid stenting procedure. Debris was retrieved before dilation in one patient, after deployment in one, and after dilation in two. Although only used in a few cases to date, the method may improve the practice of CAS in treating patients with carotid stenosis, resulting in less thromboembolic events.     

The CAPTURE registry: results of carotid stenting with embolic protection in the post approval setting.

BACKGROUND: Pivotal study data examining carotid stenting with embolic protection as a less invasive alternative to endarterectomy for high surgical risk patients have been acquired under controlled conditions with highly selected physicians and hospitals. This report examines outcomes of carotid stenting post-approval after diffusion of this technology to a broader cross-section of physicians and hospitals. METHODS: The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry to assess two important aspects of the post-IDE experience: the safety of carotid stenting by physicians with varying levels of experience as a measure of the adequacy of physician training, and the identification of rare/unexpected device-related complications. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30 days post-procedure. RESULTS: 3,500 patients were enrolled by 353 physicians at 144 sites. The 30-day primary endpoint event rate was 6.3% (95% CI: 5.5-7.1%) and did not differ among the three operator experience levels (5.3%, 6.0%, and 7.4%; P = 0.31) from most to least experienced, respectively. There were no differences in outcomes among physician specialties when adjusted for case mix. There were no unanticipated device related adverse events. CONCLUSIONS: The results of the CAPTURE study compare favorably to those achieved in the predicate pivotal investigations, and suggest that the post-approval transfer of this new therapy to the community practice setting via carotid stent training programs is effective in preparing physicians with varying experience levels and specialty training backgrounds.     

Use of filterwire EX for distal embolic protection during complex percutaneous coronary interventions: four case studies.

We describe four successful cases demonstrating the use of a novel filter-guidewire (FilterWire EX) during complex percutaneous coronary interventions in saphenous vein grafts (n = 3) and native coronary artery (n = 1) for prevention of distal embolization and consequently myonecrosis.     

Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry.

PURPOSE: To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions. METHODS: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris. RESULTS: Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p<0.001). Clinically significant (> or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p<0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection. CONCLUSION: Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.     

Clinical experiences using the FilterWire EX for distal embolic protection during complex percutaneous coronary interventions

BACKGROUND: Distal embolization during coronary angioplasty may result in vessel occlusion, no reflow and myonecrosis. This study tested the authors' clinical experiences using a guidewire system designed to preserve distal flow during angioplasty.

METHODS AND RESULTS: The FilterWire EX? (Boston Scientific, Natick, MA, USA) consists of a 0.014‐inch guidewire on which an expandable loop structure is attached to a porous polyurethane membrane. The assembly is delivered across the target lesion, followed by deployment of the filter distal to the lesion. Procedural and angiographic outcome data were obtained from patients undergoing saphenous vein grafts (SVGs) (n?=?16) or native coronary (n?=?4) interventions. The mean age was 62?±?10 years. All four patients with native coronary lesions sustained acute myocardial infarction while 15/16 patients with degenerated SVGs presented with accelerated angina pectoris. The mean proximal reference diameter was 3.62?±?0.32?mm, percentage diameter stenosis was 72?±?13%, and lesion length was 16.3?±?5.7?mm. Angiographic visible thrombus was detected in 12/20 (60%) cases. Stents were used in 19/20 patients (95%) with average stent diameter/length equal to 3.81?±?0.42/23?±?7?mm. Overall procedural success was obtained in 93.3% as no‐reflow and total CK elevation occurred in 1/16 treated patients (6.7%) despite distal embolic filtration. In‐hospital and 30‐day survival was 100% with no episodes of target vessel thrombosis and/or myocardial infarction.

CONCLUSIONS: The use of the FilterWire EX seems to be feasible and safe in suitable lesion subsets and in relatively large‐sized vessels among patients who are at high risk for distal embolization. (Int J Cardiovasc Intervent 2004; 1:?28–32)