Use of the Parodi Anti-Embolism System in Carotid Stenting: Italian Trial Results

Adami, Carlo A.; Scuro, Alberto; Spinamano, Luca; Galvagni, Elisabetta; Antoniucci, D; Farello, Gian A.; Maglione, Franco; Manfrini, Stefano; Mangialardi, Nicola; Mansueto, G.; Mascoli, Francesco; Nardelli, E.; Tealdi, D.G.

doi:10.1177/152660280200900202

Cited by 64 publications

(51 citation statements)

References 23 publications

(34 reference statements)

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“…Patient selection, operator skill, and device design all remain important in optimizing outcomes in high-risk populations, including the very elderly. Previous, smaller investigations of flow reversal yielded results similar to those in the EMPiRE study [25,26,28,29]. In the largest of these, Parodi et al [28] employed flow reversal and Wallstents (Boston Scientific) to treat carotid artery stenosis in 200 patients.…”

Section: Discussionmentioning

confidence: 72%

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Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

Clair

Hopkins

Mehta

et al. 2010

Cathet Cardio Intervent

112

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Section: Discussionmentioning

confidence: 72%

“…Subsequently, several studies found this method to be safe [25][26][27][28][29]. The Embolic Protection with Reverse Flow (EMPiRE) Clinical Study, which was conducted in the United States under an investigational device exemption from the US Food and Drug Administration (FDA), began in 2006.…”

Section: Introductionmentioning

confidence: 99%

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

Clair

Hopkins

Mehta

et al. 2010

Cathet Cardio Intervent

112

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show abstract

“…Our literature search resulted in 40 studies of CAS without cerebral protection and 14 studies of CAS with cerebral protection 17,30,[53][54][55][56][57][58][59][60][61][62][63][64] that met the inclusion criteria. Of these, several articles were excluded because they reported on patients already used in other publications from the same institutions: Theron et al 65 was excluded in favor of Guimaraens et al 58 ; several studies of the group of Roubin et al 36 -42 were excluded in favor of Roubin et al 32 ; Jordan et al 43 and Jordan et al 44 were excluded in favor of Jordan et al 22 ; Chakhtoura et al 45 62 One recent study 49 evaluating the efficacy of abciximab in patients undergoing CAS was also excluded.…”

Section: Resultsmentioning

confidence: 99%

Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection Devices

Kastrup

Gröschel

Krapf

et al. 2003

Stroke

536

315

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Background— Carotid angioplasty and stenting (CAS) is increasingly being used for treatment of symptomatic and asymptomatic carotid artery disease (CAD). To evaluate the efficacy of cerebral protection devices in preventing thromboembolic complications during CAS, we conducted a systematic review of studies reporting on the incidence of minor stroke, major stroke, or death within 30 days after CAS. Summary of Review— We searched for studies published between January 1990 and June 2002 by means of a PubMed search and a cumulative review of reference lists of all relevant publications. In 2357 patients a total of 2537 CAS procedures had been performed without protection devices, and in 839 patients 896 CAS procedures had been performed with protection devices. Both groups were similar with respect to age, sex distribution, cerebrovascular risk factors, and indications for CAS. In many studies the periprocedural complication rates had not been presented separately for patients with symptomatic and asymptomatic CAD. The combined stroke and death rate within 30 days in both symptomatic and asymptomatic patients was 1.8% in patients treated with cerebral protection devices compared with 5.5% in patients treated without cerebral protection devices (χ 2 =19.7, P <0.001). This effect was mainly due to a decrease in the occurrence of minor strokes (3.7% without cerebral protection versus 0.5% with cerebral protection; χ 2 =22.4, P <0.001) and major strokes (1.1% without cerebral protection versus 0.3% with cerebral protection; χ 2 =4.3, P <0.05), whereas death rates were almost identical (≈0.8%; χ 2 =0.3, P =0.6). Conclusions— On the basis of this early analysis of single-center studies, the use of cerebral protection devices appears to reduce thromboembolic complications during CAS. These technical aspects should be taken into account before the initiation of further randomized trials comparing CAS with carotid endarterectomy.

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“…1) By using a balloon and a filter device for distal protection and a double balloon catheter for proximal protection as EPDs, the procedure has been reported to be safe also for patients with vulnerable plaques, who have been considered a high-risk group for CAS, because a balloon is placed on the proximal side of the lesion, and debris is eliminated by flow reversal. 21) Ischemic tolerance has been reported as a problem in balloon protection, 22) but, by filter protection, the blood flow can be maintained, and the problem of ischemic tolerance can be avoided. However, the risk of passage of debris through the filter has been reported if the debris is smaller than the pore size of the filter or is liquid, or if a gap opens between the filter and vascular wall.…”

Section: Resultsmentioning

confidence: 99%

Appropriate Selection of CAS or CEA and Proper Use of Protection Device in the Event of CAS According to Carotid Plaque Characteristics

Sawada

Yasokawa

Mizutani

2016

JNET

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Objective: To assess the selection of carotid endarterectomy (CEA) or carotid artery stenting (CAS) and the choice of embolic protection device (EPD) on the basis of a preoperative magnetic resonance (MR) plaque image such as Sp/Sm (signal intensity ratio of carotid plaque against sternocleidomastoid muscle). Methods:Between August 2011 and August 2015, 180 patients who underwent CEA or CAS at our institution were retrospectively analyzed. CEA was selected when soft plaque was suspected by a plaque image of Sp/Sm ≥2, in contrast, CAS was indicated for patients with a surgically high-risk condition and for patients with a plaque image of Sp/Sm <2.Moreover, EPD was chosen by means of the plaque characterization such as Angioguard XP for Sp/Sm <2, Filter wire EZ or Spider FX for 2 ≤ Sp/Sm <3, and balloon (GuardWire PS/Mo.Ma Ultra) for 3 ≤ Sp/Sm. Then, we compared the peri-operative complication rate and hyperintensity rate on diffusion-weighted image (DWI) post-operatively. Results:In 80 cases with 3 ≤ Sp/Sm, CEA was performed for 30 cases and CAS using balloon for 50 cases. In 88 cases with 2 ≤ Sp/Sm <3, CEA was performed for nine cases and CAS using Filter wire EZ or Spider FX for 79 cases. The residual 12 cases with Sp/Sm <2 were treated with CAS using Angioguard XP. The complication rate was 2.1% in CAS and 0% in CEA. Asymptomatic hyperintensities on DWI after revascularization were detected in 24% of CAS patients and 0% of CEA patients. As for EPD, 27 of 79 CAS patients treated with Filter wire EZ or Spider FX had hyperintensities on DWI and hyperintensities were mostly observed in 21 of 39 patients with 2 ≤ Sp/Sm <3 on both T1-and T2-weighted imaging, but not in 6 of 40 patients with 2≤ Sp/Sm <3 on either T1-or T2-weighted imaging. Conclusion:The clinical outcome of patients treated with CEA was acceptable regardless of their carotid plaque components, if SAPPHIRE CEA high-risk group is accurately excluded. Considering that balloon protection should be used as EPD against soft plaque with 2 ≤ Sp/Sm <3 on both T1-and T2-weighted imaging, selection of CEA or CAS and EPD based on the MR plaque characteristics such as Sp/Sm is a useful strategy.

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Use of the Parodi Anti-Embolism System in Carotid Stenting: Italian Trial Results

Abstract: The PAES appears to be a safe and effective means of providing protection from embolic complications during carotid stenting.

Cited by 64 publications

References 23 publications

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection Devices

Appropriate Selection of CAS or CEA and Proper Use of Protection Device in the Event of CAS According to Carotid Plaque Characteristics

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