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

Grube, Eberhard; Colombo, Antonio; Hauptmann, Eugen; Londero, Hugo; Reifart, Nicolaus; Gerckens, Ulrich; Stone, Gregg W.

doi:10.1002/ccd.10348

Cited by 38 publications

(13 citation statements)

References 30 publications

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“…8 Lack of vessel apposition with the FilterWire EX may allow embolic debris to bypass the filter and may be more prone to occur in the possibly tortuous CA. Orthogonal biplanar views are necessary to ensure vessel wall apposition and may be difficult to obtain.…”

Section: Discussionmentioning

confidence: 99%

“…The DPD basket is mounted on the guidewire via a spinner tube that permits steering of the guidewire when the filter is withdrawn inside the delivery sheath with a crossing profile of 3.8 F, but with no freedom of movement along the wire axis. The use of the FilterWire DPD has been previously reported, 3,8 and shortterm outcomes of a randomized trial have been published. 27 In an ex vivo human atherosclerotic CA preparation, 100% of particles Ͼ 360 m in diameter and 93% of particles Ͼ 80 m in diameter embolized following balloon angioplasty and stent placement were captured successfully by this DPD.…”

Section: The Filterwire Ex Distal Protection Devicementioning

confidence: 99%

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Iatrogenic vasospasm in carotid artery stent angioplasty with distal protection devices

Schirmer¹,

Hoit²,

Malek³

2008

FOC

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Object Distal protection devices (DPDs) have decreased the risk of embolic stroke among patients with carotid artery (CA) disease undergoing CA stent placement. The FilterWire EX is a first-generation fixed-basket DPD with a filter rigidly attached to a guidewire. Second-generation mobile-basket DPDs (RX Accunet or SpiderFX) allow movement of the filter relative to the guidewire and can thus reduce the potential for vessel irritation, vasospasm, or intimal injury during CA stent placement. Methods Stent angioplasty was attempted in 40 CAs (37 patients) using the fixed-basket FilterWire DPD, a second-generation mobile-basket DPD, or no protection in 12, 6, and 22 arteries, respectively. Clinical presentation, angiographic details relating to the incidence of vasospasm or dissection, and clinical outcome data were recorded and analyzed. Results Vasospasm was associated with use of the fixed-basket FilterWire device (8 [67%] of 12 cases) compared with the bare unfiltered guidewire group (3 [14%] of 22) and the second-generation mobile-basket DPD group (1 [17%] of 6, p < 0.004). Secondary angioplasty was also associated with intraprocedural vasospasm. In a multivariate analysis, FilterWire use was an independent risk factor for vasospasm (p < 0.0003). Conclusions A high incidence of vasospasm was observed following CA stent placement procedures in which the fixed-basket FilterWire EX DPD was used but not in unprotected CA stent placement or procedures in which a second-generation mobile-basket DPD was used. Although this phenomenon was self-limited in all instances, vasospasm should be considered a risk of these devices and may predispose to more serious vascular injury. Coronary artery stent placement should be performed with a second-generation mobile-basket DPD to minimize the risks of embolic complications and iatrogenic vascular injury.

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Section: Discussionmentioning

confidence: 99%

Section: The Filterwire Ex Distal Protection Devicementioning

confidence: 99%

Iatrogenic vasospasm in carotid artery stent angioplasty with distal protection devices

Schirmer¹,

Hoit²,

Malek³

2008

FOC

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“…Whether filter-based catheters or balloon occlusion and aspiration systems are preferred in other clinical settings or vascular territories, such as during neurovascular intervention 11,12 or primary angioplasty for acute MI, 13 will require separate randomized trials to determine. Finally, additional comparative investigations will also be required to establish whether other filter-based distal protection catheters perform equally well, better, or worse than the FilterWire EX device.…”

Section: Discussionmentioning

confidence: 99%

Randomized Comparison of Distal Protection With a Filter-Based Catheter and a Balloon Occlusion and Aspiration System During Percutaneous Intervention of Diseased Saphenous Vein Aorto-Coronary Bypass Grafts

et al. 2003

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for the FilterWire EX Randomized Evaluation (FIRE) InvestigatorsBackground-The high rate of periprocedural complications resulting from atherothrombotic embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by distal microcirculatory protection using a balloon occlusion and aspiration system. Whether filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of use, are as effective for this purpose has not been established. Methods and Results-A total of 651 patients undergoing percutaneous intervention of 682 saphenous vein graft lesions were prospectively randomized to distal protection with the filter-based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (Pϭ0.25). Postprocedural measures of epicardial flow and angiographic complications were similar between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently in the FilterWire EX group (0% versus 1.5%, Pϭ0.03). The primary end point, the composite incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]ϭϪ1.7% [Ϫ6.4%, 3.1%]; P for superiorityϭ0.53, P for noninferiorityϭ0.0008). Conclusions-Distal protection with the FilterWire EX may be safely used as an adjunct to percutaneous intervention of diseased saphenous vein grafts and, compared with distal protection with the GuardWire balloon occlusion and aspiration system, results in similar rates of major adverse cardiac events at 30 days. (Circulation. 2003;108:548-553.)

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“…The altered hemodynamic condition in different head positions has an effect on studies concerning the potential pitfalls of carotid implants such as carotid stents (18) or carotid emboli diverters (35). The carotid stent could work as planned in a certain head position, but could, for a particular patient, be subjected to low WSS values in a different head position, yielding a situation prone to restenosis.…”

Section: Summary and Implicationsmentioning

confidence: 99%

Influence of head position on carotid hemodynamics in young adults

Glor¹,

Ariff²,

Hughes³

et al. 2004

American Journal of Physiology-Heart and Circulatory Physiology

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.-Studies in adults have shown marked changes in geometry and relative positions of the carotid arteries when rotating the head. The aim of this study was to quantify the change in geometry and analyze its effect on carotid hemodynamics as a result of head rotation. The right carotid arteries of nine young adult subjects were investigated in supine position with straight and left turned head positions, respectively. The three-dimensional (3D) carotid geometry was reconstructed by using 3D ultrasound (3D US), and the carotid hemodynamics were calculated by combining 3D US with computational fluid dynamics. It was observed that cross-sectional areas and shapes did not change markedly with head rotation, but carotid vessel center lines altered with planarification of the common carotid artery as a main feature (P Ͻ 0.05). Measured common carotid flow rates changed significantly at the individual level when the head was turned, but on the average, the change in mean common carotid flow rate was relatively small (0.37 Ϯ 1.11 ml/s). The effect of the altered center lines and flow rates on the atherogenic nature of the carotid bifurcation was evaluated by using calculated hemodynamic wall parameters, such as wall shear stress (WSS) and oscillatory shear index (OSI). It was found that WSS and OSI patterns changed significantly with head rotation, but the variations were very subject dependent and could not have been predicted without assessing the altered geometry and flow of the carotid bifurcation for individual cases. This study suggests that there is a need for standardization of the choice of head position in the 3D US scan protocol, and that carotid stents and emboli diverters should be studied in different head positions.three-dimensional ultrasound; atherosclerosis; wall shear stress; computational fluid dynamics EFFECTS OF BODY POSTURE and head positioning on respiration and cerebral hemodynamics have been investigated in a number of studies. Effects on respiration seem to suggest that body posture rather than head position has the greatest effects (6). In infants, sleeping in a prone position has been shown to be associated with increases in heart and respiratory rates, decreases in oxygen saturation, and marked pallor compared with infants sleeping in a supine position (33). These changes, however, do not occur with changes in head positions alone (11). In adults, changes in head position also do not seem to change oxygenation or maximum inspiratory pressure. Adopting a supine position, however, increases pharyngeal resistance (38) and has been shown to worsen apneic episodes in those suffering from obstructive sleep apnea (6).The hemodynamic effects of body posture and head position have also been examined. In infants, whereas cerebral blood flow rate remains constant during head rotations in the supine position, keeping the head straight favors cerebral venous drainage and helps to prevent an elevation of cerebral blood volume (29). Eichler et al. (12) showed that in infants, blood velocity profiles changed...

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

Cited by 38 publications

References 30 publications

Iatrogenic vasospasm in carotid artery stent angioplasty with distal protection devices

Iatrogenic vasospasm in carotid artery stent angioplasty with distal protection devices

Randomized Comparison of Distal Protection With a Filter-Based Catheter and a Balloon Occlusion and Aspiration System During Percutaneous Intervention of Diseased Saphenous Vein Aorto-Coronary Bypass Grafts

Influence of head position on carotid hemodynamics in young adults

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