TY - JOUR
T1 - Efficacy of a proximal occlusion catheter with reversal of flow in the prevention of embolic events during carotid artery stenting
T2 - An experimental analysis
AU - Ohki, Takao
AU - Parodi, Juan
AU - Veith, Frank J.
AU - Bates, Mark
AU - Bade, Maseer
AU - Chang, David
AU - Mehta, Manish
AU - Rabin, Joseph
AU - Goldstein, Kenneth
AU - Harvey, John
AU - Lipsitz, Evan
N1 - Funding Information:
Supported by grants from the US Public Health Service (HL 02990-05), the James Hilton Manning and Emma Austin Manning Foundation, the Anna S. Brown Trust, and ArteriA, Inc, San Francisco, Calif.
PY - 2001
Y1 - 2001
N2 - Objective: The role of percutaneous angioplasty and stenting of carotid bifurcation lesions has been limited by its potential for producing embolic debris. We evaluated the efficacy of a proximal occlusion catheter (POC) in the prevention of embolic events during carotid artery stenting. In addition, pressure measurements relevant to the clinical application of this device were obtained from 10 patients undergoing carotid endarterectomy. Methods: The POC is a guiding catheter with an occlusion balloon attached on the outside of the catheter at its distal end. Occlusion of the common carotid artery (CCA) was achieved by inflating the balloon while access to carotid bifurcation lesions was obtained through the inner lumen. The POC was inserted in the CCA of 10 dogs via the femoral artery. The side port of the POC was connected to a sheath placed in the femoral vein, thereby creating an external arteriovenous shunt. Ten artificial radiopaque particles simulating embolic particles and contrast agent were introduced in the CCA and monitored fluoroscopically. As a control, the same procedure was performed with a standard guiding catheter without an occlusion balloon. In 10 patients undergoing carotid endarterectomy the internal carotid artery (ICA) and external carotid artery stump pressures and the pressure in the internal jugular vein were measured. Results: Without the external arteriovenous shunt, in all animals there was prograde flow in the distal CCA despite CCA occlusion. This flow was derived from the thyroid artery. However, once the arteriovenous shunt was activated, reversal of flow in the distal CCA was achieved in each animal, and all the artificial particles were recovered from the side port of the POC. In the control group, each particle embolized to the brain (100%, P < .01). In the patients, the mean stump pressures in the ICA and external carotid artery and the jugular vein pressure were 51.8 ± 14.2, 62.2 ± 15.1, and 6.5 ± 3.5 mm Hg, respectively. In each case, the jugular vein pressure was the lowest among the three. Conclusions: Obtaining proximal CCA control by inflating the POC does not sufficiently prevent embolization. However, reversal of flow in the ICA can always be created with the external shunt, which effectively prevents embolization. Thus, POC may markedly lower procedural stroke rates during carotid artery stenting. The ability of POC to prevent embolization before crossing the lesion with a guidewire may be an important advantage over other distal protection devices.
AB - Objective: The role of percutaneous angioplasty and stenting of carotid bifurcation lesions has been limited by its potential for producing embolic debris. We evaluated the efficacy of a proximal occlusion catheter (POC) in the prevention of embolic events during carotid artery stenting. In addition, pressure measurements relevant to the clinical application of this device were obtained from 10 patients undergoing carotid endarterectomy. Methods: The POC is a guiding catheter with an occlusion balloon attached on the outside of the catheter at its distal end. Occlusion of the common carotid artery (CCA) was achieved by inflating the balloon while access to carotid bifurcation lesions was obtained through the inner lumen. The POC was inserted in the CCA of 10 dogs via the femoral artery. The side port of the POC was connected to a sheath placed in the femoral vein, thereby creating an external arteriovenous shunt. Ten artificial radiopaque particles simulating embolic particles and contrast agent were introduced in the CCA and monitored fluoroscopically. As a control, the same procedure was performed with a standard guiding catheter without an occlusion balloon. In 10 patients undergoing carotid endarterectomy the internal carotid artery (ICA) and external carotid artery stump pressures and the pressure in the internal jugular vein were measured. Results: Without the external arteriovenous shunt, in all animals there was prograde flow in the distal CCA despite CCA occlusion. This flow was derived from the thyroid artery. However, once the arteriovenous shunt was activated, reversal of flow in the distal CCA was achieved in each animal, and all the artificial particles were recovered from the side port of the POC. In the control group, each particle embolized to the brain (100%, P < .01). In the patients, the mean stump pressures in the ICA and external carotid artery and the jugular vein pressure were 51.8 ± 14.2, 62.2 ± 15.1, and 6.5 ± 3.5 mm Hg, respectively. In each case, the jugular vein pressure was the lowest among the three. Conclusions: Obtaining proximal CCA control by inflating the POC does not sufficiently prevent embolization. However, reversal of flow in the ICA can always be created with the external shunt, which effectively prevents embolization. Thus, POC may markedly lower procedural stroke rates during carotid artery stenting. The ability of POC to prevent embolization before crossing the lesion with a guidewire may be an important advantage over other distal protection devices.
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U2 - 10.1067/mva.2001.112278
DO - 10.1067/mva.2001.112278
M3 - Article
C2 - 11241119
AN - SCOPUS:0035108558
SN - 0741-5214
VL - 33
SP - 504
EP - 509
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
IS - 3
ER -