Efficacy of a proximal occlusion catheter with reversal of flow in the prevention of embolic events during carotid artery stenting: an experimental analysis.

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.