Abstract 20549: First in Man Experience with a Dedicated Coronary Re-Entry Device for Revascularization of Chronic Total Occlusion
Background: Successful percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO) has been shown to improve outcomes in patients with ischemia. Despite newer dedicated guidewires and techniques, success rates of PCI for CTO remain suboptimal, with failure of guidewire passage representing the most common mode of failure. New technologies are needed to improve success rates for CTO recanalization. Here we describe the first experience with a novel, dedicated re-entry device for treatment of CTO.
Methods: Nineteen consecutive patients undergoing PCI for CTO with failure to cross because of subintimal wire position were included. In each of these cases, a 1 mm crossing catheter (CrossBoss, BridgePoint Medical, Plymouth, MN) was placed in the subintimal space at the point of re-entry of collateral flow. The crossing catheter was then replaced with a dedicated re-entry balloon — a flat semi-circumferential balloon which conforms to the subadventitial space adjacent to the lumen, with two ports offset by 180 degrees for wire egress (Stingray, BridgePoint Medical) — which was positioned at the re-entry site and inflated to low pressure. One of the two ports was used to pass a wire into the artery on the angiographic side of the true lumen (Figure). The wire was then advanced into the distal true lumen and standard techniques were used to complete the PCI.
Results: Seventeen of these nineteen CTO cases (89%) were treated successfully in this manner. The mean CTO length was 43 +/− 24 mm. Four left circumflex, six left anterior descending, and nine right coronary artery lesions were attempted. One patient had an asymptomatic rise in serum creatine kinase. No other procedural complications occurred and no adverse events were noted at 30 days.
Conclusions: In this first reported successful use of a dedicated coronary artery re-entry system for CTO, there was a high success rate and low rate of procedural and short-term complications.
- © 2010 by American Heart Association, Inc.