772-3 Heparin Delivery at the Site of Angioplasty with a Novel Drug Delivery Sleeve: Initial Clinical Series

Abstract

The LocalMed InfusaSleeve (IS) is a multi-lumen array with distal micro perforations designed to deliver agent at the site of angioplasty. Prior to the procedure, the IS is loaded onto a standard dilatation catheter (DC). Using standard technique, angioplasty is performed with the IS retracted. After lesion dilatation, the IS is tracked over the DC, aligning the micro perforation region of the IS with the balloon. The balloon is reinflated bringing the array into close proximity to the arterial wall. Agent(s) is delivered at specific pressures independent of balloon inflation. We have previously shown that agent delivery into the wall is dependent upon balloon inflation and drug delivery pressures. A pilot series was performed to evaluate the safety of heparin delivery via the IS. A total of 21 patients [emergent/urgent (2), elective cases (19)] with lesions at a variety of anatomic sites [LAD(10), LCx(3), ramus intermedius(1), RCA(6) and vein graft (1)] and complexity [ACC/AHA Lesion Type: A(8), B1(l0), B2(3)] were attempted. Following PTCA, heparin (1,000 U/ml) was delivered via the IS into the arterial lumen (balloon inflation pressure = 0.5 atm, drug delivery pressure = 40 psi). Failure to track the IS was noted in 2 cases. In 2 cases (RCA) a dissection was noted following agent infusion [NHLBI Type: A(1), B(1)]. The IS was used in conjunction with standard guide catheters [8 fr (15), 9 fr (6)], DC and guide wires. At discharge, no complications were noted. 1) The IS can be used safely at a variety of anatomic sites, 2) The IS is compatible with standard PTCA equipment. 3) Local delivery of agent via LocalMed InfusaSleeve is a promising approach to reduce abrupt closure and restenosis.