INTRACORONARY HEPARIN DELIVERY IN HUMANS - ACUTE FEASIBILITY AND LONG-TERM RESULTS

Background Inefficacy of systemic drug administration for restenosis p revention may partially relate to insufficient local drug concentratio n. This study aimed to evaluate the acute feasibility and long-term ou tcome of using an infusion-perfusion coil balloon, Dispatch. Methods a nd Results In 22 patients after balloon angioplasty, the coil balloon was studied for (1) feasibility of local heparin delivery, (2) symptom s and signs of ischemia during prolonged deployment compared with angi oplasty balloon occlusion; (3) coronary pressure and flow distal to th e inflated device, and (4) long-term clinical and angiographic results . During prolonged intracoronary deployment of the coil balloon (29+/- 8 minutes), 5 of 22 patients developed mild chest pain versus 20 of 22 during angioplasty (275+/-283 seconds). Neither hemodynamic nor vecto rcardiographic signs of ischemia were detected, in contrast to angiopl asty balloon occlusion. Baseline flow across the coil balloon was 44+/ -31 mL/min, increasing by a factor of 1.8+/-0.7 during pharmacological ly induced hyperemia. A mean Volume of 14.2+/-6.1 mt containing 1416+/ -608 IU of heparin was infused locally at a pressure of 122+/-54 mm Hg . At 7+/-1-month follow-up, 1 asymptomatic patient had died, and of th e remaining 21, 17 (81%) were asymptomatic. Angiographic follow-up was obtained in 15 of 21 patients (71%), including all 4 symptomatic pati ents. Mean minimal luminal diameter after the procedure was 2.16+/-0.4 9 mm and at follow-up, 1.89+/-0.45 mm, which corresponds to a restenos is rate (diameter stenosis greater than or equal to 50%) of 7% (1/15). Conclusions Intracoronary use of the coil balloon after balloon angio plasty proved to be feasible and subjectively as well as objectively w ell tolerated during prolonged deployment by virtue of its perfusion p roperties. High volumes of heparin solution can be infused locally at very low pressure. No unfavorable clinical or angiographic long-term e ffects were observed.