Novel perfusion sleeve for use during balloon angioplasty: initial clinical experience

The perfusion sleeve (PS) is an "over-the-balloon" catheter designed to add perfusion capability to standard PTCA catheters. To evaluate the clinical effectiveness of this device, eight patients underwent standard PTCA with the PS retracted in the guide (Inflation 1-Control) and after deployment of the PS (Inflation 3-Control). Between standard inflations the PS was advanced and aligned with the already positioned PTCA balloon which was inflated for up to 15 minutes (Inflation 2-Perfusion). TIMI III flow was present in 5/7 and TIMI II flow in 2/7 patients during Inflation 2-Perfusion. Absolute ST segment shift (mm) on the ECG was significantly less at 3 minutes and prior to balloon deflation with the PS in place (1.0 +/- 1.4 and 1.1 +/- 1.1 mm) compared to Inflation 1-Control and Inflation 3-Control (2.6 +/- 1.3 and 2.3 +/- 0.3 mm) respectively (P < or = 0.05). Use of the PS in conjunction with standard PTCA is feasible, provides perfusion during prolonged balloon inflations and reduces the magnitude of ischemia.