Initial clinical experience with an IVUS-guided transmembrane puncture device to facilitate recanalization of total femoral artery occlusions.

Abstract

Failure to recanalize chronic superficial femoral artery occlusions is frequently caused by subintimal passage of the occlusion with inability to re-enter the true lumen with the guide-wire. The present study details our initial experience with the Pioneer crossing device (Medtronic, Menlo Park, CA) to facilitate recanalization of total femoral artery occlusions. 25 consecutive patients (18 male, mean age 63 years) whose failed recanalization attempts of chronic superficial femoral artery occlusions (mean occlusion length 12.7 cm) with standard techniques were re-scheduled for a secondary recanalization procedure. The Pioneer crossing device is a 6.2F rapid exchange catheter, which tracks over a 0.014"-wire. A 20MHz phased array IVUS transducer is integrated into the tip of the catheter allowing visualization of the vessel morphology. Using the guidance of the IVUS cross-sectional image supported by colour-flow imaging, the true lumen is punctured with an integrated 24G needle allowing delivery of a second 0.014"-wire. Re-entry into the true lumen was successfully accomplished in all cases without complications. In 8 cases with severe calcification predilatation of the false channel was necessary to allow advancement of the Pioneer crossing device. Furthermore, in 7 patients with severe calcification multiple puncture attempts were necessary to penetrate the dissection membrane. A procedural success (<25% residual stenosis) could be achieved in all cases after predilatation and stenting of the occlusion with self-expanding nitinol stents. The Pioneer crossing device is an effective and save tool to facilitate true lumen re-entry during recanalization of total superficial femoral artery occlusions.