Initial Clinical Experience with an IVUS-guided Transmembrane Puncture Device to Facilitate Recanalization of Total Femoral Artery Occlusions.

PURPOSE: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.MATERIAL AND METHODS: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.RESULTS: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.CONCLUSION:The Pioneer crossing device is an effective and save tool to facilitate true lumen re-entry during recanalization of total superficial femoral artery occlusions.