True lumen re-entry devices facilitate subintimal angioplasty and stenting of total chronic occlusions: Initial report

ObjectiveThe acute technical failure of endovascular treatment of chronic total occlusions (CTOs) is most often due to the inability to re-enter the true lumen after occlusion is crossed in a subintimal plane. This study reports our initial experience with true lumen re-entry devices in the treatment of CTOs.MethodsPatients with treatment of CTOs were identified from our vascular registry. All patients in whom the Pioneer catheter or the Outback catheter were used were also identified from a prospectively maintained separate database of cases in which true lumen re-entry devices were used. We used procedural data from the prospective database and reviewed the medical records. Lesion character and location, access type, location of true lumen re-entry, stent usage, procedural times, and complications, were tabulated.ResultsFrom August 2003 to December 2004, endovascular techniques were used to treat 87 CTOs in 58 iliac and 29 superficial femoral arteries. In 24 (26%), the true lumen could not be re-entered by using standard catheter and wire techniques. The true lumen was not initially re-entered in 20 (34%) of 58 of treated iliac CTOs and four (13%) of 29 of treated superficial femoral artery CTOs (73% TASC C and D lesions). Intravascular ultrasound-guided true lumen re-entry using the Pioneer catheter (21 CTOs), or fluoroscopic-guided true lumen re-entry using the Outback catheter (3 CTOs) was successful in achieving true lumen re-entry in all cases at the location desired. Total time of re-entry catheter manipulation required to achieve re-entry was <10 minutes and was routinely accomplished in