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

OBJECTIVE: The 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.
METHODS: Patients 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.
RESULTS: From 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 <3 minutes. All occlusions were stented. No cases were converted to open repair. Bleeding from the recanalization and angioplasty site occurred in four patients (15%). It was controlled with use of covered stents in two cases, and resolved after placement of uncovered stents in the other two. No significant bleeding occurred at the sites of true lumen re-entry needle deployment. All occlusions treated with true lumen re-entry devices remain clinically patent at a mean follow-up of 5.8 months.
CONCLUSIONS: Endovascular treatment of chronic total occlusions is often limited by the inability to re-enter the true lumen after subintimal crossing of the occluded segment. This occurs more commonly with treatment of iliac occlusions than in superficial femoral artery occlusions. True lumen re-entry catheters are very effective at gaining wire passage back to the true lumen and facilitating successful endovascular treatment of chronic total occlusions that would otherwise require open bypass.