A Next-Generation Guide Extension System for Percutaneous Coronary Intervention.

BACKGROUND: Guide catheter extension is an integral part of percutaneous coronary intervention (PCI). First generation guide catheter extension devices are monorail, blunt ended tubular structures with limitations. The CrossLiner™ is a next generation guide extension "system" intended to allow safe, deep, coronary intubation. METHODS: The CrossLiner was tested in a head-to-head study with the GuideLiner™ and GuideZilla™ in a porcine coronary model, with stenting. Data were collected from 8 coronary vessels from four animals, to evaluate the ability to deeply intubate the vessel with the guide extension. RESULTS: The CrossLiner crossed distally and through a distal stented segment in 8/8 vessels, while the first-generation devices were stuck proximal to the stent (n=2/8) or at the stent edge (n=4/8), or passed partially into the deployed stent with difficulty (2/8) vessels (p < 0.0002 for deliverability). The average depth of guide extension delivery/ "intubation" was 12.9±3.6 cm for the CrossLiner and 5.6±1.1 cm for the first-generation guide extension (p < 0.001). CONCLUSIONS: The CrossLiner is a next generation guide extension system that may offer advantages over first generation devices. Further clinical evaluation will be required to assess the role of this new device in PCI.

Initial clinical experience using an ostial stent positioning system (Ostial Pro) for the accurate placement of stents in the treatment of coronary aorto-ostial lesions.

OBJECTIVE: To evaluate the safety and efficacy of a new nitinol stent positioning system to assist in the placement of aorto-ostial coronary stents. BACKGROUND: The stenting of aorto-ostial lesions is technically challenging. METHODS: We report the first clinical series using the Ostial Pro to assist in the precise placement of stents in coronary aorto-ostial lesions. These results were compared to matched cases performed without the ostial positioning system. RESULTS: The Ostial Pro is a simple nitinol device with self-expanding legs that are advanced just distal to the tip of the guiding catheter. The nitinol legs prevent the entry of the guiding catheter into the target vessel and align the tip of the guiding catheter. Using the Ostial Pro positioning device, angiographic and clinical success was achieved in 30/30 (100%) cases. Excellent stent positioning was confirmed by angiography (n = 30) and intravascular ultrasound (n = 28). The final true ostial dimension was larger than the stented segment minimum luminal diameter in 30/30 cases. In a matched consecutive cohort of 30 consecutive coronary aorto-ostial stent cases placed without the Ostial Pro, we observed an ostial stent malpositioning in 18/30 (60%) of cases (p < 0.0001 vs. cases performed with Ostial Pro). CONCLUSIONS: 1) The Ostial Pro is a new FDA-cleared nitinol device that is simple to use and effective in allowing the precise placement of stent(s) at the aorto-ostial location; 2) this approach appears to provide an efficient means to assure accurate stent placement and minimal residual stenosis in these difficult-to-treat lesions.