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.
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.
Authors: Pavan K V Reddy; Joseph Daibes; Michel Skaf; Roberto Ochoa; Tomohiro Fujisaki; Patricia Lin; Apurva Patel; Tak Kwan Journal: Front Cardiovasc Med Date: 2022-07-14