Endoluminal treatment of peripheral chronic total occlusions using the Crosser® recanalization catheter
Cezar S Staniloae1, Kanika P Mody, Sidharth S Yadav
1NYU Langone Medical Center, Cardiac and Vascular Institute, 550 First Avenue, New York, NY 10016 USA. cezar.staniloae@nyumc.org.
Insights
The Crosser device safely and effectively recanalizes lower extremity chronic total occlusions (CTOs), achieving high success rates, particularly in aorto-iliac and tibial arteries. This technology improves patient outcomes by facilitating guidewire access for revascularization.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Therapy
Background:
- Lower extremity chronic total occlusions (CTOs) present significant revascularization challenges.
- The Crosser recanalization catheter aims to improve rapid and safe intraluminal guidewire access.
Purpose of the Study:
- To evaluate the Crosser device as a primary therapy for peripheral CTOs.
- To assess the technical success and safety of the Crosser device in facilitating distal vessel entry.
Main Methods:
- A retrospective study of 56 patients with 73 lower extremity CTOs treated with the Crosser device.
- Primary technical success defined as guidewire delivery solely by Crosser; secondary success included re-entry device use.
- Safety endpoints included dissections, thromboembolism, and perforations.
Main Results:
- Overall primary and secondary technical success rates were 76.7% and 87.7%, respectively.
- Highest success rates observed in aorto-iliac (90.0%) and tibial (95.2%) CTOs.
- No Crosser-related perforations occurred; lesion length >100mm and calcification predicted failure.
Conclusions:
- The Crosser device is safe and effective for facilitating guidewire entry in lower extremity CTOs.
- Efficacy is particularly notable in aorto-iliac and tibial occlusions.
- Success rates for femoral and popliteal CTOs are comparable to existing techniques.
Purpose:
Revascularization of lower extremity chronic total occlusions (CTOs) is technically challenging. The Crosser® recanalization catheter was designed to facilitate distal vessel intraluminal entry that is both rapid and safe. We present our experience with the Crosser device as primary therapy for peripheral CTOs.
Methods:
Subjects undergoing evaluation for arterial insufficiency at our institution between 2008-2010 who were noted to have a CTO in the lower extremity by duplex ultrasonography and who subsequently underwent Crosser recanalization were enrolled. Clinical characteristics, ankle-brachial indices, Rutherford-Becker symptom category, and angiographic CTO parameters were collected. Primary technical success was intraluminal delivery of the guidewire into the distal vessel solely by the Crosser device. Secondary technical success was assisted delivery using the Outback LTD® re-entry device. Safety endpoints were the occurrence of dissections, thromboembolism, and perforations related to the Crosser device. Statistical analysis was performed to find independent predictors for failure to achieve Crosser recanalization.
Results:
Fifty-six subjects with 73 CTOs were enrolled. The mean Crosser use time was 17.6 ± 12.7 minutes. The overall primary and secondary technical success rates for Crosser recanalization were 76.7% and 87.7%, respectively. Technical success was highest for CTOs located in the aorto-iliac (90.0%) and tibial (95.2%) arterial segments. There were no perforations related to the Crosser device. For successful cases, the mean ABI improved significantly from pre- to post-intervention (0.57 ± 0.13 to 0.89 ± 0.15, p < 0.001). The only predictors for failure were lesion length longer than 100 mm (p = 0.04) and calcification within 10 mm of the exit cap (p = 0.02).
Conclusion:
The Crosser device is safe and shows excellent efficacy in facilitating guidewire distal lumen entry, especially for aorto-iliac and tibial occlusions. The technical success rate for the femoral and popliteal occlusions is comparable to those reported with other recanalization techniques.
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