Recanalization of peripheral chronic total occlusions (CTO) is technically challenging especially in cases of in-stent and/or pre-stent and heavily calcified lesions. A high-frequency vibrational device (HFVD) was first used as a secondary-intention device in CTO recanalizations when they were refractory to a guidewire. The aim of this study was to assess the safety and efficacy of the HFVD as a first-line treatment for challenging CTOs and thus to define the percutaneous intentional intraluminal-assisted recanalization (PILAR) technique.
Fifty-two patients were treated with the HFVD. Only challenging CTOs were included: 7 pre-stent, 7 in-stent, and 38 highly calcified CTOs. Technical success was defined as the ability to cross the CTO using the HFVD. Secondary outcome was defined as successful intraluminal crossing. Safety endpoints were procedure-related thromboembolism or perforation. Patients were followed up at 3 months and 1 year.
The technical success rate for recanalization was 90%, of which 83% were intraluminal. The mean recanalized length was 91 ± 44 mm. One thromboembolic complication occurred, which was subsequently treated with thromboaspiration. Three-month and 1-year primary patency rates were 92% and 79%, respectively.
HFVD-based PILAR is a safe and effective technique for in-stent or pre-stent CTO recanalization of long and calcified lesions.
• Intraluminal recanalization is the preferred procedure in heavily calcified or pre-/in-stent CTO. • First-line use of assisted intraluminal recanalization for CTO defines the PILAR technique. • HFVD-based PILAR is safe and provides a high success rate for challenging CTO recanalization.