A novel approach to chronic total occlusions: The CROSSER System

Objectives: To evaluate safety and efficacy of the GROSSER CTO Recanalization System (GROSSER). Background: The GROSSER, a novel device dedicated to recanalization of chronic total occlusions (CTO), relies on a monorail catheter delivering vibrational energy to facilitate the crossing of occluded coronary arteries. Methods: We included de novo or restenotic occlusions in native coronary arteries with typically unfavorable characteristics and a prior failed guidewire attempt either performed in a previous procedure or just before the usage of the GROSSER. The end points analyzed were technical success (ability to cross or facilitate a guidewire crossing into the true lumen), angiographic success (< 20% residual stenosis and TIMI flow grade 3), and clinical success (angiographic success and freedom from major adverse cardiac events at 30 days). Results: Twenty-eight patients (30 lesions) were included. The morphology was blunt in 83.3% and the length of the occlusion was > 20 mm in 76.6%. The median age of the CTO was 9 months (range 3-60 months). Technical success was obtained in 19 (63%) occlusions and angiographic success in 16 (53%): 26.3% in lesions with prior procedural failure and 73.7% when GROSSER was attempted after initial guidewire failure. Complications were: one guidewire perforation without consequences and one peri-procedural myocardial infarction (MI). No events occurred within 30-day follow-up after discharge. Conclusions: In our experience, the GROSSER System is safe and increases the success of opening CTO refractory to guidewires. This novel device may represent an useful adjunct to the armamentarium of the interventional cardiologist.