Preliminary experience with the Frontrunner coronary catheter: novel device dedicated to mechanical revascularization of chronic total occlusions

The novel device Frontrunner coronary catheter (FCC), dedicated to recanalization of chronic total occlusions (CTOs), relies on blunt microdissections inside the plaque, allowing passage of guidewire through the lesion and adjunctive angioplasty. In order to evaluate efficacy and safety of recanalization using the FCC device, we included patients with de novo or restenotic CTOs in a native coronary artery with prior failure using a guidewire or considered unsuitable for guidewire attempt in which the FCC was attempted first. Between October 2000 and June 2003, 50 patients with 50 CTOs were included in the study. Thirty-two patients had prior failure with a mechanical wire. Device and angiographic success were obtained in 25 (50%) occlusions: 53% in lesions with prior guidewire failure and 44% when FCCs were attempted first (P = 0.8). During the first year of experience, angiographic success was 42% (5 occlusions) and in the third year 75% (12 occlusions; P = 0.12). Coronary perforation occurred in nine (18.0%) patients, leading to tamponade in two (4%) patients. Perforations occurred in 5 out of 12 attempted patients during the first year and in 4 out of 38 patients in the following period (41.7% vs. 10.5%; P = 0.04). Serious adverse events occurred in five (10%) patients within 30-day follow-up. Four non-Q-wave myocardial infarctions occurred in hospital (clinical success 42%) and one death 7 days after the index procedure. The use of FCC increases the success to open chronic total occlusions refractory to mechanical guidewires or that were considered unsuitable for an attempt with a guidewire. The risk of coronary perforation due to FCC use is relatively high and it can decrease with experience.