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

Abstract

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.

A novel approach to chronic total occlusions: The crosser system

“…Guidewire perforation is a well recognized complication of CTO recanalization with an incidence as high as 39% in a previous pilot study of the laser wire [14]. Therefore, our overall complication rate is low and comparable or lower than studies of dedicated guidewires or other new devices [15][16][17]. These preliminary findings need to be confirmed in a large multicenter, prospective trial.…”

“…This technology allows the guidewire to be redirected prior to causing a dissection or perforation. This system can also generate radiofrequency pulses to facilitate crossing hard fibrotic plaques [15]. Early data have demonstrated a success rate of 50-60% with a low peri-procedural complication rate.…”

Computed tomography angiography-guided percutaneous coronary intervention in chronic total occlusion

“…We also found that DSCT could visualize plaques in the CTOs. Despite advances in the development of angioplasty equipment (Saito et al, 2003), such as novel guidewires, as well as various complex techniques (Ng et al, 2003;Orlic et al, 2005), the success rate of PCI in CTOs remains low. Moreover, we found that successful PCI was often obtained in CTOs with a TIMI flow grade 1.…”

Retrograde recanalization of chronically occluded coronary arteries: Illustration and description of the technique

“…Despite developments in devices and guidewires dedicated for CTO lesion, failure rates are still high, between 20-35% [22,[32][33][34]. The retrograde approach has been introduced to improve recanalization rates.…”