Initial experience with a new 8 French-compatible directional atherectomy catheter: immediate and mid-term results.

The purpose of this study was to evaluate the safety and efficacy of the new Fox Hollow atherectomy device (FHT) designed for more efficient and easier plaque removal. The FHT has short rigid section and low-profile cutter mounted on a monorail catheter. The FHT catheter was utilized in 77 patients with 98 lesions. Mean reference vessel diameter was 2.75 +/- 0.51 mm. Successful atherectomy with tissue retrieval was performed in 94 lesions (96%). Following atherectomy, mean diameter stenosis was reduced from 71.1% to 31.9% and further to 10.4% following adjunctive treatment. Angiographic complications were one coronary perforation and one adventitial staining, both successfully treated with prolong balloon inflation and stent implantation. Nine patients (11.7%) had in-hospital non-Q-wave myocardial infarction (MI). One patient died (1.3%) for noncardiac reasons and one had MI (1.3%) at 6-month follow-up. Target lesion revascularization was required in 13 (13.8%) lesions and target vessel revascularization in 15 (20.3%) patients. There was target vessel failure in 17 (23.0%) patients. Plaque debulking with the FHT catheter can be performed safely and effectively in relatively small vessels and complex lesions located in mid-distal artery segments with 6-month clinical outcome similar to prior atherectomy devices.