Beyond stents: third-generation coronary devices.

Despite extraordinary growth in percutaneous transluminal coronary angioplasty (>400,000 cases in United States in 1997) patients are still routinely referred for bypass grafting in large numbers. Why? Second-generation devices (directional coronary atherectomy, high-speed rotational atherectomy [Rotablator], and stents) have expanded the application of percutaneous catheter treatment of coronary disease. Specifically, highly eccentric lesions in large vessels, heavily calcified lesions, and coronary dissections can be effectively treated with these devices. Stents have substantially reduced the incidence of restenosis, but this benefit is largely confined to vessels more than 3 mm in diameter and stenoses less than 20 mm in length. A third generation of coronary devices has evolved in the late 1990s in response to continuing failures of conventional balloon angioplasty, atherectomy, and stenting. The failures of the 1990s were (1) restenosis, including in-stent restenosis, (2) chronic total occlusions, (3) diffuse small-vessel disease, and (4) aged vein graft disease. In response to these challenges novel devices are being developed: (1) for restenosis, intracoronary radiation therapy (brachytherapy); (2) for chronic total occlusions, Prima Laser wire; (3) for diffuse small-vessel disease, percutaneous myocardial laser revascularization; and (4) for aged vein grafts, antiembolization devices. Each of these new catheter technologies will need to be economically and clinically reconciled with the multitude of minimally invasive surgical revascularization techniques that are rapidly evolving.