EXPERIENCE WITH DIRECTIONAL CORONARY ATHERECTOMY SINCE PRE-MARKET APPROVAL

Directional coronary atherectomy (DCA) received Food and Drug Administration (FDA) Pre-Market Approval in September 1990 and was then released through formal training certification of physicians at each site, Procedure volume has increased dramatically since approval, with > 17,000 DCA procedures performed in 1991 and a cumulative total of > 33,000 procedures by mid-1992, at > 670 centers in the United States. Clinical application and results since approval have generally been similar to preapproval multicenter investigational results. Comparison of pre- and postapproval usage at the Medical College of Virginia shows similar baseline characteristics and indications, although recent patients show a higher proportion of ''salvage'' DCA for failed or suboptimal angioplasty (6% vs 14%) or DCA in combination with multidevice multiple vessel intervention (30% vs 38%). Overall results in 300 patients and 345 procedures included procedural success in 95%, clinical success in 94%, with major complications in 4.6% (including urgent bypass surgery in 3.8%, Q wave myocardial infarction in 1.7%, and hospital mortality in 0.3%). Results before and after FDA approval were similar for procedural success (94% vs 96%), clinical success rate (94% vs 94%), and major complications (5.5% vs 4.4%). There was a trend toward lower urgent surgery rate (5.4% vs 3.3%) in the more recent experience. In addition to its established efficacy for highly eccentric lesions, newer applications for which DCA is being used following FDA approval include treatment of saphenous vein grafts, thrombus-associated lesions, aorto-ostial lesions, failed or suboptimal percutaneous transluminal coronary angioplasty result, bifurcation lesions, and use as part of multivessel intervention. Although comparative studies of DCA versus balloon angioplasty or other technologies will help clarify the optimal interventional approach for these indications, the post-FDA approval experience with DCA shows that a new technology can be introduced and disseminated effectively by transmitting the lessons learned during preapproval investigation to newer operators attending organized training programs.