Background: Percutaneous coronary interventions on saphenous vein grafts (SVG) and in patients with acute coronary syndromes (ACS) have been associated with the distal embolization of the thrombus and plaque and to the no-reflow phenomenon. We report on the safety and feasibility of a new distal emboli protection filter.
Methods: Angioplasty using distal filter protection (Angioguard, Cordis, Warren, NJ, USA) was attempted in 38 patients (mean age 65 +/- 11 years, 79% males) affected by ACS. A percutaneous coronary intervention was performed in 27 native coronary arteries, in 10 SVG and in one arterial graft (mean diameter stenosis 88 +/- 9%). Patients with vessels presenting severe proximal tortuosity, more than mild calcification, a diameter < 3.0 mm and a lesion length > 15 mm were excluded.
Results: It was possible to position the device in all patients (100%); in 7 patients (18%) the lesion could be crossed with the filter only after balloon predilation. Procedural success with final TIMI flow 3 was obtained in all patients and the mean residual diameter stenosis after stent implantation was 5 +/- 8%. Transient procedural complications without clinical sequelae included the no-reflow phenomenon (2 patients, 5%) and vessel perforation (1 patient, 2.5%). In no case was distal embolization observed. As regards the device-related complications, one occlusive dissection (2.5%) occurred and was successfully treated with stent implantation. In-hospital and 30-day major adverse cardiac events consisted of two non-Q wave myocardial infarctions (5%), both occurring during SVG interventions.
Conclusions: The use of the Angioguard filter for preselected lesions in patients with ACS had a high technical success and carried a low rate of device-related complications. The clinical efficacy of the device needs further evaluation.