Abstract 3469: Combined Embolic Protection and Thrombectomy in Percutaneous Coronary Intervention of Acute Myocardial Infarction Using the Proxis®-device
Background Distal embolization may occur during recanalization of thrombotic coronary occlusion, leading to poor results during primary PCI. The Proxis® device, a novel proximal embolic protection system that completely blocks antegrade flow during percutaneous coronary intervention (PCI), may prevent this complication and thus improve outcome.
Methods Between February 2004 and October 2005, 174 patients with ST- elevation acute myocardial infarction (STEMI) underwent primary PCI with combined embolic protection and thrombectomy. The Proxis® device consists of a short flexible catheter with a short circumferential balloon at the distal tip. This 7 French guiding catheter compatible device was advanced just proximal of the occlusion and the balloon at the tip was inflated. The intervention was carried out under total proximal blockage of the vessel. After withdrawal of dilatation/ stent-balloons, aspiration of the stagnant column was performed and continued when coronary flow was restored during deflation of Proxis®. Procedural success and angiographic recovery parameters (TIMI and myocardial blush grades [MGB]), ST- segment elevation resolution (STRES) and the retrieved embolic material were analysed. Follow-up of major adverse cardiac and cerebral events (MACCE) was collected until 30 days after PCI.
Results The Proxis® device was used in all 174 patients during primary PCI. The intervention was well tolerated and recanalization was achieved in all patients. 96% of patients had TIMI-3 flow; 3% had TIMI-2 flow, 1% had TIMI-1 flow and MBG 2–3 was present in 97 % of patients. The mean immediate STRES was 65.3% ± 22.3; immediate STRES > 50% was in 80% and > 70% in 50% of patients. The mean STRES at 1 hour was 80.7% ± 11.4; STRES > 50% in 100% and > 70% in 81% of patients. Debris was retrieved from 77% of patients. The 30-day MACCE-rate was 4%.
Conclusion Combined embolic protection/thrombectomy with Proxis® is feasible and safe in the setting of primary PCI. The results suggest that this device is highly effective for aspiration of embolic material during primary PCI. Moreover, angiographic and myocardial recovery with Proxis® are excellent. Randomized trails are needed to prove whether these preliminary observations can be reproduced on a larger scale.