Background and objectives: The main limitation of primary PCI in acute MI is lack of tissue reperfusion due to distal embolization. We sought to examine the safety and feasibility of a manual thrombus aspiration device in patients undergoing primary PCI.
Methods: Seventy-eight consecutive patients with ST-elevation MI eligible for primary PCI were included. The device was used immediately after guidewire crossing only if a total occlusion (thrombolysis in myocardial infarction [TIMI] flow 0) existed or if a large filling defect was observed. End points were TIMI flow immediately after thrombus aspiration and at the end of procedure and ST resolution of more than 70%.
Results: Mean age was 59+/-12 years, and 79% of patients were males. Risk factor profile included smoking in 62%, diabetes in 21%, hypertension in 46%, and hyperlipidemia in 45%. The infarct-related artery was LAD in 42%, RCA in 36%, and LCX in 22%. Initial TIMI flow was 0 in 71%, I in 10%, and II/III in 19%. Immediately after aspiration, TIMI flow was II/III in 89% of patients and I in 9%. Direct stenting was performed in 73%. Final TIMI flow was III in 90%, II in 9%, and 0 in 1%. ST-segment resolution of more than 70% was observed in 76% of patients. No major device-related complications occurred.
Conclusions: Based on this preliminary data, manual thrombus aspiration using the Export device during primary PCI appears to be feasible and safe. The advantages over routine primary PCI should be further evaluated in randomized trials.