Evaluation of the PercuSurge Guardwire Plus Temporary Occlusion and Aspiration System during primary angioplasty in acute myocardial infarction.

Thirty patients with acute myocardial infarction (AMI) underwent primary angioplasty under distal protection of PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System. Before angioplasty, protection of the distal circulation was achieved with the system, followed by balloon angioplasty and/or stenting and debris aspiration. Technical device success was 100%. Distal occlusion was well tolerated in all patients. Mean total distal occlusion time was 7.3 +/- 5.4 min. Macroscopically visible debris was aspirated from 29 cases (96.7%). Postprocedural Thrombolysis in Myocardial Infarction flow grade 3 was achieved in all cases (100%, vs. 16.7% at baseline). Myocardial blush flow grade 3 was achieved in 26 cases (86.7%). Regression of ST segment elevation >/= 50% was shown in 23 cases (76.7%). No patient developed angiographic evidence of no-reflow or distal embolization. Both angiographic and procedural success were 100%. The system is feasible, safe, and effective for distal protection against embolism during primary angioplasty in AMI.