Novel Mechanical Thrombectomy Device for the Treatment of Acute Myocardial Infarction: A Retrospective Report of Initial Results.

ABSTRACT

OBJECTIVE: The objective of this study was to assess the effectiveness of mechanical thrombectomy using the Aspire mechanical thrombectomy device (Control Medical) for the treatment of acute myocardial infarction (AMI) as measured by Thrombolysis in Myocardial Infarction (TIMI) flow post procedure compared with baseline. METHODS: This is a retrospective study for the treatment of acute myocardial infarction (AMI) in ST-segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI) patients. The study was approved by an independent ethical review board. Data were collected retrospectively from 48 subjects at three study sites. The primary endpoint was TIMI flow post thrombectomy compared with baseline. The safety endpoint was 30-day major adverse cardiac event, defined as death, MI, and target-vessel revascularization (TVR). Eligibility criteria included AMI patients ages 18-90 years who had previous treatment with the Aspire mechanical thrombectomy device, preprocedure TIMI flow 0 to 2, and ability to tolerate antiplatelet therapy. RESULTS: Of the 48 subjects, 81.2% were male, 33.3% were diabetics, 64.6% were hypertensive, 52.1% had hyperlipidemia, and 85.4% had STEMI, with 38.0% anterior and 56.0% inferior AMI. Baseline TIMI flow was 0-1 in 89.6% of subjects. Post-thrombectomy TIMI flow 2-3 was achieved in 85.4% and all subjects had TIMI flow 3 at the end of the intervention. The device did not track in 1 patient and was not used. There were 5 deaths (10.4%), all unrelated to the aspiration thrombectomy procedure, and 0% experienced a stroke. CONCLUSION: The Aspire mechanical thrombectomy device demonstrated initial effectiveness and safety. Further prospective studies using objective performance criteria to demonstrate effectiveness and safety using the Aspire mechanical thrombectomy device are necessary to determine whether short-term and long-term outcomes improve over previously published clinical trials.