Adjunctive use of the Rinspiration system for fluidic thrombectomy during primary angioplasty: the Rinspiration international registry.

BACKGROUND: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously "rinses" the vessel with turbulent flow and aspirates thrombus. METHODS: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was >or=50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous electrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). RESULTS: Mean symptom-to-PCI time was 4.7 +/- 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush >or=2 in 78%. Rates of STR >or= 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. CONCLUSIONS: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit.