Embolic protection during saphenous vein graft intervention using a second-generation balloon protection device: results from the combined US and European pilot study of the TriActiv Balloon Protected Flush Extraction System.

BACKGROUND: Stent placement in saphenous vein bypass grafts is associated with a high incidence of myonecrosis usually resulting from embolization of thrombus and friable atheroma. Embolic protection devices reduce the incidence of adverse events after vein graft stenting. However, first-generation balloon occlusion systems are still associated with a 10% incidence of periprocedural adverse events. We report the first experience with a new second-generation balloon occlusion embolic protection device, the TriActiv Balloon Protected Flush Extraction System.

METHODS: Ninety-six lesions in 78 saphenous vein grafts were treated in 74 patients. The primary end point was major adverse cardiovascular events at 30 days.

RESULTS: Device success was achieved in 92% of patients, and atheromatous debris was recovered in 69% of analyzed aspirates. By 30 days, major adverse cardiovascular events, which were limited to non-Q-wave myocardial infarctions, occurred in 16.2%. Per protocol analysis in patients with device success revealed a rate of adverse events of only 5.7%.

CONCLUSIONS: The initial experience with the TriActiv Balloon Protected Flush Extraction System demonstrated a high success rate and recovery of embolic debris with an acceptable rate of adverse events. A large randomized trial will compare this device to other embolic protection systems.