Study Design

Study Design:

Patients Enrolled: 90

Patient Populations:

A total of 90 patients were included in the pilot registry. Inclusion criteria were age >18 years with either stable or unstable angina, 1 or 2 vein graft or native vessel lesions with a reference diameter of >2.5 mm and angiographic evidence of thrombus. The patients needed to have stenosis >70% by visual inspection. MIs were classified primarily based on the level of MB isoenzyme of creatine kinase (CK-MB) as follows: Class I infarctions had CK-MB less than 3 times the upper limit of normal with no electrocardiographic (EKG) changes or clinical manifestations of heart failure or clinical instability. Intermediate Class II MIs included those with CK-MB elevations that were more than 3 times normal with EKG changes or between 3 and 8 times normal without EKG changes. Class III MIs were any Q-wave infarction or CK-MB elevations >8 times normal.

A high-risk group overall, the patient population was predominantly older males with unstable angina; the majority had a prior MI, diabetes, and high blood pressure. One-third had acute MI and 7% cardiogenic shock. In the registry, 39 native vessels and 52 vein grafts were treated with 96% of lesions being complex (ACC/AHA class B2 or C).

Drug/Procedures Used:

The 5 French POSSIS AngioJet catheter is 145 cm long and advanced over 0.014 guide wire. A stainless steel hypotube carries high-pressure saline to the distal 3.5 French tip, which ends in a loop containing 6 proximally directed jets. A pressurized high-velocity ceiling stream through the direct orifices in the distal catheter creates a vortex suction; the thrombus is then entrained and evacuated in the artery.