Functional characteristics of a new coronary perfusion balloon: Comparison with the flowtrack 40 in closed chest swine

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Abstract
This study was designed to compare a new investigational coronary perfusion balloon (Wave, Scimed Life Systems Inc.) with that of an approved, widely used, current generation device (Flowtrack 40, Advanced Cardiovascular Systems). Domestic swine were anesthetized with pentobarbital and instrumented using standard percutaneous technique. Left ventricular contractile function (dP/dt) was monitored using a micromanometer while intracoronary and surface ECGs were also recorded. Eight target vessels were studied (4 LAD and 4 Cx) in random order. The perfusion balloons were kept inflated for 10 min. Complete coronary occlusion with a standard angioplasty balloon produced marked decreases in mean aortic pressure, left ventricular developed pressure, peak + dP/dt, peak ‐dP/dt, and significant ST segment elevation in both intracoronary and surface ECG at 30 seconds. Neither the Wave or Flowtrack 40 produced any change in heart rate or mean aortic pressure. Both catheters caused a drop in left ventricular developed pressure immediately after balloon inflation. At 10 min, however, there was a small but significant decrease only with the Flowtrack 40. Similarly, peak + dP/dt was slightly depressed during Flowtrack 40 inflation at 10 min but not with the Wave catheter. Both catheters produced ST segment elevation on the surface and intracoronary electrocardiographic records. These changes were significantly greater with the Flowtrack 40 system. Thus, both the Flowtrack 40 and Wave perfusion balloons are effective in preventing ischemia during coronary occlusion in swine; however, the latter system may be more effective in this model.