Initial Clinical Trial of a Closed Loop, Fully Automatic Intra-aortic Balloon Pump

A new generation, closed loop, fully automatic intraaortic balloon pump (CL-IABP) system continuously optimizes diastolic augmentation by adjusting balloon pump parameters beat by beat without operator intervention. In dogs in sinus rhythm and with experimentally induced arrhythmias, the new CL-IABP system provided safe, effective augmentation. To investigate the system's suitability for clinical use, 10 patients meeting standard indications for IABP were studied. The patients were pumped by the fully automatic IABP system for an average of 20 hr (range, 1-48 hr). At start-up, the system optimized pumping parameters within 7-20 sec. Evaluation of 186 recordings made at hourly intervals showed that inflation began within 20 msec of the dicrotic notch 99% of the time. In 100% of the recordings, deflation straddled the first half of ventricular ejection. Peak pressure across the balloon membrane averaged 55 mmHg and, in no case, exceeded 100 mmHg. Examination of the data showed that as soon as the system was actuated it provided consistently beneficial diastolic augmentation without any further operator intervention. Eight patients improved and two died (one of irreversible cardiogenic shock and one of ischemic cardiomyopathy). No complications were attributable to the investigational aspects of the system. A fully automated IABP is feasible in the clinical setting, and it may have advantages relative to current generation IABP systems.