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Assessment of a percutaneous Hemopump in high risk coronary angioplasty patients.

This study assessed the safety and efficacy of a new 14 Fr Hemopump device. Ten high risk patients requiring percutaneous transluminal coronary angioplasty (PTCA) (last remaining patent vessel or low left ventricular ejection fraction) underwent PTCA with the prophylactic use of the Hemopump. This device was inserted percutaneously through the femoral artery using a 16 Fr sheath and placed into the left ventricle. Hemodynamic parameters (pulmonary capillary wedge pressure, cardiac output, mean aortic pressure) were recorded before, during, and after PTCA when the Hemopump was on and off. Adequate placement of the Hemopump was obtained in all patients with moderate temporary rhythm instability, and PTCA was performed in all patients. Under assist, pulmonary capillary wedge pressure was 22 +/- 8 mmHg, compared with 29 +/- 7 mmHg (P < 0.05), whereas no significant change in other hemodynamic parameters was observed. One patient experienced ventricular fibrillation twice during PTCA, which was correlated by electrical cardioversion. During this temporary cardiac arrest, the aortic blood pressure was maintained at 50 mmHg with the Hemopump. For all patients, the Hemopump was withdrawn 15 min after the end of PTCA, and the sheath was removed 4-6 hr later. However, two patients required surgical sheath removal. One patient died of cardiogenic shock in the intensive care unit. Other patients were discharged 3 days after the procedure. Long-term follow-up shows eight surviving patients. These data show that 1) the 14 Fr percutaneous Hemopump is safe, and 2) can unload the left ventricle during PTCA while maintaining mean aortic pressure and cardiac output.