A new intracardiac microaxial pump: First results of a multicenter study

As coronary artery bypass grafting (CABG) surgery in the beating heart tech nique is progressing, new devices have been developed to overcome hemodynam ic instabilities while tilting the heart for exposure of back wall vessels. A new device for in heart biventricular intracorporeal circulation was app lied in 42 patients undergoing CABG surgery (Group 1). The control group co nsisted of 38 patients operated on using a conventional cardiopulmonary byp ass setup (Group 2). The study protocol of the prospective, randomized mult icenter study was approved by the local ethics committees. Patients were in cluded following inclusion criteria and patient informed consent. Mean age, procedure time. mean arterial pressure (MAP) and hemolysis by means of pla sma free hemoglobin (fHb) were assessed preoperatively, perioperatively, on postoperative Days 1 to 3, at discharge, and at a 3 month followup, The me an age was 62.1 (range 59-74) rears (Group 1), 62.7 (range 48-72) years (Gr oup 2). procedure time was 112 min +/- 31.9 min (Group 1), 137.4 min +/- 36 .2 min (Group 2), and 2.3 +/- 0.6 (Group 1), 2.2 +/- 0.7 (Group 2), vessels were revascularized. The flow on pump was 3.7 (2.5/4.4) L/min (Group 1), 4 .9 (3.6/6.2) L/min (Group 2) which resulted in a MAP of 69.8 (4.0/133) mm H g (Group 1), 58.3 (5.3/94) mm Hg while assessing the vessels of the back wa ll. Hemolysis defined by MB was lower than 20 mg/dl at all times pre- and p ostoperatively. Intraoperative maximum values were up to 100 mg/dl in 4 pat ients (2 in Group 1 and 2 in Group 2). Body mass index was 26.4 +/- 2.6 (Gr oup 1), 27.9 +/- 3.2. New York Heart Association Class was II to III in bot h groups. There were no pump related life threatening or severe adverse eve nts. Beating heart procedures with ICC can be reliably and safely achieved. As the device is easy to use, it may deserve a more widespread use in the future.