Study Results Demonstrate Feasibility of a Continuous-Flow LV Assist Device

The continuous-flow pump, a new type of surgically implanted LV assist device, is designed to improve upon the undesirable size, noise, and limited durability of pulsatile volume-displacement devices. In a manufacturer-sponsored and designed study, patients with end-stage heart disease who were listed for transplantation were eligible for implantation of a continuous-flow device if they lacked severe renal, pulmonary, or hepatic dysfunction, and in the absence of technical obstacles. After the device was inserted, patients received heparin before transition to warfarin, aspirin, and dipyridamole. The majority of the 133 patients enrolled (average age, 50) had nonischemic cardiomyopathy.

At 24 hours after device placement, the cardiac index (L/min/m² of body surface area) increased from a mean of 2.0 preoperatively to 2.8 (P<0.001). There were significant reductions in pulmonary capillary wedge pressure (from 26 to 16 mm Hg) and in mean pulmonary artery pressure (from 37 to 26 mm Hg). Quality of life and functional status also improved significantly during the first 3 months after implantation. Overall, by 3 months, 100 (75%) of the patients had reached the primary endpoint of heart transplantation, cardiac recovery, or survival while remaining eligible for transplantation. Of these 100, 56 patients underwent transplantation, 1 had cardiac recovery, and 43 remained listed for transplantation. Adverse events included bleeding requiring surgery (31%), respiratory failure (26%), sepsis (20%), ischemic stroke (6%), hemorrhagic stroke (2%), and hemolysis (3%).