Development of rotary blood pump technology: Past, present, and future

Even though clinical acceptance of a nonpulsatile blood flow was demonstrat ed almost 45 years ago, the development of a nonpulsatile blood pump was co mpletely ignored until 20 years ago. In 1979, the first author's group demo nstrated that completely pulseless animals did not exhibit any abnormal phy siology if 20% higher blood flows were provided to them. However, during th e next 10 years (1979-1988), minimum efforts were provided for the developm ent of a nonpulsatile, permanently implantable cardiac prosthesis. In 1989, the first author and his team at Baylor College of Medicine initiated a de velopmental strategy of various types of nonpulsatile rotary blood pumps, i ncluding a 2-day rotary blood pump for cardiopulmonary bypass application, a 2 week pump for ECMO and short-term circulatory assistance, a 2 year pump as a bridge to transplantation, and a permanently implantable cardiac pros thesis. Following the design and developmental strategy established in 1989 , successful development of a 2-day pump (the Nikkiso-Fairway cardiopulmona ry bypass pump) in 4 years (1989-1993), a 2 week pump (Kyocera gyro G1E3 pu mp) in 6 years (1992-1998), and a bridge to transplant pump (DeBakey LVAD-a n axial flow blood pump) in 10 years (1988-1998) was made. Currently, a per manently implantable centrifugal blood pump development program is successf ully completing its initial Phase 1 program of 5 years (1995-2000). Implant ation exceeded 9 months without any negative findings. An additional 5 year Phase II program (2000-2005) is expected to complete such a device that wi ll be clinically available.