Initial Acute In Vivo Performance of the Cleveland Clinic PediPump Left Ventricular Assist Device

Abstract

The PediPump is a small ventricular assist device (VAD) with a hydraulic output range designed to support children from newborns to adolescents. The present report describes our initial evaluation of the PediPump as a left VAD in an acute sheep model. The PediPump was implanted in two sheep (50.8 and 62.7 kg). Pump speed was adjusted to achieve a flow of 2 L/min with the naturally occurring preload and afterload conditions to evaluate pump performance under a steady hemodynamic state for 4 hours. Upon completion, pump performance was evaluated under various blood pressure and heart rate conditions. During steady-state evaluations, the ascending aortic flow and pump speed varied slightly depending on systemic arterial pressure variations. During the hemodynamic manipulation studies, flows ranged between 0.5 and 3.2 L/min with pump speeds of 5,200-16,200 rpm and motor current of 0.06-0.75 A. The PediPump demonstrated good initial hemodynamic performance for use as an implantable left VAD. However, some depositions were detected at the time of explanation, mainly at the rear of the pump. We are continuing with further acute studies to evaluate pump performance in anticipation of beginning chronic studies to evaluate long-term biocompatibility.

Short‐Term In Vivo Performance of the Cleveland Clinic PediPump Left Ventricular Assist Device

“…The combination of robust hemodynamic performance and minimal hemolysis suggests that the PediPump may provide an important new tool in the treatment of end‐stage heart failure in children. The performance cited in this series of animals, supported for up to 30 days, is an important developmental milestone, building on the favorable results we have previously reported for the preclinical evaluation of the PediPump .…”

“…The PediPump is designed for application to a wide range of patient sizes, from infants to adolescents. The performance of the PediPump has been confirmed in both in vitro and acute in vivo 4‐h studies in a lamb model . The objectives of the present study were to evaluate the PediPump's hydraulic and electrical performance under physiologic operating conditions in a lamb model and to determine pump effects on hemolysis and end‐organ function during longer‐term support of up to 30 days.…”

The PediPump: A Versatile, Implantable Pediatric Ventricular Assist Device—Update IV

“…The basic technology that supports the PediPump, known as the "MiniMixedFlow" family of pumps, has been well described previously (2)(3)(4)(5)(6). The PediPump is a mixed-flow, rotary blood pump that employs doi:10.1111/j.1525-1594.2009.00946.x passive magnetic bearings to support the rotor axially, with touch points forward and aft to provide axial support ( Fig.…”

“…Cleveland Clinic was one of the programs that received funding from the PCSP for the development of its PediPump (Cleveland, OH, USA), which is a novel pediatric ventricular assist device (VAD). The PediPump has been described in several previous published reports (2)(3)(4)(5)(6). However, as the PCSP concludes in the Spring of 2009, timing is appropriate for an update of the PediPump's current development status.…”

The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program

“…Animal testing of the PediPump began with five six-hour acute studies in a sheep model that were used to develop the implant procedures and evaluate basic performance including in vivo hemolysis and deposition 16. Nine chronic implants have been performed with a number of these animals surviving to completion of the target 30-day period of study.…”