J. Scott Richardson

HeartMate III: pump design for a centrifugal LVAD with a magnetically levitated rotor.

A long-term, compact left ventricular assist device (LVAD), the HeartMate III, has been designed and fabricated, featuring a centrifugal pump with a magnetically levitated rotor. The pump has been optimized by in vitro testing to achieve a design point of 7 L/min against 135 mm Hg at high hydrodynamic efficiency (30%) and to be capable of up to 10 L/min under such a load. Furthermore, the pump has demonstrated no mechanical failures, low hemolysis (4–10 mg/dl plasma free Hb), and low thrombogenicity during six (40, 27, 59, 42, 27, and 49-day) in vivo bovine studies.

Effects of the pulsatile flow settings on pulsatile waveforms and hemodynamic energy in a PediVAS centrifugal pump.

The objective of this study was to test different pulsatile flow settings of the PediVAS centrifugal pump to seek an optimum setting for pulsatile flow to achieve better pulsatile energy and minimal backflow. The PediVAS centrifugal pump and the conventional pediatric clinical circuit, including a pediatric membrane oxygenator, arterial filter, arterial cannula, and ¼ in circuit tubing were used. The circuit was primed with 40% glycerin water mixture. Postcannula pressure was maintained at 40 mm Hg by a Hoffman clamp. The experiment was conducted at 800 ml/min of pump flow with a modified pulsatile flow setting at room temperature. Pump flow and pressure readings at preoxygenator and precannula sites were simultaneously recorded by a data acquisition system. The results showed that backflows appeared at flow rates of 200–800 ml/min (200 ml/min increments) with the default pulsatile flow setting and only at 200 ml/min with the modified pulsatile flow setting. With an increased rotational speed difference ratio and a decreased pulsatile width, the pulsatility increased in terms of surplus hemodynamic energy and total hemodynamic energy at preoxygenator and precannula sites. Backflows seemed at preoxygenator and precannula sites at a 70% of rotational speed difference ratio. The modified pulsatile flow setting was better than the default pulsatile flow setting in respect to pulsatile energy and backflow. The pulsatile width and the rotational speed difference ratio significantly affected pulsatility. The parameter of the rotational speed difference ratio can automatically increase pulsatility with increased rotational speeds. Further studies will be conducted to optimize the pulsatile flow setting of the centrifugal pump.

A hemodynamic evaluation of the Levitronix Pedivas centrifugal pump and Jostra Hl-20 roller pump under pulsatile and nonpulsatile perfusion in an infant CPB model.

The hemodynamic comparison of the Jostra HL-20 and the Levitronix PediVAS blood pumps is the focus this study, where pressure-flow waveforms and hemodynamic energy values are analyzed in the confines of a pediatric cardiopulmonary bypass circuit. The pseudo pediatric patient was perfused with flow rates between 500 and 900 ml/min (100 ml/min increments) under pulsatile and nonpulsatile mode. The Levitronix continuous flow pump utilized a customized controller to engage in pulsatile perfusion with equivalent pulse settings to the Jostra HL-20 roller pump. Hemodynamic measurements and waveforms were recorded at the precannula location, while the mean arterial pressure was maintained at 40 mm Hg for each test. Glycerin water was used as the blood analog circuit perfusate. At each flow rate 24 trials were conducted yielding a total of 120 experiments (n = 60 pulsatile and n = 60 nonpulsatile). Under nonpulsatile perfusion the Jostra roller pump produced small values for surplus hemodynamic energy (SHE) due to its inherent pulsatility, while the Levitronix produced values of essentially zero for SHE. When switching to pulsatile perfusion, the SHE levels for both the Jostra and Levitronix pump made considerable increases. In comparing the two pumps under pulsatile perfusion, the Levitronix PediVAS produced significantly more surplus and total hemodynamic energy than did the Jostra roller pump each pump flow rate. The study suggests that the Levitronix PediVAS centrifugal pump has the capability of achieving quality pulsatile waveforms and delivering more SHE to the pseudo patient than the Jostra HL-20 roller pump. Further studies are warranted to investigate the Levitronix under bovine blood studies and with various pulsatile settings.

Preclinical testing of the Levitronix Ultramag pediatric cardiac assist device in a lamb model.

We evaluated the effects of the Levitronix UltraMag pediatric ventricular assist system on healthy animals during 29- to 90-day periods by assessing hemocompatibility and hepatic and renal functions while operating the device in a flow range suitable for pediatric patients. Nine lambs (weight, 15 to 24 kg) received the Levitronix UltraMag with an outflow cannula anastomosed to the descending aorta and an inflow cannula inserted into the left ventricular apex. Pump function data were collected at 1-hour intervals, and postoperative hematology and clinical chemistry tests were performed weekly throughout the study. Complete necropsy and histopathologic examinations were performed at study termination. Pump and circuit were thoroughly inspected for evidence of thrombi. All animals reached the scheduled endpoint of 29 to 90 days without device-related problems. Mean flow was maintained at 1.14 ± 0.19 L/min. Hematologic values were within normal range in all animals except in one lamb that had a severe hemolytic reaction after cefazolin sodium administration. In all animals, serum glutamic-oxaloacetic transaminase and creatinine kinase levels increased after surgery but gradually returned to normal limits within 1 week. Postmortem examination of the explanted organs revealed small infarcted areas in five lamb kidneys, but renal function was unaffected. All other major organs were unremarkable. In one explanted pump (a 30-day study), a small thrombus was seen within the impeller blade. The other eight pumps were free of thrombus. The Levitronix UltraMag successfully operated in pediatric flow ranges without device-related adverse events.

Impact of the postpump resistance on pressure-flow waveform and hemodynamic energy level in a neonatal pulsatile centrifugal pump.

This study tested the impact of different postpump resistances on pulsatile pressure-flow waveforms and hemodynamic energy output in a mock extracorporeal system. The circuit was primed with a 40% glycerin-water mixture, and a PediVAS centrifugal pump was used. The pre- and postpump pressures and flow rates were monitored via a data acquisition system. The postpump resistance was adjusted using a Hoffman clamp at the outlet of the pump. Five different postpump resistances and rotational speeds were tested with nonpulsatile (NP: 5000 RPM) and pulsatile (P: 4000 RPM) modes. No backflow was found when using pulsatile flow. With isoresistance, increased arterial resistances decreased pump flow rates (NP: from 1,912 ml/min to 373 ml/min; P: from 1,485 ml/min to 288 ml/min), increased postpump pressures (NP: from 333 mm Hg to 402 mm Hg; P: from 223 mm Hg to 274 mm Hg), and increased hemodynamic energy output with pulsatile mode. Pump flow rate correlated linearly with rotational speed (RPMs) of the pump, whereas postpump pressures and hemodynamic energy outputs showed curvilinear relationships with RPMs. The maximal pump flow rate also increased from 618 ml/min to 4,293 ml/min with pulsatile mode and from 581 ml/min to 5,665 ml/min with nonpulsatile mode. Results showed that higher postpump resistance reduced the pump flow range, and increased postpump pressure and surplus hemodynamic energy output with pulsatile mode. Higher rotational speeds also generated higher pump flow rates, postpump pressures, and increased pulsatility.

THE EFFECT OF IMPELLER POSITION ON CFD CALCULATIONS OF BLOOD FLOW IN MAGNETICALLY LEVITATED CENTRIFUGAL BLOOD PUMPS

Cardiovascular disease is the leading cause of mortality globally. Among various forms of cardiovascular disease, heart failure (HF) affects 5.7 million patients in the United States with about 670,000 new patients diagnosed for the first time annually (1). The fatality rate for HF is high, with one in five people dying within 1 year (1). The number of deaths has increased (1) despite advances in surgical treatment and new pharmaceutical therapies. Many therapies are available to treat patients with HF, including lifestyle changes, medications, transcatheter interventions and surgery. However, despite optimal medical and surgical therapies, some patients still do not improve and the available therapies fail to control their symptoms; for them, cardiac transplantation may be the only treatment option. However, only approximately 2300 donor hearts become available each year resulting in around 2200 transplants (1), or only about 6% of the estimated 35,000 US patients who would benefit from a heart actually receiving a transplant. To address the need to support the circulation in patients with end-stage HF a wide variety of mechanical circulatory support devices (MCSDs) have been developed over the past four decades. These MCSDs have been developed as a bridge to transplant, a bridge to recovery, and as an end stage treatment. They can be implanted as a ventricular assist device (VAD) to support the left ventricle (LVAD) or the right ventricle (RVAD) or two devices are used to support both left and right ventricles (Bi-VAD).Copyright

Development, Pre-Clinical Validation of the UltraMag and Summary of the Clinical Experience With Levitronix Ventricular Assist System

Over 6,500 cardiac and cardiopulmonary support patients have been treated worldwide with Levitronix “MagLev” support devices, including over 850 pediatric patients. The Levitronix CentriMag and PediMag systems are currently commercially available for short term clinical cardiopulmonary support applications. A new version of ventricular assist device, the UltraMag has been developed. The UltraMag is designed for VAD support of infants and adults. The UltraMag device is intended for use for up to 90 days of extracorporeal cardiac or cardiopulmonary support. This article describes this unique technology, preclinical validation, and reports on the worldwide clinical experience with all commercially available Levitronix support systems.© 2011 ASME