The PediaFlow™ Pediatric Ventricular Assist Device

Wearden, Peter D.; Morell, Victor O.; Keller, Bradley B.; Webber, Steven A.; Borovetz, Harvey S.; Badylak, Stephen F.; Boston, J.R.; Kormos, Robert L.; Kameneva, Marina V.; Simaan, Marwan A.; Snyder, Trevor A.; Tsukui, Hiro; Wagner, William R.; Antaki, James F.; Diao, Chenguang; Vandenberghe, Stijn; Gardiner, Jeff; Li, Chung M; Noh, Daniel; Paden, Dave; Paden, B.; Wu, Jingchun; Bearnson, Gill B.; Jacobs, G; Kirk, John; Khanwilkar, Pratap S.; Long, James W.; Miles, Scott; Hawkins, John A.; Kouretas, Peter C.; Shaddy, Robert E.

doi:10.1053/j.pcsu.2006.02.001

Cited by 19 publications

(20 citation statements)

References 20 publications

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“…Ventricular assist devices (VADs) have demonstrated a significant survival benefit, reduction in morbidity, and enhanced quality of life in adults with end stage heart failure [6-8]. The success of VADs in adults make these devices an attractive treatment modality for children suffering with congenital and/or acquired cardiac disease, however there is a dearth of such therapy options for infants and young children [2-5, 9]. This situation provided the impetus for the implementation of the United States National Heart, Lung, and Blood Institute’s Pediatric Circulatory Support Program [2].…”

Section: Introductionmentioning

confidence: 99%

“…This situation provided the impetus for the implementation of the United States National Heart, Lung, and Blood Institute’s Pediatric Circulatory Support Program [2]. As part of this program the PediaFlow™ device, a maglev turbodynamic VAD, is currently under development with an objective of providing bridge to transplant circulatory support for newborns and small children at a flow rate range of 0.3 to 1.5 L/min [5, 9-10]. The second generation prototype of the PediaFlow VAD (PF2; shown in Figure 1) was able to achieve higher flow rates than our first generation PediaFlow VAD through supercritical operation by utilizing a more efficient 4-pole motor.…”

Section: Introductionmentioning

confidence: 99%

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Platelet Activation in Ovines Undergoing Sham Surgery or Implant of the Second Generation PediaFlow Pediatric Ventricular Assist Device

et al. 2011

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The PediaFlow™ pediatric ventricular assist device (VAD) is a magnetically levitated turbodynamic pump under development for circulatory support of small children with a targeted flow rate range of 0.3 - 1.5 L/min. As the design of this device is refined, ensuring high levels of blood biocompatibility is essential. In this study we characterized platelet activation during the implantation and operation of a second generation prototype of the PediaFlow VAD (PF2) and also performed a series of surgical sham studies to examine purely surgical effects on platelet activation. In addition, a newly available monoclonal antibody was characterized and shown to be capable of quantifying ovine platelet activation. The PF2 was implanted in 3 chronic ovine experiments of 16, 30, and 70 days, while surgical sham procedures were performed in 5 ovines with 30 d monitoring. Blood biocompatibility in terms of circulating activated platelets was measured by flow cytometric assays with and without exogenous agonist stimulation. Platelet activation following sham surgery returned to baseline in approximately 2 weeks. Platelets in PF2 implanted ovines returned to baseline activation levels in all three animals, and showed an ability to respond to agonist stimulation. Late term platelet activation was observed in one animal corresponding with unexpected pump stoppages related to a manufacturing defect in the percutaneous cable. The results demonstrated encouraging platelet biocompatibility for the PF2 in that basal platelet activation was achieved early in the pump implant period. Furthermore, this first characterization of the effect of a major cardiothoracic procedure on temporal ovine platelet activation provides comparative data for future cardiovascular device evaluation in the ovine model.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Platelet Activation in Ovines Undergoing Sham Surgery or Implant of the Second Generation PediaFlow Pediatric Ventricular Assist Device

et al. 2011

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“…17 This will produce longer-term options for children with heart failure. 18 Secondly, the relationship between manufacturers of mechanical devices and the US Food and Drug Administration will be critical in furthering the availability of this technology to the many patients and centers in dire need of this form of therapy. 19 Currently, the definition of compassionate use and the need for Internal Review Board institutional evaluations often limit the implantation capabilities of many centers.…”

Section: Discussionmentioning

confidence: 99%

“…This study evaluated, retrospectively, all patients18 years of age and younger who underwent VAD implantation at two separate institutions, Riley Hospital for Children/Indiana University School of Medicine in Indianapolis, IN and the Congenital Heart Center, University of Florida School of Medicine in Gainesville, FL. Data were evaluated over a 7 year period with collection being completed in October of 2007.…”

mentioning

confidence: 99%

Ventricular Assist Device Implantation in the Pediatric Population: Does Pump Size Selection and Associated Hemodynamics Impact Outcomes?

Husain¹,

Wallis²,

Fricker³

et al. 2008

ASAIO Journal

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The use of pediatric ventricular assist devices (VADs) continues to evolve with the availability of smaller blood pumps. We examine the correlation of implanting appropriate sized blood pumps with a lower incidence of VAD related complications (VADRC). A 7-year retrospective review was undertaken for all pediatric VAD patients. Optimal VAD hemodynamics were defined as cardiac index of 2.7 L/m2 and rate of 80 beats per minute (bpm) with complete fill/empty of the blood pump. Patient/blood pump size match, VAD rate and fill/empty ratios were calculated (optimum = 1.0) and then correlated with incidence of VADRC. The study included 22 patients, mean age 9.77 years (6 mo-18 yrs) and mean body surface area (BSA) of 1.14 m2 (0.14 m2-2.32 m2), who underwent VAD implantation. VADRC included death while on support (n = 5), bleeding requiring reoperation (n = 8), hemolysis (n = 2), neurologic events (n = 2), thrombus formation (n = 3), and infection (n = 3). Six patients were bridged to transplant without any VADRC. This subset of patients had a mean blood pump size match ratio of 0.98, VAD rate ratio of 0.92 and fill/empty ratio of 1.00. Patients with VADRC (n = 16) were found to have a mean blood pump size match ratio of 0.72, VAD rate ratio of 0.72 and fill/empty ratio of 0.78. We report a series of pediatric patients with wide ranging BSA receiving VAD implantation. Selection of appropriate sized blood pumps can be correlated with decreased VADRC.

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“…With weight densities of materials of the magnetic bearing fixed, the weight also represents the space occupied by the bearing. In biomedical applications such as ventricular assist devices used for heart patients [47], the weight and the volume are design objectives of significant importance in addition to power requirements. In aviation applications, the weight also adds to the carrying cost in addition to the issues of space occupied, strength, and dynamic stability of the structure.…”

Section: Mathematical Model Of the Constrained Moopmentioning

confidence: 99%

Optimum Design and Analysis of Axial Hybrid Magnetic Bearings Using Multi-Objective Genetic Algorithms

Rao

Tiwari

2012

International Journal for Computational Methods in Engineering

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Design optimization of axial hybrid magnetic thrust bearings (with bias magnets) was carried out using multi-objective evolutionary algorithms (MOEAs) and compared with the case of electromagnetic bearings (without bias magnets). Mathematical models of objective functions and associated constraints are presented and discussed. The different aspects of implemented MOEA are discussed. It is observed that the size of the bearing with bias magnets is considerably reduced as compared to the case of those without bias magnets, with the objective function as the minimization of weight for the same operating conditions. Similarly, current densities aret reduced drastically with biased magnets when the objective function is chosen as the minimization of the power loss. For illustration of various performances of the bearing, a typical design has been chosen from the final optimized population by an "a posteriori" approach. Sensitivities for both the objective functions with respect to the outer radius, the inner radius, and the height of coil are observed to be approximately in the ratio 2.5:1.6:1. Analysis of final optimized population has been carried out and is compared with the case without bias magnets and some salient points are observed in the case of using bias magnets.

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The PediaFlow™ Pediatric Ventricular Assist Device

Cited by 19 publications

References 20 publications

Platelet Activation in Ovines Undergoing Sham Surgery or Implant of the Second Generation PediaFlow Pediatric Ventricular Assist Device

Platelet Activation in Ovines Undergoing Sham Surgery or Implant of the Second Generation PediaFlow Pediatric Ventricular Assist Device

Ventricular Assist Device Implantation in the Pediatric Population: Does Pump Size Selection and Associated Hemodynamics Impact Outcomes?

Optimum Design and Analysis of Axial Hybrid Magnetic Bearings Using Multi-Objective Genetic Algorithms

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