Large Animal Models for Left Ventricular Assist Device Research and Development

Monreal, Gretel; Sherwood, Leslie C.; Sobieski, Michael A.; Giridharan, Guruprasad A.; Slaughter, Mark S.; Koenig, Steven C.

doi:10.1097/mat.0000000000000005

Cited by 36 publications

(32 citation statements)

References 79 publications

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“…11 In vivo preclinical evaluation of blood compatibility, biocompatibility, device safety and reliability of IVAD warrants a large animal model that faithfully simulates human etiology. 12 The most common animal models for VAD testing are sheep and calves. Both species tolerate the months of ICU restraint requirement well.…”

Section: Discussionmentioning

confidence: 99%

Establishment of Ovine Model for Ch-Vad Implantable Ventricular Assist Device

Yang

et al. 2019

J. Mech. Med. Biol.

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The objective of this study was to establish an ovine model for CH-VAD (CH Biomedical Inc., JiangSu, China) implantable ventricular assist device (IVAD) to evaluate experimental protocols, including anesthesia management, surgical process, autopsy criteria and a validated anticoagulation procedure. Method: IVAD was implanted into the chest of sheep without stopping the beating heart through a left thoracotomy, and the inflow cannula was connected to the left ventricular apex and the outflow cannula was anastomosed to the descending aorta. Results: Totally 23 cases were established: 6 died of an anaesthetic or surgical reasons, one died of lung infection, the other 16 cases survived for more than 15 days, among which four cases were terminated because of decrease of pump flow and the other 12 cases survived for more than 30 days. Conclusions: Sheep models suitable for implantation of CH-VAD implantable LVAD were successfully established and the appropriate safety evaluation indicators of this model were validated in the course of the animal experiments, and the survival rate of the experiments were improved gradually over time.

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Section: Discussionmentioning

confidence: 99%

Establishment of Ovine Model for Ch-Vad Implantable Ventricular Assist Device

Yang

et al. 2019

J. Mech. Med. Biol.

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“…In addition, they have a rapid growth rate, and can outgrow the cardiac output capacity of the device. 5 The purpose of this study was to use virtual implantation methods in combination with bovine cadaver studies prior to acute implants in order to enable the Realheart TAH to transition from the previously used porcine to the bovine animal model. This transition was necessary to prepare for chronic animal trials in calves.…”

Section: Sonntag Et Almentioning

confidence: 99%

“…Medical devices must first be evaluated in animal trials prior to starting clinical trials. Common large animal models for cardiac devices include pigs, sheep, and calves . The anatomy of the thorax differs significantly between these species, and also when compared to humans.…”

Section: Introductionmentioning

confidence: 99%

“…They can thus be a rather delicate animal model. In addition, they have a rapid growth rate, and can outgrow the cardiac output capacity of the device …”

Section: Introductionmentioning

confidence: 99%

“…Common large animal models for cardiac devices include pigs, sheep, and calves. 5 The anatomy of the thorax differs significantly between these species, and also when compared to humans. Hence, device developers who are designing new products must be aware of these anatomical differences prior to performing animal trials and ensure that appropriate designs are used in the animal model and for the final product that is to be implanted in humans.…”

Section: Introductionmentioning

confidence: 99%

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Virtual implantations to transition from porcine to bovine animal models for a total artificial heart

Sonntag¹,

Meyns

Ahn

et al. 2019

Artificial Organs

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Realheart total artificial heart (TAH) is a novel, pulsatile, four‐chamber total artificial heart which had been successfully tested acutely in a porcine animal model. However, the bovine model is better suited for long‐term testing and thus an evaluation of how the design would fit the bovine anatomy was required. Virtual implantation is a method that enables a computer simulated implantation based on anatomical 3D‐models created from computer tomography images. This method is used clinically, but not yet adopted for animal studies. Herein, we evaluated its suitability in the redesign of the outer dimensions and vessel connections of Realheart TAH to transition from the porcine to the bovine animal model. Virtual implantations in combination with bovine cadaver studies enabled a series of successful acute bovine implantations. Virtual implantations are a useful tool to replace the use of animals in early device development and refine subsequent necessary in vivo experiments. The next steps are to carry out human virtual implantations and cadaver studies to ensure the design is optimized for all stages of testing as well as the final recipient.

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Systems of conductive skin for power transfer in clinical applications

Kourouklis

Kaemmel

et al. 2021

Eur Biophys J

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The primary aim of this article is to review the clinical challenges related to the supply of power in implanted left ventricular assist devices (LVADs) by means of transcutaneous drivelines. In effect of that, we present the preventive measures and post-operative protocols that are regularly employed to address the leading problem of driveline infections. Due to the lack of reliable wireless solutions for power transfer in LVADs, the development of new driveline configurations remains at the forefront of different strategies that aim to power LVADs in a less destructive manner. To this end, skin damage and breach formation around transcutaneous LVAD drivelines represent key challenges before improving the current standard of care. For this reason, we assess recent strategies on the surface functionalization of LVAD drivelines, which aim to limit the incidence of driveline infection by directing the responses of the skin tissue. Moreover, we propose a class of power transfer systems that could leverage the ability of skin tissue to effectively heal short diameter wounds. In this direction, we employed a novel method to generate thin conductive wires of controllable surface topography with the potential to minimize skin disruption and eliminate the problem of driveline infections. Our initial results suggest the viability of the small diameter wires for the investigation of new power transfer systems for LVADs. Overall, this review uniquely compiles a diverse number of topics with the aim to instigate new research ventures on the design of power transfer systems for IMDs, and specifically LVADs.

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Large Animal Models for Left Ventricular Assist Device Research and Development

Cited by 36 publications

References 79 publications

Establishment of Ovine Model for Ch-Vad Implantable Ventricular Assist Device

Establishment of Ovine Model for Ch-Vad Implantable Ventricular Assist Device

Virtual implantations to transition from porcine to bovine animal models for a total artificial heart

Systems of conductive skin for power transfer in clinical applications

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