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  • Clinical Techniques
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Improving survival of animal models with implanted artificial heart valves

Lab Animal volume 45, pages 293–296 (2016)Cite this article

There are currently more than 6,500 manufacturers of medical devices in the US, which bring over $110 billion into the US economy annually1. In 2013, BCC Research valued the global market for cardiovascular medical devices at $49.4 billion and climbing, with North America occupying an estimated 47.1% share of this market2. Heart valve replacements have transformed much of this market, and now, through percutaneous placement techniques, human patients can receive new valves without surgery. Transcatheter aortic valve replacement was first approved in 2013 and is now preferred by many cardiologists as a non-surgical option for octogenarians. There is now a fierce race between manufacturers seeking to bring mitral valve replacement, percutaneous delivery and repair devices to reality, and the medical device and diagnostic industry estimates a ten-fold increase in the population of potential recipients owing to the increasing prevalence of mitral valve disease in humans worldwide3.

Because animal models are often used to establish the safety of medical devices and because the procedures of mitral valve repair and mitral valve replacement are complex, regardless of whether they are surgically or percutaneously placed, it is technically challenging to support these animal subjects through surgery and recovery, and this can often require the collaboration of veterinary critical care specialists. Companies that hope to market new devices must explain any adverse outcomes to the US Food and Drug Administration such that any potential risk to safety can be accounted for in the test device, the procedure or some other confounder. Often this accounting requires a timely and accurate diagnosis of cardiac events or any deviant hematology, acid-base disturbances and pulmonary, renal or neurologic findings. A strong level of proficiency in clinical and cardiac techniques and physiology is needed to diagnose such errant conditions and whether they are directly attributable to the device or procedure. Clinicians also need a strong understanding and familiarity with many classes of drugs and constant rate infusions that are not commonplace at traditional laboratory animal facilities. Board-certified veterinary cardiologists or related echocardiographic experts are suggested as consultants to the laboratory animal research team to ensure that the proper procedures are carried out and documented and that key cardiac landmarks and functions are correctly interpreted, diagnosed and documented.

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Figure 1
Figure 2: Sample clinical pathology and vital signs flow-sheet.

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  1. Capital Preclinical Scientific Research Consultants, LLC, Bethesda, MD

    Victoria Hampshire (Column Coordinator)

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Correspondence to Victoria Hampshire.

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Hampshire, V. Improving survival of animal models with implanted artificial heart valves. Lab Anim 45, 293–296 (2016). https://doi.org/10.1038/laban.1061

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