One of the maladaptive changes following a heart attack is an initial decline in pumping capacity, which leads to activation of compensatory mechanisms, and subsequently, a phenomenon known as cardiac or left ventricular remodeling. Evidence suggests that mechanical cues are critical in the progression of congestive heart failure. In order to mediate two important mechanical parameters, cardiac size and cardiac output, we have developed a direct cardiac contact device capable of two actions: (1) adjustable cardiac support to modulate cardiac size and (2) synchronous active assist to modulate cardiac output. In addition, the device was designed to (1) remain in place about the heart without tethering, (2) allow free normal motion of the heart, and (3) provide assist via direct cardiac compression without abnormally inverting the curvature of the heart. The actions and features described above were mapped to particular design solutions and assessed in an acute implantation in an ovine model of acute heart failure (esmolol overdose). A balloon catheter was inflated in the vena cava to reduce preload and determine the end-diastolic pressure-volume relationship with and without passive support. A Millar PV Loop catheter was inserted in the left ventricle to acquire pressure-volume data throughout the experiments. Fluoroscopic imaging was used to investigate effects on cardiac motion. Implementation of the adjustable passive support function of the device successfully modulated the end-diastolic pressure-volume relationship toward normal. The active assist function successfully restored cardiac output and stroke work to healthy baseline levels in the esmolol induced failure model. The device remained in place throughout the experiment and when de-activated, did not inhibit cardiac motion. In this in vivo proof of concept study, we have demonstrated that a single device can be used to provide both passive constraint/support and active assist. Such a device may allow for controlled, disease specific, flexible intervention. Ultimately, it is hypothesized that the combination of support and assist could be used to facilitate cardiac rehabilitation therapy. The principles guiding this approach involve simply creating the conditions under which natural growth and remodeling processes are guided in a therapeutic manner. For example, the passive support function could be incrementally adjusted to gradually reduce the size of the dilated myocardium, while the active assist function can be implemented as necessary to maintain cardiac output and decompress the heart.
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December 2011
Research Papers
Development of a Non-Blood Contacting Cardiac Assist and Support Device: An In Vivo Proof of Concept Study
Michael R. Moreno,
Michael R. Moreno
Department of Biomedical Engineering,
Texas A&M University
, College Station, TX 77843-3120; CorInnova Incorporated, College Station, TX 77845
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Saurabh Biswas,
Saurabh Biswas
Department of Biomedical Engineering,
Texas A&M University
, College Station, TX 77843-3120
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Lewis D. Harrison,
Lewis D. Harrison
CorInnova Incorporated
, College Station, TX 77845
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Guilluame Pernelle,
Guilluame Pernelle
CorInnova Incorporated
, College Station, TX 77845
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Matthew W. Miller,
Matthew W. Miller
Texas A&M Institute for Preclinical Studies,
Texas A&M University
, College Station, TX 77843; Department of Small Animal Clinical Sciences, College of Veterinary Medicine, Texas A&M University, College Station, TX 77843-4474
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Theresa W. Fossum,
Theresa W. Fossum
Texas A&M Institute for Preclinical Studies,
Texas A&M University
, College Station, TX 77843; Department of Small Animal Clinical Sciences, College of Veterinary Medicine, Texas A&M University, College Station, TX 77843-4474
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David A. Nelson,
David A. Nelson
Texas A&M Institute for Preclinical Studies,
Texas A&M University
, College Station, TX 77843
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John C. Criscione
John C. Criscione
Department of Biomedical Engineering,
Texas A&M University
, College Station, TX 77843-3120; CorInnova Incorporated, College Station, TX 77845
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Michael R. Moreno
Department of Biomedical Engineering,
Texas A&M University
, College Station, TX 77843-3120; CorInnova Incorporated, College Station, TX 77845
Saurabh Biswas
Department of Biomedical Engineering,
Texas A&M University
, College Station, TX 77843-3120
Lewis D. Harrison
CorInnova Incorporated
, College Station, TX 77845
Guilluame Pernelle
CorInnova Incorporated
, College Station, TX 77845
Matthew W. Miller
Texas A&M Institute for Preclinical Studies,
Texas A&M University
, College Station, TX 77843; Department of Small Animal Clinical Sciences, College of Veterinary Medicine, Texas A&M University, College Station, TX 77843-4474
Theresa W. Fossum
Texas A&M Institute for Preclinical Studies,
Texas A&M University
, College Station, TX 77843; Department of Small Animal Clinical Sciences, College of Veterinary Medicine, Texas A&M University, College Station, TX 77843-4474
David A. Nelson
Texas A&M Institute for Preclinical Studies,
Texas A&M University
, College Station, TX 77843
John C. Criscione
Department of Biomedical Engineering,
Texas A&M University
, College Station, TX 77843-3120; CorInnova Incorporated, College Station, TX 77845J. Med. Devices. Dec 2011, 5(4): 041007 (9 pages)
Published Online: November 28, 2011
Article history
Received:
April 25, 2011
Revised:
September 12, 2011
Online:
November 28, 2011
Published:
November 28, 2011
Citation
Moreno, M. R., Biswas, S., Harrison, L. D., Pernelle, G., Miller, M. W., Fossum, T. W., Nelson, D. A., and Criscione, J. C. (November 28, 2011). "Development of a Non-Blood Contacting Cardiac Assist and Support Device: An In Vivo Proof of Concept Study." ASME. J. Med. Devices. December 2011; 5(4): 041007. https://doi.org/10.1115/1.4005281
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