Mark S. Slaughter, MD, Guruprasad A

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Transapical miniaturized ventricular assist device: Design and initial testing Mark S. Slaughter, MD, Guruprasad A. Giridharan, PhD, Dan Tamez, BS, Jeff LaRose, MS, Mike A. Sobieski, RN, CCP, Leslie Sherwood, DVM, Steven C. Koenig, PhD The Journal of Thoracic and Cardiovascular Surgery Volume 142, Issue 3, Pages 668-674 (September 2011) DOI: 10.1016/j.jtcvs.2011.01.011 Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions

Figure 1 Computer aided design model of miniaturized ventricular assist device (MVAD, top). Primary components of this pump are anchor to ventricular apex, standpipe to adjust position of pump inside ventricle and across aortic valve, miniaturized ventricular assist device core assembly, and outflow cannula. The Journal of Thoracic and Cardiovascular Surgery 2011 142, 668-674DOI: (10.1016/j.jtcvs.2011.01.011) Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions

Figure 2 Left ventricular (LV) pressure–volume loops demonstrating effective mechanical unloading of ventricle with device support, as evidenced by leftward shift of PV loop and reduced ventricular filling and ejection pressures during miniaturized ventricular assist device (VAD) support. The Journal of Thoracic and Cardiovascular Surgery 2011 142, 668-674DOI: (10.1016/j.jtcvs.2011.01.011) Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions

Figure 3 Aortic pressure (AoP), left ventricular pressure (LVP, dashed), and aortic flow (AoF) waveforms during baseline, partial miniaturized ventricular assist device (MVAD) support, and full miniaturized ventricular assist device support. These data demonstrate that miniaturized ventricular assist device unloads native ventricle similar to clinical ventricular assist devices. The Journal of Thoracic and Cardiovascular Surgery 2011 142, 668-674DOI: (10.1016/j.jtcvs.2011.01.011) Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions

Figure 4 Apex of left ventricle was accessed via thoracotomy. Miniaturized ventricular assist device was inserted through apex of left ventricle (top left). Graphic illustration of implanted positioning of miniaturized ventricular assist device demonstrating transapical placement (top center). Fluoroscopy shows good anatomic placement of miniaturized ventricular assist device in calf (top right). Echocardiographic color Doppler images demonstrate minimal aortic regurgitation and adequate coaptation of aortic valve with transapical outflow cannula placement (bottom). The Journal of Thoracic and Cardiovascular Surgery 2011 142, 668-674DOI: (10.1016/j.jtcvs.2011.01.011) Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions

Figure 5 Average blood urea nitrogen (BUN), creatinine, plasma free hemoglobin (pfHg), and international normalized ratio (INR) values for all animals (n = 4) were within clinically accepted thresholds throughout 30-day study period. These results demonstrate that miniaturized ventricular assist device carries minimal-device related hemolysis. The Journal of Thoracic and Cardiovascular Surgery 2011 142, 668-674DOI: (10.1016/j.jtcvs.2011.01.011) Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions

Figure 6 Heart and aortic valve after animal was electively killed 30 days after miniaturized ventricular assist device implantation. Device was entirely free of thrombi (left) in all long-term animals, and there was no damage to aortic valve (right), demonstrating feasibility of long-term hemocompatibility with miniaturized ventricular assist device. The Journal of Thoracic and Cardiovascular Surgery 2011 142, 668-674DOI: (10.1016/j.jtcvs.2011.01.011) Copyright © 2011 The American Association for Thoracic Surgery Terms and Conditions