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Minimally Invasive Placement of a Novel Direct Epicardial Assist Device in a Porcine Heart Failure Model
Jeremy McGarvey, Norihiro Kondo, Manabu Takebe, Toru Shimaoka, Satoshi Takebayashi, Walter R.T. Witschey, Gerald A. Zsido, II, Joseph H. Gorman, III, James J. Pilla, Robert C. Gorman.
University of Pennsylvania, Philadelphia, PA, USA.

Objective: Despite advances in design, modern ventricular assist device (VAD) placement involves median sternotomy, cardiopulmonary bypass, and is associated with infectious/embolic complications. Accordingly, innovative approaches to assistive therapies for ischemic cardiomyopathy (ICM) remain in great demand. In this study, we examine the feasibility and function of a novel minimally invasive, off-pump epicardial assist device in a porcine ICM model.
Methods: Five male Yorkshire swine underwent selective ligation of the circumflex artery and its branches to create a 23.8±1.5% posterolateral infarct. Twelve weeks post-infarct, all animals underwent left mini-thoracotomy. A custom inflatable bladder was positioned over the epicardial surface of the infarct and firmly secured to surrounding borderzone myocardium with polypropylene mesh and minimally-invasive mesh tacks (Figure 1a). The inflation port was externalized through the chest wall and connected to an external gas pulsation system which actively inflated and deflated (Figure 1b-c, respectively) the bladder in synchrony with the cardiac cycle. All animals then underwent pressure-gated 3D cardiac MRI to assess device and ventricular function. Post-mortem, the heart was examined for evidence of mesh dehiscence, device damage, coronary injury, and ventricular perforation.
Results: All subjects successfully underwent off-pump placement of the novel epicardial assist device via mini-thoracotomy. Total operative time was under 30 minutes in all cases. Ejection fraction (EF) significantly improved from 29.1±4.8% to 39.6±4.23% (p<0.001) when compared to pre-treatment. End-systolic volume decreased (76.6±13.3ml vs 62.4±12.0ml, p<0.001) and stroke volume increased (28.6±3.4ml vs 37.9±3.1ml, p<0.05) when assisted. No change was noted in end-diastolic volume (105.1±11.4 vs 100.3±12.7). On post-mortem examination, mesh fixation and device position were excellent in all cases. No complications were noted.
Conclusions: Directed epicardial assistance improves global ventricular function in a porcine ICM model, and may provide a safe alternative to currently available invasive VAD therapies. Minimally invasive, off-pump placement of the novel assist device was easy and technically uncomplicated. Further, the technique used for device positioning and fixation suggests an entirely thoracoscopic approach is possible.


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