Lon S. Annest1, Claudio Argento1, Shizhen Liu2, Mani Vannan2, Michael Acker3, Mani Subramanian4.
1BioVentrix, San Ramon, CA, USA, 2Ohio State University, Columbus, OH, USA, 3University of Pennsylvania, Philadelphia, PA, USA, 4Lenox Hill, New York, NY, USA.
BACKGROUND: The Dor procedure has been performed for over 20 years in the surgical treatment of heart failure (HF) caused by previous infarction. Reported outcomes include over one full NYHA FC improvement, 78% five-year freedom from HF, and increase in ejection fraction (LVEF); its use is growing. The functional improvement form the operation has been attributed to volume and radius reduction of the left ventricle (LV) through scar exclusion. Since the anatomic configuration known to benefit most is the antero-septal infarct, apposition of the septum to the lateral wall with removal of circumference might be feasible from the LV epicardial approach, and may reproduce surgical results. We have previously reported achievement of successful geometric reconfiguration in a bench top model. We now submit preliminary results in the chronic ovine model.
METHODS: Heart failure and anteroseptal scar was created in four adult Dorsett or Polycross sheep weighing 50-60 kg by surgical ligation of the LAD and diagonals 60% of the distance from the base to the apex, or by coils placed transarterially. Animals were recovered for 4-6 weeks, and LV significant LV dilation and scar developed in all, followed with serial echocardiograms. Using a proprietary catheter system, the LV was reconfigured directly through the LV wall across the inter-ventricular septum, plicating the lateral wall to the septum, thereby reducing circumference, volume, and wall tension through exclusion of a portion of scar and isolating a portion of the ventricle. Animals were followed for four weeks, with post-reduction LV volumes measured and compared to preoperative values.
RESULTS: No animals died intra-operatively. Volume changes are summarized in the table below. LVESV and LVEDV decreased significantly while LVEF increased significantly. LVSV increased, but not significantly.
CONCLUSIONS: A catheter-based, transmural, direct epicardial LV approach to LV reconstruction achieves results similar to those attained surgicallyPRE POST p VALUE LVESV 87.9 ± 32.6 52.5 ± 27.1 P<0.004 LVEDV 134.0 ± 42.8 105.2 ± 39.6 P<0.022 LVSV 46.1 ± 20.1 52.8 ± 20.1 P<0.124 LVEF 34.4% ± 13.1% 50.4% ± 14.3% P<0.005
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