Harpoon - Beating Heart Artificial Cord Mitral Valve Implantation.
Krzysztof Bartus1, Andrzej Gackowski2, Jolanta Rzucidło-Resil3, Michael N D’Ambra4, Jammie S Gammie5, Radosslaw Litwinowicz1, Jerzy Sadowski1, Bogusław Kapelak1
1Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, J, Kraków, Poland, 2Jagiellonian University Medical College, J, Kraków, Poland, 3John Paul II Hospitail, Kraków, Poland, 4Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, USA., Batlimore, MD, USA, 5Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, USA., Baltimore, MD, USA
Objectives: The objective of this study was to evaluate the safety and performance of a mitral valve beating-heart repair procedure in patients with degenerative mitral regurgitation. Methods: Single center prospective study enrolled 25 patients. All patients were treated with the Harpoon Beating Heart Mitral Valve Repair System. Patients were followed up after surgery for one year. Successful implantation of cords with mitral valve reduction to moderate or less was the primary endpoint. Independent core lab was responsible to analyze the results. Results: In 25 patients were enrolled, technical success was achieved in 25 (100%); none of the patients required conversion to open surgery, no procedure was terminated. The primary endpoint was met in 25/25 (100%) patients. At discharge, there were no deaths, strokes, or renal failure or other serious adverse events. One patient required reoperation in the follow up due to the recurrent MR. No other serious adverse events were noted at 1 year. Conclusions: This very early clinical experience with use of the Harpoon beating heart mitral valve repair system demonstrates very encouraging early safety and performance results. Longer term follow up is needed to confirm safety and durability.
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