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Harpoon Beating Heart Artificial Cord Mitral Valve Implantation
Krzyszof Bartus1, Andrzej Gackowski1, Jolanta Rzucidlo-Resil2, Michael N D'Ambra3, Jammie S Gammie3, Radoslaw Litwinowicz1, Jerzy Sadowski1, Boguslaw Kapelak1
1Jagiellonian University, John Paul II Hospital, Krakow, Poland, 2John Paul II Hospital, Krakow, Poland, 3Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA
BACKGROUND: This is a single-center experience based on patients enrolled in the multi-center EU EFS and TRACER trials designed to evaluate the safety and performance of a mitral valve beating-heart repair procedure in patients with severe degenerative mitral regurgitation.
METHODS: This experience consists of 21 enrolled trial patients with follow-up out to 1 year. All patients were treated with the HARPOON Beating Heart Mitral Valve Repair System. Trial patients will be followed out to 5 years post-implant procedure. The primary performance endpoint was defined as successful implantation of at least one cord with a reduction in mitral regurgitation to moderate or less. An independent core lab and Clinical Events Committee were responsible for adjudication of results.
RESULTS: In the 21 enrolled patients, technical success defined as implantation of at least one cord was achieved in 21 (100%); none of the patients required conversion to open surgery, and no procedure was terminated. The primary performance endpoint was met in 19/21 (91%) patients. At discharge, no deaths, strokes, or renal failure were observed. Three patients required reoperation in the follow up due to recurrent MR by 1 Year. Through 1 year, freedom from death and freedom from endocarditis were both 95%.
CONCLUSIONS:This very early clinical experience with use of the HARPOON Beating Heart Mitral Valve Repair System demonstrates encouraging early safety and performance results. Longer term follow up is needed to confirm safety and durability
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