James S Gammie1, Krzysztof Bartus2, Andrzej Gackowski3, Piotr Szymanski4, Agata Bilewska5, Mariusz Kusmierczyk6, Boguslaw Kapelak2, Jolanta Rzucidlo-Resil2, Alison Duncan7, Rashmi Yadav7, Steve Livesey8, Paul Diprose9, Gino Gerosa10, Augusto D'Onofrio10, Demetrio Pittarello11, Paolo Denti11, Giovanni La Canna11, Michele De Bonis11, Ottavio Alfieri11, Judy Hung12, Piotr Kolsut6, Michael N D'Ambra13. 1. Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA. 2. Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland. 3. Department of Coronary Disease and Heart Failure, Jagiellonian University Medical College, Noninvasive Cardiovascular Laboratory, John Paul II Hospital, Krakow, Poland. 4. MSWiA Central Clinical Hospital, Centre of Postgraduate Medical Education, Warsaw, Poland. 5. Department of Cardiology and Internal Diseases, Military Institute of Medicine, Warsaw, Poland. 6. Institute of Cardiology, Warsaw, Poland. 7. Department of Surgery, The Royal Brompton & Harefield NHS Foundation Trust, London, UK. 8. Division of Cardiac Surgery, St. George's Hospital, London, UK. 9. Cardiac Anesthesia and Critical Care, University Hospital Southampton NHS Foundation Trust, Southampton, UK. 10. Division of Cardiac Surgery, Department of Cardiac Thoracic and Vascular Sciences and Public Health, Padova University Hospital, Padova, Italy. 11. Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy. 12. Division of Cardiology, Massachusetts General Hospital, Boston, MA, USA. 13. Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA.
Abstract
OBJECTIVES: The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation. METHODS: Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to ≤moderate. An independent core laboratory analysed echocardiograms. RESULTS: Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 ± 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1 year included decreased end-diastolic left ventricular volume (153 ± 41 to 119 ± 28 ml) and diameter (53 ± 5 to 47 ± 6 mm), and the mean transmitral gradient was 1.4 ± 0.7 mmHg. CONCLUSIONS: This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance. CLINICAL REGISTRATION NUMBERS: NCT02432196 and NCT02768870.
OBJECTIVES: The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation. METHODS: Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to ≤moderate. An independent core laboratory analysed echocardiograms. RESULTS: Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 ± 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patientsdied (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1 year included decreased end-diastolic left ventricular volume (153 ± 41 to 119 ± 28 ml) and diameter (53 ± 5 to 47 ± 6 mm), and the mean transmitral gradient was 1.4 ± 0.7 mmHg. CONCLUSIONS: This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance. CLINICAL REGISTRATION NUMBERS: NCT02432196 and NCT02768870.
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