European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2021
Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Gammie James S, Bartus Krzysztof, Gackowski Andrzej, Szymanski Piotr, Bilewska Agata, Kusmierczyk Mariusz, Kapelak Boguslaw, Rzucidlo-Resil Jolanta, Duncan Alison, Yadav Rashmi, Livesey Steve, Diprose Paul, Gerosa Gino, D'Onofrio Augusto, Pittarello Demetrio, Denti Paolo, La Canna Giovanni, De Bonis Michele, Alfieri Ottavio, Hung Judy, Kolsut Piotr, D'Ambra Michael N
Аннотация
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.
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.