{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T14:48:58Z","timestamp":1791470938274,"version":"4.3.4"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2020,10,10]],"date-time":"2020-10-10T00:00:00Z","timestamp":1602288000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"HARPOON Medical and Edwards Lifesciences"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>OBJECTIVES<\/jats:title>\n                  <jats:p\/>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS<\/jats:title>\n                  <jats:p>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 \u2264moderate. An independent core laboratory analysed echocardiograms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>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\u2009\u00b1\u20090.5\u2009h. Through discharge, there were no deaths, strokes or renal failure events. At 1\u2009year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1\u2009year, 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\u2009=\u200927), mild in 23% (n\u2009=\u200912), moderate in 23% (n\u2009=\u200912) and severe in 2% (n\u2009=\u20091). Favourable cardiac remodelling outcomes at 1\u2009year included decreased end-diastolic left ventricular volume (153\u2009\u00b1\u200941 to 119\u2009\u00b1\u200928\u2009ml) and diameter (53\u2009\u00b1\u20095 to 47\u2009\u00b1\u20096\u2009mm), and the mean transmitral gradient was 1.4\u2009\u00b1\u20090.7\u2009mmHg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical registration numbers<\/jats:title>\n                  <jats:p>NCT02432196 and NCT02768870.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ejcts\/ezaa256","type":"journal-article","created":{"date-parts":[[2020,6,29]],"date-time":"2020-06-29T19:17:00Z","timestamp":1593458220000},"page":"199-206","source":"Crossref","is-referenced-by-count":33,"title":["Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes"],"prefix":"10.1093","volume":"59","author":[{"given":"James S","family":"Gammie","sequence":"first","affiliation":[{"name":"Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3457-6978","authenticated-orcid":false,"given":"Krzysztof","family":"Bartus","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrzej","family":"Gackowski","sequence":"additional","affiliation":[{"name":"Department of Coronary Disease and Heart Failure, Jagiellonian University Medical College, Noninvasive Cardiovascular Laboratory, John Paul II Hospital, Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Szymanski","sequence":"additional","affiliation":[{"name":"MSWiA Central Clinical Hospital, Centre of Postgraduate Medical Education, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agata","family":"Bilewska","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Internal Diseases, Military Institute of Medicine, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariusz","family":"Kusmierczyk","sequence":"additional","affiliation":[{"name":"Institute of Cardiology, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boguslaw","family":"Kapelak","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jolanta","family":"Rzucidlo-Resil","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Duncan","sequence":"additional","affiliation":[{"name":"Department of Surgery, The Royal Brompton & Harefield NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rashmi","family":"Yadav","sequence":"additional","affiliation":[{"name":"Department of Surgery, The Royal Brompton & Harefield NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Livesey","sequence":"additional","affiliation":[{"name":"Division of Cardiac Surgery, St. George\u2019s Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Diprose","sequence":"additional","affiliation":[{"name":"Cardiac Anesthesia and Critical Care, University Hospital Southampton NHS Foundation Trust, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6261-699X","authenticated-orcid":false,"given":"Gino","family":"Gerosa","sequence":"additional","affiliation":[{"name":"Division of Cardiac Surgery, Department of Cardiac Thoracic and Vascular Sciences and Public Health, Padova University Hospital, Padova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Augusto","family":"D\u2019Onofrio","sequence":"additional","affiliation":[{"name":"Division of Cardiac Surgery, Department of Cardiac Thoracic and Vascular Sciences and Public Health, Padova University Hospital, Padova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Demetrio","family":"Pittarello","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3075-0203","authenticated-orcid":false,"given":"Paolo","family":"Denti","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"La Canna","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9329-7437","authenticated-orcid":false,"given":"Michele","family":"De Bonis","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ottavio","family":"Alfieri","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judy","family":"Hung","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Massachusetts General Hospital, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Kolsut","sequence":"additional","affiliation":[{"name":"Institute of Cardiology, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael N","family":"D\u2019Ambra","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,10,10]]},"reference":[{"key":"2021010414504885300_ezaa256-B1","doi-asserted-by":"crossref","first-page":"2397","DOI":"10.1016\/j.jacc.2017.02.026","article-title":"Relation of mitral valve surgery volume to repair rate, durability, and survival","volume":"69","author":"Chikwe","year":"2017","journal-title":"J Am Coll Cardiol"},{"key":"2021010414504885300_ezaa256-B2","doi-asserted-by":"crossref","first-page":"716","DOI":"10.1016\/j.athoracsur.2018.03.086","article-title":"Isolated mitral valve surgery: the Society of Thoracic Surgeons adult cardiac surgery database analysis","volume":"106","author":"Gammie","year":"2018","journal-title":"Ann Thorac Surg"},{"key":"2021010414504885300_ezaa256-B3","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1161\/CIRCULATIONAHA.112.001402","article-title":"Learning minimally invasive mitral valve surgery: a cumulative sum sequential probability analysis of 3895 operations from a single high-volume center","volume":"128","author":"Holzhey","year":"2013","journal-title":"Circulation"},{"key":"2021010414504885300_ezaa256-B4","first-page":"417","article-title":"Durability of mitral valve repair for mitral regurgitation due to degenerative mitral valve disease","volume":"4","author":"David","year":"2015","journal-title":"Ann Cardiothorac Surg"},{"key":"2021010414504885300_ezaa256-B5","doi-asserted-by":"crossref","first-page":"532","DOI":"10.1016\/j.ejcts.2009.03.058","article-title":"Comparison of outcomes of minimally invasive mitral valve surgery for posterior, anterior and bileaflet prolapse","volume":"36","author":"Seeburger","year":"2009","journal-title":"Eur J Cardiothorac Surg"},{"key":"2021010414504885300_ezaa256-B6","doi-asserted-by":"crossref","first-page":"1385","DOI":"10.1016\/j.athoracsur.2009.12.070","article-title":"Surgical repair of posterior mitral valve prolapse: implications for guidelines and percutaneous repair","volume":"89","author":"Johnston","year":"2010","journal-title":"Ann Thorac Surg"},{"key":"2021010414504885300_ezaa256-B7","doi-asserted-by":"crossref","first-page":"1395","DOI":"10.1056\/NEJMoa1009355","article-title":"Percutaneous repair or surgery for mitral regurgitation","volume":"364","author":"Feldman","year":"2011","journal-title":"N Engl J Med"},{"key":"2021010414504885300_ezaa256-B8","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1016\/j.jtcvs.2008.09.004","article-title":"Beating-heart, off-pump mitral valve repair by implantation of artificial chordae tendineae: an acute in vivo animal study","volume":"137","author":"Bajona","year":"2009","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2021010414504885300_ezaa256-B9","doi-asserted-by":"crossref","first-page":"440","DOI":"10.1016\/j.athoracsur.2018.01.092","article-title":"Good 5-year durability of transapical beating heart off-pump mitral valve repair with neochordae","volume":"106","author":"Kiefer","year":"2018","journal-title":"Ann Thorac Surg"},{"key":"2021010414504885300_ezaa256-B10","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1016\/j.jacc.2017.10.062","article-title":"Beating-heart mitral valve repair using a novel ePTFE cordal implantation device: prospective trial","volume":"71","author":"Gammie","year":"2018","journal-title":"J Am Coll Cardiol"},{"key":"2021010414504885300_ezaa256-B11","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1161\/CIRCULATIONAHA.116.022010","article-title":"Transapical beating-heart mitral valve repair with an expanded polytetrafluoroethylene cordal implantation device: initial clinical experience","volume":"134","author":"Gammie","year":"2016","journal-title":"Circulation"},{"key":"2021010414504885300_ezaa256-B12","doi-asserted-by":"crossref","first-page":"2739","DOI":"10.1093\/eurheartj\/ehx391","article-title":"2017 ESC\/EACTS Guidelines for the management of valvular heart disease","volume":"38","author":"Baumgartner","year":"2017","journal-title":"Eur Heart J"},{"key":"2021010414504885300_ezaa256-B13","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1016\/j.echo.2017.01.007","article-title":"Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the society for cardiovascular magnetic resonance","volume":"30","author":"Zoghbi","year":"2017","journal-title":"J Am Soc Echocardiogr"},{"key":"2021010414504885300_ezaa256-B14","doi-asserted-by":"crossref","first-page":"1440","DOI":"10.1016\/j.echo.2005.10.005","article-title":"Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology","volume":"18","author":"Lang","year":"2005","journal-title":"J Am Soc Echocardiogr"},{"key":"2021010414504885300_ezaa256-B15","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1016\/S0002-8703(00)90077-2","article-title":"Three-dimensional echocardiographic assessment of annular shape changes in the normal and regurgitant mitral valve","volume":"139","author":"Kaplan","year":"2000","journal-title":"Am Heart J"},{"key":"2021010414504885300_ezaa256-B16","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1016\/j.jtcvs.2010.09.008","article-title":"Robotic repair of posterior mitral valve prolapse versus conventional approaches: potential realized","volume":"141","author":"Mihaljevic","year":"2011","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2021010414504885300_ezaa256-B17","doi-asserted-by":"crossref","first-page":"1961","DOI":"10.1161\/CIRCULATIONAHA.115.017792","article-title":"Robotic mitral valve repair for simple and complex degenerative disease: midterm clinical and echocardiographic quality outcomes","volume":"132","author":"Suri","year":"2015","journal-title":"Circulation"},{"key":"2021010414504885300_ezaa256-B18","doi-asserted-by":"crossref","first-page":"576","DOI":"10.1016\/j.athoracsur.2015.07.029","article-title":"One hundred percent reparability of degenerative mitral regurgitation: intermediate-term results of a dynamic engineered approach","volume":"101","author":"Lawrie","year":"2016","journal-title":"Ann Thorac Surg"},{"key":"2021010414504885300_ezaa256-B19","doi-asserted-by":"crossref","first-page":"1071","DOI":"10.1016\/j.jtcvs.2008.10.026","article-title":"Recovery of left ventricular function after surgical correction of mitral regurgitation caused by leaflet prolapse","volume":"137","author":"Suri","year":"2009","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2021010414504885300_ezaa256-B20","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1016\/j.jtcvs.2010.11.030","article-title":"Left ventricular remodeling and mitral valve surgery: prospective study with real-time 3-dimensional echocardiography and speckle tracking","volume":"142","author":"Pandis","year":"2011","journal-title":"J Thorac Cardiovasc Surg"}],"container-title":["European Journal of Cardio-Thoracic Surgery"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/ejcts\/article-pdf\/59\/1\/199\/35388645\/ezaa256.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/ejcts\/article-pdf\/59\/1\/199\/35388645\/ezaa256.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,4]],"date-time":"2021-01-04T19:53:54Z","timestamp":1609790034000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ejcts\/article\/59\/1\/199\/5920584"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,10]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2020,10,10]]},"published-print":{"date-parts":[[2021,1,4]]}},"URL":"https:\/\/doi.org\/10.1093\/ejcts\/ezaa256","relation":{},"ISSN":["1010-7940","1873-734X"],"issn-type":[{"value":"1010-7940","type":"print"},{"value":"1873-734X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,1]]},"published":{"date-parts":[[2020,10,10]]}}}