title: Transapical Beating-Heart Mitral Valve Repair With an Expanded Polytetrafluoroethylene Cordal Implantation Device: Initial Clinical Experience.
abstract: Degenerative mitral valve (MV) disease is a common cause of severe mitral regurgitation (MR) and accounts for the majority of MV operations. Conventional MV surgery requires cardiopulmonary bypass, aortic cross-clamping, cardioplegia, and a thoracotomy or sternotomy and, therefore, is associated with significant disability, risks, and unpredictable rates of MV repair. Transesophageal echocardiography-guided beating-heart MV repair with expanded polytetrafluoroethylene cordal insertion has the potential to significantly reduce surgical morbidity. We report the first-in-human clinical experience with a novel preformed expanded polytetrafluoroethylene knot implantation device (Harpoon TSD-5) designed to treat degenerative MR.
  
  
  
  Through a small left thoracotomy, the device was inserted into the heart and guided by transesophageal echocardiography to the ventricular surface of the prolapsed leaflet. Multiple expanded polytetrafluoroethylene cords were anchored in the leaflet and then adjusted to the correct length to restore MV leaflet coaptation and secured at the epicardium.
  
  
  
  Eleven patients with posterior leaflet prolapse and severe MR, with mean±SD age of 65±13 years and mean ejection fraction of 69±7%, were treated with 100% procedural success. Immediate postprocedural mean MR grade was trace. At 1 month, the mean MR grade was mild with significant decreases in end-diastolic volume (139 to 107 mL; P=0.03) and left atrial volume (118 to 85 mL; P=0.04).
  
  
  
  A novel device used for beating-heart image-guided MV repair demonstrates a significant reduction in MR with favorable left ventricular and left atrial reverse remodeling. This approach has the potential to decrease invasiveness and surgical morbidity. Further follow-up is necessary to assess long-term efficacy.
  
  
  
  URL: https://clinicaltrials.gov. Unique identifier: NCT02432196.
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.). Jsgammiemd@gmail.com.
authors.forename: James S
authors.initials: JS
authors.lastname: Gammie
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Peter
authors.initials: P
authors.lastname: Wilson
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Bartus
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Andrzej
authors.initials: A
authors.lastname: Gackowski
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Judy
authors.initials: J
authors.lastname: Hung
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Michael N
authors.initials: MN
authors.lastname: D'Ambra
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Piotr
authors.initials: P
authors.lastname: Kolsut
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Bittle
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Piotr
authors.initials: P
authors.lastname: Szymanski
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Jerzy
authors.initials: J
authors.lastname: Sadowski
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Boguslaw
authors.initials: B
authors.lastname: Kapelak
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Agata
authors.initials: A
authors.lastname: Bilewska
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Mariusz
authors.initials: M
authors.lastname: Kusmierczyk
authors.affiliation: From the Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G., G.J.B., M.G.); Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland (K.B., A.G., J.S., B.K.); Institute of Cardiology, Warsaw, Poland (P.K., P.S., A.B., M.K.); Division of Cardiac Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.N.D.); Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.); and Harpoon Medical, Baltimore, MD (P.W.).
authors.forename: Mehrdad
authors.initials: M
authors.lastname: Ghoreishi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D008944:Mitral Valve Insufficiency / Q000601:surgery; D009200:Myocardial Contraction; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D019736:Prostheses and Implants; D012086:Reoperation
chemical_list: D011138:Polytetrafluoroethylene
keywords: echocardiography; mitral valve; regurgitation; surgery; valvuloplasty