title: Development of off-pump mitral valve replacement in a porcine model.
abstract: OBJECTIVE
  We describe our initial experience with on-bypass and off-bypass (off-pump) mitral valve replacement with the modified version of our novel catheter-based sutureless mitral valve (SMV) technology, which was developed to atraumatically anchor and seal in the mitral position.
  
  
  METHODS
  The SMV is a self-expanding device consisting of a custom designed nitinol framework and a pericardial leaflet valve mechanism. For the current studies, our original device was modified (SMV2) to reduce the delivery profile and to allow for controlled deployment while still maintaining the key principles necessary for atraumatic anchoring and sealing in the mitral valve position.
  
  
  RESULTS
  Ten Yorkshire pigs underwent successful SMV2 device implantation through a left atriotomy (on-pump, n = 6; off-pump, n = 4). Echocardiography and angiography revealed excellent left ventricular systolic function, no significant perivalvular leak, no mitral valve stenosis, no left ventricular outflow tract obstruction, and no aortic valve insufficiency. Postmortem examination demonstrated that the SMV2 devices were anchored securely.
  
  
  CONCLUSIONS
  This study demonstrates the feasibility and short-term success of off-pump mitral valve replacement using a novel, catheter-based device in a porcine model.
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Division of Cardiology, Children's Hospital of Philadelphia, and Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: gillespie@email.chop.edu.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Gillespie
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Chikashi
authors.initials: C
authors.lastname: Aoki
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takebayashi
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Toru
authors.initials: T
authors.lastname: Shimaoka
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Jeremy R
authors.initials: JR
authors.lastname: McGarvey
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Gorman
authors.affiliation: Gorman Cardiovascular Research Group, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Joseph H
authors.initials: JH
authors.lastname: Gorman
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000379:methods*; D002315:Cardiopulmonary Bypass / Q000379:methods*; D004195:Disease Models, Animal; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011474:Prosthesis Design; D012680:Sensitivity and Specificity; D013536:Suture Techniques; D013552:Swine
references.citation: Circulation. 2010 Apr 27;121(16):1848-57
references.pmid: 20385927
references.citation: Minim Invasive Ther Allied Technol. 2011 Apr;20(2):78-84
references.pmid: 21417840
references.citation: Circ Cardiovasc Interv. 2014 Jun;7(3):400-9
references.pmid: 24944303
references.citation: J Am Coll Cardiol. 2011 Dec 6;58(24):2475-80
references.pmid: 22133846
references.citation: Ann Thorac Surg. 2013 Aug;96(2):670-4
references.pmid: 23910107
references.citation: Eur J Cardiothorac Surg. 2013 Apr;43(4):849-55
references.pmid: 22822106
references.citation: J Am Coll Cardiol. 2004 Feb 18;43(4):698-703
references.pmid: 14975485
references.citation: Lancet. 2006 Sep 16;368(9540):1005-11
references.pmid: 16980116
references.citation: Circulation. 2005 Aug 23;112(8):1189-97
references.pmid: 16103239
references.citation: Circ Cardiovasc Interv. 2011 Dec 1;4(6):615-20
references.pmid: 22075926