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Development of Off-Pump Mitral Valve Replacement in a Porcine Model

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1 Development of Off-Pump Mitral Valve Replacement in a Porcine Model
Matthew J. Gillespie, MD, Chikashi Aoki, MD, Satoshi Takebayashi, MD, Toru Shimaoka, MD, Jeremy R. McGarvey, MD, Robert C. Gorman, MD, Joseph H. Gorman, MD  The Annals of Thoracic Surgery  Volume 99, Issue 4, Pages (April 2015) DOI: /j.athoracsur Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions

2 Fig 1 (A, B) The modified version of the Sutureless Mitral Valve2 (SMV2) device is shown. As part of ongoing design iteration, the device was modified from its original wire weave design to lower the device profile for catheter delivery, while still delivering the necessary anchoring and sealing forces. The SMV2 consists of a custom nitinol frame with “ventricular arms” designed to capture the native mitral valve leaflets in the space between the stent body and the “arms.” The atrial end of the device is designed to augment anchoring and seal, and also to permit attachment to, and controlled deployment from, the delivery catheter. The Annals of Thoracic Surgery  , DOI: ( /j.athoracsur ) Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions

3 Fig 2 Intraoperative picture showing the expanded polytetrafluoroethylene graft that was sewn onto the left atrium to provide a hemostatic chimney for transatrial off-pump Sutureless Mitral Valve2 implantation. The Annals of Thoracic Surgery  , DOI: ( /j.athoracsur ) Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions

4 Fig 3 (A–C) Sequence of the off-pump Sutureless Mitral Valve2 (SMV2) device implantation procedure. (A) A sighting left ventriculogram; the SMV2 device is compressed within the delivery catheter, which was advanced across the MV plane through the left atrial chimney. (B) Blossoming of the ventricular arms as the device is partially opened. A hemostat clamp (marked by asterisk [*]) corresponding to the mitral valve leaflets and annulus is placed externally on the chest wall to mark the target under fluoroscopy for opening the ventricular arms. The ventricular arms are designed to capture the anterior and posterior MV leaflets. Once the ventricular arms are seated appropriately, the atrial side of the device is opened in the left atrium, allowing it to expand to its nominal shape. (C) Once the position is confirmed, the device is released. (A–C) The inset pictures correspond to the various conformational changes of the SMV device during staged deployment. (LA = left atrium; LV = left ventricle.) The Annals of Thoracic Surgery  , DOI: ( /j.athoracsur ) Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions

5 Fig 4 Echocardiographic assessment after transatrial off-pump Sutureless Mitral Valve2 (SMV2) implantation. (A) Color Doppler interrogation of the SMV2 in systole; there is no mitral regurgitation. (B) Low velocity flow from the left atrium (LA) through the SMV2 into the left ventricle (LV) is seen. There is no stenosis. The Annals of Thoracic Surgery  , DOI: ( /j.athoracsur ) Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions

6 Fig 5 Angiographic assessment of the Sutureless Mitral Valve2 (SMV2) device, 3 hours after off-pump transatrial implantation. The device is securely anchored. (A) A systolic frame with no mitral regurgitation (MR) and no left ventricular outflow tract (LVOT) obstruction. (B) A diastolic frame. (C) There is no aortic valve insufficiency (AI), and normal coronary arteries. (LA = left atrium; LCx = left circumflex coronary artery; LV = left ventricle; RCA = right coronary artery.) The Annals of Thoracic Surgery  , DOI: ( /j.athoracsur ) Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions

7 Fig 6 Postmortem pictures of the Sutureless Mitral Valve2 (SMV2) device from the (A) left atrial and (B) left ventricular perspectives. There is a tight seal posteriorly between the body of the SMV2 and the native mitral valve leaflet. Panel B shows a view from the apex to the underside of the aortic valve. The ventricular arms of the SMV2 capture the anterior mitral leaflet in the space between the arms and the body of the SMV2. The left ventricular outflow tract appears unobstructed. The Annals of Thoracic Surgery  , DOI: ( /j.athoracsur ) Copyright © 2015 The Society of Thoracic Surgeons Terms and Conditions


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