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Bouma W.,University of Pennsylvania | Bouma W.,University of Groningen | Aoki C.,University of Pennsylvania | Vergnat M.,University of Pennsylvania | And 8 more authors.
Annals of Thoracic Surgery | Year: 2015

Background Current repair results for ischemic mitral regurgitation (IMR) with undersized annuloplasty rings are characterized by high IMR recurrence rates. Current annuloplasty rings treat annular dilatation, but they do little to improve (and may actually exacerbate) leaflet tethering. New saddle-shaped annuloplasty rings have been shown to maintain or restore a more physiologic annular and leaflet geometry and function. Using a porcine IMR model, we sought to demonstrate the influence of annuloplasty ring shape on leaflet coaptation. Methods Eight weeks after posterolateral infarct, eight pigs with grade 2+ or higher IMR were randomized to undergo either a 28-mm flat ring annuloplasty (n = 4) or a 28-mm saddle-shaped ring annuloplasty (n = 4). Real-time three-dimensional echocardiography and a customized image analysis protocol allowed three-dimensional assessment of leaflet coaptation before and after annuloplasty. Results Total leaflet coaptation area was significantly higher after saddle-shaped ring annuloplasty (109.6 ± 26.9 mm2) compared with flat ring annuloplasty (46.2 ± 7.7 mm2, p <0.01). After annuloplasty, total coaptation area decreased by 87.5 mm2 (or 65%) in the flat annuloplasty group (p = 0.01), whereas total coaptation area increased by 22.2 mm2 (or 25%) in the saddle-shaped annuloplasty group (p = 0.28). Conclusions This study shows that the use of undersized saddle-shaped annuloplasty rings in mitral valve repair for IMR improves leaflet coaptation, whereas the use of undersized flat annuloplasty rings worsens leaflet coaptation. Because one of Carpentier's fundamental principles of mitral valve repair (durability) is to create a large surface of coaptation, saddle-shaped annuloplasty may increase repair durability. © 2015 The Society of Thoracic Surgeons. Source


Gillespie M.J.,Gorman Cardiovascular Research Group | Gillespie M.J.,Childrens Hospital of Philadelphia | Aoki C.,Gorman Cardiovascular Research Group | Aoki C.,University of Pennsylvania | And 10 more authors.
Annals of Thoracic Surgery | Year: 2015

Purpose 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. Description 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. Evaluation 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. © 2015 The Society of Thoracic Surgeons. Source


Gillespie M.J.,Childrens Hospital of Philadelphia | Gillespie M.J.,Gorman Cardiovascular Research Group | Minakawa M.,Gorman Cardiovascular Research Group | Minakawa M.,University of Pennsylvania | And 22 more authors.
Annals of Thoracic Surgery | Year: 2013

Purpose: Transcatheter mitral valve replacement would represent a major advance in heart valve therapy. Such a device requires a specialized anchoring and sealing technology. This study was designed to test the feasibility of a novel mitral valve replacement device (the sutureless mitral valve [SMV]) designed to anchor and seal in the mitral position without need for sutures. Description: The SMV is a self-expanding device consisting of a custom-designed nitinol framework and a pericardial leaflet valve mechanism. Evaluation: Ten sheep underwent successful surgical SMV device implantation. All animals underwent cardiac catheterization 6 hours postoperatively. Hemodynamic, angiographic, echocardiographic and necroscopic data were recorded. The mean aortic cross-clamp time was 9.5 ± 3.1 minutes. 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. Necropsy demonstrated that the SMV devices were anchored securely. Conclusions: This study demonstrates the feasibility and short-term success of sutureless mitral valve replacement using a novel SMV device. © 2013 The Society of Thoracic Surgeons. Source


Robb J.D.,Gorman Cardiovascular Research Group | Minakawa M.,Gorman Cardiovascular Research Group | Rodriguez E.,Childrens Hospital of Philadelphia | Rodriguez E.,East Carolina University | And 5 more authors.
Circulation: Cardiovascular Interventions | Year: 2011

Background-Transannular patch (TAP) repair of tetralogy of Fallot often results in significant right ventricular outflow tract (RVOT) dilation and distortion. We hypothesized that insertion of Melody valves into the proximal right and left branch pulmonary arteries (PAs) would reduce pulmonary regurgitation fraction (PRF) in an ovine model of pulmonary insufficiency and dilated RVOT. Methods and Results-Ten sheep underwent baseline cardiac catheterization, surgical pulmonary valvectomy, and TAP placement. A subset (n=5) had Melody valves (2 devices per animal) inserted into the proximal right and left PAs during the surgical procedure. Melody valves were placed distal to the right-upper-lobe (RUL) artery branch, leaving the RUL "unprotected. " Preoperative MRIs (n=5) were used to determine baseline RV ejection fraction (RVEF) and left ventricular (LV) EF. All surviving animals (n=9) underwent MRI and catheterization 6 weeks postsurgery. Mean PRF was lower in the Melody valve group (15±6% versus 37±3%; P=0.014). The unprotected RUL was responsible for 64% of the PRF measured in the Melody valve group. In the non-Melody group, the RVEF was lower than baseline (P=0.003) and than in the Melody group (P=0.05). The LVEF was also lower in the non-Melody group versus baseline (P=0.004) and versus Melody (P=0.01). Conclusions-Bilateral branch PA Melody valve implantation significantly reduced PRF and altered RV and LV function favorably in a model of TAP for tetralogy of Fallot. This novel intervention may offer potential benefit in treating patients with anatomically heterogeneous disease of the RVOT. © 2011 American Heart Association, Inc. Source


Mahmood F.,Beth Israel Deaconess Medical Center | Kim H.,Beth Israel Deaconess Medical Center | Chaudary B.,Beth Israel Deaconess Medical Center | Bergman R.,Beth Israel Deaconess Medical Center | And 6 more authors.
Journal of Cardiothoracic and Vascular Anesthesia | Year: 2013

Objective: To demonstrate the clinical feasibility of accurately measuring tricuspid annular area by 3-dimensional (3D) transesophageal echocardiography (TEE) and to assess the geometric differences based on the presence of tricuspid regurgitation (TR). Also, the shape of the tricuspid annulus was compared with previous descriptions in the literature. Design: Prospective. Setting: Tertiary care university hospital. Interventions: Three-dimensional TEE. Participants: Patients undergoing cardiac surgery. Measurements and Main Results: Volumetric data sets from 20 patients were acquired by 3D TEE and prospectively analyzed. Comparisons in annular geometry were made between groups based on the presence of TR. The QLab (Philips Medical Systems, Andover, MA) software package was used to calculate tricuspid annular area by both linear elliptical dimensions and planimetry. Further analyses were performed in the 4D Cardio-View (TomTec Corporation GmBH, Munich, Germany) and MATLAB (Natick, MA) software environments to accurately assess annular shape. It was found that patients with greater TR had an eccentrically dilated annulus with a larger annular area. Also, the area as measured by the linear ellipse method was overestimated as compared to the planimetry method. Furthermore, the irregular saddle-shaped geometry of the tricuspid annulus was confirmed through the mathematic model developed by the authors. Conclusions: Three-dimensional TEE can be used to measure the tricuspid annular area in a clinically feasible fashion, with an eccentric dilation seen in patients with TR. The tricuspid annulus shape is complex, with annular high and low points, and annular area calculation based on linear measurements significantly overestimates 3D planimetered area. © 2013 Elsevier Inc. Source

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