The Experts below are selected from a list of 2028 Experts worldwide ranked by ideXlab platform
Joseph H Gorman - One of the best experts on this subject based on the ideXlab platform.
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optimized mitral Annuloplasty Ring design reduces loading in the posterior annulus
The Journal of Thoracic and Cardiovascular Surgery, 2020Co-Authors: Beatrice Ncho, Joseph H Gorman, Robert C Gorman, Eric L Pierce, Charles H Bloodworth, Akito Imai, Keitaro Okamoto, Yoshiaki Saito, Ajit P YoganathanAbstract:Abstract Objective The study objective was to develop a novel Annuloplasty Ring with regional flexibility and assess its suture force dynamics in healthy ovine subjects compared with fully rigid or fully flexible Rings. Methods Materially heterogeneous Rings were created with rigid anterior and posterior, and flexible commissural segments. These Rings were created to match the geometry of the Profile 3D Ring (Medtronic, Minneapolis, Minn). Each Ring was instrumented with 10 force transducers to measure cyclic suture forces (FC) and undersized Annuloplasty was performed in 6 healthy ovine subjects. Each FC was recorded and examined for cardiac cycles reaching a maximum left ventricular pressure of 100, 125, and 150 mm Hg. FC was compared with previously reported values from fully rigid Profile 3D and fully flexible prototype Rings. Results Relative to the fully rigid Ring, the heterogeneous Ring exhibited 48% reduction in FC at its commissural (rigid vs heterogeneous: 1.80 ± 0.94 N vs 0.95 ± 0.52 N; P Conclusions The reduced FC of the heterogeneous Ring relative to the fully rigid Ring suggests a promising approach to reduce suture loading while preserving the annular remodeling capability of fully rigid Rings. Future studies in diseased subjects are necessary to explore repair effectiveness of this Ring.
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mitral Annuloplasty Ring flexibility preferentially reduces posterior suture forces
Journal of Biomechanics, 2018Co-Authors: Eric L Pierce, Joseph H Gorman, Robert C Gorman, Charles H Bloodworth, Akito Imai, Keitaro Okamoto, Yoshiaki Saito, Ajit P YoganathanAbstract:Abstract Annuloplasty Ring repair is a common procedure for the correction of mitral valve regurgitation. Commercially available Rings vary in dimensions and material properties. Annuloplasty Ring suture dehiscence from the native annulus is a catastrophic yet poorly understood phenomenon that has been reported across Ring types. Recognizing that sutures typically dehisce from the structurally weaker posterior annulus, our group is conducting a multi-part study in search of Ring design parameters that influence forces acting on posterior annular sutures in the beating heart. Herein, we report the effect of Ring rigidity on suture forces. Measurements utilized custom force sensors, attached to Annuloplasty Rings and implanted in normal ovine subjects via standard surgical procedure. Tested Rings included the semi-rigid Physio (Edwards Lifesciences) and rigid and flexible prototypes of matching geometry. While no significant differences due to Ring stiffness existed for sutures in the anterior region, posterior forces were significantly reduced with use of the flexible Ring (rigid: 1.95 ± 0.96 N, semi-rigid: 1.76 ± 1.19 N, flexible: 1.04 ± 0.63 N; p
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mitral Annuloplasty Ring suture forces impact of surgeon Ring and use conditions
The Journal of Thoracic and Cardiovascular Surgery, 2018Co-Authors: Eric L Pierce, Joseph H Gorman, Robert C Gorman, Charles H Bloodworth, Andrew W Siefert, Thomas F Easley, Tetsushi Takayama, Tomonori Kawamura, Ajit P YoganathanAbstract:Abstract Objective The study objective was to quantify the effect of Ring type, Ring-annulus sizing, suture position, and surgeon on the forces required to tie down and constrain a mitral Annuloplasty Ring to a beating heart. Methods Physio (Edwards Lifesciences, Irvine, Calif) or Profile 3D (Medtronic, Dublin, Ireland) Annuloplasty Rings were instrumented with suture force transducers and implanted in ovine subjects (N = 23). Tie-down forces and cyclic contractile forces were recorded and analyzed at 10 suture positions and at 3 levels of increasing peak left ventricular pressure. Results Across all conditions, tie-down force was 2.7 ± 1.4 N and cyclic contractile force was 2.0 ± 1.2 N. Tie-down force was not meaningfully affected by any factor except surgeon. Significant differences in overall and individual tie-down forces were observed between the 2 primary implanting surgeons. No other factors were observed to significantly affect tie-down force. Contractile suture forces were significantly reduced by Ring-annulus true sizing. This was driven almost exclusively by Physio cases and by reduction along the anterior aspect, where dehiscence is less common clinically. Contractile suture forces did not differ significantly between Ring types. However, when undersizing, Profile 3D forces were significantly more uniform around the annular circumference. A suture's tie-down force did not correlate to its eventual contractile force. Conclusions Mitral Annuloplasty suture loading is influenced by Ring type, Ring-annulus sizing, suture position, and surgeon, suggesting that reports of dehiscence may not be merely a series of isolated errors. When compared with forces known to cause suture dehiscence, these in vivo suture loading data aid in establishing potential targets for reducing the occurrence of Ring dehiscence.
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Statistical Assessment of Normal Mitral Annular Geometry Using Automated Three-Dimensional Echocardiographic Analysis
The Annals of thoracic surgery, 2013Co-Authors: Alison M Pouch, Jeremy R. Mcgarvey, Robert C Gorman, Mathieu Vergnat, Giovanni Ferrari, Benjamin M. Jackson, Chandra M. Sehgal, Paul A. Yushkevich, Joseph H GormanAbstract:Background The basis of mitral Annuloplasty Ring design has progressed from qualitative surgical intuition to experimental and theoretical analysis of annular geometry with quantitative imaging techniques. In this work, we present an automated three-dimensional (3D) echocardiographic image analysis method that can be used to statistically assess variability in normal mitral annular geometry to support advancement in Annuloplasty Ring design. Methods Three-dimensional patient-specific models of the mitral annulus were automatically generated from 3D echocardiographic images acquired from subjects with normal mitral valve structure and function. Geometric annular measurements including annular circumference, annular height, septolateral diameter, intercommissural width, and the annular height to intercommissural width ratio were automatically calculated. A mean 3D annular contour was computed, and principal component analysis was used to evaluate variability in normal annular shape. Results The following mean ± standard deviations were obtained from 3D echocardiographic image analysis: annular circumference, 107.0 ± 14.6 mm; annular height, 7.6 ± 2.8 mm; septolateral diameter, 28.5 ± 3.7 mm; intercommissural width, 33.0 ± 5.3 mm; and annular height to intercommissural width ratio, 22.7% ± 6.9%. Principal component analysis indicated that shape variability was primarily related to overall annular size, with more subtle variation in the skewness and height of the anterior annular peak, independent of annular diameter. Conclusions Patient-specific 3D echocardiographic–based modeling of the human mitral valve enables statistical analysis of physiologically normal mitral annular geometry. The tool can potentially lead to the development of a new generation of Annuloplasty Rings that restore the diseased mitral valve annulus back to a truly normal geometry.
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Regional Annular Geometry in Patients With Mitral Regurgitation: Implications for Annuloplasty Ring Selection
The Annals of thoracic surgery, 2013Co-Authors: Arminder S. Jassar, Jeremy R. Mcgarvey, Robert C Gorman, Mathieu Vergnat, Giovanni Ferrari, Benjamin M. Jackson, Albert T. Cheung, Y. Joseph Woo, Michael A. Acker, Joseph H GormanAbstract:Background The saddle shape of the normal mitral annulus has been quantitatively described by several groups. There is strong evidence that this shape is important to valve function. A more complete understanding of regional annular geometry in diseased valves may provide a more educated approach to Annuloplasty Ring selection and design. We hypothesized that mitral annular shape is markedly distorted in patients with diseased valves. Methods Real-time 3-dimensional echocardiography was performed in 20 patients with normal mitral valves, 10 with ischemic mitral regurgitation, and 20 with myxomatous mitral regurgitation (MMR). Thirty-six annular points were defined to generate a 3-dimensional model of the annulus. Regional annular parameters were measured from these rendeRings. Left ventricular inner diameter was obtained from 2-dimensional echocardiographic images. Results Annular geometry was significantly different among the three groups. The annuli were larger in the MMR and in the ischemic mitral regurgitation groups. The annular enlargement was greater and more pervasive in the MMR group. Both diseases were associated with annular flattening, although though the regional distribution of that flattening was different between groups. Left ventricular inner diameter was increased in both groups. However, relative to the Left ventricular inner diameter, the annulus was disproportionately dilated in the MMR group. Conclusions Patients with MMR and ischemic mitral regurgitation have enlarged and flattened annuli. In the case of MMR, annular distortions may be the driving factor leading to valve incompetence. These data suggest that the goal of Annuloplasty should be the restoration of normal annular saddle shape and that the use of flexible, partial, and flat Rings may be ill advised.
Domenico Mazzitelli - One of the best experts on this subject based on the ideXlab platform.
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geometric Ring Annuloplasty for aortic valve repair duRing aortic aneurysm surgery two year clinical trial results
Innovations, 2018Co-Authors: Scott J Rankin, Domenico Mazzitelli, Steffen Pfeiffer, Theodor Fischlein, Jan Pirk, Yeong-hoon Choi, Lawrence M Wei, Vinay BadhwarAbstract:ObjectiveAn aortic Annuloplasty Ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric Ring Annuloplasty for repair of trileaflet and bi...
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geometric Ring Annuloplasty as an adjunct to aortic valve repair clinical investigation of the haart 300 device
European Journal of Cardio-Thoracic Surgery, 2016Co-Authors: Domenico Mazzitelli, Christof Stamm, Steffen Pfeiffer, Theodor Fischlein, Jan Pirk, Yeong-hoon Choi, Scott J Rankin, Christian Detter, Johannes Kroll, Friedhelm BeyersdorfAbstract:OBJECTIVES This study assessed the safety and efficacy of an internal geometric Annuloplasty Ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic Annuloplasty Ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average Ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the Rings were observed. CONCLUSIONS Geometric Ring Annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric Ring Annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
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a regulated trial of bicuspid aortic valve repair supported by geometric Ring Annuloplasty
The Annals of Thoracic Surgery, 2015Co-Authors: Domenico Mazzitelli, Steffen Pfeiffer, Theodor Fischlein, Yeong-hoon Choi, Scott J Rankin, Christian Nobauer, Christian Schreiber, Thorsten Wahlers, Rüdiger LangeAbstract:Background Annular stabilization is important duRing bicuspid aortic valve (BAV) repair to obtain the best long-term results. This report describes the early outcomes of a novel bicuspid Annuloplasty Ring for this purpose. Methods Under regulatory supervision (NCT02071849), a geometric bicuspid Annuloplasty Ring was used duRing valve repair in 16 patients. Three patients had Sievers type 0 valves, 11 had Sievers type 1, and 2 had Sievers type 2. Thirteen patients had left-/right-coronary cusp fusion, 1 had right-/noncoronary cusp fusion, and 2 had both. Moderate to severe aortic insufficiency (AI) was present in 13 of 16 patients, and 3 had mild AI with aortic aneurysms. Ascending aortic aneurysms, root aneurysms, or both were replaced in 7 of 16 patients. The Dacron-covered titanium Ring had circular base geometry and two outwardly flaRing subcommissural posts positioned opposite on the circumference. The Ring was implanted into the annulus beneath the valve, and then leaflet repair was performed. Results Immediate postrepair echocardiograms showed grade 0 residual AI in all patients, with good cusp mobility and effective height, and satisfactory gradients. There were no in-hospital or late mortalities. Two patients experienced leaflet tears from long annular suture tails, requiRing late valve replacement. After implementation of a lateral suture fixation technique, no more failures occurred. At a mean follow-up time of 9 months, the remaining 14 patients were in New York Heart Association class I, with predominant grade 0 AI. Conclusions As a technique for BAV repair, internal Ring Annuloplasty produces major annular remodeling and stabilization. Annular reduction and reshaping to a 50/50% symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation. Geometric Ring Annuloplasty could have useful applications in BAV repair.
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hemodynamic outcomes of geometric Ring Annuloplasty for aortic valve repair a 4 center pilot trial
The Journal of Thoracic and Cardiovascular Surgery, 2014Co-Authors: Domenico Mazzitelli, Bart Meuris, Christof Stamm, Jan Pirk, Scott J Rankin, Christian Nobauer, Philip S Crooke, Anke Wagner, Alan L Beavan, Charles D GriffinAbstract:Objectives A geometric Annuloplasty Ring could improve efficacy and stability of aortic valve repair. Toward this goal, a 1-piece 3-dimensional titanium Annuloplasty Ring with Dacron coveRing was developed and tested successfully in animals. The purpose of this study was to define hemodynamic outcomes with this device used as the Annuloplasty component of human aortic valve repair. Methods In a 4-center pilot trial with informed consent, 16 patients underwent aortic valve repair for aortic insufficiency, with the Annuloplasty device sutured into the annulus beneath the leaflets. Preoperative annular diameter averaged 26.5 ± 2.0 (mean ± standard deviation) mm, and average Ring size was 22.3 ± 1.2 mm. After Annuloplasty, leaflet defects were easy to identify, and 14 of 16 patients (88%) required leaflet plication and/or autologous pericardial reconstruction for leaflet defects. Three patients had ascending aortic replacement, and 2 had remodeling root replacement. One had ultrasonic leaflet decalcification and another tricuspid valve Annuloplasty. Follow-up data were from site-specific studies at the 6-month postoperative time point. Results There were no in-hospital mortalities or major complications. Preoperative aortic insufficiency grade (0-4 scale) was 3.6 ± 1.0 and fell to 1.0 ± 0.8 at 6 months ( P P 2 , and 6-month mean systolic gradient was 11.3 ± 3.3 mm Hg. Left ventricular end-diastolic diameter and ejection fraction both normalized (both P Conclusions Geometric Ring Annuloplasty facilitated aortic valve repair, allowing more precise reconstruction of leaflet defects. Aortic insufficiency reduction and systolic gradients were excellent, and expansion of valve reconstruction into broader categories of aortic valve disease seems indicated.
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transatrial antegrade approach for double mitral and tricuspid valve in Ring implantation
The Annals of Thoracic Surgery, 2013Co-Authors: Domenico Mazzitelli, A Opitz, Christian Schreiber, Christian Noebauer, Sabine Bleiziffer, Hendrik Ruge, Patrick Mayr, Peter Tassaniprell, Nicolo Piazza, R LangeAbstract:Within the last 5 years, the number of transcatheter aortic valve implantation (TAVI) procedures has increased continuously and, in parallel, the indications for TAVI have expanded (eg, failing surgical valves and Rings). Furthermore, alternative TAVI access routes such as transaxillary and transaortic have been applied successfully. We report on, to our knowledge, the first-in-human case of a combined off-pump antegrade transatrial implantation of a transcatheter valve within a mitral and tricuspid Annuloplasty Ring through an anterolateral minithoracotomy. The patient showed severe mitral valve and tricuspid valve stenosis and regurgitation 15 years after mitral valve repair and 7 years after aortic valve replacement and tricuspid valve repair.
Victoria Delgado - One of the best experts on this subject based on the ideXlab platform.
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first in man implantation of a trans catheter aortic valve in a mitral Annuloplasty Ring novel treatment modality for failed mitral valve repair
European Journal of Cardio-Thoracic Surgery, 2011Co-Authors: Arend De Weger, See Hooi Ewe, Victoria Delgado, Jeroen J BaxAbstract:The trans-catheter valve-in-valve concept has become a feasible therapeutic option for patients with failing degenerated bioprosthesis, who are deemed inoperable. However, little is known about the feasibility of this technique in failed valve Annuloplasty. We report the first-in-man implantation of a trans-catheter aortic valve within a mitral Annuloplasty Ring. Through a trans-apical trans-catheter approach, a 26-mm Sapien-Edwards valve was successfully implanted in a 72-year-old man with ischemic heart failure and failed mitral-valve Annuloplasty. The present case report provides a critical appraisal of the procedural technique.
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first in man implantation of a trans catheter aortic valve in a mitral Annuloplasty Ring novel treatment modality for failed mitral valve repair
European Journal of Cardio-Thoracic Surgery, 2011Co-Authors: Arend De Weger, Victoria DelgadoAbstract:The trans-catheter valve-in-valve concept has become a feasible therapeutic option for patients with failing degenerated bioprosthesis, who are deemed inoperable. However, little is known about the feasibility of this technique in failed valve Annuloplasty. We report the first-in-man implantation of a trans-catheter aortic valve within a mitral Annuloplasty Ring. Through a trans-apical trans-catheter approach, a 26-mm SapienEdwards valve was successfully implanted in a 72-year-old man with ischemic heart failure and failed mitral-valve Annuloplasty. The present case report provides a critical appraisal of the procedural technique. # 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.
Robert C Gorman - One of the best experts on this subject based on the ideXlab platform.
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optimized mitral Annuloplasty Ring design reduces loading in the posterior annulus
The Journal of Thoracic and Cardiovascular Surgery, 2020Co-Authors: Beatrice Ncho, Joseph H Gorman, Robert C Gorman, Eric L Pierce, Charles H Bloodworth, Akito Imai, Keitaro Okamoto, Yoshiaki Saito, Ajit P YoganathanAbstract:Abstract Objective The study objective was to develop a novel Annuloplasty Ring with regional flexibility and assess its suture force dynamics in healthy ovine subjects compared with fully rigid or fully flexible Rings. Methods Materially heterogeneous Rings were created with rigid anterior and posterior, and flexible commissural segments. These Rings were created to match the geometry of the Profile 3D Ring (Medtronic, Minneapolis, Minn). Each Ring was instrumented with 10 force transducers to measure cyclic suture forces (FC) and undersized Annuloplasty was performed in 6 healthy ovine subjects. Each FC was recorded and examined for cardiac cycles reaching a maximum left ventricular pressure of 100, 125, and 150 mm Hg. FC was compared with previously reported values from fully rigid Profile 3D and fully flexible prototype Rings. Results Relative to the fully rigid Ring, the heterogeneous Ring exhibited 48% reduction in FC at its commissural (rigid vs heterogeneous: 1.80 ± 0.94 N vs 0.95 ± 0.52 N; P Conclusions The reduced FC of the heterogeneous Ring relative to the fully rigid Ring suggests a promising approach to reduce suture loading while preserving the annular remodeling capability of fully rigid Rings. Future studies in diseased subjects are necessary to explore repair effectiveness of this Ring.
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mitral Annuloplasty Ring flexibility preferentially reduces posterior suture forces
Journal of Biomechanics, 2018Co-Authors: Eric L Pierce, Joseph H Gorman, Robert C Gorman, Charles H Bloodworth, Akito Imai, Keitaro Okamoto, Yoshiaki Saito, Ajit P YoganathanAbstract:Abstract Annuloplasty Ring repair is a common procedure for the correction of mitral valve regurgitation. Commercially available Rings vary in dimensions and material properties. Annuloplasty Ring suture dehiscence from the native annulus is a catastrophic yet poorly understood phenomenon that has been reported across Ring types. Recognizing that sutures typically dehisce from the structurally weaker posterior annulus, our group is conducting a multi-part study in search of Ring design parameters that influence forces acting on posterior annular sutures in the beating heart. Herein, we report the effect of Ring rigidity on suture forces. Measurements utilized custom force sensors, attached to Annuloplasty Rings and implanted in normal ovine subjects via standard surgical procedure. Tested Rings included the semi-rigid Physio (Edwards Lifesciences) and rigid and flexible prototypes of matching geometry. While no significant differences due to Ring stiffness existed for sutures in the anterior region, posterior forces were significantly reduced with use of the flexible Ring (rigid: 1.95 ± 0.96 N, semi-rigid: 1.76 ± 1.19 N, flexible: 1.04 ± 0.63 N; p
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mitral Annuloplasty Ring suture forces impact of surgeon Ring and use conditions
The Journal of Thoracic and Cardiovascular Surgery, 2018Co-Authors: Eric L Pierce, Joseph H Gorman, Robert C Gorman, Charles H Bloodworth, Andrew W Siefert, Thomas F Easley, Tetsushi Takayama, Tomonori Kawamura, Ajit P YoganathanAbstract:Abstract Objective The study objective was to quantify the effect of Ring type, Ring-annulus sizing, suture position, and surgeon on the forces required to tie down and constrain a mitral Annuloplasty Ring to a beating heart. Methods Physio (Edwards Lifesciences, Irvine, Calif) or Profile 3D (Medtronic, Dublin, Ireland) Annuloplasty Rings were instrumented with suture force transducers and implanted in ovine subjects (N = 23). Tie-down forces and cyclic contractile forces were recorded and analyzed at 10 suture positions and at 3 levels of increasing peak left ventricular pressure. Results Across all conditions, tie-down force was 2.7 ± 1.4 N and cyclic contractile force was 2.0 ± 1.2 N. Tie-down force was not meaningfully affected by any factor except surgeon. Significant differences in overall and individual tie-down forces were observed between the 2 primary implanting surgeons. No other factors were observed to significantly affect tie-down force. Contractile suture forces were significantly reduced by Ring-annulus true sizing. This was driven almost exclusively by Physio cases and by reduction along the anterior aspect, where dehiscence is less common clinically. Contractile suture forces did not differ significantly between Ring types. However, when undersizing, Profile 3D forces were significantly more uniform around the annular circumference. A suture's tie-down force did not correlate to its eventual contractile force. Conclusions Mitral Annuloplasty suture loading is influenced by Ring type, Ring-annulus sizing, suture position, and surgeon, suggesting that reports of dehiscence may not be merely a series of isolated errors. When compared with forces known to cause suture dehiscence, these in vivo suture loading data aid in establishing potential targets for reducing the occurrence of Ring dehiscence.
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Statistical Assessment of Normal Mitral Annular Geometry Using Automated Three-Dimensional Echocardiographic Analysis
The Annals of thoracic surgery, 2013Co-Authors: Alison M Pouch, Jeremy R. Mcgarvey, Robert C Gorman, Mathieu Vergnat, Giovanni Ferrari, Benjamin M. Jackson, Chandra M. Sehgal, Paul A. Yushkevich, Joseph H GormanAbstract:Background The basis of mitral Annuloplasty Ring design has progressed from qualitative surgical intuition to experimental and theoretical analysis of annular geometry with quantitative imaging techniques. In this work, we present an automated three-dimensional (3D) echocardiographic image analysis method that can be used to statistically assess variability in normal mitral annular geometry to support advancement in Annuloplasty Ring design. Methods Three-dimensional patient-specific models of the mitral annulus were automatically generated from 3D echocardiographic images acquired from subjects with normal mitral valve structure and function. Geometric annular measurements including annular circumference, annular height, septolateral diameter, intercommissural width, and the annular height to intercommissural width ratio were automatically calculated. A mean 3D annular contour was computed, and principal component analysis was used to evaluate variability in normal annular shape. Results The following mean ± standard deviations were obtained from 3D echocardiographic image analysis: annular circumference, 107.0 ± 14.6 mm; annular height, 7.6 ± 2.8 mm; septolateral diameter, 28.5 ± 3.7 mm; intercommissural width, 33.0 ± 5.3 mm; and annular height to intercommissural width ratio, 22.7% ± 6.9%. Principal component analysis indicated that shape variability was primarily related to overall annular size, with more subtle variation in the skewness and height of the anterior annular peak, independent of annular diameter. Conclusions Patient-specific 3D echocardiographic–based modeling of the human mitral valve enables statistical analysis of physiologically normal mitral annular geometry. The tool can potentially lead to the development of a new generation of Annuloplasty Rings that restore the diseased mitral valve annulus back to a truly normal geometry.
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Regional Annular Geometry in Patients With Mitral Regurgitation: Implications for Annuloplasty Ring Selection
The Annals of thoracic surgery, 2013Co-Authors: Arminder S. Jassar, Jeremy R. Mcgarvey, Robert C Gorman, Mathieu Vergnat, Giovanni Ferrari, Benjamin M. Jackson, Albert T. Cheung, Y. Joseph Woo, Michael A. Acker, Joseph H GormanAbstract:Background The saddle shape of the normal mitral annulus has been quantitatively described by several groups. There is strong evidence that this shape is important to valve function. A more complete understanding of regional annular geometry in diseased valves may provide a more educated approach to Annuloplasty Ring selection and design. We hypothesized that mitral annular shape is markedly distorted in patients with diseased valves. Methods Real-time 3-dimensional echocardiography was performed in 20 patients with normal mitral valves, 10 with ischemic mitral regurgitation, and 20 with myxomatous mitral regurgitation (MMR). Thirty-six annular points were defined to generate a 3-dimensional model of the annulus. Regional annular parameters were measured from these rendeRings. Left ventricular inner diameter was obtained from 2-dimensional echocardiographic images. Results Annular geometry was significantly different among the three groups. The annuli were larger in the MMR and in the ischemic mitral regurgitation groups. The annular enlargement was greater and more pervasive in the MMR group. Both diseases were associated with annular flattening, although though the regional distribution of that flattening was different between groups. Left ventricular inner diameter was increased in both groups. However, relative to the Left ventricular inner diameter, the annulus was disproportionately dilated in the MMR group. Conclusions Patients with MMR and ischemic mitral regurgitation have enlarged and flattened annuli. In the case of MMR, annular distortions may be the driving factor leading to valve incompetence. These data suggest that the goal of Annuloplasty should be the restoration of normal annular saddle shape and that the use of flexible, partial, and flat Rings may be ill advised.
Scott J Rankin - One of the best experts on this subject based on the ideXlab platform.
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Rheumatic Double Valve Repair Using Two Remodeling Annuloplasty Rings
2019Co-Authors: Richard S. Downey, Scott J Rankin, Lawrence M Wei, Vinay BadhwarAbstract:ObjectivesCardiac valve repair is a recognized approach to achieve satisfactory long-term valve function and improved survival over replacement. Concomitant aortic and mitral valve repair has been associated with excellent freedom from recurrent insufficiency or valve related complications. This video illustrates an operative approach of combined rheumatic mitral valve repair and aortic valve repair involving double remodeling Ring Annuloplasty.MethodsA 70-year-old man with NYHA class 3 congestive heart failure was found to have grade 3 aortic valve insufficiency, grade 2-3 mitral insufficiency with mild mitral stenosis, and an ejection fraction of 35%. Transesophageal echocardiography showed a trileaflet aortic valve with rheumatic nodular retraction plus retraction and thickening of the posterior mitral leaflet with good mobility of the anterior leaflet.ResultsSurgical correction included pericardial patch augmentation of the posterior mitral leaflet using glutaraldehyde-fixed autologous pericardium and rigid Ring Annuloplasty. Nodular retraction and minor leaflet calcification of the aortic valve were addressed using ultrasonic debridement, followed by implantation of a 3D aortic Annuloplasty Ring to complete the repair. Postoperative transesophageal echocardiography revealed excellent hemodynamic freedom from valvular regurgitation or stenosis.ConclusionMitral valve repair techniques are well developed and allow for successful reconstruction in selected patients with rheumatic valvular disease. The use of an aortic Annuloplasty Ring may provide a simple option for enhancing the reparability of rheumatic aortic valve insufficiency.This educational video was originally presented duRing the STSA 65th Annual Meeting. This content is published with the permission of the STSA. For more information on the STSA and its next Annual Meeting, please click here.
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geometric Ring Annuloplasty for aortic valve repair duRing aortic aneurysm surgery two year clinical trial results
Innovations, 2018Co-Authors: Scott J Rankin, Domenico Mazzitelli, Steffen Pfeiffer, Theodor Fischlein, Jan Pirk, Yeong-hoon Choi, Lawrence M Wei, Vinay BadhwarAbstract:ObjectiveAn aortic Annuloplasty Ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric Ring Annuloplasty for repair of trileaflet and bi...
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Triple Valve Repair Supported by Three Remodeling Annuloplasty Rings
2018Co-Authors: Vinay Badhwar, Wei, Lawrence M., Takashi Murashita, Roberts, Harold G., Scott J RankinAbstract:ObjectivesThe reconstruction of mitral and tricuspid valves duRing multiple-valve operations reduces mortality risk compared to replacement. Recently, similar findings have been associated with aortic valve repair. To enhance quality and outcome, it might be reasonable to consider conversion to comprehensive aortic, mitral, and tricuspid valve repair in selected patients. Video SummaryA 77-year-old 60 kg woman presented with persistent atrial fibrillation and presyncope. After guideline directed medical therapy, she persisted with class III congestive heart failure and grade 3 to 4 mitral, aortic, and tricuspid insufficiency, with an ejection fraction of 35%. A strict anterograde and retrograde blood cardioplegia protocol was employed. A biatrial Cox-Maze IV procedure with cryoablation was performed, together with left atrial appendage obliteration. The mitral valve had a rupture of a minor primary chord but overall had good structural support, and it did not require additional artificial chords. The mitral valve was repaired with a #34 mitral remodeling Annuloplasty band.The aortic root was opened with a transverse aortotomy, and traction sutures were placed at the top of all three commissures. The annulus was dilated, and the aortic leaflets were devoid of prolapse. The aortic annulus accepted a #23 Hegar’s dilator. All three leaflets sized to a #19 elliptical aortic Annuloplasty Ring, which was positioned beneath the annulus with the minor axis post under the left/noncoronary commissure. The posts of the remodeling Ring were sutured to the subcommissural spaces using three horizontal mattress sutures of 4-0 polypropylene with fine supra-annular polyester pledgets, and the Ring was passed beneath the valve. One looping horizontal mattress suture was inserted per sinus for a total of six sutures, which were then tied. At the end, all three aortic valve leaflets had equivalent effective height and coapted well in the midline.The grossly incompetent tricuspid valve measured 5 cm by echocardiogram and was repaired with a 28 mm semi-rigid Annuloplasty Ring, consistent with a tricuspid downsizing philosophy. Aortic clamp and bypass times were 127 and 160 minutes, respectively. On the post-repair echocardiogram, the mitral leaflets moved well with no residual insufficiency. Likewise, the aortic valve was fully competent, with a 9 mm Hg mean systolic pressure gradient. The tricuspid valve was competent and functioned well. The follow-up echocardiogram performed one year postoperatively showed no residual valvular insufficiency, the ejection fraction was 55%, and the patient was in functional class I.ConclusionMitral and tricuspid Annuloplasty techniques are well established, with excellent outcomes. The introduction of a remodeling aortic Annuloplasty Ring provides a straightforward option for addressing aortic insufficiency due to annular dilatation, which augments the efficiency and efficacy of triple valve repair.Video ReferencesLee R, Li S, Rankin JS, et al. Fifteen-year outcome trends for valve surgery in North America. Ann Thorac Surg. 2011;91(3):677-684.Rankin JS, Thourani VH, Suri RM, et al. Associations between valve repair and reduced operative mortality in 21,056 mitral/tricuspid double valve procedures. Eur J Cardiothorac Surg. 2013;44(3):472-477.Vohra HA, Whistance RN, Hechadi J, et al. Long-term outcomes of concomitant aortic and mitral valve repair. J Thorac Cardiovasc Surg. 2014;148(2):454-460.Dr Rankin is a consultant for BioStable Science and EngineeRing in Austin, Texas, and video production was supported by BioStable Science and EngineeRing.
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geometric Ring Annuloplasty as an adjunct to aortic valve repair clinical investigation of the haart 300 device
European Journal of Cardio-Thoracic Surgery, 2016Co-Authors: Domenico Mazzitelli, Christof Stamm, Steffen Pfeiffer, Theodor Fischlein, Jan Pirk, Yeong-hoon Choi, Scott J Rankin, Christian Detter, Johannes Kroll, Friedhelm BeyersdorfAbstract:OBJECTIVES This study assessed the safety and efficacy of an internal geometric Annuloplasty Ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic Annuloplasty Ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average Ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the Rings were observed. CONCLUSIONS Geometric Ring Annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric Ring Annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
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a regulated trial of bicuspid aortic valve repair supported by geometric Ring Annuloplasty
The Annals of Thoracic Surgery, 2015Co-Authors: Domenico Mazzitelli, Steffen Pfeiffer, Theodor Fischlein, Yeong-hoon Choi, Scott J Rankin, Christian Nobauer, Christian Schreiber, Thorsten Wahlers, Rüdiger LangeAbstract:Background Annular stabilization is important duRing bicuspid aortic valve (BAV) repair to obtain the best long-term results. This report describes the early outcomes of a novel bicuspid Annuloplasty Ring for this purpose. Methods Under regulatory supervision (NCT02071849), a geometric bicuspid Annuloplasty Ring was used duRing valve repair in 16 patients. Three patients had Sievers type 0 valves, 11 had Sievers type 1, and 2 had Sievers type 2. Thirteen patients had left-/right-coronary cusp fusion, 1 had right-/noncoronary cusp fusion, and 2 had both. Moderate to severe aortic insufficiency (AI) was present in 13 of 16 patients, and 3 had mild AI with aortic aneurysms. Ascending aortic aneurysms, root aneurysms, or both were replaced in 7 of 16 patients. The Dacron-covered titanium Ring had circular base geometry and two outwardly flaRing subcommissural posts positioned opposite on the circumference. The Ring was implanted into the annulus beneath the valve, and then leaflet repair was performed. Results Immediate postrepair echocardiograms showed grade 0 residual AI in all patients, with good cusp mobility and effective height, and satisfactory gradients. There were no in-hospital or late mortalities. Two patients experienced leaflet tears from long annular suture tails, requiRing late valve replacement. After implementation of a lateral suture fixation technique, no more failures occurred. At a mean follow-up time of 9 months, the remaining 14 patients were in New York Heart Association class I, with predominant grade 0 AI. Conclusions As a technique for BAV repair, internal Ring Annuloplasty produces major annular remodeling and stabilization. Annular reduction and reshaping to a 50/50% symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation. Geometric Ring Annuloplasty could have useful applications in BAV repair.