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Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments. [Display omitted] • Minimum core data elements have not been established for the field of transcatheter mitral valve therapies. • A collaboration of the PASSION-CV, Heart Valve Collaboratory, and STS/ACC TVT Registry has established a set of 127 core data elements based on an extensive systematic review and expert consensus. • Instantiation of core data elements in premarket and postmarket studies of transcatheter mitral interventions will promote consistency, efficiency and quality of data supporting evidence development for quality, regulatory, and clinical applications. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments. [Display omitted] [ABSTRACT FROM AUTHOR]

The objective is to investigate the biomechanical conditions of the Posterior Vertebral Column Resection (PVCR) of the constructed scoliosis 3D finite element model. A patient with scoliosis was selected; before the PVCR orthopaedy, the patient was submitted to the radiography of normal and lateral full-length vertebral column scans and the total magnetic resonance imaging (MRI) scans; then, the idiopathic scoliosis model was constructed by the 3D finite element method, and the 3D finite element software utilized in the process of model construction included Mimics software, Geomagic Studio 12 software, and Unigraphic 8.0 (UG 8.0) software; in addition, PVCR orthopaedy was utilized to correct the scoliosis of the patient, and the biomechanical parameters, such as orthodontic force, vertebral body displacement, orthopedic rod stress, stress on the pin-bone interface of the vertebral body surface, and the stress on the intervertebral disc, were studied. The 3D effective finite element model of scoliosis was successfully constructed by the Mimics software, the Geomagic Studio 12 software, and the UG 8.0 software, and the effectiveness was tested. PVCR orthopaedy could effectively solve the problem of scoliosis. The magnitude of the orthodontic force that a patient needed depended on the physical conditions and the personal orthodontic requirements of the patient. The maximum vertebral body displacement on the X-axis was the vertebral body L1, the maximum displacement on the Y-axis was the vertebral body T3, the maximum displacement on the Z-axis was the vertebral body T1, and the rang of orthopedic rod stress was 0.0050214e7 MPa to 0.045217e7 MPa, in which the maximum stress of 2 vertebral bodies in, above, and below the osteotomy area reached 0.045217e7 MPa, the stress on the pin-bone interface of the T10 vertebral body surface reached 11.83 MPa, and the stress of T8/T9 intervertebral disc reached 13.84 MPa. The 3D finite element model based on 3D finite element software was highly efficient, and its numerical simulation was accurate, which was important for the subsequent biomechanical analysis of PVCR orthopaedy. In addition, the vertebral stress of PVCR orthopaedy was different in each body part, which was mainly affected by the applied orthodontic force and the sites of the orthodontic area. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to demonstrate that short-term cardiac unloading with a left ventricular (LV) assist device (LVAD) after acute myocardial infarction (MI) can conserve calcium cycling and improve heart function. Background: Heart failure secondary to MI remains a major source of morbidity and mortality. Alterations in calcium cycling are linked to cardiac dysfunction in the failing heart. Methods: Adult Dorsett hybrid sheep underwent acute MI and were mechanically unloaded with an axial-flow LVAD (Impella 5.0) for 2 weeks (n = 6). Six sheep with MI only and 4 sham sheep were used as controls. All animals were followed for 12 weeks post-MI. Regional strains in the LV were measured by sonomicrometry. Major calcium-handling proteins (CHPs), including sarco-/endoplasmic reticulum calcium ATPase-2α (SERCA-2α), Na+-Ca2+ exchanger-1, and phospholamban, and Ca2+-ATPase activity were investigated. The electrophysiological calcium cycling in single isolated cardiomyocytes was measured with the patch-clamp technique. The related ultrastructures were studied with electron microscopy. Results: LVAD unloading alleviated LV dilation and improved global cardiac function and regional contractility compared with the MI group. The regional myocardial strain (stretch) was minimized during the unloading period and even attenuated compared with the MI group at 12 weeks. Impaired calcium cycling was evident in the adjacent noninfarcted zone in the MI group, whereas CHP expression was normalized and Ca2+-ATPase activity was preserved in the LVAD unloading group. The electrophysiological calcium cycling was also conserved, and the ultrastructural damage was ameliorated in the unloaded animals. Conclusions: Short-term LVAD unloading may conserve calcium cycling and improve heart function during the post-infarct period. [Copyright &y& Elsevier]

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics. [ABSTRACT FROM AUTHOR]

Bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) may be caused by structural or nonstructural valve dysfunction. Both surgical and transcatheter bioprosthetic valves have limited durability because of structural valve deterioration. The main objective of this summary of experts participating in a virtual workshop was to propose standardized definitions for nonstructural and structural BVD and BVF following aortic or mitral biological valve replacement with the goal of facilitating research reporting and implementation of these terms in clinical practice. Definitions of structural BVF, based on valve reintervention or death, underestimate the true incidence of BVF. However, definitions solely based on the presence of high transprosthetic gradient at a given echocardiogram during follow-up overestimate the incidence of structural BVD and BVF. Definitions of aortic or mitral structural BVD must therefore include the confirmation by imaging of permanent structural changes to the leaflets alongside evidence of deterioration in valve hemodynamic function at echocardiography follow-up. [ABSTRACT FROM AUTHOR]

Objective: To investigate the feasibility of the use of 3D-printed guiding templates for accurate placement of plates and screws for internal fixation of acetabular fractures.Methods: 3D models of the pelvises of 14 adult cadavers were reconstructed using computed tomography (CT). Twenty-eight acetabular fractures were simulated and placement positions for plates and screw trajectories were designed. Bending module was obtained by 3D cutting; guiding template was manufactured using 3D printing, and the plate was pre-bent according to the bending module. Plates and screws were placed in cadaveric pelvises using the guiding template, and 3D model was reconstructed using CT. The designed and real trajectories were matched using 3D registration including the coordinates (entry and exit points) of designed trajectory. The number of qualified points with different accuracy levels was compared using Chi-squared test.Results: Sixty-four plates and 339 screws were placed with no cortical breach. The absolute difference of the X, Y, and Z coordinates between the designed and real entry points were 0.52±0.45, 0.43±0.36, and 0.53±0.44mm, respectively. The corresponding values for the exit points were 0.83±0.67, 1.22±0.87, and 1.26±0.83mm, respectively. With an accuracy degree ≥1.9mm for the entry points and ≥3.8mm for the exit points, there was no significant difference between the designed and the real trajectories.Conclusion: The 3D-printed guiding template helped achieve accurate placement of plates and screws in the pelvis of adult cadavers. [ABSTRACT FROM AUTHOR]

Abstract: Background: The underlying molecular mechanisms of the remodeling after myocardial infarction (MI) remain unclear. The purpose of this study was to investigate the role of a survival pathway (PI3K/Akt) and an apoptosis pathway (calcineurin/BAD) in the remodeling after MI in a large animal model. Methods: Ten Dorset hybrid sheep underwent 25% MI in the left ventricle (LV, n=10). Five sheep were used as sham control. The regional strain was calculated from sonomicrometry. Apoptosis and the activation of the PI3K/Akt and calcineurin/BAD pathways were evaluated in the non-ischemic adjacent zone and the remote zone relative to infarct by immunoblotting, immunoprecipitation, and immunofluorescence staining. Results: Dilation and dysfunction of LV were present at 12weeks after MI. The regional strain in the adjacent zone was significantly higher than in the remote zone at 12weeks (36.6±4.0% vs 9.5±3.6%, p< 0.05). Apoptosis was more severe in the adjacent zone than in the remote zone. The PI3K/Akt and calcineurin/BAD pathways were activated in the adjacent zone. Dephosphorylation and translocation of BAD were evident in the adjacent zone. Regional correlation between the strain and the expression of calcineurin/BAD indicated that the activation was strain-related (R 2 =0.46, 0.48, 0.39 for calcineurin, BAD, mitochondrial BAD, respectively, p <0.05). Conclusions: The PI3K/Akt survival and calcineurin/BAD apoptotic pathways were concomitantly activated in the non-ischemic adjacent zone after MI. The calcineurin/BAD pathway is strain related and its imbalanced activation may be one of the causes of progressive remodeling after MI. [Copyright &y& Elsevier]