Search

This study sought to investigate health and healthcare disparities in the management of severe mitral regurgitation with transcatheter edge-to-edge repair using MitraClip and how racial differences impact resource utilization and costs. We retrospectively analyzed the National Inpatient Sample (NIS) for patients who underwent Transcatheter Edge-to-Edge Repair (TEER) using MitraClip between 2016 and 2018. The patients were stratified into four racial cohorts and study outcomes included high resource utilization (HRU), periprocedural complications, and total procedural costs. High resource utilization (HRU) was defined as length of stay (LOS) ≥7 days or a nonhome disposition at discharge. Multivariate logistic regression models were utilized to determine independent predictors of HRU. 17,100 weighted TEER patients were segregated by race: Caucasian (n = 13,270), others (n = 1510), African Americans, AA (n = 1245) and Hispanics (n = 1075). More African Americans and Hispanics had TEER at Urban facilities (P < 0.001), which were teaching hospitals as well (P < 0.001) but were less likely to be covered by public insurance options -Medicare or Medicaid (P < 0.001). More AA (52.2 %) and Hispanics (27.6 %) were likely to be in the lowest median annual income quartile versus Caucasians (19.2 %) (P = 0.003). AA and Hispanics had higher resource utilization (HRU), prolonged length of stay, nonhome disposition at discharge, higher procedural costs and periprocedural complications versus Caucasians. The logistic regression model revealed acute kidney injury (AKI) and actual procedural costs as independent predictors of HRU in both African American and Hispanic groups. Significant Health and healthcare disparities do exist among underrepresented, racial minority patients undergoing transcatheter edge-to-edge repair in the US. These disparities were associated with higher resource utilization and actual costs in patients with mitral regurgitation treated with TEER. [ABSTRACT FROM AUTHOR]

Objective: The MitraClip from Abbott is FDA approved intracardiac implantable device for transcatheter edge-to-edge repair (TEER). Despite a few previously published studies, there is limited safety data for its use in clinical practice, hence, we designed this study using data obtained from a safety nationwide database to demonstrate the safety profile of MitraClip.Methods: The first two of the five authors independently queried all reported adverse events from the United State Food and Drug Administration [FDA] Manufacturer and User Facility Device Experience [MAUDE] registry from January 2014 to December 2020. The primary end point was trend in reported fatal events obtained from this database. The secondary end points included the causes of reported nonfatal reports from the MAUDE registry. The trend of reported fatal events was assessed using the Cochran Armitage trend test over the period of the study.Results: During the study period, subjects included 3370 patients whose MitraClip-associated adverse events were reported and captured by MAUDE registry. Of these, 211 were fatal and 3159 nonfatal events. Fatal event reports resulted deaths and reported nonfatal events were from injuries and device system malfunction. This study demonstrated an initial upward trend from 2014 to 2015 then a subsequent statistically significant downward trend in reported fatal events from 2015 to 2020 (Cochran-Armitage test P = 0.039). The peak proportion of reported fatal events occurred in 2015, (n = 44; representing 1.25% of reported adverse events) and lowest proportion of reported fatal events took place in 2020 (n = 19; representing 0.56% of reported adverse events). The most reported nonfatal events were from malfunctioning of MitraClip system (n = 1170; representing 37% of reported nonfatal events), new unremarkable repolarization abnormalities on periprocedural EKG (n = 864; representing 27% of reported nonfatal events), leaflet rupture (n = 651; representing 21% of reported nonfatal events), and cardiogenic shock (n = 170; representing 5% of reported nonfatal events).Conclusions: This analysis of the MAUDE Registry indicated, especially within the confines of this study's limitations and poor data quality of information, an apparent downward trend of reported fatal events over the study period. Even though conclusive attributions cannot be made regarding this important finding, perhaps, this points to early evidence of a potential institutional or operator learning curve with this device. However, in view of the inferior quality of the data accrued from the MAUDE Registry, more high-precision studies are needed to better understand these changes, as the utility of MitraClip, becomes more established in clinical practice. [ABSTRACT FROM AUTHOR]

The use of percutaneous mechanical circulatory support (MCS) devices, including Impella and Intra-aortic balloon pump (IABP), in patients with cardiogenic shock has increased in recent times. We aimed to evaluate the impact of the choice of an MCS device on healthcare resource utilization. We queried the National Inpatient Sample registry between October 2016 and December 2018 to identify adults admitted for acute coronary syndrome-related cardiogenic shock and who received percutaneous coronary intervention (PCI). The study population was segregated into Impella and IABP groups using ICD 10 diagnosis codes. The primary endpoint was high healthcare resource utilization (HRU), while secondary outcomes included periprocedural complications. Propensity scoring matching was used to determine which patients in the Impella cohort had similar health to IABP patients. During the study period, 439,610 patients were admitted who received hemodynamic support using, Impella or IABP on account of acute coronary syndrome complicated by cardiogenic shock (CS). The median age (years) of the Impella cohort and IABP cohorts were similar (64.1 vs 65.1, P = 0.08). Gender distribution of the Impella CS patients was like IABP patients with female majorities in both groups, (71.9% vs 67.9%, P = 0.05). Impella CS patients had a higher representation of those with hypertension (P = 0.002), smoking (P = 0.040), obesity (P = 0.034), diabetes mellitus (P = 0.009), CHF (P = 0.030), COPD (P = 0.034), chronic liver disease (P = 0.028), and chronic kidney disease (P = 0.031). 1:1 Propensity score matching identified 2620 Impella patients' comparable severity index with the IABP patients. Patients with hemodynamic support using Impella had higher healthcare resource utilization, (HRU), the surrogate of length of stay (LOS) ≥7 or nonhome disposition at discharge, when compared with those with IABP (57.41% vs 42.76%, P < 0.0001). Impella CS patients had higher in-hospital mortality as compared to the IABP patients (55.45% vs 45.86%, P < 0.0001). Impella CS patients developed more periprocedural complications, including vascular injury (4.8% vs 1.4%, P < 0.0001), acute kidney injury (58.36% vs 41.64%, P < 0.0001), end-stage renal disease requiring dialysis (8.75% vs 1.25%, P = 0.002) when compared to the IABP patients. Among patients with ACS undergoing PCI and receiving MCS devices, those receiving Impella demonstrated higher healthcare resource utilization, higher LOS ≥7 days, and more nonhome disposition at discharge compared to patients receiving IABP. Further investigation is warranted to elucidate factors associated with these findings. [ABSTRACT FROM AUTHOR]

Abstract: Collapse behaviour of aluminium thin conical frusta with shallow spherical caps (shells of combined geometry) is studied both experimentally and numerically. These shells were of four different thicknesses and were subjected to axial compression between two rigid platens under both quasi-static and impact loading. The R/t values of the spherical portion of the shells were varied between 27 and 218, and for the conical frusta portion, mean diameter-to-thickness (D m/t) values were varied between 79 and 190. Quasi-static tests were performed on a UTM of 100T capacity with digital recording facility. Impact experiments were carried out on a drop mass set-up. A three-dimensional non-linear finite element analysis was carried out using LS-DYNA. Numerical results thus obtained were validated with the experimental results. Typical time histories of the specimen deformation and load compression curves were obtained. The behaviour of these shells of combined geometry is compared with the response of the shells of spherical or conical geometries. A discussion on their deformation behaviour, mean buckling load and energy absorbed is presented, and influence thereon of various parameters is discussed. [Copyright &y& Elsevier]

Abstract: Experimental and numerical investigations were carried out to optimize thin-walled conical shells for their use in design for energy absorption. Geometrical parameters, such as bottom diameter, height, and semi-apical angle were considered to obtain the design space. The numerical analysis and impact experiments were designed using design of experiments (DOE). A three-level, second-order Box–Bhenken technique was used to select the design points from the design space. Various set of numerical simulations were carried out using LS-DYNA. To investigate the influence of flow stress of the material on the energy absorption, numerical simulations were carried out using frusta made of aluminium, zinc, and mild steel. From the numerical results, mathematical models were created using response surface methodology (RSM). With the help of impact experiments carried out on specimens made of zinc on a drop mass test rig, a mathematical model has been developed using RSM. The mathematical models developed using experimental data and the numerical data were used as objective functions for optimization of the design. The non-dominated sorting genetic algorithm code NSGA II was used to optimize the design. The mathematical models were also used to predict the energy absorbed and deformation. The influence of various design parameters on energy absorption has been analysed and is discussed. [Copyright &y& Elsevier]

Abstract: In this paper we present experiments, simulation as well as analysis of the collapse behaviour of thin spherical shells under quasi-static loading. Various aluminium spherical shells with variation in geometrical parameters were manufactured by spinning. Experiments were performed on these shells in a universal testing machine and their load–compression histories were obtained on the machine chart recorder. Three-dimensional numerical simulations were carried out for all the specimens tested under quasi-static loading using ANSYS®. All the stages of collapse of the shell including non-symmetrical lobe formation were simulated. Material, geometric and contact nonlinearities were incorporated in the analysis. The stress–strain curves of standard samples made from the material were used as input. Piecewise linearity was taken in the plastic region of the material curve. Results thus obtained compared with the experiments well. An analysis was also carried out to study the behaviour of shells under axial compression based on the formation of rolling and stationary plastic hinges. These hinges were also simulated numerically and results match the experiments well. [Copyright &y& Elsevier]

Abstract: A study of the collapse behaviour of hemi spherical and shallow spherical shells and their modes of deformation under impact loading are presented in this paper. Aluminium spherical shells of various radii and thicknesses were made by spinning. These were subjected to impact loading under a drop hammer and the load histories were obtained in all the cases. Three-dimensional numerical simulations were carried out for all the tested specimen geometries using LS-DYNA®. Material, geometric and contact nonlinearities were incorporated in the analysis. The uni-axial stress–strain curve for the material was obtained experimentally and was assumed to be piecewise linear in the plastic region. The results from impact experiments are used for the validation of the numerical simulations. Three distinct modes of deformation, namely local flattening, inward dimpling and formation of multiple numbers of lobes were analysed and influence of various parameters on these modes is discussed. [Copyright &y& Elsevier]

Abstract: Experiments were performed wherein conical frusta of aluminium of thicknesses between 0.7 and 1.62mm and semi-apical angles range of 16–29° were axially compressed in a universal testing machine. The load–deformation curves and deformed shapes of specimens were recorded. These deformed in axisymmetric concertina mode and non-symmetric diamond modes. A three dimensional numerical simulation was carried out for all samples tested under quasi-static loading using ANSYS®. Various stages of collapse of the shell, including non-symmetrical lobe formation were simulated for the first time, and material, geometric and contact non-linearities were incorporated. The plastic region of the material curve was assumed to be piecewise linear. Tensile tests were performed on standard samples to obtain stress–strain curves. Results thus obtained compared well with the experiments. Based on the formation of rolling and stationary plastic hinges an analysis was also carried out to study the behaviour of shells under axial compression and results were compared with experimental and numerical results. [Copyright &y& Elsevier]