The Apex bileaflet mechanical heart valve Mohammadi, Hadi; Bhullar, Arpin
Journal of medical engineering & technology,
2021, Letnik:
45, Številka:
1
Journal Article
Recenzirano
Mechanical Heart Valves (MHVs) are known for their excellent lifespan and feasibly are the most reliable and stable valves amongst all prosthetic valves. Successful bileaflet MHVs such as the St. ...Jude Medical (SJM) are known for providing central blood flow and minimal pressure drop across the valve. However, due to their non-physiological flow conditions, they still suffer from hemodynamic complications, that is, red blood cell (RBC) lysis and/or thrombogenicity, to date. Our hypothesis is that the design of MHVs can be improved so that their hemodynamics can be comparable to those of tissue valves. In this study, a new concept for the design of MHVs is proposed. To accomplish this, we identified the major design limitations of bileaflet MHVs, such as the gold standard SJM valve as well as the believed contributing factors to their thrombogenicity. We developed a novel design architecture for bileaflet MHVs that addressed these limitations, and from it, the Apex Valve (AV). Our experimental assessment of the AV found that its hemodynamics were closer to that of a bioprosthetic valve than of a bileaflet MHV. This design has been filed as a US Provisional Patent.
The objective of this study was to investigate and compare the hemodynamic and turbulence characteristics upon implantation of St Jude Medical (SJM) (St Jude Medical, St Paul, Minn) and On-X (On-X ...Life Technologies, Kennesaw, Ga) bileaflet mechanical valves. Both valves are considered highly successful bileaflet mechanical valves characterized by good clinical outcomes despite their numerous design differences. Although thromboembolism remains the main disadvantage of bileaflet mechanical valves, On-X valves have been shown to need less anticoagulation therapy.
Hemodynamic assessment of a 23-mm On-X bileaflet mechanical valve and a 23-mm bileaflet SJM valve implanted in an aortic root was performed under pulsatile physiologic conditions. Time-resolved and phase-locked particle-image-velocimetry images and high-speed imaging data were acquired. Pressure gradients, effective orifice areas, dimensionless area index, leaflet position tracking, velocity, and principal Reynolds shear stress were calculated.
Pressure gradient for the On-X valve was 4.15 ± 0.099 mm Hg versus 4.75 ± 0.048 mm Hg for SJM (P < .001). Effective orifice area for the On-X valve was 2.61 ± 0.045 cm2 versus 2.36 ± 0.022 cm2 for SJM (P < .001). Area index was higher with SJM (0.87 ± 0.008) than with On-X (0.73 ± 0.013) (P < .001). On-X showed fluctuating leaflet behavior during systole, whereas SJM leaflets were stable. At peak systole, the maximal velocity with On-X was 1.86 m/s versus 2.33 m/s with SJM. Reynolds shear stress was higher with On-X compared with SJM at peak systole (95 vs 72 Pa). Higher velocity fluctuation was noted with the On-X valve.
This study shows that despite the design differences that characterize the On-X valve, the hemodynamic and turbulence parameters were not necessarily improved compared with SJM.
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The implantation of an improperly sized annuloplasty ring may result in an incompetent valve after surgical mitral valve repair. Consequently, the procedure of ring size selection is considered ...critical. Although a plethora of sizing strategies are described, the opinions on how to select the appropriate ring size differ widely and often appear arbitrary (ie, without scientific justification). These inconsistencies raise the question where, with respect to ring sizing, science stops and voodoo begins.
Micro-parameter calibration is essential in constructing an accurate and reliable numerical model of particle discrete element PFC3D 6.0 software. Micro-parameter calibration is mainly accomplished ...according to the macro-parameters obtained from static or quasi-static laboratory tests such as UCS. However, there is little current research concerning the calibration method under impact load. An SJM micro-parameter calibration method, based on the SHPB rock test and the FLAC3D/PFC3D coupling method, is proposed to solve this problem. Firstly, UCS, SHPB, and other laboratory rock tests were carried out to determine the rock sample’s macroscopic physical and mechanical parameters. Secondly, the FLAC3D/PFC3D numerical coupling model of the SHPB test was established, and the single-factor and double-factor orthogonal numerical simulation was carried out. Then, the main micro-parameters that affect the macroscopic physical and mechanical parameters of the SJM particle discrete element model were proposed. Finally, the quantitative relationship between the model’s macro-parameters and micro-parameters was established through multiple linear regression. A set of PFC3D micro-parameter calibration processes under impact load was established. The relative errors of the macro-parameters obtained from laboratory and numerical tests totaled less than 5%, which further verifies the rationality of the calibration method. This method provides some reference values for PFC3D micro-parameter calibration under impact load.
Published studies report the incidence of pannus formation with the St. Jude MedicalR prosthetic mitral valve to be 0.02%. The following report details a mitral valve malfunction due to pannus ...formation and thrombosis in a 70-year-old woman which occurred 16 months after the initial operation (SJMR 27mm) using Dacron-cuff. A second replacement using a mitral valve prosthesis (SJMR 27mm) using Teflon-cuff was successfully performed and the postperative course was uneventful. The possibility of pannus formation of St. Jude MedicalR aortic valve and its mechanism are discussed in this report.
In this study, the hemodynamic performance of the conventional St. Jude Medical (SJM) valve and our proposed design known as the oval SJM valve are studied and compared. These studies are based on a ...wide range of physiological heart rates, i.e., 70–130
bpm, in the opening phase. We designed and developed a precise computational platform to assess the hemodynamics of bileaflet mechanical heart valves for laminar and turbulent regimes. Also, as one of the fundamental changes applied to the conventional SJM vales, the housing is considered oval similar to oval shape of annulus. Results clearly indicate hemodynamic improvements in the proposed design over the SJM valve. The improvements are characterized by lower shear stress and wall shear stress distributions around the valve and leaflets, and lower valve pressure drop compared to that of the conventional SJM model. The proposed design shows potential and merits additional development.
Abstract Background Device-based fully automatic pacing capture detection is useful in clinical practice and important in the era of remote care management. The main objective of this study was to ...verify the effectiveness of the new ACAP Confirm® algorithm in managing atrial capture in the medium term in comparison with early post-implantation testing. Methods Data were collected from 318 patients (66% male; mean age, 73±10 years); 237 of these patients underwent device implantation and 81 box changes in 31 Italian hospitals. Atrial threshold measurements were taken manually and automatically at different pulse widths before discharge and during follow-up (7±2 months) examination. Results The algorithm worked as expected in 73% of cases, considering all performed tests. The success rate was 65% and 88% pre-discharge and during follow-up examination ( p <0.001), respectively, in patients who had undergone implantation. We did not detect any difference in the performance of the algorithm as a result of the type of atrial lead used. The success rate was 70% during pre-discharge testing in patients undergoing device replacement. Considering all examination types, manual and automatic measurements yielded threshold values of 1.07±0.47 V and 1.03±0.47 V at 0.2-ms pulse duration ( p =0.37); 0.66±0.37 V and 0.67±0.36 V at 0.4 ms ( p =0.42); and 0.5±0.28 V and 0.5±0.29 V at 1 ms ( p =0.32). Conclusions The results show that the algorithm works before discharge, and its reliability increases over the medium term. The algorithm also proved accurate in detecting the atrial threshold automatically. The possibility of activating it does not seem to be influenced by the lead type used, but by the time from implantation.
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