How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices.

OBJECTIVE: To examine how and to what extent medical devices using machine learning (ML) support clinician decision making. METHODS: We searched for medical devices that were (1) approved by the US Food and Drug Administration (FDA) up till February 2020; (2) intended for use by clinicians; (3) in clinical tasks or decisions and (4) used ML. Descriptive information about the clinical task, device task, device input and output, and ML method were extracted. The stage of human information processing automated by ML-based devices and level of autonomy were assessed. RESULTS: Of 137 candidates, 59 FDA approvals for 49 unique devices were included. Most approvals (n=51) were since 2018. Devices commonly assisted with diagnostic (n=35) and triage (n=10) tasks. Twenty-three devices were assistive, providing decision support but left clinicians to make important decisions including diagnosis. Twelve automated the provision of information (autonomous information), such as quantification of heart ejection fraction, while 14 automatically provided task decisions like triaging the reading of scans according to suspected findings of stroke (autonomous decisions). Stages of human information processing most automated by devices were information analysis, (n=14) providing information as an input into clinician decision making, and decision selection (n=29), where devices provide a decision. CONCLUSION: Leveraging the benefits of ML algorithms to support clinicians while mitigating risks, requires a solid relationship between clinician and ML-based devices. Such relationships must be carefully designed, considering how algorithms are embedded in devices, the tasks supported, information provided and clinicians' interactions with them.

MRI of THA Correlates With Implant Wear and Tissue Reactions: A Cross-sectional Study.

BACKGROUND: MRI is predictive of adverse local tissue reactions (ALTRs) after THA but how MRI directly relates to implant surface wear, fretting, and trunnion corrosion at different articulations between implant components remains unclear. MRI generates high-contrast images to display soft tissues around arthroplasty and may provide a surgeon the means to distinguish and differentiate host-related synovial patterns as a response to either polyethylene wear or metal wear and corrosion products. QUESTIONS/PURPOSES: The purposes of this study were (1) to correlate findings from MRI in patients who have undergone THA with direct assessment of implant wear, corrosion, and fretting from retrieved components; and (2) to distinguish the unique synovial responses on MRI in patients who have undergone THA based on bearing materials. METHODS: In this prospective study, patients undergoing THA (181 patients, 187 hips) with metal-on-metal (MoM), hip resurfacing (HRA), metal-on-polyethylene (MoP), ceramic-on-polyethylene, ceramic-on-ceramic, or modular neck designs having revision surgery (between October 2013 and June 2017) underwent preoperative MRI. A single reader blinded to the bearing surface made an assessment of the synovial response (Gwet's AC1, 0.65-0.97); these data were compared with semiquantitative histology of tissue samples by a single reader (Gwet's AC1, 0.92) and semiquantitative wear, corrosion, and fretting analysis of retrieved components using Goldberg scoring (Gwet's AC1, 0.60-0.79). Direct noncontact measurements of implant wear were also made. Correlations and analyses of variance were used to assess associations between metrics and differences by implant type, respectively. RESULTS: Correlations were found between MRI synovial thickness with severity of fretting and corrosion damage of the female head-neck trunnion of femoral stems in modular designs (ρ = 0.26 [95% confidence interval {CI}, 0.12-0.39]; p = 0.015, n = 185) and ALTR grade and volumetric wear in MoM bearings (ρ = 0.93 [95% CI, 0.72-0.98]; p < 0.001, n = 10). MRI synovial thickness was highest in patients identified with aseptic lymphocyte-dominated vasculitis-associated lesions and diffuse tissue necrosis. On MRI, MoP hips demonstrated a distinct polymeric synovial response, whereas HRA, MoM, and modular hips more commonly demonstrated ALTR. Hips classified as having a polymeric synovial response on MRI had a greater number of particles present in tissue samples. CONCLUSIONS: In this study, we demonstrated that MRI of THA can distinguish synovial responses that reflect the bearing type of the implanted THA and correlate to direct measurements of implant wear, corrosion, and fretting and histologic assessment of wear particles in periprosthetic tissues. MRI provides a means of direct, noninvasive visualization of the host-generated synovial response. Patients presenting with painful arthroplasties may be evaluated for the cause of their discomfort, specifically highlighting any concerning synovial reactions that would warrant more prompt surgical intervention. Future studies would benefit from a prospective evaluation of different implants to assess the natural longitudinal history of arthroplasty complications, including the development and prevalence of ALTR across bearing constructs. LEVEL OF EVIDENCE: Level III, diagnostic study.

Off-resonance based assessment of metallic wear debris near total hip arthroplasty.

PURPOSE: The presence of metallic debris near total hip arthroplasty can have a significant impact on longitudinal patient management. Methods for magnetic resonance imaging-based quantification of metallic debris near painful total hip replacements are described and applied to cohorts of symptomatic and control subject cases. METHODS: A combination of metal artifact reduction, off-resonance mapping, off-resonance background removal, and spatial clustering methods are utilized to quantify off-resonance signatures in cases of suspected metallosis. These methods are applied to a cohort of symptomatic hip arthroplasties composed of cobalt-chromium alloys. Magnetostatic simulations and theoretical principles are used to illuminate the potential sources of the measured off-resonance effects. Reported metrics from histological tissue assays extracted during surgical revision procedures are also correlated with the proposed magnetic resonance imaging-based quantification results. RESULTS: The presented methods identified quantifiable metallosis signatures in more than 70% of the symptomatic and none of the control cases. Preliminary correlations of the MR data with direct histological evaluation of retrieved tissue samples indicate that the observed off-resonance effect may be related to tissue necrosis. CONCLUSIONS: Magnetostatic simulations, theoretical principles, and preliminary histological trends suggest that disassociated cobalt is the source of the observed off-resonance signature. Magn Reson Med 79:1628-1637, 2018. © 2017 International Society for Magnetic Resonance in Medicine.

Diagnostic Accuracy of Zero-Echo Time MRI for the Evaluation of Cervical Neural Foraminal Stenosis.

STUDY DESIGN: A cohort study. OBJECTIVE: The aim of this study was to evaluate the clinical utility of Zero-Echo-Time (ZTE) magnetic resonance imaging (MRI) for the assessment of cervical neural foraminal stenosis (CNFS) through the comparison of inter-modality [computed tomography (CT) and ZTE-MRI] CNFS grade severity agreements. SUMMARY OF BACKGROUND DATA: Conventional MRI limited in its ability to provide direct visualization of cortical bone. The highly organized tissue structure of cortical bone results in very short T2 values that preclude acquisition of sufficient signal intensity and positive image contrast. ZTE imaging permits visualization of tissues with very short transverse relaxation times, and is capable of displaying images with CT-like contrast. METHODS: Thirty-four subjects were recruited from a clinical cohort of patients undergoing standard of care MRI and CT imaging for evaluation of CNFS. Standard of care CT imaging studies were obtained on all subjects within 6 months of their ZTE-MRI acquisition (mean time interval: 25.3 ±â€Š54.1 days; median: 0 days). ZTE-MRI and CT imaging studies were evaluated and severity of CNFS was graded on a scale from 0 to 5 (0 = none; 5 = severe). Weighted-kappa statistics were used to assess agreement between ZTE and CT grades of CNFS on both sides (right and left) of each motion segment. Ordinal logistic mixed-effects regression analyses evaluated the effects of inter-modality position differences (flexion-extension curvature) on inter-modality differences in CNFS grade. RESULTS: Substantial agreement (κ = 0.72) was found between ZTE- and CT-based grades of CNFS. Significant inter-modality differences in cervical spine curvature were found for all motion segments, except C2-3 and C3-4 (P < 0.05). However, no significant relationship was found between inter-modality differences in curvature, and inter-modality differences in CNFS grade for any motion segment (P = 0.28). CONCLUSION: Results of the current study suggest that ZTE-MRI is well-suited for the evaluation of CNFS and may have the potential to obviate the need for concurrent CT scans in some cases. LEVEL OF EVIDENCE: 2.

Assessment of Osteonecrosis in the Presence of Instrumentation for Femoral Neck Fracture Using Contrast-Enhanced MAVRIC Sequence.

BACKGROUND: Evaluating postoperative femoral neck facture (FNF) with metal fixation hardware is commonly performed using radiographs. MRI has greater sensitivity and specificity to evaluate osteonecrosis (ON) but is often challenging due to the image distortion caused by metallic hardware. QUESTIONS/PURPOSES: The aim of this study is to compare fast spin-echo (FSE) and multi-acquisition variable-resonance image combination (MAVRIC) sequences in assessing ON following metallic fixation of FNF and determining feasibility of semi-quantitative perfusion using MAVRIC. METHODS: Radiography and MRI were performed at 3 and 12 months postoperatively, using FSE and pre- and post-gadolinium contrast MAVRIC sequences in 21 FNF patients. The presence and volume of ON were recorded. Signal intensity (SI) enhancement was measured on the MAVRIC sequences within the center and rim of ON; with the ilium and femoral diaphysis as controls. The detection rate of ON between MAVRIC and FSE images was evaluated as the difference of percent enhancement across the defined regions of interest. RESULTS: ON was detected in 0% of radiographs, in 67% of FSE, and in 76% of MAVRIC images at 3 months follow-up, with similar results at 12 months. MAVRIC images had larger ON volume than FSE images at both time points. A significant percentage SI enhancement was only detected in the ON rim. CONCLUSION: Radiographs could not detect ON following metallic fixation of FNF. MAVRIC is more sensitive than FSE for determining the volume of ON. SI measurements using MAVRIC may provide an indirect assessment of perfusion.

Quantitative Ultrashort Echo Time Magnetic Resonance Imaging Evaluation of Postoperative Menisci: a Pilot Study.

BACKGROUND: Magnetic resonance imaging (MRI) visualization of meniscal signal is particularly challenging as the highly organized ultrastructure of meniscal fibrocartilage yields very short T2 values (∼6 ms) and a paucity of signal intensity during conventional image acquisition. QUESTION/PURPOSE: The purpose of this study was to evaluate the feasibility of imaging postoperative menisci using an experimental, quantitative ultrashort echo time (UTE) MRI pulse sequence. This sequence acquires short echo images (echo time (TE) ∼0.3 ms) to produce multi-echo images for quantitative T2* calculations that provide an objective measure of collagen organization. PATIENTS AND METHODS: MRI scans of the knee were acquired at 6- and 12-month intervals on a clinical 3.0 T scanner following meniscal surgery in eight patients (ages 13-41), four of whom underwent repair and the other four partial meniscectomy. Conventional MRI sequences were qualitatively evaluated for meniscal morphology and signal and correlated with quantitative UTE results. RESULTS: A wide range of mean T2* values for both postsurgical groups was measured, and these values changed for each patient between the 6- and 12-month intervals. In many instances, the UTE sequence demonstrated quantitative differences between the two time intervals that were not detected with conventional sequences. CONCLUSIONS: This pilot study presents preliminary, observational data to be used as a baseline for future studies. Although the T2* values did not reveal a trend in either group or correlate with expected signal changes on conventional MRI, we speculate that the UTE sequence may detect ultrastructural alterations in meniscal composition that are otherwise not perceived with routine fast spin echo (FSE) sequences.

The effect of freeze-thawing on magnetic resonance imaging T2* of freshly harvested bovine patellar tendon.

BACKGROUND: Analysis of fresh specimens in research studies is ideal; however, it is often necessary to freeze samples for evaluation at a later time. Limited evaluation of the effect of freeze-thawing of tendon tissue samples on inherent magnetic resonance imaging (MRI) parameters, such as ultrashort echo time (UTE) T2* values, have been performed to date. METHODS: This study performed UTE MRI on 14 bovine patellar tendons at harvest and after four consecutive freeze-thaw cycles. RESULTS: Results demonstrated a small but significant reduction (12%) in tendon T2* values after the first freeze thaw cycle, but not after successive cycles. Tendons from juvenile animals with open physis had a significant reduction of T2* following a single freeze thaw cycle, P<0.0001. CONCLUSIONS: The results of this study emphasize the importance of using uniform tendon storage protocols when using UTE MRI in preclinical models.

Word-finding impairment in veterans of the 1991 Persian Gulf War.

Approximately one quarter of 1991 Persian Gulf War Veterans experience cognitive and physiological sequelae that continue to be unexplained by known medical or psychological conditions. Difficulty coming up with words and names, familiar before the war, is a hallmark of the illness. Three Gulf War Syndrome subtypes have been identified and linked to specific war-time chemical exposures. The most functionally impaired veterans belong to the Gulf War Syndrome 2 (Syndrome 2) group, for which subcortical damage due to toxic nerve gas exposure is the suspected cause. Subcortical damage is often associated with specific complex language impairments, and Syndrome 2 veterans have demonstrated poorer vocabulary relative to controls. 11 Syndrome 1, 16 Syndrome 2, 9 Syndrome 3, and 14 age-matched veteran controls from the Seabees Naval Construction Battalion were compared across three measures of complex language. Additionally, functional magnetic resonance imaging (fMRI) was collected during a covert category generation task, and whole-brain functional activity was compared between groups. Results demonstrated that Syndrome 2 veterans performed significantly worse on letter and category fluency relative to Syndrome 1 veterans and controls. They also exhibited reduced activity in the thalamus, putamen, and amygdala, and increased activity in the right hippocampus relative to controls. Syndrome 1 and Syndrome 3 groups tended to show similar, although smaller, differences than the Syndrome 2 group. Hence, these results further demonstrate specific impairments in complex language as well as subcortical and hippocampal involvement in Syndrome 2 veterans. Further research is required to determine the extent of language impairments in this population and the significance of altered neurologic activity in the aforementioned brain regions with the purpose of better characterizing the Gulf War Syndromes.

Imaging of physeal injury: overuse.

CONTEXT: As the intensity of youth participation in athletic activities continues to rise, the number of overuse injuries has also increased. A subset of overuse injuries involves the physis, which is extremely susceptible to injury. This paper aims to review the utility of the various imaging modalities in the diagnosis and management of physeal injuries in the skeletally immature population. EVIDENCE ACQUISITION: A search for the keywords pediatric, physis, growth plate, x-ray, computed tomography, magnetic resonance imaging, and overuse injury was performed using the PubMed database. No limits were set for the years of publication. Articles were reviewed for relevance with an emphasis on the imaging of growth plate injuries. STUDY DESIGN: Retrospective literature review. LEVEL OF EVIDENCE: Level 4. RESULTS: Three major imaging modalities (radiographs, computed tomography, and magnetic resonance imaging) complement each other in the evaluation of pediatric patients with overuse injuries. However, magnetic resonance imaging is the only modality that offers direct visualization of the physis, and it also offers the best soft tissue contrast for evaluating the other periarticular structures for concomitant injury. CONCLUSION: Imaging has an important role in the diagnosis of physeal injuries, and the information it provides has a tremendous impact on the subsequent management of these patients.

Flexible longitudinal magnetization contrast in spectrally overlapped 3D-MSI metal artifact reduction sequences: Technical considerations and clinical impact.

PURPOSE: It has previously been demonstrated that increased overlap of spectral bins in three-dimensional multispectral imaging techniques (3D-MSI) can aid in reducing residual artifacts near metal implants. However, increasing spectral overlap also necessitates consideration of saturation effects for species with long T1 values. Here, an interleaved spectral bin acquisition strategy is presented for overlapping 3D-MSI that allows for flexible choice of repetition times while simultaneously addressing these cross talk concerns. METHODS: A phantom imaging experiment is used to illustrate the amplified effect of cross talk on 3D-MSI acquisitions. A methodological approach to address cross talk across a variety of prescribed repetition times is then described. Using the presented principles, a clinical subject with a total hip replacement was imaged to generate T1, proton density, and short-tau inversion recovery contrasts. In addition, a fracture instrumentation case was imaged pre- and postcontrast using T1-weighted spectrally overlapped 3D-MSI. RESULTS: Phantom results demonstrate that conventional spectral interleaving approaches can generate unwanted signal characteristics in heavily overlapped 3D-MSI. Clinical images using the presented methods successfully demonstrate T1, proton density, and inversion recovery image contrasts using heavily overlapped 3D-MSI. CONCLUSIONS: Through automated management of spectral bin distributions across multiple interleaves, a variety of longitudinal magnetization contrasts can efficiently be acquired without any clinically relevant cross-talk impact using heavily overlapped 3D-MSI.

Ultrashort echo imaging of cyclically loaded rabbit patellar tendon.

Tendinopathy affects individuals who perform repetitive joint motion. Magnetic resonance imaging (MRI) is frequently used to qualitatively assess tendon health, but quantitative evaluation of inherent MRI properties of loaded tendon has been limited. This study evaluated the effect of cyclic loading on T2* values of fresh and frozen rabbit patellar tendons using ultra short echo (UTE) MRI. Eight fresh and 8 frozen rabbit lower extremities had MR scans acquired for tendon T2* evaluation. The tendons were then manually cyclically loaded for 100 cycles to 45 N at approximately 1 Hz. The MR scanning was repeated to reassess the T2* values. Analyses were performed to detect differences of tendon [Formula: see text] values between fresh and frozen samples prior to and after loading, and to detect changes of tendon T2* values between the unloaded and loaded configurations. No difference of T2* was found between the fresh and frozen samples prior to or after loading, p=0.8 and p=0.1, respectively. The tendons had significantly shorter T2* values, p=0.023, and reduced T2* variability, p=0.04, after cyclic loading. Histologic evaluation confirmed no induced tendon damage from loading. Shorter T2* , from stronger spin-spin interactions, may be attributed to greater tissue organization from uncrimping of collagen fibrils and lateral contraction of the tendon during loading. Cyclic tensile loading of tissue reduces patellar tendon T2* values and may provide a quantitative metric to assess tissue organization.

Clinical implementation of MRI of joint arthroplasty.

OBJECTIVE: The purpose of this article is to explain the basic physics of imaging patients with metal implants, explain conflicting information regarding MRI scanning of "MR Conditional" devices, and relate our experience of scanning total joint arthroplasty (TJA) at our institution. CONCLUSION: MRI near TJA is effective with appropriate imaging protocols and standardized safety precautions. Strict adherence to MR Conditional labeling may preclude broad use of MRI for TJA assessment.

Three-dimensional magnetic resonance imaging of physeal injury: reliability and clinical utility.

BACKGROUND: Injuries to the physis are common in children with a subset resulting in an osseous bar and potential growth disturbance. Magnetic resonance imaging allows for detailed assessment of the physis with the ability to generate 3-dimensional physeal models from volumetric data. The purpose of this study was to assess the interrater reliability of physeal bar area measurements generated using a validated semiautomated segmentation technique and to highlight the clinical utility of quantitative 3-dimensional (3D) physeal mapping in pediatric orthopaedic practice. METHODS: The Radiology Information System/Picture Archiving Communication System (PACS) at our institution was searched to find consecutive patients who were imaged for the purpose of assessing a physeal bar or growth disturbance between December 2006 and October 2011. Physeal segmentation was retrospectively performed by 2 independent operators using semiautomated software to generate physeal maps and bar area measurements from 3-dimensional spoiled gradient recalled echo sequences. Inter-reliability was statistically analyzed. Subsequent surgical management for each patient was recorded from the patient notes and surgical records. RESULTS: We analyzed 24 patients (12M/12F) with a mean age of 11.4 years (range, 5-year to 15-year olds) and 25 physeal bars. Of the physeal bars: 9 (36%) were located in the distal tibia; 8 (32%) in the proximal tibia; 5 (20%) in the distal femur; 1 (4%) in the proximal femur; 1 (4%) in the proximal humerus; and 1 (4%) in the distal radius. The independent operator measurements of physeal bar area were highly correlated with a Pearson correlation coefficient (r) of 0.96 and an intraclass correlation coefficient for average measures of 0.99 (95% confidence interval, 0.97-0.99). Four patients underwent resection of the identified physeal bars, 9 patients were treated with epiphysiodesis, and 1 patient underwent bilateral tibial osteotomies. CONCLUSIONS: Semiautomated segmentation of the physis is a reproducible technique for generating physeal maps and accurately measuring physeal bars, providing quantitative and anatomic information that may inform surgical management and prognosis in patients with physeal injury. LEVEL OF EVIDENCE: Level IV.

Quantifying image distortion of orthopedic materials in magnetic resonance imaging.

PURPOSE: To determine the magnitude of image distortion between two-dimensional (2D) fast-spin-echo (FSE) images and 3D-MAVRIC by using a phantom with samples of common materials used in total joint arthroplasty. MATERIALS AND METHODS: A phantom was constructed to hold samples of 316 stainless steel, cobalt chrome, titanium, and ultra-high molecular weight polyethylene (UHMWPE), and to permit tracking of points between 2D-FSE and 3D-MAVRIC sequences. Imaging was performed with a 1.5 Tesla scanner. The displacement of points between the two acquisitions in regions of varying distance from the material sample was calculated. Measured displacements were compared with theoretical displacements calculated from MAVRIC frequency field maps, and to the known phantom dimensions. RESULTS: Bulk in-plane artifacts increased from the control scan (0.20 ± 0.07 mm), to UHMWPE (0.23 ± 0.04 mm), titanium (0.40 ± 0.34 mm), cobalt chrome (1.35 ± 0.57 mm), and to stainless steel (2.56 ± 0.62 mm). A similar pattern was found for bulk through-plane measurements: control scan (0.36 ± 0.08 mm), UHMWPE (0.38 ± 0.05 mm), titanium (1.11 ± 0.51 mm), and cobalt chrome (2.08 ± 1.83 mm). Large distortions were observed near the metal samples, and reduced with distance from the samples. The differences between the measured displacement and theoretical displacement was typically less than one pixel or one slice dimension for in-plane and through-plane measurements, respectively. The difference between the 3D-MAVRIC and known dimensions of the phantom was less than two pixels, whereas the results for the 2D-FSE were less consistent. CONCLUSION: Distortion was reduced in 3D-MAVRIC scans. Measured distortions corresponded well to theoretical calculations from frequency field map data.

MRI after arthroplasty: comparison of MAVRIC and conventional fast spin-echo techniques.

OBJECTIVE: The goal of this study was to evaluate the quality of images obtained with a prototype imaging technique, multiacquisition variable-resonance image combination (MAVRIC), compared with fast spin-echo (FSE) images in the evaluation of patients who have undergone hip, shoulder, or knee arthroplasty. MATERIALS AND METHODS: MRI with metal-artifact reduction FSE and MAVRIC sequences was performed in the care of 122 patients who had undergone 74 hip, 27 shoulder, and 21 knee arthroplasties. The FSE and MAVRIC images were subjectively graded for visualization of the synovium, prosthesis-bone interface, and hip abductors or supraspinatus tendon. The presence of synovitis, osteolysis, or supraspinatus tendon tear was recorded. RESULTS: Visualization of the synovium was significantly better on MAVRIC images than on FSE images of the hip (p < 0.0001), shoulder (p < 0.01), and knee (p < 0.01). Synovitis was detected only on the MAVRIC images of nine subjects (12%) who had undergone hip arthroplasty and five subjects (18%) who had undergone shoulder arthroplasty. Visualization of the periprosthetic bone was significantly better on MAVRIC images of the hip (p < 0.0001), shoulder (p < 0.0001), and knee (p < 0.01). Osteolysis was detected only on the MAVRIC images of 12 subjects (16%) who had undergone hip arthroplasty, six (22%) who had undergone shoulder arthroplasty, and five (24%) who had undergone knee arthroplasty. Visualization of the supraspinatus tendon was significantly better on MAVRIC images (p < 0.0001). Supraspinatus tendon tears in 12 subjects (44%) were detected only on MAVRIC images. CONCLUSION: MAVRIC complements the information on FSE images after arthroplasty and is a useful additional sequence, particularly when there is concern about synovitis, periprosthetic osteolysis, or the presence of a supraspinatus tendon tear.

Diagnosis of adult hereditary pulmonary disease and the role of genetic testing.

Genetic testing is becoming a common component of medical practice and is used to determine definitive diagnoses for several adult pulmonary diseases. It is important for pulmonologists to know when to use genetic tests for diagnosis and medical management. This article describes diagnosis of rare hereditary pulmonary disease in adults and the role of genetic testing. A summary on coding and reimbursement is included.

Effects of papillary muscle position on in-vitro dynamic strain on the porcine mitral valve.

BACKGROUND AND AIM OF THE STUDY: Improved knowledge of mitral valve (MV) mechanics is essential to understand normal MV function and design and evaluate new surgical repair procedures. Initially, the dynamic deformation of the central region of the porcine MV anterior leaflet was quantified under simulated physiological conditions to explore the effects of varying papillary muscle (PM) position. METHODS: Fresh porcine MVs were mounted in an in-vitro physiological flow loop. The PM positions were set to normal, taut, and slack states to simulate physiological and pathological PM positions. Leaflet deformation was measured by tracking the displacement of 16 markers (approximately 250 microm diameter) placed in a 5 x 5 mm section of the central region of the anterior leaflet, approximately 5 mm from the annulus and coaptation line. Local leaflet tissue strain and strain rates were calculated from measured displacements under dynamic loading conditions. A total of 11 mitral valves was studied. RESULTS: Under the normal PM positional state, the average areal strain rate during valve closure was typically approximately 620% per second. While not measurably altering the maximal areal strain rate, the slack PM position led to a delay in complete valve closure and more rapid leaflet loading (defined as delta transvalvular pressure/delta areal strain) in late systole compared to the other two PM positions. CONCLUSION: It was shown that PM position influenced the MV loading process in the central area of the anterior leaflet. The slack PM position led to a delay in complete valve closure and more rapid leaflet loading in late systole. This increase in loading rate may have long-term consequences in MV function.

An analysis of turbulent shear stresses in leakage flow through a bileaflet mechanical prostheses.

In this work, estimates of turbulence were made from pulsatile flow laser Doppler velocimetry measurements using traditional phase averaging and averaging after the removal of cyclic variation. These estimates were compared with estimates obtained from steady leakage flow LDV measurements and an analytical method. The results of these studies indicate that leakage jets which are free and planar in shape may be more unstable than other leakage jets, and that cyclic variation does not cause a gross overestimation of the Reynolds stresses at large distances from the leakage jet orifice.