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The aim of this study was to define the incidence of left ventricular thrombus (LVT) and its predictors in the contemporary era of primary percutaneous intervention (pPCI) and contrast echocardiography. We retrospectively analyzed 1,059 patients presenting with ST-elevation myocardial infarction (STEMI) to our tertiary cardiac center and treated with pPCI. Preprocedural pharmacology and procedural technique (including access route, the use of drug-eluting stents, and thrombectomy) were at the operators' discretion. Transthoracic echocardiography was performed before discharge; echo contrast agent was used when appropriate. LVT was detected in 42 subjects (4%). There were no significant differences in baseline demographics or pre-PCI clinical features between the 2 groups. Post-treatment, mean ejection fraction (EF) in patients with LVT was 35 ± 8.4% and in those without LVT was 47 ± 10%, p <0.001. Thirty-seven patients (88%) in the LVT group presented with an anterior STEMI versus 471 patients (42%) in the without LVT group (p <0.001). Apical akinesis was noted in all patients with LVT irrespective of the principal location of the MI. Multivariate analysis predictors of LVT were reduced EF, anterior site of MI, and the use of platelet glycoprotein IIb/IIIa inhibitors. After diagnosis of LVT, patients were treated with warfarin for 3 to 6 months. No significant difference in mortality was detectable at discharge between the 2 groups. In conclusion, in the contemporary era of pPCI, the incidence of LVT in patients with STEMI is significantly lower than that of the previous (thrombolysis) literature. The early presence of LVT is more likely in patients with anterior STEMI (involving the apex) and reduced EF.

We sought to determine whether balloon-expandable valve (BEV) and self-expanding valve (SEV) affect valve hemodynamics differently according to native aortic annulus size. Transcatheter aortic valve replacement can achieve superior prosthetic valve hemodynamics compared with surgical aortic valve replacement, particularly in patients with small aortic annulus. One hundred ninety-three consecutive transcatheter aortic valve replacement patients were grouped into tertiles defined by computed tomography derived aortic annulus systolic perimeter. The predischarge echocardiogram was analyzed for prosthetic valve hemodynamics. Tertile perimeter cutoffs were 73 and 80 mm. STS score decreased as annulus size increased (7.8% vs 7.6% vs 6.0%, p ≤0.05 for small, medium, and large annulus, respectively). In patients with small aortic annulus, SEV was associated with significantly higher dimensionless index (0.64 vs 0.53, p = 0.02) and lower peak velocity (1.8 vs 2.4 m/sec, p <0.001) and a trend toward lower mean gradient (7.5 vs 10.0 mm Hg, p = 0.07) compared with BEV. These differences were attenuated and absent in patients with medium and large annulus, respectively. Few patients had moderate/severe paravalvular leak, with no association with valve type or annulus size. There was no difference in mortality between tertiles or valve type at 30 days or 1 year. There was no association between aortic annulus perimeter and 1-year mortality by univariate analysis (hazard ratio 1.00, 95% CI 0.95 to 1.05, p = 0.86) or multivariate analysis (hazard ratio 1.02, 95% CI 0.95 to 1.09, p = 0.60). In conclusion, SEV hemodynamics was superior to BEV in patients with small aortic annulus. This difference was diminished in patients with larger aortic annulus. This study highlights the importance of valve selection in patients with small aortic annulus.

To determine the effects of current LBP (cLBP) and LBP history (hxLBP) on Y-Balance Test (YBT) reach and establish relationships between YBT performance and demographic, behavioral, and disability measures. Cross-sectional comparative study. Research laboratory. Forty-two participants (24 males, 18 females) aged 18–50 years (30.9 ± 8.2 yr) in three groups: cLBP, hxLBP, and healthy controls. Three YBT trials in anterior (ANT), posterolateral (PL), and posteromedial (PM) directions. YBT reach (relative to leg length) was measured and compared amongst groups. Pearson correlations were calculated between reach distances and pain, disability, and fear avoidance scores in the cLBP and hxLBP groups and age and activity level in all participants. For PL reach, cLBP (94.7 ± 10.6 cm) and hxLBP (94.2 ± 9.2 cm) groups demonstrated shorter distances versus controls (105.8 ± 6.6 cm). For PM reach, cLBP (100.7 ± 8.4 cm) and hxLBP (102.3 ± 7.6 cm) groups' distances were shorter versus controls (109.3 ± 6.7 cm). No significant difference was found for ANT reach (control = 66.4 ± 7.0 cm; cLBP = 66.2 ± 6.2 cm; hxLBP = 66.4 ± 3.1 cm). No significant correlations were identified. YBT performance is reduced in individuals with cLBP and hxLBP in the PL and PM directions but not ANT. The YBT is useful for measuring balance deficits in these populations. •YBT PL and PM distances are decreased in people with current and a history of LBP.•Anterior YBT reach distances are not reduced in these two groups.•There is no correlation between YBT distance and age, activity level, pain, or disability.•The YBT can be used to assess balance deficits in these populations.

The cost of ASD in the U.S. is estimated using a forecast model that for the first time accounts for the true historical increase in ASD. Model inputs include ASD prevalence, census population projections, six cost categories, ten age brackets, inflation projections, and three future prevalence scenarios. Future ASD costs increase dramatically: total base-case costs of$223 (175–271) billion/year are estimated in 2020; $ 589 billion/year in 2030,$1.36 trillion/year in 2040, and $ 5.54 (4.29–6.78) trillion/year by 2060, with substantial potential savings through ASD prevention. Rising prevalence, the shift from child to adult-dominated costs, the transfer of costs from parents onto government, and the soaring total costs raise pressing policy questions and demand an urgent focus on prevention strategies.

Background T1 mapping is a robust and highly reproducible application to quantify myocardial relaxation of longitudinal magnetisation. Available T1 mapping methods are presently site and vendor specific, with variable accuracy and precision of T1 values between the systems and sequences. We assessed the transferability of a T1 mapping method and determined the reference values of healthy human myocardium in a multicenter setting. Methods Healthy subjects (n = 102; mean age 41 years (range 17–83), male, n = 53 (52%)), with no previous medical history, and normotensive low risk subjects (n=113) referred for clinical cardiovascular magnetic resonance (CMR) were examined. Further inclusion criteria for all were absence of regular medication and subsequently normal findings of routine CMR. All subjects underwent T1 mapping using a uniform imaging set-up (modified Look- Locker inversion recovery, MOLLI, using scheme 3(3)3(3)5)) on 1.5 Tesla (T) and 3 T Philips scanners. Native T1-maps were acquired in a single midventricular short axis slice and repeated 20 minutes following gadobutrol. Reference values were obtained for native T1 and gadolinium-based partition coefficients, λ and extracellular volume fraction (ECV) in a core lab using standardized postprocessing. Results In healthy controls, mean native T1 values were 950 ± 21 msec at 1.5 T and 1052 ± 23 at 3 T. λ and ECV values were 0.44 ± 0.06 and 0.25 ± 0.04 at 1.5 T, and 0.44 ± 0.07 and 0.26 ± 0.04 at 3 T, respectively. There were no significant differences between healthy controls and low risk subjects in routine CMR parameters and T1 values. The entire cohort showed no correlation between age, gender and native T1. Cross-center comparisons of mean values showed no significant difference for any of the T1 indices at any field strength. There were considerable regional differences in segmental T1 values. λ and ECV were found to be dose dependent. There was excellent inter- and intraobserver reproducibility for measurement of native septal T1. Conclusion We show transferability for a unifying T1 mapping methodology in a multicenter setting. We provide reference ranges for T1 values in healthy human myocardium, which can be applied across participating sites.

The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.

The lack of detailed life history (LH) information (e.g. age, growth, size at maturity, sex composition etc.) for many species of conservation importance limits the implementation of appropriate conservation measures. Typically, LH information is acquired using lethal sampling techniques, which undermines the goal of conservation. This is particularly problematic for many shark species that have low fecundity and slow growth rates. Here we tested the use of non-invasive laser photogrammetry to measure body morphometry in vivo. We used random forest classification models to identify allometric relationships (ratios between body measurements) that discriminated between the sex and stage of sexual maturity of Scyliorhinus canicula . We coupled the use of allometric ratios (determined from cadavers) with parallel laser photogrammetry, in order to collect total length (TL) and finer scale morphometrics from 37 free-swimming individuals. TL measurements proved to be accurate (SE = 5.2%) and precise (CV = 1.8%), and did not differ significantly from the known TL of the respective animal ( t 36 = 0.7, P  = 0.5). Conditional Inference tree model predictions of free-swimming sharks correctly predicted 100% of mature males and 79% of immature males. Our results suggest that when used together, allometric ratios and parallel laser photogrammetry have the potential to be a promising alternative to collect essential life history information from free swimming animals and avoids the need for destructive sampling.

Transcatheter cardiovascular interventions increasingly rely on advanced imaging. X-ray fluoroscopy provides excellent visualization of catheters and devices, but poor visualization of anatomy. In contrast, magnetic resonance imaging (MRI) provides excellent visualization of anatomy and can generate real-time imaging with frame rates similar to X-ray fluoroscopy. Realization of MRI as a primary imaging modality for cardiovascular interventions has been slow, largely because existing guidewires, catheters and other devices create imaging artifacts and can heat dangerously. Nonetheless, numerous clinical centers have started interventional cardiovascular magnetic resonance (iCMR) programs for invasive hemodynamic studies or electrophysiology procedures to leverage the clear advantages of MRI tissue characterization, to quantify cardiac chamber function and flow, and to avoid ionizing radiation exposure. Clinical implementation of more complex cardiovascular interventions has been challenging because catheters and other tools require re-engineering for safety and conspicuity in the iCMR environment. However, recent innovations in scanner and interventional device technology, in particular availability of high performance low-field MRI scanners could be the inflection point, enabling a new generation of iCMR procedures. In this review we review these technical considerations, summarize contemporary clinical iCMR experience, and consider potential future applications.

The sponsor presented data from a patient-level meta-analysis incorporating the results from 2 European randomized trials of the Sentinel device (CLEAN-TAVI5 and MISTRAL-C6) and the results of the SENTINEL trial.3 Individual study and treatment groups were considered random and fixed effects, respectively.The panel recognized that availability of normative neurocognitive data is limited in octogenarians and stressed the importance of standardization of neurological testing in future clinical trials using recently published guidelines.7 Although there was no significant change in neurocognitive function between test and control arms in the SENTINEL trial, in post hoc analysis, there was some evidence of benefit in executive function with cerebral protection.1., C.R. Smith, M.B. Leon, M.J. Mack, Transcatheter versus surgical aortic-valve replacement in high-risk patients, N Engl J Med, Vol. 364, 2011, 2187-2198 2., De novo classification process (evaluation of automatic class III designation).Draft guidance for industry and Food and Drug Administration staff 3., S.R. Kapadia, S. Kodali, R. Makkar, Protection against cerebral embolism during transcatheter aortic valve replacement, J Am Coll Cardiol, Vol. 69, 2017, 367-377 4., A.P. Kappetein, S.J. Head, P. Genereux, Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document, J Thorac Cardiovasc Surg, Vol. 145, 2013, 6-23 5., S. Haussig, N. Mangner, M.G. Dwyer, Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI randomized clinical trial, JAMA, Vol. 316, 2016, 592-601 6., N.M. Van Mieghem, L. van Gils, H. Ahmad, Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial, EuroIntervention, Vol. 12, 2016, 499-507 7., A.J. Lansky, S.R. Messe, A.M. Brickman, Proposed standardized neurological endpoints for cardiovascular clinical trials: an Academic Research Consortium initiative, J Am Coll Cardiol, Vol. 69, 2017, 679-691

Safety and effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis have not yet been established. Transcatheter aortic valve replacement is feasible in patients with symptomatic severe aortic stenosis and low risk for surgical aortic valve replacement. The LRT study is the first US Food and Drug Administration–approved Investigational Device Exemption prospective multicenter feasibility trial of TAVR in low-risk patients. Patients determined to be low risk by the Heart Team will be enrolled to undergo TAVR with a commercially available balloon-expandable or self-expandable device. A propensity score–matched, site-specific cohort of historical surgical aortic valve replacement patients will serve as a control group treated during the site's enrollment period or within the prior 3 years. Low-risk patients with symptomatic bicuspid aortic stenosis undergoing TAVR will be enrolled into a separate registry arm. All TAVR patients will undergo 4-dimensional contrast-enhanced cardiac computed tomography 4-6 weeks after implantation to assess for subclinical leaflet thrombosis and will be followed up clinically for 5 years with yearly echocardiography to monitor prosthesis function. The LRT study will test feasibility of TAVR in low-risk patients with symptomatic severe aortic stenosis in the United States with either tricuspid or bicuspid native aortic valves. Enrollment commenced in 2016 and results are expected in 2018.