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BackgroundCoronary artery calcium (CAC) is an established predictor of future major adverse atherosclerotic cardiovascular events in asymptomatic individuals. However, limited data exist as to how CAC compares with functional testing (FT) in estimating prognosis in symptomatic patients.MethodsIn the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain (or dyspnea) and intermediate pretest probability for obstructive coronary artery disease were randomized to FT (exercise electrocardiography, nuclear stress, or stress echocardiography) or anatomic testing. We evaluated those who underwent CAC testing as part of the anatomic evaluation (n=4209) and compared that with results of FT (n=4602). We stratified CAC and FT results as normal or mildly, moderately, or severely abnormal (for CAC: 0, 1-99 Agatston score [AS], 100-400 AS, and >400 AS, respectively; for FT: normal, mild=late positive treadmill, moderate=early positive treadmill or single-vessel ischemia, and severe=large ischemic region abnormality). The primary end point was all-cause death, myocardial infarction, or unstable angina hospitalization over a median follow-up of 26.1 months. Cox regression models were used to calculate hazard ratios (HRs) and C statistics to determine predictive and discriminatory values.ResultsOverall, the distribution of normal or mildly, moderately, or severely abnormal test results was significantly different between FT and CAC (FT: normal, n=3588 [78.0%]; mild, n=432 [9.4%]; moderate, n=217 [4.7%]; severe, n=365 [7.9%]; CAC: normal, n=1457 [34.6%]; mild, n=1340 [31.8%]; moderate, n=772 [18.3%]; severe, n=640 [15.2%]; P0), whereas fewer than half of events occurred in patients with mildly, moderately, or severely abnormal FT (n=57 of 132, 43%; P

BackgroundOptimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing.MethodsIn the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain and intermediate pretest probability for obstructive coronary artery disease (CAD) were randomly assigned to functional testing (exercise electrocardiography, nuclear stress, or stress echocardiography) or coronary computed tomography angiography (CTA). Site-based diagnostic test reports were classified as normal or mildly, moderately, or severely abnormal. The primary end point was death, myocardial infarction, or unstable angina hospitalizations over a median follow-up of 26.1 months.ResultsBoth the prevalence of normal test results and incidence rate of events in these patients were significantly lower among 4500 patients randomly assigned to CTA in comparison with 4602 patients randomly assigned to functional testing (33.4% versus 78.0%, and 0.9% versus 2.1%, respectively; both P10%) who had a normal functional test were reclassified as being mildly abnormal, the discriminatory capacity improved to 0.69 (95% CI, 0.64-0.74).ConclusionsCoronary CTA, by identifying patients at risk because of nonobstructive CAD, provides better prognostic information than functional testing in contemporary patients who have stable chest pain with a low burden of obstructive CAD, myocardial ischemia, and events.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01174550.

BackgroundDiagnostic testing in the care of patients newly presenting with symptoms suggestive of coronary artery disease may influence risk factor management, independent of test type or test results. However, little is known about changes in medications and lifestyle after anatomical or functional testing.Methods and resultsWe examined what factors influenced preventive medical therapy and lifestyle practices at 60 days among 10 003 symptomatic patients (53% women; mean age 61 years) randomly assigned to anatomical testing with coronary computed tomographic angiography or functional testing (NCT01174550). We also assessed the association of preventive changes with major cardiovascular events. There were no differences in medications/lifestyle at baseline. At 60 days, relative to baseline, the computed tomographic angiography strategy was associated with a higher proportion of patients newly initiating aspirin (11.8% versus 7.8%), statins (12.7% versus 6.2%), and β-blockers (8.1% versus 5.3%), compared to functional testing (P

BackgroundPROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) found that initial use of at least 64-slice multidetector computed tomography angiography (CTA) versus functional diagnostic testing strategies did not improve clinical outcomes in stable symptomatic patients with suspected coronary artery disease (CAD) requiring noninvasive testing.ObjectiveTo conduct an economic analysis for PROMISE (a major secondary aim of the study).DesignProspective economic study from the U.S. perspective. Comparisons were made according to the intention-to-treat principle, and CIs were calculated using bootstrap methods. (ClinicalTrials.gov: NCT01174550).Setting190 U.S. centers.Patients9649 U.S. patients enrolled in PROMISE between July 2010 and September 2013. Median follow-up was 25 months.MeasurementsTechnical costs of the initial (outpatient) testing strategy were estimated from Premier Research Database data. Hospital-based costs were estimated using hospital bills and Medicare cost-charge ratios. Physician fees were taken from the Medicare Physician Fee Schedule. Costs were expressed in 2014 U.S. dollars, discounted at 3% annually, and estimated out to 3 years using inverse probability weighting methods.ResultsThe mean initial testing costs were $174 for exercise electrocardiography; $404 for CTA; $501 to $514 for pharmacologic and exercise stress echocardiography, respectively; and $946 to $1132 for exercise and pharmacologic stress nuclear testing, respectively. Mean costs at 90 days were $2494 for the CTA strategy versus $2240 for the functional strategy (mean difference, $254 [95% CI, -$634 to $906]). The difference was associated with more revascularizations and catheterizations (4.25 per 100 patients) with CTA use. After 90 days, the mean cost difference between the groups out to 3 years remained small.LimitationCost weights for test strategies were obtained from sources outside PROMISE.ConclusionComputed tomography angiography and functional diagnostic testing strategies in patients with suspected CAD have similar costs through 3 years of follow-up.Primary funding sourceNational Heart, Lung, and Blood Institute.

· The clinical implications of heterogeneity in preclinical HF remain under-investigated. · Of a community sample, 25.3% were eligible for stage B HF, based on echo abnormalities. · Echo abnormalities without HF risk factors were related to normal physical fitness. · LV dysfunction/hypertrophy with HF risk factors were related to worse exercise capacity. · Evaluation of both HF risk factors and type of echo abnormality facilitates the stratification of HF risk. Clinical and echocardiographic features may carry diverse information about the development of heart failure (HF). Therefore, we determined heterogeneity in clinical and echocardiographic phenotypes and its association with exercise capacity. In 2036 community-dwelling individuals, we defined echocardiographic profiles of left and right heart remodeling and dysfunction. We subdivided the cohort based on presence (+) or absence (-) of HF risk factors (RFs) and echocardiographic abnormalities (RF-/Echo-, RF-/Echo+, RF+/Echo-, RF+/Echo+). Multivariable-adjusted associations between subgroups and physical performance metrics from 6-minute walk and treadmill exercise testing were assessed. The prevalence was 35.3% for RF-/Echo-, 4.7% for RF-/Echo+, 39.3% for RF+/Echo-, and 20.6% for RF+/Echo+. We observed large diversity in echocardiographic profiles in the Echo+ group. Participants with RF-/Echo+ (18.6% of Echo+) had predominantly echocardiographic abnormalities other than left ventricular (LV) diastolic dysfunction, hypertrophy and reduced ejection fraction, whereas their physical performance was similar to RF-/Echo-. In contrast, participants with RF+/Echo+ presented primarily with LV hypertrophy or dysfunction, features that related to lower 6-minute walking distance and lower exercise capacity. Subclinical echocardiographic abnormalities suggest HF pathogenesis, but the presence of HF risk factors and type of echo abnormality should be considered so as to distinguish adverse from benign adaptation and to stratify HF risk. [ABSTRACT FROM AUTHOR]

Current expected normal echocardiographic measures of transcatheter heart valve (THV) function were derived from pooled cohorts of the randomized trials; however, THV function by flow state before or following transcatheter aortic valve replacement (TAVR) has not been previously reported. This study sought to assess the expected normal echocardiographic hemodynamics for the balloon-expandable THV grouped by stroke volume index (SVI). Patients with severe aortic stenosis enrolled in PARTNER (Placement of Aortic Transcatheter Valves) 1 (high/extreme surgical risk), PARTNER 2 (intermediate surgical risk), or PARTNER 3 (low surgical risk) trials with complete core laboratory echocardiography were included. Patients were grouped by low-flow (SVI LOW <35 mL/m2) and normal-flow (SVI NORMAL ≥35 mL/m2). Mean gradient, effective orifice area (EOA), and Doppler velocity index (DVI) were collected at baseline and at 30 days post-TAVR. Prosthesis-patient mismatch (PPM) was both calculated and predicted from normative data, using defined criteria. In the entire population (N = 4,991), mean age was 81.8 years, 58% of patients were male, and 42% had low flow. Compared with patients with baseline SVI NORMAL , those with SVI LOW were more likely to be male; have more comorbidities; and lower left ventricular ejection fraction, mean gradient, and EOA. Post-TAVR, SVI LOW increased to SVI NORMAL in 17.3% and SVI NORMAL decreased to SVI LOW in 12.3% of patients. Using baseline SVI, follow-up EOA, mean gradient, and DVI for patients with SVI LOW tended to be lower than for patients with SVI NORMAL. Using the post-TAVR SVI, follow-up EOA, mean gradient, and DVI were significantly lower for patients with SVI LOW than for those with SVI NORMAL (P < 0.001 for all). The incidence of calculated, but not predicted, severe PPM was higher in patients with low flow than it was in patients with normal flow, suggesting pseudo-PPM in the presence of low flow. This study demonstrates that flow affects THV hemodynamics and both baseline and follow-up SVI should be considered when predicting THV hemodynamics prior to TAVR, as well as assessing valve function following valve implantation. [Display omitted] [ABSTRACT FROM AUTHOR]

BACKGROUND: Aortic valve replacement (AVR) is recommended for severe symptomatic aortic stenosis. However, the incidence of worsening tricuspid regurgitation (TR) following transcatheter compared with surgical AVR (TAVR, SAVR), and the impact of worsening TR on outcomes, is ill-defined. Accordingly, among patients randomized to TAVR or SAVR, we describe the differential incidence of worsening TR and its association with survival. METHODS: From the PARTNER IIA trial (Placement of Aortic Transcatheter Valves IIA), 1334 patients were included with baseline and 30-day postprocedure core-lab echocardiograms. Worsening TR was defined as deterioration of =1 grade from baseline to 30 days. Outcomes included cardiovascular and all-cause death between 30 days and 2 years. Multivariable logistic regression was performed to identify associations with worsening TR; survival analyses were performed to assess associations with mortality. RESULTS: Worsening TR occurred in 17.3% (125/721) of TAVR and 27.0% (165/611) of SAVR patients. On multivariable analysis, SAVR (odds ratio, 2.09 [95% CI, 1.40-3.11]), female sex (odds ratio, 2.22 [95% CI, 1.44-3.42]), atrial fibrillation (odds ratio, 1.61 [95% CI, 1.03-2.51]), and right ventricular enlargement (odds ratio, 2.25 [95% CI, 1.17-4.31]) were associated with worsening TR. Cardiovascular and all-cause death occurred in 9.0% (26/290) and 17.9% (52/290) of patients with worsening TR, compared with 4.8% (50/1042) and 10.9% (114/1042) without worsening TR, respectively. In patients with worsening TR, cardiovascular and all-cause death were similar in TAVR compared with SAVR, (hazard ratio, 1.09 [95% CI, 0.55-2.16]) and (hazard ratio, 1.07 [95% CI, 0.62-1.87]), respectively. After adjustment, worsening TR was independently associated with cardiovascular (hazard ratio, 3.62 [95% CI, 2.08-6.29]) and all-cause death (hazard ratio, 2.11 [95% CI, 1.37-3.27]). CONCLUSIONS: Worsening TR is associated with female sex, atrial fibrillation, right ventricular enlargement, and SAVR. Regardless of mode of AVR, worsening TR is similarly associated with a poor prognosis. Future studies should focus on whether preventing or treating worsening TR improves outcomes. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the association between Doppler velocity index (DVI) and 2-year outcomes for balloon-expandable SAPIEN 3 transcatheter aortic valve replacement (TAVR) and for surgical aortic valve replacement (SAVR). DVI >0.35 is normal for a prosthetic valve, but recent studies suggest that DVI <0.50 is associated with poor outcomes following TAVR. Patients with severe aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valve) 2 (intermediate surgical risk) or PARTNER 3 (low surgical risk) trial undergoing TAVR (n = 1,450) or SAVR (n = 1,303) were included. Patients were divided into 3 DVI groups on the basis of core laboratory–assessed discharge or 30-day echocardiograms: DVI LOW (≤0.35), DVI INTERMEDIATE (>0.35 to ≤0.50), and DVI HIGH (>0.50). Two-year outcomes were assessed. Following TAVR, there were no differences among the 3 DVI groups in composite outcomes of death, stroke, or rehospitalization or in any individual components of 2-year outcomes (P > 0.70 for all). Following SAVR, there was no difference among DVI groups in the composite outcome (P = 0.27), but there was a significant association with rehospitalization (P = 0.02). Restricted cubic-spline analysis for combined outcomes showed an increased risk with post-SAVR DVI ≤0.35 but no relationship post-TAVR. DVI ≤0.35 was associated with increased 2-year composite outcome for SAVR (HR: 1.81; 95% CI: 1.29–2.54; P < 0.001), with no adverse outcomes for TAVR (P = 0.86). In intermediate- and low-risk cohorts of the PARTNER trials, DVI ≤0.35 predicted worse 2-year outcomes following SAVR, driven primarily by rehospitalization, with no adverse outcomes associated with DVI following TAVR with the balloon-expandable SAPIEN 3 valve. [Display omitted] [ABSTRACT FROM AUTHOR]

Achieving optimal cardiovascular health in rural populations can be challenging for several reasons including decreased access to care with limited availability of imaging modalities, specialist physicians, and other important health care team members. Therefore, innovative solutions are needed to optimize health care and address cardiovascular health disparities in rural areas. Mobile examination units can bring imaging technology to underserved or remote communities with limited access to health care services. Mobile examination units can be equipped with a wide array of assessment tools and multiple imaging modalities such as computed tomography scanning and echocardiography. The detailed structural assessment of cardiovascular and lung pathology, as well as the detection of extracardiac pathology afforded by computed tomography imaging combined with the functional and hemodynamic assessments acquired by echocardiography, yield deep phenotyping of heart and lung disease for populations historically underrepresented in epidemiological studies. Moreover, by bringing the mobile examination unit to local communities, innovative approaches are now possible including engagement with local professionals to perform these imaging assessments, thereby augmenting local expertise and experience. However, several challenges exist before mobile examination unit–based examinations can be effectively integrated into the rural health care setting including standardizing acquisition protocols, maintaining consistent image quality, and addressing ethical and privacy considerations. Herein, we discuss the potential importance of cardiac multimodality imaging to improve cardiovascular health in rural regions, outline the emerging experience in this field, highlight important current challenges, and offer solutions based on our experience in the RURAL (Risk Underlying Rural Areas Longitudinal) cohort study. [ABSTRACT FROM AUTHOR]

Abstract Objectives This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves. Background Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function. Methods We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves. Results For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001). Conclusions Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed. Graphical abstract [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to understand the effects of balloon post-dilatation on outcomes following transcatheter aortic valve replacement with the SAPIEN 3 valve. Background Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported. Methods The effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed. Results 208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm 2 vs. 1.66 ± 0.37 cm 2 ; p = 0.04) with no significant difference in prosthesis–patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21). Conclusions BPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke. [ABSTRACT FROM AUTHOR]

Aims In patients randomized to transcatheter or surgical aortic valve replacement (TAVR, SAVR), we sought to determine whether SAVR is associated with worsening right ventricular (RV) function and whether RV deterioration is associated with mortality. Methods and results In 1376 patients from PARTNERIIA with paired baseline and 30-day core lab echocardiograms, worsening RV function was defined as decline by at least one grade from baseline to 30 days. Our primary outcome was all-cause mortality from 30 days to 2 years. Among 744 patients with TAVR, 62 (8.3%) had worsening RV function, compared with 156 of 632 patients with SAVR (24.7%) (P  < 0.0001). In a multivariable model, SAVR [odds ratio (OR) 4.05, 95% confidence interval (CI) 2.55–6.44], a dilated RV (OR 2.38, 95% CI 1.37–4.14), and more than mild tricuspid regurgitation (TR) (OR 2.58, 95% CI 1.25–5.33) were associated with worsening RV function. There were 169 deaths, and patients with worsening RV function had higher all-cause mortality [hazard ratio (HR) 1.98, 95% CI 1.40–2.79]. This association remained robust after adjusting for clinical and echocardiographic variables. Among patients with worsening RV function, there was no mortality difference between TAVR and SAVR (HR 1.16, 95% CI 0.61–2.18). The development of moderate or severe RV dysfunction from baseline normal RV function conferred the worst prognosis (HR 2.87, 95% CI 1.40–5.89). Conclusion After aortic valve replacement, worsening RV function is more common in patients with baseline RV dilation, more than mild TR, and in patients treated with SAVR. Worsening RV function and the magnitude of deterioration have important prognostic implications. View large Download slide View large Download slide [ABSTRACT FROM AUTHOR]

Objectives This study sought to determine if indexed effective orifice area (EOAi), using left ventricular outflow tract measured from computed tomography (EOAi CT ), reclassified prosthesis–patient mismatch (PPM) compared with conventional echocardiogram-defined measurements (EOAi TTE ). Background PPM does not predict mortality following transcatheter aortic valve replacement (TAVR). However, it is unknown if the EOAi CT of the left ventricular outflow tract improves risk stratification. Methods A total of 765 TAVR patients from the PARTNER II (Placement of Aortic Transcatheter Valves II) trial S3i cohort were evaluated. EOAi was calculated using the continuity equation, and the left ventricular outflow tract area was derived from baseline computed tomography. Traditional echocardiographic categories defined PPM: absent (>0.85 cm 2 /m 2 ), moderate (≥0.65 and ≤0.85 cm 2 /m 2 ), or severe (≤0.65 cm 2 /m 2 ). Correlation of EOAi CT and EOAi TTE to 1-year outcomes was performed. Results The incidence of PPM was 24% with EOA CT compared with 45% with EOAi TTE . Only 6% of PPM was graded severe by EOAi CT compared with 9% by EOAi TTE . EOAi TTE , but not EOAi CT , defined PPM showed association with reduced left ventricular mass regression (p = 0.03 vs. p = 0.52). There was no association between PPM and death or rehospitalization at 1 year with either modality. EOA CT was associated with minor stroke at 1 year (log-rank p = 0.04), and EOAi TTE with stroke/transient ischemic attack (log-rank p = 0.030). Furthermore, when subjects with mild or greater paravalvular regurgitation were excluded, the presence of PPM did not show association with any outcome. Conclusions EOAi CT downgrades frequency and severity of PPM in patients after TAVR, and was not associated with mortality 1 year after TAVR. EOAi TTE , but not EOAi CT , was associated with less left ventricular mass regression. [ABSTRACT FROM AUTHOR]

Objectives: To characterize the subgroup of outpatient pediatric patients presenting with chest pain and to determine the effectiveness of published pediatric appropriate use criteria (PAUC) to detect pathology.Study Design: The Pediatric Appropriate Use of Echocardiography study evaluated the use and yield of transthoracic echocardiography (TTE) before and after PAUC release. Data were reviewed on patients ?18 years of age who underwent TTE for chest pain. Indications were classified as appropriate (A), may be appropriate (M), and rarely appropriate (R) based on PAUC ratings, and findings were normal, incidental, or abnormal.Results: Chest pain was the primary indication in 772 of 4562 outpatient TTE studies (17%) (median age 14 years, IQR 10-16) ordered during the study period: 458 of 772 before (59%) and 314 of 772 after (41 %) the release of PAUC with no change in appropriateness. In A indications (n?=?654), 642 (98%) were normal, 5 (1%) had incidental findings, and 7 (1%) were abnormal. A and M detected 100% of all abnormal findings (A: n?=?7; M: n?=?6; R: n?=?0), with an association between ratings and findings (P?<.001). There was no association between R rating and any pathology.Conclusions: There was no change in ordering patterns with publication of the PAUC. Despite the high rate of TTEs ordered for indications rated A, most studies were normal. Studies that detected pathology were performed for indications rated A or M, but not R. This study supports PAUC as a useful tool in pediatric chest pain evaluation that may subsequently improve the use of TTE. [ABSTRACT FROM AUTHOR]

Background Syncope is a common reason for outpatient transthoracic echocardiography (TTE). We studied the applicability of pediatric appropriate use criteria (AUC) on initial outpatient evaluation of children (≤18 years) with syncope. Methods Data were obtained before (Phase I, April-September 2014) and after (Phase II, January-April 2015) the release of the AUC document from six participating pediatric cardiology centers. Site investigators determined the indication for TTE and assigned appropriateness rating based on the AUC document: Appropriate (A), May Be Appropriate (M), Rarely Appropriate (R), or 'unclassifiable' (U) if it did not fit any scenario in the AUC document. Results Of the total 4562 TTEs, 310 (6.8%) were performed for syncope: 174/2655 (6.6%) Phase I and 136/1907 (7.1%) Phase II, P=.44. Overall, 168 (50.5%) were for indications rated A, 63 (18.9%) for M, 79 (23.7%) for R, and 23 (6.9%) for U. Release of AUC did not change the appropriateness of TTEs [A=51.6% vs 49.0%, P=.63, R=20.2% vs 28.3%, P=.09]. Overall syncope-related R indications formed 15.7% of R indications for all the echocardiograms performed in the entire Pediatric Appropriate Use (PAUSE) study (11.9% Phase I and 22.4% Phase II, P=.002). TTEs were normal in majority of the patients except 7 that had incidental findings. Conclusions In conclusion, syncope is a common reason for indications rated R and release of the AUC document did not improve appropriate utilization of TTE in syncope. Targeted educational interventions are needed to reduce unnecessary TTEs in children with syncope. [ABSTRACT FROM AUTHOR]

Clinical core laboratories, such as Echocardiography core laboratories, are increasingly used in clinical studies with imaging outcomes as primary, secondary, or surrogate endpoints. While many factors contribute to the quality of measurements of imaging variables, an essential step in ensuring the value of imaging data includes formal assessment and control of reproducibility via intra-observer and inter-observer reliability. There are many different agreement/reliability indices in the literature. However, different indices may lead to different conclusions and it is not clear which index is the preferred choice as an overall indication of data quality and a tool for providing guidance on improving quality and reliability in a core lab setting. In this paper, we pre-specify the desirable characteristics of an agreement index for assessing and improving reproducibility in a core lab setting; we compare existing agreement indices in terms of these characteristics to choose a preferred index. We conclude that, among the existing indices reviewed, the coverage probability for assessing agreement is the preferred agreement index on the basis of computational simplicity, its ability for rapid identification of discordant measurements to provide guidance for review and retraining, and its consistent evaluation of data quality across multiple reviewers, populations, and continuous/categorical data. [ABSTRACT FROM AUTHOR]

Background: Appropriate use criteria (AUC) for cardiac stress tests address concerns about utilization growth and patient safety. We systematically reviewed studies of appropriateness, including within physician specialties; evaluated trends over time and in response to AUC updates; and characterized leading indications for inappropriate/rarely appropriate testing. Methods: We searched PubMed (2005–2015) for English-language articles reporting stress echocardiography or myocardial perfusion imaging (MPI) appropriateness. Data were pooled using random-effects meta-analysis and meta-regression. Results: Thirty-four publications of 41,578 patients were included, primarily from academic centers. Stress echocardiography appropriate testing rates were 53.0% (95% CI, 45.3%–60.7%) and 50.9% (42.6%–59.2%) and inappropriate/rarely appropriate rates were 19.1% (11.4%–26.8%) and 28.4% (23.9%–32.8%) using 2008 and 2011 AUC, respectively. Stress MPI appropriate testing rates were 71.1% (64.5%–77.7%) and 72.0% (67.6%–76.3%) and inappropriate/rarely appropriate rates were 10.7% (7.2%–14.2%) and 15.7% (12.4%–19.1%) using 2005 and 2009 AUC, respectively. There was no significant temporal trend toward rising rates of appropriateness for stress echocardiography or MPI. Unclassified stress echocardiograms fell by 79% (p = 0.04) with updated AUC. There were no differences between cardiac specialists and internists. Conclusions: Rates of appropriate use tend to be lower for stress echocardiography compared to MPI, and updated AUC reduced unclassified stress echocardiograms. There is no conclusive evidence that AUC improved appropriate use over time. Further research is needed to determine if integration of appropriateness guidelines in academic and community settings is an effective approach to optimizing inappropriate/rarely appropriate use of stress testing and its associated costs and patient harms. [ABSTRACT FROM AUTHOR]

Background-The management of aortic stenosis rests on accurate echocardiographic diagnosis. Hence, it was chosen as a test case to examine the utility of continuous quality improvement (CQI) approaches to increase echocardiographic data accuracy and reliability. A novel, multistep CQI program was designed and prospectively used to investigate whether it could minimize the difference in aortic valve mean gradients reported by echocardiography when compared with cardiac catheterization. Methods and Results-The Duke Echo Laboratory compiled a multidisciplinary CQI team including 4 senior sonographers and MD faculty to develop a mapped CQI process that incorporated Intersocietal Accreditation Commission standards. Quarterly, the CQI team reviewed all moderate-or greater-severity aortic stenosis echocardiography studies with concomitant catheterization data, and deidentified individual and group results were shared at meetings attended by cardiologists and sonographers. After review of 2011 data, the CQI team proposed specific amendments implemented over 2012: the use of nontraditional imaging and Doppler windows as well as evaluation of aortic gradients by a second sonographer. The primary outcome measure was agreement between catheterization-and echocardiography-derived mean gradients calculated by using the coverage probability index with a prespecified acceptable echocardiography-catheterization difference of <10 mm Hg in mean gradient. Between January 2011 and January 2014, 2093 echocardiograms reported moderate or greater aortic stenosis. Among cases with available catheterization data pre-and post-CQI, the coverage probability index increased from 54% to 70% (P=0.03; 98 cases, year 2011; 70 cases, year 2013). The proportion of patients referred for invasive valve hemodynamics decreased from 47% pre-CQI to 19% post-CQI (P<0.001). Conclusions-A laboratory practice pattern that was amenable to reform was identified, and a multistep modification was designed and implemented that produced clinically valuable performance improvements. The new protocol improved aortic stenosis mean gradient agreement between echocardiography and catheterization and was associated with a measurable decrease in referrals of patients for invasive studies. [ABSTRACT FROM AUTHOR]

Background. Anthracycline-containing chemotherapy (Anth-C) is associated with long-term cardiovascular mortality. Although cardiovascular risk assessment has traditionally focused on the heart, evidence has demonstrated that vascular dysfunction also occurs during and up to 1 year following Anth-C. Whether vascular dysfunction persists long-term or negatively influences cardiac function remains unknown. Hence, the present study evaluated ventricular-arterial coupling, in concert with measures of vascular structure and function, in the years following Anth-C. Methods. Arterial elastance (Ea), end-systolic elastance (Ees), and ventricular-arterial coupling (Ea/Ees) were measured during rest and exercise using echocardiography. Resting vascular function (flow-mediated dilation) and structure (carotid intima-media thickness, arterial stiffness) were also measured. Results. Thirty breast cancer survivors (6.5 6 3.6 years after Anth-C) with normal left ventricular ejection fraction (LVEF) (60%66%) and 30 matched controls were studied. At rest, no differences were found in Ea, Ees, Ea/Ees, or LVEF between groups. The normal exercise-induced increase in Ees was attenuated in survivors at 50% and 75% of maximal workload (p, .01). Ea/Ees was also higher at all workloads in the survivors compared with the controls (p, .01). No differences in vascular structure and function were observed between the two groups (p . .05). Conclusion. In the years after Anth-C, ventricular-arterial coupling was significantly attenuated during exercise, primarily owing to decreased LV contractility (indicated by a reduced Ees). This subclinical dysfunction appears to be isolated to the heart, as no differences in Ea were observed. The previously reported adverse effects of Anth-C on the vasculature appear to not persist in the years after treatment, as vascular structure and function were comparable to controls. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) using a balloon-expandable valve is an accepted alternative to surgical replacement for severe, symptomatic aortic stenosis in high risk or inoperable patients. Intraprocedural transesophageal echocardiography (TEE) offers real-time imaging guidance throughout the procedure and allows for rapid and accurate assessment of complications and procedural results. The value of intraprocedural TEE for TAVR will likely increase in the future as this procedure is performed in lower surgical risk patients, who also have lower risk for general anesthesia, but a greater expectation of optimal results with lower morbidity and mortality. This imaging compendium from the PARTNER (Placement of Aortic Transcatheter Valves) trials is intended to be a comprehensive compilation of intraprocedural complications imaged by intraprocedural TEE and diagnostic tools to anticipate and/or prevent their occurrence. [ABSTRACT FROM AUTHOR]

Context: Cardiac imaging has advanced rapidly, providing clinicians with several choices for evaluating patients with suspected coronary artery disease, but few studies compare modalities directly.Objectives: To review the contemporary literature and to compare the diagnostic performance of exercise echocardiography (ECHO) and exercise single-photon emission computed tomography (SPECT) imaging in the diagnosis of coronary artery disease.Data Sources: Studies published between January 1990 and October 1997 identified from MEDLINE search; bibliographies of reviews and original articles; and suggestions from experts in each area.Study Selection: Articles were included if they discussed exercise ECHO and/or exercise SPECT imaging with thallous chloride TI 201 (thallium) or technetium Tc 99m sestamibi for detection and/or evaluation of coronary artery disease, if data on coronary angiography were presented as the reference test, and if the absolute numbers of true-positive, false-negative, true-negative, and false-positive observations were available or derivable from the data presented. Studies performed exclusively in patients after myocardial infarction, after percutaneous transluminal coronary angioplasty, after coronary artery bypass grafting, or with recent unstable coronary syndromes were excluded.Data Extraction: Clinical variables, technical factors, and test performance were independently extracted by 2 reviewers on a standardized spreadsheet. Discrepancies were resolved by consensus.Results: Forty-four articles met inclusion criteria. In pooled data weighted by the sample size of each study, exercise ECHO had a sensitivity of 85% (95% confidence interval [CI], 83%-87%) with a specificity of 77% (95% CI, 74%-80%). Exercise SPECT yielded a similar sensitivity of 87% (95% CI, 86%-88%) but a lower specificity of 64% (95% CI, 60%-68%). In a summary receiver operating characteristic model comparing exercise ECHO performance to exercise SPECT, exercise ECHO was associated with significantly better discriminatory power (parameter estimate, 1.18; 95% CI, 0.71-1.65), when adjusted for age, publication year, and a setting including known coronary artery disease for SPECT studies. In models comparing the discriminatory abilities of exercise ECHO and exercise SPECT vs exercise testing without imaging, both ECHO and SPECT performed significantly better than exercise testing. The incremental improvement in performance was greater for ECHO (3.43; 95% CI, 2.74-4.11) than for SPECT (1.49; 95% CI, 0.91-2.08).Conclusions: Exercise ECHO and exercise SPECT have similar sensitivities for the detection of coronary artery disease, but exercise ECHO has better specificity and, therefore, higher overall discriminatory capabilities as used in contemporary practice. [ABSTRACT FROM AUTHOR]

Objective: To determine the value of routine transthoracic echocardiography in patients with cerebral ischemia without known cardiac disease.Design: The literature from 1990 to 1995 was searched and relevant bibliographies from these papers reviewed. Articles reporting the prevalence and/or risk of stroke for myxoma, vegetation, mitral stenosis, left atrial thrombus, left ventricular thrombus or cardiomyopathy, patent foramen ovale, and atrial septal aneurysm were used. Prevalences and recurrent stroke risk were examined for adult patients less than and greater than 45 years.Results: Both the prevalence of transthoracic echocardiographic findings and recurrent risk of stroke differ by age. The finding of a patent foramen ovale can be expected in nearly half of younger patients with stroke, whilst transthoracic echo can be expected to yield no relevant lesion in three quarters of patients > 45 years. Warfarin anticoagulation appears beneficial in patients with mitral stenosis, left atrial thrombus, left ventricular thrombus, and left ventricular dysfunction, but is of unproven benefit for patent foramen ovale, atrial septal aneurysm, or in the absence of a risk-associated abnormality.Conclusion: For most transthoracic echo findings in stroke, optimal management strategies have not been well defined. Future research is needed to evaluate the appropriate therapeutic approaches. [ABSTRACT FROM AUTHOR]

Objectives: We evaluated temporal trends and geographic variation in choice of stress testing modality after percutaneous coronary intervention (PCI), as well as associations between modality and procedure use after testing. Background: Stress testing is frequently performed post-PCI, but the choices among available modalities (electrocardiography only, nuclear, or echocardiography; pharmacological or exercise stress) and consequences of such choices are not well characterized. Methods: CathPCI Registry® data were linked with identifiable Medicare claims to capture stress testing use between 60 and 365 days post-PCI and procedures within 90 days after testing. Testing rates and modality used were modeled on the basis of patient, procedure, and PCI facility factors, calendar quarter, and Census Divisions using Poisson and logistic regression. Post-test procedure use was assessed using Gray''s test. Results: Among 284,971 patients, the overall stress testing rate after PCI was 53.1 per 100 person-years. Testing rates declined from 59.3 in quarter 1 (2006) to 47.1 in quarter 4 (2008), but the relative use of modalities changed little. Among exercise testing recipients, adjusted proportions receiving electrocardiography-only testing varied from 6.8% to 22.8% across Census Divisions; and among exercise testing recipients having an imaging test, the proportion receiving echocardiography (versus nuclear) varied from 9.4% to 34.1%. Post-test procedure use varied among modalities; exercise electrocardiography-only testing was associated with more subsequent stress testing (13.7% vs. 2.9%; p < 0.001), but less catheterization (7.4% vs. 14.1%; p < 0.001) than imaging-based tests. Conclusions: Modest reductions in stress testing after PCI occurring between 2006 and 2008 cannot be ascribed to trends in use of any single modality. Additional research should assess whether this trend represents better patient selection for testing or administrative policies (e.g., restricted access for patients with legitimate testing needs). Geographic variation in utilization of stress modalities and differences in downstream procedure use among modalities suggest a need to identify optimal use of the different test modalities in individual patients. [Copyright &y& Elsevier]

The advent of transcatheter aortic valve replacement (TAVR) is one of the most widely anticipated advances in the care of patients with severe aortic stenosis. This procedure is unique in many ways, one of which is the need for a multimodality imaging team-based approach throughout the continuum of the care of TAVR patients. Pre-procedural planning, intra-procedural implantation optimization, and long-term follow-up of patients undergoing TAVR require the expert use of various imaging modalities, each of which has its own strengths and limitations. Divided into 3 sections (pre-procedural, intraprocedural, and long-term follow-up), this review offers a single source for expert opinion and evidence-based guidance on how to incorporate the various modalities at each step in the care of a TAVR patient. Although much has been learned in the short span of time since TAVR was introduced, recommendations are offered for clinically relevant research that will lead to refinement of best practice strategies for incorporating multimodality imaging into TAVR patient care. [ABSTRACT FROM AUTHOR]

The article investigates the relation of physician billing with nuclear stress and stress echocardiography testing after coronary revascularization. Results reveal that the overall cumulative incidence of nuclear or echocardiography stress testing within 30 days of the index cardiac-related outpatient visit following revascularization was 12.2%. The cumulative incidence of nuclear stress testing was 12.6%, 8.8%, and 5.0% among physicians who billed for technical and professional fees, professional fees only, or neither, respectively. The findings indicate that nuclear stress testing and stress echocardiography testing after revascularization were more common among patients treated by doctors who billed for technical fees, professional fees, or both.

The effects of aging on cardiovascular function and cardiac structure were determined in a rat model recommended for gerontological studies. A cross-sectional analysis assessed cardiac changes in male Fischer 344 × Brown Norway Fl hybrid rats (FBN) from adulthood to the very aged (ii = 6 per 12-, 18-, 21-, 24-, 27-, 30-, 33-, 36-, and 39-mo-old group). Rats underwent echocardiographic and hemodynamic analyses to determine standard values for left ventricular (LV) mass, LV wall thickness, LV chamber diameter, heart rate, LV fractional shortening, mitral inflow velocity, LV relaxation time, and aortic/LV pressures. Histological analyses were used to assess LV fibrotic infiltration and cardiomyocyte volume density over time. Aged rats had an increased LV mass-to-body weight ratio and deteriorated systolic function. LV systolic pressure declined with age. Histological analysis demonstrated a gradual increase in fibrosis and a decrease in cardiomyocyte volume density with age. We conclude that, although significant physiological and morphological changes occurred in heart function and structure between 12 and 39 mo of age, these changes did not likely contribute to mortality. We report reference values for cardiac function and structure in adult FBN male rats through very old age at 3-mo intervals. [ABSTRACT FROM AUTHOR]

To investigate the effects of non-ECG-triggered imaging during ultrasound studies of endothelial function, brachial artery diameters were measured throughout the cardiac cycle at rest, during reactive hyperemia, and after administration of nitroglycerin. R-wave-triggered imaging using a 7.5-MHz ultrasound transducer with acquisition every 41.7-66.7 ms was performed in 24 subjects. Cardiac cycle-related variation was computed as the maximum per cent change from the end-diastolic diameter. The range of possible errors in flow-mediated dilation (FMD) and nitroglycerin-mediated vasodilation that may result from ignoring cyclic variations in diameter was determined for each condition. True FMD, true nitroglycerin-mediated vasodilation, and the maximum and minimum values that could be erroneously calculated for FMD if timing was ignored all differed dramatically (p < 0.05). The range of apparent FMD values that could be measured was nearly three times the true FMD value. Ignoring temporal position within the cardiac cycle artifactually increased calculated FMD into the normal range, despite truly impaired FMD. Peak arterial dilation occurred before end-systole and greater baseline vessel compliance was associated with greater FMD. Brachial arterial diameters vary significantly throughout the cardiac cycle. The magnitude of this variation is similar to the arterial dilation induced by reactive hyperemia and nitroglycerin, making ECG-triggered imaging mandatory for accurate and reproducible clinical and research measurements of artery diameters and FMD. Measurement of diameters at end-diastole may be preferred to other time-points in the cardiac cycle. [ABSTRACT FROM AUTHOR]

Investigates the recommended and actual use of infectious endocarditis (IE) prophylaxis among patients undergoing echocardiography. Design; Setting; Participants; Main Outcome Measure; Results; Conclusion that increased education is needed regarding the proper use of IE prophylaxis.

Objective: Previous studies suggest that gender affects the adaptive responses of the heart to some forms of cardiac overload. It is unknown whether gender influences left ventricular (LV) remodeling after myocardial infarction (MI). Methods: We performed transthoracic echocardiographic-Doppler examinations in age-matched male (n = 17) and female (n = 16) rats before, and 1 and 6 weeks after transmural MI or sham surgery. Results: Following large MI (male = 45 ± 1% LV circumference vs. female = 48 ± 4%, p = NS), both male and female rats developed progressive LV dilatation. Infarctions caused a similar degree of global and regional LV systolic dysfunction in males and females. Male rats had significant increases in the thickness of the noninfarcted posterior wall by 6 weeks after MI. However, posterior wall thickness did not change in the infarcted female rats. Average myocyte diameter in the noninfarcted region of the heart was also greater in male than female MI rats. The combination of increased cavity size with little change in wall thickness resulted in a greater decline in relative wall thickness in the female rats compared to the males. Male rats with MI showed progressively restricted LV diastolic filling as assessed by transmitral Doppler recordings. Female rats had less of an increase in the ratio of early to late transmitral velocities and less of an increase in the E wave deceleration rate after MI. Conclusions: Female rats showed a different pattern of LV remodeling than males with less of an increase in thickness of the noninfarcted portions of the left ventricle than males, but comparable LV cavity enlargement and systolic dysfunction. Despite similar infarct size, females developed less pronounced abnormalities of LV diastolic filling. We hypothesize that the gender-related differences in postinfarction LV remodeling may contribute to the different LV filling patterns, and might ultimately relate to differences in clinical outcome. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Although right atrial (RA) enlargement is an established marker for adverse outcomes, the prognostic importance of RA dysfunction independent of RA size in pulmonary arterial hypertension is not known. Methods and Results: Study subjects with pulmonary arterial hypertension were prospectively enrolled from 2010 to 2014. RA function was measured using RA speckle-tracking longitudinal strain and strain rate (SR) during each phase of the cardiac cycle: (1) RA reservoir (peak longitudinal strain, peak systolic SR), (2) RA conduit (peak early diastolic SR), and (3) RA active contraction (peak active contraction strain, peak contraction SR). The primary outcome was a composite of time to hospitalization or death assessed on follow-up. A total of 63 subjects had complete echocardiographic data. Of these, 91% were females, and the mean age was 58±12 years. During the follow-up period (range: 1–58 months), 39 were hospitalized or had died. After multivariable adjustment for age, sex, and left atrial size, peak longitudinal strain, peak active contraction strain, and peak early diastolic SR were significantly associated with increased risk of the composite outcome (P =0.0005, P =0.0167, and P =0.0054, respectively). Conclusions: RA dysfunction independently predicts mortality and hospitalizations in patients with pulmonary arterial hypertension. [ABSTRACT FROM AUTHOR]

Presents a comment on the transgenic experiments published in an article of Volume 6 of 'Nature Medicine.' Determination of the molecular mechanisms of cardiac hypertrophy; Examination of the surviving mice by echocardiography; Differentiation between specific and nonspecific effects of expression of the transgene.

Background: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models.Objectives: This study aimed to analyze whether BCM, compared with saline control, would result in less LV dilation and fewer adverse clinical events between baseline and 6 months.Methods: In an international, randomized, double-blind, controlled trial, 303 subjects with large areas of infarction despite successful primary percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) were randomized 2:1 to BCM or saline injected into the infarct-related artery 2 to 5 days after primary PCI. The primary outcome was mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months. Secondary outcomes included change in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk time, and New York Heart Association functional class at 6 months. The primary safety endpoint was a composite of cardiovascular death, recurrent MI, target-vessel revascularization, stent thrombosis, significant arrhythmia requiring therapy, or myocardial rupture through 6 months.Results: In total, 201 subjects were assigned to BCM and 102 to saline control. There was no significant difference in change in LVEDVI from baseline to 6 months between the groups (mean change ± SD: BCM 14.1 ± 28.9 ml/m(2) vs. saline 11.7 ± 26.9 ml/m(2); p = 0.49). There was also no significant difference in the secondary endpoints. The rates of the primary safety outcome were similar between the 2 groups (BCM 11.6% vs. saline 9.1%; p = 0.37).Conclusions: Intracoronary deployment of BCM 2 to 5 days after successful reperfusion in subjects with large myocardial infarction did not reduce adverse LV remodeling or cardiac clinical events at 6 months. (IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction [PRESERVATION I]; NCT01226563). [ABSTRACT FROM AUTHOR]

The article describes the causes of paravulvar leak (PVL) after transcatheter aortic valve replacement (TAVR). It mentions that it is not surprising to anticipate a higher frequency of PVL in TAVR due to the risks of prosthesis' inappropriate sizing and the interference of the old calcified valve. A study revealed that patients having aortic annulus <22 millimeter (mm) by echocardiography do not have moderate-severe PVL after TAVR.

Background: Few studies have evaluated if diastolic function could predict outcomes in patients with aortic stenosis.Objectives: The authors aimed to assess the association between diastolic dysfunction (DD) and outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).Methods: Baseline, 30-day, and 1- and 2-year transthoracic echocardiograms from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registry were analyzed by a consortium of core laboratories and divided into the American Society of Echocardiography DD groups.Results: Among the 1,750 included, 682 (54.4%) had grade 1 DD, 352 (28.1%) had grade 2 DD, 168 (13.4%) had grade 3 DD, and 51 (4.1%) had indeterminate DD grade. Incremental baseline grades of DD were associated with an increase in combined 1- and 2-year cardiovascular (CV) death/rehospitalization (all p < 0.002) and all-cause death at 2 years (p = 0.01) but not at 1 year. Improvement in DD grade/grade 1 DD at 30 days post-TAVR was seen in 70.8% patients. Patients with improvement in ≥1 grade of DD/grade 1 DD had reduced 1-year CV death/rehospitalization (p < 0.001) and increased 2-year survival (p = 0.01). Baseline grade 3 DD was a predictor of 1-year CV death/rehospitalization (hazard ratio: 2.73; 95% confidence interval: 1.07 to 6.98; p = 0.04). Improvement in DD grade/grade 1 DD at 30 days was protective for 1-year CV death/rehospitalizations (hazard ratio: 0.39; 95% confidence interval: 0.19 to 0.83; p = 0.01).Conclusions: In the PARTNER 2 SAPIEN 3 registry, baseline DD was a predictor of up to 2 years clinical outcomes in patients who underwent TAVR. Improvement in DD grade at 30 days was associated with improvement in short-term clinical outcomes. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128; PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 [PII S3HR/NR7]; NCT03222141). [ABSTRACT FROM AUTHOR]