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This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I 2 ) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multisocietal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with fluorine-18 fluorodeoxyglucose ( 18 F-FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multifocal or diffuse heterogenous intense 18 F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more., (Copyright © 2024 by the American Society of Nuclear Cardiology, the American College of Cardiology, Heart Rhythm Society, and the Infectious Diseases Society of America. Published by Elsevier on behalf of the American Society of Nuclear Cardiology, the American College of Cardiology, Heart Rhythm Society, and by Oxford University Press on behalf of the Infectious Diseases Society of America. Published by Elsevier Inc. All rights reserved.)

Background: Frailty is associated with significant morbidity and mortality in older adults. Whether frailty predicts adverse outcomes after percutaneous left atrial appendage closure (LAAC) remains uncertain., Objective: The purpose of this study was to examine the association between frailty and clinical outcomes after percutaneous LAAC., Methods: We identified patients 65 years and older in Medicare fee-for-service claims who underwent LAAC between October 1, 2016, and December 31, 2019. Patients were identified as frail on the basis of the Hospital Frailty Risk Score (HFRS), a validated frailty measure centered on health resource utilization, with the cohort stratified into low (<5), intermediate (5-15), and high (>15) risk groups., Results: Of the 21,787 patients who underwent LAAC, 10,740 (49.3%) were considered frail (HFRS >5), including 3441 (15.8%) in the high-risk group. The mortality rate (up to 1095 days) were 16.1% in the low-risk group, 26.7% in the intermediate-risk group, and 41.1% in the high-risk group (P < .001). After adjusting for age, sex, and comorbidities, HFRS >15 (compared with HFRS <5) was associated with a higher risk of long hospital stay (odds ratio [OR] 8.29; 95% confidence interval [CI] 5.94-11.57), 30-day readmission (OR 1.80, 95% CI 1.58-2.05), 30-day mortality (OR 5.68, 95% CI 3.40-9.40), and 1-year mortality (OR 2.83, 95% CI 2.39-3.35). In restricted cubic spline models, the adjusted OR for all outcomes monotonically increased with increasing HFRS., Conclusion: Frailty is common in patients undergoing LAAC and is associated with increased risks of long hospital stay, readmissions, and short-term mortality., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine the applicability of pivotal transcatheter aortic valve replacement (TAVR) trials to the real-world population of Medicare patients undergoing TAVR., Background: It is unclear whether randomized controlled trial results of novel cardiovascular devices apply to patients encountered in clinical practice., Methods: Characteristics of patients enrolled in the U.S. CoreValve pivotal trials were compared with those of the population of Medicare beneficiaries who underwent TAVR in U.S. clinical practice between November 2, 2011, and December 31, 2017. Inverse probability weighting was used to reweight the trial cohort on the basis of Medicare patient characteristics, and a "real-world" treatment effect was estimated., Results: A total of 2,026 patients underwent TAVR in the U.S. CoreValve pivotal trials, and 135,112 patients underwent TAVR in the Medicare cohort. Trial patients were mostly similar to real-world patients at baseline, though trial patients were more likely to have hypertension (50% vs 39%) and coagulopathy (25% vs 17%), whereas real-world patients were more likely to have congestive heart failure (75% vs 68%) and frailty. The estimated real-world treatment effect of TAVR was an 11.4% absolute reduction in death or stroke (95% CI: 7.50%-14.92%) and an 8.7% absolute reduction in death (95% CI: 5.20%-12.32%) at 1 year with TAVR compared with conventional therapy (surgical aortic valve replacement for intermediate- and high-risk patients and medical therapy for extreme-risk patients)., Conclusions: The trial and real-world populations were mostly similar, with some notable differences. Nevertheless, the extrapolated real-world treatment effect was at least as high as the observed trial treatment effect, suggesting that the absolute benefit of TAVR in clinical trials is similar to the benefit of TAVR in the U.S. real-world setting., Competing Interests: Funding Support and Author Disclosures The study was funded by National Heart, Lung, and Blood Institute grant 1R01HL136708 (to Dr Yeh). Dr Butala is funded by the John S. LaDue Memorial Fellowship at Harvard Medical School; and has received consulting fees from and has ownership interest in HiLabs, outside the submitted work. Dr Secemsky has received grants from AstraZeneca, BD Bard, Boston Scientific, Cook Medical, Cardiovascular Systems, Inc., Medtronic, Philips, and the University of California, San Francisco; is a consultant for Cardiovascular Systems, Inc., Medtronic, and Philips; and is on the Speakers Bureaus of BD Bard, Cook Medical, and Medtronic. Dr Strom is funded by the National Heart, Lung, and Blood Institute (grant 1K23HL144907). Dr Brennan holds an Innovation in Regulatory Science Award from Burroughs Welcome Fund (1014158); is funded by the U.S. Food and Drug Administration (grant 1U01FD004591-01); and is a consultant for Edwards Lifesciences and Atricure. Dr Elmariah is funded by the American Heart Association (grant 19TPA34910170) and the U.S. Department of Defense (grant W81XWH1810080); has received grant support from Edwards Lifesciences and Svelte Medical; and has received consulting fees from AstraZeneca and Medtronic, outside the submitted work. Dr Yeh has received additional grant support from Abiomed, AstraZeneca, and Boston Scientific; and has received consulting fees from Abbott, Boston Scientific, Medtronic, and Teleflex, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee-adjudicated outcomes in the U.S. CoreValve studies., Background: Real-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints., Methods: Patients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated., Results: Claims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascertaining trial-adjudicated myocardial infarction (sensitivity 63.6%, specificity 97.2%, PPV 29.9%, NPV 99.3%, kappa 0.39) and acute kidney injury (sensitivity 70.2%, specificity 85.4%, PPV 38.2%, NPV 95.7%, kappa 0.41) and the poorest performance for identifying trial-adjudicated bleeding events (sensitivity 86.4%, specificity 36.8%, PPV 35.0%, NPV 86.3%, kappa 0.16)., Conclusions: Compared with trial-adjudicated outcomes, claims data performed well in ascertaining death and outcomes with procedural billing codes and more modestly in identifying other outcomes. Claims may be cautiously and selectively used to augment data collection in future cardiovascular device trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

This study aimed to evaluate changes in volume, risk profile, and outcomes among elderly individuals undergoing isolated aortic valve replacement (AVR) after TAVR approval in the United States. Retrospective cohort study of patients ≥65 years old with at least one procedural code for isolated SAVR or TAVR among the Medicare beneficiaries between January 1, 2009 and December 31, 2014. A total of 137,563 hospitalizations for isolated AVR between 2009 and 2014 were included (SAVR: 102,968 [74.9%]; TAVR: 34,595 [25.1%]). Overall AVR volumes increased by 21.8% per year after TAVR introduction, compared with 2.3% prior (p ≪ 0.001). Changes in SAVR volumes were similar both before and after TAVR introduction, (2.3% per year growth before vs. 2.1% after, p = 0.24). Although patient risk profiles increased among the AVR population (predicted 30-day mortality 4.0% in 2009 vs. 5.4% in 2014; p for trend =0.048), observed 30-day mortality (4.0% in 2009 vs. 3.9% in 2014; p for trend =0.96) and 1-year mortality (10.8% in 2009 to 12.2% in 2014; p for trend =0.069) rates remained stable. Among elderly U.S. patients enrolled in the Medicare, the introduction and the dissemination in the early phase of TAVR was associated with an expansion of AVR to high risk patients, without an observed reduction in the use of SAVR. This expansion was associated with similar mortality among all AVR patients, despite an increase in patient risk., (Copyright © 2019. Published by Elsevier B.V.)

Objectives: This study sought to evaluate the trends in isolated surgical aortic valve replacement (SAVR) procedures across hospitals with different transcatheter aortic valve replacement (TAVR) volumes among Medicare beneficiaries., Background: The volume of TAVR has increased in the United States since its approval, now exceeding that of isolated SAVR., Methods: Hospitalizations of adults (≥18 years of age) with International Classification of Diseases-9th Revision-Clinical Modification procedure codes for SAVR (35.21 or 35.22) or TAVR (35.05 or 35.06) who were included in the Medicare Provider Analysis and Review database between January 1, 2011, and December 31, 2014, were included. Trends in isolated SAVR patient characteristics, procedural volumes, and outcomes by quartile (Q) of hospital-level TAVR use were assessed over the study period., Results: A total of 37,705 isolated SAVR procedures were analyzed for the study. The annual volume of isolated SAVR procedures decreased in hospitals performing the largest number of TAVR procedures (Q3: 1,557 in 2011 to 1,391 in 2014; and Q4: 2,607 in 2011 to 1,791 in 2014). Thirty-day and 1-year mortality after SAVR also declined over the study period in hospitals with the largest TAVR volume (annual change rate in mortality for Q3: -16.4%; p < 0.001; Q4: -20.8%; p < 0.001)., Conclusions: The advent of TAVR was associated with a reduction in isolated SAVR volumes, a decrease in comorbidities among patients undergoing SAVR, and corresponding reductions in observed short- and long-term SAVR mortality among hospitals performing the greatest number of TAVRs., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility., Objective: The purpose of this study was to define major and minor adverse events with off-label MRI scans., Methods: We prospectively evaluated patients with non-MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months)., Results: A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories., Conclusion: Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)