Racial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019.

PURPOSE: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis. METHODS: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality. RESULTS: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity. CONCLUSIONS: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations.

Cost Effectiveness of Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension.

BACKGROUND: Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90 mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system. METHODS: Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP ('control' patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs). RESULTS: A mean reduction in office SBP of 8.5 mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (€6500) per QALY gained (95% confidence interval £5463-£5739 [€6341-€6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000-£30,000 (€23,214-€34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks. CONCLUSIONS: Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication.

ACC/AHA/ASE/ASNC/ASPC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2023 Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease.

The American College of Cardiology (ACC) Foundation, along with key specialty and subspecialty societies, conducted an appropriate use review of stress testing and anatomic diagnostic procedures for risk assessment and evaluation of known or suspected chronic coronary disease (CCD), formerly referred to as stable ischemic heart disease (SIHD). This document reflects an updating of the prior Appropriate Use Criteria (AUC) published for radionuclide imaging, stress echocardiography (echo), calcium scoring, coronary computed tomography angiography (CCTA), stress cardiac magnetic resonance (CMR), and invasive coronary angiography for SIHD. This is in keeping with the commitment to revise and refine the AUC on a frequent basis. As with the prior version of this document, rating of test modalities is provided side-by-side for a given clinical scenario. These ratings are explicitly not considered competitive rankings due to the limited availability of comparative evidence, patient variability, and the range of capabilities available in any given local setting1-4.This version of the AUC for CCD is a focused update of the prior version of the AUC for SIHD4. Key changes beyond the updated ratings based on new evidence include the following: 1. Clinical scenarios related to preoperative testing were removed and will be incorporated into another AUC document under development. 2. Some clinical scenarios and tables were removed in an effort to simplify the selection of clinical scenarios. Additionally, the flowchart of tables has been reorganized, and all clinical scenario tables can now be reached by answering a limited number of clinical questions about the patient, starting with the patient's symptom status. 3. Several clinical scenarios have been revised to incorporate changes in other documents such as pretest probability assessment, atherosclerotic cardiovascular disease (ASCVD) risk assessment, syncope, and others. ASCVD risk factors that are not accounted for in contemporary risk calculators have been added as modifiers to certain clinical scenarios. The 64 clinical scenarios rated in this document are limited to the detection and risk assessment of CCD and were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines.5 These clinical scenarios do not specifically address patients having acute chest pain episodes. They may, however, be applicable in the inpatient setting if the patient is not having an acute coronary syndrome and warrants evaluation for CCD.Using standardized methodology, clinical scenarios were developed to describe common patient encounters in clinical practice focused on common applications and anticipated uses of testing for CCD. Where appropriate, the scenarios were developed on the basis of the most current ACC/American Heart Association guidelines. A separate, independent rating panel scored the clinical scenarios in this document on a scale of 1 to 9, following a modified Delphi process consistent with the recently updated AUC development methodology. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented, midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is rarely appropriate.

Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US.

Importance: Professional societies and the Centers for Medicare & Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI). Objective: To model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access. Design, Setting, and Participants: This cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020. Exposures: Within each hospital referral region, TAVI sites were categorized by volume (<50 or ≥50 TAVIs per year) and separately by risk-adjusted outcome on the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy 30-day TAVI composite during the baseline period (July 2017 to June 2020). Outcomes of patients undergoing TAVIs from July 1, 2020, to March 31, 2022, were then modeled as though the patients had been treated at (1) the nearest higher volume (≥50 TAVIs per year) or (2) the best outcome site within the hospital referral region. Main Outcomes and Measures: The primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance. Results: The overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (-34; 95% CrI, -75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas. Conclusions and Relevance: In this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

Accuracy of IVUS-Based Machine Learning Segmentation Assessment of Coronary Artery Dimensions and Balloon Sizing.

Background: Accurate intravascular ultrasound (IVUS) measurements are important in IVUS-guided percutaneous coronary intervention optimization by choosing the appropriate device size and confirming stent expansion. Objectives: The purpose of this study was to assess the accuracy of machine learning (ML) automatic segmentation of coronary artery vessel and lumen dimensions and balloon sizing. Methods: Using expert analysis as the gold standard, ML segmentation of 60 MHz IVUS images was developed using 8,076 IVUS cross-sectional images from 234 patients, which were randomly split into training (83%) and validation (17%) data sets. The performance of ML segmentation was then evaluated using an independent test data set (437 images from 92 patients). The endpoints were the agreement rate between ML vs experts' measurements for appropriate balloon size selection, and lumen and acute stent areas. Appropriate balloon size was determined by rounding down from the mean vessel diameter or rounding up from the mean lumen diameter to the next balloon size. The difference of lumen area ≥0.5 mm2 was considered as clinically significant. Results: ML model segmentation correlated well with experts' segmentation for training data set with a correlation coefficient of 0.992 and 0.993 for lumen and vessel areas, respectively. The agreement rate in lumen and acute stent areas was 85.5% and 97.0%, respectively. The agreement rate for appropriate balloon size selection was 70.6% by vessel diameter only and 92.4% by adding lumen diameter. Conclusions: ML model IVUS segmentation measurements were well-correlated with those of experts and selected an appropriate balloon size in more than 90% of images.

Outcomes Associated With Peripheral Artery Disease in Myocardial Infarction With Cardiogenic Shock.

BACKGROUND: Mortality rates for patients presenting with acute myocardial infarction (AMI) and cardiogenic shock (CS) remain high despite advances in revascularization strategies and mechanical circulatory support (MCS) devices. OBJECTIVES: This study sought to elucidate the association between comorbid lower extremity peripheral artery disease (PAD) and outcomes in CS and AMI. METHODS: PAD status was defined in Medicare beneficiaries hospitalized with CS and AMI from October 1, 2015 to June 30, 2018. Primary outcomes ascertained through December 31, 2018 included in- and out-of-hospital mortality. Secondary outcomes included bleeding, amputation, stroke, and lower extremity revascularization. Multivariable regression models with adjustment for confounders were used to estimate risk. Subgroup analyses included patients treated with MCS and those who underwent coronary revascularization. RESULTS: Among 71,690 patients, 5.9% (N = 4,259) had PAD. Mean age was 77.8 ± 7.9 years, 58.7% were male, and 84.3% were White. Cumulative in-hospital mortality was 47.2%, with greater risk among those with PAD (56.3% vs 46.6% without PAD; adjusted OR: 1.50; 95% CI: 1.40-1.59). PAD patients also had greater risk of in-hospital amputation (1.6% vs 0.2%; adjusted OR: 7.0; 95% CI: 5.26-9.37) and out-of-hospital mortality (67.9% vs 40.7%; adjusted HR: 1.78; 95% CI: 1.67-1.90). MCS was less frequently utilized in PAD patients (21.5% vs 38.6% without PAD; P < 0.001) and was associated with higher mortality, need for lower extremity revascularization, and amputation risk. Findings were consistent in patients who underwent coronary revascularization. CONCLUSIONS: Among patients presenting with AMI and CS, PAD was associated with worse limb outcomes and survival. In addition to lower MCS utilization rates, those with PAD who received MCS had increased mortality, lower extremity revascularization, and amputation rates.

Trends in Transcatheter and Surgical Aortic Valve Replacement Among Older Adults in the United States.

BACKGROUND: Recent trends, including survival beyond 30 days, in aortic valve replacement (AVR) following the expansion of indications for transcatheter aortic valve replacement (TAVR) are not well-understood. OBJECTIVES: The authors sought to characterize the trends in characteristics and outcomes of patients undergoing AVR. METHODS: The authors analyzed Medicare beneficiaries who underwent TAVR and SAVR in 2012 to 2019. They evaluated case volume, demographics, comorbidities, 1-year mortality, and discharge disposition. Cox proportional hazard models were used to assess the annual change in outcomes. RESULTS: Per 100,000 beneficiary-years, AVR increased from 107 to 156, TAVR increased from 19 to 101, whereas SAVR declined from 88 to 54. The median [interquartile range] age remained similar from 77 [71-83] years to 78 [72-84] years for overall AVR, decreased from 84 [79-88] years to 81 [75-86] years for TAVR, and decreased from 76 [71-81] years to 72 [68-77] years for SAVR. For all AVR patients, the prevalence of comorbidities remained relatively stable. The 1-year mortality for all AVR decreased from 11.9% to 9.4%. Annual change in the adjusted odds of 1-year mortality was 0.93 (95% CI: 0.92-0.94) for TAVR and 0.98 (95% CI: 0.97-0.99) for SAVR, and 0.94 (95% CI: 0.93-0.95) for all AVR. Patients discharged to home after AVR increased from 24.2% to 54.7%, primarily driven by increasing home discharge after TAVR. CONCLUSIONS: The advent of TAVR has led to about a 60% increase in overall AVR in older adults. Improving outcomes in AVR as a whole following the advent of TAVR with increased access is a reassuring trend.

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States. METHODS: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables. RESULTS: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05­1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93­1.47]). CONCLUSIONS: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.

Pulmonary Embolism Response Team utilization during the COVID-19 pandemic.

Coronavirus disease 2019 (COVID-19) may predispose patients to venous thromboembolism (VTE). Limited data are available on the utilization of the Pulmonary Embolism Response Team (PERT) in the setting of the COVID-19 global pandemic. We performed a single-center study to evaluate treatment, mortality, and bleeding outcomes in patients who received PERT consultations in March and April 2020, compared to historical controls from the same period in 2019. Clinical data were abstracted from the electronic medical record. The primary study endpoints were inpatient mortality and GUSTO moderate-to-severe bleeding. The frequency of PERT utilization was nearly threefold higher during March and April 2020 (n = 74) compared to the same period in 2019 (n = 26). During the COVID-19 pandemic, there was significantly less PERT-guided invasive treatment (5.5% vs 23.1%, p = 0.02) with a numerical but not statistically significant trend toward an increase in the use of systemic fibrinolytic therapy (13.5% vs 3.9%, p = 0.3). There were nonsignificant trends toward higher in-hospital mortality or moderate-to-severe bleeding in patients receiving PERT consultations during the COVID-19 period compared to historical controls (mortality 14.9% vs 3.9%, p = 0.18 and moderate-to-severe bleeding 35.1% vs 19.2%, p = 0.13). In conclusion, PERT utilization was nearly threefold higher during the COVID-19 pandemic than during the historical control period. Among patients evaluated by PERT, in-hospital mortality or moderate-to-severe bleeding were not significantly different, despite being numerically higher, while invasive therapy was utilized less frequently during the COVID-19 pandemic.

Impact of the COVID-19 pandemic on interventional cardiology fellowship training in the New York metropolitan area: A perspective from the United States epicenter.

BACKGROUND: The healthcare burden posed by the coronavirus disease 2019 (COVID-19) pandemic in the New York Metropolitan area has necessitated the postponement of elective procedures resulting in a marked reduction in cardiac catheterization laboratory (CCL) volumes with a potential to impact interventional cardiology (IC) fellowship training. METHODS: We conducted a web-based survey sent electronically to 21 Accreditation Council for Graduate Medical Education accredited IC fellowship program directors (PDs) and their respective fellows. RESULTS: Fourteen programs (67%) responded to the survey and all acknowledged a significant decrease in CCL procedural volumes. More than half of the PDs reported part of their CCL being converted to inpatient units and IC fellows being redeployed to COVID-19 related duties. More than two-thirds of PDs believed that the COVID-19 pandemic would have a moderate (57%) or severe (14%) adverse impact on IC fellowship training, and 21% of the PDs expected their current fellows' average percutaneous coronary intervention (PCI) volume to be below 250. Of 25 IC fellow respondents, 95% expressed concern that the pandemic would have a moderate (72%) or severe (24%) adverse impact on their fellowship training, and nearly one-fourth of fellows reported performing fewer than 250 PCIs as of March 1st. Finally, roughly one-third of PDs and IC fellows felt that there should be consideration of an extension of fellowship training or a period of early career mentorship after fellowship. CONCLUSIONS: The COVID-19 pandemic has caused a significant reduction in CCL procedural volumes that is impacting IC fellowship training in the NY metropolitan area. These results should inform professional societies and accreditation bodies to offer tailored opportunities for remediation of affected trainees.

Clinical Pathway for Management of Suspected or Positive Novel Coronavirus-19 Patients With ST-Segment Elevation Myocardial Infarction.

Novel coronavirus-19 disease (COVID-19) is an escalating, highly infectious global pandemic that is quickly overwhelming healthcare systems. This has implications on standard cardiac care for ST-elevation myocardial infarctions (STEMIs). In the setting of anticipated resource scarcity in the future, we are forced to reconsider fibrinolytic therapy in our management algorithms. We encourage clinicians to maintain a high level of suspicion for STEMI mimics, such as myopericarditis which is a known, not infrequent, complication of COVID-19 disease. Herein, we present a pathway developed by a multidisciplinary panel of stakeholders at NewYork-Presbyterian/Columbia University Irving Medical Center for the management of STEMI in suspected or confirmed COVID-19 patients.

Burden of Valvular Heart Diseases in Hispanic/Latino Individuals in the United States: The Echocardiographic Study of Latinos.

OBJECTIVE: To explore the burden and clinical correlates of valvular heart disease in Hispanics/Latinos in the United States. PATIENTS AND METHODS: A total of 1818 individuals from the population-based study of Latinos/Hispanics from 4 US metropolitan areas (Bronx, New York; Chicago, Illinois; San Diego, California; and Miami, Florida) underwent a comprehensive clinical and echocardiographic examination from October 1, 2011, through June 24, 2014. Logistic regression analysis was used to examine the associations of clinical and sociodemographic variables with valvular lesions. RESULTS: The mean age was 55.2±0.2 years; 57.4% were female. The prevalence of any valvular heart disease (AVHD) was 3.1%, with no considerable differences across sex, and a higher prevalence with increasing age. The proportion of US-born vs foreign-born individuals was similar in those with vs without AVHD (P=.31). The weighted prevalence of AVHD was highest in Central Americans (8.4%) and lowest in Mexicans (1.2%). Regurgitant lesions of moderate or greater severity were present in 2.4% of the population and stenotic lesions of moderate or greater severity in 0.2%. Compared with those without AVHD, individuals with AVHD were more likely to have health insurance coverage (59.6% vs 79.2%; P=.007) but similar income (P=.06) and educational status (P=.46). Univariate regression models revealed that regurgitant lesions were associated with lower body mass index whereas stenotic lesions were associated with higher body mass index. CONCLUSION: Our data provide the first population-based estimates of the prevalence of valvular heart disease in Hispanic/Latinos. Valvular heart disease is fairly common in the Hispanic/Latino population and may constitute an important public health problem.