Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S.

BACKGROUND: Intraprocedural imaging is critical for device delivery in transcatheter left atrial appendage occlusion (LAAO). Although pivotal trials of LAAO devices were conducted using transesophageal echocardiography (TEE), intracardiac echocardiography (ICE) is an emerging imaging modality. OBJECTIVES: This study compared outcomes after ICE- and TEE-guided Watchman FLX implantation in the SURPASS (SURveillance Post Approval AnalySiS Plan) nationwide LAAO registry. METHODS: Baseline characteristics were compared using chi-square and t-tests. Outcomes were reported in unadjusted and adjusted comparisons via propensity weighting. RESULTS: Between August 2020 and September 2021, LAAO was attempted in 39,759 patients at 698 sites, including 2,272 cases (5.7%) with ICE and 31,835 (80.0%) with TEE. ICE and TEE patients had similar baseline characteristics and mean procedural times (ICE 82 minutes vs TEE 78 minutes). ICE patients were less likely to receive general anesthesia (54% vs 98%, P < 0.01). Successful device implantation (98.3% vs 97.6%) and complete seal rates at 45 days were similar (n = 25,280; 83% vs 82%). Most adverse event rates were similar; unadjusted mortality rates at 45 days were 1.1% for ICE vs 0.8% for TEE (P = 0.14), and 1.0% vs 0.7% (P = 0.27) in adjusted analyses. Even after adjustment, pericardial effusion rates requiring intervention were significantly higher with ICE at 45 days (1.0% vs 0.5%; P = 0.02). This rate decreased as operators performed more ICE-guided procedures, although 82% of operators had performed <10 ICE-guided procedures overall. CONCLUSIONS: In the largest comparison to date, ICE use was infrequent. ICE and TEE both achieved high rates of complete LAAO. ICE was associated with significantly higher rates of pericardial effusion requiring intervention.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock.

Importance: Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). Objective: To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. Design, Setting, and Participants: This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Interventions: Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Main Outcomes and Measures: Thirty-day all-cause mortality and readmissions. Results: Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. Conclusions: In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

Incidence, Treatment, and Outcomes of Symptomatic Device Lead-Related Venous Obstruction.

BACKGROUND: The incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined. OBJECTIVES: The objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention. METHODS: LRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models. RESULTS: Among 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management. CONCLUSIONS: In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization.

Improvements in Hypertension Control in the Rural Longitudinal HAALSI Cohort of South African Adults Aged 40 and Older, From 2014 to 2019.

BACKGROUND: Over half of the South African adults aged 45 years and older have hypertension but its effective management along the treatment cascade (awareness, treatment, and control) remains poorly understood. METHODS: We compared the prevalence of all stages of the hypertension treatment cascade in the rural HAALSI cohort of older adults at baseline and after four years of follow-up using household surveys and blood pressure data. Hypertension was a mean systolic blood pressure >140 mm Hg or diastolic pressure >90 mm Hg, or current use of anti-hypertension medication. Control was a mean blood pressure <140/90 mm Hg. The effects of sex and age on the treatment cascade at follow-up were assessed. Multivariate Poisson regression models were used to estimate prevalence ratios along the treatment cascade at follow-up. RESULTS: Prevalence along the treatment cascade increased from baseline (B) to follow-up (F): awareness (64.4% vs. 83.6%), treatment (49.7% vs. 73.9%), and control (22.8% vs. 41.3%). At both time points, women had higher levels of awareness (B: 70.5% vs. 56.3%; F: 88.1% vs. 76.7%), treatment (B: 55.9% vs. 41.55; F: 79.9% vs. 64.7%), and control (B: 26.5% vs. 17.9%; F: 44.8% vs. 35.7%). Prevalence along the cascade increased linearly with age for everyone. Predictors of awareness included being female, elderly, or visiting a primary health clinic three times in the previous 3 months, and the latter two also predicted hypertension control. CONCLUSIONS: There were significant improvements in awareness, treatment, and control of hypertension from baseline to follow-up and women fared better at all stages, at both time points.

Significant Improvement in Blood Pressure Levels Among Older Adults With Hypertension in Rural South Africa.

BACKGROUND: Sub-Saharan Africa is undergoing an epidemiologic transition from infectious diseases to cardiovascular diseases. From 2014 to 2019, sociodemographic surveillance was performed in a large cohort in rural South Africa. METHODS: Disease prevalence and incidence were calculated using inverse probability weights. Poisson regression was used to identify disease predictors. The percentage of individuals with controlled (<140/90 mm Hg) versus uncontrolled hypertension was compared between 2014 and 2019. RESULTS: Compared with 2014 (n=5059), study participants in 2019 (n=4176) had similar rates of obesity (mean body mass index, 27.5±10.0 versus 27.0±6.5) but higher smoking (9.1% versus 11.5%) and diabetes (11.1% versus 13.9%). There was no significant increase in hypertension prevalence (58.4% versus 59.8%; age adjusted, 64.3% versus 63.3%), and there was a significant reduction in mean systolic blood pressure (138.0 versus 128.5 mm Hg; P<0.001). Among hypertensive individuals who reported medication use in 2014 and 2019 (n=796), the proportion with controlled hypertension on medication increased from 44.5% to 62.3%. Hypertension incidence was 6.2 per 100 person-years, and age was the only independent predictor. Among normotensive individuals in 2014 (n=2257), 15.2% developed hypertension by 2019, with the majority already controlled on medications by 2019. CONCLUSIONS: The hypertension prevalence and incidence are plateauing in this aging cohort. There was a statistically and clinically significant decline in mean blood pressure and a substantial increase in individuals with controlled hypertension on medication. The prevalence of cardiometabolic risk factors did not decrease over time, suggesting that the blood pressure decrease is likely due to increased medication access and adherence, promoted by local health systems.

Comparative performance of distinct frailty measures among patients undergoing percutaneous left atrial appendage closure.

AIMS: Frailty is associated with increased morbidity and mortality in patients undergoing left atrial appendage closure (LAAC). This study aimed to compare the performance of two claims-based frailty measures in predicting adverse outcomes following LAAC. METHODS: We identified patients 66 years and older who underwent LAAC between October 1, 2016, and December 31, 2019, in Medicare fee-for-service claims. Frailty was assessed using the previously validated Hospital Frailty Risk Score (HFRS) and Kim Claims-based Frailty Index (CFI). Patients were identified as frail based on HFRS ≥5 and CFI ≥0.25. RESULTS: Of the 21,787 patients who underwent LAAC, frailty was identified in 45.6% by HFRS and 15.4% by CFI. There was modest agreement between the two frailty measures (kappa 0.25, Pearson's correlation 0.62). After adjusting for age, sex, and comorbidities, frailty was associated with higher risk of 30-day mortality, 1-year mortality, 30-day readmission, long hospital stay, and reduced days at home (p < .01 for all) regardless of the frailty measure used. The addition of frailty to standard comorbidities significantly improved model performance to predict 1-year mortality, long hospital stay, and reduced days at home (Delong p-value < .001). CONCLUSION: Despite significant variation in frailty detection and modest agreement between the two frailty measures, frailty status remained highly predictive of mortality, readmissions, long hospital stay, and reduced days at home among patients undergoing LAAC. Measuring frailty in clinical practice, regardless of the method used, may provide prognostic information useful for patients being considered for LAAC, and may inform shared decision-making in this population.

Psychometric Evaluation and Validation of the HIV Stigma Scale in Spanish among Men who have Sex with Men and Transgender Women.

Stigma and discrimination toward the LGBTQ community is pervasive and negatively impacts health. Validated measures of stigma in Spanish, however, are limited and none have specifically validated HIV-related stigma in Spanish-speaking men who have sex with men (MSM) and transgender women (TGW) in resource-limited settings. The aim of this study is to evaluate the psychometric properties of a standardized HIV Stigma Scale, translated to Spanish, including its factor structure. Measures consisted of self-reported socio-demographic measures of age, sex, sexual orientation, education, employment status, income, living situation, HIV stigma, depressive symptoms, and social support. Using SPSS AMOS 24, a confirmatory factor analysis (CFA) of the 10-item Wright HIV Stigma Scale translated to Spanish was conducted in 359 MSM and TGW with HIV recruited from HIV clinics in Lima, Peru. The path model with three sub-scales: enacted, anticipated and internalized stigma, with eight items had an adequate fit to the data. The Spanish version (HIV Stigma Scale-ES) and its dimensions are similar to the ones validated in English for people with HIV (not MSM). Each construct was deemed to be reliable and showed good construct validity. Given the need to better understand and measure stigma in Spanish-speaking MSM, the HIV Stigma Scale-ES can be a useful tool to examine stigma.

The Need to Standardize Our Language Around Dual Antiplatelet Therapy-A Call to Action.

This Viewpoint summarizes the complexity of the existing terminology used for dual antiplatelet therapy (DAPT) and the need to standardize the terminology for use in clinical cardiology and scientific research.

Frailty in patients undergoing percutaneous left atrial appendage closure.

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.

Echocardiographic and Electrocardiographic Abnormalities Among Elderly Adults With Cardiovascular Disease in Rural South Africa.

BACKGROUND: Sub-Saharan Africa is undergoing an epidemiological transition fueled by the interaction between infectious and cardiovascular diseases. Our cross-sectional study aimed to characterize the spectrum of abnormalities suggesting end-organ damage on ECG and transthoracic echocardiograms (TTE) among older adults with cardiovascular diseases in rural South Africa. METHODS: The prevalence of ECG and TTE abnormalities was estimated; χ2 analyses and multivariable logistic regressions were performed to test their association with sex, hypertension, and other selected comorbidities. RESULTS: Overall, 729 ECGs and 155 TTEs were completed, with 74 participants completing both. ECG evaluation showed high rates of left ventricular hypertrophy (LVH, 36.5%) and T wave abnormalities (13.6%). TTE evaluation showed high rates of concentric LVH (31.6%), with moderate-severe (56.8%) diastolic dysfunction. Participants with hypertension showed more cardiac remodeling on ECG by LVH (45.4% versus 22.1%, P<0.01), and TTE by concentric LVH (42.5% versus 8.2%, P<0.01) and increased left ventricular mass (58.5% versus 20.4%, P<0.0001). In multivariable logistic regression, systolic blood pressure remained significantly associated with LVH on ECG (adjusted odds ratio, 1.03 per mm Hg [95% CI, 1.03-1.04], P<0.0001) and increased left ventricular mass on TTE (adjusted odds ratio, 1.04 per mm Hg [95% CI, 1.01-1.06], P=0.001). Male participants (n=326, 40.2%) were more likely than females (n=484, 59.8%) to show ECG abnormalities like LVH (45% versus 30.8%, P<0.01), whereas females were more likely to show TTE abnormalities like concentric LVH (40.8% versus 13.5%, P<0.01) and increased left ventricular mass (58.4% versus 23.1%, P<0.0001). Similar results were confirmed in multivariable models. CONCLUSIONS: Our findings suggest that cardiovascular diseases are widespread in rural South Africa, with a larger burden of hypertensive heart disease than previously appreciated, and define the severity of end-organ damage that is already underway. Local health systems must adapt to face the growing burden of hypertension, as suboptimal rates of hypertension diagnosis and treatment may dramatically increase the heart failure burden.

Early Immunosuppression and Rapid Recovery of Cardiogenic Shock in Multisystem Inflammatory Syndrome From Convalescent COVID-19.

A previously healthy 39-year-old man presented in cardiogenic shock with evidence of multisystem inflammatory syndrome of adults 2 months after a mild case of coronavirus disease 2019. He was treated with intravenous immunoglobulin and pulse-dose corticosteroids with rapid resolution of his symptoms and normalization of biventricular function. (Level of Difficulty: Intermediate.).

New Antidiabetes Medications and Their Cardiovascular and Renal Benefits.

After 12 years of rigorous cardiovascular outcome trials (CVOTs), sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) emerged as new therapeutic options for patients with type 2 diabetes mellitus to reduce the risk of heart disease. SGLT2i additionally cause a reduction in heart failure and renal events in patients both with and without diabetes. This article reviews the major CVOTs that support the use of these agents, describes the mechanisms of action that lead to their broad cardiorenal benefits, explains current guidelines, and offers practical clinical advice to initiate and monitor treatment with these agents.

Underperformance of Contemporary Phase III Oncology Trials and Strategies for Improvement.

BACKGROUND: Statistical testing in phase III clinical trials is subject to chance errors, which can lead to false conclusions with substantial clinical and economic consequences for patients and society. METHODS: We collected summary data for the primary endpoints of overall survival (OS) and progression-related survival (PRS) (eg, time to other type of event) for industry-sponsored, randomized, phase III superiority oncology trials from 2008 through 2017. Using an empirical Bayes methodology, we estimated the number of false-positive and false-negative errors in these trials and the errors under alternative P value thresholds and/or sample sizes. RESULTS: We analyzed 187 OS and 216 PRS endpoints from 362 trials. Among 56 OS endpoints that achieved statistical significance, the true efficacy of experimental therapies failed to reach the projected effect size in 33 cases (58.4% false-positives). Among 131 OS endpoints that did not achieve statistical significance, the true efficacy of experimental therapies reached the projected effect size in 1 case (0.9% false-negatives). For PRS endpoints, there were 34 (24.5%) false-positives and 3 (4.2%) false-negatives. Applying an alternative P value threshold and/or sample size could reduce false-positive errors and slightly increase false-negative errors. CONCLUSIONS: Current statistical approaches detect almost all truly effective oncologic therapies studied in phase III trials, but they generate many false-positives. Adjusting testing procedures in phase III trials is numerically favorable but practically infeasible. The root of the problem is the large number of ineffective therapies being studied in phase III trials. Innovative strategies are needed to efficiently identify which new therapies merit phase III testing.

Practice pattern of use of high sensitivity troponin in the outpatient settings.

BACKGROUND: High-sensitivity troponin assays (hs-Tn) detect lower serum concentrations than prior-generation assays and help guide acute coronary syndrome (ACS) evaluation in emergency departments. Outpatient hs-Tn utilization is not well described. HYPOTHESIS: Outpatient providers use hs-TnT to triage patients with suspected ACS. METHODS: We compared the volume of outpatient prior-generation troponin tests in the pre-hsTn implementation period (January 2015-March 2018) with outpatient hs-TnT volume in the post-implementation period (April 2018-January 2020). Triage patterns were compared between patients with hs-TnT≥99th vs <99th percentile, using two-sample t tests. In patients triaged home, adverse events were compared between patients with hs-TnT≥99th vs <99th percentile, using log-rank tests. RESULTS: Across a large tertiary healthcare system, a mean of 80 prior-generation tests/month were ordered during the pre-hsTn implementation period compared with 12 hs-TnT tests/month in the post-implementation period. Prior-generation orders rose by 1.72 tests/month during pre-implementation, vs a decline of 2.74 hs-TnT tests/month during post-implementation (P < .001). Among 129 hs-TnT orders, most were placed by cardiologists (54%) and primary care providers (32%). Patient symptoms at the time of troponin ordering included dyspnea (34%) and chest pain (33%), although 25% were asymptomatic. Among symptomatic patients (n = 74), those with hs-TnT > 99th percentile were more likely to be sent to the ED (RR, 3.36; 95% CI, 1.22-9.25; P = .002). Among patients sent home (n = 66), those with hs-TnT > 99th percentile had more adverse events by 6 months (3.3% vs 22.2% RR, 6.67; 95% CI, 1.04-42.9; P = .026). CONCLUSIONS: In this healthcare system, outpatient troponin utilization significantly declined since hs-TnT implementation. Some providers use hs-TnT to triage patients with suspected ACS to the ED; others test asymptomatic patients and some send patients home despite high hs-TnT values.

Patient Readmission Rates For All Insurance Types After Implementation Of The Hospital Readmissions Reduction Program.

Since the implementation of the Hospital Readmissions Reduction Program (HRRP), readmissions have declined for Medicare patients with conditions targeted by the policy (acute myocardial infarction, heart failure, and pneumonia). To understand whether HRRP implementation was associated with a readmission decline for patients across all insurance types (Medicare, Medicaid, and private), we conducted a difference-in-differences analysis using information from the Nationwide Readmissions Database. We compared how quarterly readmissions for target conditions changed before (2010-12) and after (2012-14) HRRP implementation, using nontarget conditions as the control. Our results demonstrate that readmissions declined at a significantly faster rate after HRRP implementation not just for Medicare patients but also for those with Medicaid, both in the aggregate and for individual target conditions. However, composite Medicaid readmission rates remained higher than those for Medicare. Throughout the study period privately insured patients had the lowest aggregate readmission rates, which declined at a similar rate compared to nontarget conditions. The HRRP was associated with nationwide readmission reductions beyond the Medicare patients originally targeted by the policy. Further research is needed to understand the specific mechanisms by which hospitals have achieved reductions in readmissions.