Publications

BACKGROUND: Pulmonary vein isolation (PVI) is increasingly recommended as first-line therapy for atrial fibrillation. Recent data suggest growing PVI volumes but rising complication rates, although comprehensive real-world outcomes including both inpatient and outpatient encounters remain unclear.

OBJECTIVES: The purpose of this study was to evaluate patient characteristics, population rates, and 30-day outcomes of PVI in a nationwide sample of U.S. adults aged >65 years.

METHODS: First-time PVIs were identified among U.S. Medicare fee-for-service beneficiaries using Current Procedural Terminology procedural codes. Comorbidities were ascertained using International Classification of Diseases-10th Revision diagnosis codes associated with each procedural claim. Outcomes included periprocedural complications, all-cause hospitalizations, and mortality at 30 days.

RESULTS: From January 2017 through December 2021, a total of 227,133 patients underwent PVI (mean age 72.5 years, 42% women, 92.7% White) with an increasing comorbidity burden over time. PVI volume increased from 83.8 (2017) to 111.6 per 100,000 patient-years (2021), which was driven by outpatient procedures (87.8% of all PVIs). Concurrently, there was a significant decrease in complication rates (3.9% in 2017 vs 3.1% in 2021; P < 0.001) and hospitalizations (8.8% vs 7.0%; P < 0.001), with no significant change in mortality (0.4%; P = 0.08). The most common periprocedural complications were bleeding (1.8%), pericardial effusion (1.4%), and vascular access damage (0.8%).

CONCLUSIONS: The use of PVI has steadily increased among older patients in contemporary U.S. clinical practice; yet, cumulative complication and hospitalization rates at 30 days have decreased over time, with stably low rates of short-term mortality despite rising comorbidity burden among treated patients. These data may reassure patients and providers on the safety of PVI as an increasingly common first-line procedure for atrial fibrillation.

BACKGROUND: Home health care (HHC) has been increasingly used to improve care transitions and avoid poor outcomes, but there is limited data on its use and efficacy following coronary artery bypass grafting. The purpose of this study was to describe HHC use and its association with outcomes among Medicare beneficiaries undergoing coronary artery bypass grafting.

METHODS: Retrospective analysis of 100% of Medicare fee-for-service files identified 77 331 beneficiaries undergoing coronary artery bypass grafting and discharged to home between July 2016 and December 2018. The primary exposure of HHC use was defined as the presence of paid HHC claims within 30 days of discharge. Hierarchical logistic regression identified predictors of HHC use and the percentage of variation in HHC use attributed to the hospital. Propensity-matched logistic regression compared mortality, readmissions, emergency department visits, and cardiac rehabilitation enrollment at 30 and 90 days after discharge between HHC users and nonusers.

RESULTS: A total of 26 751 (34.6%) of beneficiaries used HHC within 30 days of discharge, which was more common among beneficiaries who were older (72.9 versus 72.5 years), male (79.4% versus 77.4%), White (90.2% versus 89.2%), and not Medicare-Medicaid dual eligible (6.7% versus 8.8%). The median hospital-level rate of HHC use was 31.0% (interquartile range, 13.7%-54.5%) and ranged from 0% to 94.2%. Nearly 30% of the interhospital variation in HHC use was attributed to the discharging hospital (intraclass correlation coefficient, 0.296 [95% CI, 0.275-0.318]). Compared with non-HHC users, those using HHC were less likely to have a readmission or emergency department visit, were more likely to enroll in cardiac rehabilitation, and had modestly higher mortality within 30 or 90 days of discharge.

CONCLUSIONS: A third of Medicare beneficiaries undergoing coronary artery bypass grafting used HHC within 30 days of discharge, with wide interhospital variation in use and mixed associations with clinical outcomes and health care utilization.

Health care payment reforms in the US have aimed to encourage the use of high-value care while discouraging the use of low-value care. However, little is known about whether the use of high- and low-value care differs by income level. Using data from the 2010-19 Medical Expenditure Panel Survey, we examined the use of specified types of high- and low-value care by income level. We found that high-income adults were significantly more likely than low-income adults to use nearly all types of high-value care. Findings were consistent across age categories, although differences by income level in the use of high-value care were smaller among the elderly. Our analysis of differences in the use of low-value care had mixed results. Among nonelderly adults, significant differences between those with high and low incomes were found for five of nine low-value services, and among elderly adults, significant differences by income level were found for three of twelve low-value services. Understanding the mechanisms underlying these disparities is crucial to developing effective policies and interventions to ensure equitable access to high-value care and discourage low-value services for all patients, regardless of income.

IMPORTANCE: Since 2013, the American College of Cardiology (ACC) and American Heart Association (AHA) have recommended the pooled cohort equations (PCEs) for estimating the 10-year risk of atherosclerotic cardiovascular disease (ASCVD). An AHA scientific advisory group recently developed the Predicting Risk of cardiovascular disease EVENTs (PREVENT) equations, which incorporated kidney measures, removed race as an input, and improved calibration in contemporary populations. PREVENT is known to produce ASCVD risk predictions that are lower than those produced by the PCEs, but the potential clinical implications have not been quantified.

OBJECTIVE: To estimate the number of US adults who would experience changes in risk categorization, treatment eligibility, or clinical outcomes when applying PREVENT equations to existing ACC and AHA guidelines.

DESIGN, SETTING, AND PARTICIPANTS: Nationally representative cross-sectional sample of 7765 US adults aged 30 to 79 years who participated in the National Health and Nutrition Examination Surveys of 2011 to March 2020, which had response rates ranging from 47% to 70%.

MAIN OUTCOMES AND MEASURES: Differences in predicted 10-year ASCVD risk, ACC and AHA risk categorization, eligibility for statin or antihypertensive therapy, and projected occurrences of myocardial infarction or stroke.

RESULTS: In a nationally representative sample of 7765 US adults aged 30 to 79 years (median age, 53 years; 51.3% women), it was estimated that using PREVENT equations would reclassify approximately half of US adults to lower ACC and AHA risk categories (53.0% [95% CI, 51.2%-54.8%]) and very few US adults to higher risk categories (0.41% [95% CI, 0.25%-0.62%]). The number of US adults receiving or recommended for preventive treatment would decrease by an estimated 14.3 million (95% CI, 12.6 million-15.9 million) for statin therapy and 2.62 million (95% CI, 2.02 million-3.21 million) for antihypertensive therapy. The study estimated that, over 10 years, these decreases in treatment eligibility could result in 107 000 additional occurrences of myocardial infarction or stroke. Eligibility changes would affect twice as many men as women and a greater proportion of Black adults than White adults.

CONCLUSION AND RELEVANCE: By assigning lower ASCVD risk predictions, application of the PREVENT equations to existing treatment thresholds could reduce eligibility for statin and antihypertensive therapy among 15.8 million US adults.

IMPORTANCE: The incidence of hospital encounters for acute myocardial infarction (AMI) decreased sharply early in the COVID-19 pandemic and has not returned to prepandemic levels. There has been an ongoing debate about what mechanism may underlie this decline, including patients avoiding the hospital for treatment, excess mortality from COVID-19 among patients who would otherwise have had an AMI, a reduction in the incidence or severity of AMIs due to pandemic-related changes in behavior, or a preexisting temporal trend of lower AMI incidence.

OBJECTIVE: To describe drivers of changing incidence in AMI hospital encounters during the COVID-19 pandemic.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used traditional Medicare claims from all patients enrolled in traditional Medicare from January 2016 to June 2023 (total of 2.85 billion patient-months) to calculate the rate of AMI hospital encounters (emergency department visits, observation stays, or inpatient admissions) per capita at all short-term acute care and critical access hospitals in the United States overall and by patient characteristics. Observed rates were compared with expected rates that accounted for shifts in population characteristics and the prepandemic temporal trend (as estimated over 2016-2019). Data were analyzed in November 2023.

MAIN OUTCOMES AND MEASURES: Hospital encounters for AMI.

RESULTS: On average, the study sample included 31 623 928 patients each month from January 2016 through June 2023, for a total of 2 846 153 487 patient-months during the 90-month study period. In June 2023, there were 0.044 AMI hospital encounters per 100 patients, which was 20% lower than in June 2019 (0.055 encounters per 100 patients). Early in the pandemic, AMI rates moved inversely with COVID-19 death rates and tracked patterns seen for other painful acute conditions, such as nephrolithiasis, suggesting these changes were associated with care avoidance. Changes in patient characteristics driven by excess deaths during the pandemic explained little of the decline. Later in the pandemic, the decline may be explained by the long-standing downward trend in AMI incidence; by April 2022, the observed rate of encounters matched the expected rate that accounted for this trend. During the full pandemic period, from March 2020 to June 2023, there were an estimated 5% (95% prediction interval, 1%-9%) fewer AMI hospital encounters than expected.

CONCLUSIONS AND RELEVANCE: The early reduction in AMI encounters was likely driven by care avoidance, while ongoing reductions through June 2023 likely reflect long-standing temporal trends. During the pandemic, there were 5% fewer AMI encounters than expected.

BACKGROUND: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States.

METHODS: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year.

RESULTS: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients.

CONCLUSIONS: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

BACKGROUND: Timely follow-up after cardiovascular hospitalization is recommended to monitor recovery, titrate medications, and coordinate care.

OBJECTIVE: To describe trends and disparities in follow-up after acute myocardial infarction (AMI) and heart failure (HF) hospitalizations.

DESIGN: Retrospective cohort study.

SETTING: Medicare.

PARTICIPANTS: Medicare fee-for-service beneficiaries hospitalized between 2010 and 2019.

MEASUREMENTS: Receipt of a cardiology visit within 30 days of discharge. Multivariable logistic regression models were used to estimate changes over time overall and across 5 sociodemographic characteristics on the basis of known disparities in cardiovascular outcomes.

RESULTS: The cohort included 1 678 088 AMI and 4 245 665 HF hospitalizations. Between 2010 and 2019, the rate of cardiology follow-up increased from 48.3% to 61.4% for AMI hospitalizations and from 35.2% to 48.3% for HF hospitalizations. For both conditions, follow-up rates increased for all subgroups, yet disparities worsened for Hispanic patients with AMI and patients with HF who were Asian, Black, Hispanic, Medicaid dual eligible, and residents of counties with higher levels of social deprivation. By 2019, the largest disparities were between Black and White patients (AMI, 51.9% vs. 59.8%, difference, 7.9 percentage points [pp] [95% CI, 6.8 to 9.0 pp]; HF, 39.8% vs. 48.7%, difference, 8.9 pp [CI, 8.2 to 9.7 pp]) and Medicaid dual-eligible and non-dual-eligible patients (AMI, 52.8% vs. 60.4%, difference, 7.6 pp [CI, 6.9 to 8.4 pp]; HF, 39.7% vs. 49.4%, difference, 9.6 pp [CI, 9.2 to 10.1 pp]). Differences between hospitals explained 7.3 pp [CI, 6.7 to 7.9 pp] of the variation in follow-up for AMI and 7.7 pp [CI, 7.2 to 8.1 pp]) for HF.

LIMITATION: Generalizability to other payers.

CONCLUSION: Equity-informed policy and health system strategies are needed to further reduce gaps in follow-up care for patients with AMI and patients with HF.

PRIMARY FUNDING SOURCE: National Institute on Aging.