Publications by authors named "James Freeman"
Commutability is where the measurement response for a reference material (RM) is the same as for an individual patient sample with the same concentration of analyte measured using two or more measurement systems. Assessment of commutability is essential when the RM is used in a calibration hierarchy or to ensure that clinical measurements are comparable across different measurement procedures and at different times. The commutability of three new Standard Reference Materials (SRMs) for determining serum total 25-hydroxyvitamin D [25(OH)D], defined as the sum of 25-hydroxyvitamin D [25(OH)D] and 25-hydroxyvitamin D [25(OH)D], was assessed through an interlaboratory study.
View Article and Find Full Text PDFThe perinatal period encompasses a critical window for neurodevelopment that renders the brain highly responsive to experience. Trauma, such as intimate partner violence (IPV) and early life stress/neglect, during this period negatively affects physical and mental health outcomes, including increasing ones risk for chronic pain. Although epigenetic programming likely contributes, the mechanisms that drive the relationship between perinatal trauma and adverse health outcomes, are not fully understood.
View Article and Find Full Text PDFBackground: Left atrial appendage occlusion (LAAO) is increasingly used as an alternative to oral anticoagulation for stroke prevention in select patients with atrial fibrillation. Data on outcomes in racial and ethnic minority individuals are limited. This analysis assessed differences in the use and outcomes of LAAO by race and ethnicity in a large national registry.
View Article and Find Full Text PDFArticle Synopsis
- The study aims to assess the healthcare costs associated with atrial fibrillation (AF) and atrial flutter (AFL) in the U.S., highlighting the rising prevalence and evolving management strategies.
- An analysis of data from 2016-2021 found that 1.4% of a large sampled population (over 248 million adults) had AF, with annual healthcare costs for these individuals significantly higher than those without AF ($25,451 vs $9,254).
- Expenditures related to AF rose by 11.1% during the study period, particularly impacting those with comorbid conditions; cancer patients, for instance, had the highest costs, while heart failure did not significantly add to expenditures.
Article Synopsis
- Chronic kidney disease (CKD) and kidney failure with replacement therapy (KFRT) are common in patients with atrial fibrillation (AF), and this study aimed to investigate outcomes after left atrial appendage occlusion (LAAO) procedures in these patients.
- Data from over 59,000 patients indicated that both CKD and KFRT were linked to higher rates of complications during the procedure and increased risk of death and major adverse events within one year.
- However, the study found no significant difference in the rates of stroke over the same period among patients with CKD or KFRT compared to those without.
Article Synopsis
- The study examines outcomes of percutaneous left atrial appendage occlusion (LAAO) procedures performed by either electrophysiologists (EPs) or interventional cardiologists (ICs) between 2020 and 2022, focusing on patient safety and complications.
- Key findings indicate that EPs utilized intracardiac echocardiography more frequently and achieved lower radiation exposure; however, rates of major adverse events (MAE) and in-hospital mortality were comparable between the two groups.
- Overall, LAAO was deemed safe with no significant differences in outcomes based on operator certification, highlighting the importance of continued use of these techniques by both specialties for broader patient access.
Background: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described.
Objectives: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens.
Methods: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022.
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.
Article Synopsis
- This study analyzed data from the National Cardiovascular Data Registry to evaluate how the volume of atrial fibrillation (AF) ablation procedures performed by hospitals and physicians affects procedural success and major adverse events (MAEs).
- Results showed that hospitals and physicians with higher procedural volumes had better success rates (98.5% success) and lower rates of complications (1.0% MAE), indicating that experience matters in these medical procedures.
- Specifically, lower volume hospitals (Q1) had a significantly reduced likelihood of success and an increased risk of complications, suggesting that a minimum annual volume of about 190 for hospitals and 60 for physicians is important for optimal patient outcomes.
Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion.
Circ Cardiovasc Interv
June 2024
Article Synopsis
- Higher hospital and physician volumes of WATCHMAN left atrial appendage occlusion procedures correlate with better procedural success, indicating that experience may influence outcomes.
- An analysis of over 87,000 patients revealed a 94.2% success rate overall, with lower success rates seen in lower-volume hospitals and physicians.
- The newer WATCHMAN FLX device showed improved success rates and reduced variability in outcomes across different volume categories compared to earlier models.
Background: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device.
Objective: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study.
Methods: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated.
Reduced left ventricular ejection fraction ≤40%, a known risk factor for adverse cardiac outcomes and recurrent acute ischemic stroke, may be detected during an acute ischemic stroke hospitalization. A multidisciplinary care paradigm informed by neurology and cardiology expertise may facilitate the timely implementation of an array of proven heart failure-specific therapies and procedures in a nuanced manner to optimize brain and cardiac health.
View Article and Find Full Text PDF2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.
Europace
March 2024
Article Synopsis
- Atrial fibrillation (AF) ablation has become a well-established treatment method in the last 30 years, supported by evidence showing it is safe and effective.
- In response to advancements in research and technology, new guidelines have been released over the years, the latest being necessary to provide updated recommendations for patient care.
- This revised consensus involves collaboration among major cardiac electrophysiology societies from Europe, Asia-Pacific, and Latin America to ensure comprehensive guidelines for AF treatment.
Article Synopsis
- The study aimed to evaluate the safety outcomes of left atrial appendage occlusion (LAAO) in elderly patients (octogenarians and nonagenarians) compared to younger patients under 80.
- Researchers analyzed data from the National Inpatient Sample database from 2016 to 2020, finding that octogenarians and nonagenarians had similar risks of in-hospital mortality and other complications as younger patients, although they faced higher odds of vascular complications.
- The results suggest that despite the increased age, octogenarians and nonagenarians can safely undergo LAAO, but healthcare providers should be aware of the elevated risk of vascular issues in these older patients.
Article Synopsis
- The National Cardiovascular Data Registry's LAAO Registry includes most LAAO procedures in the U.S., and this study aimed to create a model predicting in-hospital adverse events for patients undergoing LAAO with Watchman FLX.
- The study analyzed data from 41,001 procedures, using logistic regression on both development and validation cohorts to identify key predictors of major adverse events, such as age, sex, and health status.
- The resulting risk model showed moderate accuracy and offered a simplified bedside risk score, enabling healthcare professionals to better predict risks and improve decision-making in patient care.
Background: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial.
Objectives: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry.
Methods: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included.
Background: Clinical outcomes of left atrial appendage occlusion (LAAO) combined with other cardiac procedures have not been previously examined.
Objectives: This study sought to evaluate the safety and efficacy of combining LAAO with other cardiac procedures vs isolated LAAO.
Methods: We conducted a retrospective cohort study using the 2016 to 2020 National Inpatient Sample database to compare patients undergoing LAAO combined with another cardiac procedure vs isolated LAAO.
Background: Left atrial appendage occlusion (LAAO) is an approved alternative for stroke prevention in atrial fibrillation for patients with an "appropriate rationale" to avoid long-term oral anticoagulation (OAC). Many patients undergoing LAAO are at high risk of bleeding.
Objectives: This study sought to investigate whether dual antiplatelet therapy (DAPT) is a safe alternative to OAC (direct oral anticoagulation [DOAC] or warfarin) with aspirin after LAAO.
Background: Frailty is associated with significant morbidity and mortality and may have clinical implications in an advanced age population with atrial fibrillation undergoing left atrial appendage occlusion (LAAO). We sought to develop a novel frailty scale to predict worse outcomes in patients undergoing LAAO.
Methods: Patients in the NCDR LAAO Registry between 2016 and 2021 receiving percutaneous LAAO devices were categorized as non-frail (0 points), pre-frail (1-3 points), or frail (4-5 points) based on a 5-point scale representing multiple domains of frailty: hemoglobin <13.
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.