Procedure Codes Research Articles

Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database

BackgroundIncreasing medical device usage raises concerns regarding unexpected, potentially life-threatening events that pose public health risks. Such events are reported to the Food and Drug Administration (FDA), and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database, a vital tool for post market surveillance that requires information of high quality and integrity, particularly concerning reporting sources. PurposeTo analyze reporting behavior among different reporters, including manufacturers, distributors, and user facilities, by examining differences in reported factors, namely: (1) device types, (2) product problem attribution, and (3) selection of Device Problem Codes (DPCs) associated with the root causes of events. MethodsData spanning from 2005 to 2022 was retrieved from the MAUDE database using Python. Reports were grouped by reporter type and divided according to device type, and the reporter's indication of association with a product problem. Furthermore, events were classified by their respective DPCs, which were manually grouped into four categories: device issues, user issues, clinical issues, or unknown. FindingsThe analysis revealed significant variations among reporters across all examined aspects (P < 0.00001 in all comparisons according to the proportion test). Manufacturers predominantly focused on infusion pumps (10.1%) and Implant, Endosseous, Root-Form (IER) devices (7.6%), with a product problem indication rate of 29.2% in their reports. Device issues codes were the most frequently observed category in their reports, comprising 36.3%, followed by unknown codes (32%) and clinical codes (19.3%). Distributors, on the other hand, primarily reported on IER devices (89%) and exhibited the lowest product problem indication rate at 2.7%. Clinical issues codes predominated in their reports, constituting 85.7%, followed by unknown codes (6.7%). User facilities concentrated on intravascular sets (4.7%), Electrosurgical, Cutting & Coagulation & Accessories (4.2%), and Ventricular (Assist) Bypass (4.1%). Remarkably, their product problem indication rate was the highest at 56.7%. They predominantly reported device issues codes (54.3%), followed by use codes (30.8%), and unknown codes (11.4%) ImplicationsThe notable variation among different reporters underscores the importance of incorporating diverse sources when analyzing the database, particularly in cases where majority of reports originate from manufacturers. Decision-makers must approach database information comprehensively, considering data sources and diverse perspectives to inform regulatory decisions effectively. Developing strategies that encourage various reporters to contribute their unique and complementary viewpoints is advisable.

Challenges Faced by Foreign Plaintiffs in Initiating Civil Litigation in Taiwan:Practical Issues Regarding the Application of Article 96 of the Code of Civil Procedure on Litigation Security

Challenges Faced by Foreign Plaintiffs in Initiating Civil Litigation in Taiwan:Practical Issues Regarding the Application of Article 96 of the Code of Civil Procedure on Litigation Security

Distal Mononeuropathy and Nerve Release After Open and Arthroscopic Shoulder Surgery: A Matched Cohort Analysis

The purpose of this study was to determine if patients who have undergone prior open or arthroscopic shoulder surgery and develop distal mononeuropathy (DMN) achieve the same clinical benefit after nerve release compared with those who did not have a prior shoulder procedure. Patients were identified by Current Procedural Terminology code for shoulder arthroplasty, shoulder stabilization, and rotator cuff repair and if they had an ensuing nerve release (cubital or carpal tunnel) within 2 years of shoulder surgery. Another cohort that underwent nerve release surgery for DMN with no prior history of shoulder surgery was identified and subsequently matched to the first cohort by a 3:1 (control:case) ratio. Patients were included if they were over the age of 18 years. Chart reviews and surveys stored using REDCap were used to collect demographics, surgical history, EMG/nerve conduction velocity results, postoperative symptoms, and patient-reported outcomes with a minimum 2-year follow-up. In total, 120 patients were included in this analysis (28 cases, 92 controls). The most common nerve release for DMN across both cohorts was open carpal tunnel release. Following nerve release, the case group had more postoperative persistent numbness/tingling than the control group. Both groups were similar with regard to postoperative pain, weakness, or patient-reported outcome measures. Residual postoperative numbness following nerve release was more likely to occur in the forearm for the case group than the control group. Patients with a history of arthroscopic rotator cuff repair and reverse total shoulder replacement shoulder surgery before the presentation of DMN are more likely to experience persistent numbness or tingling after nerve release surgery as well as experience symptoms in the forearm than those without prior shoulder surgery. Symptom prevalence retrospective study III.

Risk factors for severe retinopathy of prematurity stratified by birth weight and gestational age in privately insured infants.

To evaluate risk factors associated with severe retinopathy of prematurity ROP (sROP) in two separate cohorts of infants. We performed a retrospective study of the Merative MarketScan Commercial Database between 2003 and 2022. Infants with ROP were stratified into two cohorts: group A (defined as infants with both birth weight [BW] <1000 g and gestational age [GA] <29 weeks) and group B (defined as infants with either BW ≥1000 g or GA ≥29 weeks). Infants with sROP were defined as those who received treatment for ROP. Outpatient and inpatient claims using International Classification of Diseases and Current Procedural Terminology codes were used to identify neonatal comorbidities. Multivariable logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for sROP requiring treatment with respect to various comorbidities. A total of 425 of 8,789 infants with ROP developed sROP (4.8%). We identified 2,726 infants in group A, of whom 387 (14.2%) required a procedure, and 6,063 in group B, of whom 38 (0.6%) required a procedure. In group A, intraventricular hemorrhage (OR = 1.38; 95% CI, 1.09-1.74) and patent ductus arteriosus ligation (OR = 1.65; 95% CI, 1.25-2.16) were the comorbidities that significantly increased the odds of sROP on multivariable analysis. In group B, infection (OR = 1.96; 95% CI, 1.01-3.80) was the only comorbidity that significantly increased the adjusted odds of sROP. Risk factors for sROP may differ between smaller and larger infants. Infection may serve as an important risk factor for ROP progression amongst larger infants due to its connection with poor postnatal growth.

Veterans' use of inpatient and outpatient palliative care: The national landscape.

Palliative care improves the quality of life for people with life-limiting conditions, which are common among older adults. Despite the Veterans Health Administration (VA) outpatient palliative care expansion, most research has focused on inpatient palliative care. This study aimed to compare veteran characteristics and hospice use for palliative care users across care settings (inpatient vs. outpatient) and dose (number of palliative care encounters). This national cohort included veterans with any VA palliative care encounters from 2014 through 2017. We used VA and Medicare administrative data (2010-2017) to describe veteran demographics, socioeconomic status, life-limiting conditions, frailty, and palliative care utilization. Specialty palliative care encounters were identified using clinic stop codes (353, 351) and current procedural terminology codes (99241-99245). Of 120,249 unique veterans with specialty palliative care over 4 years, 67.8% had palliative care only in the inpatient setting (n = 81,523) and 32.2% had at least one palliative care encounter in the outpatient setting (n = 38,726), with or without an inpatient palliative care encounter. Outpatient versus inpatient palliative care users were more likely to have cancer and less likely to have high frailty, but sociodemographic factors including rurality and housing instability were similar. Duration of hospice use was similar between inpatient (median = 37 days; IQR = 11, 112) and outpatient (median = 44 days; IQR = 14, 118) palliative care users, and shorter among those with only one palliative care encounter (median = 18 days; IQR = 5, 64). This national evaluation provides novel insights into the care setting and dose of VA specialty palliative care for veterans. Among veterans with palliative care use, one-third received at least some palliative care in the outpatient care setting. Differences between veterans with inpatient and outpatient use motivate the need for further research to understand how care settings and number of palliative care encounters impact outcomes for veterans and older adults.

Guidance for the Evaluation by Payors of Claims Submitted Using Current Procedural Terminology Codes 95165, 95115, and 95117.

Guidance for the Evaluation by Payors of Claims Submitted Using Current Procedural Terminology Codes 95165, 95115, and 95117.

Delayed fixation of distal radial fractures beyond three weeks after initial failed closed reduction increases the odds of reoperation.

We aimed to compare reoperations following distal radial fractures (DRFs) managed with early fixation versus delayed fixation following initial closed reduction (CR). We used administrative databases in Ontario, Canada, to identify DRF patients aged 18 years or older from 2003 to 2016. We used procedural and fee codes within 30 days to determine which patients underwent early fixation (≤ seven days) or delayed fixation following CR. We grouped patients in the delayed group by their time to definitive fixation (eight to 14 days, 15 to 21 days, and 22 to 30 days). We used intervention and diagnostic codes to identify reoperations within two years. We used multivariable regression to compare the association between early versus delayed fixation and reoperation for all patients and stratified by age (18 to 60 years and > 60 years). We identified 14,960 DRF patients, 8,339 (55.7%) of whom underwent early surgical fixation (mean 2.9 days (SD 1.8)). In contrast, 4,042 patients (27.0%) underwent delayed fixation between eight and 14 days (mean 10.2 days (SD 2.2)), 1,892 (12.7%) between 14 and 21 days (mean 17.5 days (SD 1.9)) and 687 (4.6%) > 21 days (mean 24.8 days (SD 2.4)) post-fracture. Patients who underwent delayed fixation > 21 days post-fracture had a higher odds of reoperation (odds ratio (OR) 1.33 (95% CI 1.11 to 1.79) vs early fixation). This worsened for patients aged > 60 years (OR 1.69 (95% CI 1.11 to 2.79)). We found no difference in the odds of reoperation for patients who underwent delayed fixation within eight to 14 or 15 to 21 days post-fracture (vs early fixation). These data suggest that DRF patients with fractures with unacceptable reduction following CR should be managed within three weeks to avoid detrimental outcomes. Prospective studies are required to confirm these findings.

Trends in Medical Encounters Involving Cannabis-Related Disorders Among US Medicare Beneficiaries, 2017-2022.

Objectives. To characterize cannabis-related disorder medical encounter trends in the US Medicare population during 2017 to 2022. Methods. We conducted a descriptive study, which included 56 624 432 beneficiaries aged 65 years or older and 10 247 953 aged 18 to 64 years with disability. All were continuously enrolled in Medicare (Fee-for-Service or Advantage) for 183 or more days before the first day of the calendar year. We identified cannabis-related disorder encounters using International Classification of Diseases, 10th Revision, Clinical Modification diagnosis codes and computed annual encounter rates per 10 000 beneficiaries. We used the Mann-Kendall test to analyze trends over time. Results. Annual cannabis-related disorder encounter trends among beneficiaries aged 65 years or older ranged from 15.9 (95% confidence interval [CI] = 15.8, 16.0) to 39.3 (95% CI = 39.1, 39.5) per 10 000. Rates among beneficiaries aged 18 to 64 years with disability ranged from 274.8 (95% CI = 273.6, 276.0) to 373.7 (95% CI = 372.3, 375.2) per 10 000. Rates increased over time across both groups, with average annual increases of 4.3 (95% CI = 3.3, 5.3; P = .01) and 17.1 (95% CI = 11.0, 23.2; P = .02) per 10 000, respectively. Conclusions. Further work is needed to explore the impact of coexisting medical conditions on outcomes that result from cannabis-related disorders. (Am J Public Health. 2024;114(S8):S694-S697. https://doi.org/10.2105/AJPH.2024.307729).

Advanced Noise-Resistant Electrocardiography Classification Using Hybrid Wavelet-Median Denoising and a Convolutional Neural Network.

The classification of ECG signals is a critical process because it guides the diagnosis of the proper treatment process for the patient. However, any form of disturbance with ECG signals can be highly conspicuous because of the mechanics involved in data acquisition from living beings, which has a significant impact on the classification procedure. The purpose of this research work is to advance ECG signal classification results by employing numerous denoising methods and, in turn, boost the accuracy of cardiovascular diagnoses. To simulate realistic conditions, we added various types of noise to ECG data, including Gaussian, salt and pepper, speckle, uniform, and exponential noise. To overcome the interference of noise from environments in the obtained ECG signals, we employed wavelet transform, median filter, Gaussian filter, and the hybrid of the wavelet and median filters. The proposed hybrid denoising method has better results than the other methods because of the use of wavelet multi-scale analysis and the ability of the median filter to avoid the loss of vital ECG characteristics. Thus, despite a certain proximity in the values, the hybrid method is significantly more accurate and reliable, as evidenced by the mean squared error (MSE), mean absolute error (MAE), R-squared, and Pearson correlation coefficient. More specifically, the hybrid approach provided an MSE of 0.0012 and an MAE of 0.025, the R-squared value for this study was 0.98, and the Pearson correlation coefficient was 0.99, which provides a very good resemblance to the original ECG confirmation. The proposed classification model is based on the modified lightweight CNN or MLCNN that was trained using the noisy and the denoised data. The findings demonstrated that by applying the denoised data, the testing accuracy, precision, recall, and F1 scores achieved 0.92, 0.91, 0.90, and 0.91 for the datasets, while the noisy data achieved 0.80, 0.78, 0.82, and 0.80, respectively. In this study, the signal quality and denoising methods were found to enhance ECG signal classification and diagnostic accuracy while encouraging proper preprocessing in future studies and applications for real-time ECG for cardiac care.

Effect of cannabis use history on postoperative opioid utilization in lumbar fusion patients: an American retrospective study.

A retrospective cohort study. To examine the effect of cannabis use history on postoperative opioid utilization in patients undergoing one- to three-level lumbar fusion for degenerative spine disease. Strategies to minimize dosing and chronic opioid use are needed for spine surgery given their widespread prescription for postsurgical pain management. In this database study, medical coding was used to identify patients who had undergone one- to three-level lumbar fusions between 2012 and 2021. Propensity score matching was used to create two equal cohorts with respect to cannabis use history. Opioid utilization rates (morphine milligram equivalents [MME]/day) and overuse rates at 6 months post-index procedure were assessed. All pvalues <0.05 were considered statistically significant. Following examination of 153,500 patient records, 1,216 patients were matched into cannabis user and non-cannabis user cohorts. Cannabis users had lower rates of opioid utilization compared to non-cannabis users as early as 2 months after fusion (47.7% vs. 41.1%, p <0.05), a relationship which persisted at 6 months (46.2% vs. 37.7%, p <0.01). Additionally, cannabis users had lower rates of high-dose opioid utilization (≥100 MME per day) during the initial 14-30 days following surgery (6.91% vs. 3.79%, p <0.05). Patients with a history of cannabis use were less likely to be using opioids as early as 2 months postoperatively and had lower rates of high-dose opioid utilization in the immediate postoperative period. Physicians operating on these patients should consider their cannabis use patterns to provide appropriate titration of pain medication over time.

Termination of Prosecution Based on Restorative Justice in Indonesia it is Associated with the Renewal Criminal Law

Criminal acts arise from various aspects of human activity, including the political, social and economic spheres. The success of law enforcement is traditionally measured by the ability to bring criminals to justice and impose appropriate penalties. However, in certain minor cases, such as theft, embezzlement, and fraud with minimal losses, the public questions the need for prosecution, as they believe that prosecution does not match the seriousness of the offense. The purpose of this study is to analyze the implications and effectiveness of prosecution discontinuation based on restorative justice in the Indonesian legal framework. Using a qualitative research approach, this study examines the regulatory structure and practical application of restorative justice in Indonesia. Data was collected through document analysis and interviews with legal practitioners to explore alignment of regulations with legal principles and community expectations. The research findings show that, although restorative justice offers a viable avenue to achieve peace between offenders and victims, its implementation in Indonesia is still limited, as it is not yet embedded in the broader criminal law system. Currently, peace agreements between the parties are only considered as a mitigating factor in the sentencing process. This research suggests that stronger legal legitimacy for restorative justice, such as the inclusion of restorative justice into the Draft Criminal Procedure Code is essential to adapt to the evolving legal culture and public expectations. The implications of this research highlight the need for comprehensive criminal law reform to ensure justice that aligns with societal values and contemporary legal standards.

Increasing Utilization of Intratympanic Injections among Medicare Fee-for-Service Providers.

To characterize national practice patterns and geographic variations in intratympanic injections among Medicare providers. Retrospective cross-sectional analysis of intratympanic injections performed in the Medicare fee-for-service population from 2013 to 2021. Center for Medicare & Medicaid Services Physician and Other Practitioners database. Providers performing outpatient intratympanic injections, documented by Current Procedural Terminology code 69801. Intratympanic injections. The number of intratympanic injections performed by individual providers, states, and geographic regions, as well as reimbursements, was analyzed annually. A total of 159,236 in-office intratympanic injections were performed. The Center for Medicare & Medicaid Services reimbursed $25,407,086; out-of-pocket patient costs were $6,591,514. The mean Medicare reimbursement rate and out-of-pocket cost per injection were $159.56 and $41.38, respectively. From 2013 to 2021, the number of intratympanic injections increased from 13,117 to 20,711 injections, representing a 57.9% increase. On linear regression, an additional 989.9 injections were performed each year (95% CI 766.4-1,213.4, p < 0.001). The number of providers performing injections also increased from 1,828 to 2,834 from 2013 to 2021 ( b = 125.6 [95% CI 111.3-140.0], p < 0.001). The population-controlled annual mean number of injections varied substantially across the United States, ranging from 12.0 injections per 100,000 beneficiaries in Oklahoma to 255.2 injections per 100,000 beneficiaries in Alabama. The number of intratympanic injections administered in the Medicare population has increased from 2013 to 2021. There is variability in practice patterns and utilization of intratympanic injections among otolaryngologists in the United States.

GUILTY PLEAS THROUGH SPECIAL CHANNELS AS AN EFFORT TO REFORM CRIMINAL PROCEDURE LAW IN INDONESIA

This research discusses the concept of setting up a guilty plea through special channels as an effort to reform criminal procedure law in Indonesia in relation to the principles of simple, fast and low cost justice. Focusing on efforts to reform criminal procedure law in Indonesia and associated with the principles of simple, fast and low cost justice, namely with the concept of Guilty Plea Arrangements through Special Paths that exist in the renewal of the Indonesian criminal procedure code. The method used in this research is normative research. The result of this research is that the special route is an effort in the renewal of criminal procedure law. By eliminating some of the evidentiary processes, the special track is considered to accelerate case handling, thus reflecting the principles of simple, fast, and low cost justice. The special path contained in article 199 of the draft criminal procedure code does not need to be included in the Indonesian Criminal Procedure Code because there is ambiguity that makes the special path require reassessment before being applied to Indonesian criminal justice.

Evaluating Long-Term Outcomes of Children Undergoing Surgical Treatment for Congenital Heart Disease for National Audit in England and Wales.

There is strong interest in the evaluation of longer-term outcome metrics for congenital heart diseases (CHDs); however, registries focus on postoperative metrics. Informed by user online discussion forums and scoping of national data, we selected sentinel CHDs and long-term outcome metrics suitable for routine monitoring. We then developed sentinel CHD phenotypes and algorithms for identifying treatment pathway procedures using clinical codes. Finally, we calculated the metrics within a retrospective national cohort analysis. The 9 selected sentinel CHDs had a higher-than-average prevalence, typically involved surgery in infancy, and were associated with an increased risk of late mortality. The selected metrics of survival and reinterventions at 1, 5, and 10 years were both important and feasible. The cohort included 29 319 (41.3% of all operated CHD births) English and Welsh children born with sentinel CHDs in 2000 to 2022. Example metrics at age 10 years included: survival-hypoplastic left heart syndrome: 57.6% (95% CI, 54.9%-60.4%), functionally univentricular heart: 86.7% (95% CI, 84.6%-88.9%), transposition of the great arteries: 93.1% (95% CI, 92.2%-93.9%), pulmonary atresia: 81.0% (95% CI, 79.1%-82.9%), atrioventricular septal defect: 88.5% (95% CI, 87.5%-89.5%), tetralogy of Fallot: 95.1% (95% CI, 94.4%-95.8%), aortic stenosis: 94.4% (95% CI, 93.3%-95.6%), coarctation: 96.7% (95% CI, 96.2%-97.3%), and ventricular septal defect: 96.9% 95% CI, (96.4%-97.3%); and (2) cumulative incidence of reintervention-hypoplastic left heart syndrome : 54.5% (95% CI, 51.5%-57.3%), functionally univentricular heart: 57.3% (95% CI, 53.9%-60.5%), transposition of the great arteries: 20.9% (95% CI, 19.5%-22.3%), pulmonary atresia: 66.8% (95% CI, 64.2%-69.1%), atrioventricular septal defect: 21.6% (20.3%-23.0%), tetralogy of Fallot: 26.6% (95% CI, 25.2%-28.0%), aortic stenosis: 31.2% (95% CI, 28.8%-33.6%), coarctation: 19.8% (95% CI, 18.6%-21.1%), and ventricular septal defect: 6.1% (95% CI, 5.5%-6.8%). It is feasible to report important long-term outcomes of survival and reintervention for sentinel CHDs using routinely collected procedure records, adding value to national audit.

Incidence and risk factors of pain following breast cancer surgery: a retrospective national inpatient sample database study

BackgroundPostoperative pain (PP) is a dynamic process that reflects the complex interplay between symptoms, treatment, and patient experiences, and its intensity is reportedly primarily related to the severity of surgical trauma. However, no large-scale national database-based study has hitherto been conducted to assess the occurrence and features related to PP following breast cancer (BC) surgery.MethodsIn this retrospective analysis, we screened BC surgery cases between 2015 and 2019 within the National Inpatient Sample (NIS) Database, utilizing the International Classification of Diseases (ICD) 10th edition clinical modification codes. The researchers identified patients who developed PP and compared them to those who did not. Factors associated with PP were then screened: patient demographics (age and race), hospital characteristics (type of insurance, bed size, teaching status, type of admission, location, and hospital area), length of stay (LOS), total cost during hospitalization, inpatient mortality, comorbidities, and perioperative complications. Data were analyzed using descriptive statistics. Multivariate logistic regression analysis was used to determine the independent risk factors for postoperative pain in BC surgery.Results39,870 BC surgery cases were identified over a five-year period from 2015 to 2019. The overall occurrence of PP following breast cancer surgery was 6.15% (2,387 cases), with a slight upward trend every year. Significant racial disparities were observed, Whites associated with a higher incidence of PP (P < 0.001). In addition, the incidence of elective admission was 11.96% lower (67.491% vs. 79.451%) than that of patients without PP following breast cancer surgery (P < 0.001). Besides, PP was related to prolonged hospitalization duration (3 vs. 2 days; P < 0.001), and higher total cost ($68,283 vs. $60,036; P < 0.001). Multivariate logistic regression identified breast cancer surgery-independent risk factors for PP, including younger age, non-elective hospital admission, rural hospitals, depression, drug abuse, metastatic cancer, psychoses, weight loss, and chronic pulmonary disease. In addition, postoperative pain for BC was associated with urinary retention, gastrointestinal complications, continuous invasive ventilation, deep vein thrombosis, urinary tract infection, blood transfusion, arrhythmia, and chest pain.ConclusionDespite the low incidence of postoperative pain in BC surgery cases, it is essential to investigate factors predisposing to PP to allow optimal care management and improve the outcomes of this patient population.

Prescription time trends in patients with high-impact chronic pain: A National Patient Registry Study.

High-impact chronic pain (HICP), defined as chronic pain with a significant impact on daily function, affects approximately 8% of the Western population. In Denmark, HICP still remains to be described at the population level. Some patients with HICP are referred to the Danish pain centres, where they are registered with a procedural code. We conducted a nationwide registry-based study of all Danish patients registered with a visit to a pain centre from January 2005 to March 2022, to explore time trends in the prescription of analgesics and sedatives in this HICP subpopulation. Furthermore, data on socioeconomics and hospital diagnoses are reported. We used data from the Central Person Registry, the Danish National Patient Registry, the Danish National Prescription Registry, combined with data on socioeconomic information from Statistics Denmark. Data was collected on prescriptions 3 months before the first visit to a pain centre. Prescriptions were stratified into five calendar periods: before 2011, 2011-2013, 2014-2016, 2017-2019, and 2020-2022. We identified 66,577 patients referred to a pain centre. Over 15 years, prescriptions before referral declined for opioids (from 53.2% to 31.7%), NSAIDs (from 28.3% to 23.5%), antidepressants (from 20.5% to 16.8%), anxiolytics (from 12.3% to 3.2%), and sleep medication (from 15.8% to 7.6%). In contrast, prescriptions increased for paracetamol (from 31.1% to 48.9%) and gabapentinoids (from 19.2% to 27.7%). In patients with HICP visiting Danish pain centres, prescriptions before referral decreased for opioids over 15 years, with a simultaneously increased prescription of gabapentinoids (gabapentin and pregabalin). This nationwide study of 66,577 Danish patients with high-impact chronic pain reveals a significant decrease in filled opioid prescriptions over the past 15 years, with a simultaneous rise in gabapentinoid use before referral to pain centres. These findings suggest a shift in clinical practice towards alternative pain management strategies. The study underscores the need for continued research into the long-term effects of these changes and their impact on patient outcomes.

Global burden of high-risk cardiovascular patients without prior myocardial infarction or stroke: VESALIUS-REAL - preliminary results from Germany

Abstract Background Clinical trial data has shown that low-density lipoprotein cholesterol (LDL-C) lowering with PCSK9-inhibitors reduced cardiovascular (CV) endpoints in patients with established atherosclerotic cardiovascular disease (ASCVD). Intervening early in patients with high CV risk prior to myocardial infarction (MI) or stroke, while perceived to be less urgent, may result in larger public health benefits. The effect of evolocumab in this population is investigated in a phase-3 clinical trial (NCT03872401: Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke [VESALIUS-CV]). This observational study examines the global burden of VESALIUS-CV-like population in the REAL-World ("VESALIUS-REAL") in eight regions (Germany, Hong Kong, Japan, South Korea, Sweden, Taiwan, UK and US) using a unified protocol across multiple databases. The multi-database study is ongoing, and the current analysis focuses on characteristics of VESALIUS-CV like patients in Germany. Methods Eligibility criteria are shown in the Figure. Data were obtained from the German Disease Analyzer (2013-2022), a representative claims database from Germany. Criteria were aligned with the clinical trial, and real-world definitions were created using diagnosis and procedure codes. Results A total of 195,621 patients were included in the present analysis (Table). At baseline, the median age was 71 years (Q1-Q3: 64-79) and 48% of patients were women. Approximately two-thirds of patients had atherosclerosis (48.5% had coronary artery disease, 13.8% had cerebrovascular disease and 13.8% had peripheral artery disease) and 33.7% had high-risk diabetes mellitus (DM), defined as DM with microvascular complications or chronic insulin use. The median baseline LDL-C was 139 (Q1-Q3: 113-166) mg/dL [3.6 (2.9 - 4.3) mmol/L] and 110,867 patients (57%) had an LDL-C ≥130 mg/dL (≥3.4 mmol/L). Overall, 69% of VESALIUS-CV like patients were receiving no background LLT. Conclusions Despite having atherosclerosis and/or high-risk DM and LDL-C exceeding target thresholds, a large proportion of VESALIUS-CV like patients were not on any LLT in Germany. Final results from VESALIUS-REAL will be able to report if this treatment gap is also observed in other countries.

Lower rate of ischemic events with PCSK9 inhibition in patients with atherosclerotic cardiovascular disease but without prior ischemic events

Abstract Background Individuals with atherosclerotic cardiovascular disease (ASCVD) without prior ischemic events, such as myocardial infarction (MI), ischemic stroke (IS), or unstable angina (UA) hospitalization, are at very high risk for having an event. Purpose To estimate the impact of PCSK9 inhibitor (PCSK9i) therapy on ischemic events in this population. Methods Patients with ASCVD were initially selected from the Optum Research Database during Jan 2016 to Dec 2022. For selected patients the index (time zero for follow-up) was required to be in a period of ASCVD without prior ischemic events, however patients may have ischemic events after index. Determination of ASCVD and ischemic events was based on diagnosis and procedure codes. For the PCSK9i group, index was initiation of PCSK9i and information before index was examined to ascertain ASCVD and rule out prior ischemic events. For each patient in the PCSK9i group, up to 5 matching patients in the no-PCSK9i group were chosen based on propensity score (PS) distance, with maximum allowable PS distance of 0.1. Among all possible choices for index for the no-PCSK9i patient, the selected one minimized the PS-distance. The primary endpoint was defined as the composite of nonfatal MI, nonfatal IS, and all-cause death. In order to further reduce bias and ensure causally interpretable estimation, the G-computation methodology was employed by marginalizing the conditional treatment effect (as estimated by a Cox model) over the baseline characteristics. Two effects were estimated: intention-to-treat (ITT) where only the treatment assignment at index was considered as the intervention, and per-protocol (PP) where the effect of sustained treatment with PCSK9i over time was estimated. Results A total of 15,067 and 66,470 patients met the selection criteria for the PCSK9i and no-PCSK9i groups, respectively. Baseline characteristics were well-balanced at index. G-computation analysis resulted in estimated survival curves over time in the two groups for the ITT and PP scenarios (Figures 1 and 2). For the ITT scenario, the estimated 5-year event rate was 18.7% (95% confidence interval [CI]: 17.1%–20.1%) in the PCSK9i group and 28.4% (95% CI: 27.7%–29.1%) in the no-PCSK9i group. The implied relative risk reduction (RRR) and absolute risk reduction (ARR) were 34.3% (p&amp;lt;0.001) and 9.7% (p&amp;lt;0.001), respectively, in favor of the PCSK9i group. For the PP scenario, the estimated 5-year event rate was 10.7% (95% CI: 9.7%–11.7%) in the PCSK9i group and 28.8% (95% CI: 28.3%–29.5%) in the no-PCSK9i group. The implied RRR and ARR were 62.7% (p&amp;lt;0.001) and 18.1% (p&amp;lt;0.001), respectively, in favor of the PCSK9i group. Conclusions Initiation of PCSK9i in patients with ASCVD but without prior ischemic events is associated with significantly and substantially lower risk for ischemic events.Event Rates Intention-to-Treat ScenarioEvent Rates Per-Protocol Scenario

Detecting Unrecognized Dementia Using Deep Learning Methods with Korean National Claims Data

Abstract Background Dementia is one of the leading causes of death in elderly people. In Korea, the government supports dementia screening for people aged 60 and older, but it is not a population-based organized screening program. It is difficult to achieve early diagnosis and early treatment. The objective of this study is to detect unrecognized dementia using Korean National Claims Data for early diagnosis. Methods This study used the National Health Insurance Claims data in Korea. The case group is the new dementia visit as an unrecognized group, while the control group was randomly selected from the general population without dementia. The predictors included health utilization, socioeconomic and demographic, procedure codes, diagnostic codes and health screenings data. The health utilization variables included length of stay, the number of outpatient visits, health expenditures and other encounter information. All medical utilization data was aggregated monthly. In the case group, 12 months of data from 6-month or 2-years before the onset of dementia were used. In the control group, 12 months of data from randomly selected time point were included. Transformer, embedding methods, and Time2Vec were used as the deep learning methods. This study included 453,306 incidents of dementia, representing almost all cases reported from 2010 to 2019 in Korea. The control group consisted of 669,873. Results After training the deep learning prediction model, the AUC for 6-month dementia prediction on the test dataset was 0.87, and for 2-year dementia prediction, it was 0.76. The most important variables were health utilization variables, especially health expenditures. The health utilization trajectories of the case group were significantly different from those of the control group. Conclusions Based on the claims data, we could detect unrecognized dementia case. We can extend the model to other chronic disease such as cancer and stroke, which are significant burden of disease. Key messages • Screening in healthcare facilities or using lab test results would be more accurate, but it would be difficult to apply to a large population due to the cost-effectiveness and timeliness constraints. • On the other hand, the detection model using the existing claims data would be helpful to to develop cost-effective mass screening program. It can cover the weakness of current screening program.

Comparison of ventricular tachyarrhythmias in HF patients on dapagliflozin versus empagliflozin

Abstract Background Ventricular tachycardia (VT) and ventricular fibrillation (VF) are devastating tachyarrhythmias that can cause sudden cardiac death in patients with heart failure (HF) if not anticipated or treated promptly. Although post-hoc analysis in DAPA-HF showed promise in their benefit, Sodium-glucose transport protein 2 inhibitors (SGLT2i) have not yet been evaluated for their effect on these tachyarrhythmias. This retrospective analysis aims to compare the 2 most commonly used SGLT2i agents, dapagliflozin and empagliflozin, and the incidence of VT in patients with HF. Methods The TriNetX Research network was used for this study. The two initial patient cohorts were created using ICD-10 codes and medication codes from the TriNetX platform. Both cohorts consisted of patients over age 60 with a history of heart failure and either VF or VT. One cohort was on treatment with dapagliflozin and the other with empagliflozin. The cohorts were balanced by propensity score matching and the greedy nearest neighbor algorithm for age, gender, race, ethnicity, hyperkalemia, and the current use of spironolactone, amiodarone, metoprolol, and carvedilol, resulting in 9,841 patients in each arm. The cohorts were then evaluated for the development of VF or VT over the subsequent five years as well as all-cause mortality. Additional cohorts were created to evaluate dapagliflozin vs empagliflozin in diabetics, nondiabetics, and patients with ejection fractions less than 35% Results Dapagliflozin was associated with an increased risk of ventricular arrhythmia in heart failure patients compared to empagliflozin (46.0% vs. 40.8%, RR 1.13, 95% CI (1.09,1.16), P value &amp;lt; 0.0001). It was also associated with higher mortality at five years (RR 1.10, 95% CI (1.03,1.18), P value 0.0034). Conclusions In comparisons between dapagliflozin and empagliflozin in heart failure patients with previously documented ventricular arrhythmias, empagliflozin had 13% less risk of recurrence of ventricular arrhythmias. Secondarily, the empagliflozin cohort also exhibited lower all-cause mortality (14.8% vs 16.3%) at five years from starting the drug. Our analysis does not disprove findings in DAPA-HF, but rather may support the potential class effect of SGLT2 inhibitors in their ability to suppress VT.(1) Importantly, the overall incidence of ventricular tachyarrhythmias is high in both cohort, given we selected a high-risk population. Notably, our documented recurrence rate is similar to past reports of recurrence after VT ablation, the gold standard for treatment of VT. (2) SGLT2 inhibitors have shown clear benefit in multiple placebo-controlled studies in terms of heart failure outcomes like mortality and readmission, but their effect on arrhythmias is one more additional benefit this class may have. (3) Given these associations, empagliflozin may be a more favorable options for HF patients who have already had VT or VF.