Reviews in cardiovascular medicine最新文献

{"title":"Age-Related Trajectories of the Triglyceride-Glucose Index and All-Cause Mortality in Older Chinese Adults.","authors":"Chenxi Li, Chenxi Ouyang, Jie Wang, Zuoshi Wen, Han Zhang, Yiwen Dai, Liujun Jiang, Mengjia Chen, Zhangquan Ying, Dongchen Zhou, Biqi Zhang, Yao Lu, Ting Chen","doi":"10.31083/RCM50652","DOIUrl":"https://doi.org/10.31083/RCM50652","url":null,"abstract":"<p><strong>Background: </strong>The triglyceride-glucose (TyG) index is recognized as an alternative biomarker of cardiometabolic health, associated with insulin resistance and the development and prognosis of cardiovascular disease (CVD). However, the prospective association between long-term TyG index trajectories and all-cause mortality in the older population remains incompletely elucidated.</p><p><strong>Methods: </strong>This longitudinal retrospective cohort study included 93,418 older adults who underwent repeated general health assessments at The Third Xiangya Hospital of Central South University between 2012 and 2020. The TyG index was calculated utilizing the formula: ln (fasting triglycerides (mg/dL) × fasting glucose (mg/dL)/2). TyG index trajectories during the follow-up were analyzed using latent class trajectory modeling (LCTM). Baseline TyG index values and TyG trajectories were analyzed using a Cox proportional hazards model to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).</p><p><strong>Results: </strong>Over a median follow-up of 5.4 years, 7364 participants died, including 4176 cardiovascular deaths. Each 1-standard deviation (SD) increase in the TyG index was associated with a 18.9% higher risk of all-cause mortality, even after accounting for traditional CVD risk factors (HR 1.189, 95% CI 1.144-1.235). Similar associations were observed when the TyG index was modeled in quartiles. Based on the observed trajectory patterns, participants were classified into four groups: low, moderate-low, moderate, and high TyG index trajectories. The low, moderate-low, and high trajectory groups were independently associated with all-cause mortality, whereas the moderate group was not. Following multivariable adjustment, the moderate-low group exhibited a 1.104-fold increase in all-cause mortality risk (95% CI: 1.047-1.165), whereas the high group demonstrated a 1.243-fold increase (95% CI: 1.139-1.357), with both findings statistically significant (<i>p</i> < 0.001). Meanwhile, no significant association was found between the low group and the study outcomes (HR 0.998, 95% CI 0.875-1.138; <i>p</i> = 0.972).</p><p><strong>Conclusions: </strong>In this large cohort of older adults, moderate-low and high TyG index trajectories were associated with an increased risk of all-cause mortality. Longitudinal patterns of the TyG index may serve as important indicators for identifying individuals at elevated risk of all-cause mortality and may support the development of targeted preventive and therapeutic interventions.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"50652"},"PeriodicalIF":2.2,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intra-Pancreatic Fat Deposition Versus Hepatic Fat in Relation to Incident Heart Failure: A Prospective Cohort Analysis.","authors":"Lishan Li, Zenghui Zhang, Siqi Gao, Bin Li, Shaojie Han, Can Lu, Zhaoyu Liu, Shaorong Wu, Jiangtao Yu, Jun Guo","doi":"10.31083/RCM52798","DOIUrl":"https://doi.org/10.31083/RCM52798","url":null,"abstract":"<p><strong>Background: </strong>Although liver fat has been extensively studied, its independent contribution to heart failure (HF) remains debated. Moreover, whether fat stored in different visceral organs confers comparable cardiovascular risk remains unclear. Therefore, this study aimed to examine the associations among intra-pancreatic fat deposition (IPFD), hepatic fat, and visceral adiposity and new-onset HF.</p><p><strong>Methods: </strong>This prospective analysis included 22,038 UK Biobank participants who were free of HF at baseline. Time-to-event associations of IPFD, liver fat, and total visceral fat volume with incident HF were estimated using Cox regression models.</p><p><strong>Results: </strong>Over a median follow-up of 13.6 years, 282 participants developed HF. Spline modeling suggested a monotonic increase in HF risk with higher IPFD, whereas liver fat showed a non-linear, inverted U-shaped pattern. In multivariable models adjusting for cardiometabolic risk factors, the highest IPFD tertile was associated with a greater risk of HF than the lowest tertile (hazard ratio [HR], 1.68; 95% confidence interval [CI], 1.15-2.46; <i>p</i> = 0.007), whereas hepatic fat was not. The association with IPFD remained significant after additional adjustment for pancreatic volume (HR, 1.62; 95% CI, 1.10-2.38), pancreatic iron (HR, 1.58; 95% CI, 1.07-2.33), HF polygenic risk score (HR, 1.58; 95% CI, 1.07-2.33), and the triglyceride-glucose (TyG) index (HR, 1.50; 95% CI, 1.00-2.26). Discrimination for incident HF was comparable between IPFD (area under the curve [AUC], 0.662; 95% CI, 0.635-0.689) and visceral fat volume (AUC, 0.663; 95% CI, 0.635-0.691).</p><p><strong>Conclusions: </strong>Greater pancreatic fat accumulation was independently associated with future HF, regardless of established cardiometabolic risk factors. These results suggest that IPFD may provide additional value for HF risk assessment and prevention-oriented metabolic profiling.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"52798"},"PeriodicalIF":2.2,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653158/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improvements in the Diagnostic Performance of Coronary Computed Tomography Angiography in the Assessment of Heavily Calcified Plaques Using a Novel Deep Learning Model.","authors":"Zhonghua Sun","doi":"10.31083/RCM53504","DOIUrl":"https://doi.org/10.31083/RCM53504","url":null,"abstract":"","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"53504"},"PeriodicalIF":2.2,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653167/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149167922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of Non-Invasive Cardiac Output Monitoring in Enhanced Recovery After Surgery for Patients With Acute Type A Aortic Dissection.","authors":"Jian Zheng, Xiangkun Xiao, Ziheng Ye, Lin Huang, Meng Rui, Yiwen Lin, Fuhua Qiu, Lei Sun, Qingsong Wu","doi":"10.31083/RCM52101","DOIUrl":"https://doi.org/10.31083/RCM52101","url":null,"abstract":"<p><strong>Background: </strong>To assess the clinical value of non-invasive cardiac output monitoring (NICOM) within an enhanced recovery after surgery (ERAS) protocol for patients undergoing acute type A aortic dissection (ATAAD) repair.</p><p><strong>Methods: </strong>This study included 242 patients who underwent total arch replacement for ATAAD between January 2024 and June 2025. Patients were stratified into two groups based on postoperative NICOM use (NICOM group, n = 141; control group, n = 101). This study compared hemodynamic parameters, 6-minute walk test (6MWT) results, postoperative recovery, and complications.</p><p><strong>Results: </strong>Baseline characteristics were similar between groups. While 30-day mortality and ventilator time were comparable, the NICOM group demonstrated significantly superior outcomes inintensive care unit (ICU) stays [3.0 (2.0-5.0) vs. 5.0 (3.0-8.0) days; <i>p</i> < 0.001] and hospitalization time [16.0 (11.0-21.0) vs. 19.0 (14.0-23.0) days; <i>p</i> = 0.001]. The NICOM group also showed lower unadjusted rates of reintubation (1.4% vs. 7.9%; <i>p</i> = 0.029), ICU readmission (2.1% vs. 8.9%; <i>p</i> = 0.036), shock (0.7% vs. 5.9%; <i>p</i> = 0.045), and acute heart failure (2.1% vs. 9.9%; <i>p</i> = 0.018), as well as a longer 6MWT distance at discharge [488.0 (433.0-532.0) vs. 457.0 (410.0-521.0) meters; <i>p</i> = 0.02]. However, after applying Bonferroni correction for multiple comparisons, only ICU stay and hospitalization time remained statistically significant; the differences in re‑intubation, ICU readmission, shock, acute heart failure, and 6MWT did not meet the corrected significance threshold.</p><p><strong>Conclusion: </strong>Integrating NICOM into the postoperative care of patients with ATAAD provides reliable, continuous hemodynamic data that facilitate precise, individualized management. This approach stabilizes circulation, reduces key complications, accelerates recovery, and improves perioperative outcomes, underscoring the vital role of this method in implementing ERAS protocols in cardiac surgery.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"52101"},"PeriodicalIF":2.2,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Skirted Prosthetic Valves Are Associated With Increased Risk of Subclinical Leaflet Thrombosis Following Transcatheter Aortic Valve Replacement: A Multicenter Study.","authors":"Yifan Yang, Qiang Li, Jing Yao, Yunfeng Yan, Moyang Wang, Xinmin Liu, Fei Yuan, Zhengming Jiang, Taiyang Luo, Qian Zhang, Yongjian Wu, Guangyuan Song","doi":"10.31083/RCM49694","DOIUrl":"https://doi.org/10.31083/RCM49694","url":null,"abstract":"<p><strong>Background: </strong>Subclinical leaflet thrombosis (SLT) is associated with an increased risk of thromboembolic events, valve dysfunction, and mortality in patients undergoing transcatheter aortic valve replacement (TAVR). However, data on the incidence and risk factors for SLT in patients undergoing TAVR using self-expanding valves (SEVs) remain limited.</p><p><strong>Methods: </strong>This study included patients who underwent TAVR using SEVs and received a postoperative four-dimensional computed tomography scan within six months at Beijing Anzhen Hospital and Fuwai Hospital. SLT was defined as the presence of hypo-attenuated leaflet thickening (HALT) with or without reduced leaflet motion (RLM), and characterized by increased leaflet thickness affecting one or more leaflets. Univariate and multivariable logistic regression analyses were conducted to explore the relationship between variables and the occurrence of SLT.</p><p><strong>Results: </strong>A total of 311 patients (mean age 72.02 ± 8.23 years, 52.4% males) were included in the analysis. HALT was detected in 91 patients (29.3%), while RLM was observed in 45 patients (14.5%). Most HALT (81.3%) and RLM (73.3%) cases were classified as grades 1-2. Multivariable logistic regression analysis revealed that using skirted prosthetic valves was significantly associated with SLT (adjusted odds ratio: 2.999; 95% confidence interval: 1.250-7.397; <i>p</i> = 0.015).</p><p><strong>Conclusions: </strong>Over one-quarter of patients undergoing TAVR using SEVs developed SLT within six months. The use of skirted prosthetic valves was independently associated with SLT.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"49694"},"PeriodicalIF":2.2,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vaccination as a Strategy for Cardiovascular Prevention: Closing a Gap in Clinical Practice.","authors":"Elvira García-de-Santiago, Alberto García-Lledó","doi":"10.31083/RCM54010","DOIUrl":"https://doi.org/10.31083/RCM54010","url":null,"abstract":"<p><p>Prevention of the consequences of atherosclerotic disease has traditionally focused on controlling individual risk factors such as dyslipidaemia, hypertension and diabetes. In recent years, the term residual risk has been used to describe the persistence of cardiovascular events despite the optimal management of these classical risk factors, with particular attention given to inflammation. Far less attention, however, has been paid to environmental risk factors, which affect entire populations and may account for a substantial proportion of temporal variations in event incidence, as well as the marked seasonal fluctuations in hospital admissions for cardiovascular disease that periodically place considerable pressure on healthcare systems. Temperature, air pollution and infectious diseases-particularly respiratory infections-may help explain why an individual with a given baseline risk experiences an event in one month rather than another. Some environmental factors may promote the development of classical risk factors, whereas others may contribute directly to atherosclerosis. All of them may act either as triggers for acute ischemic events or as destabilising factors in previously stable patients, for example those with heart failure. Infections, especially those of respiratory tract, play a key role in the natural history of cardiovascular disease. Growing evidence indicates that preventing infections through vaccination can reduce the risk of acute ischemic events, hospitalisation and death. Nevertheless, vaccination coverage for many infections, including influenza and Coronavirus disease 2019 (COVID-19), remains low. In addition, pseudo-scientific campaigns continue to spread misinformation about vaccines, thereby reducing patient adherence. Leading cardiology societies now recognise vaccination against certain infections as an evidence-based strategy for cardiovascular prevention. It is therefore essential that this information be widely disseminated among healthcare professionals, patients and the general public. Of all the available measures to control environmental risk factors, vaccination is the only intervention that clinicians can directly implement in routine clinical practice. Vaccination recommendations should therefore be regarded with the same importance as advice on diet, exercise and smoking cessation.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"54010"},"PeriodicalIF":2.2,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653174/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse Event Landscape of Pulsed Field Ablation Catheters: A Computational Review of FDA MAUDE Post-Market Surveillance Data.","authors":"Matthew W Segar, Kaleb D Lambeth, Shyon Parsa, Mehdi Razavi","doi":"10.31083/RCM53385","DOIUrl":"https://doi.org/10.31083/RCM53385","url":null,"abstract":"<p><strong>Background: </strong>Pulsed field ablation (PFA) is Food and Drug Administration (FDA)-cleared for pulmonary vein isolation in atrial fibrillation. Using a keyword-based natural language processing pipeline applied to free-text narratives in the FDA MAUDE database, we aimed to characterize and compare adverse event and device malfunction profiles across the four cleared PFA systems.</p><p><strong>Methods: </strong>We retrieved 6930 MAUDE reports for FDA product code QZI (pulsed field ablation catheter) spanning December 13, 2023 through April 30, 2026, covering all four FDA-cleared PFA systems. Reports were deduplicated and assigned to a specific device system using manufacturer and brand name fields. Concatenated free-text narratives were classified into 11 predefined adverse event categories using multi-label keyword-based natural language processing. Device malfunction reports were additionally subclassified into one of 11 hardware-specific subtypes. Descriptive statistics were used throughout.</p><p><strong>Results: </strong>Of 6930 reports, 4185 (60.4%) were classified into at least one adverse event category. The three most common categories were device/catheter malfunction (2068; 29.8%), cardiac tamponade/pericardial effusion (915; 13.2%), and stroke/TIA/cerebral embolism (600; 8.7%). PFA-specific physiologic adverse events-ST-elevation myocardial infarction (STEMI), hemolysis/acute kidney injury, and phrenic nerve palsy-accounted for 615 combined reports (8.9% of all reports). Fatality proportions were highest for vascular access complications (6.8%), esophageal/atrioesophageal injury (6.0%), and coronary artery spasm/STEMI (5.3%). Among malfunction reports, retraction/retrieval failure predominated for Farapulse (48.9%), while electrical/energy delivery failure was the leading subtype for PulseSelect (29.4%).</p><p><strong>Conclusions: </strong>Natural language processing (NLP)-assisted keyword classification enables systematic, scalable characterization of adverse event patterns across nearly 7000 real-world PFA reports. PFA-specific physiologic adverse events are identifiable through post-market surveillance data and constitute a distinct safety phenotype separate from device malfunction. This approach provides a reproducible framework for near-real-time surveillance of novel cardiac ablation systems.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"53385"},"PeriodicalIF":2.2,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149166609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of Postoperative Quality of Life in Patients With Acute Type A Aortic Dissection After Extensive Arch Repair via Partial Upper Sternotomy.","authors":"Linfeng Xie, Xiujuan Wang, Zhaofeng Zhang, Debin Jiang, Xinfan Lin","doi":"10.31083/RCM50476","DOIUrl":"https://doi.org/10.31083/RCM50476","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to compare health-related quality of life (HRQoL) in patients with acute type A aortic dissection (AAAD) who underwent extensive arch repair via partial upper sternotomy (PUS) or full median sternotomy (FS).</p><p><strong>Methods: </strong>Data were collected from 112 patients with AAAD who were divided into two groups based on the surgical approach. HRQoL was assessed using the MOS 36-item Short-Form Health Survey (SF-36) at discharge (AD), the third postoperative month (POM3), and the twelfth postoperative month (POM12), whereas anxiety symptoms were evaluated using the Spielberger State-Trait Anxiety Inventory state and trait scores (STAI-S and STAI-T) only at POM3.</p><p><strong>Results: </strong>The PUS group had a numerically lower rate of sternal wound complications than the FS group (1.8% vs. 8.8%; <i>p</i> = 0.206), with no significant differences in other in-hospital events. Overall, 112 patients completed the 1-year follow-up. Repeated-measures analyses showed progressive improvement in SF-36 scores from discharge to POM12 in both groups. Compared with the FS group, the PUS group reported better early postoperative HRQoL in selected domains, including role physical, bodily pain, role emotional, and mental health; however, these between-group differences were attenuated at POM12. At POM3, the STAI-S and STAI-T scores were significantly higher in the FS group than in the PUS group.</p><p><strong>Conclusions: </strong>Partial upper sternotomy for extensive arch repair was feasible and was not associated with an apparent increase in perioperative adverse events. Compared with full sternotomy, PUS was associated with less reported pain, lower psychological burden, and better early postoperative HRQoL in selected patients with AAAD.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"50476"},"PeriodicalIF":2.2,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149168511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fibroblast Activation Protein Inhibitor Positron Emission Tomography Imaging in Atrial Fibrillation: Current Evidence and Future Perspectives.","authors":"Yi Xu, Huiyi Qiu, Chuxian Guo, Qianyun Wang, Yongjin Tang, Chongyi Huang, Jun Guo, Feifei Wang","doi":"10.31083/RCM50485","DOIUrl":"https://doi.org/10.31083/RCM50485","url":null,"abstract":"<p><p>Fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT) has emerged as a promising molecular imaging modality for visualizing fibroblast activation and extracellular matrix remodeling. In addition to its established role in oncology imaging, FAPI PET/CT is gaining recognition in the evaluation of cardiovascular disease. Emerging evidence suggests that this technique may provide molecular insights into atrial fibroblast activation and the development of a fibrotic substrate in atrial fibrillation. Meanwhile, related findings from other arrhythmias further support a potential link between myocardial fibroblast activation and electrophysiological remodeling. This review summarizes the current evidence on FAPI PET/CT imaging in atrial fibrillation, discusses related findings in other cardiovascular conditions, and highlights future directions for research in arrhythmia imaging.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"50485"},"PeriodicalIF":2.2,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653197/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Demographic Representation in Clinical Trials for Transthyretin-Associated Cardiac Amyloidosis: A Systematic Review.","authors":"Dimitri Ford, Chima Amadi, Akshay Chandora, Matthew E Gold, Shanelle Brodeur, Ridwan Azees, Nicolas Bakinde, Anekwe E Onwuanyi, Marshaleen Henriques King","doi":"10.31083/RCM53698","DOIUrl":"https://doi.org/10.31083/RCM53698","url":null,"abstract":"<p><strong>Background: </strong>Underrepresentation of minority groups in clinical trials exacerbates health disparities and limits the generalizability of findings. Transthyretin amyloid cardiomyopathy (ATTR-CM) is a condition that disproportionately affects certain racial and ethnic groups, yet the extent to which trial enrollment reflects disease burden remains unclear. Misalignment between disease prevalence and trial representation may delay treatment development and increase the economic burden associated with late diagnosis and suboptimal management. To evaluate racial and ethnic representation in completed U.S.-based ATTR-CM clinical trials by comparing observed participant enrollment with expected enrollment based on disease prevalence, and to assess whether demographic reporting and representation improved following the 2017 Food and Drug Administration (FDA) Final Rule.</p><p><strong>Methods: </strong>This systematic review assessed US-based ATTR clinical trials registered on ClinicalTrials.gov through 2025 (search date: February 12, 2025). Only completed trials with publicly available results were included. Demographic data were extracted at the trial level. For each group, an enrollment fraction (EF) was calculated as observed enrollment ÷ expected enrollment, based on the Cardiac Amyloidosis Registry Study (CARS) prevalence; adequacy was defined as EF ≥0.75.</p><p><strong>Results: </strong>Of the 264 clinical trials on ATTR identified, 16 met the inclusion criteria. African American individuals/individuals of African descent had EFs below the adequacy threshold of 0.75 across all reviewed trial phases compared with their Asian or White counterparts. Following implementation of the FDA Final Rule in 2017, reporting of demographic data increased in the overall study population (from 60% to 83.3%). Although the racial distribution remained significantly different from the expected population distribution in both periods, the enrollment fraction for Black participants declined from 0.291 before 2017 to 0.125 after 2017, with similar decreases observed among other minority groups.</p><p><strong>Conclusions: </strong>Black individuals remain substantially underrepresented in US-based ATTR-CM clinical trials despite improved demographic reporting after the 2017 FDA Final Rule. Actionable strategies, including community engagement, diversification of trial sites, enrollment targets, and sponsor accountability, are urgently needed to improve representativeness and expand access.</p>","PeriodicalId":20989,"journal":{"name":"Reviews in cardiovascular medicine","volume":"27 9","pages":"53698"},"PeriodicalIF":2.2,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}