Antithrombotic therapy following left atrial appendage occlusion (LAAO) is recommended to prevent device-induced thrombosis and stroke. Guidelines suggest oral anticoagulants and aspirin for the first 45 days and then dual antiplatelet therapy for 6 months. However, regimens for antithrombotic therapy varies widely. This study aimed to assess the characteristics of patients receiving minimal versus standard antithrombotic therapy post-LAAO, and to examine the association between treatment type and thrombotic/bleeding risk scores. We conducted a retrospective observational study of patients who underwent LAAO at a teaching hospital between April and December 2023. Patients were categorized into minimal (DOAC only) or standard (DOAC plus aspirin) therapy groups during the first 45 days, and into minimal (SAPT) or standard (DAPT) groups from 45 days to 6 months. Outcomes included CHA2DS2-VASc and HAS-BLED scores, comorbidities, and bleeding/thrombotic events. Statistical analyses included univariate and bivariate comparisons using Chi-square, Fisher exact test, and t -tests. Among 33 patients, 82% received minimal therapy and 18% for the standard therapy in the first 45 days. Standard therapy patients had higher rates of transient ischemic attack (50% vs 7.5%), stroke (100% vs 37%), coronary artery disease (100% vs 44.4%), and NSAID use (33.3% vs 3.7%, P < .05). The CHA2DS2-VASc scores were significantly higher in the standard group (6.5 ± 0.5 vs 4.6 ± 1.4, P = .002), with no difference in HAS-BLED scores. From 45 days to 6 months, 15.2% received minimal and 84.8% for the standard therapy, with no significant differences in scores. Patients with lower CHA2DS2-VASc scores were more likely to receive minimal therapy, indicating potential for risk-guided antithrombotic management post-LAAO. Further studies are needed to validate individualized treatment strategies.
Background/Objectives: Chronic aortic regurgitation (AR) can remain asymptomatic despite progressive myocardial damage. While current surgical guidelines rely heavily on left ventricular ejection fraction (LVEF) and symptoms, these measures may fail to detect subclinical myocardial dysfunction. Global longitudinal strain (GLS), a sensitive echocardiographic marker, has emerged as a potential early biomarker in valvular disease. Therefore, this systematic review aims to assess whether impaired GLS is significantly associated with adverse clinical outcomes including symptom onset, reduced LVEF, and the need for aortic valve intervention among patients with asymptomatic moderate to severe AR and preserved LVEF. Methods: This systematic review and meta-analysis followed PRISMA guidelines and was registered with PROSPERO (CRD42024579540). Comprehensive searches of PubMed, Embase, and the Cochrane Library were completed on November 28, 2024. Screening, deduplication, and blinding were conducted using Rayyan. Eligible studies included adults with chronic, asymptomatic moderate to severe AR and preserved LVEF who underwent GLS measurement. Risk of bias was assessed using the National Heart, Lung, and Blood Institute (NHLBI) tool. A random-effects meta-analysis was performed on studies reporting multivariate hazard ratios (HRs) and 95% confidence intervals. Results: Twelve studies (N = 3278) were included in the systematic review, and four studies (n = 1125) were eligible for meta-analysis. Impaired GLS was significantly associated with adverse outcomes, yielding a pooled HR of 1.359 (95% CI: 1.106–1.668; p = 0.003). Heterogeneity was substantial (I2 = 77%), and the 95% prediction interval ranged from 0.553 to 3.340, indicating potential variability in future settings. Conclusions: GLS is a promising prognostic biomarker for identifying subclinical cardiac dysfunction in asymptomatic moderate to severe AR with preserved LVEF. Its use may enhance early risk stratification and optimize timing for surgical intervention. Larger prospective studies are needed to validate specific GLS thresholds for clinical decision-making.
Background: Lifelong anticoagulation therapy with vitamin K antagonists is recommended following mechanical aortic valve replacement (MAVR) to prevent valve thrombosis. Current guidelines recommend a standard international normalized ratio (INR) of 2.5 for patients with MAVR without additional thromboembolic risk factors, and a higher INR goal of 3.0 for those with conditions such as atrial fibrillation, prior thromboembolism, or left ventricular dysfunction. However, limited clinical evidence exists to guide anticoagulation intensity in this high-risk subgroup, necessitating a systematic review. Objective: We aimed to assess the safety and efficacy of higher-intensity INR goals (>3.0) compared to standard-intensity goals (approximately 2.5) in patients with MAVR with additional thromboembolic risk factors. Methods: This protocol describes a systematic review and meta-analysis following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. A comprehensive literature search will be conducted across PubMed, Embase, and the Cochrane Library for studies published before December 18, 2024. Eligible studies include randomized controlled trials (RCTs), cohort studies, and follow-up studies involving adult patients with MAVR on warfarin therapy, stratified by the presence of additional thromboembolic risk factors. Non–English-language studies, case reports, editorials, and animal studies will be excluded. Results: The review will synthesize existing data to compare the risks and benefits of intensified anticoagulation in patients with MAVR with additional thromboembolic risk factors. Data analysis and manuscript preparation are scheduled for July-August 2025. Conclusions: This study will provide critical evidence on INR management in high-risk patients with MAVR, potentially informing future updates to clinical guidelines and optimizing the balance between thromboembolic prevention and bleeding risk. International Registered Report Identifier (IRRID): PRR1-10.2196/73389
BACKGROUND Lifelong anticoagulation therapy with vitamin K antagonists is recommended following mechanical aortic valve replacement (MAVR) to prevent valve thrombosis. Current guidelines recommend a standard international normalized ratio (INR) of 2.5 for patients with MAVR without additional thromboembolic risk factors, and a higher INR goal of 3.0 for those with conditions such as atrial fibrillation, prior thromboembolism, or left ventricular dysfunction. However, limited clinical evidence exists to guide anticoagulation intensity in this high-risk subgroup, necessitating a systematic review. OBJECTIVE We aimed to assess the safety and efficacy of higher-intensity INR goals (>3.0) compared to standard-intensity goals (approximately 2.5) in patients with MAVR with additional thromboembolic risk factors. METHODS This protocol describes a systematic review and meta-analysis following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. A comprehensive literature search will be conducted across PubMed, Embase, and the Cochrane Library for studies published before December 18, 2024. Eligible studies include randomized controlled trials (RCTs), cohort studies, and follow-up studies involving adult patients with MAVR on warfarin therapy, stratified by the presence of additional thromboembolic risk factors. Non–English-language studies, case reports, editorials, and animal studies will be excluded. RESULTS The review will synthesize existing data to compare the risks and benefits of intensified anticoagulation in patients with MAVR with additional thromboembolic risk factors. Data analysis and manuscript preparation are scheduled for July-August 2025. CONCLUSIONS This study will provide critical evidence on INR management in high-risk patients with MAVR, potentially informing future updates to clinical guidelines and optimizing the balance between thromboembolic prevention and bleeding risk. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/73389
BACKGROUND The brain natriuretic peptide (BNP) and global longitudinal strain (GLS) are emerging biomarkers used to risk stratify patients with asymptomatic severe AR with preserved ejection fraction (EF). While numerous clinical trials have investigated the efficacy of these biomarkers in patients with aortic stenosis, only a limited number examined these biomarkers in patients with aortic regurgitation (AR). Therefore, the proposed systematic review and meta-analysis seeks to assess the prognostic value of BNP and/or GLS in patients with severe asymptomatic AR and preserved EF. OBJECTIVE This is a protocol manuscript for a systematic review and meta-analysis which will collect and synthesize high-quality clinical data on the usefulness of BNP and GLS as prognostic indicators for asymptomatic severe AR with preserved EF. By providing a comprehensive review, our study will have a significant impact in determining surgical candidacy in this patient population. METHODS In accordance with the PRISMA framework, a comprehensive search of databases, including PubMed, Cochrane and Embase will be performed to retrieve peer-reviewed, English-only, observational and experimental studies published from inception to November 2024. Studies which investigated patients aged 18+ years and having severe AR with normal EF will be included. The National Heart, Lung and Blood Institute (NHLBI) tool will be utilized to assess the quality of the studies. RESULTS The development and refinement of the search strategy took place in November 2024 and currently we are working on selection of the articles. Screening and full-texts’ retrieval are expected to be completed by April 2025. Data extraction, summarization, and risk of bias assessment will be conducted in May 2025. Meta-analysis and manuscript writing will take place between June-August 2025. CONCLUSIONS Both BNP and GLS are cost-effective and if these two biomarkers demonstrate superior prognostic potential compared to LV ejection fraction for risk stratification in patients with asymptomatic severe AR and preserved EF, they could significantly enhance the healthcare practice. CLINICALTRIAL CRD42024579540
Background: Brain natriuretic peptide (BNP) and global longitudinal strain (GLS) are emerging biomarkers used to risk-stratify patients with asymptomatic severe aortic regurgitation (AR) and preserved ejection fraction (EF). Although numerous clinical trials have investigated the efficacy of these biomarkers in patients with aortic stenosis, only a limited number have examined these biomarkers in patients with AR. Therefore, the proposed systematic review and meta-analysis seeks to assess the prognostic value of BNP and/or GLS in patients with severe asymptomatic AR and preserved EF. Objective: This is a protocol for a systematic review and meta-analysis that will aggregate and synthesize high-quality clinical data on the usefulness of BNP and GLS as prognostic indicators for asymptomatic severe AR with preserved EF. By providing a comprehensive review, our study will have a significant impact in determining surgical candidacy in this patient population. Methods: In accordance with the PRISMA-S (Preferred Reporting Items for Systematic reviews and Meta-Analyses literature search extension), which is an extension of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement for reporting literature searches in systematic reviews, a comprehensive search of databases, including PubMed, Cochrane, and Embase, will be performed to retrieve peer-reviewed, English-language, observational, and experimental studies published from inception to November 2024. Studies that investigated patients aged ≥18 years with severe AR and preserved EF will be included. The National Heart, Lung, and Blood Institute tool will be used to assess the quality of the studies. Results: Search strategy development for this systematic review began in November 2024. A Peer Review of Electronic Search Strategies review of the search strategy with 2 academic librarians occurred in December 2024, and the final search strategy was finalized by the team of investigators in January 2025. Database queries and screening of studies began in January 2025 with title screening, followed by abstract screening in January and February 2025. Full-text screening took place from February to April 2025. Data extraction occurred between April and May 2025. Synthesis and risk of bias assessment occurred between April and May 2026, followed by data analysis between June and July 2026. Manuscript drafting will begin between June 2026 and July 2026 , with manuscript writing and data dissemination continuing from May 2026 to August 2026. Findings will be submitted to a peer-reviewed journal by August 2026. Conclusions: This systematic review will synthesize the existing evidence to determine the prognostic value of BNP and GLS in patients with asymptomatic severe AR and preserved EF, which could inform future clinical guidelines for the management of this population.