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Transcatheter closure of atrial septal defect in the elderly: a systematic review and meta-analysis.Heart (British Cardiac Society) Nov 2023Despite the establishment of transcatheter closure as the treatment of choice in adults with secundum atrial septal defects (ASDs), the effectiveness of this approach in... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Despite the establishment of transcatheter closure as the treatment of choice in adults with secundum atrial septal defects (ASDs), the effectiveness of this approach in the elderly is disputed. This systematic review and meta-analysis aims to explore the impact of transcatheter ASD closure in patients ≥60 years old.
METHODS
We systematically searched four major electronic databases (PubMed, CENTRAL (Cochrane Central Register of Controlled Trials), Scopus and Web of Science), ClinicalTrials.gov, article references and grey literature. Primary outcomes were the right ventricular end-diastolic diameter (RVEDD) and the New York Heart Association functional class change, whereas secondary outcomes included systolic pulmonary arterial pressure (sPAP), left ventricular end-diastolic diameter (LVEDD), brain natriuretic peptide (BNP), tricuspid valve regurgitation (TR) change, as well as the rate of atrial arrhythmias and all-cause mortality.
RESULTS
In total, 18 single-arm cohorts comprising 1184 patients were included. RVEDD was reduced after ASD closure (standardised mean difference (SMD) -0.9, 95% CI -1.2 to -0.7). Elderly patients had 9.5 times higher odds of being asymptomatic after ASD closure (95% CI 5.06 to 17.79). Furthermore, ASD closure improved sPAP (mean difference (MD) -10.8, 95% CI -14.6 to -7), LVEDD (SMD 0.8, 95% CI 0.7 to 1.0), TR severity (OR 0.39, 95% CI 0.25 to 0.60) and BNP (MD -68.3, 95% CI -114.4 to -22.1). There was a neutral effect of ASD closure on atrial arrhythmias.
CONCLUSIONS
Transcatheter ASD closure is beneficial for the elderly population since it improves functional capacity, biventricular dimensions, pulmonary pressures, TR severity and BNP. However, the incidence of atrial arrhythmias did not change significantly after the intervention.
PROSPERO REGISTRATION NUMBER
CRD42022378574.
Topics: Adult; Humans; Aged; Middle Aged; Atrial Fibrillation; Tricuspid Valve Insufficiency; Heart Septal Defects, Atrial; Cardiac Catheterization; Treatment Outcome
PubMed: 37380331
DOI: 10.1136/heartjnl-2023-322529 -
The American Journal of Cardiology May 2024Left atrial or left atrial appendage thrombosis (LAT) is contraindicated for cardiac ablation (CA) or cardioversion (CV) of atrial fibrillation (AF). This study was... (Meta-Analysis)
Meta-Analysis
Atrial Thrombosis Prevalence Before Cardioversion or Catheter Ablation of Atrial Fibrillation: An Updated Systematic Review and Meta-Analysis of Direct Oral Anticoagulants Versus Vitamin K Antagonists.
Left atrial or left atrial appendage thrombosis (LAT) is contraindicated for cardiac ablation (CA) or cardioversion (CV) of atrial fibrillation (AF). This study was aimed to compare the frequency of LAT detected by transesophageal echocardiography (TEE) before CA or CV in patients with AF treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). We searched PubMed, Scopus, Web of Science, and Cochran Library databases from inception through July 13, 2023 to select studies reporting data on LAT identification before CA or CV using TEE in patients with AF treated with DOACs or VKAs. Pooled odds ratios (ORs) with 95% confidence interval were calculated with a random-effects model. Studies retrieved were 50 (38 observational), 29 on CA, 15 on CV, and 6 on both procedures (17,096 patients on DOACs and 13,666 on VKAs). The overall prevalence of LAT was smaller in DOACs than in VKAs, with an OR of 0.66 (0.52 to 0.84), confirmed at sensitivity analysis and in most subgroups. This finding was consistent for the 3 most reported DOACs: the pooled OR for LAT was 0.68 (0.50 to 0.90) in apixaban, 0.67 (0.51 to 0.88) in dabigatran, 0.61 (0.43 to 0.89) in rivaroxaban, and 1.10 (0.74 to 1.64) in edoxaban (not significant). In conclusion, in this large meta-analysis in patients with AF, the prevalence of LAT by TEE evaluation performed before CV or CA appears lower in those treated with DOACs than in those on VKAs. Additional research may help in better understanding differences between these classes of anticoagulant drugs in the setting of protection against AF-related left atrial thrombotic formation.
Topics: Humans; Atrial Fibrillation; Electric Countershock; Prevalence; Anticoagulants; Thrombosis; Heart Diseases; Catheter Ablation; Vitamin K; Administration, Oral; Stroke
PubMed: 38458580
DOI: 10.1016/j.amjcard.2024.02.042 -
Thrombosis Research Jan 2024Left atrial appendage occlusion (LAAO) provides an alternative for poor candidates of long-term oral anticoagulant (OAC) therapy; however, anticoagulant therapy after... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Left atrial appendage occlusion (LAAO) provides an alternative for poor candidates of long-term oral anticoagulant (OAC) therapy; however, anticoagulant therapy after surgical procedures has limited use due to associated uncertainties. We aimed to evaluate the effectiveness and safety of the short-term use of direct oral anticoagulant (DOAC) and warfarin after LAAO.
METHOD
Electronic databases such as PubMed, Embase, Medline, and Cochrane Library databases were searched up to November 11, 2022. Our study compared DOAC therapy and warfarin in patients after LAAO. A meta-analysis was conducted with the Review Manager software (version 5.4).
RESULTS
The meta-analysis included 13 cohort studies with a total of 32,607 patients. Our findings indicated that the incidence of stroke/TIA/SE, peri-device leaks>5 mm, device-related thrombosis, and all-cause mortality were not significantly different between the two groups after LAAO (P > 0.05). The DOAC group had a significantly lower incidence of major bleeding (OR = 0.83, 95 % CI: 0.74-0.94, P = 0.003), any bleeding (OR = 0.34, 95 % CI: 0.23-0.51, P < 0.001), stroke/TIA/SE and major bleeding (OR = 0.57, 95 % CI: 0.34-0.95, P = 0.03), and any major adverse event (OR = 0.89, 95 % CI:0.82-0.97, P = 0.010) than the warfarin group. The subgroup analysis revealed that the rate of stroke/TIA/SE was similar in the two groups in terms of the different regions, follow-up time, study type, anticoagulant strategy, and bleeding risk. The incidence of major bleeding in the DOAC group was significantly lower than that in the warfarin group in North America, as well as at follow-up period ≤6 months, retrospective cohort, HAS-BLED average score ≥ 3. In addition, the risk of major bleeding was higher with the combination of OAC and single antiplatelet therapy (SAPT) than with OAC alone. Finally, in the North American region, retrospective cohort, and HAS-BLED average score ≥ 3, the incidence of any serious adverse event in the DOAC group was still significantly lower than that in the warfarin group.
CONCLUSION
Compared to warfarin, DOAC reduced the risk of major bleeding and any serious adverse event in patients after LAAO. This advantage was particularly notable in North America and high-risk populations for bleeding. In addition, the incidence of device-related thrombosis, peri-device leaks, stroke/TIA/SE and all-cause mortality were similar in both groups. The risk of major bleeding was lower in patients taking OAC alone compared with those taking OAC plus SAPT, without increasing the risk of thrombosis.
Topics: Humans; Anticoagulants; Warfarin; Ischemic Attack, Transient; Atrial Appendage; Retrospective Studies; Atrial Fibrillation; Treatment Outcome; Stroke; Hemorrhage; Thrombosis
PubMed: 38035647
DOI: 10.1016/j.thromres.2023.10.021 -
JACC. Advances Sep 2023Data on the association between atrial fibrillation (AF) and venous thromboembolism (VTE) are controversial.
BACKGROUND
Data on the association between atrial fibrillation (AF) and venous thromboembolism (VTE) are controversial.
OBJECTIVES
The purpose of this study was to investigate the risk of VTE in patients with AF according to the time from AF diagnosis.
METHODS
Systematic review of MEDLINE (PubMed), Embase, Cumulative Index to Nursing and Allied Health Literature (EBSCO host), Cochrane Central Register of Controlled Trials (2020) in the Cochrane Library, and World Health Organization Global Index Medicus databases and meta-analysis of observational studies. The risk of VTE, deep vein thrombosis (DVT) and pulmonary embolism (PE) was analyzed according to the time of AF onset: 1) short (≤3 months); 2) medium (≤6 months); and 3) long (>6 months) time groups.
RESULTS
Eight studies were included with 4,170,027 patients, of whom 650,828 with AF. In the short-term group, AF was associated with the highest risk of either PE (HR: 9.62; 95% CI: 7.07-13.09; I = 0%) or DVT (HR: 6.18; 95% CI: 4.51-8.49, I = 0%). Even if to a lesser extent, AF was associated with a higher risk of VTE (HR: 3.69; 95% CI: 1.65-8.27; I = 79%), DVT (HR: 1.75; 95% CI: 1.43-2.14; I = 0%), and PE (HR: 4.3; 95% CI: 1.61-11.47; I = 68%) in the up to 6 months and long-term risk group >6 months groups (HR: 1.39; 95% CI: 1.00-1.92; I = 72%) and PE (HR: 1.08; 95% CI: 1.00-1.16; I = 0%).
CONCLUSIONS
The risk of VTE is highest in the first 3 to 6 months after AF diagnosis and decreases over time. The early initiation of anticoagulation in patients with AF may reduce the risk of VTE.
PubMed: 38939492
DOI: 10.1016/j.jacadv.2023.100555 -
Hellenic Journal of Cardiology : HJC =... 2023Atrial fibrillation (AF) and cancer often co-exist. Each has been associated with an increased risk of morbidity and mortality. The aim of this meta-analysis was to... (Meta-Analysis)
Meta-Analysis Review
AIMS
Atrial fibrillation (AF) and cancer often co-exist. Each has been associated with an increased risk of morbidity and mortality. The aim of this meta-analysis was to synthesize available data regarding the incidence of arterial thromboembolism (TE), bleeding, and all-cause mortality in patients with AF with or without cancer.
METHODS
Literature search was conducted in PubMed, Ovid MEDLINE, WebOfScience, Scopus, CENTRAL, OpenGrey, and EThOS databases to identify studies that included patients with AF and accounted for cancer status with the incidence of TE (ischemic stroke, transient ischemic attack, or arterial thrombosis), major or clinically relevant non-major bleeding, and all-cause mortality. A random-effects meta-analysis was used.
RESULTS
Overall, 17 studies were included (3,149,547 patients). The risk of TE was similar in patients with AF with comorbid cancer compared with that in AF alone (pooled odds ratio [pOR] 0.97, 95% Confidence Interval [CI] 0.85-1.11, I = 87%). Major or clinically relevant non-major bleeding (pOR 1.65, 95% CI 1.35-2.02, I = 98%) and all-cause death (pOR 2.17, 95% CI 1.83-2.56, I = 98%) were significantly higher in patients with AF with cancer than in patients with AF only. The history of TE and hypertension and mean age were significant moderators of TE risk.
CONCLUSION
In patients with AF, the presence of cancer is associated with a similar risk of TE as well as an increased risk of bleeding and all-cause death compared with the absence of cancer.
Topics: Humans; Atrial Fibrillation; Stroke; Anticoagulants; Hemorrhage; Thromboembolism; Neoplasms; Risk Factors
PubMed: 37414144
DOI: 10.1016/j.hjc.2023.06.005 -
Annals of Hematology May 2024Rivaroxaban is a new direct oral anticoagulant, and the same dose is recommended for older and young patients. However, recent real-world studies show that older... (Review)
Review
Rivaroxaban is a new direct oral anticoagulant, and the same dose is recommended for older and young patients. However, recent real-world studies show that older patients may need dose adjustment to prevent major bleeding. At present, the evidence for dose adjustment in older patients is extremely limited with only a few reports on older atrial fibrillation patients. The aim of this study was to review the morbidity data of adverse events and bleeding events across all indications for older and young patients treated with the same dose of rivaroxaban to provide some support for dosage adjustment in older patients. The PubMed, EMBASE, ClinicalTrials, Cochrane and Web of Science databases were searched for randomized controlled trials (RCTs) published between January 1, 2005, and October 10, 2023. The primary outcomes were the morbidity of bleeding events and efficacy-related adverse events. Summary estimates were calculated using a random effects model. Eighteen RCTs were included in the qualitative analysis. The overall morbidity of primary efficacy endpoints was higher in older patients compared to the young patients (3.37% vs. 2.60%, χ = 5.24, p = 0.022). Similarly, a higher morbidity of bleeding was observed in older patients compared to the young patients (4.42% vs. 6.03%, χ = 13.22, p < 0.001). Among all indications, deep vein thrombosis, pulmonary embolism and atrial fibrillation were associated with the highest incidence of bleeding in older patients, suggesting that these patients may be most need dose adjustment. Patients older than 75 years may require extra attention to prevent bleeding. The same dose of rivaroxaban resulted in higher bleeding morbidity and morbidity of efficacy-related adverse events in older patients compared to the young patients. An individualized dose adjustment may be preferred for older patients rather than a fixed dose that fits all.
PubMed: 38710878
DOI: 10.1007/s00277-024-05767-z -
Endocrine Practice : Official Journal... Jan 2024To investigate the impact of testosterone replacement therapy (TRT) on cardiovascular outcomes in hypogonadal men. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To investigate the impact of testosterone replacement therapy (TRT) on cardiovascular outcomes in hypogonadal men.
METHODS
A meta-analysis of 26 randomized controlled trials involving 10 941 participants was conducted. Various clinical outcomes, including all-cause mortality, cardiovascular-related mortality, myocardial infarction, stroke, congestive heart failure, atrial fibrillation, pulmonary embolism, and venous thrombosis, were assessed.
RESULTS
No statistically significant differences were observed between the TRT group and the control group in terms of these clinical outcomes. Sensitivity analysis and publication bias assessment supported the robustness of the findings. Meta-regression analysis found no significant associations between clinical outcomes and potential covariates, including age, diabetes, hypertension, dyslipidemia, and smoking.
DISCUSSION
Previous research on TRT and cardiovascular events, with comparisons to studies like the Testosterone Trials and the studies conducted by Vigen et al, Finkle et al, Layton et al, and Wallis et al, is provided. The significance of the systematic review and meta-analysis approach is emphasized, particularly its exclusive focus on hypogonadal patients.
CONCLUSION
This study offers reassurance that TRT does not increase mortality risk or worsen cardiovascular outcomes in hypogonadal men. However, further research, especially long-term studies involving diverse populations, is essential to strengthen the evidence base and broaden the applicability of these findings.
Topics: Humans; Male; Hormone Replacement Therapy; Hypogonadism; Randomized Controlled Trials as Topic; Testosterone; Cardiovascular Diseases
PubMed: 37797887
DOI: 10.1016/j.eprac.2023.09.012 -
The American Journal of Cardiology Oct 2023Left atrial appendage closure (LAAC) reduces the risk of thromboembolic stroke in atrial fibrillation. Peri-device leak (PDL) after LAAC may affect the subsequent risk... (Meta-Analysis)
Meta-Analysis
Left atrial appendage closure (LAAC) reduces the risk of thromboembolic stroke in atrial fibrillation. Peri-device leak (PDL) after LAAC may affect the subsequent risk of thromboembolism. We conducted a systematic review and meta-analysis to evaluate the effect of PDL after LAAC. We searched PubMed/Medline, Embase, and Google Scholar for studies reporting outcomes of PDL after LAAC from inception through October 2022. The primary outcome was the composite of stroke, transient ischemic attack (TIA), or systemic embolism (SE). Secondary outcomes included all-cause and cardiovascular mortality, ischemic stroke, TIA, and device-related thrombus. Outcomes were pooled using random-effects models. We used I statistics to assess statistical heterogeneity; I >50% considered significant heterogeneity. This study included 54,279 patients from 11 studies (6 observational, 2 nonrandomized controlled trials [non-RCTs] primary results, 2 RCT post hoc analyses, and 1 analysis combining 2 RCTs data). PDL was associated with a significant increase in the composite outcome of stroke, TIA, or SE (odds ratio 1.63, 95% confidence interval 1.06 to 2.52, p = 0.03, I = 43%) as compared with cases with no PDL. There were no significant differences in all-cause or cardiovascular mortality, ischemic stroke, TIA, or device-related thrombus. In conclusion, PDL after LAAC is associated with an increased risk of thromboembolism (composite stroke, TIA, or SE) without impacting mortality.
Topics: Humans; Atrial Appendage; Atrial Fibrillation; Embolism; Ischemic Attack, Transient; Ischemic Stroke; Observational Studies as Topic; Stroke; Thromboembolism; Thrombosis; Treatment Outcome
PubMed: 37572568
DOI: 10.1016/j.amjcard.2023.07.102 -
PloS One 2024In patients with non-valvular atrial fibrillation (NVAF), mechanical occlusion of the left atrial appendage (LAA) using a permanently implanted device may be an... (Meta-Analysis)
Meta-Analysis
Safety and efficacy of percutaneous Watchman 2.5 device versus Amplatzer Amulet for left atrial appendage closure in patients with non-valvular atrial fibrillation: A systematic review and study-level meta-analysis.
INTRODUCTION
In patients with non-valvular atrial fibrillation (NVAF), mechanical occlusion of the left atrial appendage (LAA) using a permanently implanted device may be an effective alternative to oral anti-coagulants (OAC). To facilitate left atrial appendage closure (LAAC), multiple percutaneous devices have been proposed. Watchman Generation 2.5 and Amplatzer Amulet are the two most popular used devices for preventing stroke in patients with NVAF. We sought to compare safety and efficacy outcomes between Watchman 2.5 and Amplatzer Amulet in patients undergoing LAAC procedure.
METHODS
We carried out a comprehensive and systematic search of the databases PubMed and Scopus, for all studies that compared the safety and efficacy of Watchman 2.5 and Amplatzer Amulet devices, from inception, till June 2023. We performed the statistical analysis using Review Manager (V.5.4.1 Cochrane Collaboration, London, United Kingdom). The safety outcomes of interest included device success, device-related thrombus, device embolization perioperatively and at follow-up, perioperative pericardial perfusion events, and perioperative cardiac tamponade events. Efficacy outcomes were all-cause mortality perioperatively and at follow-up, cardiovascular (CV) mortality at follow-up, stroke, major and minor bleeding events at follow-up, transient ischemic attack (TIA) in follow-up period, thromboembolic events in follow-up period, and peri-device leakage in perioperative period. All data was analysed using a random-effects model, and presented as risk ratios (RRs) with 95% confidence intervals (95%CIs).
RESULTS
Regarding safety outcomes, device success was non-significantly reduced in Watchman group when compared with Amulet (RR 0.99, p = 0.57; I2 = 34%). In contrast, device-related thrombus was non-significantly increased in Watchman 2.5 group in comparison to Amulet (RR 1.44, p = 0.11; I2 = 0%). There was no significant difference between the devices in terms of device embolization in the perioperative (RR 0.36, p = 0.38; I2 = 22%) and follow-up (RR 2.24, p = 0.13; I2 = 0%) periods. Likewise, there was no significant difference in the risks of pericardial effusion (RR 0.98, p = 0.98; I2 = 0%), and cardiac tamponade (RR 0.65, p = 0.76; I2 = 62%) perioperatively. Regarding efficacy outcomes, no significant difference was observed in all-cause mortality between devices perioperatively (RR 0.51, p = 0.32; I2 = 0%) and at follow-up (RR 1.08, p = 0.56; I2 = 0%). CV-mortality was non-significantly reduced in Watchman group when compared with Amulet (RR 0.57, p = 0.20; I2 = 0%). The Amulet device was not superior to the Watchman device in terms of stroke at follow-up (RR 1.13, p = 0.63; I2 = 0%). Sub-group analysis showed comparable ischaemic and haemorrhagic stroke events between two devices. Furthermore, at follow-up, there was no significant difference in major (RR 1.06, p = 0.63; I2 = 0%) and minor bleeding events (RR 1.81, p = 0.17; I2 = 0%) between the two devices. No difference was observed for trans-ischemic attack (RR 1.89, p = 0.24; I2 = 0%) and thromboembolic events (RR 0.96, p = 0.96; I2 = 0%) at follow-up. No significant difference was observed between devices for peri-device leakage in perioperative period (RR 2.16, p = 0.05; I2 = 0%).
CONCLUSION
The data suggested that LAAC is safe and efficacious procedure irrespective of device used, with generally low complication rates. Watchman generation 2.5 remains non-superior to Amplatzer Amulet in terms of safety and efficacy outcomes.
Topics: Humans; Atrial Fibrillation; Left Atrial Appendage Closure; Cardiac Tamponade; Treatment Outcome; Atrial Appendage; Stroke; Thrombosis; Cardiac Catheterization
PubMed: 38354181
DOI: 10.1371/journal.pone.0295804 -
Current Medical Research and Opinion Sep 2023Advancing age is a risk factor for developing non-valvular atrial fibrillation (NVAF) or acute venous thromboembolism (VTE). We assessed the comparative effectiveness,...
Comparative outcomes associated with rivaroxaban versus warfarin use in elderly patients with atrial fibrillation or acute venous thromboembolism managed in the United States: a systematic review of observational studies.
BACKGROUND
Advancing age is a risk factor for developing non-valvular atrial fibrillation (NVAF) or acute venous thromboembolism (VTE). We assessed the comparative effectiveness, safety, costs, and healthcare utilization associated with rivaroxaban versus warfarin in patients of advanced age managed in the United States (US).
METHODS
We conducted a systematic review of Medline and Embase through April 2023 to identify real-world evidence (RWE) studies of older adults (at least 65+ years of age) with either NVAF or VTE who received either rivaroxaban or warfarin in the US and reported an outcome of stroke or systemic embolism (SSE), ischemic stroke (IS), recurrent VTE, major bleeding, intracranial hemorrhage, costs, or healthcare resource utilization. We classified each outcome of interest per study as "positive" (lower risk), "negative" (higher risk), or "neutral" based upon the summary effect size of rivaroxaban versus warfarin.
RESULTS
Twenty-nine RWE studies met inclusion criteria, mostly (83%) in NVAF populations. For SSE with rivaroxaban versus warfarin, 68.8% of studies showed positive effects and 31.2% showed neutral outcome. For major bleeding, 57.7% showed neutral effects, 38.5% showed negative effects, and 3.8% of studies showed positive effects with rivaroxaban versus warfarin. Of the two studies reporting cost data, both were positive, showing lower costs for SSE for rivaroxaban versus warfarin and neutral cost for major bleeding costs.
CONCLUSIONS
This systematic review supports findings from subgroup analyses of randomized controlled trials that, compared with warfarin, rivaroxaban is associated with generally neutral or positive effects on thrombosis and a mixed picture on bleeding outcomes in older adults with either NVAF or VTE treated in the United States.
Topics: Humans; United States; Aged; Warfarin; Rivaroxaban; Atrial Fibrillation; Venous Thromboembolism; Anticoagulants; Retrospective Studies; Stroke; Venous Thrombosis; Hemorrhage; Embolism
PubMed: 37584187
DOI: 10.1080/03007995.2023.2247988