AbstractThe association of psychosocial risk factors with cardiovascular disease is well‐established, and there is a growing recognition of their influence on atrial fibrillation (AF) . A recent National Heart, Lung, and Blood Institute workshop called for transforming AF research to integrate social determinants of health. There is limited data examining the impact of psychosocial risk factors (PSRFs) on outcomes in patients with an established diagnosis of AF. Catheter ablation for AF has been shown to improve arrhythmia burden and quality of life compared with medical treatment alone. It is unknown how PSRFs affect clinical outcomes in patients undergoing AF ablation. It is important to understand this relationship, especially given the increasing adoption of catheter ablation in clinical practice.
Safety and efficacy of colchicine for the prevention of post-operative atrial fibrillation in patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials
Abstract Background and Aims Colchicine is an anti-inflammatory drug that may prevent post-operative atrial fibrillation (POAF). The effect of this drug has been inconsistently shown in previous clinical trials. We aimed to compare the efficacy and safety of colchicine vs. placebo to prevent POAF in patients undergoing cardiac surgery. Methods and results A systematic search of EMBASE, MEDLINE, SCOPUS, ClinicalTrials.gov, and the Cochrane Library for randomized controlled trials (RCTs) was conducted from inception till April 2023. The primary outcome was the incidence of POAF after any cardiac surgery. The secondary outcome was the rate of drug discontinuation due to adverse events and adverse gastrointestinal events. Risk ratios (RR) were reported using the Mantel Haenszel method. A total of eight RCTs comprising 1885 patients were included. There was a statistically significant lower risk of developing POAF with colchicine vs. placebo (RR: 0.70; 95% CI: 0.59–0.82; P < 0.01, I2 = 0%), and this effect persisted across different subgroups. There was a significantly higher risk of adverse gastrointestinal events (RR: 2.20; 95% CI: 1.38–3.51; P < 0.01, I2 = 55%) with no difference in the risk of drug discontinuation in patients receiving colchicine vs. placebo (RR: 1.33; 95% CI: 0.93–1.89; P = 0.11, I2 = 0%). Conclusion This meta-analysis of eight RCTs shows that colchicine is effective at preventing POAF, with a significantly higher risk of adverse gastrointestinal events but no difference in the rate of drug discontinuation. Future studies are required to define the optimal duration and dose of colchicine for the prevention of POAF.
Association of atrial fibrillation and outcomes in patients undergoing bone marrow transplantation
Abstract Aims Haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy for several malignant and non-malignant haematologic conditions. Patients undergoing HSCT are at an increased risk of developing atrial fibrillation (AF). We hypothesized that a diagnosis of AF would be associated with poor outcomes in patients undergoing HSCT. Methods and results The National Inpatient Sample (2016–19) was queried with ICD-10 codes to identify patients aged >50 years undergoing HSCT. Clinical outcomes were compared between patients with and without AF. A multivariable regression model adjusting for demographics and comorbidities was used to calculate the adjusted odds ratio (aOR) and regression coefficients with corresponding 95% confidence intervals and P-values. A total of 50 570 weighted hospitalizations for HSCT were identified, out of which 5820 (11.5%) had AF. Atrial fibrillation was found to be independently associated with higher inpatient mortality (aOR 2.75; 1.9–3.98; P < 0.001), cardiac arrest (aOR 2.86; 1.55–5.26; P = 0.001), acute kidney injury (aOR 1.89; 1.6–2.23; P < 0.001), acute heart failure exacerbation (aOR 5.01; 3.54–7.1; P < 0.001), cardiogenic shock (aOR 7.73; 3.17–18.8; P < 0.001), and acute respiratory failure (aOR 3.24; 2.56–4.1; P < 0.001) as well as higher mean length of stay (LOS) (+2.67; 1.79–3.55; P < 0.001) and cost of care (+67 529; 36 630–98 427; P < 0.001). Conclusion Among patients undergoing HSCT, AF was independently associated with poor in-hospital outcomes, higher LOS, and cost of care.
Same‐day discharge for left atrial appendage occlusion procedure: A systematic review and meta‐analysis
AbstractIntroductionMost patients undergoing a left atrial appendage occlusion (LAAO) procedure are admitted for overnight observation. A same‐day discharge strategy offers the opportunity to improve resource utilization without compromising patient safety. We compared the patient safety outcomes and post‐discharge complications between same‐day discharge versus hospital admission (HA) (>1 day) in patients undergoing LAAO procedure.MethodsA systematic search of MEDLINE and Embase was conducted. Outcomes of interest included peri‐procedural complications, re‐admissions, discharge complications including major bleeding and vascular complications, ischemic stroke, all‐cause mortality, and peri‐device leak >5 mm. Mantel–Haenszel risk ratios (RRs) with 95% CIs were calculated.ResultsA total of seven observational studies met the inclusion criteria. There was no statistically significant difference between same‐day discharge versus HA regarding readmission (RR: 0.61; 95% confidence interval [CI]: [0.29–1.31]; p = .21), ischemic stroke after discharge (RR: 1.16; 95% CI: [0.49–2.73]), peri‐device leak >5 mm (RR: 1.27; 95% CI: [0.42–3.85], and all‐cause mortality (RR: 0.60; 95% CI: [0.36–1.02]). The same‐day discharge study group had significantly lower major bleeding or vascular complications (RR: 0.71; 95% CI: [0.54–0.94]).ConclusionsThis meta‐analysis of seven observational studies showed no significant difference in patient safety outcomes and post‐discharge complications between same‐day discharge versus HA. These findings provide a solid basis to perform a randomized control trial to eliminate any potential confounders.
Representation of women, older patients, ethnic, and racial minorities in trials of atrial fibrillation
AbstractBackgroundRepresentation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain.MethodsWe systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease.ResultsOnly 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. The proportions of women in RCTs versus general population were 35.2% and 35.1%, of Hispanics were 11.9% and 5.2%, of Blacks were 1.2% and 5.7%, of American Indian/Alaskans were 0.2% and 0.2%, of Asians were 14.2% and 2.4%, of native Hawaiian/Pacific Islanders were 0.05% and 0.1% and of non‐Whites were 19.5% and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data.ConclusionThe reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over‐represented and Blacks, native Hawaiian/Pacific Islanders and non‐Whites were under‐represented in RCTs of AF.
Representation of Women, Older Patients, Ethnic and Racial Minorities in Trials of Atrial Fibrillation
Background: Representation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain. Methods: We systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥ 75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease. Results: Only 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. In RCTs, proportions of women, Hispanics, Blacks, American Indian/Alaskan patients, Asians, native Hawaiian/Pacific Islanders and non-Whites were 35.2%, 11.9%, 1.2%, 0.2%, 14.2%, 0.05%, and 19.5%, respectively. The corresponding proportions in general population were 35.1%, 5.2%, 5.7%, 0.2%, 2.4%, 0.1%, and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data. Conclusion: The reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over-represented and Blacks, native Hawaiian/Pacific Islanders and non-Whites were under-represented in RCTs of AF. In nearly all studied RCTs, the reporting of racial demographics did not start until later part of last decade.
Prevalence of Multiplicity and Appropriate Adjustments Among Cardiovascular Randomized Clinical Trials Published in Major Medical Journals
Background The safety and efficacy of aspirin for the primary prevention of cardiovascular disease in patients with diabetes mellitus remains controversial. Design A meta-analysis to investigate the effects of aspirin for the prevention of cardiovascular disease in diabetes mellitus. Methods Ten randomized controlled trials were selected using MEDLINE, EMBASE and CENTRAL databases until 27 September 2018. Risk ratios (RRs) with 95% confidence intervals (CIs) and risk differences (RDs) reported as incident events per 1000 person-years were calculated. Results In 33,679 patients, aspirin did not significantly reduce the risk of major adverse cardiovascular outcomes (RR 0.93, 95% CI 0.87–1.00, P = 0.06; RD −0.68 incident cases per 1000 person-years (95% CI −1.54, 0.17)), cardiovascular mortality (RR 0.95, 95% CI 0.83–1.09, P = 0.49; RD 0.11 incident cases per 1000 person-years (95% CI −0.80, 1.02)), myocardial infarction (RR 0.91, 95% CI 0.75–1.11, P = 0.36; RD −0.66 incident cases per 1000 person-years (95% CI −2.07, 0.75)), or stroke (RR 0.91, 95% C, 0.76–1.10, P = 0.33; RD −0.55 incident cases per 1000 person-years (95% CI −1.57, 0.47)). There was a significantly higher risk of total bleeding associated with aspirin (RR 1.29, 95% CI 1.07–1.55, P = 0.01; RD 1.49 incident cases per 1000 person-years (95% CI 0.36, 2.61)). Conclusion The use of aspirin for primary prevention of cardiovascular disease in patients with diabetes mellitus increases the risk of total bleeding without reducing the risk of major adverse cardiovascular outcomes.