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Clinical Therapeutics Mar 2023Pharmacologic cardioversion is an effective clinical strategy for fibrillation. Vernakalant is a novel drug used to treat atrial fibrillation (AF). This study aimed to... (Meta-Analysis)
Meta-Analysis
PURPOSE
Pharmacologic cardioversion is an effective clinical strategy for fibrillation. Vernakalant is a novel drug used to treat atrial fibrillation (AF). This study aimed to evaluate the efficacy- and tolerability-related data on vernakalant from clinical trials.
METHODS
Literature from PubMed and the Cochrane Library was systematically reviewed, and 139 eligible studies were found after specific key words were identified. Twelve randomized clinical trials discussing vernakalant cardioversion in patients with AF were chosen for the meta-analysis after scrutiny. Ten of the 12 trials used placebo while two reported data on active and established drugs to compare the effects of vernakalant. Three of the 12 trials included relevant clinical states in addition to AF.
FINDINGS
In this meta-analysis of data from 12 studies (2365 patients, 887 events), the rate of cardioversion from AF to sinus rhythm (SR) was significantly greater with vernakalant compared with placebo and active comparators (risk ratio = 5.60; 95% CI, 2.83-11.09; I test for heterogeneity, 92%). Tolerability-related data revealed that dysgeusia, paresthesia, atrial flutter, and hypotension were major adverse events that occurred with vernakalant use, but the data were not clinically significant compared to placebo and active drug (risk ratio = 1.13; 95% CI, 0.86-1.47). Eleven deaths were reported in 4 trials, with vernakalant directly implicated in two deaths. Vernakalant was well tolerated and effective in patients with rapid-onset AF.
IMPLICATIONS
Vernakalant appears to be a good choice when AF is manifested postoperatively or exists with ischemic heart disease and valvular states. Tolerability-related data are promising, but a specific trial may be required to identify the causes of the deaths considered unrelated to vernakalant use.
Topics: Humans; Atrial Fibrillation; Anti-Arrhythmia Agents; Electric Countershock; Treatment Outcome; Infusions, Intravenous; Pyrrolidines
PubMed: 36828756
DOI: 10.1016/j.clinthera.2023.01.014 -
Clinical Research in Cardiology :... Aug 2023Omecamtiv mecarbil (OM) is a direct myosin activator that augments left ventricular systolic function. This review compares OM to placebo by evaluating its effect on... (Meta-Analysis)
Meta-Analysis
KCCQ total symptom score, clinical outcome measures, and adverse events associated with omecamtiv mecarbil for heart failure with reduced ejection fraction: a systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Omecamtiv mecarbil (OM) is a direct myosin activator that augments left ventricular systolic function. This review compares OM to placebo by evaluating its effect on clinical outcomes and adverse events in patients with heart failure with reduced left ventricular ejection fraction.
METHODS AND RESULTS
A literature search of multiple databases for randomized controlled trials (RCTs) investigating OM versus placebo was undertaken. Six RCTs comprising 9596 patients were included. Use of OM was associated with a reduced risk of stroke (RR: 0.69; 95% CI 0.52-0.92). There was no significant mean difference (MD) change in the KCCQ total symptom score (MD: 1.82, 95% CI - 1.33 to 4.97), all-cause death (RR: 1.00; 95% CI 0.93-1.07), hospital readmissions (RR: 0.96; 95% CI 0.90-1.03), myocardial infarction (RR: 1.05; 95% CI 0.83-1.33), cardiovascular death (RR: 1.01; 95% CI 0.92-1.10), heart failure (HF) events (RR: 0.95; 95% CI 0.89-1.02), or a composite of cardiovascular death or HF events (RR: 0.97; 95% CI 0.93-1.02). In addition, OM was associated with an increased risk of dizziness (RR: 1.25; 95% CI 1.04-1.50) and hypotension (RR: 1.17; 95% CI 1.01-1.36). Other adverse events including ventricular tachyarrhythmias, (RR: 0.95; 95% CI 0.82-1.11), supraventricular tachyarrhythmias and atrial fibrillation/flutter (RR: 0.73; 95% CI 0.46-1.18), dyspnea (RR: 1.00; 95% CI 0.86-1.18), and acute renal injury (RR: 0.88; 95% CI 0.60-1.27) were not significant.
CONCLUSION
OM is generally well tolerated. We identified a reduced risk of stroke with use of OM. However, there was no improvement in other clinical outcomes or quality of life. Study protocol was registered in PROSPERO international prospective register of systematic reviews (CRD42022348423).
Topics: Humans; Randomized Controlled Trials as Topic; Heart Failure; Stroke Volume; Stroke; Atrial Fibrillation; Outcome Assessment, Health Care
PubMed: 36800016
DOI: 10.1007/s00392-023-02172-w -
Frontiers in Cardiovascular Medicine 2022Contact force (CF) and related parameters have been evaluated as an effective guide mark for pulmonary vein isolation, yet not for linear ablation of the cavotricuspid...
BACKGROUND
Contact force (CF) and related parameters have been evaluated as an effective guide mark for pulmonary vein isolation, yet not for linear ablation of the cavotricuspid isthmus (CTI) dependent atrial flutter (AFL). We thus studied the efficacy and safety of CF related parameter-guided ablation for CTI-AFL.
METHODS
Systematic search was performed on databases involving PubMed, EMbase, Cochrane Library and Web of Science (through June 2022). Original articles comparing CF related parameter-guided ablation and conventional parameter-guided ablation for CTI-AFL were included. One-by-one elimination, subgroup analysis and meta-regression were used for heterogeneity test between studies.
RESULTS
Ten studies reporting on 761 patients were identified after screening with inclusion and exclusion criteria. Radiofrequency (RF) duration was significantly shorter in CF related parameter-guided group ( = 0.01), while procedural time ( = 0.13) and fluoroscopy time ( = 0.07) were no significant difference between two groups. CF related parameter-guided group had less RF lesions ( = 0.0003) and greater CF of catheter-tissue ( = 0.0002). Touch-up needed after first ablation line was less in CF related parameter-guided group ( = 0.004). In addition, there were no statistical significance between two groups on acute conduction recovery rates ( = 0.25), recurrence rates ( = 0.92), and complication rates ( = 0.80). Meta-regression analysis revealed no specific covariate as an influencing factor for above results ( > 0.10).
CONCLUSION
CF related parameters guidance improves the efficiency of CTI ablation, with the better catheter-tissue contact, the lower RF duration and the comparable safety as compared with conventional method, but does not improve the acute success rate and long-term outcome.
PubMed: 36684611
DOI: 10.3389/fcvm.2022.1060542 -
Indian Heart Journal 2023The benefit of prior statin use to reduce the incidence of arrhythmia in acute coronary syndrome (ACS) is still a matter of debate. Statins have multiple pleiotropic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The benefit of prior statin use to reduce the incidence of arrhythmia in acute coronary syndrome (ACS) is still a matter of debate. Statins have multiple pleiotropic effects, which may reduce the incidence of in-hospital arrhythmia. A systematic review and meta-analysis were performed to evaluate prior statin use and the incidence of in-hospital arrhythmia in ACS.
METHODS
This systematic review was conducted as per the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). We performed a literature search through Pubmed, Proquest, EBSCOhost, and Clinicaltrial.gov. A random-effect model was used due to moderate heterogeneity. Quality assessment was performed using Newcastle Ottawa Scale. Sensitivity analysis was performed by using leave one or two out method. PROSPERO registration number: CRD42022336402.
RESULTS
Nine eligible studies consisting of 86,795 patients were included. A total of 22,130 (25.5%) patients were in statin use before the index ACS event. The prevalence of old myocardial infarction, heart failure, hypertension, diabetes mellitus, and chronic renal failure and concomitant treatment with aspirin, clopidogrel, and beta blocker was higher in the prior statin group compared to no previous statin. Overall, prior statin use was associated with a significantly lower incidence of in-hospital arrhythmia during ACS compared to no previous statin (OR 0.60; 95% CI 0.49-0.72; P < 0.00001; I = 54%, P-heterogeneity = 0.03). In subgroup analysis, previous statin use reduced the incidence of atrial fibrillation or atrial flutter (OR 0.64; 95% CI 0.43-0.95; P = 0.03; I = 73%, P-heterogeneity = 0.01) and ventricular tachycardia or ventricular fibrillation (OR 0.57; 95% CI 0.49-0.65; P < 0.00001; I = 8%, P-heterogeneity = 0.35).
CONCLUSIONS
Based on aggregate patient data, prior statin use may reduce the incidence of in-hospital arrhythmia during ACS, particularly atrial fibrillation or atrial flutter and ventricular tachycardia or ventricular fibrillation.
Topics: Humans; Atrial Fibrillation; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Acute Coronary Syndrome; Incidence; Atrial Flutter; Ventricular Fibrillation; Tachycardia, Ventricular
PubMed: 36642406
DOI: 10.1016/j.ihj.2023.01.004 -
Hellenic Journal of Cardiology : HJC =... 2023The ideal treatment for patent foramen ovale (PFO) in patients with cryptogenic stroke remains controversial and is being evaluated. The objective of this study was to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The ideal treatment for patent foramen ovale (PFO) in patients with cryptogenic stroke remains controversial and is being evaluated. The objective of this study was to evaluate the net clinical benefit (NCB) between PFO closure and medical treatment.
METHODS
We searched three electronic databases from inception until January 2022. The primary outcomes were the NCB-1, defined as the cumulative incidence of stroke, major bleeding, atrial fibrillation/flutter, and serious procedural or device complications; the NCB-2 and NCB-3 were defined as NCB1 but using a weighted factor of 0.5 and 0.25 for atrial fibrillation/flutter events, respectively. We also evaluated each component outcome of NCB as a secondary outcome. Risk ratios (RR) and 95% confidence intervals (CI) of each outcome were calculated (random-effects model).
RESULTS
Our analysis included six RCTs (n = 3750 patients). The rates of NCB-1, NCB-2, and NCB-3 were not different between PFO closure and medical treatment. The heterogeneity between trials was low to moderate. Stroke showed a significant relative decrease of 44% (95% CI, 21-60%), favoring the PFO closure arm. Atrial fibrillation/flutter increased by 4.04 times (95% CI, 1.57-8.89) in the PFO closure compared with the medical treatment group. In a meta-regression analysis, the reduction in NCB-1 with PFO closure increased as the proportion of patients treated with the Amplatzer device increased (p = 0.02), and the reduction in NCB-1, NCB-2, and NCB-3 with PFO closure increased as the proportion of patients treated with substantial PFO size increased (p = 0.03).
CONCLUSION
The NCB between PFO closure and medical treatment was not different, suggesting individualized treatment to maximize benefit.
Topics: Humans; Atrial Fibrillation; Neoplasm Recurrence, Local; Stroke; Ischemic Stroke; Foramen Ovale, Patent; Secondary Prevention; Cardiac Catheterization; Atrial Flutter; Treatment Outcome; Septal Occluder Device; Recurrence
PubMed: 36584788
DOI: 10.1016/j.hjc.2022.12.010 -
Diabetology & Metabolic Syndrome Dec 2022Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been highly recommended for glycemic control and weight reduction. However, evidence has accumulated that... (Review)
Review
Association of glucagon-like peptide-1 receptor agonists with cardiac arrhythmias in patients with type 2 diabetes or obesity: a systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been highly recommended for glycemic control and weight reduction. However, evidence has accumulated that GLP-1 RAs treatment is related to an increase in heart rate, which could potentially induce cardiac arrhythmias. This study aims to investigate the association of GLP-1 RAs therapy with incident arrhythmias in diabetic and obese patients.
METHODS
MEDLINE, EMBASE, Cochrane Library, and ClinicalTrials.gov were systematically searched from inception up to May 25, 2022. Randomized controlled trials (RCTs) comparing GLP-1 RAs with placebo or active control for adults with type 2 diabetes or obesity were included. The outcomes of interest were prespecified as incident atrial fibrillation (AF), atrial flutter (AFL), ventricular arrhythmias (VAs), and sudden cardiac death (SCD). Mantel-Haenszel relative risk (MH-RR) with a corresponding 95% confidence interval (95% CI) was estimated using a fixed-effects model.
RESULTS
A total of 56 RCTs involving 79,720 participants (44,028 GLP-1 RAs vs 35,692 control: mean age 57.3 years) were included from 7692 citations. GLP-1 RAs use overall did not significantly increase the risk of AF (RR 0.97, 95% CI 0.83-1.12), AFL (RR 0.83, 95% CI 0.59-1.17), VAs (RR 1.24, 95% CI 0.92-1.67), and SCD (RR 0.89, 95% CI 0.67-1.19), compared with controls. In further subgroup analyses, we observed an increasing trend toward incident AF with dulaglutide (RR 1.40, 95% CI 1.03-1.90) while an inverse trend with oral semaglutide (RR 0.43, 95% CI 0.21-0.87). Additionally, higher doses of GLP-1 RAs (RR 1.63, 95% CI 1.11-2.40) and higher baseline BMI (RR 1.60, 95% CI 1.04-2.48) might significantly increase the risk of VAs. No significant differences were identified in other subgroup analyses.
CONCLUSIONS
GLP-1 RAs therapy was not associated with an overall higher risk of arrhythmias, demonstrating an assuring cardiovascular safety profile. Further studies are required to determine whether the potential antiarrhythmic or arrhythmogenic effect of GLP-1 RAs is drug-specific and varies from doses or baseline BMI.
TRIAL REGISTRATION
PROSPERO Identifier: CRD42022339389.
PubMed: 36572913
DOI: 10.1186/s13098-022-00970-2 -
Europace : European Pacing,... Mar 2023To describe the role of left atrial (LA) epicardial conduction and targets of ablation in biatrial tachycardias (BiATs).
AIMS
To describe the role of left atrial (LA) epicardial conduction and targets of ablation in biatrial tachycardias (BiATs).
METHODS AND RESULTS
Consecutive patients with BiAT diagnosed by high-density mapping and appropriate entrainment were enrolled. A systematic review of case reports or series was then performed. Biatrial tachycardia was identified in 20 patients aged 63.5 ± 11.1 years. Among them, eight had LA epicardial conduction, including four via the ligament of Marshall, two via myocardial fibres between the great cardiac vein (GCV) and LA, one via septopulmonary bundle, and one via myocardial fibres between the posterior wall and coronary sinus. Ablation was targeted at the anatomical isthmus in 14, including 5 undergoing vein of Marshall ethanol infusion and 2 undergoing ablation in the GCV. Another six underwent ablation at interatrial connections, including one with septopulmonary bundle at the fossa ovalis and five at the atrial insertions of Bachmann's bundle. After a mean follow-up of 8.7 ± 3.8 months, five patients had recurrence of atrial fibrillation/flutter. Systematic review enrolled 87 patients in previous and the present reports, showing a higher risk of impairment in atrial physiology in those targeting interatrial connections (30.4 vs. 5.0%, P < 0.001) but no significant difference in short- and long-term effectiveness.
CONCLUSION
Left atrial epicardial conduction is common in BiATs and affects the ablation strategy. Atrial physiology is a major concern in selecting the target of intervention.
Topics: Humans; Atrial Fibrillation; Heart Conduction System; Treatment Outcome; Tachycardia; Heart Atria; Catheter Ablation
PubMed: 36563053
DOI: 10.1093/europace/euac231 -
Journal of the American Geriatrics... Feb 2023To perform an updated systematic review and meta-analysis of postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR). (Meta-Analysis)
Meta-Analysis Review
AIMS
To perform an updated systematic review and meta-analysis of postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR).
METHODS
We conducted a systematic literature search of PubMed, Embase, and Cochrane Library databases from the time of the first human TAVR procedure in 2002 until December 24, 2021, which was supplemented by manual searches of bibliographies. Data were collected on incidence rates, risk factors, and/or associated mortality of POD after TAVR. Pooled analyses were conducted using random effects models to yield mean differences, odds ratios, hazard ratios, and risk ratios, with 95% confidence intervals.
RESULTS
A total of 70 articles (69 studies) comprising 413,389 patients were included. The study heterogeneity was substantial. The pooled mean incidence of POD after TAVR in all included studies was 9.8% (95% CI: 8.7%-11.0%), whereas that in studies using validated tools to assess for delirium at least once a day for at least 2 consecutive days after TAVR was 20.7% (95% CI: 17.8%-23.7%). According to the level of evidence and results of meta-analysis, independent preoperative risk factors with a high level of evidence included increased age, male sex, prior stroke or transient ischemic attack, atrial fibrillation/flutter, weight loss, electrolyte abnormality, and impaired Instrumental Activities of Daily Living; intraoperative risk factors included non-transfemoral access and general anesthesia; and acute kidney injury was a postoperative risk factor. POD after TAVR was associated with significantly increased mortality (pooled unadjusted RR: 2.20, 95% CI: 1.79-2.71; pooled adjusted RR: 1.62, 95% CI: 1.25-2.10), particularly long-term mortality (pooled unadjusted HR: 2.84, 95% CI: 1.91-4.23; pooled adjusted HR: 1.88, 95% CI: 1.30-2.73).
CONCLUSIONS
POD after TAVR is common and is associated with an increased risk of mortality. Accurate identification of risk factors for POD after TAVR and implementation of preventive measures are critical to improve prognosis.
Topics: Humans; Male; Transcatheter Aortic Valve Replacement; Emergence Delirium; Aortic Valve Stenosis; Activities of Daily Living; Risk Factors; Treatment Outcome; Aortic Valve
PubMed: 36419366
DOI: 10.1111/jgs.18104 -
Academic Emergency Medicine : Official... Feb 2023The objective was to evaluate the comparative effectiveness and safety of pharmacological and nonpharmacological management options for atrial fibrillation/atrial... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The objective was to evaluate the comparative effectiveness and safety of pharmacological and nonpharmacological management options for atrial fibrillation/atrial flutter with rapid ventricular response (AFRVR) in patients with acute decompensated heart failure (ADHF) in the acute care setting.
METHODS
This study was a systematic review of observational studies or randomized clinical trials (RCT) of adult patients with AFRVR and concomitant ADHF in the emergency department (ED), intensive care unit, or step-down unit. The primary effectiveness outcome was successful rate or rhythm control. Safety outcomes were adverse events, such as symptomatic hypotension and venous thromboembolism.
RESULTS
A total of 6577 unique articles were identified. Five studies met inclusion criteria: one RCT in the inpatient setting and four retrospective studies, two in the ED and the other three in the inpatient setting. In the RCT of diltiazem versus placebo, 22 patients (100%) in the treatment group had a therapeutic response compared to 0/15 (0%) in the placebo group, with no significant safety differences between the two groups. For three of the observational studies, data were limited. One observation study showed no difference between metoprolol and diltiazem for successful rate control, but worsening heart failure symptoms occurred more frequently in those receiving diltiazem compared to metoprolol (19 patients [33%] vs. 10 patients [15%], p = 0.019). A single study included electrical cardioversion (one patient exposed with failure to convert to sinus rhythm) as nonpharmacological management. The overall risk of bias for included studies ranged from serious to critical. Missing data and heterogeneity of definitions for effectiveness and safety outcomes precluded the combination of results for quantitative meta-analysis.
CONCLUSIONS
High-level evidence to inform clinical decision making regarding effective and safe management of AFRVR in patients with ADHF in the acute care setting is lacking.
Topics: Adult; Humans; Atrial Fibrillation; Atrial Flutter; Diltiazem; Metoprolol; Anti-Arrhythmia Agents; Heart Failure; Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 36326565
DOI: 10.1111/acem.14618 -
Heart Failure Reviews Jul 2023Atrial fibrillation (AF) and atrial flutter (AFL) are associated with adverse outcomes in patients with heart failure and reduced ejection fraction (HFrEF). We... (Review)
Review
Association between sodium-glucose cotransporter-2 inhibitors and incident atrial fibrillation/atrial flutter in heart failure patients with reduced ejection fraction: a meta-analysis of randomized controlled trials.
Atrial fibrillation (AF) and atrial flutter (AFL) are associated with adverse outcomes in patients with heart failure and reduced ejection fraction (HFrEF). We investigated the effects of sodium-glucose cotransporter-2 inhibitors (SGLT2i) on the incidence of AF and/or AFL in HFrEF patients. PubMed and ClinicalTrials.gov were systematically searched until March 2022 for randomized controlled trials (RCTs) that enrolled patients with HFrEF. A total of six RCTs with 9467 patients were included (N = 4731 in the SGLT2i arms; N = 4736 in the placebo arms). Compared to placebo, SGLT2i treatment was associated with a significant reduction in the risk of AF [relative risk (RR) 0.62, 95% confidence interval CI 0.44-0.86; P = 0.005] and AF/AFL (RR 0.64, 95% CI 0.47-0.87; P = 0.004). Subgroup analysis showed that empagliflozin use resulted in a significant reduction in the risk of AF (RR 0.55, 95% CI 0.34-0.89; P = 0.01) and AF/AFL (RR 0.50, 95% CI 0.32-0.77; P = 0.002). By contrast, dapagliflozin use was not associated with a significant reduction in the risk of AF (RR 0.69, 95% CI 0.43-1.11; P = 0.12) or AF/AFL (RR 0.82, 95% CI 0.53-1.27; P = 0.38). Additionally, a "shorter" duration (< 1.5 years) of treatment with SGLT2i remained associated with a reduction in the risk of AF (< 1.5 years; RR 0.58, 95% CI 0.36-0.91; P = 0.02) and AF/AFL (< 1.5 years; RR 0.52, 95% CI 0.34-0.80; P = 0.003). In conclusion, SGLT2i therapy was associated with a significant reduction in the risk of AF and AF/AFL in patients with HFrEF. These results reinforce the value of using SGLT2i in this setting.
Topics: Humans; Atrial Fibrillation; Atrial Flutter; Treatment Outcome; Randomized Controlled Trials as Topic; Heart Failure; Ventricular Dysfunction, Left; Glucose; Sodium
PubMed: 36282460
DOI: 10.1007/s10741-022-10281-3