-
Cardiology 2019Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available... (Comparative Study)
Comparative Study Meta-Analysis
Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials.
Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20-0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32-12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16-0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29-1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.
Topics: Anticoagulants; Atrial Fibrillation; Foramen Ovale, Patent; Humans; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Septal Occluder Device; Stroke
PubMed: 31574522
DOI: 10.1159/000500501 -
JBI Database of Systematic Reviews and... Aug 2019The objective of this review was to determine if there was an association between maternal exposure to pollutant particulate matter 2.5 during the first trimester of...
OBJECTIVE
The objective of this review was to determine if there was an association between maternal exposure to pollutant particulate matter 2.5 during the first trimester of pregnancy and congenital heart defects within the first year of life.
INTRODUCTION
The environment is recognized as an important determinant of health for both the individual and population. Air pollution specifically is a major environmental risk factor impacting health with links to asthma, heart disease, obesity, and fetal developmental complications. Of the commonly monitored air pollutants, particulate matter 2.5 has associations with health, especially among vulnerable populations such as children and pregnant women. A congenital heart defect is a fetal complication that impacts 34.3 million infants globally, with more than 80% of the diagnoses having an unknown etiology. Although environmental risk factors such as air pollution are thought to be a risk factor in the diagnosis of a congenital heart defect, epidemiologic research evidence is limited.
INCLUSION CRITERIA
This review considered studies that evaluated maternal exposure to the air pollutant particulate matter 2.5 during the first trimester (weeks 1-12) of fetal development. The primary outcome was a diagnosis of a congenital heart defect in an infant within the first year of life.
METHODS
A three-step search strategy was utilized in this review and included 11 databases and two websites. Studies published from January 2002 to September 2018 were eligible for inclusion. Only papers published in English were included. Eligible studies underwent critical appraisal by two independent reviewers using standardized critical appraisal instruments from JBI. Quantitative data were extracted from the included studies independently by two reviewers. Odds ratios (ORs) and 95% confidence intervals (CIs) were extracted for the individual outcome measures, specifically atrial septal defect, ventricular septal defect, and tetralogy of fallot, respectively. The defects were identified and pooled, where possible, in statistical meta-analysis. Where statistical pooling was not possible, findings were reported narratively.
RESULTS
Five studies were identified that met the inclusion criteria, including three cohort and two case-control designs. Each individual study identified at least one statistically significant increase or inverse association between particulate matter 2.5 and a congenital heart defect. An increased risk was identified with more than seven isolated and two groupings of congenital heart defects. An inverse risk was identified with two isolated and one grouping of congenital heart defects. Meta-analysis results were: atrial septal defect, OR = 0.65 (95% CI, 0.37 to 1.15); ventricular septal defect, OR = 1.02 (95% CI, 075 to 1.37); and tetralogy of fallot, OR = 1.16 (95% CI, 0.78 to 1.73), indicating no statistically significant findings.
CONCLUSION
There was no significant evidence to support an association between air pollutant particulate matter 2.5 and a congenital heart defect in the first year of life. However, few studies met the rigorous inclusion criteria, and the studies that did had high heterogeneity, making it difficult to complete a meta-analysis with such a limited number of articles. Further research is needed to standardize the outcomes and pollutant monitoring methods, and provide comparable analysis results so that future synthesis of the literature can be conducted.
Topics: Adult; Air Pollutants; Female; Heart Defects, Congenital; Humans; Maternal Exposure; Particulate Matter; Pregnancy
PubMed: 31021973
DOI: 10.11124/JBISRIR-2017-003881 -
International Journal of Epidemiology Apr 2019Globally, access to healthcare and diagnostic technologies are known to substantially impact the reported birth prevalence of congenital heart disease (CHD). Previous... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Globally, access to healthcare and diagnostic technologies are known to substantially impact the reported birth prevalence of congenital heart disease (CHD). Previous studies have shown marked heterogeneity between different regions, with a suggestion that CHD prevalence is rising globally, but the degree to which this reflects differences due to environmental or genetic risk factors, as opposed to improved detection, is uncertain. We performed an updated systematic review to address these issues.
METHODS
Studies reporting the birth prevalence of CHD between the years 1970-2017 were identified from searches of PubMed, EMBASE, Web of Science and Google Scholar. Data on the prevalence of total CHD and 27 anatomical subtypes of CHD were collected. Data were combined using random-effect models. Subgroup and meta-regression analyses were conducted, focused on geographical regions and levels of national income.
RESULTS
Two hundred and sixty studies met the inclusion criteria, encompassing 130 758 851 live births. The birth prevalence of CHD from 1970-2017 progressively increased to a maximum in the period 2010-17 of 9.410/1000 [95% CI (confidence interval) 8.602-10.253]. This represented a significant increase over the fifteen prior years (P = 0.031). The change in prevalence of mild CHD lesions (ventricular septal defect, atrial septal defect and patent ductus arteriosus) together explained 93.4% of the increased overall prevalence, consistent with a major role of improved postnatal detection of less severe lesions. In contrast the prevalence of lesions grouped together as left ventricular outflow tract obstruction (which includes hypoplastic left heart syndrome) decreased from 0.689/1000 (95% CI 0.607-0.776) in 1995-99, to 0.475/1000 (95% CI 0.392-0.565; P = 0.004) in 2010-17, which would be consistent with improved prenatal detection and consequent termination of pregnancy when these very severe lesions are discovered. There was marked heterogeneity among geographical regions, with Africa reporting the lowest prevalence [2.315/1000 (95% CI 0.429-5.696)] and Asia the highest [9.342/1000 (95% CI 8.072-10.704)].
CONCLUSIONS
The reported prevalence of CHD globally continues to increase, with evidence of severe unmet diagnostic need in Africa. The recent prevalence of CHD in Asia for the first time appears higher than in Europe and America, where disease ascertainment is likely to be near-complete, suggesting higher genetic or environmental susceptibility to CHD among Asian people.
Topics: Confidence Intervals; Global Health; Heart Defects, Congenital; Humans; Infant, Newborn; Prevalence
PubMed: 30783674
DOI: 10.1093/ije/dyz009 -
Indian Heart Journal 2019The objective of this study was to compare safety and efficacy of patent foramen ovale (PFO) closure compared with medical therapy in patients with cryptogenic stroke... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The objective of this study was to compare safety and efficacy of patent foramen ovale (PFO) closure compared with medical therapy in patients with cryptogenic stroke (CS).
BACKGROUND
The role of PFO closure in preventing recurrent stroke in patients with prior CS has been controversial.
METHODS
We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials that compared device closure with medical management and reported on subsequent stroke and adverse events. Event rates were compared using a forest plot of relative risk using a random-effects model assuming interstudy heterogeneity.
RESULTS
A total of 6 studies (n = 3747) were included in the final analysis. Mean follow-up ranged from 2 to 5.9 years. Pooled analysis revealed that device closure compared to medical management was associated with a significant reduction in stroke (risk ratio [RR] = 0.41, 95% CI = 0.20-0.83, I = 51%, P = 0.01). There was, however, a significant increase in atrial fibrillation with device therapy (RR = 5.29, 95% CI = 2.32-12.06, I = 38%, P < 0.0001). No effect was observed on major bleeding (P = 0.50) or mortality (P = 0.42) with device therapy. Subgroup analyses showed that device closure significantly reduced the incidence of the composite primary end point among patients who had large shunt sizes (RR = 0.35, 95% CI = 0.18-0.68, I = 27%, P = 0.002). The presence/absence of atrial septal aneurysm (P = 0.52) had no effect on the outcome.
CONCLUSION
PFO closure is associated with a significant reduction in the risk of stroke compared to medical management. However, it causes an increased risk of atrial fibrillation.
Topics: Anticoagulants; Atrial Fibrillation; Foramen Ovale, Patent; Humans; Platelet Aggregation Inhibitors; Secondary Prevention; Septal Occluder Device; Stroke
PubMed: 32248916
DOI: 10.1016/j.ihj.2019.10.002 -
Circulation Apr 2019Secundum atrial septal defect (ASD) is the most common adult congenital heart defect and can present with wide variation in clinical findings. With the intention of... (Meta-Analysis)
Meta-Analysis
Interventional Therapy Versus Medical Therapy for Secundum Atrial Septal Defect: A Systematic Review (Part 2) for the 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical...
Secundum atrial septal defect (ASD) is the most common adult congenital heart defect and can present with wide variation in clinical findings. With the intention of preventing morbidity and mortality associated with late presentation of ASD, consensus guidelines have recommended surgical or percutaneous ASD closure in adults with right heart enlargement, with or without symptoms. The aim of the present analysis was to determine if the protective effect of secundum ASD closure in adults could be qualified by pooling data from published studies. A systematic review and meta-analysis were performed by using EMBASE, MEDLINE (through PubMed), and the Cochrane Library databases to assess the effect of secundum ASD percutaneous or surgical closure in unoperated adults ≥18 years of age. Data were pooled across studies with the DerSimonian-Laird random-effects model or a Bayesian meta-analysis model. Between-study heterogeneity was assessed with Cochran's Q test. Bias assessment was performed with the Newcastle-Ottawa Scale and the Cochrane Risk of Bias Tool, and statistical risk of bias was assessed with Begg and Mazumdar's test and Egger's test. A total of 11 nonrandomized studies met the inclusion criteria, contributing 603 patients. Pooled analysis showed a protective effect of ASD closure on New York Heart Association functional class and on right ventricular systolic pressure, volumes, and dimensions. Two additional studies comprising 652 patients were reviewed separately for mortality outcome and primary outcome of interest because they did not meet the inclusion criteria. Those studies showed that ASD closure was associated with a weak protective effect on adjusted mortality rate but no significant impact on atrial arrhythmias in patients >50 years of age. Across all studies, there was significant heterogeneity between studies for nearly all clinical outcomes. The overall body of evidence was limited to observational cohort studies, the limitations of which make for low-strength evidence. Even within the parameters of the included studies, quality of evidence was further diminished by the lack of well-defined clinical outcomes. In conclusion, pooled data analysis on the impact of secundum ASD closure in adults was notably limited because of the lack of randomized controlled trials in patients with only secundum ASD. The few cohort studies in this population demonstrated improvement in functional status and right ventricular size and function as shown by echocardiogram. However, our findings suggest that at the time of this publication, insufficient data are available to determine the impact of ASD repair on mortality rate in adults.
Topics: Adolescent; Adult; Age Factors; Cardiac Catheterization; Cardiology; Consensus; Evidence-Based Medicine; Heart Septal Defects, Atrial; Humans; Middle Aged; Practice Guidelines as Topic; Treatment Outcome; Young Adult
PubMed: 30586769
DOI: 10.1161/CIR.0000000000000605 -
Cerebrovascular Diseases (Basel,... 2018Despite some evidence of left-sided septal pouch (LSSP) involvement in the pathogenesis of cardioembolic stroke, the question of LSSP clinical significance still remains... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Despite some evidence of left-sided septal pouch (LSSP) involvement in the pathogenesis of cardioembolic stroke, the question of LSSP clinical significance still remains unsolved. In this study, we aimed to determine the association between the LSSP presence and cryptogenic stroke using meta-analytical approach.
METHODS
We performed a systematic review of electronic databases for studies that compared the presence of LSSP in subjects with cryptogenic stroke and non-stroke control. Data were extracted and pooled into a meta-analysis.
RESULTS
Seven studies (400 cryptogenic stroke patients and 1,456 non-stroke controls) were included in the meta-analysis. A total of 138 LSSPs were identified among the cryptogenic stroke patients, with a pooled prevalence of 29.8% (95% CI 17.5-43.7%), and 268 LSSPs were identified in the non-stroke controls, with a pooled prevalence of 21.0% (95% CI 13.7-29.5%). After meta-analysis, the risk of cryptogenic stroke was higher in patients with an LSSP than in patients without LSSP (OR 1.52; 95% CI 1.15-2.00; p < 0.001). No significant heterogeneity was detected across the included studies (p > 0.05).
CONCLUSION
Our meta-analysis demonstrated association between LSSP and cryptogenic stroke. In our univariate analysis, the risk of cryptogenic stroke is higher among patients with LSSP than in cases without the LSSP.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Brain Ischemia; Female; Heart Septal Defects, Atrial; Humans; Intracranial Embolism; Male; Middle Aged; Prevalence; Prognosis; Risk Assessment; Risk Factors; Stroke; Young Adult
PubMed: 30517929
DOI: 10.1159/000495573 -
BMC Medicine Nov 2018In 2005, the FDA cautioned that exposure to paroxetine, a selective serotonin reuptake inhibitor (SSRI), during the first trimester of pregnancy may increase the risk of... (Meta-Analysis)
Meta-Analysis
Selective serotonin reuptake inhibitor use during early pregnancy and congenital malformations: a systematic review and meta-analysis of cohort studies of more than 9 million births.
BACKGROUND
In 2005, the FDA cautioned that exposure to paroxetine, a selective serotonin reuptake inhibitor (SSRI), during the first trimester of pregnancy may increase the risk of cardiac malformations. Since then, the association between maternal use of SSRIs during pregnancy and congenital malformations in infants has been the subject of much discussion and controversy. The aim of this study is to systematically review the associations between SSRIs use during early pregnancy and the risk of congenital malformations, with particular attention to the potential confounding by indication.
METHODS
The study protocol was registered with PROSPERO (CRD42018088358). Cohort studies on congenital malformations in infants born to mothers with first-trimester exposure to SSRIs were identified via PubMed, Embase, Web of Science, and the Cochrane Library databases through 17 January 2018. Random-effects models were used to calculate summary relative risks (RRs).
RESULTS
Twenty-nine cohort studies including 9,085,954 births were identified. Overall, use of SSRIs was associated with an increased risk of overall major congenital anomalies (MCAs, RR 1.11, 95% CI 1.03 to 1.19) and congenital heart defects (CHD, RR 1.24, 95% CI 1.11 to 1.37). No significantly increased risk was observed when restricted to women with a psychiatric diagnosis (MCAs, RR 1.04, 95% CI 0.95 to 1.13; CHD, RR 1.06, 95% CI 0.90 to 1.26). Similar significant associations were observed using maternal citalopram exposure (MCAs, RR 1.20, 95% CI 1.09 to 1.31; CHD, RR 1.24, 95% CI 1.02 to 1.51), fluoxetine (MCAs, RR 1.17, 95% CI 1.07 to 1.28; CHD, 1.30, 95% CI 1.12 to 1.53), and paroxetine (MCAs, RR 1.18, 95% CI 1.05 to 1.32; CHD, RR 1.17, 95% CI 0.97 to 1.41) and analyses restricted to using women with a psychiatric diagnosis were not statistically significant. Sertraline was associated with septal defects (RR 2.69, 95% CI 1.76 to 4.10), atrial septal defects (RR 2.07, 95% CI 1.26 to 3.39), and respiratory system defects (RR 2.65, 95% CI 1.32 to 5.32).
CONCLUSIONS
The evidence suggests a generally small risk of congenital malformations and argues against a substantial teratogenic effect of SSRIs. Caution is advisable in making decisions about whether to continue or stop treatment with SSRIs during pregnancy.
Topics: Abnormalities, Drug-Induced; Cohort Studies; Female; Humans; Infant; Pregnancy; Pregnancy Trimester, First; Risk; Selective Serotonin Reuptake Inhibitors
PubMed: 30415641
DOI: 10.1186/s12916-018-1193-5 -
EuroIntervention : Journal of EuroPCR... Apr 2019
Meta-Analysis
Topics: Atrial Fibrillation; Foramen Ovale, Patent; Humans; Randomized Controlled Trials as Topic; Septal Occluder Device; Stroke
PubMed: 30327284
DOI: 10.4244/EIJ-D-18-00767 -
Journal of the American College of... Apr 2019Secundum atrial septal defect (ASD) is the most common adult congenital heart defect and can present with wide variation in clinical findings. With the intention of... (Comparative Study)
Comparative Study
Interventional Therapy Versus Medical Therapy for Secundum Atrial Septal Defect: A Systematic Review (Part 2) for the 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical...
Secundum atrial septal defect (ASD) is the most common adult congenital heart defect and can present with wide variation in clinical findings. With the intention of preventing morbidity and mortality associated with late presentation of ASD, consensus guidelines have recommended surgical or percutaneous ASD closure in adults with right heart enlargement, with or without symptoms. The aim of the present analysis was to determine if the protective effect of secundum ASD closure in adults could be qualified by pooling data from published studies. A systematic review and meta-analysis were performed by using EMBASE, MEDLINE (through PubMed), and the Cochrane Library databases to assess the effect of secundum ASD percutaneous or surgical closure in unoperated adults ≥18 years of age. Data were pooled across studies with the DerSimonian-Laird random-effects model or a Bayesian meta-analysis model. Between-study heterogeneity was assessed with Cochran's Q test. Bias assessment was performed with the Newcastle-Ottawa Scale and the Cochrane Risk of Bias Tool, and statistical risk of bias was assessed with Begg and Mazumdar's test and Egger's test. A total of 11 nonrandomized studies met the inclusion criteria, contributing 603 patients. Pooled analysis showed a protective effect of ASD closure on New York Heart Association functional class and on right ventricular systolic pressure, volumes, and dimensions. Two additional studies comprising 652 patients were reviewed separately for mortality outcome and primary outcome of interest because they did not meet the inclusion criteria. Those studies showed that ASD closure was associated with a weak protective effect on adjusted mortality rate but no significant impact on atrial arrhythmias in patients >50 years of age. Across all studies, there was significant heterogeneity between studies for nearly all clinical outcomes. The overall body of evidence was limited to observational cohort studies, the limitations of which make for low-strength evidence. Even within the parameters of the included studies, quality of evidence was further diminished by the lack of well-defined clinical outcomes. In conclusion, pooled data analysis on the impact of secundum ASD closure in adults was notably limited because of the lack of randomized controlled trials in patients with only secundum ASD. The few cohort studies in this population demonstrated improvement in functional status and right ventricular size and function as shown by echocardiogram. However, our findings suggest that at the time of this publication, insufficient data are available to determine the impact of ASD repair on mortality rate in adults.
Topics: Echocardiography; Heart Septal Defects, Atrial; Humans; Practice Guidelines as Topic
PubMed: 30121241
DOI: 10.1016/j.jacc.2018.08.1032 -
BMJ Open Jul 2018To examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus... (Meta-Analysis)
Meta-Analysis
Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence.
OBJECTIVE
To examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone.
DESIGN
Systematic review and network meta-analysis (NMA) supported by complementary external evidence.
DATA SOURCES
Medline, EMBASE and Cochrane CENTRAL.
STUDY SELECTION
Randomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke.
REVIEW METHODS
We conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
RESULTS
Ten RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): -87, 95% credible interval (CrI) -100 to -33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD -20, 95% CrI -27 to -2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD -71, 95% CrI -100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI -5 to +65, moderate certainty).
CONCLUSIONS
In patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding.
PROSPERO REGISTRATION NUMBER
CRD42017081567.
Topics: Anticoagulants; Atrial Fibrillation; Brain Ischemia; Cardiac Surgical Procedures; Combined Modality Therapy; Foramen Ovale, Patent; Humans; Network Meta-Analysis; Platelet Aggregation Inhibitors; Postoperative Complications; Recurrence; Secondary Prevention; Stroke
PubMed: 30049703
DOI: 10.1136/bmjopen-2018-023761