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Systematic review

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Patent Foramen Ovale Closure for Treating Migraine: A Meta-Analysis.

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Authors Zhang Y , Wang H , Liu L
Journal Journal of interventional cardiology
Year 2022
Links Pubmed DOI PubMed Central

This article includes 3 Primary studies 3 Primary studies (3 references)

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BACKGROUND: Observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine. OBJECTIVE: This study evaluated the efficacy and safety of PFO closure in patients with migraine using evidence-based medicine. METHODS: The Pubmed (MEDLINE), Embase, and Cochrane Library databases were searched for randomized controlled trials (RCTs), cohort studies, and retrospective case series from January 1, 2001, to February 30, 2021. The Jadad scale and R 4.1.0 software were used to assess the quality of the literature and meta-analysis, respectively. RESULTS: In total, three randomized controlled trials, one pooled study, and eight retrospective case series including 1,165 participants were included in the meta-analysis. Compared with control intervention in migraine, PFO closure could significantly reduce headache frequency (OR = 1.5698, 95% CI: 1.0465-2.3548, p=0.0293) and monthly migraine attacks and monthly migraine days (OR = 0.2594, 95% CI: 0.0790-0.4398, p=0.0048). Subgroup analysis of patients who all completed PFO surgery showed resolution of migraine headache for migraines with aura (OR = 1.5856, 95% CI: 1.0665-2.3575, p=0.0227). CONCLUSIONS: Treatment with PFO closure could reduce the frequency of headaches and monthly migraine days and is an efficient treatment for migraine attacks with aura.

Systematic review

Unclassified

Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis.

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Journal BMJ open
Year 2015
Links Pubmed DOI PubMed Central

This article includes 21 Primary studies 21 Primary studies (21 references)

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OBJECTIVES: To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms. DESIGN: A systematic review and meta-analysis. DATA SOURCES AND STUDY SELECTION: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014. DATA SYNTHESIS: Effect sizes (ES) in the active and placebo arms in the trials' primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered. RESULTS: We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R(2) of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration. CONCLUSIONS: The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.

Systematic review

Unclassified

Patent foramen ovale and migraine attacks: a systematic review.

Authors Lip PZ , Lip GY
Journal The American journal of medicine
Year 2014
Links Pubmed DOI

This article includes 38 Primary studies 38 Primary studies (38 references)

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BACKGROUND: Migraine headache and the presence of a patent foramen ovale have been associated with each other, although the precise pathophysiological mechanism(s) are uncertain. The purpose of this systematic review was to identify the extent of patent foramen ovale prevalence in migraineurs and to determine whether closure of a patent foramen ovale would improve migraine headache. METHODS: An electronic literature search was performed to select studies between January 1980 and February 2013 that were relevant to the prevalence of patent foramen ovale and migraine, and the effects of intervention(s) on migraine attacks. Of the initial 368 articles presented by the initial search, 20 satisfied the inclusion criteria assessing patent foramen ovale prevalence in migraineurs and 21 presented data on patent foramen ovale closure. RESULTS: In case series and cohort studies, patent foramen ovale prevalence in migraineurs ranged from 14.6% to 66.5%. Case-control studies reported a prevalence ranging from 16.0% to 25.7% in controls, compared with 26.8% to 96.0% for migraine with aura. The extent of improvement or resolution of migraine headache attack symptoms was variable. In case series, intervention ameliorated migraine headache attack in 13.6% to 92.3% of cases. One single randomized trial did not show any benefit from patent foramen ovale closure. The data overall do not exclude the possibility of a placebo effect for resolving migraine following patent foramen ovale closure. CONCLUSION: This systematic review demonstrates firstly that migraine headache attack is associated with a higher prevalence of patent foramen ovale than among the general population. Observational data suggest that some improvement of migraine would be observed if the patent foramen ovale were to be closed. A proper assessment of any interventions for patent foramen ovale closure would require further large randomized trials to be conducted given uncertainties from existing trial data.

Systematic review

Unclassified

Amplatzer occluder versus CardioSEAL/STARFlex occluder: a meta-analysis of the efficacy and safety of transcatheter occlusion for patent foramen ovale and atrial septal defect.

Authors Li Y , Zhou K , Hua Y , Wang C , Xie L , Fang J , Rong X , Shen J
Journal Cardiology in the young
Year 2013
Links Pubmed DOI

This article includes 6 Primary studies 6 Primary studies (6 references)

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OBJECTIVE: Percutaneous transcatheter occlusion has benefited thousands of patients suffering from patent foramen ovale and atrial septal defect. However, no general agreement has been reached on the superiority among occluders. Thus, a meta-analysis between the two most commonly adopted types of occluders was conducted. METHODS: The literature review has identified relevant studies up to May, 2011 in the databases of PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and World Health Organization clinical trials registry centre. Meta-analysis was performed in a fixed/random effects model using Revman 5.1.1. Information on complications and outcomes was extracted. RESULTS: Analysis from included studies reports an outcome in favour of the Amplatzer. The Amplatzer has proven its superiority in efficacy with a significantly lower risk of early (95% confidence interval = 0.09-0.34) and long-term (95% confidence interval = 0.14-0.97) residual shunt rate for atrial septal defect occlusion, although no significant difference in performance has been reported for patent foramen ovale. In addition, the Amplatzer has also remarkably reduced the risk of embolisation by the device (95% confidence interval = 0.07-0.45) for atrial septal defect and new-set atrial fibrillation (95% confidence interval = 0.18-0.48) for patent foramen ovale. On evaluation of recurrent thrombotic events, it was found that the Amplatzer greatly lowered the rate of thrombus formation on the device (95% confidence interval = 0.02-0.21) for patent foramen ovale; however, no statistical difference was found on atrial septal defect evaluation. However, the result indicated no statistically significant difference between the two kinds of occluders in stroke and transient ischaemic attack of patent foramen ovale. CONCLUSION: The meta-analysis has proven the Amplatzer to be the superior occluder, serving better prognosis with more fluent procedure and less complications.

Systematic review

Unclassified

Patent foramen ovale closure and medical treatments for secondary stroke prevention: a systematic review of observational and randomized evidence.

Journal Stroke; a journal of cerebral circulation
Year 2012
Links Pubmed DOI PubMed Central

This article is included in 1 Structured summary of systematic reviews 57 Structured summaries of systematic reviews (1 reference)

This article includes 57 Primary studies 57 Primary studies (57 references)

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BACKGROUND AND PURPOSE: Patients discovered to have a patent foramen ovale in the setting of a cryptogenic stroke may be treated with percutaneous closure, antiplatelet therapy, or anticoagulants. A recent randomized trial (CLOSURE I) did not detect any benefit of closure over medical treatment alone; the optimal medical therapy is also unknown. We synthesized the available evidence on secondary stroke prevention in patients with patent foramen ovale and cryptogenic stroke. METHODS: A MEDLINE search was performed for finding longitudinal studies investigating medical treatment or closure, meta-analysis of incidence rates (IR), and IR ratios of recurrent cerebrovascular events. RESULTS: Fifty-two single-arm studies and 7 comparative nonrandomized studies and the CLOSURE I trial were reviewed. The summary IR of recurrent stroke was 0.36 events (95% confidence interval [CI], 0.24-0.56) per 100 person-years with closure versus 2.53 events (95% CI, 1.91-3.35) per 100 person-years with medical therapy. In comparative observational studies, closure was superior to medical therapy (IR ratio=0.19; 95% CI, 0.07-0.54). The IR for the closure arm of the CLOSURE I trial was higher than the summary estimate from observational studies; there was no significant benefit of closure over medical treatment (P=0.002 comparing efficacy estimates between observational studies and the trial). Observational and randomized data (9 studies) comparing medical therapies were consistent and suggested that anticoagulants are superior to antiplatelets for preventing stroke recurrence (IR ratio=0.42; 95% CI, 0.18-0.98). CONCLUSIONS: Although further randomized trial data are needed to precisely determine the effects of closure on stroke recurrence, the results of CLOSURE I challenge the credibility of a substantial body of observational evidence strongly favoring mechanical closure over medical therapy.

Systematic review

Unclassified

Meta-analysis of transcatheter closure versus medical therapy for patent foramen ovale in prevention of recurrent neurological events after presumed paradoxical embolism.

Journal JACC. Cardiovascular interventions
Year 2012
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 48 Structured summaries of systematic reviews (1 reference)

This article includes 48 Primary studies 48 Primary studies (48 references)

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OBJECTIVES: In this study, a meta-analysis of observational studies was performed to compare the rate of recurrent neurological events (RNE) between transcatheter closure and medical management of patients with cryptogenic stroke/transient ischemic attack (TIA) and concomitant patent foramen ovale (PFO). BACKGROUND: A significant controversy surrounds the optimal strategy for treatment of cryptogenic stroke/TIA and coexistent PFO. METHODS: We conducted a MEDLINE search with standard search terms to determine eligible studies. RESULTS: Adjusted incidence rates of RNE were 0.8 (95% confidence interval [CI]: 0.5 to 1.1) events and 5.0 (95% CI: 3.6 to 6.9) events/100 person-years (PY) in the transcatheter closure and medical management arms, respectively. Meta-analysis of the limited number of comparative studies and meta-regression analysis suggested that the transcatheter closure might be superior to the medical therapy in prevention of RNE after cryptogenic stroke. Comparison of the anticoagulation and antiplatelet therapy subgroups of the medical arm yielded a significantly lower risk of RNE within patients treated with anticoagulants. Device-related complications were encountered at the rate of 4.1 (95% CI: 3.2 to 5.0) events/100 PY, with atrial arrhythmias being the most frequent complication. After transcatheter closure, RNE did not seem to be related to the pre-treatment shunt size or the presence of residual shunting in the follow-up period. Significant benefit of transcatheter PFO closure was apparent in elderly patients, patients with concomitant atrial septal aneurysm, and patients with thrombophilia. CONCLUSIONS: Rates of RNE with transcatheter closure and medical therapy in patients presenting with cryptogenic stroke or TIA were estimated at 0.8 and 5.0 events/100 PY. Further randomized controlled trials are needed to conclusively compare these 2 management strategies.