Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack.
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ABSTRACT:
SUBMITTER: Li J
PROVIDER: S-EPMC7389291 | biostudies-literature | 2015 Sep
REPOSITORIES: biostudies-literature
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Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack.
Li Jie J Liu Junfeng J Liu Ming M Zhang Shihong S Hao Zilong Z Zhang Jing J Zhang Canfei C
The Cochrane database of systematic reviews 20150908 9
<h4>Background</h4>The optimal therapy for preventing recurrent stroke in people with cryptogenic stroke and patent foramen ovale (PFO) has not been defined. The choice between medical therapy (antithrombotic treatment with antiplatelet agents or anticoagulants) and transcatheter device closure has been the subject of intense debate over the past several years. Despite the lack of scientific evidence, a substantial number of people undergo transcatheter device closure (TDC) for secondary stroke ...[more]
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Project description:Cryptogenic stroke (CS) represents one-third of all ischaemic strokes. Studies have shown approximately that half of patients with CS have concomitant patent foramen ovale (PFO), with clear data supporting paradoxical embolization as an aetiology of CS. This article is the first of a multi-part review and will detail the history of PFO closure and the clinical trials that have evaluated the efficacy of PFO device closure. Data favour PFO closure in CS for reducing stroke in appropriate patients and should be considered as a treatment modality.
| S-EPMC9524620 | biostudies-literature
Project description:BackgroundPatients who had a cryptogenic stroke (CS) suspected to be causally related to a patent foramen ovale (PFO) are candidates for percutaneous PFO closure. In such patients, it is important to screen for atrial fibrillation (AF). Limited guidance is available regarding AF monitoring strategies in CS patients with PFO addressing optimal monitoring technology and duration.AimTo provide a narrative review of cardiac rhythm monitoring in CS patients considered for PFO closure, including current practices, stroke recurrences after CS, findings from monitoring studies in CS patients, and predictors for AF detection published in the literature. To propose a personalized strategy for cardiac monitoring in CS patients, accounting for aspects predicting AF detection.Summary of reviewAF detection in CS patients is predicted by age, left atrial enlargement, prolonged PR interval, frequent premature atrial contractions, interatrial conduction block, diabetes, prior brain infarctions, leukoaraiosis, elevated B-type natriuretic peptide (BNP)/N-terminal pro B-type natriuretic peptide (NT-proBNP) levels, and a family history of AF, as well as composed scores (e.g. CHA2DS2-VASc, atrial fibrillation in embolic stroke of undetermined source (AF-ESUS)). The causal role of the PFO may be accounted for by the risk of paradoxical embolism (RoPE) score and/or the PFO-Associated Stroke Causal Likelihood (PASCAL) classification.ConclusionA personalized approach to AF detection in CS patients is proposed, accounting for the likelihood of AF detection and aimed at obtaining sufficient confidence regarding the absence of AF in patients considered for PFO closure. In addition, the impact of high-risk PFO features on the monitoring strategy is discussed.
| S-EPMC10037544 | biostudies-literature
Project description:BackgroundResults of randomized controlled trials (RCT) do not provide definite guidance for secondary prevention after ischemic stroke (IS)/transient ischemic attack (TIA) attributed to patent foramen ovale (PFO). No recommendations can be made for patients > 60 years. We aimed to compare interventional and medical PFO-management in cryptogenic IS/TIA patients, including patients > 60 years.MethodsProspective case series including consecutive cryptogenic IS/TIA patients with PFO at Tuebingen university stroke unit, Germany. 'PFO-closure' was recommended in patients ≤70 years when featuring high-risk PFO (i.e., with atrial septal aneurysm, spontaneous, or high-grade right-to-left shunt during Valsalva). Primary (recurrent IS/intracranial hemorrhage) and secondary endpoints (e.g., disability) were assessed during ≥1-year follow-up; planned subgroup analyses of patients ≤60/> 60 years.ResultsAmong 236 patients with median age of 58 (range 18-88) years, 38.6% were females and median presenting National Institutes of Health Stroke Scale score was 1 (IQR 0-4). Mean follow-up was 2.8 ± 1.3 years. No intracranial hemorrhage was observed. Recurrent IS rate after 'PFO-closure' was 2.9% (95%CI 0-6.8%) and 7% (4-16.4) in high-risk PFO patients ≤60 (n = 103) and > 60 years (n = 43), respectively, versus 4% (0-11.5) during 'medical therapy alone' MTA (n = 28). 42 low-risk PFO patients treated with MTA experienced no recurrent IS/TIA.ConclusionsIn our real-world study, IS recurrence rate in 'PFO-closure' high-risk PFO patients ≤60 years was comparable to that observed in recent RCT. High-risk PFO patients > 60 years who underwent PFO-closure had similar IS recurrence rates than those who received MTA. MTA seems the appropriate treatment for low-risk PFO.Trial registrationClinicalTrials.gov, registration number: NCT04352790 , registered on: April 20, 2020 - retrospectively registered.
| S-EPMC8015114 | biostudies-literature
Project description:Patent foramen ovale (PFO) is a common congenital heart defect that can contribute to cryptogenic stroke, particularly in younger patients lacking traditional risk factors. The present study describes the case of a 14-year-old male patient who experienced an acute ischemic stroke without identifiable atheroembolic risk factors. Comprehensive diagnostic imaging revealed a marked right-to-left shunt through a PFO, identified as the probable cause of the stroke. The patient was treated with dual antiplatelet therapy and subsequently underwent successful percutaneous PFO closure. At 6 months following the procedure, the patient exhibited notable neurological recovery. The present case report highlights the critical need for evaluating PFO as a potential etiology of cryptogenic stroke in younger populations, emphasizing the advantages of a multidisciplinary approach and timely intervention in preventing recurrent events.
| S-EPMC11609884 | biostudies-literature
Project description:Background and purposePatent foramen ovale (PFO) is significantly associated with cryptogenic stroke (CS). However, even in patients with CS, a PFO can be an incidental finding. We sought to estimate the probability that a PFO in a patient with CS is incidental.MethodsA systematic search identified 23 case-control studies examining the prevalence of PFO in patients with CS versus control subjects with stroke of known cause. Using simple assumptions and Bayes' theorem, we calculated the probability a PFO is incidental in patients with CS. Random effects meta-analyses estimated the odds ratio (OR) of a PFO in CS versus control subjects in different age populations, with or without atrial septal aneurysms, and were used to summarize across studies the probability that a PFO in CS is incidental.ResultsThe summary OR (95% CIs) for PFO in CS versus control subjects was 2.9 (CI, 2.1 to 4.0). The corresponding ORs for young and old patients (< or >or=55 years) were 5.1 (3.3 to 7.8) and 2.0 (>1.0 to 3.7), respectively. The corresponding probabilities that a PFO in patients with CS is incidental were 33% (28% to 39%) in age-inclusive studies, 20% (16% to 25%) in younger patients, and 48% (34% to 66%) in older patients. These probabilities were much lower when an atrial septal aneurysm was present.ConclusionsIn patients with otherwise CS, approximately one third of discovered PFOs are likely to be incidental and hence not benefit from closure. This probability is sensitive to patient characteristics such as age and the presence of an atrial septal aneurysm, suggesting the importance of patient selection in therapeutic decision-making.
| S-EPMC2764355 | biostudies-literature
Project description:BackgroundClosure of a patent foramen ovale reduces the risk of recurrent stroke compared with medical therapy alone in young patients with cryptogenic strokes revealed by randomized control trials. Some cost-effectiveness analyses outside Japan have shown that patent foramen ovale closure is cost-effective, but no studies have examined cost-effectiveness in Japan. The objective of this study is to assess cost-effectiveness, from the perspective of a Japanese healthcare payer, of patent foramen ovale closure versus medical therapy alone for patients with patent foramen ovale related to cryptogenic strokes.MethodsA cost-effectiveness study was conducted by developing a decision tree and a Markov model. Probabilities and a 5.9-year time horizon followed the RESPECT study. Utilities and costs were based upon published studies and assumptions. All assumptions were assessed by experts, including a cardiologist and a statistical expert. The target population comprised patients with cryptogenic stroke and patent foramen ovale, aged 60 years or younger. The model was discounted at 2.0% and its cycle was one month. A willingness-to-pay threshold is set at $50,000 / quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio was evaluated. Then one-way sensitivity analyses as deterministic sensitivity analysis, and probabilistic sensitivity analyses were performed to assess data robustness.ResultsIncremental quality-adjusted life years, incremental costs, and incremental cost-effectiveness ratio were 0.464, $13,562, and $29,208 per QALY gained, respectively. One-way sensitivity analysis showed that the stable state utility score difference between patent foramen ovale closure and medical therapy had the largest impact on incremental cost-effectiveness ratio. Patent foramen ovale closure is cost-effective at a stable state utility score difference of >0.051, compared with medical therapy. Probabilistic sensitivity analyses demonstrated that patent foramen ovale closure was 50.3% cost-effective.ConclusionsPatent foramen ovale closure was cost-effective compared with medical therapy for Japanese patients with cryptogenic stroke who were ≤60 years.
| S-EPMC9165785 | biostudies-literature
Project description:Interventional patent foramen ovale (PFO) closure should be performed in patients aged 16 to 60 years (after extensive neurological and cardiological diagnostic work-up) with a history of cryptogenic ischaemic stroke and patent foramen ovale, with moderate or extensive right-to-left shunt. In patients with cryptogenic ischaemic stroke and patent foramen ovale, who reject a PFO closure, there is no evidence of superiority of oral anticoagulation over antiplatelet therapy. Therefore, secondary prevention should be performed with aspirin or clopidogrel. Atrial fibrillation, pericardial tamponade, and pulmonary embolism are reported complications during and after implantation of an occluder. However, these events are so rare that they should not influence the recommendation for implantation. This article is an abridged and translated version of the guideline published in Nervenarzt: Diener, HC., für die Deutsche Gesellschaft für Neurologie (DGN), Grau, A.J. et al. Nervenarzt (2018) 89: 1143. 10.1007/s00115-018-0609-y.
| S-EPMC7650129 | biostudies-literature
Project description:ObjectiveWe examined the influence of clinical, radiologic, and echocardiographic characteristics on antithrombotic choice in patients with cryptogenic stroke (CS) and patent foramen ovale (PFO), hypothesizing that features suggestive of paradoxical embolism might lead to greater use of anticoagulation.MethodsThe Risk of Paradoxical Embolism Study combined 12 databases to create the largest dataset of patients with CS and known PFO status. We used generalized linear mixed models with a random effect of component study to explore whether anticoagulation was preferentially selected based on the following: (1) younger age and absence of vascular risk factors, (2) "high-risk" echocardiographic features, and (3) neuroradiologic findings.ResultsA total of 1,132 patients with CS and PFO treated with anticoagulation or antiplatelets were included. Overall, 438 participants (39%) were treated with anticoagulation with a range (by database) of 22% to 54%. Treatment choice was not influenced by age or vascular risk factors. However, neuroradiologic findings (superficial or multiple infarcts) and high-risk echocardiographic features (large shunts, shunt at rest, and septal hypermobility) were predictors of anticoagulation use.ConclusionBoth antithrombotic regimens are widely used for secondary stroke prevention in patients with CS and PFO. Radiologic and echocardiographic features were strongly associated with treatment choice, whereas conventional vascular risk factors were not. Prior observational studies are likely to be biased by confounding by indication.
| S-EPMC4248455 | biostudies-literature
Project description:ObjectivesTo provide a comprehensive comparison of patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke or transient ischaemic attack (TIA) and demonstrated PFO.DesignSystematic review with complete case meta-analysis and sensitivity analyses. Data sources included MEDLINE and EMBASE from 1980 up to May 2013. All randomised controlled trials (RCTs) comparing treatment with percutaneous catheter-based closure of PFO to anticoagulant or antiplatelet therapy in patients with cryptogenic stroke or TIA and echocardiographically confirmed PFO or atrial septal defect (ASD) were eligible.Participants1967 participants with prior stroke or TIA and echocardiographically confirmed PFO or ASD.Primary outcome measuresThe primary outcome of interest was recurrence of ischaemic stroke. We utilised data from complete cases only for the primary endpoint and combined data from trials to estimate the pooled risk ratio (RR) and associated 95% CIs calculated using random effects models.ResultsWe identified 284 potentially eligible articles of which three RCTs including 2303 patients proved eligible and 1967 patients had complete data. Of the 1026 patients randomised to PFO closure and followed to study conclusion 22 experienced non-fatal ischaemic strokes, as did 34 of 941 patients randomised to medical therapy (risk ratio (RR) 0.61, 95% CI 0.34 to 1.07; heterogeneity: p=0.34, I(2)=8%, confidence in estimates low due to risk of bias and imprecision). Analyses for ischaemic stroke restricted to 'per-protocol' patients or patients with concomitant atrial septal aneurysm did not substantially change the observed RRs. Complication rates associated with either PFO closure or medical therapy were low.ConclusionsPooled data from three RCTs provides insufficient support that PFO closure is preferable to medical therapy for secondary prevention of cryptogenic stroke in patients with PFO.
| S-EPMC3948581 | biostudies-literature
Project description: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, I2 = 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, I2 = 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, I2 = 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.
| S-EPMC7136357 | biostudies-literature