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.

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

OBJECTIVES\nIn 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).\n\n\nBACKGROUND\nA significant controversy surrounds the optimal strategy for treatment of cryptogenic stroke/TIA and coexistent PFO.\n\n\nMETHODS\nWe conducted a MEDLINE search with standard search terms to determine eligible studies.\n\n\nRESULTS\nAdjusted 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.\n\n\nCONCLUSIONS\nRates 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.

Abstract 11028: Meta-Analysis of Transcatheter Closure Versus Medical Therapy for Patent Foramen Ovale in Prevention of Recurrent Neurological Events After Presumed Paradoxical Embolism

We have conducted a systematic review of air embolism complications of neurosurgery in the sitting position and patent foramen ovale (PFO) closure. It assesses the risk and benefit of PFO closure before neurosurgery in the sitting position. The databases Medline, Embase, and Cochrane Controlled Trial Register were systematically searched from inception to November 2007 for keywords in both topics separately. In total, 4806 patients were considered for neurosurgery in sitting position and 5416 patients underwent percutaneous PFO closure. The overall rate of venous air embolism during neurosurgery in sitting position was 39% for posterior fossa surgery and 12% for cervical surgery. The rate of clinical and transoesophageal echocardiography detected paradoxical air embolism was reported between 0% and 14%. The overall success rate for PFO closure using new and the most common closure devices was reported 99%, whereas the average risk of major complications is <1%. On the basis of our systematic review, we recommend screening for PFO and considering closure in cases in which the sitting position is the preferred neurosurgical approach. Our proposed management including the time of PFO closure according to available data is presented. However, the conclusions from our systematic review may be limited due to the lack of level A evidence and from using data from observational cohort studies. Thus, definite evidence-based recommendations require prospective evaluation of the issue in well-designed studies.

Patent foramen ovale and neurosurgery in sitting position: a systematic review

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 comparat...

Patent Foramen Ovale Closure and Medical Treatments for Secondary Stroke Prevention A Systematic Review of Observational and Randomized Evidence

Background
Device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) are both associated with short- and long-term complications. Our knowledge of the complication rates of ASD and PFO closure is limited. Our objective was to review the peri-procedural and long-term complications of ASD and PFO closure.

Methods
Medline, EMBASE, and Scopus databases were searched between 1973 and 2012. A total of 28,142 patients from 203 case series were included. Of these 203 articles, 111 were reporting ASD closure, 61 were reporting PFO closure, and 31 were reporting both. Pooled incidence rates of cardiac complications were calculated separately for peri-procedural and at follow-up.

Results
Peri-procedural major complications were reported from 0% to 9.4%, with a pooled estimate rate of 1.4% (95% CI: 1.3–1.6%). It was 1.6% (95% CI: 1.4–1.8%) in ASD group, 1.1% (95% CI: 0.9–1.3%) in PFO group, and 1.3% (95% CI: 0.9–1.9%) in ASD/PFO group. The most common major complication was the device embolization requiring surgery. Peri-procedural minor complications were reported with a pooled estimate rate of 1.4% (95% CI: 1.2–1.7%). It was 1.6% (95% CI: 1.2–2.1%) in ASD group, 1.3% (95% CI: 1.0–1.7%) in PFO group, and 1.5% (95% CI: 1.1–1.2.1%) in ASD/PFO group. The most frequent major complications at follow-up were cerebrovascular events [1.3% (95% CI: 1.1–1.6%)] and device thrombosis [1.2% (95% CI: 1.0–1.4%)]. Both were more frequent in PFO group.

Conclusion
Device closure of ASD and PFO are associated with non-negligible serious complications, both in early and long-term. © 2013 Wiley Periodicals, Inc.

Short and long term complications of device closure of atrial septal defect and patent foramen ovale: meta-analysis of 28,142 patients from 203 studies.

Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) has become increasingly utilized. The indications and results of percutaneous closure are diverse.



Aim: To assess the indications, results, and complications of percutaneous closure of ASD and PFO in our tertiary center.



Method: Case note review and retrospective analysis of all consecutive patients undergoing percutaneous closure over a 3-year period from January 2003 to October 2005 with a mean follow-up of 19 months (4–36).



Results: There were 185 consecutive patients. The mean age was 44.9 years (SD 12.9) and 53% (n = 98) were males. There was 59% (n = 109) PFO and 41% (n = 76) ASD. The predominant indication for PFO closure was cerebrovascular accident (CVA) (42.2%, n = 46)- and for ASD, dilated right ventricle (68.4%, n = 52). Of all procedures, 94.6% (n = 175) were first time and 5.4% (n = 10) were redo for residual shunt. Overall, the success rate was 96.8% (n = 179) with two patients referred for surgical closure due to the large size of ASD and unsuitability for percutaneous closure, two procedures abandoned due to pericardial effusion, and two abandoned because the PFO was too small to cross. The Amplatzer device was used in 92.7% (n = 166) and the Starflex in 7.3% (n = 13). Minor complications were recorded in 10 patients (5.4%), of which 4 (2.2%) had minor venous access bleeding, 1 patient (0.5%) had retroperitoneal hematoma, and 2 patients (1.1%) had transient atrial fibrillation. One patient (0.5%) had transient inferior ST elevation during the procedure, one patient (0.5%) reported chest pain postprocedure, and one patient (0.5%) developed septicemia 3 weeks postprocedure. Major complications were recorded in three patients (1.5%), one patient (0.5%) with retroperitoneal hematoma requiring blood transfusion and two patients (1%) with pericardial effusion following transseptal puncture, requiring aspiration. No death, stroke, or device embolization was recorded.



Conclusion: Our experience with percutaneous closure in adults demonstrates excellent results and safety with few complications. Percutaneous device closure will replace surgical closure for many ASDs and PFOs.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1540-8183.2007.00279.x

Percutaneous closure of patent foramen ovale and atrial septal defect: procedure outcome and medium-term follow-up

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Percutaneous closure of patent foramen ovale and atrial septal defect: procedure outcome and medium-term follow-up