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

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.

Determinants of antithrombotic choice for patent foramen ovale in cryptogenic stroke

Objective: We 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. Methods: The 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. Results: A 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. Conclusion: Both 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.

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis.

AIMS The preferred antithrombotic strategy for secondary prevention in patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) is unknown. We pooled multiple observational studies and used propensity score-based methods to estimate the comparative effectiveness of oral anticoagulation (OAC) compared with antiplatelet therapy (APT). METHODS AND RESULTS Individual participant data from 12 databases of medically treated patients with CS and PFO were analysed with Cox regression models, to estimate database-specific hazard ratios (HRs) comparing OAC with APT, for both the primary composite outcome [recurrent stroke, transient ischaemic attack (TIA), or death] and stroke alone. Propensity scores were applied via inverse probability of treatment weighting to control for confounding. We synthesized database-specific HRs using random-effects meta-analysis models. This analysis included 2385 (OAC = 804 and APT = 1581) patients with 227 composite endpoints (stroke/TIA/death). The difference between OAC and APT was not statistically significant for the primary composite outcome [adjusted HR = 0.76, 95% confidence interval (CI) 0.52-1.12] or for the secondary outcome of stroke alone (adjusted HR = 0.75, 95% CI 0.44-1.27). Results were consistent in analyses applying alternative weighting schemes, with the exception that OAC had a statistically significant beneficial effect on the composite outcome in analyses standardized to the patient population who actually received APT (adjusted HR = 0.64, 95% CI 0.42-0.99). Subgroup analyses did not detect statistically significant heterogeneity of treatment effects across clinically important patient groups. CONCLUSION We did not find a statistically significant difference comparing OAC with APT; our results justify randomized trials comparing different antithrombotic approaches in these patients.

Patent arterial duct, bottle-meal, and fatal myocardial ischaemia

A patent arterial duct in pre-term neonates is frequent. Systemic complications consecutive to left-to-right shunting are well known but fatal myocardial ischaemia has not been described till now. The presented premature baby died from catecholamine refractory cardiogenic shock. Autoptic examination revealed acute ischaemic changes predominantly in the inner third of myocardium, speaking of coronary hypoperfusion due to a steal phenomenon secondary to the patent arterial duct.

Improvement of migraine headaches after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism

Patent foramen ovale (PFO) has been linked to migraine, and an improvement in migraine prevalence or frequency has been reported after PFO closure for other reasons. We sought to identify whether there is a specific patient population of migraineurs which may be more susceptible to benefiting from PFO closure.

Prevention of stroke in patients with patent foramen ovale

Patent foramen ovale is found in 24% of healthy adults and 38% of patients with cryptogenic stroke. This ratio and case reports indicate that patent foramen ovale and stroke are associated, probably because of paradoxical embolism. In healthy people with patent foramen ovale, embolic events are not more frequent than in controls, and therefore no primary prevention is needed. However, once ischaemic events occur, the risk of recurrence is substantial and prevention becomes an issue. Acetylsalicylic acid and warfarin reduce this risk to the same level as in patients without patent foramen ovale. Patent foramen ovale with a coinciding atrial septal aneurysm, spontaneous or large right-to-left shunt, or multiple ischaemic events potentiates the risk of recurrence. Transcatheter device closure has therefore become an intriguing addition to medical treatment, but its therapeutic value still needs to be confirmed by randomised-controlled trials.

Figulla PFO occluder versus Amplatzer PFO occluder for percutaneous closure of patent foramen ovale

Percutaneous closure of patent foramen ovale (PFO) has been shown safe and feasible using several devices. The Occlutech Figulla single layer PFO Occluder (FPO) constitutes an alternative to the Amplatzer PFO Occluder (APFO).

Impact of percutaneous patent foramen ovale closure on migraine course

Migraine is a neurological disorder characterized by an increased individual susceptibility to respond to certain triggers by a propagating wave of neuronal depolarization that culminates in typical migraine headaches. Patients with a patent foramen ovale or any kind of right-to-left shunt are more likely to have migraine; and patients with migraine with aura are more likely to have a patent foramen ovale than patients without migraine. Nonrandomized reports of patent foramen ovale closure in divers, in patients with paradoxical embolism and in migraine patients with ischemic brain lesions have shown an impressive reduction in migraine headaches during follow-up. To date, the only double-blind, randomized controlled trial with a sham procedure in the control arm failed to show any benefit, probably owing to inadequate patient selection and maybe because of a high residual shunt rate. Two other randomized trials continue to enroll patients with migraine with aura and drug-refractory headaches and their results are awaited.

Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (<45 versus ≥45 years), presence of atrial septal aneurysm (ASA yes or no) and number of embolic events before randomization (one versus more than one event). Primary endpoints are death, nonfatal stroke and peripheral embolism. Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).