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Welcome to the International PFO Consortium



Newsletter 2017

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The PFO Consortium is approaching the target sample size of 2000 patients!
We would like to thank all centers for their outstanding ongoing effort! The manuscripts of the already performed interim analyses of the first 1000 patients with cryptogenic stroke are in preparation. The first analysis (presented at the International Stroke Conference 2015) showed that the presence of cardiovasular risk factors but not specific PFO features were associated with prior cerebrovascular events. In the second analysis (presented at the International Stroke Conference 2016) we compared the effect of echocardiographic features of the PFO and conditions promoting paradoxical embolism between patients with a high likelihood of having a pathogenic PFO and patients with a low probability of having a pathogenic PFO. A Valsalva Maneuver at onset was much more frequent in patients in the higher RoPE stratum. There were no differences in echocardiographic features between groups. The third analysis (also presented at the International Stroke Conference 2016) was about gender differences in the variables used for RoPE score calculation. We again used the Rope Score stratification and found that more women than men are classified as having an incidental PFO because of their advancing age rather than the accumulation of risk factors. However, givent he results of the current randomized trials, these results lost some of their importance and the manuscript needs a critical revision.
You are warmly welcomed to share your ideas for future analysis with us.

Database Upgrade
In February 2016, an amendment to the protocol of the International PFO Consortium (extension of the database, final follow-up at the end of the study, use of the RoPE-score for analysis of the data of the International PFO Consortium, transfer of the existing database to a RedCap Database) was accepted by the Ethics Committee.The new RedCap database is in preparation and is expected to be put in operation in the next months.


Newsletter 2015

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The PFO Consortium is approaching the target sample size of 1500 patients!
We would like to thank all centers for their outstanding ongoing effort! A manuscript of a preliminary analysis of the baseline data of 1000 patients is in preparation. So far, we would like to share with you a few details about the collected data:
Patients with closure: 582
New patients since last month: 6
Average age: 59
Ratio male / female: 945 / 558

Oral presentation at the International Stroke Conference in Nashville

In February 2015, results of an interim analysis of our study were presented during the International Stroke Conference 2015 in Nashville (TN). We compared 114 patients with both clinical and radiological evidence of previous stroke with 661 patients with first-­‐ever clinical and radiological stroke. We found that vascular risk factors, age and the antiphospholipid-­‐antibody-­‐syndrom but not TEE features were associated with stroke recurrence in patients with cryptogenic stroke and PFO. The full presentation is attached.

Save the date! 3rd European PFO Summit in Zurich on October 16, 2015
After the great success of the 2nd European PFO Summit, a third one will take place on October 16, 2015 in Zürich, Switzerland. An exciting meeting is being planned. The topics of the main sessions will be: embolic stroke, embolic stroke of unknown source and PFO-­‐related stroke. There will also be two workshops: “Percutaneous closure of PFO” and “Detection of Right-­‐to-­‐Left-­‐Shunt”. The program is attached. You are warmly invited to attend the summit!

New study coordinator
After four years of unparalleled commitment to the PFO consortium, Barbara Mangold is leaving us. Her job will be taken over by Sylvie Nuc. Mrs. Nuc will start her new job in July 2015. Until then, you may contact Marie-­Luise Mono, Executive Director of the PFO Consortium (marie-luise.mono<at> for all questions that might come up with regard to the study. We would like to thank Mrs. Mangold for the excellent work and welcome Mrs. Nuc to her new position.


ESOC 2017

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News from the European Stroke Organisation Conference
Two new clinical trials showing a reduction in recurrent strokes with the closure of a patent foramen ovale (PFO) look set to change clinical practice. The CLOSE trial and the Gore-REDUCE trial were both presented at the 3rd European Stroke Organisation Conference (ESOC) 2017 in Prague. Both trials were conducted in carefully selected stroke patients in whom PFO was suspected to be a cause of their strokes:

1. Reducing Recurrent Stroke With PFO Closure (The Gore REDUCE Clinical Study for PFO closure)
In the Gore-REDUCE Study, closure of a PFO with a GORE® Helex® or or GORE® CARDIOFORM Septal Occluder device was associated with a significant reduction in risk of recurrent stroke in adults < 60 years with PFO and cryptogenic stroke. The study included 664 patients across 63 centres in 7 countries, with a previous stroke of unknown origin.

Key findings from the Gore-Reduce Study:
The study achieved statistical significance with both its primary endpoints (recurrent clinically apparent stroke, silent ischemia on brain imaging) with a 77% relative reduction in clinical stroke hazard and a 49% relative risk reduction in new brain infarction.
PFO closure with a GORE® HELEX® or CARDIOFORM® device was associated with a reduction in recurrent clinically apparent stroke (HR 0.23, 95% CI 0.09-0.62, p=0.001) and silent ischaemia on brain imaging (RR 0.51, 95% CI 0.29 to 0.91, p=0.024) with a  number needed to treat of 28 over 2 years.
There was a small increase in the periprocedural risk of atrial fibrillation (6.6% vs 0.4%, p<0.001).
Effective closure was achieved in 94.5% of patients.

2. Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE) Study
In the CLOSE Study, closure of a high-risk PFO was associated with a significantly lower rate of recurrent stroke in patients with a PFO who had experienced a cryptogenic stroke. This academically-driven, multicentre study (32 study sites in France and 2 sites in Germany) compared whether endovascular closure of PFO reduced the risk of recurrent strokes compared to blood thinning drugs alone. It included 663 patients who had experienced a stroke of unknown origin.

Key findings from the CLOSE study:
PFO closure significantly reduced the risk of recurrent stroke compared to anti-platelet therapy (HR 0.03, 95% CI 0 to 0.25, p < 0.001).
The difference in risk of recurrent stroke with anticoagulants vs. anti-platelet therapy was not significant (HR 0.43, 95% CI 0.1 to 1.5, p=0.17).
There was an increased risk of atrial fibrillation with PFO closure, mostly periprocedural and of uncertain significance.
CLOSE and Gore-REDUCE are the first studies to independently show benefit from endovascular closure of higher-risk PFOs, associated with a moderate shunt or and atrial septal aneurysm. This has the potential to significantly change clinical practice for a large population of patients in whom an inability to define the cause of their stroke left them without a specific treatment option.


Invitation to the European PFO Summit

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It is our great pleasure to invite you to Zurich, Switzerland for the European Patent Foramen Ovale (PFO) Summit to be held on October 18, 2013. Organized by the International PFO Consortium in cooperation with the Institute for Medicine and Communication (IMK) AG, the summit aims at bringing together neurologists, interventional cardiologists, cardio- and neurovascular ultrasound technologists, and other specialist sharing a common interest in diagnostic, treatment and prevention of patients with stroke and PFO. Please click here to visit the conference page and register. We are looking forward to seeing you in Zurich very soon!

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Last updated on 4.5.2015