There were several notable findings. Issue10.1021/pr0627286 Hornung et al.1 report on the longer term results of a randomized trial which compared three different devices: the Amplatzer PFO/ASD occluder (ACA Medical, Plymouth, MN, USA), the Helex septal occluder (W.L. There are several accepted observations which could serve as facts: David R. Holmes, Jr, Robert D. Brown, Jr, ‘There are no facts, only interpretations’, European Heart Journal, Volume 34, Issue 43, 14 November 2013, Pages 3336–3338,, This editorial refers to ‘Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale’†, by M. Hornung et al., on page 3362and ‘Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials’‡, by P. Rengifo-Moreno et al., on page 3342. Perhaps most important were significant differences detected in the primary composite endpoint of transient ischaemic attack (TIA), stroke, cerebral death, or paradoxical embolism between the three different devices. All of these devices had CE mark approval. Given the significant limitations of a meta-analysis in general, and the specific limitations of combining clinical trials using different devices and, importantly, very different medical management approaches in both the closure and medical arms, one should be extremely hesitant to utilize such data to change clinical practice. endstream Some of the results of these subgroup analyses are not consistent with conventional thinking. 5 0 obj This modification captures and encompasses many of the issues highlighted in the articles by Hornung et al.1 and Pabb et al.2 related to the complex multifaceted field of patent foramen ovale (PFO) closure and stroke. In addition, the frequency of new-onset atrial fibrillation at follow-up varied, being highest in patients in the CardioSeal-STARflex group. Search for other works by this author on: Department of Neurology, Mayo Clinic, 200 First St. S.W, Rochester, MN 55905, USA, Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale, Benefit of patent forament ovale transcatheter closure versus medical therapy on recurrent vacular events: a systematic review and meta-analysis of randomized controlled trials, Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review, Patient foramen ovale—assessment and treatment, Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis, Meta-analysis of transcatheter closure versus medical therapy for patent foramen ovale in prevention of recurrent neurological events after presumed paradoxical embolism, Closure or medical therapy for cryptogenic stroke with patent foramen ovale, Closure of patent foramen ovale versus medical therapy after cryptogenic stroke, Percutaneous closure of patent foramen ovale in cryptogenic embolism, Published on behalf of the European Society of Cardiology. This rhythm by itself may result in thrombus in the left atrial appendage (LAA) and the potential for stroke. '�w^(r"���V9'AN����s叫�%Bۉ,��Ry�$�hߪ����M}���1� endstream endobj In addition, the presence of an atrial septal aneurysm (defined by some authors as complex anatomy) was not associated with an increased incidence of events in either the device- or medically treated groups, although there was heterogeneity in this regard. There was, however, no significant difference between the three devices regarding the combined stroke and death rate or stroke and vascular death. No patients were lost to follow-up during a mean follow-up time of 59.2 ± 6.0 months. �)� x�s During follow-up, however, 36% of patients had required a second intervention for closure of a residual shunt. Oxford University Press is a department of the University of Oxford. 11 0 obj There are a number of meta-analyses of observational studies of PFO closure and outcome.5,6. 7 0 obj x�S�*�*T0T0 B�����i�����U�"� ��� 13 0 obj Proteome Res. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only.