Secondly, large numbers of patients are needed because the event rates of stroke/TIA are low both in patients treated with closure and in those treated medically. In addition, the frequency of new-onset atrial fibrillation at follow-up varied, being highest in patients in the CardioSeal-STARflex group. In the last sentence of the Discussion, the authors suggest that the finding ‘has the potential to affect clinical practice’ and ‘these results might be the best evidence of significant benefit from TC PFO closure’. During follow-up, however, 36% of patients had required a second intervention for closure of a residual shunt. There are a number of meta-analyses of observational studies of PFO closure and outcome.5,6. approach this meta-analysis of three recently published clinical trials, each of which failed to show a significant benefit of transcatheter PFO closure over medical therapy? One would have thought that younger patients with presumed fewer co-morbid conditions would have benefited more because the aetiology of a central nervous system ischaemic event would have been more likely to be related to paradoxical embolus via the PFO. endobj 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. There were several notable findings. ), but the quote It is a principal of trial design that if the primary trial endpoint is negative, any other analyses should be considered hypothesis-generating. Some of the results of these subgroup analyses are not consistent with conventional thinking. ��w3T�PI�2T0 BC#K=scC#��\. At 5 years of follow-up, complete closure rates ranged from 100% in the Amplatzer group to 96.8% in patients treated with Helex occluders. endobj Get find and learn more Friedrich Nietzsche Quotes God is dead. A mechanical fix to a mechanical structural problem makes attractive and intuitive sense to both patients and physicians alike, irrespective of the results of randomized trials. 9 0 obj endobj This endpoint occurred in 3.0, 4.1, and 5.9%, respectively, for Amplatzer, Helex, and CardioSeal-STARflex (P = 0.042 comparing results with Amplatzer with those with the other two devices). endstream H��W�n��~���E��$H'�t�Lc��� CI, confidence interval; HR, hazard ratio; TIA, transient ischaemic attack. Yet his shadow still looms. Immediately, the quote should strike one as somewhat strongly social constructionist - the view that most of what we believe or know are endobj ͐,.�. In the subsequent Conclusions section, the authors approach the conclusions with more delicacy and less certainty, using the phrases ‘TC PFO closure showed a possible benefit in reducing the incidence of recurrent neurological events’ or ‘may be beneficial’. All rights reserved. Such delicacy/hesitancy in the conclusions appears entirely appropriate given the negative conclusions of each study. endobj Issue10.1021/pr0627286 For full access to this pdf, sign in to an existing account, or purchase an annual subscription. In addition, the presence of an atrial septal aneurysm (defined by some authors as complex anatomy) was not associated with an increased incidence of events in either the device- or medically treated groups, although there was heterogeneity in this regard. endobj '�w^(r"���V9'AN����s叫�%Bۉ,��Ry�$�hߪ����M}���1� For example, in younger patients <45 years there was no significant benefit compared with the older patients when randomized to the closure group. 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.


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