Published online by Cambridge University Press: 21 February 2012
Treatment of patent foramen ovale in young patients with stroke is not supported by robust scientific evidence. In clinical practice, a pragmatic approach is needed to guide such therapeutic decisions. This study aims at standardising the diagnostic pathway for stroke patients younger than 55 years of age with a patent foramen ovale; elaborating a therapeutic algorithm; discussing every case in regular interdisciplinary counselling meeting; and setting up a follow-up schedule to assess clinical outcomes.
This is a cohort study on the effect of a standardised treatment of stroke patients with a patent foramen ovale. The primary endpoints include occurrence of recurrent ischaemic events, major bleeding, and device-related complications. The secondary endpoints include drug- or procedure-related side effects, persistence of right-to-left shunt, and persistent cardiac arrhythmia of new onset.
A total of 103 patients have been enrolled. In all, 51 patients underwent percutaneous atrial septal repair; of these, one had minor post-procedural bleeding. At 12 months, 25% of this group of patients showed a latent I grade shunt, one patient a latent II degree shunt, and none had a persistent shunt. The remaining 52 patients were addressed to medical therapy; one of them experienced stroke recurrences while on medical therapy.
This model of implementation of available evidence to clinical practice via a group-based, multi-disciplinary counselling provides a shared and coherent decision pathway and yielded a very low rate of recurrent events and therapy-related complications. This approach could be replicated in specific protocols for other complex or neglected clinical problems.
Other members of the VEROSTROKE group: 1Federico Beltrame MD, 1Adolfo Benini MD, 1Paolo Benussi MD, 2Giuseppe Moretto, 3Antonio Fiaschi MD, 1Isabella Loschiavo MD, 4Gionata Molinari MD, 4Gabriele Pesarini MD, 4Antonia Prioli MD, 4Laura Rossi MD, and 4Corrado Vassanelli MD. From: 1Department of Medicine, Cardiology Unit; University Hospital of Verona, Verona, Italy; 2Department of Neurosciences, Neurology Unit, University Hospital of Verona, Verona, Italy; 3Department of Neurological and Visual Sciences, Section of Clinical Neurology, University Hospital of Verona, Verona, Italy; 4Department of Medicine, Division of Cardiology, University Hospital of Verona, Verona, Italy.