Ανοικτό Ωοειδές Τρήμα (PFO) 2017

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1 Ανοικτό Ωοειδές Τρήμα (PFO) 2017 Χ. Ντέλλος Διευθυντής Καρδιολογικού Τμήματος Τζάνειο Νοσοκομείο Πειραιά

2 Δήλωση οικονομικών συμφερόντων: Καμία

3 Γιατρέ, τι είναι αυτό το ωοειδές;

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6 Ανοικτό Ωοειδές Τρήμα Φυσιολογικά: - Σε όλα τα νεογέννητα - Στα περισσότερα παιδιά - Στον ένα στους τρεις ενήλικες

7 Η «συμμορία» του PFO PFO Ανεύρυσμα Μεσοκολπικού Διαφράγματος Δίκτυο Chiarri και ευσταχιανή βαλβίδα Φλεβοθρόμβωση και πιέσεων RA

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12 «Το καλό PFO είναι το κλειστό PFO!» «Η συμμορία του PFO» Η γενοκτονία των PFO Υπερηχογραφιστές «κυνηγοί PFO» Επεμβατικοί «βιαστές PFO» Η συμμορία των «PFOφιλων»

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15 Evidence Based Medicine Prospective Population Based Studies Randomised Controlled Trials Guidelines

16 Patent Foramen Ovale: Innocent or Guilty? Evidence from a Prospective Population Based Study. SPARC (Stroke Prevention: Assesment of Risk in a Community) Conclusions PFO is not an independent risk factor for future cerebrovascular events in the general population. A larger study is required to test the putative stroke risk associated with Atrial Septal Aneurysm. Meissner et al. JACC 2006.

17 Patent foramen ovale and the risk of ischemic stroke in a multiethnic population NOMAS (Northern Manhattan Study) Conclusions PFO, alone or together with ASA (Atrial Septal Aneurysm), was not associated with an increased stroke risk in this multiethnic cohort. The independent role of ASA needs further assessment in appositely designed and powered studies. Di Toullio MR, et al. J Am Coll Cardiol 2007;49:

18 Several ongoing randomized trials for RESPECT trial over of 8 years (2008): CLOSURE 1 trial PC (Percutaneous Closure) trial Their results may clarify the affectiveness of percutaneous closure as compared with medical therapy.

19 GUIDELINES for Prevention of Stroke in patients with Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals from the AMERICAN HEART ASSOCIATION/AMERICAN STROKE ASSOCIATION/AMERICAN ACADEMY OF NEUROLOGY For patients with an ischemic stroke or TIA and a PFO, antiplatelet therapy is reasonable to prevent a recurrent event. Class II a, Level B Warfarin is reasonable for high-risk patients who have other indications for oral anticoagulation such as those with an underlying hypercoagulable state or evidence of venous thrombosis. Class II a, Level C Sacco R. et al. Stroke 2006;37:

20 GUIDELINES for Prevention of Stroke in patients with Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals from the AMERICAN HEART ASSOCIATION/AMERICAN STROKE ASSOCIATION/AMERICAN ACADEMY OF NEUROLOGY PATENT FORAMEN OVALE Insufficient data exist to make a recommendations about PFO closure in patients with a first stroke and a PFO. PFO closure may considered for patients with recurrent cryptogenic stroke despite medical therapy. Class II b, Level C Sacco R. et al. Stroke 2006;37:577-6

21 FDA RECOMMENDATIONS 2007 Off-label closure should be discouraged. Patients and physicians should be educated about the lack of evidence of benefit of closure and the need for completion of trials. Pinto T. et al. Circulation 2007;116:

22 It might be time for other arms of government or the professional societies to take a tougher stance on off-label use of devices for PFO closure. Meeting on March 2, 2007 of the FDA s Circulatory System Devices Panel.

23 PATENT FORAMEN OVALE AND MIGRAINE The first double blind randomized trial PFO closure in refractory migraine, MIST, has failed to show a benefit on the primary efficacy end point: cessation of attacks during the analysis period included between 3 and 6 months after the procedure. There is thus at present no scientific reason to look for PFO or to close PFO in migraine patients. Rev Neurol (Paris), 2007 Jan; 163(1) : 17-25

24 Patent Foramen Ovale and Migraine NOMAS (Northern Manhattan Study) Conclusions In this multiethnic, elderly, population based cohort, PFO detected with transthoracic echocardiography and agitated saline was not associated with self-reported migraine. Circulation, Sept. 2008

25 The incidence of migraine has not been found higher in patients with atrial septal defect C.Ntellos, H.Bilianou, I.Karantzis et al Tzanio Hospital Piraeus 70 patients with ASD, mean age 54±17 The incidence of migraine in our patients with ASD is 2.8%, lower than that reported in the general population and is not influenced by the closure of the defect 2007

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28 ΠΡΟΣΕΞΤΕ ΤΟ PFO ΣΑΣ! ΤΟ ΔΙΚΟ ΣΑΣ ΚΑΙ ΤΩΝ ΠΑΙΔΙΩΝ ΣΑΣ! ΚΥΚΛΟΦΟΡΟΥΝ PFOΦΙΛΟΙ! (Ελεύθερη απόδοση πρόσφατης οδηγίας του FDA)

29 A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex Septal Closure System Versus Best Medical Therapy in Patients with a Stroke or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale Anthony J Furlan MD Gilbert Humphrey Professor Chairman Department of Neurology Co-Director Neurological Institute University Hospitals Case Medical Center Case Western Reserve University School of Medicine For the CLOSURE I Investigators Trial Sponsor: NMT Medical Boston

30 CONCLUSIONS CLOSURE I is the first completed, prospective, randomized, independently adjudicated PFO device closure study Superiority of PFO closure with STARFlex plus medical therapy over medical therapy alone was not demonstrated no significant benefit related to degree of initial shunt no significant benefit with atrial septal aneurysm insignificant trend (1.8%) favoring device driven by TIA 2 year stroke rate essentially identical in both arms (3%) Major vascular (procedural) complications in 3% of device arm Significantly higher rate of atrial fibrillation in device arm (5.7%) 60% periprocedural

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49 O «άρρωστος» δικαιούται να ξέρει όλη την αλήθεια! Μισές αλήθειες κάνουν ένα μεγάλο ψέμα!