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Ανοικτό Ωοειδές Τρήμα (PFO) 2017
www.ntellos.gr
Χ. Ντέλλος
Διευθυντής Καρδιολογικού Τμήματος
Τζάνειο Νοσοκομείο Πειραιά
Δήλωση οικονομικών συμφερόντων:
Καμία
Γιατρέ,
τι είναι αυτό το ωοειδές;
Ανοικτό Ωοειδές Τρήμα
Φυσιολογικά:
- Σε όλα τα νεογέννητα
- Στα περισσότερα παιδιά
- Στον ένα στους τρεις ενήλικες
Η «συμμορία» του PFO
PFO
Ανεύρυσμα Μεσοκολπικού Διαφράγματος
Δίκτυο Chiarri και ευσταχιανή βαλβίδα
Φλεβοθρόμβωση και πιέσεων RA
«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»
Evidence Based Medicine
• Prospective Population Based Studies
• Randomised Controlled Trials
↓
Guidelines
Patent Foramen Ovale: Innocent or Guilty?
Evidence from a Prospective
Population Based Study.
SPARC (Stroke Prevention: Assesment of Risk in a
Community)
Meissner et al. JACC 2006.
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.
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;49:797-802
Several ongoing randomized trials for
over of 8 years (2008):
RESPECT trial
CLOSURE 1 trial
PC (Percutaneous Closure) trial
Their results may clarify the affectiveness of
percutaneous closure as compared with medical
therapy.
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 CSacco R. et al. Stroke 2006;37:577-617
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
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
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;116:677-682
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.
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
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
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
ΠΡΟΣΕΞΤΕ ΤΟ PFO ΣΑΣ!
ΤΟ ΔΙΚΟ ΣΑΣ ΚΑΙ ΤΩΝ ΠΑΙΔΙΩΝ ΣΑΣ!
ΚΥΚΛΟΦΟΡΟΥΝ PFOΦΙΛΟΙ!
(Ελεύθερη απόδοση πρόσφατης οδηγίας του FDA)
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 MDGilbert 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
• 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
CONCLUSIONS
O «άρρωστος» δικαιούται να ξέρει όλη την αλήθεια!
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