Ανοικτό Ωοειδές Τρήμα (PFO) 2017

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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

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