Safety and long-term results of patent foramen ovale transcatheter closure in patients with thrombophilia.
OBJECTIVE
Trials on transcatheter closure of patent foramen ovale (PFO) in different settings attempted to exclude patients with thrombophilia for the risk of device thrombosis. Authors sought to retrospectively evaluate safety and results of transcatheter PFO closure in patients with confirmed coagulation abnormalities.


METHODS
Between December 2006 and December 2008, 30 out of 98 consecutive patients (mean age 40+/-10.9 years, 23 females) referred to Rovigo General Hospital for transcatheter closure had coagulation abnormalities including mutations of factor V Leiden, factors X, VIII, protein C, S, MHFTR factors, and antiphospholipid and anticardiolipin antibodies, hyperhomocisteinimia. All patients underwent preoperative transesophageal echo and brain magnetic resonance imaging, and intra-cardiac echo-guided transcatheter PFO closure.


RESULTS
Success rate was 100%; there was no difference in occlusion and complications rates between patients with and without thrombophilia: in particular no device thrombosis or recurrent cerebral ischemia or stroke were observed during the follow-up. Patients with thrombophilia had a higher incidence of atrial septal aneurysm, migraine with aura and deep venous thrombosis in the previous medical history compared to patients without.


CONCLUSIONS
Despite its small sample, this study suggests that patients with coagulation abnormalities should not be excluded from the trial; they have potentially a higher risk of stroke through a PFO compared to other patients, and transcatheter closure is as safe and effective as in general population with almost no additional therapy rather than aspirin.
Rigatelli
G
G
Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Ital. jackyheart@libero.it
Dell'Avvocata
F
F
Giordan
M
M
Camerotto
A
A
Panin
S
S
Ronco
F
F
Cardaioli
P
P
D000328:Adult; D021721:Balloon Occlusion / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D019851:Thrombophilia / Q000150:complications* / Q000175:diagnosis; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional