Residual shunt after patent foramen ovale closure: preliminary results from Italian patent foramen ovale survey.
BACKGROUND
Percutaneous patent foramen ovale (PFO) closure is accepted as treatment for cryptogenic ischemic stroke/transient ischemic attack in young subjects. However, a thorough evaluation of residual right-to-left shunt (rRLS) after PFO closure is needed. Our aims were to analyze the characteristics related to PFO diagnosis and closure, focusing on rRLS and clinical recurrences until 24-month follow-up. Data were extrapolated from the 12-month Italian PFO Survey.


METHODS
In all, 1035 patients were included. PFO diagnosis and right-to-left shunt (RLS) were assessed by contrast-enhanced transesophageal and/or transthoracic echocardiography and/or transcranial Doppler.


RESULTS
PFO diagnosis with RLS data were available in 894 of 1035 (86.4%) patients. rRLS was investigated in 49.6% (6 months), 27.1% (12 months), and 3.5% (24 months), and observed in 19.5% (6 months) and 18.2% (12 months) of subjects. Large permanent rRLS was observed in less than 3% of RLS-positive patients after 1 year. Eleven of 14 and 3 of 14 neurological recurrences were observed in 10 of 444 (2.25%) and 2 of 243 (0.8%) patients within the 6- and 12-month follow-up, respectively. Among these, no large rRLS was reported. There were no neurological events at 2-year follow-up. Forty of 444 subjects had non-neurological complications, mostly cardiac arrhythmias within the sixth month.


CONCLUSIONS
PFO closure is a safe procedure. rRLS is not uncommon but large rRLS is rare. Clinical complications, mostly related to cardiac arrhythmias, are not unusual. Evaluation of the data of the whole survey is underway.
Department of Cerebrovascular Diseases, Fondazione Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Neurological Institute C. Besta, Milan, Italy. Electronic address: lcaputi@istituto-besta.it.
Luigi
L
Caputi
Gianfranco
G
Butera
Gian Paolo
GP
Anzola
Mario
M
Carminati
Maria Rita
MR
Carriero
Massimo
M
Chessa
Eustaquio
E
Onorato
Gianluca
G
Rigatelli
Giuseppe
G
Sangiorgi
Gennaro
G
Santoro
Isabella
I
Spadoni
Gian Paolo
GP
Ussia
Carlo
C
Vigna
Mario
M
Zanchetta
Eugenio
E
Parati
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012042:Registries; D016896:Treatment Outcome; D014463:Ultrasonography
Patent foramen ovale; closure; right-to-left shunt; stroke; transient ischemic attack