ABSTRACT
AIMS:
Patients with cryptogenic embolic events and a
patent foramen ovale (PFO) are at
risk of
paradoxical embolism causing recurrent cerebral events; however, transcatheter PFO closure remains controversial. The aim of this
multicentre trial was to demonstrate the feasibility and
safety of transcatheter closure of PFO with the
HELEX Septal Occluder.
METHODS AND
RESULTS:
The study enrolled 128
patients (66
female; mean age, 50 years). Mean (+/-SD) PFO size was 10+/-3.7 mm; 38
patients also had an atrial septal
aneurysm.
Device implantation was successful in 127
patients.
Device-related events during implantation or follow-up were
device embolisation, wire-frame fracture, and retrieval cord breaks (two cases each; no sequelae). Other adverse events included atrial
arrhythmia (two
patients),
migraine, convulsion, and
transient ischaemic attack (one case each). There were no recurrent
strokes, deaths, perforations, or accumulations of thrombi on the
device. Within a mean follow-up period of 21+/-11 months, complete PFO closure using one
device was achieved in 114
patients (90%). Five
patients with a moderate to large residual shunt received a second
device.
CONCLUSION:
The HELEX Occluder can be used for PFO closure.
Device- and
procedure-related
complications are rare. The closure
procedure appears to reduce
recurrence rates of
stroke and
transient ischaemic attack.
