Background Percutaneous closure of patent foramen ovale (PFO) is standard treatment for patients with paradoxical embolism but studies examining the efficacy of the various occluders are lacking.
Objective To evaluate short- and medium-term closure rates of three common occluders.
Methods One hundred and sixty-six adults (47±12 (18–81 years)) were evaluated with transthoracic bubble echocardiography before and after PFO closure. Only patients with large PFOs were included (>30 bubbles in the left heart after Valsalva).
Results Three occluders were used: Amplatzer (AGA Medical Corporation) (n=80, 48%), Gore Helex (n=48, 29%) and Premere TM (St Jude Medical) (n=38, 23%). One (0.6%) neurological event occurred during follow-up. At 6 months significant residual shunting after Valsalva was highest in the group that received the Helex (58.3%), and lower for Premere (39.5%) and Amplatzer (32.5%). At final follow-up residual shunting remained higher in patients with the Helex (33.3%) than in Premere (18.5%) and Amplatzer (11%). Amplatzer had a significantly lower residual shunt rate than Helex (p<0.05 at 6 months and final follow-up). The Premere had an intermediate residual shunt rate. Septal aneurysm also predicted residual shunting (RR=24.7, 95% CI: 8.2 to 74.4, p<0.0001).
Conclusions Percutaneous PFO closure is an efficacious progressive treatment but closure rates also depend on the presence of aneurysm and differ between occluders.
- Patent foramen ovale
- septal occluder
- transient ischaemic attack (TIA)
- device closure
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Competing interests MST is a proctor for St Jude Medical and AGA Medical, RPM is also a proctor for AGA Medical. There are no other conflicts of interest to declare.
Provenance and peer review Not commissioned; externally peer reviewed.