Gore Helex septal occluder for percutaneous closure of patent foramen ovale associated with atrial septal aneurysm: short- and mid-term clinical and echocardiographic outcomes.

OBJECTIVES: To evaluate the short- and mid-term clinical and echocardiographic outcome of HELEX Septal Occluder (HSO) implantation in patients with patent foramen ovale (PFO) and atrial septal aneurysm (ASA).

BACKGROUND: Percutaneous closure of PFO and ASA with HSO device has not been systematically studied.

METHODS: We studied 90 patients with PFO and ASA with documented paradoxical embolic events. The procedural and clinical results of 30 consecutive patients treated with HSO were compared with those obtained in 30 consecutive patients treated with the Amplatzer PFO (APO) and with those of a further 30 consecutive patients treated with the Amplatzer Cribriform (AMF). Primary endpoint was the persistence of moderate to severe residual right-to-left shunting (rRLS) at 6-month follow-up. The incidence of death or recurrent embolic events (REE) at 1-year follow-up were also investigated.

RESULTS: The procedure was successfully completed in all patients. There was one HSO device embolization. Immediate moderate RLS was significantly higher in the HSO group compared to APO and AMF groups (20% vs 3% vs 0%, respectively; P=.008). The incidence of moderate rRLS decreased but was still significant at 6-month follow-up (17% in the HSO group vs 3% in the APO group; P=.02). At 1-year follow-up, moderate rRLS persisted only in the HSO group (7%). No deaths or REE were observed during hospitalization or at 1-year follow-up.

CONCLUSION: HSO device seems to be a second-line device as compared to Amplatzer occluders for the treatment of PFO and ASA.