• Device closure
• echocardiography (transoesophageal)
• education
• non-coronary intervention

Two women at the age of 62 and 42 years underwent secundum type atrial septal defect (ASD) closure with the recently introduced ATRIASEPT II device (Cardia Inc, Eagan, Minnesota, USA). ASD closure devices of size 24 mm and 20 mm were implanted without complications. Intracardiac echocardiography demonstrated satisfactory device deployment. The first patient developed atrial fibrillation approximately 6 weeks after the procedure and therefore underwent a follow-up transoesophageal echocardiography, which demonstrated recanalisation of the interatrial septum due to multiple perforations on both sides of the counter occluder. The second patient was seen 5 weeks after successful implantation and transthoracic echocardiography revealed normal findings for the time being, but a follow-up transoesophageal echocardiography 3 months after the procedure demonstrated recanalisation and significant left-to-right shunting due to perforations very similar to those observed in the first patient. Endoscopic device removal has been successfully performed in both individuals. On exposure, the devices appeared to be implanted properly, and the frames were completely intact. However, the polyvinyl alcohol coatings showed multiple perforations and were partly dissolved. Postoperative recovery was uneventful. The search for technical and physiological reasons is ongoing (figure 1).

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Figure 1

(A) Recanalisation (arrow) after atrial septal defect device closure with proper position of the occluder but significant left-to-right shunting. LA, left atrium; RA, right atrium; S, shunt. (B) In-situ view of the ATRIASEPT II closure device exposed from the right atrium. Coating perforations are shown (arrows). (C) Removed occluder with intact frame but multiple perforations.

We report these adverse events of ASD device failure, since additional cases must be expected elsewhere. That is why we would strongly recommend to re-examine all patients implanted with an ATRIASEPT II ASD closure device at the earliest opportunity and to conduct follow-up examinations for a minimum of 1 year.