Follow-up results of transcatheter occlusion of atrial septal defects with buttoned device

Abstract

Background: Feasibility, effectiveness and safety of transcatheter occlusion of secundum atrial septal defect (ASD) with buttoned device have been demonstrated.

Objectives: To evaluate the follow-up results of the ASD with buttoned device method to assess its long term efficacy and safety.

Patients and methods: Patient age at device implantation ranged from seven months to 51 years and weight ranged from 3.6 to 105 kg. Successful implantation of the device was accomplished in 20 of 22 consecutive patients (91%) seen during a 33-month period ending August 1992. Patients were divided into three groups based on the type of shunt across the ASD: group I (n = 14)--left-to-right shunt; group II (n = 5)--presumed paradoxical embolism; and group III (n = 1)--right-to-left shunt. These 20 patients were followed for 29 +/- 11 months, range 16 to 52 months. Follow-up included clinical evaluation, chest x-ray and echo-Doppler studies, and was performed two weeks, and three, six and 12 months after occlusion and yearly thereafter. Most patients received 5 to 10 mg/kg/day acetylsalicylic acid for 12 weeks following the device implantation.

Results: In 14 left-to-right shunt ASD closures, the right ventricular size diminished from 2.3 +/- 0.6 to 1.7 +/- 0.3 cm immediately after closure (P < 0.01) and remained decreased (1.6 +/- 0.46 cm) at last follow-up. Paradoxical/flat septal motion was present in 11 of 14 patients (79%) before closure while such an abnormal septal motion was not present in any at follow-up. Small to trivial left-to-right shunts across the implanted device were seen in six of 14 patients (43%) immediately after closure while trivial shunts were present in three of 14 (21%) at follow-up. Small shunts became trivial and trivial shunts disappeared. None of the patients had any clinical signs of ASD and none required surgical intervention during the follow-up period. None of the five patients with cerebrovascular accident (CVA)/paradoxical embolism had recurrence of CVA. Repeat transesophageal contrast echocardiographic study with Valsalva revealed minimal right-to-left shunt in two of five patients (40%) initially, which disappeared at follow-up. The single patient with CVA secondary to atrial right-to-left shunt following previous tetralogy repair had a transient ischemic episode four months after closure and underwent surgery at the discretion of the primary cardiologist. There were no wire fractures on follow-up x-rays. None developed endocarditis.

Conclusions: These data indicate that effective ASD occlusion can be accomplished in left-to-right shunt and paradoxical embolism patients. Modification of the device to position the square-shaped patch on the right atrial side may be necessary to prevent CVA in patients with right-to-left shunts.