FOLLOW-UP RESULTS OF TRANSCATHETER OCCLUSION OF ATRIAL SEPTAL-DEFECTSWITH BUTTONED DEVICE

BACKGROUND: Feasibility, effectiveness and safety of transcatheter occ lusion of secundum atrial septal defect (ASD) with buttoned device hav e been demonstrated. OBJECTIVES: To evaluate the follow-up results of the ASD with buttoned device method to assess its long term efficacy a nd safety. PATIENTS AND METHODS: Patient age at device implantation ra nged from seven months to 51 years and weight ranged from 3.6 to 105 k g. 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 sh unt 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-lef t shunt. These 20 patients were followed for 29 +/- 11 months, range 1 6 to 52 months. Follow-up included clinical evaluation, chest x-ray an d echo-Doppler studies, and was performed two weeks, and three, six an d 12 months after occlusion and yearly thereafter. Most patients recei ved 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 sept al motion was not present in any at follow-up. Small to trivial left-t o-right shunts across the implanted device were seen in six of 14 pati ents (43%) immediately after closure while trivial shunts were present in three of 14 (21%) at follow-up. Small shunts became trivial and tr ivial shunts disappeared. None of the patients had any clinical signs of ASD and none required surgical intervention during the follow-up pe riod. None of the five patients with cerebrovascular accident (CVA)/pa radoxical embolism had recurrence of CVA. Repeat transesophageal contr ast echocardiographic study with valsalva revealed minimal right-to-le ft shunt in two of five patients (40%) initially, which disappeared at follow-up. The single patient with CVA secondary to atrial right-to-l eft shunt following previous tetralogy repair had a transient ischemic episode four months after closure and underwent surgery at the discre tion of the primary cardiologist. There were no wire fractures on foll ow-up x-rays. None developed endocarditis. CONCLUSIONS: These data ind icate that effective asd occlusion can be accomplished to left-to-righ t shunt and paradoxical embolism patients. Modification of the device to position the square-shaped patch on the right atrial side may be ne cessary to prevent CVA in patients with right-to-left shunts.