Transcatheter closure of perimembranous ventricular septal defect with the Amplatzer(®) membranous VSD occluder 2: initial world experience and one-year follow-up.

OBJECTIVES: To describe the initial world experience and mid-term follow-up of perimembranous ventricular septal defect (pmVSD) closure with a newly designed occluder.

BACKGROUND: Transcatheter closure of pmVSDs has been associated with a substantial risk of complete heart block, prompting many centers to abandon this intervention.

METHODS: A prospective multicenter cohort study was conducted on patients with pmVSD undergoing catheter closure using the Amplatzer(®) Membranous VSD Occluder 2 in the initial 4 pilot centers.

RESULTS: Nineteen patients, median age 6 years (range 1.4-62 years), were enrolled and followed for 14 ± 3 months (range 8-20 months). The median weight was 26 kg (range 9.3-96 kg) and the mean Qp/Qs ratio was 1.8 ± 0.7. The defect on left ventricular side measured 9.9 ± 3.5 mm and the orifice on right ventricular side was 8.1 ± 2.8 mm by echocardiography. Mean device size was 9.4 ± 2.4 mm (range 5-14 mm). An eccentric device was employed in 9 patients (47%) and a concentric device in 10 (53%). Overall, 18 patients (95%) had successful device implants. Procedural time was 122 ± 39 min. There were no procedural complications. Mild residual shunting was initially observed in 14 (78%) patients. At last follow-up, mild residual shunting persisted in only 3 (17%) patients. There was no significant increase in aortic or tricuspid regurgitation. No patient had any degree of AV block, although one developed a transient left anterior fascicular block. Holter evaluation, obtained in all patients, was unremarkable in all.

CONCLUSIONS: This early cohort experience using a novel adapted transcatheter closure device for pmVSD suggests that the procedure is feasible, safe, and effective.