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A. Tzikas, D. Aguirre, D. Velasco-Sanchez, X. Freixa, M. Alburquenque, P. Khairy, J.L. Bass, J. Ramirez, R. Ibrahim, J. Miro, Transcatheter closure of perimembranous ventricular septal defect with a new occluder: one-year follow-up, European Heart Journal, Volume 34, Issue suppl_1, 1 August 2013, P2077, https://doi.org/10.1093/eurheartj/eht308.P2077
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Purpose: Transcatheter closure of peri-membranous ventricular septal defects (pmVSDs) has been associated with a significant risk of complete heart block, leading most groups to abandon the technique. We describe the initial world experience of pmVSD closure with a newly designed occluder.
Methods: Patients with pmVSD underwent catheter closure using the Amplatzer® Membranous VSD Occluder 2 (St. Jude Medical, MN, USA).
Results: Nineteen patients from the 4 centers initially involved worldwide were prospectively included and followed for a 12±3 months. Patients ranged in age from 1.4 to 62 years (median 6 years) and in weight from 9.3 to 96 kg (median26 kg). The Qp/Qs ratio was (mean ± SD) 1.9±1.6. The size of the defect on left ventricular side was (mean ± SD) 9.9±3.5 mm (range 4.6 – 16 mm) and the orifice on right ventricularside was 8.1±2.8 mm (range 3.9 – 14 mm) by echocardiography. Mean device size was 9.4±2.4 mm (range 5 – 14 mm). An eccentric device was used in 9 patients (47%) and a concentric device in 10 (53%). A device was successfully implanted in 18 patients (95%). Procedural time was 122±39 min (range 60 – 207 min). There were no significant procedural complications. Mild (0-2 mm) residual shunt was initially observed in 14 patients (78%). At last follow-up, mild residual shunt was still observed in only 3 patients (17%). There was no significant increase of aortic or tricuspid regurgitation, compared to pre-catheterization levels. No patient showed conduction abnormalities on the ECG, and 17 out of 18 had a Holter evaluation, which was normal in all.
Conclusions: Transcatheter closure of pmVSD with the Amplatzer pmVSD Occluder 2 is safe and effective. No conduction abnormalities or any other complications were observed on short and one-year follow of this initial human series.
