Occlusion of the perimembranous ventricular septal defect using CERA® devices

High incidence of atrioventricular (AV) block has been the major limitation of percutaneous closure of perimembranous ventricular septal defect (PMVSD).

Prospective, multicenter, nonrandomized study including 55 patients who were submitted to 56 procedures from March 2010 to November 2010. Inclusion criteria were PMVSD with diameter ≥ 5 mm or if ≤5 mm with hemodynamic significance and age ≥ 1 year. Exclusion criteria were fixed pulmonary arterial hypertension and associated congenital heart disease needing surgical repair. Procedures were performed under general anesthesia and monitored by transthoracic echocardiography (TTE). The device choice was based on left ventricle (LV) angiography and on TTE images. PMVSDs were crossed by retrograde approach.

Mean age was 9.3 ± 7.5 years, and mean weight was 29.1 ± 15.9 kg. Thirty-five (63.6%) patients were females. Mean pulmonary arterial mean pressure, mean LV diastolic diameter, and mean Q(p) /Q(s) were 24.0 ± 6.5 mm Hg, 43.0 ± 5.9 mm, and 2.2 ± 0.8, respectively. Associated nonsurgical malformations were present in 9 (16.3%) patients, and PMVSDs were multifenestrated in 16 (46.2%) cases. Mean PMVSDs diameter was 5.8 ± 1.8 mm by angiography and 6.8 ± 2.3 mm by TTE. New rhythm disturbance without clinical significance was observed in 29% of the patients and was reversible in 87.5%. After procedure, trivial residual shunt was present in 5 (8.9%) patients and moderate residual shunt in other 5 (8.9%). At late FU (mean of 298.7 ± 88.9 days), 91% of the patients had no residual shunts. Third-degree AV block and severe aortic regurgitation occurred in one patient each.

In this experience, PMVSD closure with CERA® devices showed to be safe and effective with low incidence of complications at immediate and mid-term FU.