Occlusion of the perimembranous ventricular septal defect using CERA devices

ABSTRACT

Background: High incidence of atrioventricular (AV) block has been the major limitationof percutaneous closure of perimembranous ventricular septal defect (PMVSD). Methods:Prospective, multicenter, nonrandomized study including 55 patients who weresubmitted to 56 procedures from March 2010 to November 2010. Inclusion criteriawere PMVSD with diameter 5 mm or if 5 mm with hemodynamic significance andage 1 year. Exclusion criteria were fixed pulmonary arterial hypertension and associatedcongenital heart disease needing surgical repair. Procedures were performedunder general anesthesia and monitored by transthoracic echocardiography (TTE). Thedevice choice was based on left ventricle (LV) angiography and on TTE images.PMVSDs were crossed by retrograde approach. Results: Mean age was 9.3 6 7.5years, and mean weight was 29.1 6 15.9 kg. Thirty-five (63.6%) patients were females.Mean pulmonary arterial mean pressure, mean LV diastolic diameter, and mean Qp/Qswere 24.0 6 6.5 mm Hg, 43.0 6 5.9 mm, and 2.2 6 0.8, respectively. Associated nonsurgicalmalformations were present in 9 (16.3%) patients, and PMVSDs were multifenestratedin 16 (46.2%) cases. Mean PMVSDs diameter was 5.8 6 1.8 mm by angiographyand 6.8 6 2.3 mm by TTE. New rhythm disturbance without clinical significance wasobserved in 29% of the patients and was reversible in 87.5%. After procedure, trivialresidual shunt was present in 5 (8.9%) patients and moderate residual shunt in other 5(8.9%). At late FU (mean of 298.7 6 88.9 days), 91% of the patients had no residualshunts. Third-degree AV block and severe aortic regurgitation occurred in one patienteach. Conclusions: In this experience, PMVSD closure with CERAVR devices showed tobe safe and effective with low incidence of complications at immediate and mid-termFU.