Device closure of muscular ventricular septal defects in infants less than one year of age using the Amplatzer devices: feasibility and outcome.

Objective: In this study, we evaluated the feasibility, safety, and outcome of device closure of muscular ventricular septal defects (mVSD) in infants less than 1 year of age using the Amplatzer devices.

Background: Closure of mVSDs continues to represent a surgical challenge with significant morbidity. Hence, device closure is becoming an attractive and reliable alternative. However, little is known about the feasibility of this procedure in small infants.

Methods: Between July 1999 and September 2006, device closure of mVSD was attempted in 20 infants ranging in age from 3 days to 12 months (median +/- SD; 4.6 +/- 3.8) and in weight from 3.2 to 8.9 kg (4.6 +/- 1.9) under TEE guidance by percutaneous or hybrid (perventricular) techniques. The size of the VSD as assessed by TEE ranged from 3 to 11 mm (6.0 +/- 2.2) and the Qp:Qs ratio ranged from 0.7 to 8.8 (2.8 +/- 2.3).

Results: The device was successfully placed in 19/20 infants and it ranged in size from 4 to 14 mm (8.0 +/- 2.6). It was percutaneously deployed in 11/19 and by the hybrid approach in 8/19. There were 30 devices placed in 19 infants with multiple devices placed in 5/19 infants. Fluoroscopy times ranged from 11 to 136 min (41 +/- 28) and procedure times ranged from 57 to 291 min (178 +/- 68). The success rate as defined by complete closure or a trivial shunt was 84% immediately and 100% at 1-year follow-up. Major complications occurred in 4/20 patients: wire perforation and hemopericardium (n = 1), device migration (n = 1), transient electromechanical dissociation (n = 1), and mediastinitis (n = 1). At a median follow-up of 3.8 years, all patients improved and had no hemodynamically significant VSDs. No major complications were encountered in patients with multiple devices.

Conclusions: In infants less than 1 year of age, percutaneous and perventricular device closure of mVSDs is technically feasible and highly effective with low morbidity. Long term safety and efficacy needs to be assessed.