Solysafe is a new self-centering device with helicoidal structure made of Phynox and two polyester patches. Coaxial control catheters are screwed to each end, so patch deployment is independently controlled. Implantation is through a 10 Fr short sheath in femoral vein. The device is advanced over a 0.018’’ guide-wire through the ASD and deployed by manipulating the control catheters. Patches are locked with a clicking mechanism. The device is released by unscrewing the control catheters. The procedure can be reversed.
We report the initial experience with Solysafe for ASD closure in pediatric patients.
ASD closure procedures using Solysafe from May to October 2008 were reviewed. Procedures were performed under fluoroscopic and echocardiographic guidance. Device size was selected according to balloon stretched diameter.
Solysafe device was used in 7 patients (3 female), median age 7 years (6-14), median weight 22.8 kg (19.5-58) and median stretched diameter 17 mm (9-18). Six devices were implanted. In one patient needing a Solysafe 25 device, a Solysafe 20 device (largest available at that time) was deployed but prolapsed through the defect and was uneventfully removed. Intraprocedure echocardiography demonstrated complete closure in 4 patients and small residual shunt in 2. A very low device profile was remarkable. No intraprocedure complications occurred. Median follow-up of 6 months (2-8) demonstrated 100% closure rate and no complications.
The new Solysafe device is safe and effective for ASD closure in pediatric patients. The implanted device profile is remarkable. 10 Fr sheath needed for implantation limits its use in small children.