A European multicentric experience using the CardioSEAL((R)) and Starflex double umbrella devices to close interatrial communications holes within the oval fossa

In this review, we describe the experience from 13 European centres using t he CardioSEAL and Starflex double umbrella devices to close interatrial com munications within the oval fossa (so-called 'secundum' defects). Between O ctober 1996 and April 1999, the procedure was attempted in 334 patients wit h a mean age of 12 years and a mean weight of 44kg. The mean measured stret ched diameter of the defect was 15 mm. In the overall group, the defect was solitary in 245 patients (73%), multiple in 21 (6%), associated with an an eurysm of the flap valve in 15 (5%), was represented by patency of the oval foramen in 44 (13%), and was a fenestration in a Fontan repair in 9 (3%). In all patients, the devices were inserted under general anesthesia, using fluoroscopic and transesophageal echocardiographic control. Implantation wa s achieved in 325 (97,3%). The device embolized within either a few minutes or a few hours in 13 patients (4%). Of these, uncomplicated surgical repai r was undertaken in 10, while the device was retrieved in 3 using catheters and a second device was successfully implanted. Residual shunting was dete cted immediately after the procedure in 41% of the patients, with the incid ence decreasing to 31% at discharge, 24% at 1 month, 21% at 6 months, and 2 0.5% at one year. During the period of follow-up, elective surgical repair became necessary in two patients, due to malposition of the device in one, and late embolization in the other. Fractures of arms were seen in 6.1%, mo st commonly with the largest devices. All those with fractured arms of the device were asymptomatic, and no clinical complications related to the frac tures were observed. There mere no arrythmias, endocarditis, valvar distort ion, thromboembolic events, or other complications. After one year of follo w-up, clinical success, defined as complete closure of the defect or presen ce of only a trivial leak, had been obtained in 92.5% of the patients. We c onclude, therefore, that these devices produce excellent results when used to close defects of small to moderate size. Results are less than optimal, or else complications ensure, when attempts are made to close very large de fects.