8
Registry Group – Fenestrated Fontan
Methods
Device Patients
Device placement was attempted in 442 patients. The patients underwent cardiac catheterization.
Position and size of the defect were confirmed by angiography. The size of the defect was
determined by obtaining the "stretched" diameter of the defect with a compliant balloon catheter. If
the size and position of the defect were determined to be feasible for transcatheter closure, device
placement was attempted. Nineteen (19) patients did not receive the device due to anatomical
conditions. There was one acute embolization. Thus 423 patients received 433 devices. The
patients were instructed to avoid strenuous activity for a period of 1 month and to take aspirin for 6
months post placement (3-5mg/kg/day). Additionally, patients were examined and a transthoracic
echocardiogram (TTE) was conducted at 24 hours, 6 months, and 1 year.
Surgical Control Group
Surgical repair of an atrial septal defect requires sternotomy, cardiopulmonary bypass, aortic cross
clamp and right atriotomy. If the defect is small, primary repair by suturing the defect is feasible;
however, if the defect is large, then patch closure is the preferred method. Different surgeons use
different material for the patch. Most surgeons use pericardium, however, some surgeons use
GORE-TEX to repair the ASD. At the end of the operation, the surgeon inserts chest tubes to drain
any blood. The chest tubes remain for 24–48 hours after which they are removed. The patient
spends 3–5 days at the hospital after which they go home. A total of 154 patients underwent
surgical closure of their ASD. The surgical group required a 12-month visit.
Table 4. Pre-closure – Fenestrated Fontan
Age (years)
Mean ± s.d.(N)
7.8 ± 6.9 (48)
[range]
[1.6, 44.9]
Gender
Female
29/48 (60.4%)
Male
Height (cm)
Mean ± s.d.(N)
114.5 ± 25.2 (46)
[range]
[78,168]
Weight (kg)
Mean ± s.d.(N)
22.4 ± 13.5 (48)
[range]
[9.7, 68.7]
Medical History
CHF
1/48 (2.1%)
Failure to thrive
1/48 (2.1%)
Stroke
2/48 (4.2%)
Heart murmur
26/47 (55.3%)
Pulmonary ejection murmur
2/47 (4.3%)
Mid diastolic murmur
1/47 (2.1%)
Right axis deviation
11/45 (24.4%)
Peaked P-waves
1/45 (2.2%)
Cardiomegaly
20/45 (44.4%)
100092311_ASD.book Page 8 Monday, January 6, 2014 11:00 AM
