Thirty-eight patients were added to the update, so a total of 54 patients (26 male) were included according to the selection criteria [8]. The mean age was 5.0±6.6 years (range, 0.6 to 30.0 years) and the mean body weight was 18.7±12.8 kg (range, 7.8 to 55.0 kg) in the series. The mean VSD diameter measured by preoperative TTE was 4.4±1.4 mm (range, 2.0 to 5.5 mm) and 4.4±1.1 mm (range, 3.0 to 7.0 mm) by TEE after general anesthesia(Table 1). Before the procedure, 10 patients (18.5%) had trivial aortic regurgitation without aortic valve prolapse, and five patients (9.3%) had trivial tricuspid regurgitation. One patient was found with trivial pulmonary regurgitation (1.9%) preoperatively.
Table 1. Characteristics of Study Patients
Sex (male/female)
|
26/28
|
Mean age at time of procedure (years)
|
5.0 ± 6.6 (range, 0.6–14.0)
|
Mean body weight (kg)
|
18.7 ± 12.8 (range, 7.8–40.0)
|
Mean VSD diameter by TTE (mm)
|
4.4± 1.4 (range, 2.0–5.5)
|
Mean VSD diameter by TEE (mm)
|
4.4 ±1.1 (range, 3.0–7.0)
|
Mean eccentric occluder diameter (mm)
|
7.1 ±1.3 (range, 5.0–10.0)
|
Preoperative arrhythmia
|
|
Atrioventricular block
|
0 (0%)
|
Right bundle branch block
|
0 (0%)
|
Other arrhythmia
|
0 (0%)
|
Preoperative valve regurgitation
|
|
Aortic regurgitation
|
10 trivial (18.5%)
|
Pulmonary regurgitation
|
1 (1.9%)
|
Tricuspid regurgitation
|
5 trivial (9.3%)
|
Regarding the outcomes of percutaneous perventricular device closure, 53 patients completed the percutaneous perventricular device closure successfully (53/54, 98.1%). The mean size of the device for VSD closure was 7.1±1.3 mm (range, 5.0 to 10.0 mm), and the device size of diameter for the RV tunnel was 5.0 mm or 6.0 mm. No death, residual shunt, device dislocation or obstruction of the RV outflow tract was observed in the patients in the updated study (Table 1). Fifty-four patients were followed up for 3 months, while 49 patients for 6 months, 41 for 1 year, 32 for 2 years, 24 for 3 years, and 13 for 4 years (Table 2).
Table 2. Follow-Up Outcomes of Percutaneous Perventricular Device Closure
In-Hospital / Follow-Up
|
|
Death
|
|
Residual Shun
|
|
RVOT
Obstruction
|
|
Valve Regurgitation
n/n (%)
|
|
|
n/n(%)
|
|
n/n(%)
|
|
n/n(%)
|
|
AR
|
PR
|
TR
|
After procedure in the OR
|
|
0/54 (0%)
|
|
4/54 (7.4%)
|
|
0/54 (0%)
|
|
1/54 (1.9%)
|
0/54 (0%)
|
3/54 (0%)
|
|
Discharge
|
|
0/54 (0%)
|
|
0/54 (0%)
|
|
0/54 (0%)
|
|
0/54 (0%)
|
0/54 (0%)
|
0/54 (0%)
|
|
3 months
|
|
0/54 (0%)
|
|
0/54 (0%)
|
|
0/54 (0%)
|
|
1/54 (1.9%)
|
0/54 (0%)
|
1/54 (0%)
|
|
6 months
|
|
0/49 (0%)
|
|
0/49 (0%)
|
|
0/49 (0%)
|
|
1/49 (2.0%)
|
0/49 (0%)
|
1/49 (0%)
|
|
1 years
|
|
0/41 (0%)
|
|
0/41 (0%)
|
|
0/41 (0%)
|
|
1/41 (2.4%)
|
0/41 (0%)
|
1/41 (0%)
|
|
2 years
|
|
0/32 (0%)
|
|
0/32 (0%)
|
|
0/32 (0%)
|
|
1/32 (3.1%)
|
0/32 (0%)
|
0/32 (0%)
|
|
3 years
|
|
0/24 (0%)
|
|
0/24 (0%)
|
|
0/24 (0%)
|
|
0/24 (0%)
|
0/24 (0%)
|
0/24 (0%)
|
|
4 years
|
|
0/13 (0%)
|
|
0/13 (0%)
|
|
0/13 (0%)
|
|
0/13 (0%)
|
0/13 (0%)
|
0/13 (0%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AR = aortic regurgitation; OR = operating room; PR = pulmonary regurgitation; RVOT = right ventricular outflow tract; TR = tricuspid regurgitation;
No new findings were observed in the updated patients in terms of new postoperative aortic, pulmonary or tricuspid valve problems or any new onset of arrhythmia (Table 1). From TTE clinical follow-up, there was no acceleration of blood flow in the RVOT (Fig.1).
Preoperative aortic regurgitation in 9 patients had disappeared during the follow-up period, with one case which remained stable during the follow-up periods. Device-related aortic regurgitation was not found. Thrombosis, hemolysis, infective endocarditis, or conduction abnormalities were not encountered, other than the case in which bleeding occurred in one patient due to undesired dislodgement of the delivery sheath [8]. This case was regarded as unsuccessful. In another two cases in the updated study, a small amount of pericardial effusion was found after several hours in the ICU (maximal depth: 8mm and 1.0 cm respectively). A single-lumen central venous catheter was used to drain the pericardial cavity and the effusion did not increase.
The postoperative recovery was smooth. The mean postoperative hospital stay was 3.2±2.5 days (range, 2.0 to 6.0 days). The second unsuccessful case received blood transfusion in the previous report [8].