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Background: Given the increasing popularity of off-pump transthoracic device closure (OTDC) of ventricular septal defect (VSD) since 2007, a comparative analysis of the different treatments (surgical vs. transthoracic device closure) for VSDs is needed.
Methods: A total of 436 patients with VSDs were randomly divided into two groups: 248 patients treated with OTDC (device group) and 188 patients underwent traditional surgical repair (surgical group). Patients were followed up with the same standard protocol. Clinical, ECG, and echocardiographic data before and after operation were analyzed. Several characteristics (e.g. operating time, complications, blood transfusions, hospital stay time, cost of hospitalization and complications after operations) were also compared between the two groups.
Results: There were no differences between the two groups according to preoperative baseline characteristics (table 1). There was no occurrence of main complications in both two groups during hospital stay and follow-up. Minor complications (such as incomplete right bundle branch block, trace to mild tricuspid regurgitation, hydropericardium, and so on) occurred in both groups. The differences between two groups were shown in table 2. The cardiac function was NYHA class I in all subjects.
Conclusions: OTDC of VSD is an effective method which can save lots of blood products and extracorporeal circulation medical supplies. It can serve as a reasonable alternative treatment with fewer complications and good cosmetic effect for traditional cardiac surgery.
Table 1. Preoperative baseline characteristics of patients undergoing transthoracic device or surgical closure of isolated VSD

Characteristic	Transthoracic device closure	Surgical closure	pValue
Number	248	188
Gender
Male	137	92
Female	111	96
Age (months)	21.5±18.7 (3-180)	18.6±14.3 (2-90)	0.12
Body weight (kilogram)	14.7±10.9 (4.5-48)	12.5±9.6 (4-29)	0.31
Chest X-ray
Cardiothoracic ratio	0.55±0.09 (0.47-0.61)	0.56±0.11 (0.49-0.63)	0.28
ECG
iRBBB	18	11
iLBBB	1	0
cRBBB	3	8
Echocardiography
VSD size, mm	5.2±2.9 (3-10)	5.8±3.7 (3-12)	0.09
VSD location
Perimembranous	235	154
Subarterial	5	23
Muscular	8	11
Trace to mild TR	23	26
AR	3	7
LVEF (%)	61.3±5.8 (58-71)	58.3±6.9 (55-68)	0.18
LV-RV grandient (mmHg)	55.3±12.8 (41-69)	48.2±21.4 (39-56)	0.04

Table 2. Procedural characteristics and follow-up data of patients undergoing transthoracic device or surgical closure of isolated VSD

Characteristic	Transthoracic device closure	Surgical closure	pValue
Number	248	188
Operating time (minutes)	30.5±19.7	95.6±53.8	0.001
Mechanical ventilation time (hours)	0.8±0.6	3.2±2.8	0.02
ICU stay (hours)	18.6±9.5	24.8±17.2	0.012
Blood transfusion (%)	12 (4.84)	188 (100)	<0.001
Complications before discharge
Hydropericadium (%)	12 (4.84)	17 (9.04)	0.03
Incision infection (%)	4 (1.61)	7 (3.72)	0.02
ECG
iRBBB or cRBBB (%)	31 (12.5)	27 (14.4)	0.25
iLBBB	1	0
cAVB	0	0
Echocardiography
Trace to mild TR (%)	36 (14.5)	35 (18.6)	0.36
AR (%)	2 (0.8)	8 (4.3)	0.02
Residual shunting
Trivial to small (%)	27 (10.9)	31 (16.5)	0.17
Moderate	0	1
Hemolysis	0	0
Hematuria	0	0
Thrombembolism	0	0
Cost of hospitalization (1,000 RMB)	25.97±10.24	29.56±15.38	0.52
Follow-up time (months)	36.5±18.7	36.1±19.5	0.88
Follow-up rate (%)	236 (95.2)	178 (94.7)	0.67
Complications during follow-up
ECG
iRBBB or cRBBB (%)	35 (14.8)	33 (18.5)	0.61
iLBBB	1	0
cAVB	0	0
Echocardiography
Trace to mild TR (%)	22 (9.3)	25 (14.0)	0.09
AR (%)	1 (0.4)	6 (3.4)	<0.001
Residual shunting
Trivial to small (%)	11 (4.7)	27 (15.2)	0.02
Moderate	0	0

iRBBB, incomplete right bundle branch block; iLBBB, incomplete left bundle branch block; cRBBB, complete right bundle branch block; cAVB, complete atrioventricular block; TR, tricuspid regurgitation; AR, aortic regurgitation; LV, left ventricle; RV, right ventricle; LVEF, left ventricle ejection fraction.