Background
Methods
Patients’ clinical details
No | Sex | Age (y) | Weight (kg) | LDVSD (mm) | Number of holes | Size of holes (mm) | MD (mm) | 1st device (mm) | 2nd device (mm) | ICMT (min) | Procedure time (min) |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | M | 39 | 80 | 19 | 4 | 7.0,2.0,2.5,1.5 | 7.2 | 9,sc | 5,wc | 68 | 135 |
2 | M | 1 | 9 | 8 | 2 | 2.6,2.0 | 7.0 | 4,sc | 4,wc | 45 | 75 |
3 | M | 1 | 12 | 9 | 2 | 2.7,2.5 | 5.3 | 4,sc | 4,sc | 50 | 88 |
4 | M | 3 | 18 | 12 | 2 | 6.0,2.5 | 9.0 | 8,sc | 4,sc | 47 | 115 |
5 | M | 3 | 16 | 14 | 4 | 5.6,2.5,1.5,1.5 | 10.0 | 8,sc | 5,wc | 48 | 100 |
6 | M | 20 | 56 | 18 | 2 | 3.2,2.5 | 6.5 | 6,sc | 4,sc | 90 | 160 |
7 | F | 3 | 14 | 12 | 2 | 2.5,2.5 | 5.5 | 4,sc | 4,wc | 45 | 84 |
8 | M | 19 | 64 | 15 | 2 | 3.5,2.5 | 6.0 | 6,sc | 4,sc | 65 | 108 |
9 | M | 3 | 13 | 11 | 2 | 2.8,2.2 | 6.1 | 4,sc | 4,sc | 53 | 100 |
10 | M | 6 | 19 | 13 | 3 | 3.2,2.0,1.5 | 5.0 | 7,wc | 4,sc | 40 | 99 |
11 | F | 1 | 7 | 10 | 3 | 2.5,2.0,1.5 | 5.3 | 5,sc | 4,sc | 45 | 120 |
12 | F | 1 | 12 | 9 | 3 | 2.5,2.0,1.5 | 5.5 | 5,wc | 4,sc | 33 | 80 |
13 | F | 8 | 25 | 17 | 2 | 3.8,2.5 | 6.5 | 6,sc | 4,sc | 60 | 105 |
14 | F | 5 | 28 | 10 | 2 | 3.0,2.3 | 5.2 | 5,sc | 4,sc | 50 | 98 |
15 | F | 13 | 54 | 15 | 2 | 3.5,2.5 | 5.8 | 6,sc | 4,sc | 62 | 108 |
16 | M | 4 | 19 | 9 | 2 | 3.0,2.5 | 5.3 | 5,sc | 4,sc | 38 | 70 |
Device and delivery system
Transesophageal echocardiography (TEE)
Procedure
Patient follow-up
Statistical analysis
Results
Intraoperative results
Postoperative and follow-up results
Variable | IADR | At discharge | 1 Month | 6 Months | 12 Months | 24 Months | 36 Months | 48 Months |
---|---|---|---|---|---|---|---|---|
Preexisting AR (%) | 2/16(13) | 1/16(6) | 0/16(0) | 0/16(0) | 0/16(0) | 0/11(0) | 0/7(0) | 0/3(0) |
New AR (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Preexisting TR (%) | 8/16(50) | 7/16(44) | 4/16(25) | 1/16(6) | 1/16(6) | 1/11(9) | 0/7(0) | 0/3(0) |
New TR (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Preexisting MR (%) | 5/16(31) | 2/16(13) | 2/16(13) | 1/16(6) | 0/16(0) | 0/11(0) | 0/7(0) | 0/3(0) |
New MR (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
New IRBBB (%) | – | 3/16(19) | 2/16(13) | 1/16(6) | 1/16(6) | 0/11(0) | 0/7(0) | 0/3(0) |
Mild residual shunt (%) | 6/16(38) | 5/16(31) | 3/16(19) | 1/16(6) | 1/16(6) | 0/11(0) | 0/7(0) | 0/3(0) |
Discussion
Advantages of the perventricular approach
Advantages of double-device implanting technique
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First, both of them are simple, which decrease the cost of the procedure.
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Second, the DDS simplify the device closure process. Because of the excellent manipulability, the DDS loaded with the device, generally permits direct entry into the large hole without using the probe, guidewire, and loader.
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Third, the PADS makes it easy to cross the residual hole from right to left. The hollow probe can approach the residual hole with very good echocardiographic visualization. It improves the possibility of crossing the defect and minimizes the risk of entrapping the guidewire by the first implanted device. In some patients, the jet of the residual hole is towards the right atrium or apex, the distal end of the probe can be made an angle so that it can point towards the jet to introduce the guidewire to cross the defect.
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Fourth, the risk of injuring the cardiac valves or other structures is decreased. The PADS and DDS enter the defect directly without passing through any cardiac valve, which avoid chordal and trabecular entrapment.
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Fifth, The device stay suture has improved the safety of this technique. It has the ability to retrieve a suboptimally placed device through a larger delivery sheath and prevents device dislocation and embolization after device release.