Table 1.
Characteristics of included studies
| Study | Region | Design | Study quality* | Anatomy (percentage of pmVSD, %) | Manufacturer of device | Device size (mm) † | Inclusion criteria | Group | Age (yr) † | Weight (kg) † | Defect size (mm) † |
|---|---|---|---|---|---|---|---|---|---|---|---|
| PDC vs. CSR | |||||||||||
| Chen 2013 [24] | China | PCS | 2b, 18 | 100 | SHSMA | 8.8 ± 1.8 | Isolated pmVSD, 5–12 mm in size | PDC | 13.3 ± 11.9 | 34.2 ± 16.8 | 7.6 ± 1.6 |
| CSR | 13.7 ± 13.5 | 34.6 ± 18.5 | |||||||||
| Hu 2014 [25] | China | PCS | 2b, 20 | 100 | SHSMA | 8.4 ± 2.1 | Isolated pmVSD ≤10 mm, no more than mild AR | PDC | 3.7 ± 2.3 | 16.7 ± 7.5 | 7.0 ± 2.0 |
| CSR | 1.4 ± 0.6 | 15.6 ± 5.0 | 6.8 ± 2.1 | ||||||||
| Hu 2015 [26] | China | RCS | 2b, 17 | 100 | Lifetech Med | 7.6 ± 2.0 | Isolated pmVSD ≤10 mm, no AR | PDC | 5.3 ± 3.6 | 18.1 ± 10.4 | 5.1 ± 2.2 |
| CSR | 4.4 ± 3.0 | 16.4 ± 6.1 | 4.2 ± 1.8 | ||||||||
| Luo 2015 [27] | China | RCS | 2b, 17 | 100 | SHSMA | NA | Isolated pmVSD, no severe PAH | PDC | 3.7 ± 5.5 | 14.9 ± 13.0 | 4.5 ± 1.6 |
| CSR | 3.7 ± 2.4 | 15.9 ± 5.3 | 4.6 ± 2.4 | ||||||||
| Voitov 2017 [28] | Russia | RCT | 1b, 22 | 81.9 | SHSMA | 4–11 | Isolated VSD ≤10 mm, no more than mild AR | PDC | 2.9 ± 0.4 | 13.9 ± 1.2 | 5.3 ± 0.3 |
| CSR | 3 ± 0.4 | 14.5 ± 1.2 | 6.2 ± 0.5 | ||||||||
| Xing 2015 [29] | China | RCS | 2b, 19 | 86.9 | AGA, SHSMA and Lifetech Med | 6.5 ± 5.3 | Restrictive isolated VSD, no severe PAH | PDC | 1 ± 0.6 | 9.8 ± 5.9 | 5.2 ± 3.0 |
| CSR | 0.9 ± 0.7 | 8.6 ± 7.8 | 6.8 ± 3.8 | ||||||||
| Xu 2012 [30] | China | PCS | 2b, 19 | 100 | SHSMA | 4–18 | Isolated pmVSD, 3–12 mm, no more than mild AR, age < 2 years | PDC | 0.7 ± 0.3 | 9.8 ± 1.8 | 5.1 ± 1.5 |
| CSR | 0.5 ± 0.2 | 7.7 ± 1.9 | 6.4 ± 1.7 | ||||||||
| Yao 2013 [31] | China | RCS | 2b, 12 | 70.9 | SHSMA | NA | Isolated VSD, no more than severe PAH | PDC | 4.7 ± 0.4 | 18.4 ± 1.0 | NA |
| CSR | 4.6 ± 0.5 | 17.7 ± 1.2 | NA | ||||||||
| Liu 2018 [32] | China | RCT | 1b, 26 | 100 | Lifetech Med | 8.9 ± 1.4 | isolated pmVSD with 3 to 10 mm, normal or mild PAH | PDC | 2 ± 0.7 | 13.2 ± 1.9 | 5.5 ± 1.4 |
| CSR | 2 ± 0.7 | 13.2 ± 1.9 | 5.5 ± 1.4 | ||||||||
| Chen 2018 [33] | China | RCS | 2b, 17 | 100 | Lifetech Med and Shandong Visee | 6–14 | pmVSD< 10, with no AR | PDC | 1.3 ± 1.2 | 8.3 ± 2.6 | 4.2 ± 1.1 |
| CSR | 1.2 ± 1.1 | 8.1 ± 2.5 | 5.1 ± 1.2 | ||||||||
| TDC vs. CSR | |||||||||||
| Yang 2014 [9] | China | RCT | 1b, 24 | 100 | SHSMA | 7.4 | Age 3–12 years, Weight > 10 kg, VSD > 3 mm | TDC | 5.5 ± 2.6 | 22.1 ± 13.8 | 5.2 ± 6.1 |
| CSR | 5.8 ± 2.4 | 20.5 ± 12.4 | 5.9 ± 5.3 | ||||||||
| Liu 2012 [10] | China | RCS | 2b, 18 | 100 | SHSMA | 6.2 ± 2.3 | Age > 3 years, Weight > 10 kg, VSD < 16 mm | TDC | 18.1 ± 15.1 | NA | 4.1 ± 1.4 |
| CSR | 7.5 ± 9.4 | NA | 6.3 ± 4.1 | ||||||||
| Pawelec-Wojtalik 2005 [11] | Poland | RCS | 2b, 15 | 100 | AGA | 6.4 ± 2.2 | Weight > 5 kg | TDC | 7.8 ± 6.4 | 28.1 ± 21.3 | 6.2 ± 1.1 |
| CSR | 2.6 ± 2.3 | 16.7 ± 8.4 | 4.8 ± 0.9 | ||||||||
| Cheng 2007 [34] | China | PCS | 2b, 18 | 100 | AGA | NA | Weight > 10 kg, VSD < 12 mm | TDC | 7.5 ± 2.4 | NA | 4.8 ± 2.3 |
| CSR | 4.4 ± 2.5 | NA | 8.2 ± 2.3 | ||||||||
| Zheng 2009 [35] | China | RCS | 2b, 17 | 77.8 | AGA | NA | Age > 2.5 years, Weight > 11 kg, VSD 3–12 mm | TDC | 2.5–15.5 | 11–63.5 | 3–12 |
| CSR | 2.8–52.5 | 11.5–68 | 3–36 | ||||||||
| Oses 2010 [36] | Canada | RCS | 2b, 16 | 100 | AGA | 6.4 ± 2.2 | VSD size < 6 mm, no age or Weight limit. VSD size > 6 mm, age > 6 years or Weight > 6 kg | TDC | 9.1 ± 5.1 | NA | 9.4 ± 3.9 |
| CSR | 1.8 ± 3.6 | NA | |||||||||
| Chen 2014 [37] | China | RCS | 2b, 16 | 100 | SHSMA | 6.5 ± 2.1 | Isolated pmVSD | TDC | 16 ± 11.7 | 41.3 ± 18.5 | 4.1 ± 1.2 |
| CSR | 3.8 ± 2.4 | 15.3 ± 5.3 | 4.3 ± 1.3 | ||||||||
| Zhu 2007 [38] | China | RCS | 2b, 16 | 100 | AGA, SHSMA | 8.1 ± 2.5 | NA | TDC | 11 ± 8 | 33 ± 17 | 4.4 ± 1.1 |
| CSR | 3–51 | 33 ± 16 | 5.2 ± 1 | ||||||||
| Chen 2015 [39] | China | RCS | 2b, 17 | 100 | NA | NA | Age > 2 years, Weight > 8 kg, VSD < 14 mm | TDC | 5 ± 1.2 | 16.5 ± 4.5 | 4.3 ± 1.7 |
| CSR | 4.9 ± 1.4 | 16.2 ± 5 | 5.4 ± 1.6 | ||||||||
| Xiao 2008 [40] | China | RCS | 2b, 15 | 100 | AGA | NA | Age > 3 years, Weight > 5 kg, VSD < 12 mm | TDC | 11.2 ± 6.8 | NA | 5.6 ± 1.3 |
| CSR | 12 ± 7.6 | NA | 6.1 ± 1.8 | ||||||||
| Chen 2010 [41] | China | RCS | 2b, 16 | 94.9 | Lifetech Med | NA | Age > 3 years, Weight > 10 kg, VSD < 10 mm | TDC | 10.6 ± 11.1 | NA | 5.5 ± 2.4 |
| CSR | 8.3 ± 7.9 | NA | 7.4 ± 6 | ||||||||
| TDC vs. PDC | |||||||||||
| Huang 2019 [42] | China | RCS | 2b, 16 | 100 | Lifetech Med and AGA | 6.6 ± 2.8 | isolated VSD with no AR | TDC | 6.2 ± 6.3 | 33.1 ± 21.5 | 5.9 ± 2.3 |
| PDC | 6.5 ± 5.2 | 31.5 ± 23.4 | 6.1 ± 2.1 | ||||||||
| PDC vs. TDC vs. CSR | |||||||||||
| Fang 2018 [43] | China | RCS | 2b, 17 | 100 | Shandong Visee | 6–14 | isolated VSD with no PAH | PDC | 1.6 ± 1.3 | 10.1 ± 2.3 | 5.3 ± 1.1 |
| TDC | 2.1 ± 0.8 | 10.6 ± 2.8 | 5.1 ± 1 | ||||||||
| CSR | 1.4 ± 1.5 | 9.5 ± 3.1 | 5.9 ± 1.1 | ||||||||
| Chen 2019 [44] | China | RCS | 2b, 17 | 100 | Shandong Visee and AGA | 4.8 ± 1.4 | restrictive pmVSD with no severe PAH | PDC | 2.7 ± 1.5 | 18.8 ± 2.3 | 4.3 ± 0.7 |
| TDC | 2.9 ± 0.7 | 19.7 ± 3.9 | 4.2 ± 0.9 | ||||||||
| CSR | 2.7 ± 1.1 | 19.3 ± 3.0 | 4.4 ± 0.8 | ||||||||
PDC perventricular device closure; TDC transcatheter device closure; CSR conventional surgical repair; PCS Prospective cohort study; RCS retrospective cohort study; VSD ventricular septal defects; pmVSD perimembranous VSD; yr year; mm millimeter; RCT Randomized controlled trial; NA not available; SHSMA Shanghai Shape Memory Alloy Co., Ltd.; AGA AGA Medical Corporation; Lifetech Med Lifetech Scientific Co., Ltd.; Shandong Visee Shandong Visee Medical Devices Co., Ltd.; AR aortic regurgitation; PAH pulmonary artery hypertension; PDC perventricular device closure; TDC transcatheter device closure; CSR conventional surgical repair; *Studies were categorized by Evidence-based Medicine Levels of Evidence and assessed by Downs and Black scoring system [19, 20]; †Continuous variables were presented as mean ± standard deviation or median (interquartile range) or just range