Effectiveness and safety of perventricular device closure in congenital perimembranous ventricular septal defects: A systematic review and meta-analysis_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LI Mengsi ¹ , LI Dongxu ² , YIN Xiaorong ¹ ,  AN Qi ²

1. Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

AN Qi, Email: anqi@scu.edu.cn

Keywords：

Ventricular septal defect; perimembranous; perventricular device closure; complications; meta-analysis

DOI：

10.7507/1007-4848.201811044

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Objective To investigate the safety and effectiveness of perventricular device closure (PDC) for congenital ventricular septal defects (VSD) by a meta-analysis.Methods PubMed, The Cochrane Library, EMbase and China Biology Medicine (CBM) databases were searched for studies on PDC of VSD up to October 2018 by computer. We included studies only with more than 80% patients diagnosed with perimembranous VSD. A meta-analysis was performed to obtain pooled estimates of success rate and incidences of complications with 95% confidence interval (CI). Subgroup analysis stratified by percentage of perimembranous VSD was performed. Risk difference (RD) was used in the comparison of perioperative data with follow-up data. Results Fifteen studies (2 randomized controlled trials, 3 retrospective cohorts, and other 10 retrospective single-arm studies) involving 4 164 patients (3 848 patients with perimembranous VSD) were included in this meta-analysis. The pooled success rate was 95.4%. Incidences of residual shunt, aortic insufficiency, tricuspid insufficiency, and third-degree atrioventricular block were 5%, 0.1%, 3%, and less than 0.001% respectively. Improvements of residual shunt and aortic insufficiency were confirmed in follow-up patients. Conclusion PDC of congenital perimembranous VSDs is safe and yields good results. Because some limitations can not be overcomed, multicenter randomized controlled trials are needed to confirm our results.

Citation： LI Mengsi, LI Dongxu, YIN Xiaorong, AN Qi. Effectiveness and safety of perventricular device closure in congenital perimembranous ventricular septal defects: A systematic review and meta-analysis. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2019, 26(3): 251-259. doi: 10.7507/1007-4848.201811044 Copy

1.	Mitchell SC, Korones SB, Berendes HW. Congenital heart disease in 56, 109 births. Incidence and natural history. Circulation, 1971, 43(3): 323-332.
2.	Anderson RH, Becker AE, Tynan M. Description of ventricular septal defects-or how long is a piece of string? Int J Cardiol, 1986, 13(3): 267-278.
3.	Schmidt KG, Cassidy SC, Silverman NH, et al. Doubly committed subarterial ventricular septal defects: Echocardiographic features and surgical implications. J Am Coll Cardiol, 1988, 12(6): 1538-1546.
4.	Diab KA, Cao QL, Hijazi ZM. Device closure of congenital ventricular septal defects. Congenit Heart Dis, 2007, 2(2): 92-103.
5.	Warden HE, Cohen M, Lillehei CW, et al. Experimental closure of interventricular septal defects and further physiologic studies on controlled cross circulation. Surg Forum, 1955, 5: 22-28.
6.	Holzer RJ, Sallehuddin A, Hijazi ZM. Surgical strategies and novel alternatives for the closure of ventricular septal defects. Expert Rev Cardiovasc Ther, 2016, 14(7): 831-841.
7.	Yin S, Zhu D, Lin K, et al. Perventricular device closure of congenital ventricular septal defects. J Card Surg, 2014, 29(3): 390-400.
8.	Aleem IS, Karamlou T, Benson LN, et al. Transcatheter device versus surgical closure of ventricular septal defects: a clinical decision analysis. Catheter Cardiovasc Interv, 2006, 67(4): 630-636.
9.	Diab KA, Cao QL, Hijazi ZM. Perventricular closure of muscular ventricular septal defects: How do I do it? Ann Pediatr Cardiol, 2008, 1(1): 27-33.
10.	Pedra CA, Pedra SR, Chaccur P, et al. Perventricular device closure of congenital muscular ventricular septal defects. Expert Rev Cardiovasc Ther, 2010, 8(5): 663-674.
11.	Kitagawa T, Kitaichi T, Sugano M, et al. Techniques and results in the management of multiple muscular trabecular ventricular septal defects. Gen Thorac Cardiovasc Surg, 2013, 61(7): 367-375.
12.	Bacha EA. Comment on " Perventricular device closure of ventricular septal defects: six months results in 30 young children”. Ann Thorac Surg, 2008, 86(1): 146.
13.	Butera G, Carminati M, Chessa M, et al. Transcatheter closure of perimembranous ventricular septal defects: early and longterm results. J Am Coll Cardiol, 2007, 50(12): 1189-1195.
14.	Sullivan ID. Transcatheter closure of perimembranous ventricular septal defect: is the risk of heart block too high a price? Heart, 2007, 93(3): 284-286.
15.	Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P): elaboration and explanation. BMJ, 2015, 350: g7647.
16.	Nyaga VN, Arbyn M, Aerts M. Metaprop: a Stata command to perform meta-analysis of binomial data. Arch Public Health, 2014, 72(1): 39.
17.	DerSimonian R, Kacker R. Random-effects model for meta-analysis of clinical trials: an update. Contemp Clin Trials, 2007, 28(2): 105-114.
18.	Hu Y, Li Z, Chen J, et al. Results of comparing transthoracic device closure and surgical repair with right infra-axillary thoracotomy for perimembranous ventricular septal defects. Interact Cardiovasc Thorac Surg, 2015, 20(4): 493-498.
19.	Voitov A, Omelchenko A, Gorbatykh Y, et al. Outcomes of perventricular off-pump versus conventional closure of ventricular septal defects: a prospective randomized study. Eur J Cardiothorac Surg, 2017, 51(5): 980-986.
20.	Xing Q, Wu Q, Shi L, et al. Minimally invasive transthoracic device closure of isolated ventricular septal defects without cardiopulmonary bypass: long-term follow-up results. J Thorac Cardiovasc Surg, 2015, 149(1): 257-264.
21.	Liu H, Lu FX, Zhou J, et al. Minimally invasive perventricular versus open surgical ventricular septal defect closure in infants and children: a randomised clinical trial. Heart, 2018, 104(24): 2035-2043.
22.	Tao K, Lin K, Shi Y, et al. Perventricular device closure of perimembranous ventricular septal defects in 61 young children: early and midterm follow-up results. J Thorac Cardiovasc Surg, 2010, 140(4): 864-870.
23.	Zhu D, Lin K, Tang ML, et al. Midterm results of hybrid perventricular closure of doubly committed subarterial ventricular septal defects in pediatric patients. J Card Surg, 2014, 29(4): 546-553.
24.	陆国梁, 马伦超, 杨超, 等. 经胸微创室间隔缺损封堵术 142 例. 实用医学杂志, 2015, 31(8): 1294-1295.
25.	赵龙, 朱宪明, 刘志平, 等. 微创胸骨下段小切口室间隔缺损封堵术的临床分析. 中国心血管病研究, 2014, 12(1): 38-41.
26.	Zeng XJ, Sun SQ, Chen XF, et al. Device closure of perimembranous ventricular septal defects with a minimally invasive technique in 12 patients. Ann Thorac Surg, 2008, 85(1): 192-194.
27.	Ou-Yang WB, Wang SZ, Hu SS, et al. Perventricular device closure of perimembranous ventricular septal defect: effectiveness of symmetric and asymmetric occluders. Eur J Cardiothorac Surg, 2017, 51(3): 478-482.
28.	Yang Y, Gao L, Xu X, et al. Echocardiographic assessment and guidance in minimally invasive surgical device closure of perimembranous ventricular septal defects. Heart Surg Forum, 2014, 17(4): E206-E211.
29.	Sun Y, Zhu P, Zhou P, et al. Intra-operative device closure of perimembranous ventricular septal defect without cardiopulmonary bypass under guidance of trans-epicardial echocardiography: a single center experience. J Cardiothorac Surg, 2016, 11(1): 87.
30.	Xu HS, Inamdar KY, Firoj KM, et al. Perventricular device closure of ventricular defects in 235 young children: a single-center experience. J Thorac Cardiovasc Surg, 2013, 146(6): 1551-1553.
31.	Wang S, Zhuang Z, Zhang H, et al. Perventricular closure of perimembranous ventricular septal defects using the concentric occluder device. Pediatr Cardiol, 2014, 35(4): 580-586.
32.	Chen Q, Hong ZN, Zhang GC, et al. Intraoperative device closure of isolated ventricular septal defects: experience on 1,090 cases. Ann Thorac Surg, 2018, 105(6): 1797-1802.
33.	Lock J, Block P, McKay R, et al. Transcatheter closure of ventricular septal defects. Circulation, 1988, 78(2): 361-368.
34.	Amin Z, Berry JM, Foker JE, et al. Intraoperative closure of muscular ventricular septal defect in a canine model and application of the technique in a baby. J Thorac Cardiovasc Surg, 1998, 115(6): 1374-1376.
35.	Wells WJ. " The times they are a-changin’”. J Thorac Cardiovasc Surg, 2015, 149(1): 265-266.
36.	Schreiber C. Editorial comment: Know-how transfer from east- to west-perventricular closure of perimembranous ventricular septal defects. Eur J Cardiothorac Surg, 2012, 42(5): 805-806.
37.	Schreiber C, Vogt M, Kühn A, et al. Perventricular closure of a perimembranous VSD: treatment option in selected patients. Thorac Cardiovasc Surg, 2012, 60(1): 78-80.
38.	Omelchenko AY, Zhuang Z, Schreiber C, et al. Surgical off-pump closure of perimembranous ventricular septal defects. Asian Cardiovasc Thorac Ann, 2014, 22(1): 31-35.
39.	Yang L, Tai BC, Khin LW, et al. A systematic review on the efficacy and safety of transcatheter device closure of ventricular septal defects (VSD). J Interv Cardiol, 2014, 27(3): 260-272.
40.	Liu L, Zhao TL, Yang YF, et al. Intraoperative device closure of subaortic ventricular septal defects. J Card Surg, 2013, 28(4): 456-460.
41.	Gan C, An Q, Lin K, et al. Perventricular device closure of ventricular septal defects: six months results in 30 young children. Ann Thorac Surg, 2008, 86(1): 142-146.
42.	Saurav A, Kaushik M, Mahesh Alla V, et al. Comparison of percutaneous device closure versus surgical closure of peri-membranous ventricular septal defects: A systematic review and meta-analysis. Catheter Cardiovasc Interv, 2015, 86(6): 1048-1056.
43.	Yang J, Yang L, Wan Y, et al. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J, 2010, 31(18): 2238-2245.

1. Mitchell SC, Korones SB, Berendes HW. Congenital heart disease in 56, 109 births. Incidence and natural history. Circulation, 1971, 43(3): 323-332.
2. Anderson RH, Becker AE, Tynan M. Description of ventricular septal defects-or how long is a piece of string? Int J Cardiol, 1986, 13(3): 267-278.
3. Schmidt KG, Cassidy SC, Silverman NH, et al. Doubly committed subarterial ventricular septal defects: Echocardiographic features and surgical implications. J Am Coll Cardiol, 1988, 12(6): 1538-1546.
4. Diab KA, Cao QL, Hijazi ZM. Device closure of congenital ventricular septal defects. Congenit Heart Dis, 2007, 2(2): 92-103.
5. Warden HE, Cohen M, Lillehei CW, et al. Experimental closure of interventricular septal defects and further physiologic studies on controlled cross circulation. Surg Forum, 1955, 5: 22-28.
6. Holzer RJ, Sallehuddin A, Hijazi ZM. Surgical strategies and novel alternatives for the closure of ventricular septal defects. Expert Rev Cardiovasc Ther, 2016, 14(7): 831-841.
7. Yin S, Zhu D, Lin K, et al. Perventricular device closure of congenital ventricular septal defects. J Card Surg, 2014, 29(3): 390-400.
8. Aleem IS, Karamlou T, Benson LN, et al. Transcatheter device versus surgical closure of ventricular septal defects: a clinical decision analysis. Catheter Cardiovasc Interv, 2006, 67(4): 630-636.
9. Diab KA, Cao QL, Hijazi ZM. Perventricular closure of muscular ventricular septal defects: How do I do it? Ann Pediatr Cardiol, 2008, 1(1): 27-33.
10. Pedra CA, Pedra SR, Chaccur P, et al. Perventricular device closure of congenital muscular ventricular septal defects. Expert Rev Cardiovasc Ther, 2010, 8(5): 663-674.
11. Kitagawa T, Kitaichi T, Sugano M, et al. Techniques and results in the management of multiple muscular trabecular ventricular septal defects. Gen Thorac Cardiovasc Surg, 2013, 61(7): 367-375.
12. Bacha EA. Comment on " Perventricular device closure of ventricular septal defects: six months results in 30 young children”. Ann Thorac Surg, 2008, 86(1): 146.
13. Butera G, Carminati M, Chessa M, et al. Transcatheter closure of perimembranous ventricular septal defects: early and longterm results. J Am Coll Cardiol, 2007, 50(12): 1189-1195.
14. Sullivan ID. Transcatheter closure of perimembranous ventricular septal defect: is the risk of heart block too high a price? Heart, 2007, 93(3): 284-286.
15. Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P): elaboration and explanation. BMJ, 2015, 350: g7647.
16. Nyaga VN, Arbyn M, Aerts M. Metaprop: a Stata command to perform meta-analysis of binomial data. Arch Public Health, 2014, 72(1): 39.
17. DerSimonian R, Kacker R. Random-effects model for meta-analysis of clinical trials: an update. Contemp Clin Trials, 2007, 28(2): 105-114.
18. Hu Y, Li Z, Chen J, et al. Results of comparing transthoracic device closure and surgical repair with right infra-axillary thoracotomy for perimembranous ventricular septal defects. Interact Cardiovasc Thorac Surg, 2015, 20(4): 493-498.
19. Voitov A, Omelchenko A, Gorbatykh Y, et al. Outcomes of perventricular off-pump versus conventional closure of ventricular septal defects: a prospective randomized study. Eur J Cardiothorac Surg, 2017, 51(5): 980-986.
20. Xing Q, Wu Q, Shi L, et al. Minimally invasive transthoracic device closure of isolated ventricular septal defects without cardiopulmonary bypass: long-term follow-up results. J Thorac Cardiovasc Surg, 2015, 149(1): 257-264.
21. Liu H, Lu FX, Zhou J, et al. Minimally invasive perventricular versus open surgical ventricular septal defect closure in infants and children: a randomised clinical trial. Heart, 2018, 104(24): 2035-2043.
22. Tao K, Lin K, Shi Y, et al. Perventricular device closure of perimembranous ventricular septal defects in 61 young children: early and midterm follow-up results. J Thorac Cardiovasc Surg, 2010, 140(4): 864-870.
23. Zhu D, Lin K, Tang ML, et al. Midterm results of hybrid perventricular closure of doubly committed subarterial ventricular septal defects in pediatric patients. J Card Surg, 2014, 29(4): 546-553.
24. 陆国梁, 马伦超, 杨超, 等. 经胸微创室间隔缺损封堵术 142 例. 实用医学杂志, 2015, 31(8): 1294-1295.
25. 赵龙, 朱宪明, 刘志平, 等. 微创胸骨下段小切口室间隔缺损封堵术的临床分析. 中国心血管病研究, 2014, 12(1): 38-41.
26. Zeng XJ, Sun SQ, Chen XF, et al. Device closure of perimembranous ventricular septal defects with a minimally invasive technique in 12 patients. Ann Thorac Surg, 2008, 85(1): 192-194.
27. Ou-Yang WB, Wang SZ, Hu SS, et al. Perventricular device closure of perimembranous ventricular septal defect: effectiveness of symmetric and asymmetric occluders. Eur J Cardiothorac Surg, 2017, 51(3): 478-482.
28. Yang Y, Gao L, Xu X, et al. Echocardiographic assessment and guidance in minimally invasive surgical device closure of perimembranous ventricular septal defects. Heart Surg Forum, 2014, 17(4): E206-E211.
29. Sun Y, Zhu P, Zhou P, et al. Intra-operative device closure of perimembranous ventricular septal defect without cardiopulmonary bypass under guidance of trans-epicardial echocardiography: a single center experience. J Cardiothorac Surg, 2016, 11(1): 87.
30. Xu HS, Inamdar KY, Firoj KM, et al. Perventricular device closure of ventricular defects in 235 young children: a single-center experience. J Thorac Cardiovasc Surg, 2013, 146(6): 1551-1553.
31. Wang S, Zhuang Z, Zhang H, et al. Perventricular closure of perimembranous ventricular septal defects using the concentric occluder device. Pediatr Cardiol, 2014, 35(4): 580-586.
32. Chen Q, Hong ZN, Zhang GC, et al. Intraoperative device closure of isolated ventricular septal defects: experience on 1,090 cases. Ann Thorac Surg, 2018, 105(6): 1797-1802.
33. Lock J, Block P, McKay R, et al. Transcatheter closure of ventricular septal defects. Circulation, 1988, 78(2): 361-368.
34. Amin Z, Berry JM, Foker JE, et al. Intraoperative closure of muscular ventricular septal defect in a canine model and application of the technique in a baby. J Thorac Cardiovasc Surg, 1998, 115(6): 1374-1376.
35. Wells WJ. " The times they are a-changin’”. J Thorac Cardiovasc Surg, 2015, 149(1): 265-266.
36. Schreiber C. Editorial comment: Know-how transfer from east- to west-perventricular closure of perimembranous ventricular septal defects. Eur J Cardiothorac Surg, 2012, 42(5): 805-806.
37. Schreiber C, Vogt M, Kühn A, et al. Perventricular closure of a perimembranous VSD: treatment option in selected patients. Thorac Cardiovasc Surg, 2012, 60(1): 78-80.
38. Omelchenko AY, Zhuang Z, Schreiber C, et al. Surgical off-pump closure of perimembranous ventricular septal defects. Asian Cardiovasc Thorac Ann, 2014, 22(1): 31-35.
39. Yang L, Tai BC, Khin LW, et al. A systematic review on the efficacy and safety of transcatheter device closure of ventricular septal defects (VSD). J Interv Cardiol, 2014, 27(3): 260-272.
40. Liu L, Zhao TL, Yang YF, et al. Intraoperative device closure of subaortic ventricular septal defects. J Card Surg, 2013, 28(4): 456-460.
41. Gan C, An Q, Lin K, et al. Perventricular device closure of ventricular septal defects: six months results in 30 young children. Ann Thorac Surg, 2008, 86(1): 142-146.
42. Saurav A, Kaushik M, Mahesh Alla V, et al. Comparison of percutaneous device closure versus surgical closure of peri-membranous ventricular septal defects: A systematic review and meta-analysis. Catheter Cardiovasc Interv, 2015, 86(6): 1048-1056.
43. Yang J, Yang L, Wan Y, et al. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J, 2010, 31(18): 2238-2245.

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Effectiveness and safety of perventricular device closure in congenital perimembranous ventricular septal defects: A systematic review and meta-analysis

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