Effectiveness and Safety of Bioabsorbable Anti-adhesive Pericardial Substitute to Eliminate Pericardial Adhesion: A Randomized Controlled Trial_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

WANGDe ,  LIShou-jun , GUOShao-xian , HUAZhong-dong , ZHANGHao

State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, P. R. China;

Corresponding author：

LIShou-jun, Email: drlishoujun@yahoo.com

Keywords：

Anti-adhesion; Multistage cardiac surgery; Absorbability; Pericardial substitute

DOI：

10.7507/1007-4848.20160227

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Objective To explore effectiveness and safety of bioabsorbable anti-adhesive pericardial substitute (GM042) to eliminate pericardial adhesion. Methods Eighty patients who were expected to undergo multistage cardiac surgery in three years were randomly divided into a trial group (40 patients) and a control group (40 patients). The mean age of the patients in the trial group was 1.79±1.72 years and 1.63±1.52 years in the control group. Finally, 73 patients were included with 36 patients (13 females and 23 males) in the trial group and 37 patients (20 males and 17 females) in the control group. The trial group used GM042 to fill the pericardium defect at the first surgery while the control group didn't. The manipuility, safety, and the anti-adhesive role of GM042 were evaluated. Results There was no significant difference in clinical indexes between at first surgery and six months after surgery in the trial group. There was no significant adverse event correlated to GM042. GM042 presented fine maneuverability during surgery. The adhesive score of the trial group was significantly lower than that of the control group (P<0.05). Adhesion score, pericardiac thickening, calcification, and visibility of heart surface structures were better in the trial group than those in the control group (P<0.05). Conclusion GM042 presented anti-adhesion effect and safety in cardiac surgery. Therefore, it's applicable to patients requiring re-operation.

Citation： WANG De, LI Shou-jun, GUO Shao-xian, HUA Zhong-dong, ZHANG Hao. Effectiveness and Safety of Bioabsorbable Anti-adhesive Pericardial Substitute to Eliminate Pericardial Adhesion: A Randomized Controlled Trial. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2016, 23(10): 944-948. doi: 10.7507/1007-4848.20160227 Copy

1.	张浩, 王德, 花中东, 等. 姑息性右心室肺动脉连接术在肺动脉闭锁合并室间隔缺损治疗中的应用. 中国胸心血管外科临床杂志, 2013, 20(2): 135-138.
2.	郭少先, 吕小东, 刘迎龙, 等. 改良Fontan手术治疗复杂先天性心脏病. 中国胸心血管外科临床杂志, 2007, 14(2): 89-92.
3.	O'Brien MF, Harrocks S, Clarke A, et al. How to do safe sternal reentry and the risk factors of redo cardiac surgery: A 21-year review with zero major cardiac injury. J Card Surg, 2002, 17(1): 4-13.
4.	Duncan DA, Yaacobi Y, Goldberg EP, et al. Prevention of postoperative pericardial adhesions with hydrophilic polymer solutions. J Surg Res, 1988, 45(1): 44-49.
5.	Loop FD. Catastrophic hemorrhage during sternal reentry. Ann Thorac Surg, 1984, 37(4): 271-272.
6.	Cannata A, Petrella D, Russo CF, et al. Postsurgical intrapericardial adhesions: Mechanisms of formation and prevention. Ann Thorac Surg, 2013, 95(5): 1818-1826.
7.	胡光柱, 罗丽娟, 郭家龙, 等. 心脏术后心包粘连形成的预防概况. 医学综述, 2012, 18(1): 76-79.
8.	Yoshioka I, Saiki Y, Sakuma K, et al. Bioabsorbable gelatin sheets latticed with polyglycolic acid can eliminate pericardial adhesion. Ann Thorac Surg, 2007, 84(3): 864-870.
9.	Matsumura G, Shin'oka T, Ikada Y, et al. Novel anti-adhesive pericardial substitute for multistage cardiac surgery. Asian Cardiovasc Thorac Ann, 2008, 16(4): 309-312.
10.	Heydorn W, Daniel J, Wade C. A new look at pericardial substitutes. J Thorac Cardiovasc Surg, 1987, 94(2): 291-296.
11.	Dobell AR, Jain AK. Catastrophic hemorrhage during redo sternotomy. Ann Thorac Surg, 1984, 37(4): 273-278.
12.	谭伟, 方海宁, 李树松, 等. 再次心脏手术对策分析. 中国现代手术学杂志, 2010, 14(5): 350-354.
13.	Sakuma K, Iguchi A, Ikada Y, et al. Closure of the pericardium using synthetic bioabsorbable polymers. Ann Thorac Surg, 2005, 80(5): 1835-1840.
14.	Laks H, Hammond G, Geha AS. Use of silicone rubber as a pericardial substitute to facilitate reoperation in cardiac surgery. J Thorac Cardiovasc Surg, 1981, 82(1): 88-92.
15.	Gallo JI, Pomar JL, Artinano E, et al. Heterologous pericardium for the closure of pericardial defects. Ann Thorac Surg, 1978, 26(2): 149-154.
16.	Wallwiener D, Meyer A, Bastert G. Adhesion formation of the parietal and visceral peritoneum: An explanation for the controversy on the use of autologous and alloplastic barriers? Fertil Steril, 1998, 69(1): 132-137.
17.	Lopes JB, Dallan LA, Campana-Filho SP, et al. Keratinocyte growth factor: A new mesothelial targeted therapy to reduce postoperative pericardial adhesions. Eur J Cardiothorac Surg, 2009, 35(2): 313-318.
18.	Shen J, Xu ZW. Combined application of acellular bovine pericardium and hyaluronic acid in prevention of postoperative pericardial adhesion. Artif Organs, 2014, 38(3): 224-230.
19.	Colak N, Nazli Y, Alpay MF, et al. Effect of topical n-acetylcysteine in the prevention of postoperative pericardial adhesion formation in a rabbit model. Cardiovasc Pathol, 2013, 22(5): 368-372.
20.	Bel A, Ricci M, Piquet J, et al. Prevention of postcardiopulmonary bypass pericardial adhesions by a new resorbable collagen membrane. Interact Cardiovasc Thorac Surg, 2012, 14(4): 469-473.

1. 张浩, 王德, 花中东, 等. 姑息性右心室肺动脉连接术在肺动脉闭锁合并室间隔缺损治疗中的应用. 中国胸心血管外科临床杂志, 2013, 20(2): 135-138.
2. 郭少先, 吕小东, 刘迎龙, 等. 改良Fontan手术治疗复杂先天性心脏病. 中国胸心血管外科临床杂志, 2007, 14(2): 89-92.
3. O'Brien MF, Harrocks S, Clarke A, et al. How to do safe sternal reentry and the risk factors of redo cardiac surgery: A 21-year review with zero major cardiac injury. J Card Surg, 2002, 17(1): 4-13.
4. Duncan DA, Yaacobi Y, Goldberg EP, et al. Prevention of postoperative pericardial adhesions with hydrophilic polymer solutions. J Surg Res, 1988, 45(1): 44-49.
5. Loop FD. Catastrophic hemorrhage during sternal reentry. Ann Thorac Surg, 1984, 37(4): 271-272.
6. Cannata A, Petrella D, Russo CF, et al. Postsurgical intrapericardial adhesions: Mechanisms of formation and prevention. Ann Thorac Surg, 2013, 95(5): 1818-1826.
7. 胡光柱, 罗丽娟, 郭家龙, 等. 心脏术后心包粘连形成的预防概况. 医学综述, 2012, 18(1): 76-79.
8. Yoshioka I, Saiki Y, Sakuma K, et al. Bioabsorbable gelatin sheets latticed with polyglycolic acid can eliminate pericardial adhesion. Ann Thorac Surg, 2007, 84(3): 864-870.
9. Matsumura G, Shin'oka T, Ikada Y, et al. Novel anti-adhesive pericardial substitute for multistage cardiac surgery. Asian Cardiovasc Thorac Ann, 2008, 16(4): 309-312.
10. Heydorn W, Daniel J, Wade C. A new look at pericardial substitutes. J Thorac Cardiovasc Surg, 1987, 94(2): 291-296.
11. Dobell AR, Jain AK. Catastrophic hemorrhage during redo sternotomy. Ann Thorac Surg, 1984, 37(4): 273-278.
12. 谭伟, 方海宁, 李树松, 等. 再次心脏手术对策分析. 中国现代手术学杂志, 2010, 14(5): 350-354.
13. Sakuma K, Iguchi A, Ikada Y, et al. Closure of the pericardium using synthetic bioabsorbable polymers. Ann Thorac Surg, 2005, 80(5): 1835-1840.
14. Laks H, Hammond G, Geha AS. Use of silicone rubber as a pericardial substitute to facilitate reoperation in cardiac surgery. J Thorac Cardiovasc Surg, 1981, 82(1): 88-92.
15. Gallo JI, Pomar JL, Artinano E, et al. Heterologous pericardium for the closure of pericardial defects. Ann Thorac Surg, 1978, 26(2): 149-154.
16. Wallwiener D, Meyer A, Bastert G. Adhesion formation of the parietal and visceral peritoneum: An explanation for the controversy on the use of autologous and alloplastic barriers? Fertil Steril, 1998, 69(1): 132-137.
17. Lopes JB, Dallan LA, Campana-Filho SP, et al. Keratinocyte growth factor: A new mesothelial targeted therapy to reduce postoperative pericardial adhesions. Eur J Cardiothorac Surg, 2009, 35(2): 313-318.
18. Shen J, Xu ZW. Combined application of acellular bovine pericardium and hyaluronic acid in prevention of postoperative pericardial adhesion. Artif Organs, 2014, 38(3): 224-230.
19. Colak N, Nazli Y, Alpay MF, et al. Effect of topical n-acetylcysteine in the prevention of postoperative pericardial adhesion formation in a rabbit model. Cardiovasc Pathol, 2013, 22(5): 368-372.
20. Bel A, Ricci M, Piquet J, et al. Prevention of postcardiopulmonary bypass pericardial adhesions by a new resorbable collagen membrane. Interact Cardiovasc Thorac Surg, 2012, 14(4): 469-473.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Effectiveness and Safety of Bioabsorbable Anti-adhesive Pericardial Substitute to Eliminate Pericardial Adhesion: A Randomized Controlled Trial

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