The application and progress of vascular closure devices_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

JIA Hao ,  LU Shuyang , SUN Yongxin , WANG Chunsheng

Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, P. R. China;

Corresponding author：

LU Shuyang, Email: lu.shuyang@zs-hospital.sh.cn

Keywords：

Vascular closure devices; peripheral vessels; minimally invasive; review

DOI：

10.7507/1007-4848.202204018

Video：

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Peripheral vascular path is an important approach for minimally invasive cardiovascular surgery and cardiovascular interventional diagnosis and treatment, and the treatment of the vascular approach after surgery is directly related to the postoperative braking time and comfort of patients. The traditional treatment methods mainly include compression fixation of puncture point or incision of skin to suture blood vessels, but the disadvantages such as long postoperative immobilization, potential vascular complications and patient discomfort are obvious. The application of vascular closure devices can reduce the shortcomings of traditional treatment methods, but different vascular closure devices have their characteristics and application scope, and improper application may lead to serious complications. This paper reviewed the information of several commonly used vascular closure device and relevant clinical research data in recent years, and introduced the characteristics, application and clinical effects of common vascular closure devices.

Citation： JIA Hao, LU Shuyang, SUN Yongxin, WANG Chunsheng. The application and progress of vascular closure devices. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(12): 1791-1796. doi: 10.7507/1007-4848.202204018 Copy

1.	魏来, 陈楠, 杨晔, 等. 2019年度中国微创心血管外科手术统计. 中国胸心血管外科临床杂志, 2021, 28(2): 149-153.
2.	Cooper MA, Hutfless S, Segev DL, et al. Hospital level under-utilization of minimally invasive surgery in the United States: Retrospective review. BMJ, 2014, 349: g4198.
3.	Beurtheret S, Karam N, Resseguier N, et al. Femoral versus nonfemoral peripheral access for transcatheter aortic valve replacement. J Am Coll Cardiol, 2019, 74(22): 2728-2739.
4.	Liu Z, Xu Y, Xu X, et al. Comparison of success rate and complications of totally percutaneous decannulation in patients with veno-arterial extracorporeal membrane oxygenation and endovascular aneurysm repair. Front Med (Lausanne), 2021, 8: 724427.
5.	Matta A, Canitrot R, Nader V, et al. Prevalence of posttranscatheter aortic valve implantation vascular complications in real life. J Interv Cardiol, 2021, 2021: 5563486.
6.	Yufa A, Mikael A, Gautier G, et al. Percutaneous axillary artery access for peripheral and complex endovascular interventions: Clinical outcomes and cost benefits. Ann Vasc Surg, 2022, 83: 176-183.
7.	Berti S, Bedogni F, Giordano A, et al. Efficacy and safety of ProGlide versus Prostar XL vascular closure devices in transcatheter aortic valve replacement: The RISPEVA Registry. J Am Heart Assoc, 2020, 9(21): e018042.
8.	Maniotis C, Andreou C, Karalis I, et al. A systematic review on the safety of Prostar XL versus ProGlide after TAVR and EVAR. Cardiovasc Revasc Med, 2017, 18(2): 145-150.
9.	Seeger J, Gonska B, Rodewald C, et al. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol, 2016, 223: 564-567.
10.	Barbash IM, Barbanti M, Webb J, et al. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. Eur Heart J, 2015, 36(47): 3370-3379.
11.	Gaba RC, Parvinian A, Trinos EM, et al. Safety and efficacy of StarClose SE vascular closure system in high-risk liver interventional oncology patients. J Vasc Access, 2012, 13(4): 415-420.
12.	刘丹丹, 陈龙. StarClose血管闭合器和股动脉压迫止血器对脑血管造影后股动脉穿刺止血效果的比较. 中国医疗器械信息, 2021, 27(14): 7-8, 102.
13.	Kim SH, Behnes M, Baron S, et al. Extravascular compared to intravascular femoral closure is associated with less bleeding and similar MACE after percutaneous coronary intervention. Int J Med Sci, 2019, 16(1): 43-50.
14.	Lucatelli P, Fanelli F, Cannavale A, et al. Angioseal VIP® vs. StarClose SE® closure devices: A comparative analysis in non-cardiological procedures. J Cardiovasc Surg (Torino), 2017, 58(1): 80-86.
15.	Shah SS, Perez G, Snelling BM, et al. Off-label use of the Angioseal vascular closure device for femoral arteriotomy: Retrospective analysis of safety and efficacy. J Neurointerv Surg, 2017, 9(10): 982-985.
16.	Abando A, Hood D, Weaver F, et al. The use of the Angioseal device for femoral artery closure. J Vasc Surg, 2004, 40(2): 287-290.
17.	Looby S, Keeling AN, McErlean A, et al. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol, 2008, 31(3): 558-562.
18.	Upponi SS, Ganeshan AG, Warakaulle DR, et al. Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures: A randomized controlled trial. Eur J Radiol, 2007, 61(2): 332-334.
19.	Kara K, Mahabadi AA, Rothe H, et al. Safety and effectiveness of a novel vascular closure device: A prospective study of the ExoSeal compared to the Angio-Seal and ProGlide. J Endovasc Ther, 2014, 21(6): 822-828.
20.	Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing compression, Perclose ProGlide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: The CAP trial. Catheter Cardiovasc Interv, 2008, 71(1): 1-5.
21.	Ko TY, Kao HL, Liu YJ, et al. Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol, 2019, 293: 76-79.
22.	Hermiller JB, Leimbach W, Gammon R, et al. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol, 2015, 27(3): 129-136.
23.	Dou E, Winokur RS, Sista AK. Venous access site closures using the VASCADE vascular closure system. J Vasc Interv Radiol, 2016, 27(12): 1885-1888.
24.	Tondelli TO, Winokur RS, Sista AK. Use of the VASCADE arterial closure device to achieve hemostasis after a deep venous procedure. J Vasc Interv Radiol, 2015, 26(9): 1409-1410.
25.	Postalian A, Krajcer Z. MANTA versus Perclose for large-bore vessel closure: The evidence continues to grow. Catheter Cardiovasc Interv, 2021, 98(3): 586-587.
26.	Al-Abcha A, Saleh Y, Halboni A, et al. Meta-analysis investigating the efficacy and safety of the MANTA versus ProGlide vascular closure devices after transcatheter aortic valve implantation. Am J Cardiol, 2022, 169: 151-154.
27.	Mahalwar G, Shariff M, Datla S, et al. Meta-analysis of ProGlide versus MANTA vascular closure devices for large-bore access site management. Indian Heart J, 2022, 74(3): 251-255.
28.	Kmiec L, Zerdzitzki M, Schmid C, et al. Evaluation of the MANTA vascular closure device in transfemoral TAVI. Thorac Cardiovasc Surg, 2023, 71(2):84-93.
29.	Ballı Ö, Çakır V, Coşkun M, et al. Implementation of the EXOSEAL vascular closure device in the transpopliteal arterial approach. J Vasc Interv Radiol, 2018, 29(8): 1180-1186.
30.	Ketterle J, Rittger H, Helmig I, et al. Comparison of Exo-Seal(®) and Angio-Seal (®) for arterial puncture site closure: A randomized, multicenter, single-blind trial. Herz, 2015, 40(5): 809-816.
31.	Scheinert D, Sievert H, Turco MA, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: Initial clinical results for Mynx. Catheter Cardiovasc Interv, 2007, 70(5): 627-633.
32.	Scott MC, Spencer HJ, Ali AT, et al. Mynx vascular closure device in arterial endovascular procedures. Ann Vasc Surg, 2018, 46: 112-117.
33.	Resnic FS, Majithia A, Marinac-Dabic D, et al. Registry-based prospective, active surveillance of medical-device safety. N Engl J Med, 2017, 376(6): 526-535.
34.	Noori VJ, Eldrup-Jørgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg, 2018, 68(3): 887-899.
35.	Heitzinger G, Brunner C, Koschatko S, et al. A real world 10-year experience with vascular closure devices and large-bore access in patients undergoing transfemoral transcatheter aortic valve implantation. Front Cardiovasc Med, 2022, 8: 791693.

1. 魏来, 陈楠, 杨晔, 等. 2019年度中国微创心血管外科手术统计. 中国胸心血管外科临床杂志, 2021, 28(2): 149-153.
2. Cooper MA, Hutfless S, Segev DL, et al. Hospital level under-utilization of minimally invasive surgery in the United States: Retrospective review. BMJ, 2014, 349: g4198.
3. Beurtheret S, Karam N, Resseguier N, et al. Femoral versus nonfemoral peripheral access for transcatheter aortic valve replacement. J Am Coll Cardiol, 2019, 74(22): 2728-2739.
4. Liu Z, Xu Y, Xu X, et al. Comparison of success rate and complications of totally percutaneous decannulation in patients with veno-arterial extracorporeal membrane oxygenation and endovascular aneurysm repair. Front Med (Lausanne), 2021, 8: 724427.
5. Matta A, Canitrot R, Nader V, et al. Prevalence of posttranscatheter aortic valve implantation vascular complications in real life. J Interv Cardiol, 2021, 2021: 5563486.
6. Yufa A, Mikael A, Gautier G, et al. Percutaneous axillary artery access for peripheral and complex endovascular interventions: Clinical outcomes and cost benefits. Ann Vasc Surg, 2022, 83: 176-183.
7. Berti S, Bedogni F, Giordano A, et al. Efficacy and safety of ProGlide versus Prostar XL vascular closure devices in transcatheter aortic valve replacement: The RISPEVA Registry. J Am Heart Assoc, 2020, 9(21): e018042.
8. Maniotis C, Andreou C, Karalis I, et al. A systematic review on the safety of Prostar XL versus ProGlide after TAVR and EVAR. Cardiovasc Revasc Med, 2017, 18(2): 145-150.
9. Seeger J, Gonska B, Rodewald C, et al. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol, 2016, 223: 564-567.
10. Barbash IM, Barbanti M, Webb J, et al. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. Eur Heart J, 2015, 36(47): 3370-3379.
11. Gaba RC, Parvinian A, Trinos EM, et al. Safety and efficacy of StarClose SE vascular closure system in high-risk liver interventional oncology patients. J Vasc Access, 2012, 13(4): 415-420.
12. 刘丹丹, 陈龙. StarClose血管闭合器和股动脉压迫止血器对脑血管造影后股动脉穿刺止血效果的比较. 中国医疗器械信息, 2021, 27(14): 7-8, 102.
13. Kim SH, Behnes M, Baron S, et al. Extravascular compared to intravascular femoral closure is associated with less bleeding and similar MACE after percutaneous coronary intervention. Int J Med Sci, 2019, 16(1): 43-50.
14. Lucatelli P, Fanelli F, Cannavale A, et al. Angioseal VIP® vs. StarClose SE® closure devices: A comparative analysis in non-cardiological procedures. J Cardiovasc Surg (Torino), 2017, 58(1): 80-86.
15. Shah SS, Perez G, Snelling BM, et al. Off-label use of the Angioseal vascular closure device for femoral arteriotomy: Retrospective analysis of safety and efficacy. J Neurointerv Surg, 2017, 9(10): 982-985.
16. Abando A, Hood D, Weaver F, et al. The use of the Angioseal device for femoral artery closure. J Vasc Surg, 2004, 40(2): 287-290.
17. Looby S, Keeling AN, McErlean A, et al. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol, 2008, 31(3): 558-562.
18. Upponi SS, Ganeshan AG, Warakaulle DR, et al. Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures: A randomized controlled trial. Eur J Radiol, 2007, 61(2): 332-334.
19. Kara K, Mahabadi AA, Rothe H, et al. Safety and effectiveness of a novel vascular closure device: A prospective study of the ExoSeal compared to the Angio-Seal and ProGlide. J Endovasc Ther, 2014, 21(6): 822-828.
20. Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing compression, Perclose ProGlide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: The CAP trial. Catheter Cardiovasc Interv, 2008, 71(1): 1-5.
21. Ko TY, Kao HL, Liu YJ, et al. Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol, 2019, 293: 76-79.
22. Hermiller JB, Leimbach W, Gammon R, et al. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol, 2015, 27(3): 129-136.
23. Dou E, Winokur RS, Sista AK. Venous access site closures using the VASCADE vascular closure system. J Vasc Interv Radiol, 2016, 27(12): 1885-1888.
24. Tondelli TO, Winokur RS, Sista AK. Use of the VASCADE arterial closure device to achieve hemostasis after a deep venous procedure. J Vasc Interv Radiol, 2015, 26(9): 1409-1410.
25. Postalian A, Krajcer Z. MANTA versus Perclose for large-bore vessel closure: The evidence continues to grow. Catheter Cardiovasc Interv, 2021, 98(3): 586-587.
26. Al-Abcha A, Saleh Y, Halboni A, et al. Meta-analysis investigating the efficacy and safety of the MANTA versus ProGlide vascular closure devices after transcatheter aortic valve implantation. Am J Cardiol, 2022, 169: 151-154.
27. Mahalwar G, Shariff M, Datla S, et al. Meta-analysis of ProGlide versus MANTA vascular closure devices for large-bore access site management. Indian Heart J, 2022, 74(3): 251-255.
28. Kmiec L, Zerdzitzki M, Schmid C, et al. Evaluation of the MANTA vascular closure device in transfemoral TAVI. Thorac Cardiovasc Surg, 2023, 71(2):84-93.
29. Ballı Ö, Çakır V, Coşkun M, et al. Implementation of the EXOSEAL vascular closure device in the transpopliteal arterial approach. J Vasc Interv Radiol, 2018, 29(8): 1180-1186.
30. Ketterle J, Rittger H, Helmig I, et al. Comparison of Exo-Seal(®) and Angio-Seal (®) for arterial puncture site closure: A randomized, multicenter, single-blind trial. Herz, 2015, 40(5): 809-816.
31. Scheinert D, Sievert H, Turco MA, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: Initial clinical results for Mynx. Catheter Cardiovasc Interv, 2007, 70(5): 627-633.
32. Scott MC, Spencer HJ, Ali AT, et al. Mynx vascular closure device in arterial endovascular procedures. Ann Vasc Surg, 2018, 46: 112-117.
33. Resnic FS, Majithia A, Marinac-Dabic D, et al. Registry-based prospective, active surveillance of medical-device safety. N Engl J Med, 2017, 376(6): 526-535.
34. Noori VJ, Eldrup-Jørgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg, 2018, 68(3): 887-899.
35. Heitzinger G, Brunner C, Koschatko S, et al. A real world 10-year experience with vascular closure devices and large-bore access in patients undergoing transfemoral transcatheter aortic valve implantation. Front Cardiovasc Med, 2022, 8: 791693.

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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

The application and progress of vascular closure devices

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