Efficacy and safety of Angio-Seal™ VIP vascular closure device compared to manual compression for access site hemostasis in patients who underwent antegrade common femoral artery puncture for popliteal and/or below the knee intervention

Abstract

Aim: Antegrade common femoral artery puncture has become the preferred method for popliteal and below-the-knee interventions. There has been an increasing use of vascular closure devices aimed at reducing hospital stays and enhancing patient comfort. This study aimed to evaluate the efficacy and safety of the Angio-Seal™ VIP vascular closure device compared to manual compression for access site sealing in patients with popliteal and/or below-the-knee disease who underwent antegrade common femoral artery puncture. Material and Methods: A total of 104 patients who underwent revascularization through antegrade common femoral artery puncture were randomly assigned to two groups based on the technique used for access site sealing: Angio-Seal™ VIP (n = 52) and manual compression (n = 52). The effectiveness of the two methods and the duration of hospitalization for both groups were analyzed. Complication rates were assessed during hospitalization and at a 3-month follow-up. Results: Successful access site hemostasis without complications was achieved in 48 of 52 patients (92.30%) in the Angio-Seal™ VIP group and in 47 of 52 patients (90.38%) in the manual compression group (p = 0.42). Major complication rates did not differ between the Angio-Seal™ VIP (3.84%) and manual compression groups (3.84%, p = 1.00). However, the duration of hospitalization was significantly shorter in the Angio-Seal™ VIP group (10.4 hours vs. 28.6 hours, p = 0.03). Conclusions: The Angio-Seal™ VIP device demonstrated safety and effectiveness comparable to manual compression for achieving hemostasis at the access site in patients undergoing antegrade common femoral artery puncture and was associated with a shorter duration of hospitalization.

Keywords

• vascular closure device
• antegrade
• femoral
• hemostasis

Angio-Seal™ VIP vasküler kapama cihazının, popliteal ve/veya diz altı müdahale için antegrad femoral arter ponksiyonu yapılan hastalarda girişim yeri hemostazı için etkililik ve güvenliği açısından manuel kompresyon ile karşılaştırılması

Abstract

Amaç: Antegrad femoral arter ponksiyonu, popliteal ve diz altı müdahaleler için tercih edilen yöntem haline gelmiştir. Hastanede kalış sürelerini azaltmayı ve hasta konforunu artırmayı amaçlayan vasküler kapatma cihazlarının kullanımı giderek artmaktadır. Bu çalışmanın amacı, popliteal ve/veya diz altı hastalığı olan ve antegrad femoral arter ponksiyonu yapılan hastalarda, girişim yeri hemostazının sağlanmasında, Angio-Seal™ VIP vasküler kapatma cihazının etkililiği ve güvenliğini manuel kompresyon ile karşılaştırmaktır. Gereç ve Yöntemler: Antegrad femoral arter ponksiyonu ile revaskülarizasyon yapılan toplam 104 hasta, girişim yeri kapatma tekniğine dayanarak rasgele iki gruba atanmıştır: Angio-Seal™ VIP (n = 52) ve manuel kompresyon (n = 52). Her iki grup için yöntemlerin etkinlikleri ve hastaların hastanede kalış süreleri analiz edilmiştir. Komplikasyon oranları, hastanede yatış süresince ve 3 aylık takipte değerlendirilmiştir. Bulgular: Angio-Seal™ VIP grubundaki 52 hastadan 48'inde (%92,30) komplikasyonsuz başarılı girişim yeri hemostazı sağlanmışken, manuel kompresyon grubundaki 52 hastadan 47'sinde (%90,38) bu başarı elde edilmiştir (p=0,42). Majör komplikasyon oranları Angio-Seal™ VIP (%3,84) ve manuel kompresyon grupları arasında (%3,84, p = 1,00) farklılık göstermemiştir. Ancak, hastanede kalış süresi Angio-Seal™ VIP grubunda belirgin şekilde daha kısa bulunmuştur (10,4 saate kıyasla 28,6 saat, p = 0,03). Sonuçlar: Angio-Seal™ VIP cihazı, antegrad femoral arter ponksiyonu yapılan hastaların girişim yerinde hemostaz sağlamada, manuel kompresyon ile karşılaştırılabilir güvenlik ve etkinlik göstermiş ve daha kısa hastanede kalış süresi ile ilişkili bulunmuştur.

Keywords

• vasküler kapatma cihazı
• antegrad
• femoral
• hemostaz

Supporting Institution

The authors received no financial support for the research and/or authorship of this article.

Ethical Statement

This study was approved by Izmir City Hospital Ethics Committee with protocol number 2024/178.

References

1. Kapoor B, Panu A, Berscheid B. Angio-seal in antegrade endovascular interventions: technical success and complications in a 55-patient series. J Endovasc Ther 2007; 14: 382-6.
2. Rimon U, Khaitovich B, Yakubovich D, Bensaid P, Golan G, Silverberg D. The Use of ExoSeal Vascular Closure Device for Direct Antegrade Superficial Femoral Artery Puncture Site Hemostasis. Cardiovasc Intervent Radiol 2015; 38: 560-4.
3. Tagliaferro FB, Orgera G, Mascagni L, Laurino F, Tipaldi MA, Cariati M et al. FemoSeal vascular closure device for antegrade common femoral artery access: Safety and technical notes. J Vasc Access 2019; 24: 1129729819854593.
4. Pruski MJ Jr, Blachut AM, Konkolewska M, Janas A, Hrycek E, Buszman PP et al. MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge. Vasc Endovascular Surg 2017; 51: 67-71.
5. Mukhopadhyay K, Puckett MA, Roobottom CA. Efficacy and complications of Angioseal in antegrade puncture. Eur J Radiol 2005; 56: 409-12.
6. Üçkan İ, Lafçı A, Göğüş N. Endovasküler prosedürlerde uygulanan anestezi yöntemlerinin intraoperatif ve postoperatif etkilerinin karşılaştırılması. Turk J Clin Lab 2020; 11: 262-9.
7. Cragg J, Lowry D, Hopkins J, Parker D, Kay M, Duddy M et al. Safety and Outcomes of Ipsilateral Antegrade Angioplasty for Femoropopliteal Disease. Vasc Endovascular Surg 2018; 52: 93-7.
8. Li Y, Esmail A, Donas KP, Pitoulias G, Torsello G, Bisdas T et al. Antegrade vs Crossover Femoral Artery Access in the Endovascular Treatment of Isolated Below-the-Knee Lesions in Patients With Critical Limb Ischemia. J Endovasc Ther 2017; 24: 331-6.

9. Amin FR, Yousufuddin M, Stbales R, Shamim Q, Al- Nasser FM, Coats AJS et al. Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the AngioSeal device vs. the FemoStop device. International Journal of Cardiology 2000; 76: 235-40.
10. Kurşaklioğlu H, Iyisoy A, Barçin C, Celik T, Nitzan R, Köse S, Amasyali B, Işik E. The experience with the Epiclose-T vascular access closure device: a human study. Anadolu Kardiyol Derg 2008; 8: 38-42.
11. Deuling JHH, Vermeulen RP, Anthonio RA, van den Heuvel AFM, Jaarsma T, Jessurun G et al. Closure of the femoral artery after cardiac catheterization: a comparison of AngioSeal, StarClose and manual compression. Catheterization and Cardiovascular Interventions 2008; 71: 518-23.
12. Martin JL, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M et al. A randomized trial comparing compression, PerClose ProGlideT M and AngioSeal VIPT M for arterial closure following percutaneous coronary intervention: the CAP trial. Catheterization and Cardiovascular Interventions 2008; 71: 1-5.
13. Shammas NW, Rajendran VR, Alldredge SG, Witcik WJ, Robken JA, Lewis JR et al. Randomized comparison of VasoSeal and AngioSeal closure devices in patients undergoing coronary angiography and angioplasty. Catheterization and Cardiovascular Interventions 2002; 55: 421-5.
14. Hermanides RS, Ottervanger JP, Dambrink JH, de Boer MJ, Hoorntje JC, Gosselink AT, et al. Closure device or manual compression in patients undergoing percutaneous coronary intervention: a randomized comparison. J Invas Cardiol 2010; 22: 562-6.
15. Minko P, Katoh M, Gräber S, Buecker A. Obesity: an independent risk factor for insufficient hemostasis using the AngioSeal vascular closure device after antegrade puncture. Cardiovasc Intervent Radiol 2012; 35: 775-8.
16. Looby S, Keeling AN, McErlean A, Given MF, Geoghegan T, Lee MJ. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol 2008; 31: 558-62.
17. Biondi-Zoccai GG, Fusaro M, Tashani A, Mollichelli N, Medda M, De Giacobbi G et al. Angioseal use after antegrade femoral arteriotomy in patients undergoing percutaneous revascularization for critical limb ischemia: a case series. Int J Cardiol 2007; 118:398-9.
18. Lupattelli T, Tannouri F, Garaci FG, Papa G, Pangos M, Somalvico F et al. Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther 2010; 17: 366-75.
19. Das R, Ahmed K, Athanasiou T, Morgan RA, Belli AM. Arterial Closure Devices Versus Manual Compression for Femoral Haemostasis in Interventional Radiological Procedures: A Systematic Review and Meta-Analysis. Cardiovasc Intervent Radiol 2010; 34: 723-38.
20. Upponi SS, Ganeshan AG, Warakaulle DR, Phillips-Hughes J, Boardman P, Uberoi R. Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures - A randomized controlled trial. Eur J Radiol 2007; 61: 332-4.
21. Chatzigeorgiadis P, Hellwig K, Almasi-Sperling V, Meyer A, Lang W, Rother U. Major vascular complications after transfemoral arterial closure system implantation: a single center study. Int Angiol 2020; 39: 139-44.
22. Cox T, Blair L, Huntington C, Lincourt A, Sing R, Heniford BT. Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures. Surg Technol Int 2015; 27: 32-44.