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

Öz

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.

Anahtar Kelimeler

• 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

Öz

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.

Anahtar Kelimeler

• vasküler kapatma cihazı
• antegrad
• femoral
• hemostaz

Destekleyen Kurum

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

Etik Beyan

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

Kaynakça

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