A multi-center, prospective, post-market registry to evaluate procedural outcomes using the cardiva medical VASCADE vascular closure system (VCS) for the management of the femoral arteriotomy after percutaneous endovascular procedures via antegrade access

Craig Walker, Stefan Kiesz, Barry Bertolet, David Weatherford, Pradeep K. Nair, Mehdi H. Shishehbor

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Objectives. The objective of the ANTEGRADE-PVD registry was to evaluate short-term outcomes when sealing antegrade femoral puncture sites with an extravascular site-closure system after peripheral endovascular procedures. Background. Peripheral vascular intervention via antegrade access is growing rapidly. Antegrade access has multiple advantages in treating critical peripheral arterial obstructions and is crucial in patients in whom retrograde contralateral access is contraindicated; however, this access is often shunned because of the risk of access-site complications. Methods. This registry was a multi-center, single-arm, post-market registry assessing the extravascular use of the VASCADE Vascular Closure System after antegrade femoral access for treatment of peripheral arterial disease. The primary efficacy outcome measure was time to hemostasis (TTH). Secondary efficacy outcome measures included time to ambulation (TTA) and time to discharge (TTD). Procedural outcomes and complications were assessed through hospital discharge and 30 ± 7 days. Results. A total of 52 patients were enrolled. Mean age was 66.7 ± 9.86 years, 33% of subjects were female, and mean body mass index was 28.3 ± 4.46 kg/m2. Procedural success rate was 98%. Mean TTH was 5.87 ± 2.44 minutes. Hemostasis after a mandatory 5-minute hold was achieved in <10 minutes in 92% of subjects without reversal of anticoagulants. Mean TTA was 4.94 ± 4.97 hours and 83% of subjects achieved ambulation in ≤5 hours. Mean TTD was 5.97 ± 5.85 hours with 88% of patients achieving discharge in ≤8 hours. The major complication rate was 1.9% and minor complication rate was 1.9%. Conclusion. This study confirms safe and effective performance of the VASCADE VCS device when used in antegrade femoral access.

Original languageEnglish (US)
Pages (from-to)E102-E107
JournalVascular Disease Management
Volume15
Issue number9
StatePublished - Sep 2018
Externally publishedYes

Keywords

  • Access
  • Antegrade
  • Closure
  • PAD

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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