A systematic review of vascular closure devices for femoral artery puncture sites.
Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter
Femoral Artery, Humans, Punctures, Vascular Closure Devices, Vascular Surgical Procedures
OBJECTIVE: The aim of this review was to provide an up-to-date summarization of available Food and Drug Administration-approved vascular closure devices (VCDs) and to analyze current evidence comparing individual devices with one another and with manual compression (MC). The review includes indications for use, advantages and disadvantages, safety and efficacy, and outcomes.
METHODS: A review of literature available on VCDs was conducted using PubMed and MEDLINE. Only clinical trials published within the last 10 years evaluating the efficacy of different VCDs with access obtained through common femoral artery or vein were included. All literature included in this review was published in English and used human participants.
RESULTS: The search strategy yielded 34 relevant articles. These studies included procedures ranging from diagnostic catheterizations to percutaneous endovascular aneurysm repair. There is considerable heterogeneity in the studies, with a wide variety of definitions and different outcome measures. The review demonstrated that VCDs provided improvement in the patients' comfort and satisfaction as well as in the time to hemostasis and ambulation. Most studies are underpowered to show differences, but even after meta-analysis or Cochrane review, complication rates as well as safety and efficacy between devices and MC remained comparable.
CONCLUSIONS: VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture.
Noori, Vincent J and Eldrup-Jørgensen, Jens, "A systematic review of vascular closure devices for femoral artery puncture sites." (2018). Maine Medical Center. 1372.