Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures.

PURPOSE: A multitude of vascular closure devices (VCDs) are currently on the market for femoral arteriotomy closure after diagnostic and interventional angiography. Randomized, controlled trials (RCTs) comparing these devices to manual compression (MC) and their effect on time to hemostasis, time to ambulation, time to discharge, and immediate as well as long term complications have been studied. A systematic and through review of these evaluations and outcomes has not previously been performed.

MATERIALS AND METHODS: A systematic review was completed to include all available RCTs comparing vascular closure device use to manual compression. Devices meeting inclusion criteria were as follows: VasoSeal® (Datascope Corporation, Montvale, NJ), AngioSeal™ (Sherwood-Davis & Geck, St Louis, MO/St Jude Medical, St Paul, MN), ProGlide® (Abbott Vascular, Abbott Park, IL), ProStar® (Abbot Vascular, Menlo Park, CA), StarClose SE® (Abbott Vascular, Redwood City, CA), ExoSeal™ (Cordis, Warren, NJ), Boomerang™ Wire (Cardiva Medical, Mountainview, CA), FemoSeal™ (St Jude Medical Systems, Uppsala, Sweden), EVS™ (expanded vascular stapling, Angiolink Co, Taunton, MA), X-PRESS™ (X-Site Medical, Blue Bell, PA), Duett™ (Vascular Solutions, Minneapolis, MN), EpiClose-T® (CardioDex Ltd., Tirat Ha Carmel, Israel), and FISH™ (femoral introducer sheath and hemostasis, FISH Device, Bloomington, IN). Vascular closure devices were compared both to manual compression and across all devices used for the following outcomes: time to hemostasis, time to ambulation, time to discharge, and outcomes such as bleeding, hematoma, pseudoaneurysm, limb ischemia, and overall major and minor complications, as well as impact on quality of life, cost analysis, and trends over time. Both diagnostic and interventional procedures were included.

RESULTS: PUBMED and MEDLINE searches were carried out for VCDs identifying 1,363 articles. Manuscripts that included manual compression in the study numbered 176. Of these, 34 randomized controlled trials were included. Studies that met inclusion criteria were published from 1992-2015 and described a total of 14,401 patients, 5,659 patients undergoing MC, and 8,742 patients undergoing VCD placement. Overall, the rate of procedural success for VCD patients was 95.7%. The highest rate of unsuccessful device deployment was seen in the ExoSeal™ subset, which averaged 37.9% failure. The overall median time to hemostasis for manual compression was 22.9 minutes compared to VCDs at 5.95 minutes; FemoSeal™ had the shortest median time to hemostasis of 0.75 minutes. When comparing the type of procedure and its median time to hemostasis, MC versus VCD was 17 minutes versus 3.7 minutes for diagnostic procedures and 29.1 minutes versus 7.6 minutes for interventional procedures with similar sheath sizes at 6 and 7 French, respectively. Similarly, median time to ambulation for MC was eight hours compared to 3.5 hours for patients who received a VCD. Median time to discharge was similar at 1.6 days. However, time to discharge has diminished over the last decade comparing MC to VCD, with a median time to discharge of 3.1 versus 2.2 days compared to current trends at 0.8 versus 0.5 days, respectively. The overall rates of complications were similar between MC at 13.1% versus VCDs at 12.2% but varied significantly according to the VCD that was selected. For patients randomized to the vascular closure device who had undergone prior angioplasty, 94.4% of these patients preferred the use of VCD if a further angioplasty were to be performed in the future. A 13% reduction in overall costs with VCD was demonstrated due to earlier discharge and less required time with physician and nursing staff.

CONCLUSION: Overall, the review of 34 RCTs demonstrates the utility of VCDs has shortened time to hemostasis, ambulation, and discharge compared to patients receiving MC. Over the last decade, with emphasis on and implementation of same-day procedures, use of VCDs has resulted in a reduction in time to discharge to half a day and a significant decrease in cost. Overall complication rates are similar, but vary between different devices on the market. Better short-term quality of life has also been described with the use of VCDs compared to MC. Further clinical and financial improvements may be found as newer technological advances of VCDs become available.