Clinical and Subclinical Femoral Vascular Complications after Deployment of two Different Vascular Closure Devices or Manual Compression in the Setting of Coronary Intervention

Abstract

Background: In the past two decades vascular closure devices (VCD) have been increasingly utilized as an alternative to manual compression after percutaneous femoral artery access. However, there is a lack of data confirming a significant reduction of vascular complication in a routine interventional setting. Systematic assessment of puncture sites with ultrasound was hardly performed.Methods: 620 consecutive patients undergoing elective or urgent percutaneous coronary intervention were randomly allocated to either Angioseal (AS; n = 210), or Starclose (SC; n = 196) or manual compression (MC; n = 214). As an adjunct to clinical evaluation vascular ultrasonography was used to assess the safety of each hemostatic method in terms of major and minor vascular complications. The efficacy of VCDs was assessed by achievement of puncture site hemostasis.Results: No major complications needing transfusion or vascular surgery were observed. Furthermore, the overall incidence of clinical and subclinical minor complications was similar among the three groups. There was no differences in the occurrence of pseudoaneurysmata (AS = 10; SC = 6; MC = 10), arteriovenous fistula (AS = 1; SC = 4; MC = 2) and large hematoma (AS = 11; SC = 10; MC = 14). The choice of access site treatment had no impact in the duration of hospital stay (AS = 6.7; SC = 7.4; MS = 6.4 days).Conclusions: In the setting of routine coronary intervention AS and SC provide a similar efficacy and safety as manual compression. Subclinical vascular injuries are rare and not related to VCD use.

Extravascular compared to Intravascular Femoral Closure is Associated with Less Bleeding and Similar MACE after Percutaneous Coronary Intervention

“…However, the intravascular VCD was significantly associated with a higher rate of surgical repair due to distal embolization of either the anchor footplate alone or in combination with thrombus compared to extravascular VCD (0.7% for AngioSeal™, 0.2% for StarClose SE®, p < 0.05). Yeni et al, however, found no significant differences of vascular and bleeding complications between intravascular and extravascular devices after PCI 32. Interestingly, a recent comparison of AngioSeal™ and StarClose SE® in non-cardiological procedures revealed also no statistically significant difference between both groups in terms of bleedings and time to hemostasis 33.…”

Vascular Closure Devices versus Manual Compression in Cardiac Interventional Procedures: Systematic Review and Meta-Analysis

“…Another evidence of the hemostasis efficacy of VCDs is the reduction of TTA, which directly determines patient satisfaction. After successful hemostasis, conventional MC requires patients to remain on bed rest for 6-12 hours depending on the operation type [ 39 , 50 , 56 ]. According to previous studies, back pain, inconvenient diet, dysuria, and difficult defecation were the main causes of patient discomfort during this long period [ 51 , 52 ].…”

Direct carotid exposure approach in the treatment of anterior circulation unruptured intracranial aneurysms for elderly patients

“…Closure devices themselves can also cause complications such as pseudoaneurysms and larger hematomas. 20,21 However, off-label use of a closure device after such procedures has been previously reported. 22,23 As already reported by Nii et al 4 and Doffer et al, 5 the percutaneous carotid approach is uncertain in hemostasis because the puncture site cannot be seen under direct vision as compared to DCEA.…”