Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices

Abstract

In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011

“…[5][6][7]45 In addition, the current results support previous studies demonstrating VCDs to be of greater value in patients receiving anticoagulant agents by reducing bleeding complications. [23][24][25][26][27][28] Conversely, although VCDs have been associated with life-threatening complications, 21,[30][31][32][33][34][35] this study did not demonstrate any signal of an adverse mortality impact in any of the prespecified subgroups, and indeed showed a more pronounced effect in the higher-risk groups, with the exception of cardiogenic shock where the effect was neutral.…”

“…Historically manual compression, including the use of femoral clamps, has remained the gold standard for achieving femoral arterial hemostasis, 43,44 and despite >20 years of use of VCDs, their safety remains controversial. 21,[30][31][32][33][34][35] Adding to this field is the reported outcomes of VCDs during a 5-year period in a population-based study from the BCIS database. Strikingly, it was shown that VCDs were systematically implanted in lower-risk subjects.…”

“…[17][18][19][20][21][22] Although evidence has accrued that VCDs (compared with manual compression) may be of greater value in higher-risk subjects-such as those receiving anticoagulant agents-in terms of reducing bleeding complications, [23][24][25][26][27][28][29] with 1 population-based study (US CathPCI registry, n=1 819 611) 29 associating the most frequently used VCDs with a substantial reduction in bleeding and vascular complications, this has proven to be controversial, particularly because VCDs in themselves have been associated with life-threatening complications. 21,[30][31][32][33][34][35][36] Consequently, the 2010 American Heart Association guidelines give a class IIa recommendation for VCD (reasonable to perform the procedure) to achieve faster hemostasis and improve patient comfort and a class III recommendation (procedure should not be performed because it is not helpful and may be harmful) when used with the intent to reduce vascular complications. 37 Given the potential association of VCDs with a reduction in vascular-related complications, [23][24][25][26][27][28][29] it is hypothesized that the uniform use of VCD in femoral-based PCI may confer a potential short-term mortality benefit compared with manual pressure, particularly in higher-risk subjects such as those with acute coronary syndrome or receiving more potent anticoagulant therapy.…”

Control of local haemostasis with the AngioSeal® vascular closure device in peripheral endovascular interventions via 6-9 F femoral artery access

“…In one of the studies there was a tendency towards higher frequency of local complications in female patients, which was probably related to the lower diameter of the femoral artery in comparison to male patients [19]. Retrospective series by Assali et al [20] and Dangas et al [21] suggested a higher frequency of local complications after coronary interventions in patients who received vascular closure devices (including the AngioSeal ® device) in comparison to patients who had a compression dressing, but the number of patients with the AngioSeal ® device was approximately 4-fold [20] or even over 13-fold [21] lower than patients with conventional haemostasis. Also, implantation of the AngioSeal ® device was not routinelly preceded in by angiography of the ipsilateral femoral artery.…”

Outpatient percutaneous coronary intervention: Ready for prime time?

“…Some authors using the femoral access and closure devices have described preliminary experience to accelerate ambulation time to discharge patients on the same day (21,30,38). It should be realized that closure devices have not been demonstrated to lower the risk of vascular complications compared with manual compression (39). In that regard, the radial approach offers distinct advantages because it allows immediate ambulation, rapid hemostasis and clearly reduces access site complications and bleeding compared with the femoral approach (40).…”