Randomized comparison of vasoseal and angioseal closure devices in patients undergoing coronary angiography and angioplasty

Abstract

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.

Safety and efficacy of the Perclose suture-mediated closure device following carotid artery stenting under clopidogrel platelet blockade

“…In the STAND II trial [14] a median time to hemostasis of 19 min was reported using the Perclose device vs 243 min using manual compression after coronary angiography. Shammas et al reported a time to hemostasis of 20 min on average using VasoSeal and AngioSeal [11]. The reasons for this discrepancy, particularly between the STAND II trial and our report, are not evident.…”

“…Regarding the aggressive anticoagulation therapy and the modern platelet inhibition therapy, Cura et al achieved a technical success rate of 93.6% in patients treated with glycoprotein IIb-IIIa receptor antagonists [15]. Deployment failure of AngioSeal and VasoSeal has been reported higher in up to 7.7 and 5.2% of cases, respectively [11], which indicates a slight advantage for using the Perclose devices. The success rate of manual compression is obviously high and is reported to be approximately 98.9% in the literature [14].…”

Safety and efficacy of femoral artery closure with the FemoSeal® device after coronary angiography using a 7 French sheath

“…As myriad previous studies clearly demonstrated shorter times to hemostasis with different femoral closure devices compared to manual/ mechanical compression 13 , we decided not to include a control group treated with manual compression [14][15][16][17][18][19] . Given the inconsistent data in regard to possible differences in time to hemostasis between diagnostic and interventional procedures 16,20,21 , we observed no such difference in time to hemostasis in our study. This is in accordance with previous reports for the FemoSeal® system for the closure of smaller arterial puncture sites and might be interpreted as an additional safety aspect.…”

The clinical effectiveness of length of bed rest for patients recovering from trans-femoral diagnostic cardiac catheterisation

“…Advancement in technology over the past decade has seen the introduction of vascular closure devices 14,30 to minimise bleeding and haematoma formation and allow early ambulation. However, this method of active closure has not been widely adopted.…”