Active Versus Passive Anchoring Vascular Closure Devices Following Percutaneous Coronary Intervention: A Safety and Efficacy Comparative Analysis. - 2016

CONCLUSIONS: AngioSeal and Mynx appear to be equally safe and efficacious VCDs following PCI. The passive anchoring system may prove desirable as no intra-arterial anchor remains upon device removal.Copyright (c) 2015, Wiley Periodicals, Inc. METHODS: A total of 4,074 patients between 2008 and 2014, representing an era when both devices were available, were included. Thirty-two percent were acute coronary syndromes (37% STEMI). VCD choice was at the operator's discretion and included AngioSeal (n=2,910) or Mynx (1,164). Cardiogenic shock or patients receiving intra-aortic balloon pumps were excluded. Safety was assessed by vascular complications defined as either vascular injury (perforation, dissection, acute limb ischemia, arteriovenous fistula, pseudoaneurysm with thrombin injection, or surgical repair) or access-site bleed (hemoglobin droP >3g/dL requiring transfusion, retroperitoneal bleed, or hematoma >5cm, or the composite of both. Efficacy was evaluated by device failure and defined as inability to achieve immediate hemostasis or use of additional hemostatic mechanisms. Outcomes at 30-days were evaluated. OBJECTIVE: We evaluate the prevalence of complications and failure rates between the most commonly used "active" anchoring vascular closure device (VCD), AngioSealTM and the "passive" anchoring VCD, MynxTM, in all-comers undergoing percutaneous coronary intervention (PCI). RESULTS: Groups (AngioSeal vs Mynx) were fairly balanced with regards to bleeding risk factors of gender (male, 65% vs 66%), body mass index (30+/-6 vs 30+/-7), heart failure class III/IV (5% vs 6%), chronic kidney disease (15% vs 17%), use of glycoprotein IIb/IIIa inhibitor (5% vs 4%), or bivalirudin (86% vs 88%), all P >0.5. The AngioSeal group was slightly younger (64+/-12 vs 65+/-12, P<0.001) with less peripheral arterial disease (11.3% vs 13.9%, P=0.03), and increased 7F sheath use compared with Mynx (59% vs 22%, P<0.001). Safety and efficacy outcomes were similar between groups.


English

0896-4327


*Acute Coronary Syndrome/su [Surgery]
*Hemostasis, Surgical/is [Instrumentation]
*Percutaneous Coronary Intervention/ae [Adverse Effects]
*Postoperative Hemorrhage/su [Surgery]
*Vascular Closure Devices
Aged
Aneurysm, False/et [Etiology]
Aneurysm, False/pc [Prevention & Control]
Comparative Effectiveness Research
Female
Hemostasis, Surgical/mt [Methods]
Humans
Male
Middle Aged
Percutaneous Coronary Intervention/mt [Methods]
Risk Factors
Treatment Outcome
Vascular Closure Devices/ae [Adverse Effects]
Vascular Closure Devices/cl [Classification]


MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center
MedStar Washington Hospital Center


MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute
MedStar Heart Institute


Comparative Study
Journal Article