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

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Citation: Journal of Interventional Cardiology. 29(1):108-12, 2016 Feb.PMID: 26728544Institution: 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 CenterDepartment: 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 InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal ArticleSubject headings: *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]Year: 2016ISSN:
  • 0896-4327
Name of journal: Journal of interventional cardiologyAbstract: 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.All authors: Baker NC, Escarcega RO, Kiramijyan S, Koifman E, Lipinski MJ, Magalhaes MA, Negi SI, Torguson R, Waksman RFiscal year: 2016Digital Object Identifier: Date added to catalog: 2017-03-06
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Journal Article MedStar Authors Catalog Article 26728544 Available 26728544

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.

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