MethodsManagement of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device
Section snippets
Methods
A suture-mediated closure device for percutaneous use was compared with manual compression in order to achieve hemostasis at the femoral access site. The device incorporated 2 components: a sheath holding 1 or 2 pairs of needles connected by a suture loop, and a rotating barrel used to facilitate the positioning of the device before needle deployment and to guide the needles during their travel through the subcutaneous tract. The number of needles was related to the device size. The 6Fr device
Results
Between April and September 1996, 600 patients were enrolled in the study. Data analysis of the study end points was possible on 590 patients (98% of data). The patient population consisted of 189 interventional cases and 401 patients undergoing diagnostic catheterization procedure. The demographics of the 2 treatment groups were comparable and representative of the overall population undergoing catheterization procedures at our institution. There was no difference between the 2 groups
Discussion
We report a pilot study (registry) of >1,000 patients undergoing percutaneous vascular suture with the Techstar and the Prostar suture device between June 1995 and February 1996,9, 10 with high success and low complications. In this randomized, prospective study we could demonstrate a high device success rate (94.3%) after elective coronary angiography and coronary interventions, with a low local complication rate associated with suturing device closure compared with manual compression (device
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Cited by (119)
Risk Factors for Closure Failure following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation
2020, Annals of Vascular SurgeryFemoSeal<sup>®</sup> Device Use for Femoral Artery Closure by Different Techniques
2018, Annals of Vascular SurgeryImpact of closure devices on vascular complication and mortality rates in TAVI procedures
2017, International Journal of CardiologyFemoral arterial closure using ProGlide® is more efficacious and cost-effective when ambulating early following cardiac catheterization
2016, IJC Heart and VasculatureCitation Excerpt :Instead we sought to thoroughly evaluate the efficiency of ProGlide-mediated femoral artery closure in terms of safe, early TTA and TTD and further assess patient experience and the economic value of each hemostasis strategy. Previous prospective trials evaluating the safety of VCDs versus manual compression during invasive cardiac procedures reported similar procedural success and complication rates [15,17,21–24]. However, to our knowledge this is the first prospective study using a Perclose VCD to clearly demonstrate the safety of early ambulation (within 30 min) following any type of cardiac catheterization.
Quality improvement guidelines for vascular access and closure device use
2014, Journal of Vascular and Interventional RadiologyCitation Excerpt :The most commonly occurring complication was arterial occlusion of the femoral artery at the puncture site (47), possibly caused by arterial luminal narrowing or foreign body reaction caused by the intraarterial anchor. The rate of occlusion for the Angio-Seal device is comparable to those of other VCDs, including non–collagen-based devices (13,15,17,49). As the Angio-Seal device relies on a bioabsorbable intravascular anchor, distal embolization of this retained component is a potential risk.
Arterial thrombosis after using angio-seal
2011, Annals of Vascular Surgery