OBJECTIVES: The ProGlide® vascular closure device (Abbott Vascular, Redwood City, CA, USA) is approved for the closure of arterial punctures (typically 5-21 Fr sheath; maximum outer diameter, 26 Fr). However, a failure rate of about 2-8% is reported. This study was conducted to analyse factors predisposing to failure when the devices were used for the closure of large hole (16-26 Fr) arteriotomies, and to determine the predictive cut off values of predisposing factors. METHODS: In this retrospective study, the ProGlide® device was used to achieve vascular access site closure in 458 patients undergoing repair of abdominal aortic aneurysm, thoracic aortic aneurysm, type B aortic dissection, or transcatheter aortic valve implantation. The primary endpoint was device failure, defined as inability to achieve common femoral artery (CFA) closure; successful repair, development of acute lower limb ischaemia and haemodynamic compromise; or delayed pseudoaneurysm formation during the follow up period, requiring open repair. RESULTS: Overall, ProGlide® failure occurred in 7.6% of cases. Factors that predisposed to failure included a history of peripheral arterial disease (PAD) (p < .001), the presence of CFA calcification (p < .001), the depth of the skin puncture site ≥ 33 mm (p < .001), body mass index (BMI) of ≥28.7 kg/m2 (p < .001), and use of sheath size ≥ 19 Fr (p < .001). CONCLUSION: Factors such as BMI, history of PAD, the presence of CFA calcification, the depth of the skin puncture site, and sheath size are significantly associated with ProGlide® failure. Hence, careful patient and device selection and operating procedure are paramount to achieve successful outcomes.
|頁（從 - 到）||615-622|
|期刊||European Journal of Vascular and Endovascular Surgery|
|出版狀態||已發佈 - 十月 2019|
Chen, I-M., Lee, T-H., Chen, P-L., Shih, C-C., & Chang, H-H. (2019). Factors in ProGlide® Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French. European Journal of Vascular and Endovascular Surgery, 58(4), 615-622. https://doi.org/10.1016/j.ejvs.2019.03.037