Factors in ProGlide® Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French

I-Ming Chen, Tsung-Hsing Lee, Po-Lin Chen, Chun-Che Shih, Hsiao-Hunag Chang

Research output: Contribution to journalArticlepeer-review

21 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)615-622
Number of pages8
JournalEuropean Journal of Vascular and Endovascular Surgery
Issue number4
Publication statusPublished - Oct 2019
Externally publishedYes


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