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 journalArticle

1 Citation (Scopus)

Abstract

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
Volume58
Issue number4
DOIs
Publication statusPublished - Oct 2019
Externally publishedYes

Fingerprint

Femoral Artery
Punctures
Equipment Failure
Blood Vessels
Peripheral Arterial Disease
Causality
Body Mass Index
Sequoia
Thoracic Aortic Aneurysm
Equipment and Supplies
Skin
False Aneurysm
Abdominal Aortic Aneurysm
Patient Selection
Statistical Factor Analysis
Dissection
Lower Extremity
Ischemia
Retrospective Studies
Hemodynamics

Cite this

Factors in ProGlide® Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French. / Chen, I-Ming; Lee, Tsung-Hsing; Chen, Po-Lin; Shih, Chun-Che; Chang, Hsiao-Hunag.

In: European Journal of Vascular and Endovascular Surgery, Vol. 58, No. 4, 10.2019, p. 615-622.

Research output: Contribution to journalArticle

Chen, I-Ming ; Lee, Tsung-Hsing ; Chen, Po-Lin ; Shih, Chun-Che ; Chang, Hsiao-Hunag. / Factors in ProGlide® Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French. In: European Journal of Vascular and Endovascular Surgery. 2019 ; Vol. 58, No. 4. pp. 615-622.
@article{83523a14b34b4abbbe61b7be419410a8,
title = "Factors in ProGlide{\circledR} Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French",
abstract = "OBJECTIVES: The ProGlide{\circledR} 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{\circledR} 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{\circledR} 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{\circledR} failure. Hence, careful patient and device selection and operating procedure are paramount to achieve successful outcomes.",
author = "I-Ming Chen and Tsung-Hsing Lee and Po-Lin Chen and Chun-Che Shih and Hsiao-Hunag Chang",
note = "Copyright {\circledC} 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.",
year = "2019",
month = "10",
doi = "10.1016/j.ejvs.2019.03.037",
language = "English",
volume = "58",
pages = "615--622",
journal = "European Journal of Vascular and Endovascular Surgery",
issn = "1078-5884",
publisher = "W.B. Saunders Ltd",
number = "4",

}

TY - JOUR

T1 - Factors in ProGlide® Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French

AU - Chen, I-Ming

AU - Lee, Tsung-Hsing

AU - Chen, Po-Lin

AU - Shih, Chun-Che

AU - Chang, Hsiao-Hunag

N1 - Copyright © 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

PY - 2019/10

Y1 - 2019/10

N2 - 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.

AB - 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.

U2 - 10.1016/j.ejvs.2019.03.037

DO - 10.1016/j.ejvs.2019.03.037

M3 - Article

C2 - 31500989

VL - 58

SP - 615

EP - 622

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

SN - 1078-5884

IS - 4

ER -