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Efficacy and Safety of Augmenting the Preclose Technique with a Collagen-Based Closure Device for Percutaneous Endovascular Aneurysm Repair

  • Clinical Investigation
  • Published:
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Abstract

Purpose

To report our experience of selectively augmenting the preclose technique for percutaneous endovascular aneurysm repair (p-EVAR) with an Angio-Seal device as a haemostatic adjunct in cases of significant bleeding after tensioning the sutures of the suture-mediated closure devices.

Materials and Methods

Prospectively collected data for p-EVAR patients at our institute were analysed. Outcomes included technical success and access site complications. A logistic regression model was used to analyse the effects of sheath size, CFA features and stent graft type on primary failure of the preclose technique necessitating augmentation and also on the development of complications.

Results

p-EVAR was attempted via 122 CFA access sites with a median sheath size of 18-French (range 12- to 28-French). Primary success of the preclose technique was 75.4 % (92/122). Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5 % (25/122). The overall p-EVAR success rate was 95.1 % (116/122). There was a statistically significant relationship (p = 0.0093) between depth of CFA and primary failure of preclose technique. CFA diameter, calcification, type of stent graft and sheath size did not have significant effects on primary preclose technique failure. Overall 4.9 % (6/122) required surgical conversion but otherwise there were no major complications.

Conclusion

Augmentation with an Angio-Seal device is a safe and effective adjunct to increase the success rate of the preclose technique in p-EVAR.

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Conflict of interest

The authors declare that they have no conflict of interest.

Statement of Informed Consent

Informed consent was obtained from all the patients included in this report.

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Corresponding author

Correspondence to Rafiuddin Patel.

Appendices

Appendix

Society of Interventional Radiology Clinical Practice Guidelines classification of complications by outcome [15].

Minor Complications

  1. A.

    No therapy, no consequence

  2. B.

    Nominal therapy, no consequence; includes overnight admission (less then 23 h) for observation only

Major Complications

  1. A.

    Require therapy, minor hospitalisation (more then 24 h but less then 48 h)

  2. B.

    Require major therapy, unplanned increase in level of care, prolonged hospitalisation (more then 48 h)

  3. C.

    Cause permanent adverse sequelae

  4. D.

    Result in death.

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Patel, R., Juszczak, M.T., Bratby, M.J. et al. Efficacy and Safety of Augmenting the Preclose Technique with a Collagen-Based Closure Device for Percutaneous Endovascular Aneurysm Repair. Cardiovasc Intervent Radiol 38, 821–826 (2015). https://doi.org/10.1007/s00270-014-1004-0

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  • DOI: https://doi.org/10.1007/s00270-014-1004-0

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