1. Randomized multicenter trial on percutaneous versus open access in endovascular aneurysm repair (PiERO).
- Author
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Vierhout BP, Pol RA, Ott MA, Pierie MEN, van Andringa de Kempenaer TMG, Hissink RJ, Wikkeling ORM, Bottema JT, Moumni ME, and Zeebregts CJ
- Subjects
- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Catheterization, Peripheral adverse effects, Female, Humans, Male, Middle Aged, Netherlands, Pain etiology, Pain prevention & control, Punctures, Risk Factors, Single-Blind Method, Surgical Wound Infection diagnosis, Surgical Wound Infection microbiology, Time Factors, Treatment Outcome, Wound Healing, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Catheterization, Peripheral instrumentation, Endovascular Procedures adverse effects, Femoral Artery, Surgical Wound Infection prevention & control, Vascular Access Devices
- Abstract
Background: In endovascular valve and aortic repair, vascular access through a percutaneous approach has become the competing technique to an open surgical approach. The effect on postoperative complications and surgical site infections (SSIs) has been investigated, but randomized evidence is lacking. The objective was to investigate whether percutaneous access of the common femoral artery (CFA) with a percutaneous closure device would decrease the number of SSIs compared with open surgical access of the CFA in endovascular aneurysm repair (EVAR)., Methods: Patients with an abdominal aortic aneurysm suitable for EVAR were randomized to open or percutaneous access of the main device (MD) through the CFA. Through the contralateral side, access was obtained with the other technique than the one for which the MD was randomized. The primary outcome was number of SSIs. Secondary outcomes were wound complications, visual analog scale for pain scores, and standardized wound assessment scores during follow-up. Preoperative screening culture and groin biopsy specimens were obtained from all patients., Results: Both groups contained 137 groins. SSI rate was 1.5% in the open group vs 0% in the percutaneous group. For MDs only, SSI rate was 3.1% (odds ratio, 3.3; 95% confidence interval, 0.31-347; P = .34). Wound complications were comparable in both groups. Neither nasal nor groin Staphylococcus aureus carriage had a significant effect on SSIs, Southampton Wound Assessment score, or visual analog scale score. Adjusted pain score was 0.69 lower, in favor of percutaneous access. Wound assessment was better after 2 weeks (odds ratio, 3.57; 95% confidence interval, 1.02-12.44; P = .046), also in favor of percutaneous access., Conclusions: Percutaneous access of the CFA does not reduce the number of SSIs. It does, however, reduce pain and improve wound healing with less inflammation 1 day and 2 weeks after EVAR, respectively., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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