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Adherence to instruction for use after endovascular repair of popliteal artery aneurysm

Wrede, Axel LU ; Lehti, Leena LU ; Eiberg, Jonas Peter LU and Acosta, Stefan LU orcid (2022) In Vascular 30(2). p.276-284
Abstract

Objectives: Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. Methods: The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. Results: The two groups of patients treated within (n = 10) and not within... (More)

Objectives: Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. Methods: The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. Results: The two groups of patients treated within (n = 10) and not within (n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome. Forty-five patients (81.8%) received stent graft placement with at least one deviation according to IFU. Distal oversizing >20% was the most frequent deviation against IFU (n = 22, 40.0%). Primary patency at one year was 72%. Diameter size difference >1 mm between overlapping stent grafts (6/14 [43%], p = 0.013) and renal insufficiency (5/12 [42%], p = 0.0086) were associated with lower primary patency at one year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95% CI 1.17–2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95% CI 1.018–2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. Conclusion: The majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference >1 mm between overlapping stent grafts was associated with a higher loss of primary patency at one year. Multi-center studies with larger sample size and long-term follow up of patency are warranted.

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author
; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
endovascular repair, Gore Viabahn® Endoprosthesis, Instructions For Use, Popliteal artery aneurysm, stent graft patency
in
Vascular
volume
30
issue
2
pages
276 - 284
publisher
BC Decker
external identifiers
  • pmid:33874806
  • scopus:85104779696
ISSN
1708-5381
DOI
10.1177/17085381211007312
project
Open and endovascular surgery for popliteal artery aneurysm
language
English
LU publication?
yes
id
91f913e4-423d-48d6-b363-679e2573f6fd
date added to LUP
2021-05-11 15:54:03
date last changed
2024-06-29 12:13:20
@article{91f913e4-423d-48d6-b363-679e2573f6fd,
  abstract     = {{<p>Objectives: Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. Methods: The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. Results: The two groups of patients treated within (n = 10) and not within (n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome. Forty-five patients (81.8%) received stent graft placement with at least one deviation according to IFU. Distal oversizing &gt;20% was the most frequent deviation against IFU (n = 22, 40.0%). Primary patency at one year was 72%. Diameter size difference &gt;1 mm between overlapping stent grafts (6/14 [43%], p = 0.013) and renal insufficiency (5/12 [42%], p = 0.0086) were associated with lower primary patency at one year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95% CI 1.17–2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95% CI 1.018–2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. Conclusion: The majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference &gt;1 mm between overlapping stent grafts was associated with a higher loss of primary patency at one year. Multi-center studies with larger sample size and long-term follow up of patency are warranted.</p>}},
  author       = {{Wrede, Axel and Lehti, Leena and Eiberg, Jonas Peter and Acosta, Stefan}},
  issn         = {{1708-5381}},
  keywords     = {{endovascular repair; Gore Viabahn® Endoprosthesis; Instructions For Use; Popliteal artery aneurysm; stent graft patency}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{276--284}},
  publisher    = {{BC Decker}},
  series       = {{Vascular}},
  title        = {{Adherence to instruction for use after endovascular repair of popliteal artery aneurysm}},
  url          = {{http://dx.doi.org/10.1177/17085381211007312}},
  doi          = {{10.1177/17085381211007312}},
  volume       = {{30}},
  year         = {{2022}},
}