Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™".
Bypass surgery
Great saphenous vein bypass
Infrainguinal bypass
Non-reversed bypass
Valvulotomy
Journal
Langenbeck's archives of surgery
ISSN: 1435-2451
Titre abrégé: Langenbecks Arch Surg
Pays: Germany
ID NLM: 9808285
Informations de publication
Date de publication:
30 Nov 2023
30 Nov 2023
Historique:
received:
27
09
2023
accepted:
19
11
2023
medline:
1
12
2023
pubmed:
30
11
2023
entrez:
29
11
2023
Statut:
epublish
Résumé
To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46-91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20-70 cm) with a median diameter of 5.0 mm (range 3-6 mm) and 4.0 mm (range 2-6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD.
Identifiants
pubmed: 38030864
doi: 10.1007/s00423-023-03189-5
pii: 10.1007/s00423-023-03189-5
pmc: PMC10687093
doi:
Types de publication
Observational Study
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
449Investigateurs
E Weigang
(E)
J Kemke
(J)
D Branzan
(D)
M Wilhelmi
(M)
S Classen
(S)
K Pfister
(K)
M Kuhnert
(M)
S Seifert
(S)
W Derwich
(W)
K Stavroulakis
(K)
Informations de copyright
© 2023. The Author(s).
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