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™"
- PMID: 38030864
- PMCID: PMC10687093
- DOI: 10.1007/s00423-023-03189-5
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™"
Abstract
Purpose: 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.
Methods: 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.
Results: 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).
Conclusion: 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.
Keywords: Bypass surgery; Great saphenous vein bypass; Infrainguinal bypass; Non-reversed bypass; Valvulotomy.
© 2023. The Author(s).
Conflict of interest statement
The authors declare no competing interests.
Figures
![Fig. 1](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10687093/bin/423_2023_3189_Fig1_HTML.gif)
![Fig. 2](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10687093/bin/423_2023_3189_Fig2_HTML.gif)
Similar articles
-
Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry.Vascular. 2021 Aug;29(4):589-596. doi: 10.1177/1708538120966126. Epub 2020 Oct 22. Vascular. 2021. PMID: 33090947
-
Technical factors in lower-extremity vein bypass surgery: how can we improve outcomes?Semin Vasc Surg. 2009 Dec;22(4):227-33. doi: 10.1053/j.semvascsurg.2009.10.004. Semin Vasc Surg. 2009. PMID: 20006802 Review.
-
Intraoperative duplex monitoring of infrainguinal vein bypass procedures.J Vasc Surg. 2000 Apr;31(4):678-90. doi: 10.1067/mva.2000.104420. J Vasc Surg. 2000. PMID: 10753275
-
Infrainguinal arterial reconstruction with non-reversed autologous vein after angioscopy guided valvulotomy ex situ.Eur J Vasc Endovasc Surg. 1995 Aug;10(2):211-4. doi: 10.1016/s1078-5884(05)80114-5. Eur J Vasc Endovasc Surg. 1995. PMID: 7655974
-
Femoral-distal bypass with in situ greater saphenous vein. Long-term results using the Mills valvulotome.Ann Surg. 1991 May;213(5):457-64; discussion 464-5. doi: 10.1097/00000658-199105000-00011. Ann Surg. 1991. PMID: 2025066 Free PMC article. Review.
References
-
- Farber A et al (2022) Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med 387(25):2305–2316 - PubMed
-
- Stierli P, et al. Angioscopy guided in situ bypass versus angioscopy guided non reversed bypass for infrainguinal arterial reconstructions. A comparison of outcome. J Cardiovasc Surg (Torino) 1995;36(3):211–7. - PubMed
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources