Initial experience with minimally invasive in situ bypass procedure with blind valvulotomy

Gangadharan, Sidhu P.; Reed, Amy B.; Chew, David K.; Conte, Michael S.; Belkin, Michael; Whittemore, Anthony D.; Donaldson, Magruder C.

doi:10.1067/mva.2002.123325

Cited by 5 publications

(5 citation statements)

References 27 publications

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“…Malmstedt detected 26.2% incompletely disrupted valves of 61 inspected valves in total when using a comparable valvulotome. Furthermore, the quantity of grafts with remained valves in this study corresponds to a similar result from Gangadharan et al with remained valves in 3 of 37 cases (8.1%) [ 10 ].…”

Section: Discussionsupporting

confidence: 90%

“…There is a need for more data regarding this topic, as insufficiently disrupted valves still pose a common problem during vein bypass surgery which can negatively influence this approach [ 6 , 7 ]. Safety, efficacy, as well as effectiveness, are reported in a small number of reports and different settings (minimally invasive, Hydro-Valvulotome), mostly during in situ bypass surgeries [ 8 – 10 ]. Evidence concerning safety and efficacy during valvulotomy, including the AndraValvulotome™, in bypass surgery is still lacking and must be improved.…”

Section: Introductionmentioning

confidence: 99%

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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™”

Souri,

Liebetrau,

Hyhlik-Dürr

et al. 2023

Langenbecks Arch Surg

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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.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

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™”

Souri,

Liebetrau,

Hyhlik-Dürr

et al. 2023

Langenbecks Arch Surg

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“…In 10 patients (24%), in situ greater saphenous vein (GSV) grafts were used with a limited incision approach with blind valvulotomy as reported previously by our group. 29 Three patients had bilateral grafts, which were both included in the study and analyzed as independent data points. Pooled results from all 41 grafts studied are presented in Table II.…”

Section: Resultsmentioning

confidence: 99%

Early adaptation of human lower extremity vein grafts: wall stiffness changes accompany geometric remodeling

Jacot

Abdullah

Belkin

et al. 2004

Journal of Vascular Surgery

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“…Another closed method to avoid a long skin incision is endovascular visualization of the saphenous vein. This locates vein branches, which are then clipped or cauterized [21,22]. A third method is an angioscopically assisted technique, which allows valvulotomy and occlusion of the venous branches by coil delivery within the vein [23][24][25].…”

Section: Closed Techniquementioning

confidence: 99%

In Situ Saphenous Vein Bypass—Forty Years Later

Connolly

2005

World j. surg.

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In situ saphenous vein bypass, which was performed first by Rob in 1959, but introduced by Hall in 1962, has been widely applied as an alternative to the reversed bypass. Now, forty years later, it seems appropriate to review its current place and technique. Of the presumed original benefits of the in situ operation, it is now clear that the hemodynamic flow of converging (in situ) versus diverging vein (reversed) boundaries plus better vein/artery size match are the main advantages. It is now popular belief that the reversed saphenous vein graft to the popliteal artery has no significant hemodynamic disadvantage because the vein is of comparable diameter at the knee and in the groin. In contrast, vein bypass from the groin to the ankle strongly favors the in situ procedure because of the convergence of the walls of the vein below the knee and better vein/artery size match. The most controversial facet of the in situ operation has been the question of valvulotome is superior to lyse valves and whether to perform the operation open as originally described, or closed to avoid skin complications from a long groin to ankle incision. Preoperative vein mapping is advantageous for all saphenous vein conduit operations. For open leg in situ procedures, skin bridges and incisions made directly over the vein, directed by mapping, will minimize skin complications. Use of endoscopic in situ techniques is ideal but only with an experienced endoscopist. Valve lysis has improved but is still not foolproof.

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Initial experience with minimally invasive in situ bypass procedure with blind valvulotomy

Cited by 5 publications

References 27 publications

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™”

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™”

Early adaptation of human lower extremity vein grafts: wall stiffness changes accompany geometric remodeling

In Situ Saphenous Vein Bypass—Forty Years Later

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