Early Results of the Sandwich Technique Using Cyanoacrylate Glue and Polidocanol Foam Sclerotherapy for the Treatment of Varicose Veins
Stefano Ricci
Round 1
Reviewer 1 Report
Comments and Suggestions for Authors
General remarks
In this interesting paper the Authors report their experience with a combination of methods (cyanoacrylate glue and polidocanol) for achieving intrafascial incompetent veins closure. They call this procedure “sandwich technique” in analogy to the technique suggested by Sakakibara et al. In reality, these Authors performed glue injections every 5 cm along the vein to treat and then injected foam in the intermediate spaces, so justifying the sandwich concept. In the present research, the glue injection sites are not well specified: Cyanoacrylate glue was injected into the most critical locations, like the area 2-4 distally from the saphenofemoral or saphenopopliteal junction, connection of intrafascial segment of the incompetent saphenous vein with epifascial incompetent tributary, or most severe dilatations of saphenous vein. This means that possibly only two glue injections could be sufficient, while the whole saphenous tract would be injected by foam, not being a proper sandwich technique. The sentence: Foam was firstly administered in 0.5-1.0 mL boluses between previously injected drops of cyanoacrylate glue. In this way a “sandwich” consisting of glue drops and sclerosing foam completely closed the target intrafascial vein., is, as a consequence, confusing and should be explained and detailed.
Interestingly, the clinical outcome has been very satisfying, although only early results of the treatments were reported, in a pathology needing a longer surveillance time. The advantage of the combined technique, as underlined by the Authors, is to minimize their respective risks, even if the hand manipulation of two methods could create some authorisation questions in some countries. Even the costs should be considered every time two methods are combined. What is the cost of glue every time you use it?
The absence of any inconveniences is interesting also as this method needs several more vein’s access, without the possibility of blood aspiration (for glue injection) and potential risk of wrong positioning. Furthermore, when two glue closures sequestrate a vein tract devoid of drainage and foam is added, a possible situation of vein induration/thrombosis occur . Did the Authors observe any similar episode?
Specific remarks
The citation 27 of Giovanni et al. is wrong, In fact Giovanni is the name while Alongi is the surname, the mistake being at the original issue.
I suggest the citation of the paper: Lorenzo Tessari, Mirko Tessari. Foam-glue syringe: a novel combined echo-guided endovascular treatment. Veins and Lymphatics. 2023;12:11594. doi:10.4081/vl.2023.11594.
It describes a syringe that allows glue and foam injection through the same puncture needle. Although not functional to the sandwich technique (where the vein’s access must be different) the novel tool can be considered in this new field of interest.
Author Response
We kindly thank you for valuable comments regarding our submission. Amended parts of the text are underlined in red.
- The term “sandwich technique” is widely used for the description of the closure of incompetent gonadal veins with microcoils and foam sclerotherapy. By the same token, this term has been used to describe our method of addressing varicose veins of the lower extremities. The term “sandwich technique” does not necessarily mean that the two occluding modes are applied symmetrically, like in the Sakakibara case. Besides, our approach to the varicose vein treatment does not follow CHIVA strategy, but requires a complete closure of all incompetent superficial and intrafascial veins, like in traditional surgical stripping or thermal ablation methods.
In order to avoid confusion, we added some clarifications to the methodology described:
“Usually, 5-8 drops of glue were injected. There were fewer glue applications if the intrafascial segment of saphenous vein was short, or in a case of intrafascially located neovascularization.”
- Since the cost of glue may be very different in particular countries, I would suggest not to mention it in this particular paper (an article focusing on financial issues of the procedure would be a proper one); just for your information - in our country 1 vial of Venex cyanoacrylate is ~120 EUR, the cost of remaining equipment is ~10 EUR, thus is affordable for patients even if the procedure is nor reimbursed.
- Regarding incorrect position of the needle, this possibility is excluded, since the procedure is done under ultrasonographic control, and the tip of needle is clearly visible during injection. Of note, 25G needle were used, and these needles are very well visible during injection. Also, the length of a needle was always adjusted to the depth of target vein, which facilitates proper positioning of the needle tip.
Regarding potential sequestration of blood between glue drops, actually the glue never closes the vein completely. After injection of the sclerosant, foam quite easily penetrates through the glue drops and fills the target vein completely. Besides, both glue and foam sclerosant evoke venous spasm, which is clearly visible under sonographic control. This has already been described in our paper:
“Immediately after the procedure all target intrafascial veins were contracted, filled with the glue and sclerosing foam. There were no remaining patent segments of these veins visible on ultrasound.”
At follow-up the ultrasonographic picture of target vein is similar to that observed after sclerotherapy alone: the vein is closed with hyperechoic mass (sclerothrombus); the only difference is a much higher efficacy of this new method in comparison with traditional foam sclerotherapy under sonographic control, particularly regarding large diameter veins.
We added some information regarding follow-up appearance of the target vein:
“Ultrasonographic pictures of the target veins at follow-ups were similar to those observed after traditional ultrasonographic-guided sclerotherapy: the vein was narrower than preprocedurally and closed with hyperechoic masses. Glue deposits were clearly visible as acoustic shadow-evoking masses.”
Indeed, there is typically an induration during first postprocedural weeks. Still, since it regards intrafascially located veins, it is usually of a negligible clinical relevance; long term surveillance is however needed to evaluate is actual clinical meaning. Probably it is similar to that observed after other endovascular methods of vein ablation.
- Regarding reference to the G.Alongi’s paper, I would suggest to leave it as it is. This mistake is already in all available scientific databases; otherwise this valuable contribution would not be citied, also there would be a problem with our paper, since it would cite a “non-existing“ article.
- Following your suggestion, the paper by Tessari is citied and commented.
“Another technique of simultaneous administration of cyanoacrylate glue and sclerosing foam has recently been suggested. In this method the glue and foam are injected at the same place through the same needle [29]. this particular method is particularly useful when the varicose veins are managed with the so-called CHIVA approach, ie. varicosities are not excised or ablated, but they are closed in some locations only, depending on hemodynamic pattern of the venous network of extremity [30,31].”
Reviewer 2 Report
Comments and Suggestions for Authors
The authors presented a retrospective evaluation of the results of treating varicose veins using the sandwich method involving cyanoacrylate adhesive and foam sclerotherapy. In this retrospective analysis of patient series, they illustrate that the novel sandwich technique for varicose vein treatment, incorporating cyanoacrylate adhesive and foam sclerotherapy, proves to be both safe and effective. Their initial findings align with outcomes from treatments using exclusively N-butyl cyanoacrylate administered via specialized applicators. Moreover, the authors showcased a notably favorable outcome for this therapeutic approach. Within their patient series, no significant adverse events were linked to the treatments, and the preliminary results of these procedures were exceedingly encouraging, achieving a 100% technical success rate and a primary assisted success rate of 100% in 77 treated veins.
Author Response
Herein is enclosed the revised version of the manuscript. Amended parts of the text are underlined in red. There are also two additional references (30 and 31)
