SaphenionFactCheck – Vein glue for varicose veins

SaphenionFactCheck – Vein glue for varicose veins / update 8

SaphenionFactCheck – Vein glue: News of the German Society of Phlebology

The German Society of Phlebology has included in the current guidelines „S2k guideline for the diagnosis and treatment of varicosis“ also the therapy with the vein glue VenaSeal as therapy recommendation for the therapy of truncal varicose veins.

(published by: AWMF online – The Portal of Scientific Medicine, AWMF Register No. 037/018, class S2k)

SaphenionFactCheck – Vein glue for varicose veins / update 8

The SaphenionFactCheck – Vein glue for Varicose Veins has been published regularly by us for 4 years and aims to compare international publications on the topic with their own experiences and to remain meaningful. We continue to see increasing interest among our patients and will record the highest number of VenaSeal procedures in our patients to date in 2019.

However, this development is in contrast to the still controversial expert discussion. The current decision of the DGP (German Society for Phlebology) to include the vein glue in the recommendation list of varicose vein therapy – „Endovenous chemical processes“ – reflects the worldwide and also nationwide increase in therapy numbers with this innovative and effective therapy techniques.

Thus once again an incentive to look for current results in the literature.

SaphenionFactCheck – Vein gluen: 88 months experience on 2506 treated veins

More than 88 months ago, we started to use vein glue in the treatment of truncal varicose veins. There are now 2506 treated veins in the Op annals. We have used the vein glue in 1321 patients.

In addition to many well-informed patients, who in the meantime directly inquire about this therapy method, statutory health insurance companies have in some cases acknowledged the no longer so new procedure.

Here the letter of a patient after the positive decision of her health insurance to the cost assumption:

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Most private insurance companies have also accepted the treatment option of varicose vein glue as part of the cost estimates. Likewise, according to reports from our patients, the aid agencies of the federal government, the states of Berlin / Brandenburg, Mecklenburg, Saxony / Anhalt, Saxony and Thuringia as well as Lower Saxony and Schleswig – Holstein are prepared to pay the costs for this therapeutic procedure approved in Europe in 2011.

SaphenionFactCheck – Vein glue for varicose veins: Long Term results

After 88 months of practical work with the vein adhesive, we see – as well as the international studies – the high effectiveness with the very low rate of side effects. Initially approved and used by the manufacturer exclusively for normal caliber truncal varicose veins, the glue has conquered further fields of application of endovenous therapy.

This becomes clear in the literature analysis. Colleagues from the US, Korea, and Holland, from Russia and Hong Kong, have submitted 3/5 – year studies. In addition to our own 7 – year long – term study, Morrisson et al., Gibbson et al., the results are nearly identical in all studies; the closure rate after these long periods is between 94-97%. Our results after 88 months of use are 96.1% closure rate.
After 88 months of practical work with the vein glue, we see – as well as the international studies – the high effectiveness with the very low rate of side effects. Initially approved and used by the manufacturer exclusively for normal caliber truncal varicose veins, the glue has conquered further fields of application of endovenous therapy.

Thus, the vein glue is equal to or better than the established radio wave system in terms of effectiveness – but with significantly fewer side effects and a shortened post-op recovery phase.

The ability to work is restored the same day about 3 hours after the therapy or the following day.

Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15. PubMed PMID: 29914814.

SaphenionFactCheck – Vein glue: Therapy extensions

The treatment of the so-called „open leg“ (ulcus cruris) has become much easier, more effective and faster. The vein glue is minimally invasive even with the most severe findings.

Park I. Successful use of VenaSeal system for the treatment of large great saphenous vein of 2.84-cm diameter. Ann Surg Treat Res. 2018 Apr;94(4):219-221. doi: 10.4174/astr.2018.94.4.219. Epub 2018 Mar 26. PubMed PMID: 29629358; PubMed Central PMCID: PMC5880981.

SaphenionFactCheck – Vein glue: Outpatient Therapy Serious Illness

In the meantime, we treat patients with dementia or debilitation Parkinson ’s and trisomy patients on an outpatient basis with a light sedative.

Also, systemic infectious diseases, such as hepatitis or HIV are not a contraindication – patients with these underlying diseases have been successfully treated with the vein glue several times – without side effects.

Multi-allergic diseases are also no contraindications for treatment with vein glue.

Patients with lifelong thrombosis/embolism therapy should be successfully treated on an outpatient basis without stopping or switching over the medically necessary medication.

SaphenionFactCheck – Vein glue: Side effects and complications

A recent search in the international literature in preparation for this update has described the occurrence of contact dermatitis (skin inflammation after contact with cyanoacrylate) in two cases and, in one case, a – presumed – VenaSeal allergy. Further complications in the application or the post-op course are still not shown. We have not seen an allergy in 1321 patients after VenaSeal therapy.

Jones AD, Boyle EM, Woltjer R, Jundt JP, Williams AN.J Vasc Surg Cases Innov Tech. 2019 Aug 7;5(3):372-374. doi: 10.1016/j.jvscit.2019.05.004. eCollection 2019 Sep.PMID: 31440717 

Also our repeatedly published and presented a statement on alleged phlebitis after the vein glue – it is a tissue reaction of the surrounding tissue – have now also been confirmed in another scientific work:

Nasser H, Ivanics T, Shakaroun D, Lin J. Severe phlebitis-like abnormal reaction following great saphenous vein cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul;7(4):578-582. doi: 10.1016/j.jvsv.2019.03.010. Epub 2019 May 8. PubMed PMID: 31078516.

SaphenionFactCheck – Vein glue – 88 months application experience

Based on the 88 – months practical experience of 2506 treated truncal varicose veins in 1321 patients we would like to confirm from a clinical – technical point of view for the fact check:

The vein glue is fully biocompatible, so far we have not seen any allergy. There are two papers in the literature describing a contact allergy of the skin after touching the Venaseal glue. Allergies after injection into the truncal varicose veins have so far only been described in one case worldwide.

As a result, the rate of side effects is significantly lower than comparable endovenous thermal techniques in the treatment of truncal varicose veins.

Watts TJ, Thursfield D, Haque R. Allergic contact dermatitis caused by VenaSeal tissue adhesive. Contact Dermatitis. 2019 Jun;80(6):393-395. doi: 10.1111/cod.13206. Epub 2019 Jan 30. PubMed PMID: 30582174.

The bioresorption of the glue lasts between 12 – 24 months. The same resorption processes also occur in humans as in the more than 150 publications on bioresorption in animals. The resorption models in animal experiments all show biodegradation of the cyanoacrylate glue between 4 and 9 months. The absorption of the vein glue is also to be followed macroscopically during regular ultrasound examinations.

But not only that: in the meantime, we have histological findings from human veins 10 – 12 months after endovenous cyanoacrylate sealing. These show in all three cases a complete degradation of the glue in the remains of the vein. And here, in addition to our results, there is now another publication:

Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul 4. pii: S2213-333X(19)30325-7. doi: 10.1016/j.jvsv.2019.04.014. [Epub ahead of print] PubMed PMID: 31281102.

SaphenionFactCheck – Vein glue: The therapy

SaphenionFactCheck – Vein glue – Therapy on the lower leg veins, risk of recidive varicose veins

On the lower leg, thermal therapy (laser, radio wave, hot steam) has now come into critical light internationally and nationally, since the number of nerve lesions after thermal therapy is not negligible. At the annual conference of the German Society of Phlebology in September 2017 in Stuttgart, this topic was dedicated to a separate session. The result was overwhelmingly critical of the thermal treatment of SSV or GSV on the lower leg or recurrent varicose veins after radically stripping surgery.

The SONOVEIN procedure as a non-invasive therapy is expected to be at the GSV. At the SSV can only be used very seldom, as the SSVV is usually between 0.5 – 0.9 cm (own ultrasound – control measurements on 60 standing patients) below the skin – but with the SONOVEIN therapy is no longer possible is to protect the skin from burns.

Here, many colleagues now recommend a waiver of the thermal processes laser and radio wave, alternatively, the catheter-based microfoam therapy or just the vein adhesive are possible. Based on our own experience, based on our study of over 500 patients, we have defined an indication for microfoam or VenaSeal. We treat stem veins on the lower leg with a diameter of up to 0.5 cm by using of microfoam, truncal varicose veins with a larger diameter are treated with vein glue.

This eliminates our alternative recommendation radio wave catheter for the truncal varicose veins on the lower leg, as we have expressed so far in our educational discussions. On the lower leg we now treat exclusively with non-thermal methods.

This procedure has now also been anchored in the „Current Guidelines for Varicosis Therapy“ of The German Society of Phlebology

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From our point of view, radical stripping is no longer indicated on the lower leg.

Approval Europe 2011! Canada 2014, USA 2/2015.

In the US, after approval by the FDA in 2/2015, a run on the adhesive method can be seen. There are now nearly 40 venous centers in Germany, which are certified for the use of the vein glue VenaSeal. The systems are also approved in England, Ireland and the Northern European as well as in the Baltic countries and others.

In the meantime, the US Center for Health Care and Medical Care has issued new regulations for both practicing physicians and ambulatory hospital patients to cover the cost of the VenaSeal vein glue as of 1.1.2018.

And the vein glue has found its way into the German guidelines for the treatment of varicosis.

SaphenionFactCheck – Vein glue: Spider veins and retinal veins?

The vein glue for varicose veins is not – as here and there to read and also requested – suitable for the treatment of cosmetically disturbing retinal veins and spider veins. For this purpose, the micro-foam, which has been the „gold standard“ since 2010, is available as a combination therapy.

A simultaneous double therapy with microfoam (ethoxysclerol) is possible but carries the risk of phlebitis in itself. Scientific studies on this combination therapy have Gibson et al. submitted. It is important to first wait for the healing of the truncal varicose veins – in many cases, there is a significant decrease in varicose side branches.

Photos / Videos

Medtronic – VenaSeal animation;

UtziusCopenhagen, State Gallery of Art;

Nele Zierau – VenaSeal-Therapy;

Utzius – Teterow Bahnhofsgallerie – Rando Geschewski

Literatur / Links:

http://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/GOAE/endovenoese_Radiofrequenzobliteration.pdf

Kopie von Seite 11 des FDA – Approvals: Biokompatibilität des VenaSeal – Venenklebers:

Table 4: Results of Biocompatibility Testing – VenaSeal Adhesive (Polymerized and Unpolymerized States) Test Method Reference Results Cytotoxicity (Elution Method) ISO 10993-5.

The cumulative results of the VenaSeal adhesive material cytotoxicity testing, incombination with assessments of toxicological risk and in vivo use, support an overallfavorable cytotoxicity profile for the VenaSeal adhesive material per its intended use.

ISO MaximizationSensitization Study(Guinea Pigs)ISO 10993-10VenaSeal adhesive does not elicit asensitization response

ISO Intracutaneous Reactivity – ISO 10993-10: The cumulative results support that theVenaSeal adhesive material does not cause intracutaneous reactivity (Material Mediated Rabbit Pyrogenicity

ISO 10993-5US Pharmacopeia Section 151: The cumulative results support that the VenaSeal adhesive material is non-pyrogenic.

Acute Systemic Toxicity- ISO 10993-11: The cumulative results support that the VenaSeal adhesive material is not considered to cause acute systemic toxicity

Subacute / Subchronic ToxicityImplantation (13 weeks) – ISO 10993-11 / ISO 10993-6: The cumulative results support that the VenaSeal adhesive material does not result in any specific adverse systemic toxicological findings in the tissues examined Genotoxicity (Bacterial Mutagenicity, invitro Mouse Lymphoma Assay,Mouse Micronucleus Assay)

ISO 10993-3: The cumulative results support that the VenaSeal adhesive material is non-mutagenic Hemo-compatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time, Plateletand Leukocyte Count), ASTM F-756-08

ISO 10993-4: The cumulative results support that the VenaSeal adhesive material is non-hemolytic and not chronic toxicity Implantation (26 Weeks)

ISO 10993-11/ ISO 10993-6: The cumulative results support that VenaSeal – adhesive does not cause any significant adverse systemic or local toxicity in the tissues examined.

Quelle: Summary – Food and Drug Administration

Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul 4. pii: S2213-333X(19)30325-7. doi: 10.1016/j.jvsv.2019.04.014. [Epub ahead of print] PubMed PMID: 31281102.

Nasser H, Ivanics T, Shakaroun D, Lin J. Severe phlebitis-like abnormal reaction following great saphenous vein cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul;7(4):578-582. doi: 10.1016/j.jvsv.2019.03.010. Epub 2019 May 8. PubMed PMID: 31078516.

Watts TJ, Thursfield D, Haque R. Allergic contact dermatitis caused by VenaSeal tissue adhesive. Contact Dermatitis. 2019 Jun;80(6):393-395. doi: 10.1111/cod.13206. Epub 2019 Jan 30. PubMed PMID: 30582174.

Gibson K, Minjarez R, Gunderson K, Ferris B. Need for adjunctive procedures following cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Three-month data from a postmarket evaluation of the VenaSeal System (the WAVES Study). Phlebology. 2019 May;34(4):231-237. doi: 10.1177/0268355518801641. Epub 2018 Sep 18. PubMed PMID: 30227791.

Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15. PubMed PMID: 29914814.

Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. 2017 Apr;25(2):149-156. doi: 10.1177/1708538116651014. Epub 2016 Jul 9. PubMed PMID: 27206470.

Park I. Successful use of VenaSeal system for the treatment of large great saphenous vein of 2.84-cm diameter. Ann Surg Treat Res. 2018 Apr;94(4):219-221. doi: 10.4174/astr.2018.94.4.219. Epub 2018 Mar 26. PubMed PMID: 29629358; PubMed Central PMCID: PMC5880981.

Park I. Initial Outcomes of Cyanoacrylate Closure, VenaSeal System, for the Treatment of the Incompetent Great and Small Saphenous Veins. Vasc Endovascular Surg. 2017 Nov;51(8):545-549. doi: 10.1177/1538574417729272. Epub 2017 Oct 2. PubMed PMID: 28969499.

Shaĭdakov EV, Mel’tsova AZ, Porembskaia OI, Kudinova EA, Korzhevskiĭ DÉ, Kirik OV, Sukhorukova EG. [Experience with using cyanoacrylate glue in endovascular treatment of varicose veins]. Angiol Sosud Khir. 2017;23(4):62-67. Russian. PubMed PMID: 29240057.

Lam YL, De Maeseneer M, Lawson J, De Borst GJ, Boersma D. Expert review on the VenaSeal® system for endovenous cyano-acrylate adhesive ablation of incompetent saphenous trunks in patients with varicose veins. Expert Rev Med Devices. 2017 Oct;14(10):755-762. doi: 10.1080/17434440.2017.1378093. Review. PubMed PMID: 28892412.

Chan YC, Law Y, Cheung GC, Ting AC, Cheng SW. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebology. 2017 Mar;32(2):99-106. doi: 10.1177/0268355516638200. Epub 2016 Jul 9. PubMed PMID: 27052039.

Lane TR, Kelleher D, Moore HM, Franklin IJ, Davies AH. Cyanoacrylate glue for the treatment of great saphenous vein incompetence in the anticoagulated patient. J Vasc Surg Venous Lymphat Disord. 2013 Jul;1(3):298-300. doi: 10.1016/j.jvsv.2012.09.007. Epub 2013 Feb 15. PubMed PMID: 26992590.

Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31. PubMed PMID: 25650040.

https://scholar.google.de/scholar?q=Resorption+2+butyl+cyanoacrylate&hl=de&as_sdt=0&as_vis=1&oi=scholart

Zierau UT and Lahl W: Recurrence Discussion in Varicose Veins Therapy – A Critical Examination of the Vein Stump discussion; J. Vasc. Endovasc. Therapy 2019, Vol.4 No.2:13

Park I, Kim D. Correlation Between the Immediate Remnant Stump Length and Vein Diameter After Cyanoacrylate Closure Using the VenaSeal System During Treatment of an Incompetent Great Saphenous Vein. Vasc Endovascular Surg. 2019 Oct 3:1538574419879563. doi:10.1177/1538574419879563. 
[Epub ahead of print] PubMed PMID: 31581906.
Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul 4. pii: S2213-333X(19)30325-7. doi: 10.1016/j.jvsv.2019.04.014. [Epub ahead of print] PubMed PMID: 31281102.
Navarro-Triviño FJ, Cuenca-Manteca J, Ruiz-Villaverde R. Allergic contact dermatitis with systemic symptoms caused by VenaSeal. Contact Dermatitis. 2019 Oct 31. doi: 10.1111/cod.13431. [Epub ahead of print] PubMed PMID: 31674037.
Jones AD, Boyle EM, Woltjer R, Jundt JP, Williams AN. Persistent type IV hypersensitivity after cyanoacrylate closure of the great saphenous vein. J Vasc Surg Cases Innov Tech. 2019 Aug 7;5(3):372-374. doi: 10.1016/j.jvscit.2019.05.004. eCollection 2019 Sep. PubMed PMID: 31440717; PubMed Central PMCID: PMC6699189


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