SaphenionScience: 87 months vein glue

SaphenionScience: 87 months vein glue in 1301 cases

SaphenionScience: 87 months veinglue: Nearly all operative disciplines are using cyanoacrylate i.e dermatology, ophthalmology, orthopedics, surgery, orthodontics, interventional radiologists, vascular surgery.

The risk of allergic reaction is not real – we didn`t found any exactly reports or scientific study in medline or pubmed or have seen ourself an allergic reaction all over the time.

The CE approval for sealing veins was in 9/2011 for Europe, the FDA approval in the US followed in 2/2015. The FDA states in its documentation: VenaSeal® is bio-compatibel and bioresorptive, non-carcinogenic and non-allergenic!

In the meantime, sealing veins with Venaseal in the USA has been declared as insurance obligation.

Treatment with Cyanoacrylate glue is using for a long time. Since 1949 the chemical compound is known, first being used in operative medicine in the early 60s as a Tissue adhesive or replacement of wound sutures.

SaphenionScience: 87 months veinglue in 1301 cases

Until 31st Oktober 2019 we sealed GSV in 1674 cases, SSV in 627 cases, VSAL in 88 cases, VSAM in 61 cases, Femoropopliteal vein in 11 cases, Giacomini`s vein in 2 cases. 

Age of patients was between 17 – 92 y.

Treatment of one truncal vein in 377 cases, 728 patients received treatment for two truncal veins simultaneously, in 158 cases we treated three truncal veins. In 33 cases patients have got treatment of four truncal veins, in 3 case 5 truncal veins. One patient was treated for 6 truncal veins and an aneurysma in a single session (summary: 1301 patients). In 16 cases we treated truncal veins with ulcera crures: they healed 2 to 12 weeks after. We also treated patients with HIV, hepatitis or Parkinson without any pathological reaction or side effects.

Nearly all procedures carried out under sedation (dormicum i.v.), 163 patients without anesthesia (12,5%), one patient performed pain acupuncture in itself.

Nearly all patients choose music during op and left without compression stockings. We recommend compression stockings with a vein diameter up 1.2 cm. A 12 – chamber compression therapy immediately post op received 36% of patients.

VenaSeal of junction of GSV and SSV – ultrasound control

SaphenionScience: 87 months veinglue on 2464 truncal varicose veins: Our results

Duplex control follow up over 86 months: the first day 2464 veins were re-examined. 2448 veins were sealed initially   = 99,35% closure rate.

After 14 – 30 days we found 48 partial and 12 completely recanalized veins able to follow up of 2454 sealed truncal veins (99,50%) = 97,55% closure rate.

Three to four months post operationem we had 50 partial and 20 complete recanalisations able to follow up 1873 veins (76 %) = 97,16% closure rate.

After eight to ten months we observed 59 partial and 35 complete recanalisations able to follow up 1607 veins (65,2%) = 96,19% closure rate.

No further recanalisations were found after 87 months up to now! The closure rate over all the time of 87 months = 96,19%.      

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SaphenionScience: 87 months veinglue: closure rate

SaphenionScience: 87 months veinglue – technique and side effects.

For the treatment of one truncal vein we need 1.2 ml to 1.8 ml of glue. The time of treatment for one GSV by experienced specialists is 8 – 12 min., for two veins 30 – 35 min.

Unspecific inflammatory reaction of tissue in 189 veins (7,7% truncal veins – no phlebitis!). Bleeding for> 12h ex punctio in 22 cases (continued anticoagulatio perioperative). Lymph-fistula at the puncture site in 19 cases (0,7%).

Glue(?) pimpel with cutaneous perforation 10 – 12 months after sealing in 3 cases. Open this pimple with incision, made a histopathological examination. The pimpels were healed in 14 days.

There was not to be found: sensory or motor nerv damages, no hyp-/ paresthesia, no permanent skin reaction, no phlebitis or thrombosis, no embolism.

SaphenionScience – 87 months vein glue: Our experiences and discussion

VenaSeal is one of the endovenous techniques with a high standard of effectiveness – quality standards are the same like other procedures. The cyanoacrylate vein glue (VenaSeal) has been included in the guidelines of the German Society of Phlebology (DGP) and is recommended.

VenaSeal treatment of all truncal veins, side branches and perforator veins until a diameter of 1,5 – 2 cm is real. Higher diameters are possible!

VenaSeal is first choice in treatment of truncal veins of the lower leg and truncal veins of GSV 3 – 4°.  VenaSeal is the expensive of all endovenous techniques, thats why therapy of more than one truncal vein simultaneously is recommendable. We can treat in normal 3 – 4 truncal veins with one catheter – Six truncal varicose veins were also closed simultaneously in one session, depending on the severity and anatomy. Here it is quite clear that the SONOVEIN Echotherapy is more likely to be used simultaneously with a maximum of 1 – 2 truncal veins.

The painscore is significantly lower (1.3 VenaSeal – 3.4 radio frequency) than in radiofrequency or laser therapy. It remains to be seen to what extent the new noninvasive procedure SONOVEIN Echotherapy shows the same results.

Closure rate of VenaSeal® compared to radiowave / Laser is same or better. VenaSeal® works without mechanical or thermal energy, side effects of laser or radio wave are not an issue here.

Neither general anesthesia nor tumescence is required, as a rule postoperative compression therapy is not necessary either. This also seems to be possible with SONOVEIN Echotherapy.

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SaphenionScience: 87 months veinglue: VenaSeal vs.Radio Frequency closure rate over 7 years

SaphenionSience – 87 months vein glue: Our resumes  

The radical surgery today is only necessary for very less special cases. In this regard, contrary statements from reviewers, colleagues, and health insurance companies are after a long time of use (8 years) urgently to question. Thermal catheter therapy is not out, but the endovenous pathway has become more sophisticated! The latest noninvasive SONOVEIN Echotherapy is also a thermal procedure but does not require catheters or vascular puncture.

VenaSeal was approved in 2011 in Europe – since first approval there was no change of catheters or glue or treatment protocol. After the first approval protocol there is not to be find an other therapy procedure. So we have to change the technique to get guideline conform results by ourselfs.  

VenaSeal is safe in treatment of truncal veins, sidebranches and perforator veins. But- why there is not to be find perforator catheter, a SSV – catheter or a sealing needle?  Why we need an expensiv Teflon – catheter? VenaSeal is first choice in treatment of truncal veins of the lower leg – but why there is since 2011 the same glue quantity inside the glue ampoule? In normal You have to throw the rest of glue away…!

After 18 years working with endovenous techniques: Our experience with endovenous therapy and especially with super glue VenaSeal® made it our basic therapy of  all truncal varicous veins. In addition to the VenaSeal treatment and radiowave therapy or sealing foam therapy of varicose veins, we will also carry out SONOVEIN Echotherapy in the future. However, the indications for SONOVEIN Echotherapy and the advantages in relation to the VenaSeal – system still have to be precisely defined by the physicians.

Photos / Videos:

Utzius – Museum Barberini, Potsdam – DDR Malerei

Utzius: Ultrasound pictures

Madleen Hauberg: video interview

Papers /Links:

Gibson et al.: Twenty-four-month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.

Ivanova, Patricija: Post procedere neuropathy: comparison of surgery, EVLA and glue; Presentation on 2nd. NEEF, Riga, 17th.August 2019. 

Lawson J, S Gauw, C van Vlijmen, P Pronk, M Gaastra, M Mooij, C Wittens: Sapheon: the solution? Phlebology 2013;0:1-8

Morrison, Nick, and Kathleen Gibson: Veclose Study: Preliminary Month 1 Data; 2nd Annual Cyanoacrylate Embolization Symposium, Mainz, Jan. 18, 2014

Proebstle TM, Alm J,  Rasmussen L, Dimitri S, LawsonJA,  WhiteleyM,, Franklin IJ,  Davies AH: The European Multicenter Study On Cyanoacrylate Embolization Of Refluxing Great Saphenous Veins Without Tumescent Anaesthesia And Without Compression Therapy. eScope – study; Abstract presented  to the American Venous Forum  Annual Meeting 2013, Phoenix ( AZ) the  USA

Rasmussen LH, Bjoern L, Lawaetz M, Lawaetz B, Blemings A, Eklof B.:  Randomised clinical trial comparing endovenous laser ablation withthe  stripping of the great Saphenous vein: clinical outcome and recurrence after 2years. Eur J Vasc Endovasc Surg 2010;39:630 – 35

Thum, J: Single Center Erfahrungen aus 234 Stammvenenbehandlungen mit viskösem n – Butyl – 2 – Cyanoacrylat- Verwendbarkeit, Akzeptanz, Ergebnisse; vasomed 1, 2019; 28 – 31

Üdris, Ints: 6 years single center results „Baltic Vein Clinic“ of truncal varicose vein sealing; Presentation on 2nd. NEEF, Riga, 17th. August 2019.

Zierau U Th.: Venenverklebung versus Radiofrequenztherapie bei Varicosis – Verlaufsstudie über 36 Monate mit 1139 Behandlungen. vasomed 28 (2016) 212 – 216. 

Zierau U Th.: http://www.saphenion.de/news/konsensus-1-neef-endovenoese-krampfadertherapie.

http://vascular-endovascular-therapy.imedpub.com/venaseal-in-varicose-veinshistopathological-changes-of-tissue-and-veins.pdf

http://evtoday.com/2017/04/three-year-veclose-data-and-1-year-waves-data-presented-for-medtronics-venaseal-closure-system

http://www.saphenion.de/news/sealing-lower-leg-truncal-veins-kleben-von-stammkrampfadern-am-unterschenkel/J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613.

http://www.ncbi.nlm.nih.gov/pubmed/?term=veclose

http://www.ncbi.nlm.nih.gov/pubmed/27052039

http://www.ncbi.nlm.nih.gov/pubmed/23482526

https://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?query=venaseal&v%3Aproject=nlm-main-website

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841327

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