SaphenionScience – 86 months vein glue / update

SaphenionScience – 86 months vein glue in 2413 truncal varicose veins / update

SaphenionScience – 86 months Treatment with Cyanoacrylat: 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.

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 report or scientific study in medline or pubmed. 

FDA – approval states: VenaSeal® is bio-compatible / bio-resorptive / not carcinogenic and not allergenic! 

SaphenionScience – 86 months vein glue in 1278 cases

Until 30st September 2019 we sealed GSV in 1647 cases, SSV in 611 cases, VSAL in 84 cases, VSAM in 59 cases, Femoropopliteal vein in 10 cases, Giacomini`s vein in 2 cases. 

Age of patients was between 17 – 91 Y.

Treatment of one truncal vein in 373 cases, 717 patients received treatment for two truncal veins simultaneously, in 151 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: 1278 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.), 156 patients without anesthesia (12,2%), one patient performed pain acupuncture in itself.

A 12 – chamber compression therapy immediately postoperatively received 30% of patients (SaphenionRostock).

Nearly all patients choose music during op and left without compression stockings. We recommend compression stockings with a vein diameter up 1.2 cm.

Interview with a 74-year-old patient one day after simultaneous therapy of 4 truncal varicose veins.

SaphenionScience – 86 months vein glue on 2403 truncal varicose veins: Our results

Duplex control follow up over 86 months: the first day 2403 veins were re-examined. 2397 veins were sealed initially   = 99,34% closure rate.

After 14 – 30 days we found 47 partial and 12 completely recanalized veins able to follow up of 2401 sealed truncal veins (99,50%) = 97,55% closure rate.

Three to four months post operationem we had 48 partial and 19 complete recanalisations able to follow up 1823 veins (75,5 %) = 97,28 % closure rate.

After eight to ten months we observed 57 partial and 32 complete recanalisations able to follow up 1572 veins (65,1 %) = 96,30% closure rate.

No further recanalisations were found after 86 months up to now! The closure rate over all the time of 86 months = 96,30%.      

SaphenionScience – 86 months vein glue: 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 8 – 12 min., for two veins 25 – 30 min.

Unspecific inflammatory reaction of tissue in 187 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 (0,8%).

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: hyp-/paresthesia, permanent skin reaction, no phlebitis or thrombosis, no embolism.

SaphenionScience – 86 months vein glue: Three human cases histopathology of sealed veins.

There was not to be found any rest of glue, no particels or chemical elements of  2 – butyl – cyanoaccrylate inside the rest of veins and wounds or in pathological and histological examinations! 

The histopathological examination paper

SaphenionScience – 86 months vein glue: Our experiences

Quality standards for endovenous therapy have been developed, all            colleagues have secure quality criteria for all trans – catheter treatment methods.

In contrast to most other methods VenaSeal® is performed without using thermal or mechanical energy – the side effects of laser or radiowave are not an issue, the pain score compared to radiowave is significantly lower (1,3– 3,4)

We neither need general anesthesia or tumescence, nor do we need compression stockings.

We can treat two or more truncal veins simultaneously in one single session.

Dieses Bild hat ein leeres Alt-Attribut. Der Dateiname ist VenaSeal®-vs.-Radio-Frequency-7-years-1024x632.jpg

SaphenionScience – 86 months vein glue: Our discussion

   

VenaSeal is one of the endovenous techniques with a high standard of effectiveness – quality standards are the same like other procedures.   VenaSeal treatment of all truncal veins, side branches and perforatorveins 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 – depends on the vein anatomy and graduation!   

Closure rate of VenaSeal® compared to radiowave is same / better. Also general vein diameter more than 2 cm is possible to be treating with glue.   

SaphenionSience – 86 months vein glue: Our resumes  

After 18 years working with endovenous techniques: Our experience with endovenous therapy and especially with super glue VenaSeal® made it our basic therapy of truncal varicous veins. The radical surgery today is only necessary for special cases. The thermal ablation is not out, but the way of therapy is much more differentiated.

SaphenionScience – 86 months vein glue: Our questions…

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– since2011 – the same glue quantity inside the glue ampoule? In normal You have to throw the rest of glue away…!

VenaSeal is the much expensive of all endovenous techniques, thats why therapy of more than one truncal vein simultaneously is recommendable – but why we have to pay the same price for a catheter — system developed from 2003 to 2011? 

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

Zierau UTh.: 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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