VenaSeal® – glue – We report about our actually results of a retrospective comparative study of VenaSeal® – glue in the treatment of 1475 saphenous veins (1034 GSV, 415 SSV, 26 VSAA ) in 832 cases. Treatment included also ulcera crures in 6 cases.
Since 17 years by now, varicosis has been increasingly treated endovenously. At the start, the rather inconvenient VNUS®Closure plus procedure and the more convenient linear laser procedure were used, and these were followed in 2006 / 2007 by the bipolar RFITT® – catheter, the VNUS®ClosureFast – system and the radial laser. Thus, in the course of the last few years, plenty of experience has been gathered with endoluminal therapy, quality criteria have been defined and standards for the different techniques have been developed. The author has applied Venaseal for the first time in a great saphenous vein on 1st. August 2012.
Materials and method:
During the time period from 1st. August 2012 to 31st Mai 2017 (58 month), Venaseal® – glue was applied to achieve closure of the vein in 1475 saphenous veins. In 262 patients one saphenous vein were treated; in 503 patients two saphenous veins were treated; in 61 patients 3 saphenous veins were treated and in 6 cases all the four saphenous veins were treated simultaneously.
In VSAA veins we treatet the inguinal trunc in length between 12-25 cm.
The follow-up observation period in our study was up to 58 months.
In 1034 cases the great saphenous vein was treated, in 415 cases the small saphenous vein was treated an in 26 cases the trunks of VSAA were sealed.
VenaSeal® – Closure interventions were performed under light sedation with Dormicum or under local anesthesia for venous access accompanied by music therapy, 32 patients did`nt got any anaesthesia.
All patients are given a follow-up examination by duplex sonography in the scope of a prospective study (our own quality management) on the 1st / 14 – 30th day, 70 – 90th. day as well as after 6 and 12 months. After this we controlled every following year. All duplex sonography examinations post intervention were done by an other collegue, not by the vascular surgeon treated the truncal veins.
On the 1st. day 1475 saphenous veins were checked (1463 were closed initially = 99,2 %) in the scope of follow-up. Up to the 30th. day, partial recanalization was found in 30 veins, and complete recanalization was found in 7 veins. This corresponds to a closure rate of 97,5 %
Over a time period of 3 months up to now, we were able to follow up 1314 saphenous veins (89,1 %) of all veins that had been treated), and here we found 30 partial and 9 complete recanalizations. The closure rate is 97,4 %.
1143 saphenous veins (77,5 %) were followed up over a 6-month time period, and 32 partial and 11 complete recanalizations were found, – resulting in an effectiveness of 97.1 %.
No further recanalizations were found after a 37 – month follow – up period in 1067 saphenous veins (72,3%) up to now. All leg ulceras were healed until to 14 days after intervention.
1475 veins having been glued with Venaseal® – glue, the results achieved over the entire time period of 58 months are equivalent to a closure rate of 97.1 %. – This is nearly the same result like published in the „Veclose – study“ – http://evtoday.com/2017/04/three-year-veclose-data-and-1-year-waves-data-presented-for-medtronics-venaseal-closure-system
Here the colleagues present a closure rate of 96,8 % in sealing GSV. Congrats!
All our patients were able to leave the office between 30 and 120 minutes after the intervention.
In the case of VenaSeal, we have up to now refrained from applying compression therapy in 98% of all cases. We prefer to use compression stockings only in cases, the diameter of the treated vein ist over 1,2 cm or in treatment of venous aneurysm or ectatic varicose veins.
We found side effects in 10 % of all cases. An unspecific inflammatory reaction of tissue we have seen in 8 % of all cases. A long term ecchymosis we saw in 2 of treated patients, especially in extra anatomic subcutaneous truncal veins. Bleeding ex punctio > 12h we found in 14 cases – intra operativ continued anticoagulation.
Lymph fistulas at the puncture side we saw in 3 cases, In one patient we had to therapy a glue pimple with cutaneous perforation after 11 month post sealing.
There was not to be found: hyp – / paresthesia, permanent skin reaction, no phlebitis or thrombosis and no allergenic reaction!
Now we have guidelines in Europe using endovenous systems at first (ESVS 2015) in treatment of truncal saphenous veins. Thus, the colleagues who work with endovenous procedures meanwhile have reliable criteria for a high-quality therapy.
All these endovenous methods also have clinical advantages and quite significantly reduce side effects and complications such as still occur regularly today as in the past in connection with the conventional surgical technique.
In Venaseal we do not need anesthesias anymore and can in most cases do without postoperative compression therapy. Elastic stockings should nevertheless by all means be recommended after the treatment of thicker saphenous varicose veins measuring > 1,2 cm, and they become compulsory where we intend to apply gluing therapy in larger lumens measuring 1.5 cm and more.
The significantly reduced side effects and a well-nigh negligible pain score are also clear advantages in comparison to laser and radio wave therapy. No paresthesias, no hypesthesias, no phlebitis, rare occurrence of skin pigmentations are only a few of the important advantages of the VenaSeal® procedure.
The results of first long time comparative studies show that the VenaSeal® glue is clearly superior with regard to postoperative side effects though. Both the pain score and the rate of side effects are very low in comparison. Particularly pain as well as the neurological side effects no longer play any significant role at all. These are the main problem associated with laser and radio wave therapy though.
In practical work with VenaSeal®, all insufficient saphenous veins should as far as possible always be treated in one session. In practical also perforators and junctions of side branches should be treated. And also ectatic or aneurysmatic parts of truncal veins we can treat with glue.
Independently of this, we at SAPHENION® meanwhile regard Venaseal® – glue as treatment of first choice in the range of catheter – supported therapeutic procedures for lower leg truncal varicose veins, f.e. GSV and SSV or distal VSAA.
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