Varicose vein adhesive successful – long-term results over 71 months

Saphenion reports monthly on long-term results with the venous adhesive

We report again on our own long-term experience in gluing varicose veins with the vein seal VenaSeal. In the period from 01.08.2012 to 30.06.2018 (71 months), the venous adhesive was used on 1925 trunk veins in 1050 patients. There were 1330  GSV, 512 SSV,  VSAL in 53 cases and VSAM in 29 cases and in two cases the Giacominivene. In 10 patients, a leg ulcer could be completely healed within 2 weeks. The therapy has also been used in cases of dementia or early childhood debility as well as in immunosuppression (HIV) and hepatitis patients. Also in 3 patients with multiallergy disposition the adhesive could be used successfully and without any side effects. In 87 cases, our patients deliberately avoided any local anesthetic or tranquilizer.

 

Varicose veins for 71 months

From August 1st. 2012 Saphenion will be working with the vein adhesive and we will be using it in parallel with radiofrequency therapy. Meanwhile, over 98% of patients choose the adhesive for the treatment of truncal varicose veins.   The age of the patients was 17-90 years.

According to the guidelines of the European societies, indications are according to the guidelines of the European specialist societies truncal varicose veins 2 °         ( n.  Hach) in the saphenous vein and from 2 ° degrees in the smaller saphenous vein. With accessory varicose veins (VSAL, VSAM) we glue the sections that reach the groin in a length of 12 to 25 cm. This complies with the American ACP guidelines for the treatment of VSAA.

In the meantime, technical indications have broadened the indications. Now we are treating Rezas veins, decisive truncal vein, venous angiomas and aneurysms as well as perforating veins using VenaSeal.

Especially in strong and obesepatients, we see very clear advantages of the catheter method radio wave and venous adhesive – in many cases we have been able to successfully treat the sealing glue  in this patient group as well. In the meantime, we reject a classic stripping operation in the obese patient due to the very large op – areas and correspondingly high number of side effects.

Results:

On the first day, all 1925 truncal veins were examined, 1912 veins were initially closed = closure rate 99.32%.

By the 30th. day we found a partial recanalization in 37  veins and a complete recanalization in 9 cases. This corresponds to a closure rate of 97.61%.  

Over a period of 3 – 4 months, we were able to re – examine 1539 veins (80.1%), we saw 39 partially recanalized and 13 completely recanalized veins, the closure rate is 97.30%.

After 6 – 8 months, we were able to follow up on 1326 veins (68,9%) – here we found 43 partially recanalized and 25 completely recanalized  truncal veins after sealing  (96.47%).  Further recanalizations were not found for 71  months with a follow – up of 1200 veins (62.3%).  

The closure rate  of the venous adhesive in our single center study is 96.47% after a long – term period of 71 months.

More than 95% of patients left the practice after 30-90 min. without compression stocking.  Already on the 1st. post op day could be started with the usual sport / competitive sports in certain stress levels (except weight training – here we recommend over 14 days waiver of leg press, etc.). Also sauna sessions are possible again after 4-5 days – here are amazing subjective positive effects – a much higher heat tolerance and the absence of any complaints are described.

For – in all other therapy procedures essential compression stocking therapy – we recommend after sealing of veins only if strongly extended veins from 1.2 cm in diameter and venous extensions or aneurysms are treated.

 

Side effects:

We see mild side effects in 8% of all cases. In 7%, a non specific foreign body reaction develops (tissue red  and swelling). This is indicated by a local reddening along the treated vein or as a planar reaction. However, this is not phlebitis, as often misdiagnosed.

Pigmentation developed in 1% of the cases treated by us. This is especially true in cases where the phlebotomy occurred just below the normal anatomy directly under the skin (subcutaneous course).

In 15 patients a slight bleeding tendency of the puncture site was evident. All 15 patients did not have to discontinue their anticoagulant medication under VenaSeal therapy (e.g., Marcumar, Falithrom, ASA, Plavix, Xarelto).

In 5 cases we saw a lymph fistula at the puncture site, which healed after 14 days compression bandage. We were able to find an adhesive pimple with opening of the skin in one patient after 11 months – this was emptied minimally invasively and then healed.

We have seen a glue noise into the junction in 13 cases – in these cases we treated with NMH for 7 days without any side effects or complications.

We did not see any allergy or hematoma, no sensation, no numbness or other neurological side effects. Post – operative swelling was extremely rare, short-term lymphedema is possible. There was no thrombosis in all 1036 patients  due to suspected adhesive drainage into the deep veins. We did not seen any permanent skin alteration or pigmentation or other side effects and complications known from venous surgery.  We also did not seen an appositional thrombosis at the catheter tip.

Discussion

Over a period of 71 months (5 years and 11 months) sealing truncal varicose veins with the VenaSeal system, we achieved a closure efficiency of 96.47%. These are almost the same results as in the current multi-center study „VeClose – study“. This was published in late April 2017. The colleagues presented a closure rate of 96.8% in the venous life of the stock varicose veins over a study period of 3 years.

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

The results are therefore almost identical after 3 years, as well as after almost 6 years of use. Thus, the first single center long-term results beyond the required 3 years of scientific control are available. The occlusive efficacy of the sealing glue is slightly better than in current long-term studies of the radio wave. We did not find any long – term studies on laser therapy over a period of more than 2 years.

International Scientific Recommendations

We are currently following the European Guidelines for the Use of Endovenous Op Techniques (ESVS 2015) – the gold standard that recommends the use of catheters for the treatment of common varicose veins and includes the US guidelines and UK guidelines.

Thus, all colleagues who work with endovenous techniques worldwide have analog and comprehensible quality criteria for the respective endovenous therapy.

Varicose vein sealing is at SAPHENION`s 1st. choice All endovenous procedures have many advantages over the radical surgical therapy and show good functional as well as much better cosmetic results with a significantly reduced complication rate and fewer side effects!

In the meantime varicose vein sealing  therapy is the treatment of choice for truncal varicose veins. On the lower leg, the venous adhesive is preferable to the laser and radio wave, as well as superheated, to avoid nerve damage to the lower leg. The closure rate of the venous adhesive is comparable or higher than that of the radio wave – but we see significantly less pain and side effects.

Even in obese patients, the use of endovenous catheter based therapy – and especially the vein adhesive is very effective and gentle. Here we don’t give from this time any recommendations for the radical therapy „Stripping „

As recently published here, the modified application of the venous adhesive provides many opportunities for more sophisticated treatment strategies.

 

 

 

 

 

Links:

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