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急速に普及する「NBCAによる下肢静脈瘤治療」・安全なNBCA

Non tharmal(熱を使わない)な下肢静脈瘤治療法が急速に全世界へ普及しています、

この治療はNBCAと呼ばれ、従来のレーザーやRFに較べて「痛みや腫れが少ない。」ことが特長です。

手術時の局所麻酔薬(TLA)も必要とせず 術後の圧迫のための靴下も不要です。従来の手術で問題となっていた腫れや痛み 術後の血栓形成のリスクを軽減しました。

2011年欧州承認、2015年には米国のFDA承認を受けており、安全性や有効性が広く確認され、世界に普及し始めました。(日本では未承認)

この次世代治療は「身体にやさしい」治療として、世界的にブームなっています。

venaseal-6 ベナシール

 

過去にレーザー治療が登場した2005年時代と同様に 

「ついに10年毎でのパラダイムシフトがやって来そうです!」

 

<TV番組リンク 2016年>

 

<2011年~ヨーロッパの臨床データーが発表されました。約4年間の成功率は97.3パーセントでした。>

VenaSeal – Closure: Results over 49 month

Summary

We report about newest results of a retrospective comparative study of VenaSeal – Closure in the treatment of 1228 saphenous veins (862 GSV, 360 SSV, 6 saphena – accessoria – inguinalis veins) in 687 cases. Treatment included also ulcera crures in 6 cases.

The present research paper sheds light on the advantages and disadvantages and presents the 49 – month results of an single-center ambulatory clinical study with retrospective design.

Introduction

Since 15 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. In addition, 13 years ago, far from the beaten tracks of radio wave and laser, the development of a fascinatingly simple, yet nevertheless highly effective method of gluing veins – the VenaSeal® closure technique – was initiated. After CE approval had been granted in the autumn of 2011, a number of vein centers in Germany and Europe started using the VenaSeal® system. By now, 17 centers are working successfully with the new therapy system in Germany alone.

The author has applied Venaseal for the first time in a great saphenous vein on 1st. August 2012.

Results

Over the course of 49 months of application of the VenaSeal® system, permanent complete closure of the treated vein could be verified by means of duplex sonography in 1195 veins (97,3%).

On the 1st day 1228 saphenous veins were checked (1217 were closed initially = 99,1%) in the scope of follow-up, and up to the 30th day, partial recanalization was found in 24 veins, and complete recanalization was found in 4 veins. This corresponds to a closure rate of 97,6%

Over a time period of 3 months up to now, we were able to follow up 975 saphenous veins (79,4 % of all veins that had been treated), and here we found 24 partial and 6 complete recanalizations. The closure rate is thus 97,5%

905 saphenous veins (73,7%) were followed up over a 6-month time period, and 24 partial and 9 complete recanalizations were found, resulting in an effectiveness of 97.3%.

No further recanalizations were found after a 37-month follow-up period in 700 saphenous veins (57%) up to now.

All leg ulceras were healed until to 14 days after intervention.

1228 veins having been glued with Venaseal®, the results achieved over the entire time period of 49 months are equivalent to a closure rate of 97.3%.

Side effects

The pain score for subjectively felt pain on the 1st. day post-surgery (range 1-10) was between 1 and 3 (2.1) – in RFITT 3-8 = 4,1). In 163 treated veins (13,3%), we observed a postoperative unspecific inflammatory skin reaction after approx. 10 – 14 days in the Venaseal group; with appropriate antiphlogistic treatment with ibuprofen and cooling dressings, this subsided within 3-5 days.

In all other cases subjected to follow-up examinations, no complications of any kind, no paresthesias or hypesthesias, no permanent skin reactions, no phlebitis or thrombosis or infections were observed. Only in three cases we were seen a lymphatic fistula at the peripherial punktion.

In particular, even subcutaneously situated saphenous veins could be glued without any significant skin reaction (reddening, swelling). We also clearly prefer VenaSeal® in treatment of SSV, Due to the large number of neurological sensations in connection with treatment by Laser and Radiofrequency.

Nearly all patients were greatly surprised at the fully ambulatory intraoperative procedure and the brief and pleasant postoperative convalescence phase.

All 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 97 % of all cases. We prefer to use compression stockings only in cases, the diameter of the treated vein ist over 1,5 cm or in treatment of venous aneurysm or ectatic varicous veins.

<臨床文献 バリクローズ イスタンブール大学>

A prospective comparison of a new cyanoacrylate glue and laser ablation for the treatment of venous insufficiency

  1. Ahmet Kürşat Bozkurt1
  2. Muhammet Fatih Yılmaz2

  1. 1Istanbul University Cerrahpaşa Medical Faculty, Istanbul, Turkey

  2. 2Department of Cardiovascular Surgery, Kayseri Research and Training Hospital, Kayseri, Turkey
  1. Ahmet Kürşat Bozkurt, Hakkı Yeten Caddesi Terrace Fulya No: 13 Center 2K: 5, D: 10, Fulya, Şişli, İstanbul, Turkey. Email: akbozkurt@yahoo.com

Abstract

Introduction Cyanoacrylate ablation is the newest nonthermal vein ablation technique. The one-year results of a prospective comparative study of a new cyanoacrylate glue versus endovenous laser ablation for the treatment of venous insufficiency is presented.

Material and methods A total of 310 adult subjects were treated with cyanoacrylate ablation or endovenous laser ablation. The primary endpoint of this study was complete occlusion of the great saphenous vein. Secondary endpoints were procedure time, procedural pain, ecchymosis at day 3, adverse events, changes from baseline in Venous Clinical Severity Score, and Aberdeen Varicose Vein Questionnaire.

Results Operative time was shorter (15 ± 2.5 versus 33.2 ± 5.7, <0.001), and periprocedural pain was less (3.1 ± 1.6 versus 6.5 ± 2.3, <0.001) in cyanoacrylate ablation group compared to the endovenous laser ablation group. Ecchymosis at the third day was also significantly less in cyanoacrylate ablation group (<0.001). Temporary or permanent paresthesia developed in seven patients in endovenous laser ablation group and none in cyanoacrylate ablation group (p = 0.015). One, three, and 12 months closure rates were 87.1, 91.7, and 92.2% for endovenous laser ablation and 96.7, 96.6, and 95.8% for cyanoacrylate ablation groups. Closure rate at first month was significantly better in cyanoacrylate ablation group (<0.001). Although there is a trend of better closure rates in cyanoacrylate ablation patients, this difference did not reach to the statistical difference at sixth and 12th month (p = 0.127 and 0.138, respectively). Both groups had significant improvement in Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire postoperatively (<0.001), but there was no significant difference in Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire scores between the groups at first, sixth, and 12 months. Only a slightly better well-being trend was noted in cyanoacrylate ablation group in terms of Aberdeen Varicose Vein Questionnaire scores (p = 0.062).

Conclusions The efficacy and safety analysis shows that cyanoacrylate ablation is a safe, simple method which can be recommended as an effective endovenous ablation technique. The follow-up data more than one year will clarify the future role of cyanoacrylate ablation for the treatment incompetent great saphenous veins.