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The paper is about long-time experiences in sealing
truncal varicose veins: 78 month follow up in the treatment of 1161 cases and
2162 truncal varicose veins. Since 20 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® closure fast 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 present research paper sheds light on the
advantages and disadvantages and presents the 78 month results of a
single-center praxis study with a prospective design.
We will report about our experiences and results of
a prospective comparative study of VenaSeal® - Closure in the
treatment of 2162 saphenous veins (1492 GSV, 550 SSV, VSAL in 63 cases, VSAM in
40 cases, Giacomini’s vein in 2 and femoropopliteal vein in 4 cases). Treatment
included also lower leg ulcers in 12 cases.
INTRODUCTION
In the
base, all varicose veins should be treated actively. This we can find in nearly
all guidelines worldwide. All the specialists know that mobilization and
compression alone cannot normalize the venous function of outflow venous blood
from the leg. An insufficient varicose vein is working like a downpipe - the
blood pressure at the lower leg is increased chronically. And so we get the
typical chronic venose disease. Nearly 70% of all adults in Europe have
clinical signs of this CVD (Figure 1).
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 [1-7].
One very important technical development
combined with the beginning of the endovenous therapy was the color ultrasound (duplex) - we can see
the catheter inside
the
MATERIALS AND METHOD
Based on
the manufacturer's application instructions, sealing with the VenaSeal®
- the system was started 1-3 cm from the saphenofemoral junction, and a spot of
glue was applied at intervals of 2-3 cm, depending on the diameter and the
flow/the pressure of the vein. Thick branch-offs of auxiliary side branches
were additionally treated with single-shot glue. The maximal diameter of treated
truncal veins was 2-3 cm, also venous aneurysms, ectatic veins and perforators
were treated.
The
follow-up observation period in our study was up to 76 months.
The great
saphenous vein was treated in 1492 cases, in 560 cases the small saphenous vein
was treated and in 103 cases the trunk of an inguinal accessories vein was
sealed. Two of Giacomini`s veins and four femoropopliteal veins also were
treated.
VenaSeal®
interventions were performed under light sedation with Dormicum or local
anesthesia for venous access accompanied by music therapy, 119 patients (10.3%)
didn't get any anesthesia or sedation. One patient performed pain acupuncture
on herself.
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/70-90th
day as well as after 6 and 12 months. After this, we controlled every following
year. Nearly all duplex sonography examinations post-intervention was done by
another colleague, not by the vascular surgeon treated the truncal veins (Figure 3).
RESULTS
During the
time period from 1st August 2012 to 31st January 2019 (78 months), Venaseal®
was applied to achieve closure of the vein in 2162 truncal varicose veins. In
345 patients one saphenous vein was treated; in 661 patients two saphenous
veins were treated; in 126 patients 3 saphenous veins were treated. In 26 cases
4 truncal veins and in two cases 5 veins, in one case 6 truncal veins were
treated simultaneously.
Grade 2-3
saphenous varicosis of the GSV according to Hach, and in the case of the SSV
and acc. saphenous varicose veins grade 2 to Hach, was the inclusion criterium.
In accessory veins, we treated the inguinal trunk in length between 15-30 cm.
On the 1st
day, all 2162 veins were checked (2147 veins were closed initially=99.31%) in the scope of follow-up and
up to the 30th day, partial recanalization was found in 41 veins and complete
recanalization was found in 10 veins. This corresponds to a closure rate of 97.64%.
Over a time
period of 3 months up to 4 months after the treatment, we were able to follow
up 1627 saphenous veins (75.2% of all veins that had been treated) and here we
found 43 partial and 16 complete recanalizations. The closure rate is thus 97.27%.
In 1408
saphenous veins (65.1%) were followed up over a 6-8 month time period and 50
partial and 29 complete recanalizations were found, resulting in the
effectiveness of 96.35% (Figure 4).
No further
recanalizations were found after 78 months.
In the
follow-up period of 5 years after therapy we controlled 1255 truncal varicose
veins (58.0%) up to now.
All 12 leg
ulcers were healed until to 12 weeks after intervention.
2162
truncal varicose veins having been sealed with Venaseal®, the
results achieved over the entire time period of 78 months are equivalent to a
closure rate of 96.35%.
The pain
score (range 1-10) for subjectively felt pain on the 1st day post -
sealing was between 1.6 and 3.4 (2.1) - in RFITT between 3.8 and 4.1.
In 174
treated veins (7.9%), we observed a postoperative unspecific inflammatory skin
reaction after approx. 10-14 days in the Venaseal group; with appropriate
antiphlogistic treatment with ibuprofen and ethanolic cooling bandages, 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 11 cases, we have seen a
lymphatic fistula at the peripheral punction.
In
particular, even subcutaneously situated
saphenous veins could be glued without any significant skin reaction
(reddening, swelling).
We also
clearly prefer Sealing in the treatment of SSV and now also in GSV due to a large
number of neurological sensations in connection with treatment by Laser and
Radiofrequency [11,12] (Figures 5 and 6).
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 min after the
intervention.
In the case
of non-tumescent, non-thermal sealing we have up to now refrained from applying
compression therapy in over 95% of all cases. We prefer to use compression
stockings only in cases, the diameter of the treated vein is over 1.5 cm or in
the treatment of a venous aneurysm or ectatic varicose veins.
DISCUSSION
In the last
20 years, the necessary quality criteria for endovascular interventions on
veins with varicose changes were largely laid down, and several comparative
studies on functional efficiency of radical stripping surgery on the one hand
and endovenous treatments, on the other hand, were furthermore conducted. By
now, it has emerged as an undeniable fact that endovenous interventions do not
only exhibit a merely cosmetic advantage as was hitherto assumed. They 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.
Thus, the
colleagues who work with endovenous procedures meanwhile have reliable criteria
for a high - quality therapy [1,4,6,12-16].
The
VenaSeal® - closure procedure is the newest technical development in
the series of endovenous therapeutic procedures. Although it is a
catheter-based procedure in terms of the basic principle of the therapeutic
approach, it differs fundamentally with regard to the closure technique. While
the glue likewise gives rise to a certain temperature (approx. 45-50°C), the
procedure is not a thermal one. Side effects as those known to occur in
connection with laser and radio wave therapy ultimately play no significant
role here. The necessary reliable closure is achieved by means of non-tumescent
non-thermal cyanoacrylate superglue, the basic chemical formula of which has
been known since several decades, and which is being used in neuroradiology in
the treatment of vascular malformations since 1981. We also worked with this
glue since 1988 in vascular surgery at the Charitè hospital.
By the way
- the sealing therapy is not a new idea - also in the Golden Twenties, German
surgeons and phlebologists were sealing truncal varicose veins with glucose
solution. Also, the world known surgeon Ferdinand Sauerbruch was a friend of
sealing, Since 1928/1929 all patients in Sauerbruch`s hospital Charitè Berlin,
treated by truncal varicose veins, were sealed [17].
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 sealing therapy
in larger lumens measuring 1.5 cm and more, ectatic veins, junction aneurysms
and also perforator veins.
The
significantly reduced side effects and a well - nigh negligible pain score are
also clear advantages in comparison with laser and radio wave therapy. No
paresthesias, no hypesthesias, no phlebitis, the extremely rare occurrence of
skin pigmentations are only a few of the important advantages of the VenaSeal®
- procedure.
In the
final analysis, the new procedure has to meet solely the hard criterion of
efficacy, namely the permanence of an effective vein closure. And as far as
this aspect is concerned, both the first results of the eSCOPE study [15] and the results of single-center studies and also
currently of the VeClose study [14]
are very good. The closure rate is similarly high as that achieved with radio
waves, namely between 93-100% when all results are summarized.
Thus, the
Sealing procedure appears to be on the same level with, or even superior to the
high-frequency radio wave system [5,18]. In the time periods between 12 and 36
months covered by follow-up examinations up to now, both procedures have proven
quite clearly superior (99.6%) [13,15,18] to laser therapy in terms of
effectiveness.
The results
of first comparative studies show that the vein 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 [12]. Particularly pain, as well as
the neurological side effects, no longer plays any significant role at all.
These are the main problem associated with laser and radio wave therapy though,
especially in the therapy of lower leg veins like SSV (Figure 7).
By now,
VenaSeal® has undeniably become at SAPHENION the therapy of the
first choice for the treatment of the SSV. Here, we meanwhile consider the
well-known risk of neurological side effects and complications associated with
the application of the laser and radio frequency techniques as being too high
[3-6,13-15,18].
In the
light of the 18 years of experience, we have gathered by now, we recommend that
every vein center that applies endovenous treatment should have at least 2
alternative treatment procedures at its disposal. For us, this means that in
practical work with VenaSeal®, all insufficient saphenous veins
should as far as possible always be treated in one session.
Independently
of this and including all experiences with modifications of the sealing
technique we at SAPHENION® meanwhile regard the non-tumescent, non-thermal
Sealing Therapy as treatment of the first choice in the range of catheter -
supported therapeutic procedures in truncal varicose veins GSV, SSV or VSAA -
varicosis.
And we see
this method as a very good method also in ultrasound-guided treatment of
aneurysmatic and receive junctions and perforator veins.
CONFLICT OF INTERESTS
There are
no conflicts of interest; the present research paper was not sponsored.
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