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The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins


Abstract and Figures

Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither tumescent anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P < .0001). Side effects were generally mild; a phlebitic reaction occurred in eight cases (11.4%) with a median duration of 6.5 days (range, 2-12 days). Pain without a phlebitic reaction was observed in five patients (8.6%) for a median duration of 1 day (range, 0 -12 days). No serious adverse event occurred. Paresthesia was not observed. Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of tumescent anesthesia or compression stockings.
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From the American Venous Forum
The European multicenter cohort study on
cyanoacrylate embolization of reuxing great
saphenous veins
Thomas Michael Proebstle, MD,
Jens Alm, MD,
Sameh Dimitri, MD,
Lars Rasmussen, MD,
Mark Whiteley, MS, FRCS (Gen),
James Lawson, MD,
Daniel Cher, MD,
Alun Davies, MA, DM, FRCS, FEBVS,
Mainz and Hamburg, Germany; Chester, Guildford, and London,
United Kingdom; Naestved, Denmark; Alkmaar, The Netherlands; and Palo Alto, Calif
Objective: Cyanoacrylate (CA) embolization of reuxing great
saphenous veins (GSVs) has been previously described. The
outcomes from a multicenter study are still lacking.
Methods: A prospective multicenter study was conducted in
seven centers in four European countries to abolish GSV
reux by endovenous CA embolization. Neither tumescent
anesthesia nor postinterventional compression stockings were
used. Varicose tributaries remained untreated until at least
3 months after the index treatment. Clinical examination,
quality of life assessment, and duplex ultrasound evaluation
were performed at 2 days and after 1, 3, 6, and 12 months.
Results: In 70 patients, of whom 68 (97.1%) were available for
12-month follow-up, 70 GSVs were treated. Two-day follow-
up showed one proximal and one distal partial recanalization.
Three additional proximal recanalizations were observed at
3-month (n [ 2) and 6-month (n [ 1) follow-up. Cumulative
12-month survival free from recanalization was 92.9% (95%
condence interval, 87.0%-99.1%). Mean (standard deviation)
Venous Clinical Severity Score improved from 4.3 % 2.3 at
baseline to 1.1 % 1.3 at 12 months. Aberdeen Varicose Vein
Questionnaire score showed an improvement from 16.3 at
baseline to 6.7 at 12 months (P < .0001). Side effects were
generally mild; a phlebitic reaction occurred in eight cases
(11.4%) with a median duration of 6.5 days (range, 2-
12 days). Pain without a phlebitic reaction was observed in
ve patients (8.6%) for a median duration of 1 day (range, 0 -
12 days). No serious adverse event occurred. Paresthesia was
not observed.
Conclusions: Endovenous CA embolization of reuxing GSVs
is safe and effective without the use of tumescent anesthesia or
compression stockings. (J Vasc Surg: Venous and Lym Dis
Endovenous thermal ablation (EVTA) by radiofre-
quencyorlaserisasafeand effective treatment of
reuxing great saphenous veins (GSVs) and has replaced
traditional high ligation and stripping in ofcial recom-
mendations of various leading Vascular Societies in the
United States
and the United K ingdom.
EVTA certainly is a successful treatment modality with
limited downtime,
it requires the use of perivenous
tumescent anesthesia and can still cause a variety of
side effects like postoperative pain, bruising, and sensory
nerve damage.
As an alternative treatment without
the use of tumescent local anesthesia, foam sclerother-
apy has also been engaged for treatment of reuxing
saphenous veins, but anatomic 1-year success rates
have been report ed dis appoi ntingly low on the order
of 70%.
From the Department of Dermatology, University Medical Center, Mainz
the Dermatologikum Hamburg, Hamburg
; the Countess of Chester
Hospital, Chester
; The Danish Vein Centers, Naestved
; The Whiteley
Clinic, Guildford
; the Centrum Oosterwal, Alkmaar
; Wild Iris Consul-
ting LLC, Palo Alto
; and the Imperial College London, London.
This study was funded by Sapheon, Inc (Morrisville, NC).
This trial (NCT01570101) was registered in March 2012 (before enroll-
ment began) on
Author conict of interest: All authors except D.C. received research sup-
port associated with the reported study. D.C. is a consultant to Sapheon.
In addition, T.P. and J.A. are consultants to the sponsor. T.P. and S.D.
are stock owners of the sponsor.
Presented in part at the Twenty-fth Annual Meeting of the American
Venous Forum, Phoeni x, Ariz, February 27-March 2, 2013; the XVII
World Meeting of the International Union of Ph lebology (UIP), Boston,
Mass, September 8-13, 2013, where it received th e UIP Gold Award; and
the Twenty-sixth Annual Meeting of the American Venous Forum, New
Orleans, La, February 19-21, 2014.
Reprint requests: Thomas Michael Proebstle, MD, Department of Derma-
tology, University Medical Center Mainz, Langenbeckstr 1, 55131
Mainz, Germany (e-mail:
The editors an d reviewers of this art icle have no relev ant nancial rela-
tionships to disclose per the Journal policy that requires reviewers to
decline review of any manuscript for which they may have a conict
of int e rest .
Copyright Ó 2015 The Authors. Published by Elsevi er Inc. on behalf of the
Society for Vascular Surgery. This is an open access article under the CC
BY-NC-ND license ( -nd/3.0/).
An embolizing treatment of reuxing GSVs using a
specic cyanoacrylate (CA) adhesive has recently been
described, and 2-year follow-up of rst-in-man use has
just been reported.
Endovenously delivered CA immedi-
ately occludes the vessel. It elicits a granulomatous foreign
body reaction and a concomitant inammatory vein wall
reaction, leading to subsequent brotic degradation.
as a well-understood substance
already in use in other
medical devices is potentially advantageous for abolition of
saphenous vein reux because (1) it does not require the
use of tumescent anesthesia; (2) by chemically bonding
vein walls to each other, it obviates the need for postinter-
ventional compression stockings; and (3) it precludes the
risk of treatment-related sensory nerve damage.
This paper describes the 1-year-results of the prospec-
tive European multicenter cohort study that was initiated
in December 2011, shortly after approval by European reg-
ulatory authorities (CE mark) and subsequent commercial-
ization of endovenous use of CA adhesive.
Study design. This prospective, multicenter clinical
study on endovenous CA embolization of reuxing GSVs
(NCT01570101) was performed in seven specialized vein
centers in four European countries. Each site obtained local
ethics committee approval before initiation, and all partici-
pants signed an ethics committee-approved, study-specic
informed consent form before participation. Consecutive
patients were included if they had symptomatic GSV
incompetence with or without visible varicosities conrmed
by duplex ultrasound imaging and a Clinical, Etiologic,
Anatomic, and Pathologic (CEAP) stage of C2, C3, or C4.
Additional inclusion and exclusion criteria were used as
listed in Table I. Before treatment, patients underwent
clinical examination, including CEAP classication and
Venous Clinical Severity Score (VCSS) and duplex ultra-
sound examination of the vein system; in addition, patients
completed the EQ-5D quality of life survey
and the
Aberdeen Varicose Vein Questionnaire (AVVQ).
tients returned to the clinic at 48 hours and at 1, 3, 6, and
12 months. At each clinic visit, patients underwent physical
examination, CEAP classication, VCSS, and assessment of
potential adverse events and duplex ultrasound examina-
tion of the target limb. All physical examinations and
duplex ultrasound examinations were performed by the
local investigator or by staff under his supervision. Patients
also completed EQ-5D and AVVQ. Reintervention and
adjunctive vein treatment for potentially remaining tribu-
taries at the target limb were disallowed until after the 3-
month visit was complete.
Procedure technique. Endovenous embolization of
the GSV with the proprietary Sapheon VenaSeal (Sapheon
Inc, Morrisville, NC) CA adhesive and delivery system was
performed as described previously.
In brief, the delivery
system consists of a 7F introducer sheath/dilator, a 5F
delivery catheter, a 3-mL syringe, and a dispenser gun. The
5F delivery catheter has a hydrophobic coating to prevent
adhesion to delivered CA as well as air-lled microchannels
to enhance sonographic visibility. Each pull of the trigger
delivers 0.09 mL of CA. Sapheon CA is a custom formu-
lation of CA, having properties of rapid polymerization
when it is exposed to an aqueous environment, high vis-
cosity, and plasticizers to enhance exibility in its nal
polymerized state. The GSV is accessed at the distal point
of reux percutaneously with a micropuncture introducer
kit (Cook, Bloomington, Ind), followed by insertion of a
0.035-inch J guidewire (Cook). With use of ultrasound
control, a 7F introducer sheath/dilator is advanced to the
saphenofemoral junction (SFJ) and positioned approxi-
mately 5 cm caudal to the SFJ. The distance of 5 cm was
Table I. Eligibility criteria
Inclusion criteria
Age $18 years and #70 years
Symptomatic primary GSV incompetence diagnosed by clinical symptoms, with or without visible varicosities, and conrmed by duplex
ultrasound imaging
GSV on standing preprocedure Doppler ultrasound examination $3 mm and #10 mm (maximum diameter)
CEAP classication of C2, C3, or C4
Ability to walk unassisted
Ability to attend follow-up visits
Ability to understand the requirements of the study and to provide written informed consent
Exclusion criteria
Life expectancy <1 year
Regular pain medication
Anticoagulation including heparin or coumadin
Previous deep venous thrombosis
Previous supercial thrombophlebitis in GSV
Previous venous treatment on target limb
Known hypercoagulable disorder
Conditions that prevent routine vein treatment, like acute disease, immobilization or inability to ambulate, and pregnancy
Tortuous GSV that will limit catheter placement in the opinion of the investigator ($2 primary access sites are not allowed)
Incompetent ipsilateral small saphenous vein or anterior accessory GSV
Known sensitivity to the CA adhesive
Participation in another clinical study involving an investigational agent or treatment within 30 days of enrollment
CA, Cyanoacrylate; CEAP, Clinical, Etiologic, Anatomic, and Pathologic classication; GSV, great saphenous vein.
Volume 3, Number 1
Proebstle et al 3
chosen both to give space for ultrasound compression be-
tween the delivery catheter and the SFJ and to allow slight
glue propagation toward the SFJ after injections. The 3-
mL syringe containing CA extracted from its shipping
vial is attached to the delivery catheter. The catheter is
primed with the dispenser gun to ll all but the nal 3 cm
of catheter tubing. The primed delivery catheter is inserted
into the introducer sheath and secured with a spin-lock
mechanism. Then 5 cm of the catheter tip is exposed
distal to the sheath tip and positioned 5 cm from the SFJ.
After leg elevation of about 15 degrees, CA delivery con-
sists of an initial double CA injection spaced 1 cm apart,
followed by a 3-cm pullback and 3-minute localized
compression directly over the injected vein segment.
Repeated injections of CA followed by pullbacks of 3 cm
and 30-second localized compressions of delivered CA
then take place until the entire targeted vein segment is
treated. The catheter is removed and compression applied
to the catheter entry site until hemostasis is achieved. A
single small bandage is applied, and venous occlusion is
conrmed by duplex ultrasound. Patients were discharged
and instructed to resume normal activities, avoiding
strenuous activities for 1 day.
Statistical evaluation. As CA embolization is a novel
embolization technique in the eld of venous disease, the
studys primary end point was the proportion of patients
with complete occlusion of the target vein at 6-month
duplex ultrasound evaluation. Whereas closure of the
target vein promotes improved clinical symptoms in almost
all patients, some cases have improvement already with
only partial closure. For this reason, direct assessment of
vein closure was chosen to be more informative compared
with clinical scores with respect to a more accurate measure
of the devicesefcacy.
Complete occlusion was dened as no segments of
patency longer than 10 cm.
As a secondary analysis of
the complete occlusion rate, the proportion of patients
with freedom from >10 cm of recanalization was tabulated
by life-table methods and plotted with Kaplan-Meier anal-
ysis. The studys secondary end point was the rate of all
adverse events. Changes from baseline in VCSS, AVVQ,
and the general quality of life tool EQ-5D were evaluated
by repeated measures analysis of variance. P values < .05
were considered statistically signicant. Calculations were
performed with SAS (version 9.0; Cary, NC) or R.
Between December 2011 and July 2012, 70 patients
were enrolled. Participating centers in the order of authors
included 20, 15, 11, 10, 7, 4, and 3 patients, respectively.
Fifty-ve patients (78.6%) were women; mean (range) age
and body mass index were 48.4 years (22-72 years) and
25.6 (18.9-43.4), respectively. Mean GSV diameter at
the SFJ was 7.8 6 2.1 mm (range, 6.6-14.0 mm). General
risk factors included a family history of venous disease (n ¼
21), cigarette smoking (n ¼ 9), hypertension (n ¼ 5),
abnormal blood lipids (n ¼ 4), obesity (n ¼ 4), and dia-
betes mellitus (n ¼ 3).
Anatomic results. All enrolled patients received a
technically successful study procedure. Thirty-four pa-
tients (49%) underwent treatment of the left GSV. Forty
patients (57%) had no ultrasound-detectable tributaries in
the treatment zone; 23 (33%) had one or two tributaries,
and seven (10%) had more than two tributaries. Four pa-
tients (6%) had perforating veins in the treatment zone. All
tributaries or perforators were left untreated for at least
3 months after study treatment. Mean treated vein length
was 37.6 cm (range, 7-72 cm). Average net treatment time
measured from catheter in to catheter out was 18.6 mi-
nutes (range, 8-74 minutes). Immediately after the pro-
cedure, all but one patient had complete closure of the
target GSV. This single case still showed ow in the
proximal 20 cm of the GSV fed through a large tributary
entering at the distal point of ow. To achieve full
occlusion, foam sclerotherapy was injected immediately,
resembling a protocol deviation. At 48 hours, this GSV was
fully occluded and remained so during 12 months of
Sixty-eight patients (97.1%) were available for the 12-
month visit. During 12 months of follow-up, a total of
ve patients were detected with partial recanalization,
dened as patency in the treated segment by duplex ultra-
sound examination of more than 10 cm. Two of these pa-
tients had recanalization observed at 48 hours of follow-up,
two at 3 months, and one at 6 months. All but one case
showed patency originating at the SFJ; this case, which
had recanalization at the distal 20 cm of the CA-
embolized GSV segment, was noticed at 2-day follow-up.
The proximal part of the GSV in this case, however,
remained occluded until 12-month follow-up. The other
case with recanalization at 48 hours presented with a prox-
imal open GSV segment of 25 cm in length but was
observed closed at 1-month follow-up and recanalized
again after 3 months. The distal segment of the GSV, how-
ever, remained occluded until 12-month follow-up.
Fig 1. Survival free from recanalization of the target vein.
4 Proebstle et al January 2015
At 3 months of follow-up, two additional cases were
observed with a proximal GSV recanalization of 12 and
25 cm, respectively, both with a durable GSV occlusion
distally. The last recanalization at 6-month follow-up pre-
sented as a microchannel recanalization of the proximal
20 cm of the GSV. Noteworthy, none of the patients
with recanalization appeared to become clinically symp-
tomatic, and all recanalizations had junctions with large
tributaries. By life-table methods, the 12-month complete
occlusion rate was 92.9% (95% condence interval,
87.0-99.1%) (Fig 1).
Clinical improvement. Patients showed signicant
improvement of venous symptoms after GSV embolization.
VCSS improved from a mean of 4.3 at baseline to 1.1 at
12 months (Fig 2); changes in VCSS from baseline were
statistically signicant for all follow-up intervals (P <
.0001). There was no statistically signicant difference
between patients showing sustained occlusion of the once
embolized GSV and those who experienced a partial
recanalization during follow-up.
Remarkably, as indicated by VCSS subdomain scores,
the proportion of patients whose target limbs were free
from visible varicosities increased from 1.4% at baseline to
41.4% at 3 months of follow-up. Even more pronounced
in the same period, the proportion of patients free from
edema and pain increased from 41.4% and 32.9% at base-
line to 90.0% and 82.1%, respectively. The improvements
were largely preserved during 12-month follow-up (Fig 3).
Similarly, quality of life scores showed signicant
improvement (Table II). EQ-5D, which was modestly
depressed at baseline, improved at all follow-up visits to
near-maximum levels (P ¼ .0009). AVVQ score also
improved signicantly from a baseline value of 16.3 to
6.7 at 12 months (P < .0001).
Side effects. Adverse events were mild and self-
limited. Eight patients (11.4%) had a postprocedure phle-
bitic reaction along the treated vein or its tributaries
dened as reddening of the overlying skin and pain on
palpation. The median onset of symptoms was observed
6 days (range, 3-11 days) after the procedure; the median
duration was 6.5 days (range, 2-12 days). Pain without
phlebitic reaction was noticed in ve patients (8.6%) for a
median duration of 1 day (range, 0-12 days), starting at a
median of 0 days (range, 0-3 days) after the procedure.
Specic treatment of phlebitic reactions was under the
discretion of the treating physician, but only two patients
under this condition received nonsteroidal anti-
inammatory drugs for 2 and 15 days, respectively. No
serious adverse event occurred, and moreover, paresthesia
was not observed.
One patient (1.4%) developed a localized infection at
the access point, and one (1.4%) had minor access point
bruising. Finally, one patient (1.4%) had diagnosed prostate
cancer 6 months after study treatment, which was deemed
not related to the study treatment. One patient (1.4%)
had glue extension measuring 6 mm beyond the SFJ recog-
nized immediately after the procedure and still present at 1-
year follow-up. Low-molecular-weight heparin was given
for 2 weeks with spontaneous resolution. Thrombus exten-
sions into the deep vein system were not observed.
EVTA is currently the gold standard for treatment of
GSV reux and is recommended as rst-line therapy in the
United States
and the United Kingdom.
Whereas EVTA
produces high venous occlusion rates with limited down-
it requires at least perivenous tumescent anes-
thesia, which can cause postoperative pain, bruising, and
other complications, such as sensory nerve damage,
even if the last risk is difcult to differentiate from heat
damage during endothermal treatment. Ultrasound-
guided foam sclerotherapy is also widely used because of
its low cost and high versatility, but success rates for
Fig 2. Change in Venous Clinical Severity Score (VCSS) by time
since treatment.
Freedom from symptom (%)
Months after treatment
Fig 3. Proportion of patients free from varicosities, edema, and
pain at baseline and during study follow-up.
Volume 3, Number 1
Proebstle et al 5
treatment of the GSV are as low as 75%,
with frequently
needed repetitive treatment sessions. Sclerotherapy is also
marred by postprocedure inammation and staining, visual
and, rarely, stroke related to paradoxical
air embolism.
All of these treatments also require post-
operative graduated compression stockings to support
closure of the treated vein, compliance with which is well
known to be frequently poor, particularly in countries
with a predominantly sunny climate. Obviously, in our
study, CA embolization treatment of reuxing GSVs does
not necessarily require the use of graduated compression
stockings. However, in this study, what benet compres-
sion stockings could add under special circumstances like
CA embolization of huge-diameter veins has not been
formally evaluated. Unfortunately, we cannot say whether
their use might have prevented some treatment failures.
Shortly after completion of the feasibility study on rst-
in-man use of CA for GSV embolization,
this European
prospective multicenter cohort study was set up to obtain
anatomic and clinical data from seven centers in four
different countries, all with previous expertise in endother-
mal treatments of GSV reux. The CA delivery system re-
quires skill sets familiar to those who perform thermal vein
ablation. The proprietary formulation used in the current
clinical study was designed to have high viscosity, rapid
polymerization, and a rubber-like elasticity once polymer-
ized. The polymerized adhesive chemically bonds to the
apposed intimal walls of the vein, effectively embolizing
the vein by immediate closure. This, in general, is followed
by a subacute inammatory tissue response, a typical
foreign body reaction, leading to a brotic transformation
and degradation of glue and vein wall over time.
The closure rate reported herein was similar to that
observed in a prior feasibility trial
and mirrors the ef-
cacy of thermal techniques.
Per protocol, no adjunctive
therapy like foam sclerotherapy or phlebectomy was per-
formed until after the 3-month follow-up visit. Many com-
parable thermal clinical trials have allowed adjunctive
therapy even at the time of study treatment
or shortly
thereafter, theoretically increasing overall ef cacy of study
treatment. Remarkably, in the current study, we observed
that all ve cases of recanalization were somehow con-
nected to untreated tributaries with high blood ow or
even reux. Identication and potential treatment of those
large-diameter tributaries during the initial procedural visit
would likely have increased the efcacy of CA embolization
of GSVs during routine treatments. Noteworthy, in this
study, the anatomic results of CA embolization were
achieved without the use of tumescent local anesthesia or
graduated compression stockings. Even if not addressed
in the current study, C5 and C6 patients should also be
treatable by CA embolization as long as the principles of
sterile administration of the glue are respected in venous ul-
cer patients. As expected, paralleling anatomic success of
CA embolization, clinical outcomes measured by VCSS
as well as patient-rated disease-specic (AVVQ) and
generic quality of life measurements (EQ-5D) showed
marked improvement. Improvements were both statisti-
cally signicant and durable over the total follow-up time
of 12 months. On the other hand, adverse events were
generally mild and self-limited. Remarkably, unlike with
thermal ablation or classic surgery, paresthesia was not
recorded as a side effect of CA embolization in this study.
A phlebitic reaction in the treatment zone and in untreated
varicosities was the most common event in eight legs
(11.4%); however, only two patients used nonsteroidal
anti-inammatory drugs to ameliorate it. Pain as an adverse
event was noted in ve more patients, of whom four
required the use of analgesics. The rate of this kind of
adverse event was in the range of thermal ablation of the
In the prior study of CA for varicose vein emboliza-
21% of treated legs showed thrombus extension, sug-
gesting a risk of inadvertent glue embolization to the
pulmonary arteries. Even if it is clinically without meaning
and spontaneous resolution occurred without specic treat-
ment, these observations of extensions to the deep vein sys-
tem might have been a matter of concern to some
physicians. In the current study, with adjusted instructions
for use increasing the distance to the SFJ for placement of
the rst shot of CA, only one subject had a thrombus
extension of 6 mm into the common femoral vein, suggest-
ing that in conjunction with careful ultrasound monitoring
during the rst delivery of CA, glue embolization proxi-
mally can be reliably avoided. Treatment was 2 weeks
with low-molecular-weight heparin; the thrombus exten-
sion resolved thereafter without any clinical sequelae.
In this prospective multicenter study on endovenous
CA embolization of reuxing GSVs, CA proved safe and
efcient, without the use of perivenous tumescent anes-
thesia and without postprocedure compression stockings.
Table II. Subject-rated scores by study visit
Visit EQ-5D index EQ-5D change from baseline AVVQ AVVQ change from baseline
Baseline 84.8 (15.7) d 16.25 (7.99) d
Month 1 96.9 (7.1) 12.0 (15.9) 9.76 (7.62) 6.49 (8.16)
Month 3 96.8 (7.7) 12.0 (16.5) 7.62 (6.34) 8.63 (7.50)
Month 6 96.6 (7.7) 11.7 (17.3) 6.28 (5.83) 9.97 (8.36)
Month 12 94.5 (11.4) 9.5 (17.6) 6.67 (6.40) 9.64 (8.99)
AVVQ, Aberdeen Varicose Vein Questionnaire.
All values shown are mean (standard deviation).
6 Proebstle et al January 2015
However, further work is required to compare CA against
endothermal ablation in randomized controlled trials.
Conception and design: TP, AD
Analysis and interpretation: TP, AD
Data collection: TP, JA, SD, LR, MW, JL, DC, AD
Writing the article: TP, AD, DC
Critical revision of the article: TP, JA, SD, LR, MW, JL,
Final approval of the article: TP, JA, SD, LR, MW, JL, DC,
Statistical analysis: TP, AD, DC
Obtained funding: TP, JA, SD, LR, MW, JL, DC, AD
Overall responsibility: TP
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following peripheral venous interventions. Phlebology 2011;26:280-4.
Submitted Jul 25, 2014; accepted Sep 8, 2014.
Volume 3, Number 1
Proebstle et al 7
... Even though endovenous thermal ablation (EVTA) methods are safe and effective methods in the treatment of greater saphenous vein (GSV) insufficiency and have replaced high ligation and stripping, there are some limitations such as requiring perivenous tumescent anesthesia and side effects such as postoperative pain, burning, and sensory nerve damage. 1 Cyanoacrylate (CA), a wellknown chemical substance, has recently been used as an embolizing agent in the treatment of GSV insufficiency, and the results regarding the use of this method, which is based on granulomatous body reaction and fibrotic degradation due to accompanying vein wall inflammation, have started to be published. 2 In addition to the advantages of CA, which has a similar success rate with EVTA methods in the treatment of GSV insufficiency, such as not requiring tumescent anesthesia, eliminating the need for compression stockings, and absence of treatment-related sensory nerve damage, 1,3 the adverse events related to the procedure are also mild and limited. 1 To the best of our knowledge, the publications in literature do not mention about a significant negative effect of endovenous catheter ablation (EVCA) embolization. ...
... 2 In addition to the advantages of CA, which has a similar success rate with EVTA methods in the treatment of GSV insufficiency, such as not requiring tumescent anesthesia, eliminating the need for compression stockings, and absence of treatment-related sensory nerve damage, 1,3 the adverse events related to the procedure are also mild and limited. 1 To the best of our knowledge, the publications in literature do not mention about a significant negative effect of endovenous catheter ablation (EVCA) embolization. ...
... EVTA methods, which have recently replaced the classical surgery methods in the treatment of venous insufficiency and whose effectiveness and safety have been proven, are accepted as the gold standard in the treatment of this disease. 1 Various thermal ablation methods are among the frequently-used methods in the treatment of GSV insufficiency with high venous occlusion and similar success rates, [3][4][5] and we have also successfully applied endovenous laser ablation (EVLA) and endovenous readiofrequency (EVRF) treatments for a long time in our current practice. ...
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Background: Cyanoacrylate (CA) has been used as an embolizing agent in the treatment of greater saphenous vein (GSV) insufficiency in recent years and the results regarding the use of this method have started to be published. To the best of our knowledge, the publications in literature do not mention about a significant negative effect of endovenous CA (EVCA) embolization. We aimed to evaluate the effects and undesirable events of this relatively new treatment method and compare them with literature, using the follow-up data of our patients. Methods: Patients who had GSV insufficiency for at least 3 months and were treated with EVCA embolization because of this disease were included in the study. Patients were excluded if they had deep vein thrombosis (DVT), excessive tortuous GSV, and peripheral neuropathy. Hospital archive records were reviewed and undesirable events like DVT, thrombophlebitis, and pain related to this treatment procedure were recorded. Results: EVCA embolization procedure was performed in a total of 54 patients with an average age of 49.36 ± 13.06 years for the purpose of treating GSV insufficiency. One patient was observed to develop n-butyl CA (NBCA) extension of approximately 5 mm from saphenofemoral junction (SFJ) to the main femoral vein and painful thrombophlebitic reaction was observed in 6 extremities at the first control examination. Conclusion: In our opinion, while EVCA embolization is a treatment option with similar success rates to endovenous thermal ablation (EVTA), it should be kept in mind that there may be a possibility of developing thrombophlebitis and NBCA extension or thrombus extension to the deep veins.
... [6,7] Similarly, in the pioneer study of VenaSeal ™ in Europe -the eSCOPE study, seventy patients were evaluated and followed up at 6 months, 1 year, and 3 years. [8] The United States pivotal trial, VeClose, was , July 18, 2022, IP:] a prospective trial with a 1:1 randomization comparing VSCS to radiofrequency ablation (RFA, ClosureFast™ catheter, Medtronic). This trial was conducted at ten sites with 242 patients, out of which, 108 patients were treated with VSCS and followed up at day 3, 1, 3, and 12 months. ...
... Comparison of various studies[6][7][8][9][10][11][12] ...
Background: Varicose veins is a common disease in nearly 37.25% of the Indian population significantly affecting the quality of life. Endovenous thermal ablation has been the first-line treatment for superficial venous reflux. A new technique, available now, is nonthermal nontumescent vein sealing system (VenaSeal™), which comprises endovenous delivery of cyanoacrylate tissue adhesive into the vein causing obliteration of lumen and has shown better results in terms of safety and efficacy. Being a new modality, only handful of institutes across India perform this procedure and there is a scarcity of Indian data on its outcomes. Aims and Objectives: To evaluate the outcomes of VenaSeal™ glue ablation in terms of vein occlusion rates and improvement in Venous Clinical Severity Score (VCSS). Materials and Methods: Single-centre prospective study of fifty patients over 1 year and 4 months with 3- and 6-month follow-up. Results: The study showed the mean age of the study group to be 43.8 years and the majority (90%) had an early varicose vein (C2/C3) disease. The average length of vein treated per limb was 89.1 cm, and the average glue used per limb was 2.95 ml. All patients showed improvement in VCSS score from preoperative average of 2.6 ± 1.4 to 0.32 ± 0.19 (P < 0.0001, n = 89) with target vein occlusion rate of 100% at 3 months and 97.75% at 6 months. Conclusion: Thus, VenaSeal™ glue ablation procedure is a promising and effective modality for the treatment of varicose veins with excellent treatment success rates, minimal complications, and maximum patient acceptability. It is a feasible Out patient department (OPD) based procedure.
... [2][3][4][5] Many previous researches such as the eSCOPE trial and the VeClose study demonstrated the efficacy of CAC for the treatment of incompetent saphenous veins; however, the complications of CAC have not been well described. [6][7][8] Among them, phlebitis-like abnormal reaction (PLAR) is the most common complication and impairs the quality of life of patients. [9,10] This erythematous reaction is characterized by itching with pain, heating sensation, induration, erythema, and/or generalized hives. ...
... This is higher than the incidence reported in the American (16 to 20%) and European literature (11.4%). [2,6,7] In the present study, PLAR occurred in 15.5% of patients, similar to other studies. The benefit-risk ratio should be well considered in patients at high risk for PLAR following CAC procedure. ...
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Objectives: This study aims to evaluate the incidence of phlebitis-like abnormal reaction (PLAR), possible risk factors for the reaction, and the management of PLAR after cyanoacrylate closure (CAC) of great saphenous vein (GSV) or small saphenous vein (SSV) in patients with chronic venous insufficiency (CVI). Patients and methods: Between June 2020 and March 2021, a total of 90 patients (35 males, 55 females; mean age: 47.6±6.0 years; range, 28 to 69 years) who underwent CAC procedure for GSV or SSV insufficiency were retrospectively analyzed. The patients were divided into two groups: those with PLAR (Group 1) and no PLAR (Group 2). Both groups were compared in terms of possible risk factors. The primary goal was to evaluate the incidence, onset time, duration, severity and possible risk factors for PLAR and Venous Clinical Severity Score (VCSS) and Visual Analog Scale-Pain (VAS-pain) scores of the patients and to compare the groups one week after the procedure. The secondary goal was to evaluate the technical success, recanalization, mortality, major adverse events, and other postoperative complications. Results: No technical failure and device-related complications were encountered. Anatomic success rate was 100% after CAC procedures. The incidence of PLAR was 14 cases (15.5%). All mild or moderate PLARs occurred within a week of the procedures. During the six-month follow-up period, the target veins were completely occluded in all patients (100%) without any recanalization. Although older age (p=0.042), female sex (p=0.145), obesity (p=0.145), and history of drug allergy (p=0.131) were more common in the PLAR group, they did not reveal statistical significance. Logistic regression analysis revealed that no dependent variable was a risk factor associated with the development of PLAR. All PLAR cases were seen in the target GSV. Improvement in the VCSS scores were not statistically significant between baseline and the one-week control between two groups. Conclusion: Although PLAR can be seen at high incidence rates, it is a preventable complication with various technical modifications applied during CAC procedure as treatment strategies. According to the present results, no dependent variable was found to be a risk factor for development of PLAR and a risk model could not be devised for the development of PLAR according to any dependent variable. Keywords: Cyanoacrylate, hypersensitivity reaction, inflammation, phlebitis, varicose veins.
... It typically resolves within 2 weeks. 35 Localized ecchymosis, tightness, and PLAR were found more frequently in our elderly patients, although there was no statistically significant difference between the age groups. PLAR was a mild to moderate severity and well-tolerated occurrence in both groups, with erythema and itching limited to the skin overlaying the treated target vein. ...
Objectives Cyanoacrylate closure (CAC) procedure has become an alternative treatment method that has become increasingly popular in the treatment of chronic venous insufficiency (CVI) in recent years. The present study was designed to assess the feasibility, tolerance, results, and efficacy of CAC for truncal varicosities in elderly population. Methods In this retrospective single-center observational cohort study, CAC procedure was performed in 160 patients (184 limbs) with truncal varicose vein insufficiency. The patients were divided into two groups: elderly group, and younger group. The primary outcome of this study was to assess the feasibility, tolerance, and safety of the CAC procedure for truncal varicosities in elderly population over 70 years. The Venous Clinical Severity Score (VCSS), visual analogue scale of pain (VASP) and occlusion rate of the treated target veins of the patients were evaluated and compared among groups. The secondary outcomes were to evaluate and compare technical success, mortality, major adverse events, and other postoperative complications between the groups. Results All operations were carried out under local anesthesia. There were no technical failures or device-related complications. Anatomic success rate was 100% after procedures. The occlusion rate for the elderly group at 2 weeks, 6 months, and 12 months was 100%, 92.3%, and 92.3%, respectively, while the occlusion rate for the younger group was 100%, 97%, and 94.7%, respectively. There was no significant difference in occlusion rates between two groups (p > .05) (Log Rank = 0,231). Improvement in the VCSSs was statistically significant between baseline and 12 months after procedure in both groups (p < .001). Improvement in the VASPs was statistically significant between baseline and 2 weeks after procedure in both groups (p < .001). There were no symptoms or signs of sural nerve injury, hematoma, or phlebitis in either group. Conclusions Although it has some potential risks, it is conceivable that the CAC procedure may be applied in selected fit elderly patients for the treatment of CVI. Age appeared to have no effect on the early and mid-term prognosis of the CAC procedure performed in the study cohort.
... О возможности применения технологии VenaSeal в клинической практике сообщается в исследования х easibility и eSCOPE [21,[24][25][26][27][28], которые проводились сравнительно на небольшом количестве пациентов (38 и 70 человек соответственно). Срок наблюдения составил 36 мес. ...
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Introduction . Over the past decade, thermal tumescent (TT) ablation became the “gold standard” treatment of varicose veins. Non-thermal non-tumescent (NTNT) methods emerged in response to minimize the interventional invasion. Aim. To evaluate the two-year results of cyanoacrylate adhesive closure (CAC). Methods . Between July 2019 and July 2021, CAC was performed in 457 patients (average age 57.8 ± 15.7 years), on 634 limbs and 725 saphenous veins. Patient distribution according to CEAP was: C2 – 38%; C3 – 37%; C4 – 19%; C5 – 4%; C6 – 2%. The inclusion criteria were: incompetence of sapheno-femoral/popliteal junction and axial reflux > 0.5 sec, diameter of saphenous trunk > 6 mm, presence of varicosities. CAC was performed according to the protocol of the American Vein Closure System In more than 2/3 of cases (76.2%), CAC was performed selectively without tributary treatment . The pain was assessed by visual-analogue scale (VAS). The control ultrasound was performed on the 3rd day, 1, 3, 6, and 12 months post-intervention. Results . Anatomical success was achieved in 100%. The VAS pain score was < 3 in 93% of patients. Partial recanalization occurred in 4 (0.6%) patients. Distal deep vein thrombosis was detected in 2 (0.3%) patients, migration of glue – in 7 (1%) patients, phlebitislike skin reaction – in 50 (11%), superficial thrombophlebitis – in 20 (4.4%) and soft tissue granuloma at the access site was diagnosed in 6 (1.3%) patients. Conclusion . CАC is a highly effective and safe treatment method with 99.4% occlusion rate in s. two-year follow-up period.
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N-butylcyanoacrylate ablation, along with mechanochemical ablation, is one of the best-known non-thermal ablation treatment methods for varicose vein. N-butyl cyanoacrylate ablation is comparable to thermal ablation in terms of efficacy and safety, and offers the benefit of not requiring tumescent injections and the use of compression stockings. N-butyl cyanoacrylate (NBCA) is a liquid monomer that undergoes an exothermic polymerization reaction to form a solid upon initiation with hydroxyl anions. A new technique for venous insufficiency is non-thermal ablation with vein sealing system which comprises the endovenous delivery of cyanoacrylate tissue adhesive to the vein causing fibrosis.
Chronic venous disease is a common disease, the prevalence of which increases with age, and can cause debilitating symptoms that adversely affect the quality of life. The risk factors include family history, female sex, obesity, pregnancy, parity, and history of deep vein thrombosis. Moreover, it is associated with venous obstruction, reflux, or both, which, in turn, leads to ambulatory venous hypertension. Chronic venous disease is the leading cause of leg ulcers, which place a significant cost burden on the health care system. Compression therapy remains the cornerstone of treatment, particularly for more advanced disease. Superficial saphenous vein reflux can be associated with significant symptoms. Catheter techniques, both thermal and nonthermal, have demonstrated efficacy and safety in successful closure and symptom improvement. Deep vein obstruction can be broadly divided into thrombotic and nonthrombotic and can lead to symptomatic chronic venous disease. Recanalization using balloons and stents has been increasingly used and studied in such patients. It is critical to develop training opportunities and guidelines to improve evidence-based and appropriate care for cardiologists treating chronic venous disease.
The authors present a review on endovasal techniques applied for the treatment of varicose veins in the lower extremities. These techniques are minimally invasive, though are not universal. They still have complications and relapses. To select the most effective one among them is not an easy task. We are facing the need to improve the existing modalities and to look for the new ones aimed to personalize care for each patient.
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Cyanoacrylate glue closure (CAC) is being increasingly used as a minimally invasive procedure for the treatment of symptomatic incompetent saphenous veins. The most common adverse event associated with CAC has been phlebitis, including hypersensitivity phlebitis, superficial thrombophlebitis, and granulomatous phlebitis. This complication can be serious and debilitating. In the present report, we have described a case of symptomatic septicemia after CAC that required surgical excision of the treated saphenous veins.
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We reported a case of endovenous glue-induced thrombosis (EGIT) in treating small saphenous varicose veins using cyanoacrylate closure (CAC). The polymerized cyanoacrylate (CA) extended to the gastrocnemial vein (GCV), forming a fresh thrombus. The patient was an 80 yo woman and complained of frequent calf muscle cramping. Preoperative duplex scan findings showed reflux in the left below-knee great saphenous vein (GSV) and left small saphenous vein (SSV). CEAP classification and revised VCSS were (C3-S Ep As,p,d Pr GSVb, SSV) and 3, respectively. We used a total of 11 glue drops in SSV (15 cm) and below knee GSV (15 cm) during CAC. At two weeks after CAC, we confirmed the occlusion of left SSV and below knee GSV, and found the extension of the polymerized CA to GCV and the formation of thrombus. Because the patient complained of the mild tightness of the left leg at 23 days after CAC, we prescribed oral anticoagulant until 45 days after CAC, the day of the disappearance of thrombus. Since SSV often has various networks, preoperative anatomical diagnosis is essential. It is necessary to keep in mind that EGIT can occur in cases where GCV merges to SSV.
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To evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins. Incompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous tumescent anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months. Of 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836-1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively (p < .0001). Edema improved in 89% of legs (n = 34) at 48 hours follow-up. At baseline, only 13% were free from pain. At 6, 12 and 24 months, 84%, 78% and 64% were free from leg pain, respectively. The first human use of endovenous cyanoacrylate for closure of insufficient great saphenous veins proved to be feasible, safe and effective. Clinical efficacy was maintained over a period of 24 months.
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Cyanoacrylates, a group of rapidly polymerizing adhesives, have found widespread uses in oral and general surgery as well as surgical subspecialties, for example as hemostatic and anastomotic agents. They have been utilized most recently as materials for embolotherapy of complex cerebral and extra-cerebral vascular anomalies. The histopathology that results from their deposition in human tissues is thus an important consideration, and the subject of this review. Particular attention is given to the fate of cyanoacrylates in cerebral lesions after iatrogenic embolization procedures. The apparent toxicity of these plastics on blood vessel walls is discussed in relation to experimental observations. It is imperative that clinicians who use this group of substances evaluate their potential functions in the light of the pathologic findings.
Varicose veins in the lower limbs are a common problem, estimated to affect at least a third of the UK population.1 Although some individuals with varicose veins remain asymptomatic, others may experience pain, aching, heaviness, and itching, that can impair quality of life.2 3 About 10% of people with varicose veins go on to develop skin changes, such as pigmentation or eczema,4 while about 3% may develop venous ulcers.5 At present there is substantial variation across the UK as to who qualifies for referral or treatment, and how varicose veins are treated.6 Clear guidance on which individuals should be referred to specialist vascular services, as well as the most clinically effective and cost effective treatment, is required. This article summarises the most recent recommendations from the National Institute for Health and Care Excellence (NICE).7 NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets. ### Referral to a vascular service Refer people to a vascular service if they have any of the following:
The aim of this study was to evaluate occlusion rates of great saphenous veins (GSV) with a diameter between 5-10 mm that received a pre-treatment size reduction via perivenous tumescent application (TA) followed by catheter-directed foam sclerotherapy (CDFS). A prospective blinded randomized clinical trial comparing the occlusion rates of GSV at 1-, 6-, and 12-month follow-up. Fifty patients were included and randomized into two groups. CDFS was performed accessing the GSV at knee level and applying 8 mL of 2% polidocanol-foam (EasyFoam) while the catheter was withdrawn. Strictly perivenous TA was performed in group 1 before applying the sclerosant agent. Occlusion rates and clinical scores were assessed by blinded examiners. After 12 months in group 1 full occlusion was achieved in 73.9%, partial occlusion in 8.7%, and 17.4% were classified as treatment failure. In group 2, 75% of the targeted GSV were fully occluded, 20% were partially occluded, and 5% were diagnosed as treatment failure. Both groups showed a significant reduction of the vein diameter. Patient's tolerance and satisfaction with the treatment was high in both groups. No benefit could be found using additional TA to reduce the vein diameter before the treatment.
In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed In the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states (see Table 3). The data were collected using a visual analogue scale similar to a thermometer (see Table 2). The EuroQol Instrument Is Intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group.
Purpose: To conduct a pilot study to demonstrate a novel method of using a proprietary cyanoacrylate (CA) for closure of superficial veins. Materials and methods: Right and left superficial epigastric veins from two swine models were utilized due to the vein's similarities with the human great saphenous vein. Under ultrasound guidance, access was gained and a 5-F delivery catheter was advanced to the junction of the superficial epigastric and abdominus rectus veins. A dispenser gun was then utilized to inject 0.16 mL of CA while compression was applied cephalad to the end of the catheter. Immediately after delivery, the catheter was pulled back 3 cm and manual compression was employed for 30 seconds. After this first injection, the ultrasound probe was repositioned caudad to the injection and cephalad to the catheter tip and another 0.16 mL injection was delivered with immediate 3 cm pullback of the delivery system. Manual compression was applied at the caudad end of the treated vein for 30 seconds. This process was repeated until the entire target segment was treated. Results: At 30 days postimplantation, the treated veins were occluded with no evidence of recanalization or migration. Histological findings revealed that the lumen was dilated by coalescing, arborizing clear spaces with entrapped lytic erythrocytes, demarcated by a thin band of granular eosinophilic material. Spindle cells with dense eosinophilic matrix replaced the tunica intima and disrupted the tunica media. Conclusion: Results of this initial study demonstrated that intravascular injection of CA is feasible for closure of superficial veins in animal models. These findings warrant further animal studies of this proprietary CA to assess efficacy, safety and its effects on perivenous structures.