Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3727_Библиотеки_им_академика_М_И_Перельмана
.pdf
454 Chapter 44 Cyanoacrylate glue treatment of incompetent superficial truncal veins
https://t.me/med1917
44.5 A. Immediate postprocedural duplex ultrasound (DUS) image demonstrates patent supercial epigastric vein (red arrowhead) and
patent SFJ. Note the occluded GSV (red arrow) with homogenous CAG during the earlier phases of polymerization. B and C. One-week
postprocedure DUS demonstrating hyperechoic CAG casting an acoustic shadow (B, red arrow) and absence of ow (C). D. Six-week
postprocedural DUS demonstrating markedly hyperechoic CAG within the GSV due to complete polymerization of the CAG.
Tributary vein treatments such as phlebectomy or sclerotherapy can be performed simultaneously or staged based
on preprocedural shared decision making. Compression
therapy is required after the procedure if these adjunctive
procedures are performed simultaneously. Clinical and
venous duplex follow-up requirements vary according to
personal provider preferences, patient complaints, and
risk factors for venous thrombosis. Follow-up duplex
after a successful treatment must demonstrate hyperechoic material within the vessel, the corresponding
acoustic shadow/attenuation (Figures 44.5B and D), and
a lack of ow in the treated vein on color doppler (Figure
44.5 C).
44.7 CONCLUSION
CAG ablation is a nonsclerosant NTNT treatment for
symptomatic saphenous vein incompetence that is generally safe and effective. Although other commercial CAGs
exist, VenaSeal is the only FDA-approved CAG available
in the United States and is the product with the most published literature. Complications reported are mostly minor.
Postprocedural phlebitis is the most common adverse
event. But most of these resolve within days with NSAIDs
and conservative management. Hypersensitivity reactions
can occur with CAG, which can be managed by antihistamines and corticosteroids. Appropriate patient selection
and patient education are critical for optimal results.
Guidelines and Consensus Statement 44.0 of the American Venous Forum on cyanoacrylate glue treatment of the
incompetent supercial truncal veins*
No. Guidelines Grade of
44.1 For patients with symptomatic axial reux of the GSV, we recommend either thermal or nonthermal ablation from the groin to below the knee, depending on the
available expertise of the treating physician and the preference of the patient.
44.2 For patients with symptomatic axial reux of the SSV, we recommend either thermal or nonthermal ablation from the knee to the upper or mid-calf, depending on
the available expertise of the treating physician and the preference of the patient.
44.3 For patients with symptomatic axial reux of the AAGSV or PAGSV, we suggest
either thermal or nonthermal ablation, with additional phlebectomy, if needed,
depending on the available expertise of the treating physician and the preference
of the patient.
Consensus Statement
44.4 In patients with reux in the below-knee GSV, ablation to the lowest point of reux resulted in better early outcome. Nonthermal techniques are better for ablation of reuxing distal calf saphenous veins to avoid thermal nerve injury.
recommendation
1
(strong)
1
(strong)
2
(weak)
Quality of
evidence
B
(moderate)
C
(low to very low)
C
(low to very low)
* Based on recommendations of Reference 33.
REFERENCES
https://t.me/med1917
References 455
★ Systematic review
♦ Guidelines
♦ 1. Gloviczki P, Lawrence PF, Wasan SM, et
al. The 2022 Society for Vascular Surgery,
American Venous Forum, and American
Vein and Lymphatic Society clinical
practice guidelines for the management
of varicose veins of the lower extremities.
Part I. Duplex scanning and treatment
of supercial truncal reux: Endorsed by
the Society for Vascular Medicine and
the International Union of Phlebology. J
Vasc Surg Venous Lymphat Disord. 2023
Mar;11(2):231–261.e6.
★
2. Bissacco D, Stegher S, Calliari FM,
Viani MP. Saphenous vein ablation
with a new cyanoacrylate glue device:
A systematic review on 1000 cases.
Minim Invasive Ther Allied Technol.
2019;28(1):6–14.
3. Almeida JI, Min RJ, Raabe R, McLean
DJ, Madsen M. Cyanoacrylate adhesive
for the closure of truncal veins: 60-day
swine model results. Vasc Endovasc Surg.
2011;45(7):631–5.
4. Shaĭdakov EV, Mel’tsova AZ, Porem-
bskaia OI, Kudinova EA, Korzhevskiĭ
D, Kirik OV, et al. [Experience with
using cyanoacrylate glue in endovascular
treatment of varicose veins]. Angiol Sosud
Khir. 2017;23(4):62–7.
5. Parsi K, Kang M, Yang A, Kossard S. Granuloma formation following cyanoacrylate glue injection in peripheral veins and
arteriovenous malformation. Phlebology.
2020;35(2):115–23.
6. Park I. Human saphenous vein histopathology 2 years after cyanoacrylate
closure using the venaseal™ system. Ann
Vasc Surg. 2021;71:534.e17–21.
7. Parsi K, Roberts S, Kang M, Benson S,
Baker L, Berman I, et al. Cyanoacrylate
closure for peripheral veins: Consensus
document of the Australasian College of
Phlebology. Phlebology. 2020;35(3):153–75.
8. Almeida JI, Javier JJ, Mackay E, Bautista C,
9. Proebstle T, Alm J, Dimitri S, Rasmussen
10. Morrison N, Gibson K, Vasquez M, Weiss
11. Morrison N, Kolluri R, Vasquez M,
TM
Proebstle
late adhesive for treatment of saphenous
vein incompetence. J Vasc Surg Venous
Lymphat Disord. 2013;1(2):174–80.
L, Whiteley M, Lawson J, et al. Threeyear follow-up results of the prospective
European Multicenter Cohort Study on
Cyanoacrylate Embolization for treatment
of reuxing great saphenous veins. J
Vasc Surg Venous Lymphat Disord.
2021;9(2):329–34.
R, Jones A. Five-year extension study
of patients from a randomized clinical
trial (VeClose) comparing cyanoacrylate
closure versus radiofrequency ablation for
the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat
Disord. 2020;8(6):978–89.
Madsen M, Jones A, Gibson K. Comparison of cyanoacrylate closure and
radiofrequency ablation for the treatment
. First human use of cyanoacry-
of incompetent great saphenous veins:
36-Month outcomes of the VeClose
randomized controlled trial. Phlebology.
2019;34(6):380–90.
12. Kolluri R, Chung J, Kim S, Nath N, Bhalla
BB, Jain T, et al. Network meta-analysis
to compare VenaSeal with other supercial venous therapies for chronic venous
insufciency. J Vasc Surg Venous Lymphat
Disord. 2020;8(3):472–81.e3.
13. Gibson K, Ferris B. Cyanoacrylate
closure of incompetent great, small and
accessory saphenous veins without the
use of post-procedure compression: Initial
outcomes of a post-market evaluation of
the VenaSeal System (the WAVES Study).
Vascular. 2017;25(2):149–56.
14. Gibson K, Minjarez R, Gunderson K,
Ferris B. Need for adjunctive procedures
following cyanoacrylate closure of
incompetent great, small and accessory
saphenous veins without the use of
postprocedure compression: Three-month
data from a postmarket evaluation of
the VenaSeal System (the WAVES Study).
Phlebology. 2019;34(4):231–7.
15. Joh JH, Lee T, Byun SJ, Cho S, Park HS,
Yun WS, et al. A multicenter randomized
controlled trial of cyanoacrylate closure
and surgical stripping for incompetent
great saphenous veins. J Vasc Surg Venous
Lymphat Disord. 2022;10(2):353–9.
16. Tang TY, Yap CJ, Soon SX, Chan SL,
Choke ET, Chong TT. One-year outcome
using cyanoacrylate glue to ablate
truncal vein incompetence: A Singapore
VenaSeal™ real-world post-market
evaluation study (ASVS). Phlebology.
2021;36(8):609–19.
17. Yasim A, Eroglu E, Bozoglan O, Mese B,
Acipayam M, Kara H. A new non-tumescent endovenous ablation method for
varicose vein treatment: Early results
of N-butyl cyanoacrylate (VariClose
Phlebology. 2017;32(3):194–9.
18. Eroglu E, Yasim A, Ari M, Ekerbicer H,
Kocarslan A, Kabalci M, et al. Mid-term
results in the treatment of varicose veins
with N-butyl cyanoacrylate. Phlebology.
2017;32(10):665–9.
19. Wilczko J, Szary C, Plucinska D, Grzela
T. Two-year follow-up after endovenous
closure with short-chain cyanoacrylate
versus laser ablation in venous insufciency. J Clin Med. 2021;10(4).
20. Linn YL, Yap C, Soon S, Chan SL,
Khoo V, Chong TT, et al. Registry to
investigate the efcacy and safety of the
VenaBlock(©) VeIn SEaling system for
VaRicose veins in SingApore—Six months
results of the RIVIERA trial. Phlebology.
2021;36(10):816–26.
21. O’Banion LA, Reynolds KB, Kochubey
M, Cutler B, Tefera EA, Dirks R, et al.
A comparison of cyanoacrylate glue and
radiofrequency ablation techniques in
the treatment of supercial venous reux
in CEAP 6 patients. J Vasc Surg Venous
Lymphat Disord. 2021;9(5):1215–21.
22. Tang TY, Rathnaweera HP, Kam JW,
Chong TT, Choke EC, Tan YK. Endovenous cyanoacrylate glue to treat varicose
®
).
veins and chronic venous insufciency-Experience gained from our rst 100+
truncal venous ablations in a multi-ethnic
Asian population using the medtronic
VenaSeal™ closure system. Phlebology.
2019;34(8):543–51.
23. Chan SSJ, Yap CJQ, Tan SG, Choke ETC,
Chong TT, Tang TY. The utility of endovenous cyanoacrylate glue ablation for
incompetent saphenous veins in the setting
of venous leg ulcers. J Vasc Surg Venous
Lymphat Disord. 2020;8(6):1041–8.
24. VenaSeal Spectrum: Global post-market randomized controlled trial:
ClinicalTrials.gov; 2023 [updated
December 19, 2022]. Available from:
https://clinicaltrials.gov/ct2/show/
NCT03820947?cond=venaseal&draw=2&rank=3.
25. Bahi M, Guazzo L, Taumoepeau
L. Real-world short-term VenaSeal
ablation outcomes for symptomatic
saphenous incompetence. Vascular.
2022:17085381221077511.
★
26. Lam YL, De Maeseneer M, Lawson J,
De Borst GJ, Boersma D. Expert review
on the VenaSeal
cyano-acrylate adhesive ablation of
incompetent saphenous trunks in patients
with varicose veins. Expert Rev Med
Devices. 2017;14(10):755–62.
27. VenaSeal
Product code: VS-402 instructions for use:
Medtronic; 2018 [updated March 2018].
Available from: https://manuals.medtronic.com/content/dam/emanuals/cardio/
MS-510522-001_RevB_view_color.pdf.
28. Park I. Initial outcomes of cyanoacrylate
closure, VenaSeal system, for the treatment of the incompetent great and small
saphenous veins. Vasc Endovascular Surg.
2017;51(8):545–9.
29. Fiengo L, Gwozdz A, Tincknell L, Harvey
V, Watts T, Black S. VenaSeal closure despite allergic reaction to n-butyl cyanoacrylate. J Vasc Surg Cases Innov Tech.
2020;6(2):269–71.
30. Jones AD, Boyle EM, Woltjer R, Jundt JP,
Williams AN. Persistent type IV hypersensitivity after cyanoacrylate closure of the
great saphenous vein. J Vasc Surg Cases
Innov Tech. 2019;5(3):372–4.
31. Navarro-Triviño FJ, Cuenca-Manteca
J, Ruiz-Villaverde R. Allergic contact
dermatitis with systemic symptoms
caused by VenaSeal. Contact Dermatitis.
2020;82(3):185–7.
32. Shanmugam S, Wilkinson M. Allergic
contact dermatitis caused by a cyanoacrylate-containing false eyelash glue. Contact
Dermatitis. 2012;67(5):309–10.
33. Gloviczki P, Lawrence PF, Wasan SM, et
al. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical
practice guidelines for the management
of varicose veins of the lower extremities. Part II: Endorsed by the Society of
Interventional Radiology and the
Society for Vascular Medicine. J Vasc
Surg Venous Lymphat Disord. 2024
Jan;12(1):101670.
®
system for endovenous
TM
closure system manual;
44
https://t.me/med1917
CHAPTER
45
https://t.me/med1917
Mechanical occlusion chemically assisted
ablation (MOCA) and high intensity focused
ultrasound (HIFU) for chronic venous disease
Raymond Kennedy† and Steve Elias
45.1 INTRODUCTION
Endovenous ablative technologies continue to evolve. Currently, all endovenous technologies can be classied under
two general categories: thermal tumescent (TT) or nonthermal nontumescent (NTNT), rst introduced in 2014.
new category has since been added: thermal nontumescent
(TNT) with the development of HIFU. This will be discussed
later in this chapter. The TT technologies include radiofrequency and laser. NTNT technologies encompass MOCA
ablation, cyanoacrylate, ScleroSafe, and polidocanol endovenous microfoam, with others continuing to emerge. The
NTNT segment is the fastest growing due to some inherent advantages: minimal nerve or skin injury, safety when
clinically indicated to treat disease below the knee and/or to
the ankle, decreased patient discomfort due to the decreased
needle sticks by avoiding tumescence, and the elimination of
any capital equipment (generator). As with TT techniques,
all NTNT approaches can be performed in an ofce setting
in under an hour. Most patients can return to normal activity almost immediately (Table 45.1).
The advantages of NTNT do not sacrice safety, efcacy,
or clinical outcomes when compared to TT techniques and
have all been shown to signicantly improve quality of life
(QoL) measures.
axial vein (great saphenous vein [GSV], small saphenous
4,5
We know that successful occlusion of an
2,3
1
A
vein [SSV], anterior accessory, ASV, etc.) improves a patient’s
QoL no matter what technology is used.
dence is so compelling regarding QoL improvement that
societal and government health agencies have recommended
that endovenous ablation be the rst modality of choice
for symptomatic axial vein incompetence.
cessful ablation is not about treating the vein—it is about
treating the patient. The idea of the occlusion rate being
the primary endpoint has faded in recent years. Instead, the
primary endpoint of “did we improve the patient’s QoL?”
is now at the forefront, as it should be. Physician-derived
and patient-reported outcome measures are now what vein
specialists and third-party payers consider to be primary
endpoints. We treat patients, not veins. With these concepts
in mind, we can better understand where the NTNT technologies of MOCA ablation and HIFU ablation can be best
utilized when caring for patients with venous disease. As of
this writing, two modalities fall under the MOCA category:
ClariVein and Flebogriff. HIFU has one: Sonovein.
6
In fact, the evi-
7.8
However, suc-
45.2 MOCA ABLATION: CLARIVEIN
ClariVein has the longest follow-up for both MOCA and
NTNT technologies. It was the rst of the new NTNT
technologies to be reported and was developed by Michael
TABLE 45.1 Thermal tumescent, thermal nontumescent and nonthermal nontumescent technologies
TT NTNT
• Radiofrequency
• Laser
TT NTNT/TNT
• Larger veins >10 mm
• Longer follow-up
• Nerves/skin: injury reported
• Patient discomfort: tumescence
• Guidelines—recommend
Abbreviations: TT: thermal tumescent; NTNT: nonthermal nontumescent; TNT: thermal nontumescent; GSV: great saphenous vein; SSV: small saphenous vein.
†
This chapter is dedicated to Ray Kennedy MD, outstanding Vascular Fellow, who died too suddenly and died too soon.
DOI: 10.1201/9781003328971-50
• Mechanical occlusion chemically assisted
• Cyanoacrylate embolization
• Polidocanol endovenous microfoam
• High intensity focused ultrasound (TNT)
• GSV/SSV/C6/below-knee GSV
• Shorter follow-up but equal QoL improvement
• Nerves/skin: no issue
• Patient comfort: better during and after
• Guidelines—recommend
457457
458 Chapter 45 Mechanical occlusion chemically assisted ablation
https://t.me/med1917
Tal and John Marano (Figure 45.1).9 First-in-human evaluations were performed in February 2009.
10
There are two
components to the device/technique: (1) mechanical damage and decreased surface tension between blood and the
vein wall by a rotating wire (Figures 45.2 and 45.3) and (2)
simultaneous installation of a chemical detergent: a liquid
sclerosant (sodium tetradecyl sulfate [STS] or polidocanol).
The mechanical disruption allows for improved penetration of the sclerosant through endothelial cell membranes
to cause irreversible brosis of the media, which ultimately
leads to vessel occlusion.
11,12
The wire rotates at 3500 rpm,
causing direct endothelial damage and a breakdown of the
surface tension, as well as vein spasm to deter the sclerosant from injecting into a blood-lled vein (Figures 45.4 and
45.5). The sclerosant is pulled up the shaft of the wire, exits
the catheter sheath approximately 2 cm from the tip of the
rotating wire, and is released, thus directly “injecting” sclerosant into the damaged vein wall (Figure 45.5). This action
allows for subendothelial penetration of sclerosant to aid in
damage of the media. One can think of the rotating wire as
a sprinkler releasing sclerosant from the tip. In the original
trial, all veins received 12 cc of 1.5% STS liquid. A pullback
45.3 Mechanical occlusion chemically assisted ablation angled
wire rotated.
45.1 Mechanical occlusion chemically assisted ablation (Clar-
iVein) device.
45.2 Mechanical occlusion chemically assisted ablation angled
wire unsheathed.
45.4 Mechanical occlusion chemically assisted ablation mech-
anism of action.
45.5 Mechanical occlusion chemically assisted ablation wire
rotating/sclerosant injection.
rate of 1.5 mm/second, or 1 cm every 7 seconds, was chosen due to the similarity of existing laser pullback rates at
that time. The volume of sclerosant used was irrespective
of the length of the vein being treated, and occlusion rates
were 96% at 1 year with minimal complications: no deep
vein thrombosis (DVT), nerve, or skin damage. Venous Clinical Severity Scores (VCSS) improved as expected with an
occluded GSV. Greater than 2-year follow-up was reported
by the same group demonstrating a 96% occlusion rate.13
Each component—mechanical and chemical—is essential
for optimal results, as inferior outcomes were produced
if either the mechanical or chemical component was used
45.2 MOCA ablation: ClariVein 459
https://t.me/med1917
individually. Recent QoL studies have also demonstrated
signicantly less postoperative pain, faster recovery, and earlier work resumption, in addition to decreased procedural
time compared to other available interventions.
14
45.2.1 Technique
Since the time of the original report, the technique has continued to be modied, with the current recommendations
as follows:
1. Micropuncture access with ultrasound (US) guidance.
2. Placement of a 4-Fr or 5-Fr micropuncture sheath into
the vein.
3. No further wire or sheath exchanges required and no
tumescence required.
4. Passage of the angled catheter portion of the device
proximally into the targeted vein.
5. Unsheathing of the wire and placement of the wire tip
2 cm from the saphenofemoral junction (SFJ) or just at
the fascial curve of the saphenopopliteal junction (SPJ).
6. Attachment of the motor unit and the syringe containing sclerosant.
7. Volume of sclerosant determined by diameter and
length treated (table available). Usually for GSV ablation 8–10 mL and SSV 4–6 mL.
8. Begin rotation only, no injection for the rst centimeter
of pullback to induce vein spasm (i.e., from a position
2–3 cm from the SFJ).
9. After 1 cm of rotation-only, begin drip infusion; the
patient will only feel a vibration.
10. Maintain a constant rate of pullback (1.5 mm/second)
with continuous drip infusion.
11. Reload syringe as needed with wire rotation paused.
12. Post treatment, have the patient ex their ankles to
wash out any sclerosant in the deep system.
13. Wrap legs as per your individualized protocol. This
author uses 4- and 6-inch Ace bandages from the ankle
to mid-thigh.
14. Encourage patient ambulation; they may resume normal activity on the next day.
2% polidocanol, which can increase the treatment dose up
to 15 mL (of 2% STD), making it easier to treat multiple
veins or perform bilateral procedures.
Always conrm placement of the wire prior to starting
treatment with the US, though US visualization is not routinely needed or necessary during the pullback. If there is
a larger segment of vein (>8–10 mm), then the US probe
should be used to partially compress that section in order
to improve vein wall contact. Routine pressure may lead
to the rotating wire being caught on the vein wall, which
can occur in roughly 5% of cases. A quick jerk of the wire
will free the catheter off of the vein wall (the wire cannot be broken by pulling it). This is akin to pulling a bandage quickly off of the skin. You will know the catheter
is caught when you hear the motor slow down and the
patient experiences a “pulling” sensation. When performing a concomitant phlebectomy, these authors recommend
access and placement of the MOCA ablation device and
delaying treatment until the phlebectomy segment has been
completed. This sequence minimizes the potential dwell
time of sclerosant in the deep system, thus minimizing the
risk of DVT (which has a reported rate worldwide of less
than 0.5%).
An alternative method that simultaneously performs
all three actions of mechanical wire rotation, wire pullback, and sclerosant injection uses a 20-cc syringe pump
preloaded with sclerosant (as opposed to the included 5-cc
syringe). This method potentially allows for a more even
distribution of sclerosant (as it is now automated), does
not require the stoppage of treatment to rell the 5-cc
syringe, and allows the operator to place more focus on the
pullback speed with one fewer task at hand. Recent studies
have demonstrated positive results, with a higher level of
consistency and reproducibility utilizing this method.
When imaging post-treatment, it is important to not
only use grayscale US but color-ow duplex as well. With
MOCA ablation, the vein is immediately occluded but
can take 3–6 months longer to contract (Figure 45.6).
Therefore, any early US with grayscale will show a dilated
vein. The additional use of color-ow duplex will document the absence of ow, verifying a successful treatment.
16
14,15
17
45
45.2.2 Technical pearls
The pullback rate is much more important for success than
sclerosant volume. When failures are analyzed, the operator
has often pulled the catheter back too fast, leaving insufcient time for optimal vein wall contact. In the original
study, all veins received 12 cc of 1.5% STS regardless of the
length treated, with successful treatment and without evidence of DVT. Obviously, depending on the length of vein
treated, some veins received slightly too much or slightly
too little sclerosant, yet a 96% occlusion rate was achieved
with no DVT or skin or nerve injury. The pullback rate
was always the same, thus implying it is more important
than exact sclerosant volume. The technique is forgiving
of volume but less forgiving of pullback rate, and therefore
it is better to pull “too slow” and give “too much” sclerosant than the contrary. The type of detergent sclerosant
also does not affect outcomes; however, the maximum single treatment dose should not exceed 10 mL of 3% STD.
The Dutch have reported comparable results with 1% and
2
45.6 Ultrasound post-mechanical occlusion chemically
assisted at 6 months.
460 Chapter 45 Mechanical occlusion chemically assisted ablation
https://t.me/med1917
This nding contrasts with TT ablation. As with most
other endovenous treatments, the postprocedure compression and activity instructions have become less onerous.
Elderman et al.
18
demonstrated a signicant improvement
in pain scores with the use of compression up to 7 days
post-treatment and less analgesia usage compared to no
compression. Other studies have not been able to replicate
these ndings and conclude compression had no impact on
the effectiveness of obliterated veins, satisfaction scores, or
19
This author uses compression for 24 hours post-
QoL.
MOCA ablation. Return to full activity is encouraged the
next day. These instructions apply when phlebectomy is
not included.
45.2.3 Results
In 2017 when the last iteration of this Handbook was written, only 16 articles had been published regarding MOCA
ablation (ClariVein) in the peer-reviewed literature, with
only 60,000 procedures performed worldwide. The results
were overwhelmingly coincident, with occlusion rates of
greater than 90%, and improvements in QoL measures
were signicant.
will be discussed. The longest follow-up has been by the
author of the original clinical trial at greater than 2 years.
Van Eekeren et al.
using polidocanol instead of STS. In addition, all of the
QoL measures improved at 1 year.
One of the advantages of any NTNT technology is safety
and the lack of risk of nerve injury when treating any belowknee venous segment. Boersma et al.
results for MOCA ablation when treating the SSV. No nerve
injury occurred, and the occlusion rate was 94%. These results
are encouraging in that SSV treatment has the concern of potential injury to three nerves: sural, tibial, and peroneal. Many
physicians have been loath to treat the SSV with TT due to
nerve risk and DVT. This study did not experience either issue.
In terms of the management of more advanced disease
states, C6 ulcer patients experience another advantage with
NTNT technologies. In C6 patients, if the axial disease reux
is to the ankle, it is desirable to treat the entire pathologic
segment. Tumescence is hard to place in an area of ulceration
and signicant lipodermatosclerosis. This author has used
retrograde cannulation of the GSV in these circumstances
with good results. Moore et al.
of ClariVein ablation in a C6 patient with SSV incompetence with good results. Two older studies compared ClariVein ablation to radiofrequency ablation. Van Eekeren
20
Some studies that address specic topics
21
reported similar results at 1 year when
22
reported the 1-year
23
have reported on the use
12
24
concluded that MOCA ablation yielded less postop-
et al.
erative pain, faster recovery, and sooner return to work than
radiofrequency ablation. Bootun et al.
25
randomized 119
patients to MOCA or radiofrequency ablation and found
MOCA ablation had lower intraoperative pain scores with
equal occlusion rates and QoL improvements compared to
radiofrequency ablation. These early study ndings were
strengthened in 2020, where a meta-analysis of 615 patients
again demonstrated high anatomical success rates and fewer
major complications when compared to thermal ablation.
45.2.4 Summary
ClariVein ablation currently has the longest follow-up
of any NTNT technology. Studies support its use for the
great majority of incompetent supercial axial veins. All
measures are as good, if not better, than comparative TT
technologies. There are unique advantages of the NTNT
techniques and of MOCA ablation specically. At the conclusion of this chapter, a summary of the benets, indications, and contraindications of all the TT and NTNT
technologies will be presented.
45.3 MOCA ABLATION: FLEBOGRIFF
Flebogriff is the other MOCA technology currently available worldwide, except in the United States as of this writing,
and has been used since 2022 with over 50 articles/reports
published. The advantages of Flebogriff as an NTNT technology is very similar to ClariVein. Therefore, this will not
be discussed in this section. It is similar to ClariVein in
that there is a chemical and mechanical component, tting
through a 4-Fr access sheath, and requires only one needle
puncture. Differences are that foam sclerosant is used, pullback rates are faster and can vary with equal results, and
mechanical damage is produced by prongs/hooks touching
the vein wall. Occlusion rates are comparable at approximately 93%–97%.
Access is made with a 4-Fr micropuncture sheath and
a 0.035 guidewire is advanced proximally to the SFJ/SPJ
with the provided kit (Figure
Flebogriff catheter is inserted and positioned 2–3 centimeters distal from the SFJ/SPJ, and the patient is placed
in Trendelenburg position. Five cutting prongs are then
exposed by retracting the outer sheath, and the catheter is pulled back at a reported rate of 1–5 cm/second,
with foam simultaneously injected at a rate of 1.5 mL/
cm of vein (Figures
45.8 and 45.9). The reported foam
45.7). Over this wire, the
12
45.7 MOCA (Flebogriff™) kit.
45.8 MOCA (Flebogriff™) prongs extruded.
45.9 MOCA (Flebogriff™) mechanism of action.
https://t.me/med1917
concentration of polidocanol has ranged from 1% to 3%.
Thus far, use of another sclerosant such as STS has not
been reported. It is our feeling that this will work just
as well as polidocanol, if not better. There does not seem
to be a true consensus regarding techniques, as various
pullback rates and various foam concentrations seem to
achieve similar results. The technique is still in evolution,
but we recommend a more rigorous treatment protocol
be developed.
In addition, the mechanism of action is unclear. Whether
it is a “scraping” of the endothelium or a breakdown of the
surface tension between blood and the vein wall has yet to
be determined. As opposed to ClariVein, histologic studies
are not currently available. Despite this, the device appears
to work, with reported occlusion rates hovering around
26–29,32
93%.
24 months with a 93% occlusion rate.
As with any successful occlusion of an axial vein, VCSS
scores improve.
was 9 and improved to 3 by the 12-month follow-up.
Major complications are minimal, with a DVT rate of
0.5% and no nerve injury, while minor complications consist of phlebitis and pigmentation. Flebogriff appears to be
as efcacious as ClariVein with less of a concern for maintaining a particular pullback rate. Although not currently
available in the United States as of this writing, it is being
used worldwide with similar success when performed correctly. The technique may also be simpler and more forgiving for the operator as well.
26–31
The longest reported follow-up is by Iłżecki at
26,28,29
On average, the pretreatment VCSS
28
45.3.1 HIFU: Sonovein
The use of HIFU for treatment of venous disease is relatively new, but the use of HIFU in other elds of medicine
is not. The effective treatment of breast lesions, thyroid nodules, brain tumors, and Parkinsonian tremors,
among other disease states, has been demonstrated.
How does it work? When high intensity ultrasound is
focused at a point, heat is produced. In the technique
of Sonovein, temperatures reach about 85°C. Sonovein
is the rst TNT. The device has two ultrasound units
at the working end (Figure
tissue (vein segment) to be treated, and the HIFU segment focuses a cone of energy to the target tissue (Figure
45.11). There is a diaphragm that keeps the skin cool
when the unit is ring.
45.10). One visualizes the
33–36
45.3 MOCA ablation: Flebogriff 461
45.10 HIFU (Sonovein™) unit.
45.3.2 Technique
This differs from all other TT and NTNT modalities in
that treatment can be done in the ofce without the need
for sterile gowning, draping, etc., and without any needle
punctures (Figure 45.12).
1. The patient is placed on an exam table, and the depth
of vein with compression by the ultrasound probe is
recorded. This needs to be between 10 mm and 20 mm
from the skin.
2. Treatment begins approximately 2–3 cm from the SFJ
or SPJ.
3. With the vein compressed by the VTU, the target tissue is visualized, placing the aiming marker (seen on
the touchscreen) on the posterior wall of the collapsed
vein.
4. Treatment starts at one end of the compressed vein
and then continues either laterally or medially
depending on the starting point. Successful treatment
of the target tissue can be conrmed immediately
(Figure 45.13).
5. After successful treatment of one level, the device then
moves the aiming beam 3 mm down the vein and treatment starts at this level in a similar manner.
6. The path of treatment can be conceptualized as treating
a rung of a ladder for its entire length and then moving
down to the next rung.
7. The reason for moving 3 mm between treatment levels
is that the spread of heat is about 1.5 mm; allowing for
spread from the level above and below that covers the
3 mm in between. We will discuss modications of this
later in this section.
8. When treatment is completed, the patient can get up and
leave. No compression is used.
45
462 Chapter 45 Mechanical occlusion chemically assisted ablation
https://t.me/med1917
HIFU transducer3 MHzfor treatment
Embeddedultrasoundfor visualization
7.5 MHz
Singleuse membrane and liquidfor
coolingand coupling
45.11 Visualization & Treatment Unit (VTU). The VTU has two functions: The 3 MHz transducer creates the high intensity ultrasound
waves, focused in an area as small as a rice grain, depositing heat up to 85 degrees Celsius . . . and that totally extra corporeal.
Embedded is a 7.5 MHz transducer for real-time ultrasound-imaging. To avoid skin-reactions the coupling part of the head is permanently cooled by a circulating liquid system.
45.12 Patient positioning.
45.13 Target tissue destroyed post HIFU.
https://t.me/med1917
463
45
45.3.3 Technical considerations
It is our experience and others that the vein size and depth
matter for successful results. In general, the target vein in
the supine position should be less than 10 mm in diameter,
and the depth from the skin (while compressed) needs to be
between 10 mm and 20 mm. If the vein is too shallow, there
is a risk of increased pain and skin injury; being too deep
makes it harder for the focused ultrasound energy to reach
the tissue. Even with these limitations, the great majority
of veins will qualify. HIFU is not a pain-free procedure.
Patients do feel warmth and discomfort when the device is
ring. This is very short-lived, as the treatment cycle is only
0.5 or 1 second with the current iteration. In the rst U.S.
trial performed by the senior author, no patient needed any
oral, intravenous, or local anesthesia for treatment, and
all stated they would undergo treatment for other veins if
necessary. Other reports have documented the use of some
local/oral anesthesia. For the U.S. trial, it was important
to successfully treat all subjects with no anesthesia and
no needle punctures. As of this writing, these results were
reported at the American Venous Forum Annual Meeting
in February 2023.
45.3.4 Results
In early 2023, 12 sites throughout the world are using
Sonovein. In addition, the senior author is the only site
in the United States. While there has been a lot of experience, few peer-reviewed articles have been published. The
earliest publication was by Whiteley in 2019, which introduced the concept and technique, but only ve patients
had been treated and no results were reported.
37
In 2021
Alfred Obermayer, the rst person to use the Sonovein
device, reported the successful use of HIFU for perforator ablation in a patient with a venous ulcer.
Croucher and Whiteley reported their results of the treatment of 41 truncal veins and 145 incompetent perforating
veins. Follow-up was problematic for many patients due
to COVID travel restrictions. Of those who returned for
scans, 83% of truncal veins and 88% of perforators were
closed at various time intervals.
senior author has completed the rst U.S. Sonovein trial
of 20 GSVs. At the 3-month interval, 95% of treated GSVs
are without reux, and VCSS has improved from 6.9 to
1.3. Successful results were documented with grayscale
US for vessel occlusion/shrinkage and color-ow duplex
ultrasound for ow and reux (Figure
be more studies published and longer follow-up that
address QoL improvement.
38
As of this writing, the
33
In 2022,
45.14). There will
45.3.5 Summary
The experience with Sonovein is very early, and the technology and technique are both evolving as we gain more
experience. It is a disruptive technology in that its mechanism of action and the patient experience are much different from the current technologies that are being used.
One thing is certain: it does work. It is able to destroy
target tissue. While the actual time it takes to treat a
certain length of vein compared to other technologies is
currently longer, the overall length of the entire patient
experience is not signicantly increased. There is no need
for creating a sterile eld involving prepping and draping
or having the patient change clothes. The time to instill
tumescent anesthesia is obviated. It is our belief that
Соседние файлы в папке Библиотека им академика М.И. Перельмана