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464 Chapter 45 Mechanical occlusion chemically assisted ablation
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45.14 Post HIFU.
treatment time can be further shortened by increasing
the distance between treatment points on a vein. While
the current recommendation is 3 mm apart, we believe
this distance can be doubled with similar results and will
shorten treatment time by 50%. Where might we see clinical scenarios that are advantageous for Sonovein aside
from routine truncal veins? One area already reported
by Obermayer is for pathologic perforating veins. HIFU
focuses on a small point of tissue. PAPS does the same
thing with either laser or radiofrequency. Using HIFU to
spot-weld PPVs shut essentially becomes a completely
noninvasive procedure. Other areas of potential benet
are for neovascularization and a completely noninvasive
ASVAL treatment. In conclusion, HIFU will nd a place
in managing venous disease as we all gain more experience and as the technology matures. This is the nature of
new, disruptive technology.
45.4 DISCUSSION
The NTNT and TNT options are the next wave of disruptive technology regarding the treatment of supercial
venous disease. MOCA and HIFU are two examples of
45.5 Overall summary 465
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this. In other chapters of this Handbook, currently used
different NTNT technologies are discussed, and their
advantages are similar to those of MOCA and HIFU. Many
other unique technologies are currently in development,
such as Wavella. Both MOCA and HIFU show improved
QoL after treatment equal to the TT modalities. Clearly,
this is why most patients seek help. They want to feel better
and get back to their lives. These techniques either require
only one needle puncture (MOCA) or no needle punctures
(HIFU). TT technologies require the use of tumescence,
which is the most discomforting aspect of endovenous
ablation for patients and physicians. Accurate placement of
tumescence is the most difcult part of the learning curve
and is also the part of the procedure that patients nd most
painful. Eliminating tumescence is a laudable goal as long
as outcomes are similar to TT results. As illustrated earlier,
the literature does support similar outcomes with TT and
NTNT technologies. In fact, the most recent Society for
Vascular Surgery/American Venous Forum guidelines for
the management of supercial venous disease recently published state: “In summary, both thermal and non-thermal
ablation techniques are safe and effective, but we cannot
recommend one technique over the others. All techniques
result in improved QoL scores and good clinical effectiveness 3 to 5 years after the procedures.”
39
It is this author’s belief that any vein specialist needs
to be facile with at least one TT and one NTNT/TNT
technique. There are certain clinical scenarios in which
one type of approach is more advantageous than another
(Table 45.2). Most below-knee pathologies are better
treated with NTNT techniques in order to minimize nerve
and skin issues.
In addition, if pathology and reux exist
to the ankle level, the NTNT techniques can safely accomplish treatment goals. This is even more advantageous
with advanced C5 or C6 disease when tumescence is dif-
cult to place in an area of skin changes or ulcer. Access
can also be made retrograde from the knee level.
5
MOCA
ablation can also be safely used for epifascial veins
because there is only a minor phlebitic reaction. HIFU has
the advantage of targeting pathologic perforating veins
with good efcacy.
41
Almost any TT or NTNT technology can be safely used
in the above-knee axial vein. However, these authors feel
that for large veins of greater than 10–12 mm, TT options
are better. Veins of greater than 10–12 mm have been
treated with success with NTNT technologies, but large
veins in general require more energy better delivered by a
thermal mode of action. Recanalized veins from previous
thrombophlebitis or previous failed ablations are better
treated with TT technologies or perhaps cyanoacrylate for
similar reasons (Table 45.2).
Specically within the NTNT/TNT category, each
technology has its own unique advantages and disadvantages.
Which NTNT/TNT technique is best? There is no one
“best” technology. Many factors need to be considered: cost,
reimbursement, vein specialist comfort with the technique,
patients’ experience, and the unique clinical/anatomical
scenario. One thing is clear: all NTNT/TNT technologies
positively impact the patients’ QoL.
45.5 OVERALL SUMMARY
All new technologies and techniques undergo evolution
from initial development, to early adoption, to general use.
MOCA ablation and HIFU ablation are no exceptions.
These techniques have been modied as more experience
has accrued and device improvement has occurred. This
new class of ablation will persist and grow. The removal of
45
TABLE 45.2 Advantages and disadvantages of nonthermal nontumescent technologies
NTNT technology Advantages Disadvantages
MOCA ablation No foreign body left
Uses approved liquid sclerosant
Longest follow-up of all NTNT technologies
Tortuous veins: angled wire
Perforators: PAPS
60,000 patients worldwide
CAE Segmental ablation
Pullback rate variable eliminated
Second longest follow-up
No post-procedure compression
Perforators: PAPS?
VBAS Pullback rate variable eliminated
Uses approved liquid or foam sclerosant
PEM Pullback rate variable eliminated
Tortuous veins: foam traverses
Also treats branch varicosities
Perforators: PAPS
Abbreviations: NTNT: nonthermal nontumescent; MOCA: mechanical occlusion chemically assisted; CAE: cyanoacrylate embolization: IFU: instructions for
use; VBAS: V block–assisted sclerotherapy; PAPS: percutaneous ablation of perforators; PEM: polidocanol endovenous microfoam.
Need to pullback/inject simultaneously
Longest learning curve
Compression: 5 days
Foreign body left
Phlebitic reaction
Tortuous veins: difcult
Foreign body left
Shorest follow-up
Smallest number treated
Tortuous veins: difcult
Compression: 7 days
Requires two people for procedure
IFU: 2 weeks of compression
Not indicated for small saphenous veins
466 Chapter 45 Mechanical occlusion chemically assisted ablation
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tumescence from endovenous procedures is a goal that is
worthwhile for both patients and treating vein specialists.
Whenever a technique is made simpler with equal or better
results, everyone benets.
improve patients’ lives, they ultimately are reimbursed. This
should follow for the NTNT/TNT group as well.
When evaluating or using new technologies, one should
take the open-minded approach of:
The main challenge as of this writing is universal reimbursement for MOCA ablation, HIFU, and the other NTNT
technologies. This story is familiar to all of us who began using
the TT technologies of laser and radiofrequency ablation in
the early 2000s. If technologies show safety and efcacy and
Respect the elders,
Embrace the new,
Encourage the improbable and the impractical,
Without bias.
Guidelines and Consensus Statements 45.0 of the American Venous Forum on MOCA and HIFU for chronic venous disease
No. Guidelines Grade of
recommendation
45.1 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
1
(strong)
available expertise of the treating physician and the preference of the patient.
45.2 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
1
(strong)
the available expertise of the treating physician and the preference of the patient.
45.3 For patients with symptomatic axial reux of the AAGSV or PAGSV, we suggest
either thermal or nonthermal ablation, with additional phlebectomy, if needed,
2
(weak)
depending on the available expertise of the treating physician and the preference
of the patient.
Consensus Statements
45.4 Nonthermal techniques are better for ablation of reuxing distal calf saphenous veins to avoid nerve injury from thermal
techniques.
45.5 HIFU is a disruptive new technology for vein ablation without the need for anesthesia. The technology is in evolution and will
nd a place in managing supercial and perforating venous disease.
Quality of
evidence
B (moderate)
C
(low to very low)
C
(low to very low)
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CHAPTER
46
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The management of incompetent
perforating veins
Mary A. Binko, Misaki M. Kiguchi, Peter F. Lawrence, and Eric S. Hager
46.1 INTRODUCTION
Incompetent perforating veins (IPVs) are usually associated
with advanced stages of chronic venous insufciency (CVI)
and ulceration, although they may also occur in patients
with CEAP C2 varicose veins (1). Most large reuxing
IPVs are associated with more severe clinically signicant
venous disease with higher rates of ulcer recurrence (2).
The reuxing perforator veins located beneath venous
ulcers contribute to local ambulatory venous hypertension,
causing impaired wound healing secondary to brin cuffing and impaired oxygen delivery. The ablation of IPVs has
become an important treatment for patients with advanced
CVI who fail standard compression therapy, ablation of
supercial venous axial reux, and/or deep venous stenting.
The treatment of IPVs has evolved dramatically from
invasive, open surgery to minimally invasive modern techniques. Dr. Linton originally described open ligation of
perforating veins through incisions in already lipodermatosclerotic and ulcerated skin, often leading to delayed wound
healing and infection (3, 4). The development of subfascial
endoscopic perforator surgery (SEPS) revived interest in
the treatment of IPVs, as this endoscopic technique placed
ports in normal skin remote to the lipodermatosclerotic
skin for access to the subfascial space and allow dividing of
IPVs. By eliminating incisions in compromised skin, SEPS
improved healing of venous ulcers with fewer wound complications as well as shorter recovery time (4–6). However,
the mid-term results from the North American Subfascial
Endoscopic Perforator Surgery registry required general or
regional anesthesia and reported ulcer recurrence rates of
16% and 28% at 1 and 2 years, respectively, similar to
the recurrence rates for open ligation (7, 8). The failure of
perforator closure following SEPS was shown to be a risk
factor for ulcer recurrence (9). The development of minimally invasive venous devices and techniques ushered in
the percutaneous ablation of incompetent perforator veins.
Currently the three most common percutaneous modalities are ultrasound-guided foam sclerotherapy (UGFS),
radiofrequency ablation (RFA), and endovenous laser
ablation (EVLA). There have recently been reports of ultrasound-guided glue ablation of the perforator vein at the
level of the fascia (10, 11). The success for IPV ablation closure using percutaneous modalities is predictive of venous
ulcer healing as well as reduced ulcer recurrence (12–15).
46.2 ANATOMY AND PATHOPHYSIOLOGY
OF PERFORATING VEINS
The anatomy of perforating veins is discussed in detail in
Chapter 2, but their relevance to the management of IPVs
is detailed in this section. Normal perforators allow venous
ow from the supercial to the deep system across the fascia. The bicuspid venous valves maintain unidirectional
ow by preventing ow reversal during muscle contraction. However, there may be a subset of perforators without valves in normal limbs, allowing for bidirectional ow
between the venous systems (16). Pathologic perforators
allow venous ow from the deep to supercial system,
causing ambulatory venous hypertension.
Early cadaveric dissections found an abundance of
large perforating veins in the medial calf and ankle, where
venous ulcers most commonly form (Figure 46.1a) (3). Following the introduction of SEPS, further anatomic study
focused on characterizing the perforators in the medial leg
between the medial malleolus and the tibial tuberosity (17).
The posterior tibial perforators, also known as Cockett
perforators, connect the posterior accessory great saphenous vein to the posterior tibial veins. Cockett perforators
are classied as I, II, and III based on the distance from
the sole of the foot or the medial malleolus (currently we
measure incompetent perforator veins by the distance from
the sole of the foot). Cockett II and III perforators are most
commonly targeted for ablation and are found 7–9 cm and
10–12 cm from the medial malleolus, respectively (17).
Delis conrmed on ultrasound the most common location
for IPVs as the middle and lower third of the medial calf
(18). In the proximal half of the leg, the paratibial perforators connect the great saphenous vein (GSV) to the
posterior tibial veins. Boyd perforator, also located in the
proximal leg near the tibial tuberosity, connects the GSV
to the popliteal vein (17). The eponyms of these perforator
veins is of historic interest only.
On duplex ultrasound, there is an increase in both
the number and diameter of IPVs in patients with venous
ulcers (2, 19). Stuart et al. (19) found patients with venous
ulcers had one to four IPVs in the medial calf. These dilated
and low-resistance pathologic perforators allow for larger
volumes of blood ow from the deep to supercial system at rates as high as 60 mL per minute during muscle
DOI: 10.1201/9781003328971-51
469469
470 Chapter 46 The management of incompetent perforating veins
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46.1 (a) Schematic depicting the most common location and distribution of venous ulcers. (b) Duplex ultrasound showing a patho-
logic perforating vein above a venous ulcer targeted for ablation.
contraction (19, 20). The venous pressures are elevated in
the supramalleolar area due to pathologic perforators, akin
to “leaking bellows” (21). The local venous hypertension
leads to brin cuff formation, white cell–mediated inammation, and impaired oxygen and nutrient delivery (22).
This creates a milieu that is susceptible to ulceration and
poor healing. Therefore, the IPVs usually selected for ablation are those adjacent to the area of lipodermatosclerosis
and venous ulceration (Figure 46.1b) (12).
46.3 TREATMENT INDICATIONS
Given the minimally invasive nature of percutaneous ablation techniques, most patients with advanced CVI and IPVs
are eligible for treatment. The main contraindications to
treatment include DVT within the last 3 months. Based on
grade 2B evidence, the practice guidelines from the Society
for Vascular Surgery and the American Venous Forum currently recommend treatment of pathologic IPVs with reux
≥500 ms and diameter ≥3.5 mm in patients with CEAP C5
and C6 disease (23, 24). In addition, patients with C4b disease who are at risk for developing venous ulcers, indicated
by skin changes such as progressive lipodermatosclerosis
or malleolar pain, can also be considered for treatment
(24). However, there is still less evidence to support treatment of IPVs in the early stages of CVI, including C2 and
C3 disease (23, 25, 26). Updated guidelines from the Society for Vascular Surgery, American Venous Forum, and
American Vein and Lymphatic Society continue to oppose
initial treatment of pathologic perforators concurrently
with ablation of supercial axial reux in patients with C2
disease (26). No further recommendations regarding C3
disease have been established.
As perforator vein reux most commonly occurs with
supercial axial venous reux, the treatment of IPVs can
be concurrent or subsequent to treatment of supercial
axial venous reux (24). However, the treatment of IPVs is
usually staged, as ablation of supercial axial reux alone
often corrects pathologic perforator vein reux and contributes to successful healing of ulceration (27, 28). Therefore,
patients with incompetent perforators after ablation of axial
veins (saphenous and small saphenous) who have persistent
symptoms and a persistently dilated and reuxing perforator are appropriate candidates for perforator ablation (Figure 46.2). A recent study of all three procedural options for
treatment of venous ulcers—truncal vein ablation, perforator vein ablation, and iliac vein stenting—demonstrated that
each contributes independently to ulcer healing (29). Since
truncal vein ablation (great saphenous, small saphenous,
or anterior accessory saphenous) is the simplest and most
reliable procedure, most venous specialists start with that
procedure, although some begin with iliac vein stenting (29).
46.4 PREOPERATIVE EVALUATION
The preoperative evaluation requires comprehensive imaging with duplex ultrasound by a certied technologist. The
exam should be performed with the patient standing or in
reverse Trendelenburg position to characterize and delineate the supercial, deep, and perforating veins.
The saphenous vein should be imaged in transverse and
longitudinal views to systematically identify perforators
passing through the fascia. To determine if a perforator is
pathologic, color Doppler should be used while eliciting
reux (30). There are several methods for eliciting reproducible reux, including manually squeezing the calf or
automatically inating pneumatic cuffs (30).
46.5 PERCUTANEOUS ABLATION
TECHNIQUES
46.5.1 Ultrasound-guided foam sclerotherapy
Under ultrasound guidance, the perforator vein is imaged
in both transverse and longitudinal views, as it allows for
triangulation of the IPV for access planning. A 23-guage
needle is inserted into a varicose vein connected to the IPV.
Conrmation of intraluminal access is demonstrated by
back-bleeding. Although not approved for specic use by
the FDA, either proprietary 1% polidocanol foam (Varithena, Boston Scientic Corporation, West Conshohocken,
PA) or physician-compounded foam (PCF) can be used.
46.5 Percutaneous ablation techniques 471
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46.2 Treatment algorithm for management of nonhealing venous ulcers and indication for ablation of IPVs.
The foam sclerosant is introduced into the IPV through the
23-guage needle. While injecting, compression of the deep
vein by the ultrasound transducer can be an effective way
of limiting the amount of foam that enters the deep system.
A maximum of 10 cc of foam is used per session to limit
the amount of gas introduced. The patient is also asked to
repeatedly dorsiex the ankle to augment ow through the
deep system. The deep veins should also be imaged after
injection to conrm the absence of foam.
46.5.2 Radiofrequency ablation
RFA has gained popularity for the treatment of IPVs. Two
techniques for perforator ablation are frequently used and
are often determined by IPV anatomy, physician expertise, and available equipment. The radiofrequency stylet
catheter (ClosureFast, Medtronic, Minneapolis, MN) can
be used in a direct puncture technique or with a Seldinger
technique over a glide wire. In long straight IPVs, direct
access can be achieved by interrogating the IPV with an
ultrasound and anesthetizing the skin with lidocaine near
the junction of the supercial vein and IPV (Figure 46.3).
Direct puncture can then be performed and the catheter
advanced.
With short or tortuous IPVs, direct puncture can be
challenging, and therefore, the Seldinger technique is
preferred. Puncture of the vein can be achieved with a
standard micropuncture kit and a glide wire advanced
through the IPV into the deep system. This allows the
RFA catheter to be introduced safely to the target area.
The perforator vein is imaged in the longitudinal view,
and the catheter is advanced within the perforator vein
to 2–3 mm from the deep vein. Once nal catheter position is conrmed, tumescent anesthesia of 1% lidocaine
is inltrated surrounding the perforator vein. The vein is
treated in four quadrants (0, 90, 180, 270 degrees) for
30–90 seconds at a temperature of 85°C with impedance
less than 400 ohms. The catheter is removed in 3- to 5-mm
increments with repeated treatment of the four quadrants.
A retrospective case-control study found no difference
between a protocol time of 6 minutes at 85°C, 4 minutes
at 90°C, and 3 minutes at 95°C (31). The transducer is
used to apply external pressure during the procedure to
improve contact of the catheter with the vein wall. Once
the catheter is removed, ultrasound imaging is repeated
to conrm the absence of DVT as well as closure of the
perforating vein.
46.5.3 Endovenous laser ablation
Under ultrasound guidance, the 400-μm laser microber (AngioDynamics, Latham, NY) is inserted through
a 21-gauge needle. The perforating vein is imaged in the
longitudinal view and the ber is advanced within the perforator, up to 2–3 mm from the deep vein. Once the nal
position of the ber tip is conrmed, tumescent anesthesia
of 1% lidocaine is inltrated surrounding the perforating
vein. The ber is connected to the 1470-nm diode laser
472 Chapter 46 The management of incompetent perforating veins
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46.3 (a) Under ultrasound guidance, the RFA catheter is advanced within the perforator until 2–3 mm from the deep vein. (b) Duplex
ultrasound showing the RFA catheter within the lumen of the perforating vein.
(AngioDynamics, Latham, NY). The generator is set at a
power of 5–10 W in continuous pullback mode. Higher
energy levels are needed for perforator ablation compared
to supercial axial ablation (32). Instead of a bare ber, a
slim radial ber (ELVeS-Radial Slim Kit, Biolitec Biomedical Technology GmbH, Jena, Germany) was also recently
used for perforator ablation (15, 32). The radial ber emits
360 degrees of laser energy through a small-diameter tip.
Following the procedure, ultrasound imaging is repeated
to conrm the absence of DVT as well as closure of the
perforating vein.
46.5.4 Postoperative care
Following treatment of perforating veins, patients are
advised to continue with daily compression therapy and
wound care. Patients can resume all activities. A postprocedure ultrasound is typically performed within 72 hours to
2 weeks to ensure closure of the treated perforator as well
as absence of DVT.
46.6 CLINICAL OUTCOMES OF
PERFORATING VEIN ABLATION
The treatment of IPVs developed as an adjunct for venous
ulcers, since compression therapy alone often failed to
heal nonhealing ulcers and prevent recurrent ulcers. The
Effect of Surgery and Compression on Healing and Recurrence (ESCHAR) trial demonstrated surgical treatment
of supercial axial reux reduced ulcer recurrence at 4
years compared to compression alone (Figure 46.4) (33).
Although only supercial axial reux was corrected, this
trial shifted treatment paradigms toward intervention for
patients who cannot heal venous ulcers using compression alone. The treatment of IPVs has also been shown to
improve ulcer healing and reduce ulcer recurrence, historically through SEPS and currently through percutaneous
ablation of perforators (Table 46.1). Alden et al. (34)
compared compression alone with multiple concurrent
interventions, including RFA ablation of supercial veins
and UGFS of perforating veins, for treatment of 95 venous
ulcers. In comparison to compression alone, ulcer healing
time was shorter in the intervention group (7.9 versus 22
weeks, p < 0.001) and recurrence was reduced at 1 year
(22.9% versus 48.9%, p = 0.004) (34). In another study,
patients undergoing RFA ablation of perforating veins
showed improved ulcer healing, increasing at a rate of 0.9
2
/month with compression alone to healing at a rate of
cm
2
2.9 cm
46.5) (35).
forator reux rarely occurs alone, but rather in combination with supercial or deep reux (1, 2). Many
studies simultaneously treat both supercial and perforator reux, making it difcult to discriminate between
the role of perforator ablation alone in ulcer healing and
recurrence. Lawrence et al. (12) treated IPVs in patients
with recalcitrant venous ulcers despite ablation of supercial axial reux. At a mean of 4.5 months, 90% of ulcers
healed following ablation of at least one perforator with
RFA (12). Harlander-Locke et al. (13) studied ulcer recurrence in patients with C5 disease presenting with signs of
imminent ulceration despite treatment with compression
therapy for at least 3 months followed by supercial axial
ablation, if indicated, for at least 3 months before IPV
ablation was performed. Following RFA ablation of IPV,
ulcer recurrence rates were 0% at 6 months and 4.8%
at 12 and 18 months (13). Seren et al. (15) examined the
treatment of IPVs in patients with recalcitrant venous
ulcers, where 28 of 36 patients were treated with IPV
ablation alone and 8 of 36 were treated with concomitant supercial axial ablation. At a mean of 11.5 months,
95% of ulcers healed following ablation of at least one
perforator with EVLA. The ulcer recurrence rates were
0% at 6 months, 2.7% at 12 months, and 5.5% at 18
months (15). Furthermore, two studies examined ulcer
healing in patients undergoing isolated treatment of IPVs
with UGFS (14, 36). Masuda and colleagues reported
a healing rate of 67.6% with an average healing time
of 35.6 days following IPV treatment with UGFS (36).
/month following IPV ablation (p < 0.05) (Figure
The ablation of IPVs has been controversial, as per-
46.6 Clinical outcomes of perforating vein ablation 473
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46.4 Ulcer recurrence for patients who underwent compression alone compared to compression plus surgery, including supercial
venous surgery or calf perforator surgery. At 4 years, ulcer recurrence was signicantly reduced in the compression plus surgery
group compared to compression alone. (From Gohel et al. [33].)
TABLE 46.1 Clinical results of percutaneous ablation techniques
Author, year Treatment
Masuda et al., 2006 (36) UGFS 37
Alden et al., 2013 (34) UGFS 48 65 23 12
Kiguchi et al., 2014 (14) UGFS 73 59 34
Marsh et al., 2010 (43) RFA 3 100 14
Lawrence et al., 2011 (12) RFA 75 90
Harlander-Locke et al., 2012 (13) RFA 21
Harlander-Locke et al., 2012 (35) RFA 110 76 7 12
Hissink et al., 2010 (45) EVLA 5 80 3
Dumantepe et al., 2012 (47) EVLA 5 80
Seren et al., 2017 (15) EVLA 40 95
+
Number of limbs with ulcers, ++number of limbs with CEAP 5 disease, *healing with closure of at least one perforator.
modality
The ulcer recurrence rate was 32.4% in this study and
was associated with recurrent perforators (36). Kiguchi
et al. (14) demonstrated higher rates of IPV thrombosis
in patients with healed than nonhealed ulcers following
UGFS (69% versus 38%, p < 0.001). The only positive
predictor of ulcer healing in this study was successful
thrombosis of IPVs (14). In a multi-institution retrospective review, Reitz and colleagues analyzed ulcer healing
No of
ulcers
+
++
Ulcer
healing (%)
68 32
*
*
Ulcer
recurrence (%)
4 13
5 25
6 20
Mean or median
follow-up (months)
and recurrence for 232 patients who underwent percutaneous ablation of perforators by UGFS, EVLA, or RFA
during their index procedure despite 6 weeks of compression therapy (37). At a median follow-up of 13 months,
ulcer healing occurred in 57% and recurred in 25% of
venous ulcers (37). These studies strongly suggest that
percutaneous ablation of perforator veins independently
improves ulcer healing.
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