PresentedVascular Surg

1Division oCentral TexasMedicine, Tem

2Departmeof Medicine, R

The Management of Chronic VenousInsufficiency With Ulceration: The Role ofMinimally Invasive Perforator Interruption

Carlos A. Rueda,1 Emilia N. Bittenbinder,1 Clifford J. Buckley,1 William T. Bohannon,1

Marvin D. Atkins,1 and Ruth L. Bush,2 Temple and Round Rock, Texes

Background: The purpose of this study was to analyze the long-term outcomes associatedwith interruption of incompetent perforator veins (IPV) using minimally invasive techniques asadjunctive therapies in the management of patients with chronic venous insufficiency (CVI).Methods: This is a retrospective review of a prospectively maintained venous databasecollected over 6 years (2005e2011). The study cohort included 64 patients with CVI stage C5or C6 who underwent minimally invasive perforator interruption with subfascial endoscopicperforator surgery (SEPS) or radiofrequency ablation of IPV (RFA-IPV) as part of the manage-ment of their CVI. All patients were referred for evaluation after having failed conservative treat-ment with compression dressings. Relevant patient characteristics and comorbidities wererecorded along with symptom resolution, venous ulcer healing, recurrence, and surgical compli-cations. In addition to clinic follow-up examination by a surgical provider, chart notes from othersubspecialties were also reviewed. We also conducted telephone assessments in patients whohad been lost to clinic follow-up in order to provide complete outcome data.Results: In this subset (n ¼ 64) of patients with CVI who had adjunctive IPV treatment,41 (64%) underwent SEPS and 23 (36%) patients underwent RFA-IPV along with ablation ofthe greater saphenous vein for C5 or C6 disease. The mean patient follow-up was 37 months.There were no differences in patient demographics or risk factors. Twenty-three (88%) SEPSand 12 (100%) RFA-IPV patients (P ¼ NS) with C6 disease went on to completely heal theirvenous ulcers after the procedure with an average healing time of 5.2 (SEPS) and 4.4 (RFA-IPV) months (P ¼ NS). Overall, 7 (17%) SEPS and 6 (23%) RFA-IPV patients (P ¼ NS) devel-oped a recurrent ulcer after surgical treatment. Procedural complications were seen in 14 (34%)SEPS and 2 (9%) RFA-IPV patients (P ¼ NS), mostly minor. Major complications only occurredin the SEPS group consisting of 2 major amputations caused by pain from nonhealing ulcers and1 deep venous thrombosis.Conclusions: This study supports the premise that in patients with advanced venous disease,there may be a demonstrable benefit directly attributable to perforator interruption. Our recurrentulceration rates are acceptable, with low complication rates in patients undergoing RFA-IPV,thereby making this procedure more attractive in patients with multiple comorbidities. Wesupport an aggressive approach to patients with C5/C6 disease that includes perforator elimina-tion when appropriate.

INTRODUCTION

Chronic venous insufficiency (CVI) is associated

withmultiple complications, including venous stasis

at the 22nd Annual Winter Meeting of the Peripheralery Society, Vail, CO, January 27e29, 2012.

f Vascular Surgery, Scott and White Healthcare andVeterans Healthcare System, Texas A&M College ofple, TX.

nt of Surgery, Texas A&M Health Science Center Collegeound Rock Campus, Round Rock, TX.

ulcers, which account for a loss of up to 2 million

work days in addition to individual discomfort

and disability.1 Conventional treatment has tradi-

tionally been multilayered compression dressings,

Correspondence to: Ruth L. Bush, MD, MPH, 2401 South 31st Street,Temple, TX 76534, USA; E-mail: rbush@medicine.tamhsc.edu

Ann Vasc Surg 2013; 27: 89–95http://dx.doi.org/10.1016/j.avsg.2012.09.001� Annals of Vascular Surgery Inc.

Manuscript received: April 17, 2012; manuscript accepted: September 5,

2012.

89

90 Rueda et al. Annals of Vascular Surgery

although recent data support more aggressive inter-

vention to improve both ulcer healing and ulcer

recurrence rates.2e4 Incompetent veins as the

source of lower extremity venous hypertension are

often found to be the culprits in this condition. In

addition to superficial and deep venous reflux, the

severity of CVI has been directly correlated with

the number and size of incompetent perforator

veins (IPVs) in a limb.5 Functioning as communi-

cating veins between the deep and superficial

venous systems, IPVs transverse the muscle fascia

and connect the 2 venous systems in the lower

extremity. Homans6 first described the relationship

of perforator vein incompetence and venous ulcera-

tion in 1917. As the valves in these veins become

incompetent, venous reflux and hypertension

develops, exacerbating CVI.

When patients have ulcers refractive to conserva-

tive therapy, surgical options for reflux have been

explored after thorough evaluation and appropriate

duplex imaging. There are several therapeutic

modalities available to the clinician to treat this

problem. The traditional Linton procedure was

open surgical ligation of the IPVs, first described in

1938.7 Subfasical endoscopic perforator surgery

(SEPS) was developed as a less invasive alternative

in the 1980s by Hauer et al.8 and remarkably

reduced postoperative complications and hospital

duration of stay. This technique entails direct visual-

ization and dissection of perforator veins using

endoscopic techniques. The outcomes after SEPS

have yielded both adequate ulcer healing rates and

low ulcer recurrence rates. However, wound

complications have continued to be commonly re-

ported after SEPS.9 The evolution of catheter-

based technology for the treatment of superficial

venous insufficiency has been extended to the abla-

tion of IPV in recent years. Endothermal ablation,

including the use of radiofrequency energy, was

developed for IPV (RFA-IPV) and can be performed

in an outpatient setting with the use of ultrasound.

This technique uses the direct application of heat to

induce closure of the incompetent vessel.10

Despite the development andwideuse ofmultiple

treatment options for IPVs, there has been contro-

versy over the role and importance of perforator

interruption in the literature. No randomized

controlled trial has successfully studied IPV interrup-

tion while adequately controlling for concomitant

greater saphenous vein (GSV) therapy or for type

of associated venous insufficiency. It remains

unclear whether or not IPV interruption is of actual

benefit in promoting ulcer healing or in the treat-

ment of recalcitrant or recurrent venous ulcerations.

The purpose of this study was to analyze the long-

term outcomes associated with interruption of IPVs

using minimally invasive techniques as adjunctive

therapies in the management of patients with CVI.

METHODS

This study was a retrospective chart review of

patients evaluating the long-term outcomes of

SEPS and RFA-IPV in patients with CVI stage C5

and C6 treated between 2005 and 2011. SEPS proce-

dures were performed between 2005 and 2008;

SEPS was replaced by RFA in the last 3 years of

the study. All patients were referred for evaluation

after having failed conservative, nonsurgical treat-

ment with compression therapy. Because patients

were referred from a variety of wound care centers,

podiatrists, and primary care providers, many

different types and pressures of compression

garments were most likely used, as well as other

wound care modalities (e.g., skin substitutes) at

the discretion of the treating physician. We did not

have specific data on the classes or types of wound

care treatments before referral to our vascular

surgery department. Relevant patient characteristics

and comorbidities were recorded. Other variables

recorded included a history of deep venous throm-

bosis (DVT), ankle-brachial index (ABI), the nature

of the venous reflux (deep and superficial), along

with symptom resolution, venous ulcer healing,

venous ulcer recurrence, and periprocedural

complications. The patient follow-upwas conducted

in an outpatient clinic setting by a surgical provider.

The study was approved by both Scott and White

and the Central Texas Veterans Healthcare System

Institutional Review Boards.

Preoperative evaluation included a complete

history and physical examination along with duplex

ultrasound of the superficial and deep venous

system of the affected extremity, including identifi-

cation of any IPV. The investigation included all

axial and perforator veins for the presence of

thrombus and/or reflux. Venous diameter was also

recorded. The duplex ultrasounds were performed

by an experienced, registered vascular technologist.

The sonogram was conducted to evaluate for DVT,

the presence of GSV recanalization or untreated

saphenous duplication, and identification of the

IPV. A perforator was incompetent if retrograde

flow was >0.5 seconds or >3.5 mm in size. The

perforator veins chosen for treatment were in the

vicinity of the ulceration. Perforator veins that

were remote from the site of active or healed ulcer-

ation (>15e20 cm from the ulcer site) were not

treated, regardless of size. Finally, all patients under-

went procedures to treat GSV reflux before or

Vol. 27, No. 1, January 2013 Perforator vein interruption for chronic venous insufficiency 91

during IPV interruption. Because the purpose of this

study was to isolate only those C5 or C6 patients

who had perforator interruption as part of their

venous intervention, we have included only

patients who had IPV interruption as part of their

care. The cohorts do not include patients who had

axial venous ablation or ligation/stripping alone

without perforator interruption.

Postoperative care varied by procedure, but all

patients were placed in elastic compression

garments and instructed to elevate the treated limb

with mild ambulation. Following this intervention,

most patients are placed in 20e30 mm Hg compres-

sion garments because we have found that both

compliance and comfort are improved with this

grade of compression. If the patient had an active

ulceration, multilayer compression garments were

used over the wound. Follow-up duplex ultrasound

was conducted at both 1 week and 30 days postpro-

cedure to evaluate for DVT and other IPV as well as

successful ablation. Local wound care was conduct-

ed by wound care specialists; however, compliance

to the therapy was not assessed in this study.

SEPS

General anesthetic or regional anesthesia was used

along with appropriate antibiotics and DVT prophy-

laxis. A standard 2-port technique was used for all

SEPS patients as previously described.11 Briefly, an

incision was made approximately 2 fingerbreadths

distal and 4 fingerbreadths medial to the anterior

tibial tuberosity. The subcutaneous tissues were

dissected to the level of the muscle fascia. An inci-

sion was created longitudinally along the muscle

fascia and balloon dissection was used to create

a working area along the subfascial space. A 5-mm

endoscopic port was inserted for the camera and

light source. CO2 was used to insufflate the area

and the pressure was maintained between 25 and

30 mm Hg. A second 5-mm port was placed under

direct visualization over the medial aspect of the

calf about 5 to 7 cm distal to the initial port place-

ment. A dissector and a harmonic scalpel were

used through this port to interrupt all visualized

perforator veins to the level of the ankle.

RFA-IPV

For this procedure, local anesthetic was used with

appropriate antibiotics and DVT prophylaxis. Before

the start of the procedure, ultrasound was used to

identify and mark the level of the perforators that

would be treated. Ultrasound was used to access the

IPV with the ClosureRFS stylet (VNUSMedical Tech-

nologies, San Jose, CA). The radiofrequency

generator (RFG-PLUS) was used as the power source

for the stylet.Verificationof accurateplacementof the

stylet was conducted with the ultrasound and by

constant impedance feedback, which was considered

accurate between 200 U and 400 U. Finally, beforeablation treatment, tumescent solution was infused

into the area of the perforator to prevent thermal

damage and provide analgesia. The treatment time

varied depending on the size and length of the perfo-

rator. Appropriate treatment was confirmed with no

flow revealed via ultrasound in the IPV.

Of note, the cohorts were not randomized, but

rather reflect changes in clinical practice as endove-

nous thermal ablation techniques became available

for perforation ablation. Endovenous ablation was

introduced into our clinical practice in 2009. Before

2009, SEPS was the primary treatment modality for

patients with IPVs.

RESULTS

There were a total of 64 patients with CVI stage C5

or C6 undergoing IPV interruption. There were 41

(64%) patients treated with SEPS and 23 (36%)

patients treatedwith RFA-IPV. Therewere no signif-

icant demographic differences noted among groups

(Table I). There were no statistical differences in

age, bodymass index (BMI), or incidence of diabetes

mellitus (DM) between groups. Most patients in

both groups were men; there was no difference in

the number of patients with a history of DVT or

the presence of superficial and/or deep venous

reflux. There was no difference in ABI between

the groups. The mean patient follow-up was 37

months (range, 20e120 months).

There were a total of 26 stage C5 patients; 15

(37%) were treated with SEPS and 11 (48%) were

treated with RFA-IPV (P ¼ 0.14). There were 38

stage C6 patients; 26 (63%) were treated with

SEPS and 12 (52%) were treated with RFA-IPV

(P¼ 0.18). Four (15%) patients with stage C5 devel-

oped ulcer recurrences after the procedure. Two

patients were treated with SEPS and 2 treated with

RFA-IPV (Table II).

Twenty-three (88%) patients with stage C6

healed venous ulcerations after undergoing SEPS.

The mean healing time was 5.2 months (range,

1e9 months). There were 5 recurrences in this

group (Table III). Twelve (100%) patients with stage

C6 healed venous ulcerations after undergoing

RFA-IPV. The mean healing time was 4.4 months

(range, 1e7 months). There were 4 recurrences in

this group (Table IV). There were no statistical

differences between these groups.

Table I. Demographics and risk factors of the subfascial endoscopic perforator surgery or radiofrequency

ablation of the incompetent perforator vein cohorts

SEPS (n ¼ 41) RFA-IPV (n ¼ 23) P value

Mean age, yr (range) 59 (30e83) 60 (35e87) 0.17

Male gender, n (%) 28 (68) 16 (70) 0.12

Mean BMI, kg/m2 (range) 29 (20e40) 31 (20e45) 0.19

C5, n (%) 15 (37) 11 (48) 0.14

C6, n (%) 26 (63) 12 (52) 0.18

History of DVT, n (%) 10 (24) 10 (43) 0.16

Superficial venous reflux, n (%) 27 (66) 23 (100) 0.19

Deep venous reflux, n (%) 7 (17) 17 (74) 0.09

Previous venous surgery, n (%) 13 (32) 5 (22) 0.15

ABI (range) 0.93 (0.89e1.12) 0.95 (0.90e1.21) 0.22

Diabetes mellitus, n (%) 9 (22) 6 (23) 0.13

ABI, ankle-brachial index; BMI, body mass index; DVT, deep venous thrombosis; RFA-IPV, radiofrequency ablation of incompetent

perforator vein; SEPS, subfascial endoscopic perforator surgery.

Table II. Patients with C5 disease who developed

ulcer recurrences

ProcedureAge(yr) Sex

BMI > 30kg/m2 DVT

Deepvenousreflux

Diabetesmellitus

SEPS 66 F No Yes No No

SEPS 54 M Yes No No Yes

RFA-IPV 87 M No Yes Yes No

RFA-IPV 75 M No Yes No No

BMI, body mass index; DVT, deep venous thrombosis; F, female;

M, male; RFA-IPV, radiofrequency ablation of incompetent

perforator vein; SEPS, subfascial endoscopic perforator surgery.

Table III. Patients with C6 disease who

developed ulcer recurrences after subfascial

endoscopic perforator surgery

Age (yr) SexBMI > 30kg/m2 DVT

Deep venousreflux Diabetes

68 M Yes No Yes No

49 M No Yes Yes No

69 M No Yes No Yes

71 F No No No Yes

57 M Yes Yes No No

BMI, body mass index; DVT, deep venous thrombosis; F, female;

M, male.

Table IV. Patients with C6 disease who

developed ulcer recurrences after radiofrequency

ablation of the incompetent perforator vein

Age SexBMI > 30kg/m2 DVT

Deep venousreflux Diabetes

85 F No No No No

76 M Yes Yes Yes No

54 M No No No Yes

56 F Yes No Yes No

BMI, body mass index; DVT, deep venous thrombosis; F, female;

M, male.

92 Rueda et al. Annals of Vascular Surgery

Fourteen (34%) SEPS patients and 2 (9%)

RFA-IPV patients had procedural complications

(P < 0.05). Minor complications in the SEPS group

included 3 wound infections and 8 patients with

neuralgia treated with medical therapy. Minor

complications in the RFA-IPV group included 2

patients with neuralgia treated with medical

therapy. Neuralgia was defined as sensory deficit

along the course of the saphenous vein.

Three (7%) patients undergoing SEPS had major

procedural complications. Two patients underwent

limb amputations because of debilitating pain after

nonhealing venous ulcers. One patient was

a 76-year-old man with a BMI of 26 kg/m2, an

ABI of 0.89, and a history of DM; the second patient

was an 83-year-old man with a BMI of 26 kg/m2, an

ABI of 0.91, and a history of DM. One patient devel-

oped a DVT after SEPS; he was a 57 year-old man

with a BMI of 30 kg/m2 and a history of a DVT in

the same leg, and he was treated with anticoagula-

tion. There were no major complications in patients

undergoing RFA-IPV.

Postprocedure hospital admissionwas required in

26 (62%) patients undergoing SEPS and 3 (13%)

patients undergoing RFA-IPV (P < 0.05). The

mean duration of hospital stay for SEPS patients

was 1.5 days (range, 1e7 days), and the mean dura-

tion of hospital stay for RFA-IPV was 1.3 days

(range, 1e2 days; P ¼ 0.18).

DISCUSSION

Venous hypertension can lead to skin changes and

ulceration in patients with CVI. We know from the

Vol. 27, No. 1, January 2013 Perforator vein interruption for chronic venous insufficiency 93

comparison of surgery and compression with

compression alone in chronic venous ulceration

(ESCHAR) study2da randomized trial comparing

compression therapy alone to compression therapy

with the addition of surgical intervention for CVIddid not necessarily reduce ulcer healing rates, but

decreased ulcer recurrence rates and led to longer

ulcer-free time periods. This improvement in

ulcer-free time was regardless of the presence deep

venous incompetence. This benefit is presumed to

be from the hemodynamic benefit these patients

experience. Via extrapolation, some of these

changes can be modified by aggressively treating

the superficial venous reflux with ablation techni-

ques.12e14

Several authors have also hypothesized that by

treating superficial venous reflux and interrupting

IPVs, the pathophysiologic factors leading to venous

ulceration can be reversed.15,16 Our study supports

the hypothesis that the interruption of IPV is bene-

ficial for the treatment of CVI stages C5 and C6. In

this cohort, there was long-term success in wound

healing using both SEPS and RFA-IPV with low

ulcer recurrence. In addition, patients undergoing

endovenous thermal ablation of their IPVs benefited

from a lower complication rate than those under-

going SEPS. In addition, RFA-IPV has allowed the

movement of IPV interruption to the outpatient

setting, leading to increased patient access and the

elimination of general anesthesia. SEPS often

required inpatient care because of the use of general

anesthesia and postoperative pain control. Many of

the patients included in these cohorts were treated

within the Veterans Affairs health care system,

where procedures are often regionalized and

patients may stay overnight because they had trav-

eled long distances. This is particularly true in

central Texas, which covers a large geographic area.

There continues to be debate on the optimal treat-

ment for patients with CVI stage C5 or C6 with asso-

ciated IPV. Nonrandomized data suggest that

superficial vein ablation along with phlebectomies

promotes wound healing and decreases the risk of

ulcer recurrence.13,17,18 Numerous investigators,

however, have reported the clinical benefits of inter-

ruption of IPV including Linton,7 Cocket,19 and,

more recently, Stuart et al.20,21 There are data sup-

porting the assertion that the ablation of superficial

venous reflux leads to improvement in hemody-

namic results secondary to synchronous deep

venous reflux.22,23 It has not been clearly estab-

lished that this alone will improve IPV reflux and

thereby accelerate wound healing. An alternative

therapy to eliminate perforator veins is ultrasound-

guided foam sclerotherapy. This technique has

been shown to be effective in perforator interruption

and ulcer healing with a low complication profile,

although repeated injections may be necessary.24

More contemporary trials have shown benefits

from IPV interruption using SEPS in the treatment

of patients with CVI stages C4, C5, and C6.25e29

These trials have produced data supporting the use

of IPV interruption with SEPS along with treatment

of the superficial venous system to decrease venous

reflux and reduce ambulatory venous hypertension.

One randomized control trial evaluating SEPS after

GSV stripping found that IPVs do not remain closed

after standard varicose surgery and that the addition

of SEPS did not increase morbidity but did reduce

the number of IPVs.30 However, upon short

follow-up, the effect on ulcer recurrence and quality

of life were no different between groups. SEPS,

while effective in the treatment of CVI and venous

ulcerations, is not without significant limita-

tions.31,32 Technical drawbacks to SEPS exist, such

as the high cost of equipment and the risk of DVT.

As stated by Kalra and Glovicki,33 the clinical and

hemodynamic improvements that may occur after

SEPS are difficult if not impossible to assess. Also,

in patients who have long-standing and advanced

fibrosis and lipodermatosclerosis, it is difficult to

advance the SEPS instrumentation far enough

distally to visualize and/or ligate perforator veins

that are in close proximity to the ulcerative area.

Failure to ligate the perforating veins has been re-

ported to have a recurrent ulceration rate of 70%

in patients with CVI.28,33 Other complications of

SEPS that have been reported are sural and tibial

nerve injury, intraoperative bleeding in the tight

lower extremity compartment, and liponecrosis.32

Percutaneous thermal ablation techniques have

been evaluated in numerous small nonrandomized

trials24e31 that have provided evidence supporting

the use of percutaneous thermal ablation tech-

niques to treat perforators.10,34e40 The limitations

of these studies include the small number of

patients, the limited description of the treatment

received before the procedure, the fact that the

majority of the studies have treated mild CVI (stages

C2eC3), the fact that duplex criteria for incompe-

tence is not included as a variable in the analyses,

the limited length of follow-up, the fact that

concomitant procedures are commonly performed

and the effect of percutaneous thermal ablation

is not entirely clear, and the lack of functional

outcomes. However, they report low complication

rates, including neuralgia and DVT. One recent

study evaluated 45 patients with CVI stage

C6 suffering from nonhealing ulcers associated

with IPV.39 The authors treated patients with

94 Rueda et al. Annals of Vascular Surgery

percutaneous radiofrequency ablation and reported

that 90%of patients healed the ulcer after successful

perforator ablation. In this study, no patients healed

a venous ulcer without at least 1 perforator vein

being interrupted. The study concluded that this

technique has a significant learning curve, but

complications are uncommon and the ulcer healing

rate is >90% after successful IPV interruption.

Our series evaluated SEPS and RFA-IPV, and

although it was not a randomized trial, it provides

insight into the modern treatment of IPV and

its utility. Despite the continued debate of IPV inter-

ruption, this series suggests benefits from successful

closure of IPV. After undergoing RFA-IPV, all stage

C6 patients healed venous ulcerations with a low

recurrence rate that is comparable to patients

undergoing SEPS in our study consistent with other

study results. In addition, stage C5 patients had low

recurrence rates after undergoing RFA-IPV. RFA-

IPV had very low complication rates and can be per-

formed in an outpatient setting using only local

anesthesia, making the technique attractive for use

in a patient population with multiple comorbidities.

The limitations of our series include the relatively

small cohort size and retrospective review of data.

Another limitation is the lack of data on wound

care techniques, type and gradient of preprocedure

compression therapy, and ulcer dimensions.

CONCLUSION

The treatment approach of stage C5 and C6 CVI

remains debatable, which is distressing in such

a prevalent, chronic, and disabling condition.

However, there is growing evidence that patients

with stage C5 or C6 CVI with IPV can benefit from

IPV interruption after conservative medical treat-

ment has failed. Although SEPS in our series led to

3 serious complications, it is a successful technique

that can heal venous ulcers and has low recurrence

rates. RFA-IPV is a newer minimally invasive tech-

nique that is proving to have a comparable ulcer

healing rate and a low recurrence rate combined

with a low complication rate that can be performed

in the outpatient setting. We advocate an aggressive

approach to patients with CVI and venous ulcera-

tions that includes IPV interruption when

appropriate.

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