From the Society for Clinical Vascular Surgery
Endovenous laser therapy and radiofrequency
ablation of the great saphenous vein: Analysis of
early efficacy and complications
Alessandra Puggioni, MD, Manju Kalra, MBBS, Michele Carmo, MD, Geza Mozes, MD, and
Peter Gloviczki, MD, Rochester, Minn
Background: Endovenous laser therapy (EVLT) and radiofrequency ablation (RFA) are new, minimally invasive
percutaneous endovenous techniques for ablation of the incompetent great saphenous vein (GSV). We have performed
both procedures at the Mayo Clinic during two different consecutive periods. At the time of this report, no single-
institution report has compared RFA with EVLT in the management of saphenous reflux. To evaluate early results, we
reviewed saphenous closure rates and complications of both procedures.
Methods: Between June 1, 2001, and June 25, 2004, endovenous GSV ablation was performed on 130 limbs in 92
patients. RFA was the procedure of choice in 53 limbs over the first 24-month period of the study. This technique was
subsequently replaced by EVLT, which was performed on the successive 77 limbs. The institutional review board
approved the retrospective chart review of patients who underwent saphenous ablation. According to the CEAP
classification, 124 limbs were C2-C4, and six were C5-C6. Concomitant procedures included avulsion phlebectomy in
126 limbs, subfascial endoscopic perforator surgery in 10, and small saphenous vein ablation in 4 (EVLT in 1, ligation
in 1, stripping in 2). Routine postoperative duplex scanning was initiated at our institution only after recent publications
reported thrombotic complications following RFA. This was obtained in 65 limbs (50%) (54/77 [70%] of the EVLT
group and 11/53 [20.8%] of the RFA group) between 1 and 23 days (median, 7 days).
Results: Occlusion of the GSV was confirmed in 93.9% of limbs studied (94.4% in the EVLT [51/54] and 90.9% in the
RFA group [10/11]). The distance between the GSV thrombus and the common femoral vein (CFV) ranged from –20
mm (protrusion in the CFV) to ?50 mm (median, 9.5 mm) and was similar between the two groups (median, 9.5 mm
vs 10 mm). Thrombus protruded into the lumen of the CFV in three limbs (2.3%) after EVLT. All three patients were
treated with anticoagulation. One received a temporary inferior vena cava filter because of a floating thrombus in the
CFV. Duplex follow-up scans of these three patients performed at 12, 14, and 95 days, respectively, showed that the
thrombus previously identified at duplex scan was no longer protruding into the CFV. No cases of pulmonary embolism
occurred. The distance between GSV thrombus and the saphenofemoral junction after EVLT was shorter in older
patients (P ? .006, r2? 0.13). The overall complication rate was 15.4% (20.8% in the EVLT and 7.6% in the RFA group,
P ?.049) and included superficial thrombophlebitis in 4, excessive pain in 6 (3 in the RFA group), hematoma in 1, edema
in 3 (1 in the RFA group), and cellulitis in 2. Except for two of the three patients with thrombus extension into the CFV,
none of these adverse effects required hospitalization.
Conclusion: GSV occlusion was achieved in >90% of cases after both EVLT and RFA at 1 month. We observed three cases
of thrombus protrusion into the CFV after EVLT and recommend early duplex scanning in all patients after endovenous
saphenous ablations. DVT prophylaxis may be considered in patients >50 years old. Long-term follow-up and
comparison with standard GSV stripping are required to confirm the durability of these endovenous procedures. (J Vasc
Endovenous laser therapy (EVLT) and radiofrequency
ablation (RFA) of the great saphenous vein (GSV) have
been recently introduced as alternative, minimally invasive
techniques for the treatment of saphenous vein incompe-
tence. These procedures were designed to ablate the GSV
through a percutaneous approach to minimize the discom-
fort and complications associated with conventional strip-
ping. The RFA catheter delivers radiofrequency energy to
whereas EVLT releases thermal energy both to the blood
and to the venous wall, causing localized tissue damage.
Relative simplicity and high patient satisfaction have made
these procedures increasingly popular among medical spe-
cialties such as surgery, dermatology, radiology, and gyne-
Early reports on endovenous saphenous ablation dem-
onstrate high occlusion rates and different patterns of com-
plications related to these two different techniques. Re-
ported complication rates range between 4% and 23% after
RFA1,2 and between 0% and 10% after EVLT.3,4 Occlusion
rates have been high with both techniques, but they have
been somewhat higher after EVLT (98% to 100%)4,5 than
after RFA (83% to 100%).6,7
report, no single-institution, peer-reviewed report had
From the Division of Vascular Surgery, Mayo Clinic.
Competition of interest: none.
Presented at the Thirty-third Annual Meeting of the Society for Clinical
Vascular Surgery, Coral Gables, Fla, Mar 9-13, 2005.
Correspondence: Manju Kalra, MD, Mayo Clinic, Vascular Surgery Divi-
sion, Rochester, MN 55905.
Copyright © 2005 by The Society for Vascular Surgery.
compared RFA with EVLT in the management of saphe-
nous reflux. To evaluate the early efficacy and side effects of
these two techniques, we reviewed our experience.
The clinical records of 92 consecutive patients who
underwent endovenous GSV ablation over a 3-year period
between June 1, 2001, and June 25, 2004, were retrospec-
tively reviewed. Data on 130 extremities were included in
the analysis. All patients had symptomatic varicose veins
with documented GSV incompetence and were classified
according to the CEAP (clinical, etiologic, anatomic,
tails, and postoperative course were recorded and analyzed
(Table I). The institutional review board approved the
retrospective chart review of patients who underwent GSV
The severity and extent of GSV reflux were evaluated
preoperatively with duplex scanning. All duplex scans were
performed with a color duplex system (Acuson Sequoia
512, Siemens, Erlangen, Germany) in our accredited, non-
invasive vascular laboratory. Reflux in the superficial (GSV
and small saphenous vein) and deep (femoral vein and
popliteal vein) venous systems was assessed with patients in
the standing position by inflation/deflation of a calf ple-
thysmographic cuff. Reflux was defined as reversed flow
lasting ?0.5 seconds.8 Presence of incompetent perfora-
tors was not routinely evaluated.
Statistical analysis. Comparison between the two
groups was performed with the Fisher’s exact test or ?2test
for categoric variables and the t test or Wilcoxon test for
continuous variables, as appropriate. Linear regression
analysis was used to assess the correlation between two
continuous variables. P ? .05 was considered statistically
Description of techniques. Before surgery, lower-
extremity varicosities were marked in the standing position
in preparation for stab avulsions. These outpatient proce-
dures were performed in the operating room under general
or epidural anesthesia supplemented with local tumescent
anesthesia. The patients were placed in the supine position,
and under duplex ultrasound guidance, the GSV was punc-
tured with an 18-gauge needle or, rarely, accessed by
cutdown at the knee level.
The unsheathed laser or radiofrequency catheter was
advanced over a wire and its position confirmed to be distal
to the saphenofemoral junction (SFJ), 1 cm below the
confluence of the inferior epigastric vein. The saphenous
cent anesthesia (50 mL of 1% lidocaine and 1 mL of
epinephrine [1:1,000] diluted in 1L of normal saline)
under duplex ultrasound guidance from knee to groin
around the catheter.
The patient was then placed in Trendelenburg position
and the GSV was treated with either RFA or EVLT. RFA
was the procedure of choice over the first 24-month period
of the study (53 limbs); a 6F radiofrequency catheter was
used in 29 limbs (54.7%) and an 8F in 24 (45.3%). This
technique was subsequently replaced by EVLT, which was
performed on 77 successive limbs.
Successful obliteration (Fig 1) and absence of common
femoral vein (CFV) thrombus were confirmed by intraop-
erative duplex ultrasound scans. Stab avulsion phlebecto-
mies and other concomitant procedures were performed
when indicated. At the completion of the operation a
two-layer compressive dressing (Kerlix [Kendall Co, Mans-
field, Mass] and ACE bandages [BD, Franklin, NJ]) was
applied from toes to groin to be maintained for the follow-
ing 2 days. Patients were discharged the same day upon
recovery from the anesthesia with instruction to ambulate
At time of discharge, all patients were prescribed a
standard dose of analgesics. Postoperative pain was defined
as excessive when this required an additional prescription
refill or caused significant limitation of activities of everyday
living. Thrombophlebitis was defined as the presence of an
indurated cord at the site of the treated GSV associated
with localized hyperemia, edema, and tenderness requiring
treatment with anti-inflammatory agents. Edema was de-
fined as the new onset of swelling in the treated lower
extremity that was exacerbated by ambulation and relieved
by leg elevation.
Endovenous laser therapy. Veins of all sizes were
treated with this procedure. After the GSV was cannulated
with a 45-cm-long 5F angio sheath over a J-tip guidewire,
an 810-nm diode laser fiber (Diomed, Andover, Mass) was
inserted and advanced proximally. The veins were treated
by delivering 14 W of continuous energy and withdrawing
the laser fiber at a speed of 3 mm/s, until a distance of 2 cm
above the knee access site was reached.
Radiofrequency ablation. The Closure system (VNUS
Medical Technologies Inc, San Jose, Calif) was used to
treat veins from 2 to 12 mm in diameter. A 6F or 8F
catheter was used. These were introduced in the GSV
through a vascular sheath with the Seldinger technique.
Table I. Demographic and clinical data for 92 patients
(130 limbs) treated with endovenous saphenous ablation
EVLT No. (%)RFA No. (%)
52.2 ? 12.6
50.28 ? 13.1
EVLT, Endovenous laser therapy; RFA, radiofrequency ablation; SEPS,
subfascial endoscopic perforator surgery; SSV, small saphenous vein.
JOURNAL OF VASCULAR SURGERY
Volume 42, Number 3
Puggioni et al 489
The catheter was withdrawn at a rate of 2 to 3 cm/m,
maintaining a temperature between 82°C and 90°C.
operative duplex scanning (?1 month from surgery) was
initiated at our institution only after the introduction of
EVLT and publications on thrombotic complications after
on color duplex ultrasound analysis (Fig 1). The proximal
extent of GSV thrombus was measured from the SFJ.
One hundred and thirty limbs in 92 patients were
treated and represent the subjects of this study. Seventy-
seven patients were women (83.7%) and 15 were men
84 years). One hundred and twenty-four limbs had symp-
tomatic varicose veins, with or without skin changes (C2-
C4), and six had a history of venous ulcers (C5-C6).
Etiology was primary valvular incompetence in 126 limbs
and post-thrombotic syndrome in four. Preoperative deep
venous reflux was detected in 33 limbs (25.4%); this was
localized in the femoral vein in 23 (17.7%) and in the
popliteal vein in 20 (15.5%).
Length of GSV treated by EVLT ranged between 10
and 45 cm (mean, 30 ? 7 cm). A mean of 48 ? 10 J/cm
and 1452 ? 374 J/limb (range, 500 to 2327 J) was
Adjunctive procedures included avulsion phlebecto-
mies in 126 limbs, small saphenous vein ablation in 4, and
subfascial endoscopic perforator surgery in 10. Indications
for subfascial endoscopic perforator surgery were a history
of venous ulcers (C5-C6) in six limbs and advanced skin
changes (C4) in four. Small saphenous vein reflux was
abolished by EVLT in 1 case, sapheno popliteal ligation in
1, and stripping in 2.
Immediate technical success was obtained in all (100%)
of EVLT procedures and in 51 (96%) of 53 of RFA cases
numerous attempts to cannulate the GSV, and formal
stripping was performed.
significant persistent flow in nine cases, thus necessitating
repeated treatment during the same anesthesia, whereas
EVLT was always successful (17% vs 0%, P ? .002). At the
end of operation, duplex ultrasound scans demonstrated
residual minimal flow in 16 limbs (12%), representing
11.3% of RFA and 13% of EVLT procedures (P ? .99).
However, this finding was not considered clinically signifi-
cant, and no further intervention was deemed necessary.
Early postoperative duplex ultrasound scans were per-
formed in 65 limbs (50%) (54/77 [70%] of the EVLT
group and 11/53 [20.8%] of the RFA group) between 1
and 23 days (median, 7 days). These studies revealed early
partial GSV recanalization in four limbs (6.1%). Of these,
5.6% (3/54) were in the EVLT group, and 9.1% (1/11)
were in the RFA group of patients who received an early
postoperative duplex scan. One of these patients had recur-
rent symptomatic leg varicosities, and GSV stripping with
phlebectomies was performed 7 months later. The other
three patients remained asymptomatic, and no further in-
tervention was performed.
A comparison of intraoperative and early postoperative
duplex ultrasound scans revealed that postoperative recan-
alization had occurred in one (9%) of 11 limbs with mini-
mal GSV flow at the end of procedure (EVLT group), and
Fig 1. Duplex examinations (longitudinal views) of the great saphenous vein (GSV) at the saphenofemoral junction
(SFJ). a, Pretreatment scan demonstrated an incompetent SFJ after augmentation. b, Intraoperative color duplex
interrogation showed successful occlusion of the GSV with a patent, 3-mm proximal stump (arrow 1) and absence of
flow within the treated segment (arrow 2).
JOURNAL OF VASCULAR SURGERY
490 Puggioni et al
in three (5.5%) of 55 limbs, with intraoperative evidence of
complete GSV occlusion (2 in the EVLT and 1 in the RFA
Postoperative duplex scans revealed protrusion of the
GSV thrombus into the CFV in three (2.3%) asymptomatic
patients, all in the EVLT group; no case was identified in
the RFA patients studied with duplex ultrasound scanning.
None of these patients had a history of previous DVT or a
known hypercoagulable state. Treatment consisted of sub-
cutaneous low-molecular-weight heparin in two cases and
unfractionated intravenous heparin in one. In one case, a
temporary inferior vena cava filter was also inserted because
protuberant thrombus appeared to be floating in the CFV.
Two weeks later, the thrombus previously identified at
duplex ultrasound scan was seen no longer to protrude into
the CFV, and the filter was removed. No thrombus was
identified in the filter, and patient remained asymptomatic
during a 3-month follow-up. Similarly, thrombus com-
pletely resolved in the other two patients on duplex ultra-
sound scans performed 12 and 95 days later.
The distance between the proximal GSV thrombus and
and ?50 mm (median, 9.5 mm) and was similar between
the EVLT and RFA groups (median, 9 vs 10 mm). After
EVLT, the distance between the GSV thrombus and the
SFJ was significantly shorter in older patients (r2? 0.13,
P ? .0064) (Fig 2) but not after RFA (P ? .39). When
EVLT patients were grouped by age, we found that the
mean age of those whose GSV thrombus extent was ?2
mm from the SFJ (66%) was 56 ? 3.1 years, whereas mean
age was 49.1 ? 2.2 years (P ? .063) (Fig 3) in those whose
distance was ?2 mm (33%).
The overall complication rate was 15.4% (20.8% after
EVLT and 7.6% after RFA, P ? .039) and included throm-
bus protrusion in the CFV in 3, urinary retention in 1,
superficial thrombophlebitis in 4, excessive pain in 6, he-
matoma in 1, edema in 3, and cellulitis in 2 (Table II).
None of the patients had bilateral edema. No cases of
clinically evident pulmonary embolism or thermal skin in-
jury occurred. Except for two of those with thrombus
extension into the CFV, hospitalization was not required
for any of these patients.
Endovascular techniques of saphenous vein ablation
have been introduced as minimally invasive alternatives to
high ligation and open surgical stripping of the incompe-
tent saphenous vein. Although stripping can lead to painful
and prolonged postoperative recovery in some patients,
with risks of infection, hematoma, and nerve injury,9,10
reports of endovenous procedures claim earlier return to
work and decreased postoperative pain.2,11 Encouraging
results after RFA and EVLT have been reported in several
This retrospective review compared the early success
and complications of two endovenous procedures of GSV
ablation performed at a single institution during two con-
secutive study periods. A drawback of this study was that
duplex scanning after RFA was performed only in the later
and thrombus progression in this group are limited and
Fig 2. Relationship between distance of great saphenous vein
(GSV) thrombus from saphenofemoral junction (SFJ) and age in
the endovenous laser therapy group (n ? 54).
Fig 3. Age distribution among endovenous laser therapy patients
with a distance of great saphenous vein (GSV) thrombus and
saphenofemoral junction (SFJ) of ?2 mm and ?2 mm.
Table II. Complications after endovenous laser therapy
and radiofrequency ablation of the great saphenous vein
(n ? 77)
(n ? 53)
EVLT, Endovenous laser therapy; RFA, radiofrequency ablation.
JOURNAL OF VASCULAR SURGERY
Volume 42, Number 3
Puggioni et al 491
were not statistically analyzed. We have recently described
the three cases of progression of GSV thrombus into the
CFV after EVLT in detail.12 This study found a higher need
for repeated treatment of the saphenous vein during the
group (17% vs 0%) because of duplex evidence of patency
after the first pass of the Closure catheter. This finding was
more than the usual intraoperative residual flow and was
considered as inadequate closure, necessitating repeated
obliteration during the same anesthesia. Most data available
in literature about early success of endovenous saphenous
ablation procedures pertain to the early postoperative pe-
riod, but few authors report on immediate intraoperative
success. Although the successful immediate retreatment of
an incompletely obliterated venous segment with RFA may
not be considered relevant in terms of outcome, when two
different procedures are compared, it is important to report
in detail not only the clinical but also the technical results,
as all of these factors might affect the preference of one
procedure over the other one.
The Endovenous Radiofrequency Obliteration (Clo-
sure) Versus Ligation and Stripping in a Selected Patient
Population (EVOLVeS) study was designed to compare
RFA with stripping of the GSV. Immediate success on the
day of treatment was reported for 95% (42/44). A scan
obtained 72 hours after the procedure showed flow in the
proximal GSV in 16.3% (7/44) of limbs. Five of these
segments had reflux in the open segment. Two of these
closed at 1 week, and an additional segment closed at 3
Our data confirm these observations. When we com-
pared intraoperative with postoperative duplex ultrasound
findings, we found no apparent correlation between the
presence of minimal GSV flow at the end of procedure and
recanalization. Noncompliance with postoperative com-
pression could have been one of the causes of early recan-
alization, but we were unable to monitor this.
Previous reports have also reported slightly higher oc-
clusion rates with EVLT (98% to 100%)4,5 than with RFA
(83% to 100%).6,7 In our series, early recanalization was
infrequent in both groups; most patients remained asymp-
tomatic and required no further treatment. Evidence of
minimal residual flow at the end of procedure was not
associated with premature recanalization of the GSV. Al-
though we did not monitor closely compliance with post-
operative compression, we believe that this may be a con-
tributing factor for recanalization.
It is possible that this variability in occlusion rates is due
to the different mechanism of action between these two
techniques. RFA of the target vein is obtained by heat-
induced venous spasm and collagen shrinkage, whereas
EVLT causes both heating of blood components and ther-
mal damage to the endothelium. Therefore, adequate vein
emptying by leg elevation, the use of perisaphenous infil-
tration with tumescent solution, and maintenance of an
the RFA technique. This could be the subject of future
The higher occurrence of painful thrombophlebitis and
cellulitis with the EVLT technique is probably due to the
incomplete vein emptying with intraluminal thrombus and
surrounding inflammation. Other authors4,11 have ob-
served similar complications after EVLT. Absence of flow
proximal to the inferior epigastric vein at postoperative
duplex scans is most likely due to the presence of throm-
treated area. Routine postoperative duplex scanning was
initiated at our institution only after recent publications of
thrombotic complications after RFA.7,13,14 Current rates
of DVT pooled from large series are considered similar
between EVLT and RFA (0.3% vs 0.4% to 2.1%)14,15 and
stripping (5.7%).16 Hingorani et al17 reported an incidence
of DVT of 16% after RFA. Occurrence of proximal throm-
bus extension after EVLT is low: Timperman et al18 re-
ported only one case of DVT after 111 procedures.
In our experience, three patients were observed with
saphenous thrombus protrusion into the CFV. Although
two of these three patients clearly could not be classified as
having a classic DVT, anticoagulation was introduced and
was effective in all three, with complete resolution of the
thrombus on duplex scans performed 2 to 12 weeks later.
No case of pulmonary embolism has been reported
with the EVLT technique, but two cases of this serious
complication have been described after RFA.13,14
It is possible GSV thrombi caused by laser energy have
different characteristics from those occurring after RFA.
Pathologic examination of veins treated by EVLT shows
homogeneous thrombotic occlusion of the vessel19,20 due
to generation of steam bubbles, whereas RFA causes colla-
activation of the coagulation cascade in RFA ablation pro-
cedures is not related to the delivery of energy but to the
placement of intravascular catheters and to the prolonged
duration of the ablation procedure.21
Another significant finding was the inverse correlation
observed between the distance of GSV thrombus from the
SFJ and patients’ ages in the EVLT group; this observation
has not been reported previously. In particular, most of
patients who developed an extension of GSV thrombus to
?2 mm from the SFJ were ?50 years old.
Previous studies demonstrated a significant increase in
occurrence and propagation of spontaneous DVT in the
older population.22,23 From these data, it can be argued
that patients ?50 years old undergoing endovenous pro-
cedures are at the greatest need for thromboprophylaxis in
the perioperative period. Only prospective randomized
studies will answer this question. Our initial enthusiasm for
the RFA technique was tempered by the need for repeat
treatment of the saphenous vein during the same operation
in some cases, the need for continuous monitoring of
catheter temperature, and the need for an irrigation system
the RFA catheter, the pullback treatment time is shorter,
and the saphenous obliteration rates are likely higher. Sim-
ilar observations have recently been reported by Almeida,24
JOURNAL OF VASCULAR SURGERY
492 Puggioni et al
who recently compared an experience with RFA and EVLT Download full-text
at a single institution.
The overall success rate of endovenous ablation tech-
niques in occluding incompetent GSVs was 94% at 1
month. EVLT was associated with somewhat higher occlu-
sion rates, but postoperative complications in our experi-
ence were more frequent after EVLT than after RFA.
Compression treatment after endovenous saphenous abla-
tion may be important. All patients who receive en-
dovenous procedures should undergo early postoperative
duplex scanning to rule out proximal extension of throm-
bus, confirm occlusion, and exclude more distal DVT. Our
data suggest that older patients tend to develop more
proximal GSV thrombi after ablation; thus DVT prophy-
laxis may be considered in patients ?50 years old.
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Submitted Mar 9, 2004; accepted May 1, 2005.
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Puggioni et al 493