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From the American Venous Forum
Can phlebectomy be deferred in the treatment of varicose veins?
Daniel L. Monahan, MD, Roseville, California
Objective: This study was designed to observe the clinical sequelae
of varicose veins after great saphenous vein (GSV) ablation and to assess
possible predictability of spontaneous varicose vein regression.
Methods: Patients with symptomatic varicose veins secondary to GSV
insufficiency treated with radiofrequency ablation (RFA) were enrolled in
the study. Up to five of the largest varicose veins in each limb were mapped,
sized, and documented before RFA. No varicose vein was treated either at the
time of RFA or within 6 months postoperatively. Varicose vein status was
recorded at follow-up visits.
Results: Fifty-four limbs in 45 patients were included. A total of 222
varicose veins were documented before RFA (4.1 ± 1.1 varicose veins
per limb) with an average size of 11.4 ± 3.7 mm. During the follow-up period,
complete resolution of visible varicose veins was seen in 13% of limbs after
RFA alone, and 63 (28.4%) varicose veins spontaneously resolved. A further
88.7% (141/159) of varicose veins decreased in size an average of 34.6%
(4.3 ± 3.4 mm). Preoperatively, 19.4% of varicose veins were above the
knee and 75.7% were below the knee. Complete varicose vein resolution was 41.9%
(18/43) above the knee and 25.6% (43/168) below the knee. For the above-knee
varicose veins, 88.4% (38/43) were located medially, and all the resolved ones
(47.4%, 18/38) were medial varicose veins. Resolution rates of the 168 below-knee
varicose veins were 30.6% (33/108) of medial, 23.1% (6/26) of anterior, 20.0%
(3/15) of lateral, and 5.3% (1/19) of posterior.
Conclusions: Great saphenous vein ablation resulted in subsequent
resolution or regression of many lower-limb visible varicose veins. With further
study, the predictability of varicose vein regression may perhaps be increased,
which can then direct the treatment strategy to further leverage the advantages
of minimally invasive endovenous procedures. ( J Vasc Surg 2005;42:1145?9.)
The traditional surgical treatment of symptomatic varicose veins arising from
great saphenous vein (GSV) insufficiency has involved eliminating or reducing
venous hypertension in the GSV, accompanied by elimination of visible varicosities
by stab (avulsion) phlebectomy.1 In fact, the complete
extirpation of all visible varicosities is considered by many to be an inviolable
tenet of varicose vein surgery.2 Depending on the
extensiveness of varicosities to be eliminated, the performance of multiple
phlebectomies, usually under general anesthesia, contributes to postoperative pain
and morbidity as well as prolonged recovery and delayed return to normal activity.
The development of minimally invasive treatment of the GSV with radiofrequency
ablation (RFA) eliminated part of the substantial surgical trauma involved in
treating these patients.3 In the hands of many surgeons,
it is still accompanied by multiple phlebectomies. The study reported here arose
out of a desire to minimize surgical trauma in treating these patients, yet
retain completeness and durability of treatment.
A strategy was initiated to perform the GSV ablation procedure without concomitant
phlebectomy and to subsequently treat visible varicose veins with sclerotherapy.
Patients were seen within 3 days after the ablation procedure, with the intent to
perform sclerotherapy at that time. After pursuing this strategy in approximately
30 patients, it was observed at the postoperative visit that the varices in
many patients were substantially diminished from their preoperative size.
Occasionally, patients deferred sclerotherapy for varying reasons, and on their
subsequent return, further regression?and some disappearance?of their varices was
noted. Some of these patients had such complete regression of their varicose veins
after GSV ablation alone that no further treatment of the varices was pursued.
This study was undertaken in an attempt to address the question of whether complete
elimination of surface varicosities is an obligatory accompaniment to treating the
GSV to achieve a satisfactory and durable symptomatic and cosmetic outcome. The
study represents a preliminary observational experience with a staged approach to
treating varicose veins that result from chronic superficial venous hypertension.
This approach involves treating the GSV with radiofrequency ablation, with delayed
treatment of residual varicosities at 6 months.
Methods
Starting in January 2003, 49 patients referred to this office were enrolled.
During the enrollment period, an additional 25 potential study patients were
treated with the same strategy but not enrolled: 16 patients were not able
to comply with follow-up, 8 had hospital-based procedures with no pre-operative
vein measurements, and 1 patient declined. Four of the 49 patients enrolled
were lost to follow-up. Of the 45 patients included, there was no selection
bias based on clinical features. No patient with a history of deep venous
thrombosis or with abnormal deep veins on ultrasound examination was included
in the study.
All patients were advised of the treatment strategy and protocol for the study,
as well as standard treatment options, including multiple phlebectomies. Signed
informed consent was obtained for all patients.
All patients underwent a duplex ultrasound diagnostic study that used a 10-MHz
probe in an office setting. The standard examination included an assessment for
patency and incompetence throughout the length of the great and lesser saphenous
veins, with patients reclining at 60°. When results were questionable, the
patients were re-examined while standing. Perforators were sought at standard
anatomic locations as well as in relation to the presence of otherwise unexplained
varicosities. The deep veins were also assessed, above, at, and below the
saphenofemoral and saphenopopliteal junctions.
Patients included in the study underwent successful RFA of the GSV of one or
both legs. Ablation failed in three limbs in three patients who underwent
bilateral treatment. These three limbs were excluded from the study. The
extent of ablation extended from the saphenofemoral junction to the lowest
point of reflux in the GSV, but not below the upper calf.
The RFA procedure was performed under local and tumescent anesthesia. Most
patients were treated in the office, and an oral sedative (5 mg diazepam)
was taken preoperatively. Those treated in an outpatient surgery center
setting received intravenous sedation. No patient received a prescription
for postoperative analgesia. All patients were seen 1 to 3 days postoperatively,
and postoperative follow-up at 2 and 6 months was completed.
Preoperatively, and at each postoperative visit, symptoms were assessed and
recorded. CEAP clinical classification was also determined. For each limb, the
five largest visible varicosities were identified for measurement at their
maximum diameters with the patient standing. Only varices linked to the GSV were
included. Those varices linked to the lesser saphenous vein or incompetent
perforator veins were also managed within the staged strategy, but not included
in the study.
The clinical end point of the study was the change in size of the varicose veins
in response to saphenous ablation alone. An electrocardiogram caliper and a
millimeter scale were used to determine the external diameter of the vein on the
skin. These measurements were recorded on a clinical follow-up form. At the end
of the 6-month period, patients were given the option of sclerotherapy treatment
of any remaining varices, if needed. No patients requested, or were treated with,
phlebectomy. All treatment was done on an ambulatory basis without interruption of
daily activities, other than for the time taken for treatment and the follow-up
sessions themselves.
Results
The 54 limbs of the 45 patients included in this report underwent successful
ablation of the GSV. The preoperative CEAP distribution is shown in the Table.
In the 54 limbs, 222 varicose veins were documented before RFA. An average of
4.1 ± 1.1 varicose veins, with an average diameter of 11.4 ± 3.7 mm, were
documented per limb. Four patients with five treated limbs never returned after
their 72-hour postoperative check-up, and 10 patients with 10 treated limbs did
not return after the 2-month evaluation. Thirty-one patients with 39 treated
limbs completed the 6-month study. Two of the patients who did not complete the
follow-up protocol moved and could not be contacted. The other patients were
contacted but declined further follow-up, reporting satisfaction with their
present status.
The following results reflect measurements obtained at each patient?s last visit
during the study period. During the follow-up period, 28.4% (n = 63) of varicose
veins spontaneously resolved, 4.5% were resolved at 2 months, and another 23.9%
had resolved by 6 months. Overall, complete varicose vein resolution was seen
in 13.0% of limbs after RFA alone. Among 159 varicose veins that did not resolve,
141 (88.7%) decreased in size, on an average of 34.6% (4.3 ± 3.4 mm)(P < .05,
paired t test). Ten (6.3%) varicose veins did not change in size, and four (2.5%)
varicose veins increased in size by an average of 18.6% (1.3 ± 0.5 mm).
Varicose vein distribution before treatment is shown in Fig 1. Preoperatively,
19.4% and 5.0% of varicose veins were either above the knee or at the knee area,
respectively, and 75.7% were below the knee. As illustrated in Fig 2,
complete varicose vein resolution was 41.9% (18/43) for above-knee locations,
18.2% (2/11) at the knee area, and 25.6% (43/168) for varicose veins documented
below the knee.
For the varicose veins located above the knee, 88.4% (38/43) were located medially,
and all the resolved ones were medial varicose veins (18/38, 47.4%). For the 168
below-knee varicose veins, 64.3% were medial, 15.5% anterior, 11.3% posterior,
and 8.9% lateral. Resolution of below-knee varicose veins was observed in 30.6%
(33/108) of medial locations, 23.1% (6/26) of anterior locations, and 20.0% (3/15)
of laterally located varicose veins. Of the 22 varicose veins located posteriorly
above or below the knee, only one resolved spontaneously during the follow-up
period.
In addition to spontaneously resolved varicose veins, some varicose veins decreased
to a size of ≤6 mm—or in four instances, thrombosed—and required no further cosmetic
procedure. Of the 159 unresolved varices, 98 were assessed at 6 months. Of these,
47 had regressed to ≤6mm in diameter and generally required no further treatment
(Fig 3).
After the 6-month study period, of the 39 limbs of 31 patients that completed the
6-month protocol, 16 limbs (41.0%) had no further treatment after RFA. Twelve limbs
(30.1%) underwent ultrasound-guided sclerotherapy of incompetent tributaries of the
GSV associated with persistent varices. Three limbs (7.7%) underwent sclerotherapy
for surface varices. Eight limbs (20.1%) had both ultrasoundguided and surface
sclerotherapy.
During the study period, no new varices or recurrences of regressed varices were
observed. As noted, three limbs failed ablation during the study period and were
excluded from the analysis, since the object was to assess the effect of the
varices when the underlying source of venous hypertension was eliminated.
No serious complications occurred in the study group. Mild cases of superficial
phlebitis in the untreated varices have been observed in this practice. Because of
this, a compression stocking is prescribed to be worn for a week after GSV ablation.
No superficial phlebitis occurred in this study group, however.
A review of the charts of those 25 patients not included in the study, though not
containing objective verification of varicose vein regression, revealed relatively
similar events in further treatment. Thirty-six limbs were treated, of which 6
limbs (16.7%) had no further treatment after GSV ablation, 15 limbs (41.7%)
underwent subsequent ultrasoundguided sclerotherapy for incompetent tributaries,
and 13 limbs (36.1%) had sclerotherapy of surface varices. Two limbs (5.6%)
underwent both ultrasound-guided sclerotherapy and sclerotherapy of surface varices.
The higher rate of subsequent interventions compared with the study group reflected
the desire to proceed to treatment of persistent varices sooner rather than following
a deferment period. Consequently, with less time allowed for regression, more
varices were visible for treatment.
In a phone survey of the study group in January 2005, which represented 12 to 24
months of follow-up, 36 patients with 46 treated limbs were contacted. Compared
with their preoperative status, 30 reported absence of symptoms, and six reported
improvement. With regard to visible varices before surgery, 16 reported absence of
varices, and 20 reported improvement. None reported new symptoms or new varicosities.
There was 100% satisfaction with the treatment strategy.
Discussion
Historically, the complete extirpation of visible varicose veins has been a
fundamental tenet in the optimal treatment of varicose veins arising from GSV
insufficiency. In a review of the history of varicose vein surgery in the United
States, no prior study was identified in which the GSV alone was treated and
phlebectomies deferred. In reports by Homans4 and
Mayo5 at the beginning of the
20th century, the need for complete removal of visible varicosities was encouraged
to prevent recurrence. This dogma was repeated throughout the remainder of the last
100 years. It was, and is, believed that complete removal of the surface varicosities
interrupts incompetent tributaries and reduces recurrence rates. Despite technologic
innovations and the ensuing improvements in diagnosis and treatment, this tenet has
apparently never been challenged or confirmed by direct study.
In the United States, emphasis was directed to treating primarily the GSV.
Homans4
is credited with first pursuing this treatment goal with high ligation of the GSV
along with complete division of proximal tributaries.6
Eventually, perfection of GSV
stripping was described by Myers 1 and Lofgren.7 de
Takats8 staged treatment with
high ligation of the GSV followed by sclerotherapy, and recorded the phenomenon
of regression of varices between treatments, but never reported the consequences of
leaving the surface varices untreated.
In Britain, Fegan9 and Hobbs10
later described treatment that focused on sclerotherapy
techniques for ablation of incompetent perforator veins. Interestingly, they both
noted regression of varicosities after ablation of underlying incompetent perforator
vein sources of venous hypertension, 9,
11 and Fegan even asserted that the peripheral
varicosities could recover venous wall tone and valvular
competence.9 He cited the
frequent regression in the puerperium of varicosities arising during pregnancy as an
example of this event. However, despite Fegan?s assertion and regardless of the
approach taken to eliminate underlying sources of venous hypertension, the complete
extirpation of visible varicosities has generally been forcefully
maintained.2,12
The observations reported here suggest that an approach focusing on eradication of
sources of venous hypertension may decrease the necessity of treating surface
varicosities. Suggest is the operative word here, for longer follow-up and greater
numbers of patients will be needed to determine what place, if any, this strategy
will ultimately have in the treatment of varicose veins. This approach provides the
opportunity of savings in both time and cost in the treatment of surface varicosities.
The attendant pain, disability, and cosmetic consequences of surgical phlebectomy
are also avoided while satisfactory cosmetic and symptomatic outcomes are still
achieved.
A surface varicose vein may represent a first-order tributary from the GSV, or
perhaps a second, third, or higher order. The resolution or persistence of a
surface varix after ablation of the GSV may reflect this relationship. It is
interesting to note that most of the varicosities were medially located, especially
in the above-knee region. In aboveknee varicose veins, 41.9% resolved spontaneously
after GSV ablation, which may suggest their direct relationship with the GSV. All of
the resolved above-knee varicose veins were medially located. Posterior varicose
veins were less prone to resolve spontaneously, whether the location was above or
below the knee.
The persistence of varicosities often reflected an incompetent tributary of the GSV.
Treating these persistent tributaries with ultrasound-guided sclerotherapy, rather
than directly treating the surface varices, usually resulted in further regression
of surface varices and presumably helped prevent recurrence. These additional
treatments are nearly painless, take little time, and allow continuation of normal
activity. The ultimate place and timing of these additional treatments will require
further specific study.
It must be remembered that data were collected for the five largest varices on a
given limb. Regression of smaller varices, though not documented, seemed to be more
complete. In some instances, a previous varix could still be appreciated as a barely
visible or palpable dilation of 3 to 6mm, having become cosmetically irrelevant to
the patient. Because symptomatic resolution was so excellent with the ablation
procedure alone, many patients turned down cosmetic sclerotherapy for barely
noticeable residual varices. These untreated varices are, of course, the center of
future evaluation in these patients. Durability of varicose vein regression,
affirmed in our relatively early follow-up, awaits future reports.
The current study was designed to challenge conventional treatment strategies.
Further follow-up of this study group is planned and will be reported. Many
questions still need to be answered in future studies, such as whether aggressive
treatment of incompetent tributaries and perforators after saphenous vein ablation
will result in greater and more durable regression of varicose veins, and how we
can reliably predict which varices will or will not regress.
This observational study had certain methodologic weaknesses; however, even with
its weaknesses, the results are felt to be compelling enough to warrant notice and
further study. These preliminary data suggest the need for a larger randomized
study that would be designed to verify the current findings. Though patient
numbers are relatively small, if regression reliably and durably occurs, then it
should be observable in even a few patients.
Only the five largest varices of each limb were documented. The caliper technique
was, admittedly, fairly simplistic, and it did not reflect the complete extent of
varicose vein involvement of a given limb. In retrospect, a method such as grading
by photograph, perhaps accompanied by computer-assisted image analysis, might give
more accurate information. Ultrasound measurements would be helpful in demonstrating
the long-term fate of veins that regress beyond visual discernment.
Even with these limitations, though, regression was demonstrated with very high
statistical significance. The failure in patient compliance with completing the study
protocol perhaps reflects our general patient population.
The phone survey results are important even though they are not objective and their
validity can be questioned. Symptom eradication and good cosmetic outcome are the
primary goals of these patients. If at 12 to 24 months these goals are still
fulfilled, this validates treatment durability to some degree. Objective follow-up
is necessary, however, and these patients will be recalled in the future for
documentation of their outcomes.
Conclusion
This study represents a first attempt to provide evidence for a deferred strategy
for varicose vein treatment. If proven durable, the advantage of this strategy is
obvious. Bruising, hematoma, infection, and other wound-related morbidities
associated with phlebectomy are eliminated as well as attendant pain. The need for
general anesthesia and a formal operating room setting are eliminated. Normal
activity is essentially uninterrupted. These benefits, along with our documented
regression rate, might encourage a revision of current practice strategies if
long-term recurrence parallels or improves upon historical standards.
References
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