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Standards of Practice

Multi-disciplinary Quality Improvement


Guidelines for the Treatment of Lower
Extremity Superficial Venous Insufficiency
with Ambulatory Phlebectomy from the Society
of Interventional Radiology, Cardiovascular
Interventional Radiological Society of Europe,
American College of Phlebology and Canadian
Interventional Radiology Association
Sanjoy Kundu, MD, FRCPC, Clement J. Grassi, MD, Neil M. Khilnani, MD, Fabrizia Fanelli, MD,
Sanjeeva P. Kalva, MD, Arshad Ahmed Khan, MD, J. Kevin McGraw, MD, Manuel Maynar, MD,
Steven F. Millward, MD, Charles A. Owens, MD, Leann S. Stokes, MD, Michael J. Wallace, MD,
Darryl A. Zuckerman, MD, John F. Cardella, MD, and Robert J. Min, MD, for the Cardiovascular Interventional
Radiological Society of Europe, American College of Phlebology, and Society of Interventional Radiology
Standards of Practice Committees

J Vasc Interv Radiol 2010; 21:1–13


Abbreviations: AP ⫽ ambulatory phlebectomy, CEAP ⫽ clinical status, etiology, anatomy, and pathophysiology [classification], CVD ⫽ chronic venous disease,
DVT ⫽ deep vein thrombosis, EVTA ⫽ endovenous thermal ablation, GSV ⫽ great saphenous vein, SSV ⫽ small saphenous vein, VCSS ⫽ venous clinical sever-
ity score

PREAMBLE spectrum ranges from cosmetic abnor- edema, skin ulceration, and subsequent
malities including spider telangiectasias to major disability. Venous hypertension
LOWER extremity venous insufficiency is varicose veins with or without associated caused by incompetent valves in the su-
a heterogeneous medical condition whose signs and symptoms including severe perficial veins is by far the most com-
mon cause of this condition. This docu-
ment will review the appropriate means
by which ambulatory phlebectomy (AP)
From the Vein Institute of Toronto (S.K.), Toronto; ventional Radiology Unit (F.F.), Department of Radio-
is to be used to maximize the benefit for
Department of Radiology (S.F.M.), Peterborough Re- logical Sciences, “SAPIENZA” University of Rome, patients who undergo the procedure.
gional Health Centre, Peterborough, Ontario, Canada; Rome, Italy; and Las Palmas de Gran Canaria Univer- The membership of the Society of
Department of Radiology (C.J.G.), Boston Healthcare sity (M.M.), Hospiten Rambla Hospital, Santa Cruz de Interventional Radiology (SIR) Stan-
System VAMC, Boston, Massachusetts; Department of Tenerife, Spain. Received December 6, 2008; final revi-
Radiology (S.P.K.), Massachusetts General Hospital, sion received January 13, 2009; accepted January 18,
dards of Practice Committee repre-
Boston, Massachusetts; Geisinger Health System 2009. Address correspondence to S.K., c/o Debbie sents experts in a broad spectrum of
(J.F.C.), Danville, Pennsylvania; Department of Inter- Katsarelis, 3975 Fair Ridge Dr., Suite 400 N., Fairfax, interventional procedures from both
ventional Radiology (A.A.K.), Washington Hospital VA 22033; E-mail: sanjoy_kundu40@hotmail.com the private and academic sectors of
Center, Bethesda, Maryland; Cornell Vascular
(N.M.K.) and Department of Radiology (R.J.M.), New None of the authors have identified a conflict of medicine. Generally, Standards of
York Presbyterian Hospital–Weill Cornell Medical interest. Practice Committee members dedicate
Center, New York, New York; Department of Inter- This document was prepared by the standards commit-
the vast majority of their professional
ventional Radiology (J.K.M.), Riverside Methodist tee of the Society of Interventional Radiology (SIR). After time to performing interventional pro-
Hospital, Columbus; Department of Radiology
(D.A.Z.), University of Cincinnati Hospital, Cincinnati,
completion, the document was presented to the Cardio- cedures; as such they represent a valid
vascular and Interventional Radiological Society of Eu- broad expert constituency of the sub-
Ohio; Departments of Radiology and Surgery rope and American College of Phlebology, which
(C.A.O.), University of Illinois Medical Center, Chi- made recommendations and offered their endorse- ject matter under consideration for
cago, Illinois; Department of Radiology and Radiolog- ment for this standard of practice position statement. standards production. Representatives
ical Sciences (L.S.S.), Vanderbilt University Medical
Center, Nashville, Tennessee; Department of Interven-
from the Cardiovascular and Interven-
© SIR, 2010
tional Radiology (M.J.W.), The University of Texas tional Radiology Society of Europe
M. D. Anderson Cancer Center, Houston, Texas; Inter- DOI: 10.1016/j.jvir.2009.01.035 (CIRSE) and the American College of

1
2 • Guidelines for Phlebectomy for Lower-extremity Venous Insufficiency January 2010 JVIR

Phlebology broaden the expertise to superficial venous insufficiency. The and definitive eradication of the target
include multispecialty and interna- most important elements of care are vein with minimal damage to the skin
tional experience. (i) pretreatment evaluation and patient (14 –24).
Technical documents specifying the selection (ii), performance of the proce- Interventional physicians have be-
exact consensus and literature review dure, and (iii) postprocedure follow-up come increasingly involved in the as-
methodologies as well as the institu- care. The outcome measures or indica- sessment and treatment of lower-ex-
tional affiliations and professional cre- tors for these processes are indications, tremity venous insufficiency with the
dentials of the authors of this docu- success rates, and complication rates. advent of endovenous thermal abla-
ment are available upon request from Although practicing physicians should tion (EVTA) for the treatment of trun-
SIR, 3975 Fair Ridge Dr., Suite 400 strive to achieve perfect outcomes, in cal vein incompetence (25). An impor-
North, Fairfax, VA 22033. practice all physicians will fall short of tant consideration in the treatment of
ideal outcomes to a variable extent. truncal reflux is the appropriate treat-
METHODOLOGY Therefore, in addition to quality im- ment of the incompetent and dilated
provement case reviews conducted after tributary and perforator veins where
SIR produces its Standards of Prac- individual procedural failures or com- AP is a key adjunct in the treatment
tice documents using the following plications, outcome measure thresholds algorithm.
process. Standards documents of rele- should be used to assess treatment These guidelines are written to be
vance and timeliness are conceptual- safety and efficacy in ongoing quality used in quality improvement programs
ized by the Standards of Practice Com- improvement programs. For the pur- to assess AP. The most important pro-
mittee members. A recognized expert pose of these guidelines, a threshold is a cesses of care are (i) patient selection, (ii)
is identified to serve as the principal specific level of an indicator that, when performing the procedure, and (iii)
author for the standard. Additional reached or crossed, should prompt a monitoring the patient. The outcome
authors may be assigned dependent review of departmental policies and measures or indicators for these pro-
upon the magnitude of the project. procedures to determine causes and to cesses are indications, success rates, and
An in-depth literature search is per- implement changes, if necessary. complication rates. Outcome measures
formed using electronic medical litera- Thresholds may vary from those listed are assigned threshold levels.
ture databases. Then a critical review of here; for example, patient referral pat-
peer-reviewed articles is performed terns and selection factors may dictate a DEFINITIONS
with regards to the study methodology, different threshold value for a particular
results, and conclusions. The qualitative indicator at a particular institution. Although practicing physicians
weight of these articles is assembled into Therefore, setting universal thresholds should strive to achieve perfect out-
an evidence table, which is used to write is very difficult and each department is comes (eg, 100% success, 0% complica-
the document such that it contains evi- urged to adjust the thresholds as needed tions), in practice all physicians will fall
dence-based data with respect to con- to higher or lower values to meet its short of this ideal to a variable extent.
tent, rates, and thresholds. specific quality improvement program Thus indicator thresholds may be used
When the evidence of literature is situation. to assess the efficacy of ongoing quality
weak, conflicting, or contradictory, improvement programs. For the pur-
consensus for the parameter is reached INTRODUCTION poses of these guidelines, a threshold is
by a minimum of 12 Standards of a specific level of an indicator which
Practice Committee members using a During the past decade the scope of should prompt a review. “Procedure
modified Delphi consensus method treatments for lower-extremity venous thresholds” or “overall thresholds”
(Appendix A) (1,2). For purposes of insufficiency has undergone dramatic reference a group of indicators for a
these documents, consensus is defined evolution and change. AP, microsurgi- procedure, eg, major complications.
as 80% Delphi participant agreement cal phlebectomy, office phlebectomy, Individual complications may also be
on a value or parameter. ambulatory stab avulsion phlebectomy, associated with complication-specific
The draft document is critically re- and Muller’ phlebectomy are all syn- thresholds. When measures such as in-
viewed by the Standards of Practice onyms for an outpatient procedure by dications or success rates fall below a
Committee members, either by tele- which dilated incompetent surface veins (minimum) threshold, or when compli-
phone conference calling or face-to-face can be avulsed through multiple stab cation rates exceed a (maximum) thresh-
meeting. The finalized draft from the incisions. This technique was first de- old, a review should be performed to
Committee is sent to the SIR member- scribed by Aulus Cornelius Celsus (25 determine causes and to implement
ship for further input/criticism during a BC to 45 AD) and reinvented by Robert changes, if necessary. Thresholds may
30-day comment period. These com- Muller, a Swiss dermatologist, in the vary from those listed here; for example,
ments are discussed by the Standards of mid-1950s. This procedure has been per- patient referral patterns and selection
Practice Committee, and appropriate re- formed for incompetent tributary factors may dictate a different threshold
visions made to create the finished stan- branches of the great or small saphe- value for a particular indicator at a par-
dards document. Prior to its publication nous veins, perforators, reticular veins, ticular institution. Thus, setting univer-
the document is endorsed by the SIR veins supplying telangiectasias, facial sal thresholds is very difficult and each
Executive Council. veins, and foot veins (3–13). Small seg- department is urged to alter the thresh-
The current guidelines are written to ments of veins are removed through olds as needed to higher or lower val-
be used in quality improvement pro- minute skin incisions (1–3 mm) or nee- ues, to meet its own quality improve-
grams to assess AP for lower extremity dle puncture, with the goal of complete ment program needs.
Volume 21 Number 1 Kundu et al • 3

space. The word “small” replaces


“lesser” or “short” by international
consensus (26,27).
Anterior and posterior accessory
GSVs.—The anterior and posterior ac-
cessory GSVs are located in the saphe-
nous space and travel parallel and ante-
rior or posterior to the GSV. The anterior
accessory GSV is much more common.
Giacomini vein.—The Giacomini vein
is an intersaphenous vein that is a com-
munication between the GSV and SSV.
It represents a form of SSV cephalad
extension that connects the SSV with the
posterior circumflex vein of the thigh, a
posterior tributary of the proximal GSV.
Truncal veins.—The term “truncal
veins” refers to the saphenous veins and
their intrafascial straight primary
tributaries.
Reticular vein.—The term “reticular
vein” refers to collector veins connecting
spider veins or skin capillary networks
to the superficial venous system or to
perforating veins. These veins may be-
come enlarged and appear as “green”
veins under the skin surface.
Spider vein.—The term “spider vein”
refers to fine enlarged capillary net-
works on the skin surface having a
spider-like appearance. Spider veins
may be red or a blue color.

Disease Process

Figure. Superficial and deep venous system of the lower extremity. Venous reflux.—Veins contain valves
that direct blood flow in one direction.
Usually this is from the foot toward the
Complications can be stratified on Deep veins.—The deep veins are heart and from the skin toward the mus-
the basis of outcome. Major complica- those found deep to the muscular fas- cles. When the valves fail, blood can
tions result in admission to a hospital cia. These include the tibial, peroneal, flow retrogradely and such flow is de-
for therapy (for outpatient proce- popliteal, femoral, and iliac veins. fined as reflux. Clinically significant re-
dures), an unplanned increase in the GSV.—An important component of flux in truncal veins lasts for greater
level of care, prolonged hospitaliza- the superficial venous system, the than 0.5–1.0 seconds following release of
tion, permanent adverse sequelae, or GSV begins on the dorsum of the foot, compression on the muscular mass be-
death. Minor complications result in and ascends along the medial aspect of low the vein itself.
no sequelae; they may require nominal the leg to ultimately drain into the Venous obstruction.—Obstruction of
therapy or a short hospital stay for femoral vein near the groin crease. venous segments will impede venous
observation (generally overnight). This vein resides in a space deep to the drainage and can lead to venous hyper-
superficial and superficial to the deep tension. Thrombosis is the most com-
Anatomy fascia. This location is known as the mon cause of acute venous obstruction.
saphenous space. The word “great” Such thrombosis can lead to permanent
Superficial veins.—The veins of the replaces “greater” or “long” by inter- occlusion or recanalization with or with-
lower extremity that are superficial to national consensus (26,27). out valvular incompetence in that vas-
the fascia surrounding the muscular SSV.—Another important superfi- cular segment.
compartment are considered the su- cial vein, the SSV begins on the lateral Chronic venous disease.—Chronic ve-
perficial veins. These include innu- aspect of the foot and ascends up the nous disease (CVD) is the clinical entity
merable venous tributaries known as midline of the calf. In as many as two that results from chronic venous hyper-
collecting veins as well as the great thirds of cases it drains into the popli- tension (28). The overwhelming major-
saphenous vein (GSV) and small sa- teal vein and in at least one third of ity of patients with stigmata of venous
phenous vein (SSV) and their major cases it extends more cephalad. The hypertension have primary (or degener-
named tributaries (Fig). SSV also resides in the saphenous ative) disease of the vein wall with re-
4 • Guidelines for Phlebectomy for Lower-extremity Venous Insufficiency January 2010 JVIR

sultant valvular dysfunction in the su- Venous clinical severity score (VCSS).— Tumescent Anesthesia
perficial veins, which leads to reflux VCSS is an additional means of grading
(29). This subset of CVD is known as the spectrum of disease severity (34,35). The term “tumescent anesthesia” re-
superficial venous insufficiency. Patho- The VCSS allows more detailed descrip- fers to the delivery of large volumes of
physiologically significant reflux of the tion of the severity of attributes of dilute local anesthetic agent to create a
GSV or in one of its primary tributaries chronic venous insufficiency compared large region of anesthesia. This form of
is present in 70%– 80% of patients with with the CEAP system. The VCSS is an delivery typically causes a localized
chronic venous insufficiency. SSV reflux important complement to CEAP in re- swelling, leading to the use of the term
is found in 10%–20% and nonsaphenous porting clinical success of an interven- “tumescent.” Popularized by plastic
superficial reflux is identified in 10%– tion (Table 2). surgeons, this concept has been used in
15% of patients (30,31). Venous obstruc- the treatment of veins by delivering the
tion, deep vein reflux, muscular pump anesthetic solution perivenously.
TREATMENT METHODS
failure, and congenital anomalies are
much less common causes. Venous ob- AP Clinical Success
struction is the most common of these
other causes of CVD and is almost al- Also known as microphlebectomy or Clinical success is defined as an im-
ways the result of previous deep vein stab phlebectomy, AP is a procedure by provement in the clinical status of a pa-
thrombosis (DVT). It is initially an ob- which varicose tributaries are removed tient as defined by one of the objective
structive disease but usually progresses with small hooks through 3–4-mm skin assessment instruments, such as the
to a combination of obstruction and su- nicks using only local anesthesia. CEAP or VCSS classification, by at least
perficial and deep venous reflux (32). one grade. In practice, most patients
Reflux or outflow vein obstruction lead EVTA treated with AP will also be treated with
to an increase in pressure in the super- adjunctive EVTA or compression sclero-
ficial venous system. The veins them- EVTA refers to the procedure by therapy. It is generally believed that clini-
selves can dilate if unconstrained and which thermal energy is endovenously cal success will be dependent on the thor-
the pressure causes stretching of recep- delivered to the lumen of a vein with the oughness of the adjunctive procedures
tors in the vein wall, which leads to goal of causing the veins to irreversibly that are performed, as well as the success
discomfort to the patient. The pressure occlude. It is usually employed to elimi- of AP.
itself can adversely affect local tissues nate incompetent superficial truncal veins
and metabolic processes leading to responsible for the manifestations of su-
damage in the vein wall, the skin, and perficial venous insufficiency. The associ- COMPLICATIONS
subcutaneous tissues. ated varicose tributary and reticular veins
Paresthesia and Dysesthesia
Neovascularization.—Neovascular- and telangiectasias are treated separately
ization describes the presence of multi- with adjunctive therapies including AP Paresthesia and dysesthesia describe
ple small tortuous connections between and compression sclerotherapy. the loss or aberration, respectively, of
the saphenous stump or the femoral normal sensory perception. Injury to the
vein and a residual saphenous vein or Sclerotherapy saphenous or sural nerves adjacent to
one its patent tributaries (new or dilated the GSV, SSV, or tributary veins can
preexisting vessels outside the origi- Sclerotherapy is a procedure by lead to these sensory disturbances.
nally treated venous wall) that can occur which a medication is injected into a
following surgical ligation of the saphe- vein in order to irreversibly occlude it.
nofemoral junction or less commonly This is usually done with a syringe Deep Vein Thrombophlebitis
the saphenopopliteal junction. This is a and needle, although these medica-
Deep vein thrombophlebitis is throm-
very common pattern of recurrence fol- tions can be injected with a catheter or
bosis in the veins deep to the muscular
lowing surgical ligation of the GSV and intravenous cannula.
fascia.
its tributary veins near the saphe-
nofemoral junction and presents as a Duplex Ultrasound
tangle of blood vessels in the vicinity of Superficial Thrombophlebitis
the saphenofemoral junction. Duplex ultrasound (US) is the most
Clinical status, etiology, anatomy, and important imaging test to investigate Superficial thrombophlebitis is
pathophysiology (CEAP) classification.— patients with CVD. It uses grayscale thrombosis in veins superficial to the
“CEAP” is an acronym for a descriptive imaging to visualize the venous anat- muscular fascia. The veins involved are
classification system that summarizes omy and evaluate patency. Color and usually the subcutaneous collecting
the disease state in a given patient with pulse-wave Doppler imaging is used veins, which are the tributaries of the
lower-extremity venous insufficiency to investigate direction and velocity of saphenous veins. The GSV or SSV may
(29,33). The system describes the clinical blood flow through the veins to iden- or may not be thrombosed.
status, etiology, anatomy, and patho- tify reflux. Duplex US to evaluate
physiology of the problem. This clinical CVD is much more complicated and Arteriovenous Fistula
status scale is the most frequently used time-consuming than to detect DVT,
component in grading patients based on as it also involves the analysis of seg- An arteriovenous fistula is an abnor-
physical observations of disease severity mental competence of all the deep, su- mal connection between an artery and a
(Table 1). perficial, and perforator veins. vein. Such a connection may be created
Volume 21 Number 1 Kundu et al • 5

Table 1
CEAP Classification of CVD
Class Description
Clinical classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasias or reticular veins
C2 Varicose veins, distinguished from reticular veins by a diameter ⱖ3 mm
C3 Edema
C4 Changes in skin and subcutaneous tissue
C4a Eczema, pigmentation (and additionally corona phlebectasia)
C4b Lipodermatosclerosis or atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
Symptom classification
S Symptomatic, including ache, pain, tightness, skin irritation, heaviness, and
muscle cramps, and other complaints attributable to venous dysfunction
A Asymptomatic
Etiologic classification
Ec Congenital
Ep Primary
Es Secondary (postthrombotic)
En No venous cause identified
Anatomic classification
As Superficial veins
Ap Perforator veins
Ad Deep veins
An No venous location identified
Pathophysiologic classification
Pr Reflux
Po Obstruction
Pr,o Reflux and obstruction
Pn No venous pathophysiology identifiable
Level of investigation
Level I Office visit, with history and clinical examination, which may include use of a
hand-held Doppler scanner
Level II Noninvasive vascular laboratory testing, which now routinely includes duplex
color scanning, with some plethysmographic method added as desired
Level III Invasive investigations or more complex imaging studies, including ascending and
descending venography, venous pressure measurements, CT, or MR imaging
Example
A patient has painful swelling of the leg, and varicose veins, lipodermatosclerosis, and active ulceration. Duplex scanning on
May 17, 2004, showed axial reflux of the great saphenous vein above and below the knee, incompetent calf perforator
veins, and axial reflux in the femoral and popliteal veins. There are no signs of postthrombotic obstruction.
Classification according to basic CEAP: C6,S, Ep,As,p,d, Pr (2004-05-17, L II)

iatrogenically by a penetrating injury or as cal evaluation by a physician who is PRETREATMENT


part of a primary vascular disease process. appropriately trained in the care of ve- ASSESSMENT
nous diseases. The body of knowledge
Toxicity Related to Tumescent required includes a thorough under- Clinical evaluation of the patient be-
Anesthesia standing of venous anatomy, physiol- fore treatment in an outpatient setting
ogy, pathophysiology, diagnosis, du- provides the physician an opportunity
Toxicity can develop from the use plex US, and treatment options. The to perform a focused venous history
of large doses of lidocaine used for requisite knowledge and clinical expe- along with a relevant medical history,
perivenous anesthesia. Close follow-up rience can be acquired through train- followed by focused venous physical
with monitoring and management of ing in Accreditation Council for examination and evaluation of the pa-
ancillary therapy is appropriate for the Graduate Medical Education–recog- tient’s venous system with Duplex US.
radiologist. nized (or approved) postgraduate Only after such an examination can the
residency or fellowship programs. physician communicate the appropriate
PHYSICIAN CREDENTIALING Knowledge and skills can also be ac- treatment options. Patients with duplex
quired through continuing medical US– documented truncal incompetence
Before treatment, all patients with education and/or mentored clinical have the option of selecting EVTA, surgi-
CVD should undergo a through clini- experience (11). cal high ligation and/or stripping, or US-
6 • Guidelines for Phlebectomy for Lower-extremity Venous Insufficiency January 2010 JVIR

Table 2
Venous Clinical Severity Score
Attribute 0 (Absent) 1 (Mild) 2 (Moderate) 3 (Severe)
Pain None Occasional, not restricting Daily, moderate activity Daily, severe limiting
activity or requiring limitation, occasional activities or
analgesics analgesics requiring regular
use of analgesics
Varicose veins None Few, scattered branch Multiple: GSV varicose Extensive: thigh and
varicose veins veins confined to calf calf or GSV and
or thigh SSV distribution
Venous edema None Evening ankle only Afternoon edema, above Morning edema
ankle above ankle and
requiring activity
change, elevation
Skin pigmentation None or focal, low Diffuse, but limited in Diffuse over most of Wider distribution
intensity (tan) area and old (brown) gaiter distribution (above lower one
(lower one third) or third) and recent
recent pigmentation pigmentation
(purple)
Inflammation None Mild cellulitis, limited to Moderate cellulitis, Severe cellulitis
marginal area around involves most of gaiter (lower 1/3 and
ulcer area (lower 2/3) above) or
significant venous
eczema
Induration None Focal, circum malleolar Medial or lateral, less Entire lower third of
(⬍5 cm) than lower third of leg leg or more
Number of active ulcers 0 1 2 ⬎2
Active ulceration duration None ⬍3 mo ⬎3 mo, ⬍1 y Not healed ⬎1 y
Active ulcer, size None ⬍2 cm diameter 2–6 cm diameter ⬎6 cm diameter
Compressive therapy Not used or not Intermittent use of Wears elastic stockings Full compliance:
compliant stockings most days stockings and
elevation

guided sclerotherapy to initiate treatment. Table 3 licus should be performed. This should
Patients also have the option of conserva- Symptoms Associated with Chronic be performed in the standing position
tive treatment with graded medical com- Venous Insufficiency (except for nonambulatory patients) and
pression stockings. Subsequently or con- should include the lower extremities as
Aching
currently the patient may undergo AP or well as the lower pelvis in patients in
Throbbing
sclerotherapy of the dilated tributary Heaviness whom iliac vein occlusion is possible.
branches of the GSV or SSV. Fatigue Visible vein abnormalities including tel-
Pruritus angiectasias, reticular veins, and vari-
Medical History Night cramps cose veins should be documented.
Restless legs Edema of the extremities should be doc-
A complete medical history of the Generalized pain or discomfort umented and calf and ankle diameter
presenting venous problem, previous Leg swelling measurements obtained in cases of
therapy and response, previous history questionable edema. Careful attention
of thrombosis, comorbidities, medica- should be directed at the skin near the
tions, allergies, and any pertinent family medial and lateral malleolus of the an-
history should be obtained from the pa- worst cases may form ulcers. A fam- kle, as this region is most vulnerable to
tient. Chronic venous insufficiency ily and coagulation history searching the effects of chronic venous hyperten-
causes symptoms in many patients that for evidence of a hypercoagulable sion. Manifestations of CVD such as co-
can impact their quality of life. These state should also be obtained. Labo- rona phlebectasia, eczema, lipodermato-
symptoms are summarized in Table 3. ratory and further hematologic eval- sclerosis, and ulceration should also be
All of these symptoms are worsened uation is strongly recommended for documented. It is suggested that a stan-
with prolonged standing or sitting, im- patients with a history suggestive of dardized means of clinically assessing
prove with movement, and are most no- a hypercoagulable state. the severity of the effects of the
ticeable at the end of the day. In long- chronic venous hypertension, such as
standing cases, patients may develop Physical Examination the CEAP scale, be used to document
skin changes in the form of eczema, one’s findings (Table 1) (29). In addi-
corona phlebectasia, pigmentation, A complete physical examination of tion, it is strongly recommended that a
and lipodermatosclerosis, and in the the patient below the level of the umbi- written documentation of the history,
Volume 21 Number 1 Kundu et al • 7

clinical and duplex US examination struction. Venous reflux is diagnosed


Table 4
findings be created for each patient, when there is reversal of flow from the Indications and Contraindications
including a discussion of the impres- expected physiologic direction for more
sion and clinical recommendations. than 0.5 seconds following a provoca- Indications
Photographs of the visible findings are tive maneuver to create physiologic Asymptomatic varicose veins for
flow. These maneuvers include calf or cosmetic purposes
also helpful to document the severity Symptomatic varicose veins
and extent of the disease before treat- foot compression by the examiner, dor-
Complications of varicose veins
ment. siflexion by the patient, or a Valsalva Superficial thrombophlebitis
maneuver to assess for competency of Recurrent thrombophlebitis
the saphenofemoral junction or saphe- Bleeding
Duplex US nopopliteal junction. A standardized re- Contraindications
port should be created and used to de- Absolute
Duplex US is essential in all pa- scribe the findings for each examination Infectious dermatitis or cellulitis in
tients with CEAP classification of C2 in each patient. The use of diagrams area to be treated
or higher and in patients with clinical significantly enhances the future under- Severe peripheral edema
standing and communication of impor- Seriously ill patients
symptoms of leg pain, swelling, or
Patients not able to follow
night cramps to identify reflux and tant clinical findings.
postoperative instructions
patency and to establish the pattern of Allergies to local anesthetics
disease. The technique of duplex US Relative
for CVD is different than for the eval- Ancillary Imaging Pregnant or nursing patients
uation of lower-extremity DVT. The Obstructed deep venous system
In unique or isolated clinical situa- Liver dysfunction
goals, objectives, and technique of this tions, patients may require further im- Severe uncorrectable coagulopathy
examination have been reviewed in a aging to characterize venous obstruc- or hypercoagulable states
consensus statement by the Union In- tion, reflux, or venous anomalies in the Inability to wear compression
ternationale de Phlebologie, American pelvis or lower extremity such as a con- stockings
College of Phlebology, and SIR in sev- ventional intravenous or endovascular Inability to ambulate
eral recent publications (38 – 40). Dur- catheter contrast venogram, or com-
ing this examination, it is important to puted tomographic (CT) or magnetic
evaluate the anatomy and the physiol- resonance (MR) venogram. Rarely pa-
ogy of both the superficial and deep tients require a conventional catheter, if marked tortuosity is absent. The GSV
venous systems. A thorough knowl- CT, or MR arteriogram to evaluate for and SSV are not appropriate veins for
edge of the anatomy of the superficial the possibility of an arteriovenous mal- AP as they lie below the superficial fas-
venous system and its common vari- formation. Following clinical and imag- cia and are too deep for AP. Varicose
ants is necessary. Accurate use of the ing evaluation, the patient’s clinical state groin pudendal veins and labial veins
newly accepted nomenclature to de- should be summarized as to the sever- are also appropriate indications for AP.
scribe these veins is essential for med- ity, cause, anatomic location, and patho-
Incompetent dilated perforator veins
ical reporting (26,27,39). The aim of physiology using the CEAP classifica-
close to the skin surface are also candi-
tion system (Table 1) (29).
the duplex US is to define all of the dates for AP. Dilated reticular veins of
incompetent pathways and their the popliteal area, lateral thigh and leg,
sources, which involve saphenous INDICATIONS AND ankle, and dorsal venous network of the
and nonsaphenous veins, perforat- CONTRAINDICATIONS foot are less common indications for AP.
ing veins, and deep veins. The eval- FOR AP Networks of thick blue spider veins
uation should also include an assess- may also be removed by AP. Body areas
ment of the patency of the deep Indications for AP other than the lower extremity where
venous system, including the femo- AP may be used include dilated perior-
ral and popliteal vein. The indications for AP include bital, temporal, or frontal facial venous
The necessary equipment includes asymptomatic varicose veins for cos-
networks, and dilated veins of the ab-
metic purposes, symptomatic varicose
grayscale US and pulse-wave Doppler dominal wall, arms, or the dorsum of
veins not responding to conservative
imaging equipment using frequencies of the hands (44). However, it should be
treatment, and patients with complica-
7.5–10 Mhz, although higher and lower tions of varicose veins such as superfi- noted that removal of functional veins
frequencies may be used depending on cial thrombophlebitis, recurrent throm- for purely aesthetic purposes is a subject
the patient’s morphology. Color Dopp- bophlebitis, and bleeding (22,41,42). of debate, and a practice avoided by
ler imaging is very useful and readily Varicose branch tributary veins close to some physicians in an effort to preserve
available as a package with most units the skin surface, such as major tributary functional veins. The AP technique may
including pulse-wave Doppler equip- branches of the GSV or SSV such as the also be used for drug implant extraction
ment. Duplex US should be performed anterior thigh circumflex vein, posterior or to perform vein biopsies (45,46). Pa-
in the standing position and the exam- thigh circumflex vein, or anterior acces- tients, or their representatives, must be
iner should thoroughly evaluate the sory great saphenous vein, are good in- able to give informed consent and be in
GSV, SSV, their named tributaries, and dications for AP. These veins may also good health with normal cardiovascular
the deep veins for both reflux and ob- be treated with sclerotherapy or EVTA and pulmonary status (Table 4).
8 • Guidelines for Phlebectomy for Lower-extremity Venous Insufficiency January 2010 JVIR

Contraindications for AP procedure table. With the patient in a tracted. Most microincisions may be
recumbent position, there is typically left alone without any sutures or tape
Absolute contraindications for AP in- contraction and change in position of placed on them. An alternative is to
clude infectious dermatitis or cellulitis the vein(s) to be treated. Transillumi- place gauze on the microincisions with
in the area to be treated, severe periph- nation can be used to again locate the a long stretch bandage on top. Tape or
eral edema, lymphedema, serious ill- vein to be treated. Once the vein to be adhesive bandages applied on micro-
ness, inability to follow postoperative treated is localized with light guid- incisions may lead to blistering, aller-
instructions, and allergies to local anes- ance, a second set of markings using a gic dermatitis, or pigmentation. When
thetic agents (22,41– 43). Relative contra- different color surgical pen or marker the microincisions are longer than 3
indications include patients who are should be placed directly on the vein mm, a single 6 – 0 nylon suture can be
pregnant or nursing, have a obstructed (47–53). The area to be treated should applied to obtain a better closure.
deep venous system (ie, relying on su- then be prepared in a sterile fashion. There are several types of hooks that
perficial venous system for venous Tumescent anesthesia should then be have been exclusively designed for AP.
drainage), liver dysfunction (ie, limiting instilled around the vein to permit The hooks differ in their sharpness and
metabolism of local anesthetic agent), vein extraction and limit patient dis- shape of the tip. Common hooks used
severe uncorrectable coagulopathy or comfort. Tumescent mixtures with include the Muller hooks and Ramalet
hypercoagulable states, inability to wear concentrations from 0.01% to 0.1% li- hooks (3– 8). There are many new gen-
compression stocking secondary to in- docaine may be used. The amount of
adequate arterial circulation, or hyper- erations of hooks being created. Com-
local anesthetic agent used should fol- mercial over-the-counter hooks are
sensitivity to compression stockings and low the usual recommendations ac-
inability to ambulate after the procedure available for AP, but care must be used
cording to the patient’s body weight. during use. Once the hook is introduced
(Table 4). Up to 5 mg of lidocaine per kilogram through the microincision, it should be
of body weight can be administered. If rotated and moved in a perpendicular
Treatment Guidelines for AP epinephrine is added, up to 7 mg/kg plane against the vein to be removed. If
of lidocaine can be administered. If the there is difficulty introducing the hook,
Treatment of proximal to distal amount of local anesthesia to be used a blunt dissector may be introduced
CVD is of critical importance for good is more than the recommended maxi- through the microincision to free the
patient outcomes and to limit recur- mum dose, then the procedure should perivenous adventitial tissues. Once the
rence and appearance of new veins. be staged and divided into multiple
vein is hooked, it should be brought to
After a proper clinical evaluation, any sessions. The interval between ses-
the skin surface gently through the mi-
GSV or SSV reflux must first be treated sions is at the discretion of the physi-
croincision and grasped with a mos-
with EVTA, sclerotherapy, or high li- cian and patient. Epinephrine may be
quito clamp. With a gentle rotating mo-
gation and/or stripping. AP may be used for most procedures. The poten-
tion, the vein should be loosened from
performed concurrently or after treat- tial advantage of epinephrine is con-
the perivenous adventitial tissues and
ment of proximal venous disease. traction of superficial veins possibly
decreasing the amount of bleeding af- slowly avulsed. Very gentle traction
AP may be performed in an outpa-
tient office or hospital setting. The fa- ter AP. The potential risks associated should be applied with a mosquito
cility should be equipped with good with epinephrine include skin necrosis clamp as the vein is removed. Traction
lighting and resuscitation capabilities, and tachycardia. If the patient’s age is on the mosquito clamp allows removal
including medications to treat allergic greater than 60 years, lidocaine with- of the vein and also outlines the course
reactions and volume replacement out epinephrine may be used to pre- of the vein. As the segment of vein be-
agents in case of excessive blood loss. vent cardiac complications. Sodium comes larger and longer with gentle
A procedure table capable of Tren- bicarbonate may be used to buffer the traction, the mosquito clamp should be
delenburg position may be helpful in tumescent solution and make the infil- repositioned closer to the skin surface to
performing the procedure. The proce- tration less painful (22,41,54 –58). decrease the tensile force on the vein. It
dure is typically performed under lo- Cutaneous microincisions are per- is an option to divide the vein between
cal anesthesia and no premedication is formed with an 18-gauge needle, the mosquito clamps. It is important to
usually given. Before starting the pro- number 11 blade grasped transversely note that the mosquito clamp should
cedure, the patient is placed in a with a needle holder, or ophthalmic never be introduced into the microinci-
standing position, preferably on a scalpels. The size of the microincisions sion. It is recommended that the tip of
platform for the comfort of the practi- varies between 1 mm and 3 mm in the mosquito clamp be pointed upward
tioner. Photographs can be taken of length. A longer microincision leads to as it is either pulled or rolled over the
the area to be treated for documenta- a more visible scar and a greater pos- vein in the same or in a counter direc-
tion of the pretreatment appearance. sibility of scar formation or pigmenta- tion while traction is applied. It is im-
In the standing position, the veins to tion. In the thigh, lower leg, and foot, portant that the physician try to remove
be treated with AP can be marked out the microincisions may be performed the entire segment of the vein that has
with a surgical pen or permanent vertically for a potentially better cos- been marked. Retained segments of var-
marker. The marking should ideally metic result. Around the knee, the ten- icose veins will develop superficial
be done by the physician performing sion lines can be followed. The inter- thrombophlebitis, leading to induration
the procedure. val between the microincisions can and bruising and leaving hard, tender,
The patient should then be placed vary from 1 cm to 5 cm, depending on or lumpy areas for prolonged periods of
in a supine or prone position on the size, length, and types of veins ex- time. These areas will have a tendency
Volume 21 Number 1 Kundu et al • 9

to leave dark pigmentation in the over- tis, or pigmentation. A class II closed- SUCCESS RATES
lying skin. Hemostasis is achieved by toe graduated compression stocking
intra- and postprocedural local com- based on the site of treatment should Clinical success, as described in the
pression. be worn over the dressing to apply section on treatment methods, is de-
AP in the ankle or foot region fined as an improvement in the clinical
extra pressure and keep the dressings
should be only performed after signif- status of a patient as defined by one of
in place. The sterile gauze or absorbent
icant experience has been obtained in the objective assessment instruments,
pads should be removed between 2 to
other areas in the lower extremity. such as the CEAP or VCSS classifica-
7 days after the procedure based on tion, by at least one grade. Setting an
Special care must be paid to these ar- the size and location of the veins that
eas to avoid neurovascular injury. The appropriate success rate threshold for
have been removed. The compression AP is difficult. There are many vari-
hooking technique should be much stocking should be left on for a period
more gentle and deliberate than in ables that will affect the eventual suc-
of 2– 4 weeks depending on the cess of the procedure. These include
other areas in the lower extremity. The amount of bruising after the gauze
foot should be dorsiflexed to decrease patient population, type of CVD
and institution treatment protocol, treated, anatomica location of treat-
tension of the anatomic structures. Af- and until absorbent pads have been
ter the vein is hooked it should come ments, the experience of the physician,
removed (18,22,41). preprocedural assessment, and post-
out easily. If the patient experiences Patients should be instructed to
pain or removal of the vein requires a procedural care. There are no refer-
walk around the office for a minimum ences in the literature suggesting ap-
large amount of tension, it is a strong
of 30 minutes after the procedure, to propriate thresholds. However, based
possibility that a different structure
ensure there is no postprocedural on anecdotal evidence there is a suc-
such as a nerve or tendon has been
bleeding and that the dressings and cess rate in the range of 75%–95%
hooked. The hook should then be re-
stockings are comfortable and tolera- (58,70).
moved and reinserted and another at-
tempt made. Aggressive insertion of ble for the patient. After the initial am-
the hook into the microincision and bulation, patients can be discharged.
Patients should be instructed not to COMPLICATIONS
“hooking” of structures should be
avoided to prevent complications. AP drive home as the tumescent anesthe- Complications secondary to AP may
in the pretibial area must be per- sia may have lingering effects on the be classified as cutaneous, vascular, lo-
formed with caution because the large motor nerves. Patients should be en- cal anesthesia–related, or neurologic.
number of lymphatic vessels located couraged to ambulate as much as pos- Complications may be secondary to in-
in this area. AP in the popliteal fossa sible at home. More vigorous exercise correct patient indications, postopera-
should also be performed with great is generally discouraged for the first tive dressings, or surgical technique.
care as the skin behind the knee is week to avoid developing increased Many complications can be avoided as
quite thin and microincisions are eas- central venous pressure on the treated the operating physician’s skill and expe-
ily enlarged by aggressive hooking. area. Long periods of immobility such rience develops. However, it should be
Any additional tissue extruded from as those that occur with air flights or noted that complications may still occur
microincision sites should be rein- long car rides soon after AP should be with perfect surgical technique. Major
serted (59 – 65). discouraged to minimize venous stasis complications are very rare. The vast
and the risk of DVT. Pain control may majority of complications are minor
be achieved using an over-the-counter in nature as per the SIR classification
POSTTREATMENT CARE medication such as ibuprofen or, if a of complications (Appendix B). The
large segment of vein has been re- different types of complications sec-
After AP is completed, the leg
moved, acetaminophen (300 mg) with ondary to AP are listed in Table 5
treated should be cleaned. The appli-
codeine phosphate (30 mg) and caf- (4,5,18,20,21,23,24,54,57,70 –74).
cation of antiseptic powder or solution
should be avoided, as it may induce feine (15 mg) may be prescribed.
silicotic granulomas (66). Adequate Patients should return to the office
after 4 –7 days or as per institution pro- Cutaneous Complications
dressing of the area treated is a critical
step in the follow-up care. The micro- tocol to have the dressings removed and A number of different types of skin
incisions should be covered with ster- the microincisions checked. After the lesions may occur after AP. Most can be
ile gauze or absorbent (ie, nonadhe- dressings are removed, patients should prevented by proper application of
sive) pads and then with a high continue to wear the compression stock- postoperative dressings. Blisters occur
elasticity (ie, long-stretch) bandage. ings for a total of 2– 4 weeks depending secondary to skin shearing (eg, with
This achieves compression across the on the amount of bruising. Patients Steri-Strips or adhesive bandages) and
treated area, preventing postproce- should return for further follow-up ap- may lead to postbullous hypopigmenta-
dural hemorrhage, pain, and other pointments at approximately 4 –12 tion (transient or permanent) or tran-
complications. The bandage should be weeks. At each follow-up appointment, sient hyperpigmentation. Blister forma-
applied distally too proximally to the microincisions should be checked tion may be prevented by avoiding the
cover the treated area (67,68). Tape or for healing. Residual reticular veins or use of adhesive dressings and using
adhesive bandages should not be ap- telangiectasias may be treated with scle- gauze dressings with a short- or long-
plied on the microincisions because of rotherapy at the operator’s discretion stretch bandage. Transient hyperpig-
the risk of blistering, allergic dermati- (7,22,41,60,62). mentation may result from hemosiderin
10 • Guidelines for Phlebectomy for Lower-extremity Venous Insufficiency January 2010 JVIR

boring vein may occur some days after


Table 5
Complications Seen after AP
AP. Conservative measures including
compression or oral antiinflammatory
Common Rare drugs, or invasive therapy such as
Cutaneous
evacuation of the clots and AP of the
Transient pigmentation Contact dermatitis inflamed vein followed by compres-
Skin blisters Infection sion and ambulation, will help relieve
Keloids the symptoms.
Tattooing with marking pen DVT has rarely been reported after
Foreign body (silicotic) granuloma AP. This would be considered a major
Necrobiosis lipoidica complication per SIR criteria and treat-
Vascular ment would include anticoagulation
Hematomas Postoperative hemorrhage along with compression (18). Edema is
Matting (neovascularity)
most commonly the result of an incor-
Superficial phlebitis
DVT rectly applied dressing and will resolve
Edema after one night without the compression
Lymphatic pseudocyst bandage. Edema may persist for several
Local anesthetic Concomitant anesthesia of deeper nerves months after AP of the foot or SSV, as a
Neurologic Postoperative pain result of unrecognized lymphatic insuf-
Carpotarsal syndrome ficiency (76). Lymphocele is a rare com-
Transitory or permanent sensory deficit plication of AP of the ankle, pretibial or
Neuroma popliteal areas with rapid development
of a soft, painless fluctuant nodule. This
may be punctured and drained. Alter-
natively compression with circular mas-
staining (after hematoma resorption) Vascular Complications sage may be helpful. Neovascularity or
and postinflammatory melanocytic hy- “matting” is a complication of AP, scle-
peractivity. Hyperpigmentation most The incidence of vascular complica- rotherapy, and surgical ligation and
commonly fades in weeks to months tions is correlated with the size and type stripping. The cause is unknown, and
without treatment. However, sun pro- of treated vessels (more likely with per- the matting may resolve spontaneously
tection (ie, sunblock and skin coverings) forator veins) and location of AP (more or be treated with sclerotherapy after a
and UV avoidance are critical to avoid common in thigh and popliteal fold), or 3-month interval.
melanogenesis in treatment areas. Con- the patient’s history (previous sclero-
tact dermatitis is very rare because of therapy, phlebitis, lipodermatosclero-
Local Anesthetic Complications
the new generation of hypoallergenic sis). Appropriate compression and
topical medications and dressings. Visi- dressing should reduce the incidence Anaphylactic reactions to local anes-
ble scarring after AP is rare and can be and hopefully avoid such complica- thetic agents are very rare. Toxic reac-
avoided with tiny incisions, minimizing tions. tions may occur after accidental intra-
skin trauma. Scarring tends to persist Postprocedural bleeding from the vascular injection or use of concentrated
longer in the younger patient popu- microincision sites may occur when solutions or in individually sensitive pa-
lation, and they should be made the patient stands up or after some tients. Infiltration of the local anesthetic
aware of this before AP. Keloid for- minutes of walking after undergoing agent must be stopped if signs such as
mation is also very rare even in pa- the procedure. This type of bleeding malaise, tremor, or paresthesias occur.
tients at risk, most likely secondary can be controlled by additional pres- Rarely, tumescent anesthesia may pene-
to the small size of the incisions. Hy- sure with gauze pads and reinforce- trate more deeply, particularly in the
pertrophic scars are also unusual ment of the pressure dressing. There- popliteal fold area, leading to infiltration
and mainly observed in the dorsum fore it is advisable to reassess the of motor fibers of the peroneal nerve
of the foot, where they fade very dressing after 30 minutes of ambula- and causing transient nerve palsies such
slowly. Tattooing with a marking tion. Postprocedural bleeding occurs as drop foot, which clears within several
pen is rare and can be prevented by more frequently with perforator avul- hours. It is important to test the mobility
avoiding performing incisions over sion and in patients with postthrom- of the foot before the patient stands up.
areas marked with a marking pen. botic syndrome. Careful and pro-
Skin necrosis is also very rare and longed compression of the incision Neurologic Complications
has been reported after the use of 1% after removal of perforator vein is rec-
lidocaine with 1/100,000 epineph- ommended. Neurologic symptoms may be arise
rine. Therefore it is recommended Diffuse postprocedural hematomas as a result of the compressive dressing
1/400,000 epinephrine be used (56). are frequently seen, depending on the application and can be relieved with re-
Foreign body granulomas along the fragility of the patient’s skin and effec- moval and reapplication of the dressing.
incision sites are no longer observed, tiveness of the compression. These Intraprocedure manipulation of a nerve
with the elimination of postproce- are typically self-limited. Superficial is very painful and may cause transient
dural application of antiseptic pow- thrombophlebitis of incompletely re- postprocedural paresthesias. If a patient
der (8,66,75). moved varicose veins or in the neigh- describes pain on insertion of the AP
Volume 21 Number 1 Kundu et al • 11

Table 6
APPENDIX A: CONSENSUS
Threshold and Suggested Complication Rates for AP METHODOLOGY
Complication Reported (%) Suggested (%) Reported complication-specific rates
in some cases reflect the aggregate of
Cutaneous major and minor complications. Thresh-
Skin blisters 1–20 10 olds are derived from critical evaluation
Transient pigmentation 1–18 15
Visible scars 3–5 7
of the literature, evaluation of empirical
Contact dermatitis 1–3 3 data from Standards of Practice Com-
Infections 0.5–2 2 mittee members’ practices, and, when
Keloids 0.5–1 1 available, the SIR HI-IQ System national
Vascular database.
Major hematomas 0.1–2.5 3
Postprocedural hemorrhage 0.3–4.3 4
Superficial thrombophlebitis 0.1–3 3 APPENDIX B: SOCIETY OF
Neovascularity or matting 1.3–9.5 10 INTERVENTIONAL
Lymphocele 0.1–2.5 3 RADIOLOGY STANDARDS OF
Persistent edema 0.1–1.3 1.5
DVT 0.5 0.5
PRACTICE COMMITTEE
Neurologic CLASSIFICATION OF
Paresthesia 0.2–4.6 5 COMPLICATIONS BY
Transient nerve palsies 0–4 5 OUTCOME
Minor Complications
A. No therapy, no consequence
hook or upon exteriorization of “vein,” CVD. Thorough training and careful B. Nominal therapy, no conse-
the structure should be released and the technique are essential for producing quence; includes overnight admission
AP hook reinserted to prevent nerve optimal results and preventing com- (up to 23 hours) for observation only.
damage. If nerve injuries are observed, plications.
they typically occur in AP of the SSV as
the sural nerve may be damaged by the Major Complications
hook, leading to paresthesia, or Acknowledgments: Sanjoy Kundu, MD,
FRCPC, authored the first draft of this doc- C. Require therapy, minor hospital-
transected with permanent complete
sensory loss over a large cutaneous area.
ument and served as topic leader during ization (⬎ or ⫽ to 24 hrs, but ⬍48
the subsequent revisions of the draft. hours).
Published rates for individual types Clement J. Grassi, MD, is chair of the SIR
of complications are highly dependent D. Require major therapy, un-
Standards of Practice Committee. John F.
on patient selection and are based on Cardella, MD, is Councilor of the SIR Stan-
planned increase in level of care, pro-
series comprising several hundred pa- dards Division. Other members of the longed hospitalization (⬎48 hours).
tients, which is a volume larger than Standards of Practice Committee and SIR E. Permanent adverse sequelae
most individual practitioners are likely who participated in the development of F. Death.
to treat. Generally, the complication- this clinical practice guideline are as fol-
specific thresholds should be set higher lows: John “Fritz” Angle, MD, Ganesh An- References
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SIR DISCLAIMER
The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles that
generally should assist in producing high quality medical care. These guidelines are voluntary and are not rules. A
physician may deviate from these guidelines, as necessitated by the individual patient and available resources. These
practice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of
care that are reasonably directed towards the same result. Other sources of information may be used in conjunction
with these principles to produce a process leading to high quality medical care. The ultimate judgment regarding the
conduct of any specific procedure or course of management must be made by the physician, who should consider all
circumstances relevant to the individual clinical situation. Adherence to the SIR Quality Improvement Program will
not assure a successful outcome in every situation. It is prudent to document the rationale for any deviation from the
suggested practice guidelines in the department policies and procedure manual or in the patient’s medical record.

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