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11 Chemic a l S u p e r fi cial Vein Ablation
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a
Fig. 11.9 Advancing the needle along the long axis of the ultrasound probe. ( a ) ultrasound image of needle course into
target vein and ( b ) visual image of injection technique
b
air-based foam, while there is evidence that the use of biocompatible gas to produce foam allows for higher volumes to be injected safely [ 16 , 20 ].
11.4.2 Effi cacy of Foam Sclerotherapy
Fig. 11.10 Inserting the needle along the short axis of
the ultrasound probe
of advancing the needle or catheter along the long axis of the ultrasound probe so that the needle is visualized all the way from the skin insertion site to the target vein. This is different than the “trian­gulation” technique typically favored by radiolo­gists, wherein the needle is inserted along the short axis of the probe allowing visualization of the tip only when it arrives at the target vein (Fig.
11.10 ).
The volume of foam injected at each site is determined by the size of the treatment vein and the volume required to replace blood in the vein with foam but is usually limited to 0.5–3 mL. The total volume of foam used per treatment session is the subject of debate, as little data has been published regarding the volume of foam neces­sary to achieve successful vein sclerosis while limiting side effects. The upper limit of foam is generally considered to be 10 mL when utilizing
Effi cacy trials have been conducted internation­ally [ 8 , 2126 ]. Successful ablation has been reported to range from 68 to 100 %, with follow­ up from 1 month to 10 years, though interpreta­tion of these results is diffi cult because of the differences in defi nitions of success, the use of surrogate markers (occlusion or narrowing of the treated vein, resolution of refl ux), differing pri­mary outcome markers (resolution of symptoms, improved quality of life scores, recurrent varices, ulcer healing), and the number of ultrasound­guided foam sclerotherapy sessions needed to achieve success, among others. Recently a consensus document has been published under the auspices of the Union Internationale de Phlebologie (UIP) in an attempt to standardize duplex reporting following treatment of lower extremity venous disorders [
27 ].
It is also important to state that simply creating thrombosis of a target vein will likely not result in permanent occlusion of the vein. Damage to or destruction of the vein wall is necessary to ensure sclerosis [
28 ]. It may be necessary to produce
injury through the intimal layer into the media in order to achieve the desired destruction [ 29 ].
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11.4.3 Methods to Improve Foam Sclerotherapy Effi cacy
Various methods have been proposed to improve effi cacy: agitation methods which enhance the durability and uniformity of foam [ 18 , 30 , 31 ], increased sclerosant concentration [ 22 ] or vol- ume used [ 22 , 32 ], indwelling catheter method [ 18 , 33 ], foam production methods resulting in smallest bubble size possible [ 18 ], and leg eleva- tion (for “empty vein”) [ 34 ]. In spite of a num- ber of well-conducted studies [ 22 , 25 , 35 , 36 ] in a review of the published and unpublished data available in the world literature, Jia et al. [ 14 ] concluded that there exists insuffi cient data to determine the optimal volume of foam, opti­mal concentration, and optimal foam-producing method.
Recently, a method of catheter-directed foam sclerotherapy utilizing ultrasound-guided perive­nous tumescent injection has gained interest for reported better effi cacy [ 18 , 33 ].
By increasing the direct contact of the scleros­ing agent with the endothelium, foam production methods that create microbubbles of smaller size may add to the effi cacy: fi rst, by displacing blood as much as possible from the targeted vein and second, by greatly increasing the total surface area of the smaller bubbles to which the active sclerosant is attached, thereby increasing endo­thelial contact [ 23 , 37 , 38 ].
For similar reasons, leg elevation prior to the injection will also help clear blood from the vein, thus allowing greater sclerosant contact with the endothelium and less sclerosant mixing with and deactivation by blood.
11.4.4 Safety of Foam Sclerotherapy
Early reports regarding UGFS did not study safety aspects beyond local tissue reactions or venous thrombosis. Primarily because of con­cern about neurosensory adverse reactions fol­lowing UGFS [ 39 , 40 ], more recent reports have looked at such concerns more closely [ 16 , 41 44 ]. Minor or major complications following
Table 11.1 A list of side effects and adverse events
reported to be associated with UGFS
Deep venous thrombosis (DVT) Superfi cial thrombophlebitis (STP) Localized perivenous tissue injury Paradoxical embolism Neurosensory effects Respiratory effects
foam sclerotherapy have almost uniformly been very limited in incidence and in duration [ 62 ]. The practitioner needs to be aware of these risks and their management in order to discuss risk­benefi t decisions with patients regarding the use of UGFS.
UGFS may have the potential for pulmonary, visual, and/or cerebral effects, particularly in a patient with a patent foramen ovale, or other right-to-left shunt, which may be more common in patients with varicose veins than in the general population [ 45 ] (Table 11.1 ).
11.4.4.1 Deep Venous Thrombosis
Data is lacking on the true incidence of DVT fol­lowing liquid sclerotherapy. There appears to be a higher incidence of DVT following UGFS than is generally assumed following the use of liquid scle­rosants, especially in foam sclerotherapy studies wherein patients are routinely examined for DVT by duplex scanning as opposed to duplex scanning only when warranted by symptoms [ 9 , 22 ]
However, these thromboses most often involve calf veins that, if followed closely, are most often of limited clinical signifi cance. Symptomatic or femoral-popliteal DVT remain rare, except in the smaller diameter duplicated femoral vein segment [ 46 ] or in Myers’ study, veins larger than 5 mm in diameter [ 47 ]. There is confl icting in vitro evidence regarding scle­rosant foam effect on coagulation [ 48 , 49 ] and in vivo as well [ 50 ]. In the clinical setting, however, Hamel- Desnos has presented evidence that mir­rors the author’s experience: foam sclerotherapy can be successfully and safely performed on patients with documented thrombophilia with no increased risk of DVT, given prophylactic anti­coagulation [ 51 ].
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11.4.4.2 Superfi cial Thrombophlebitis
Superfi cial thrombophlebitis probably should be considered a direct consequence of treatment, unless thrombophlebitis extends beyond the region treated or if the infl ammation is signifi ­cantly worse than routinely observed. The inci­dence varies from less than 1–18 % in the literature probably because of individual inter­pretation of the clinical fi ndings [ 52 ].
11.4.4.3 Perivenous Tissue Injury
Extravascular tissue injury with the use of UGFS has been reported to be less than 2 % likely because of the benign effects of foam extravasated in the perivenous tissue (signifi cantly lower con­centration). This is in contrast to the more dam­aging effects of some liquid sclerosants (typically three to four times the concentration of foam).
11.4.4.4 Paradoxical Embolism
A right-to-left shunt, present in 25–30 % of the gen­eral population, and perhaps even higher in patients with varicose veins [ 45 ], may allow emboli or deg- radation products released from damaged endothe­lium to pass to the arterial circulation and affect the microcirculation of any organ. Whether symptoms are related to particulate or bubble emboli or to endothelial destruction products (such as endothe­lin-1, a potent vasoconstrictor) is currently under investigation. What is known is that UGFS has the potential for nearly always rare and transient pulmonary, cardiac, visual, and/or cerebral effects, particularly in a patient with a patent foramen ovale or other right-to-left shunt.
A rare complication, thromboembolism has also been reported following UGFS when either a thrombus forms in and embolizes from a deep vein or a thrombus extension from a truncal or perforator vein embolizes. In the presence of a right-to-left shunt, the embolus can progress to the arterial circulation with variable sequelae depending on the location of the embolus.
11.4.4.5 Neurosensory Effects
Reports of signifi cant adverse neurologic events are very few. Forlee et al. reported one case of stroke following varicose vein foam injection sclero-
therapy [ 40 ]. The patient was subsequently found to have a very large patent foramen ovale. Also reporting neurologic events in patients, Ceulen et al. [ 39 ], Bush and colleagues [ 53 ], and Ma and Parsi [ 54 ] have also reported neurologic events in patients. Because of numerous anecdotal reports of similar events, the true incidence may not be as rare as is reported. The question could be whether all patients should be screened for right-to- left shunt prior to UGFS. The consensus opinion of international experts [ 55 ] is that these uncommon neurosensory effects do not justify such pre-sclero­therapy screening, since similar serious incidents have occurred following liquid sclerotherapy, ther­mal ablation, or surgical stripping [ 5658 ].
It is imperative, however, that the practicing phlebologist has protocols to deal with such seri­ous adverse events should one occur.
Transient visual disturbances, or scotomas, have been mentioned when evaluating adverse events following foam sclerotherapy. Frequencies of occurrence vary from 0 to 6 % following air­based foam injection, with most publications indicating a frequency around 1 % [ 14 , 59 ]. Other events have been described in the litera­ture. True migraine or ocular migraine is uncom­mon, but Gillet and colleagues found in a study of 20 patients with visual disturbances following UGFS that clinical features of migraine with aura were present in all patients, suggesting a strong association between visual disturbances follow­ing UGFS and migraine [ 60 ]. Since it has been established that twice as many patients (50 %) with a history of migraine with aura have right­to- left shunts as is seen in the normal population (25 %) [ 6 , 61 ], it may be reasonable to expect that patients with a history of migraine with aura have an increased risk of suffering neurosensory events following UGFS.
11.4.4.6 Respiratory Effects
Acute respiratory diffi culties are rarely reported in the literature but may be commonly seen in phlebologic practice. Chest tightness, transient shortness of breath, and dry cough have been described as uncommon or rare adverse events, but all appear self-limited [ 16 ].
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11.4.4.7 Long-Term Effects: Pulmonary, CNS, Visual
Long-term adverse pulmonary effects such as pulmonary fi brosis are of theoretical concern but have not been identifi ed. Such side effects have also been reported with liquid sclerosants. Pulmonary embolism is a concern, but its occurrence is rare and may relate more to other patient conditions than to the procedure itself [ 20 , 63 ].
11.4.5 Foam Sclerotherapy: Methods
to Improve Safety
Several methods have been proposed to improve the safety of foam sclerotherapy (Table 11.2 ).
The use of an indwelling catheter is thought to improve safety of UGFS by minimizing extrava­sation of foam (as seen with direct needle injec­tion) and by allowing for immediate instillation of foam following production in order to deliver the highest quality of foam possible (no lag time
Table 11.2 Proposed methods for improved safety
Indwelling catheter (balloon-tipped or open-ended) Saphenofemoral junction occlusion Limitations of volume Low-silicone syringe Non-air-based foam Maneuvers to limit or prevent foam migration
between foam production and instillation as with direct needle injection) [ 64 , 65 ].
When performing UGFS, a balloon-tipped catheter can be used to occlude the saphenofemo­ral or saphenopopliteal junction, theoretically preventing foam from entering the deep venous system. However, it has been shown [ 6668 ] by ultrasound examination that foam is still seen in the deep system as having moved through myriad perforator veins. In fact, many phlebologists believe it is better to have foam gradually migrat­ing into the deep venous system than to have a large bolus enter the central circulation when the occlusive balloon is defl ated.
Limiting the volume of foamed sclerosant injected at any one time has been proposed as a method to minimize the risk of symptomatic bub­ble embolization [ 55 , 69 ]. However, in studies of foam sclerotherapy with simultaneous monitor­ing using transthoracic echocardiography and transcranial Doppler, the author has shown that the use of even very small volumes of foam does not prevent foam migration to the central venous circulation or across a PFO (Fig. 11.11 ) [ 70 ].
It is presumed that the use of low-silicone syringes enhances foam stability, because silicone helps speed foam degradation. Thus, foam will remain of good quality longer with silicone- free or low-silicone syringes, allow­ing for more time to complete a successful injection [ 18 , 30 ].
Fig. 11.11 In studies of
foam sclerotherapy with simultaneous monitoring using transthoracic echocardiography and transcranial Doppler, the use of even very small volumes of foam does not prevent foam migration to the central venous circulation or across a PFO
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The type of gas used to create the foam will also infl uence foam degradation. Tessari has shown that a gas combination of CO 2 and O 2 with 70 % CO 2 and 30 % O 2 to produce foam will result in more stable, longer-lasting foam than pure CO 2 -based foam [ 71 ]. Because of its pre- sumably more rapid dissolution, CO 2 /O 2 -based foam (70 % CO 2 /30 % O 2 combination) has been shown by the author to be 7 and 40 times less likely, respectively, to produce side effects or complications compared to pure CO 2 -based foam and air-based foam [ 44 ].
Maneuvers such as preinjection and/or postin­jection leg elevation and limiting patient mobility for a few minutes immediately after injection were found to be ineffective in eliminating foam migration into the central circulation or, for that matter the arterial circulation in the presence of a right-to-left shunt [ 17 ].
However, in a study of a proprietary manu­factured foam injected into patients with known right-to-left shunts, Regan et al. [ 42 ] noted no cardiac, neurologic, or visual field changes in patients undergoing foam sclero­therapy. It is uncertain whether to assume the findings of this study of a proprietary manu­factured foam are similar for “home-made” foam used by most phlebologists. But the lack of evidence for serious long-term adverse events in spite of the huge worldwide experience with self-manufactured foam is reassuring [ 72 ].
11.5 Postoperative Care
Although Level 1 evidence for the use of post­operative compression is lacking, compression and early ambulation are regarded by many phlebologists as the cornerstones of successful postoperative management, no matter which modality of truncal vein ablation is chosen. Extrinsic compression using foam padding, short stretch and/or elastic bandages, compres­sion hose, and early ambulation and return to normal activities all will likely help to minimize postoperative discomfort and avoid complica­tions, such as deep venous thrombosis.
Conclusion
All published reports support UGFS as a reasonably safe method of superfi cial venous ablation. Effi cacy, simplicity, economy, and serial applications have made UGFS an attrac­tive and effi cient treatment option. Side effects and complications of UGFS are nearly always transient and infrequent or rare. Evaluations of the use of foam sclerotherapy are ongoing and likely will result in more refi ned evidence­based guidelines that will address its indica­tions and methods to enhance effi cacy and ensure safety. Most investigators agree on the need for adequate training in this technique to reduce the risk of complications.
Acknowledgements The author gratefully acknowl­edges the contribution of Diana Neuhardt, RVT, of Compudiagnostics for her clinical assistance and provi­sion of the excellent duplex images in this manuscript, as well as editing assistance provided by Adrienne Travis and Denise Bork.
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Surgical Techniques
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Marc A. Passman
1 2
Contents
12.1 Introduction ................................................ 161
12.2 Patient Evaluation ...................................... 162
12.2.1 Indications .................................................... 162
12.2.2 Diagnostic Evaluation .................................. 162
12.3 Classifi cation............................................... 163
12.4 Clinical Decision Making .......................... 164
12.4.1 Failure of Nonoperative Measures ............... 164
12.4.2 Clinical Severity ........................................... 165
12.4.3 Patient Risk Factors ..................................... 166
12.4.4 Anatomic Varicose Vein Distribution
and Pattern ................................................... 166
12.4.5 Staged vs. Combined Approaches ............... 166
12.5 Operative Setting ....................................... 167
12.6 Patient Expectations .................................. 167
12.7 Operative Techniques ................................ 167
12.7.1 Great Saphenous Vein .................................. 167
12.7.2 Small Saphenous Vein ................................. 168
12.7.3 Varicose Veins .............................................. 168
12.8 Outcomes .................................................... 170
12.8.1 Postoperative Follow-Up ............................. 170
12.9 Complications ............................................. 170
12.10 Results ......................................................... 171
12.11 Evidence-Based Guidelines ....................... 171
12.12 Summary..................................................... 172
References ................................................................. 173
M. A. Passman , MD Section of Vascular Surgery and Endovascular Therapy , University of Alabama at Birmingham , Birmingham , AL , USA e-mail: marc.passman@ccc.uab.edu
Abstract
Coordinated treatment of superfi cial venous insuffi ciency involves comprehensive patient evaluation, appropriate venous testing usually with venous ultrasound as the cornerstone of diagnostic evaluation, and sound clinical deci­sion making based on current evidence-based guidelines. While nonoperative measures focusing on compression are recommended as initial therapy, operative approaches offer additional opportunity for improved out­comes. As treatment options are shifting to less invasive options, traditional open opera­tive approaches directed at both axial saphe­nous vein refl ux and varicose vein problems still have a role in appropriately selected patients with symptomatic superfi cial venous insuffi ciency. This chapter discusses surgical techniques for venous disease.
12.1 Introduction
Superfi cial venous insuffi ciency involves incom­petence of the great saphenous vein (GSV), small saphenous vein (SSV), and associated patterns of secondary varicose veins. Within the superfi cial venous system, there is also the potential for pri­mary varicose veins without associated axial or segmental refl ux, dilated reticular veins, and venous telangiectases. Venous insuffi ciency can be isolated to the superfi cial venous system or can include concomitant deep (see Chap. perforator disease (see Chap.
14 ).
16 ) and
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The prevalence of all chronic venous insuffi ciency has varied in reports but may be as high as 40 % in women and 17 % in men. Active venous ulcers are present in up to 0.5 % of indi­viduals, and between 0.6 and 1.4 % have healed ulcers. Estimates for varicose veins are even higher at 73 % in women and 56 % in men. For all patients with chronic venous insuffi ciency, those with isolated superfi cial venous refl ux may involve up to 35 %. The age-matched distribu­tion of venous insuffi ciency corresponding to these prevalence estimates has also translated to a fi nancial burden to patients and society with lost productivity, employment issues, and disabilities. Fortunately, superfi cial venous insuffi ciency and associated problems are very amenable to surgi­cal correction [ 14 ].
This chapter will review treatment of superfi ­cial venous insuffi ciency including patient evalu­ation, clinical decision making, nonoperative measures, traditional open operative approaches directed at axial saphenous vein refl ux and thrombosis and varicose vein problems, out­comes, and current evidence-based guidelines.
12.2 Patient Evaluation
12.2.1 Indications
The most common complaints associated with superfi cial venous insuffi ciency and varicose veins are pain, aching, throbbing, heaviness, tingling, burning, cramping, itching, unsightliness, discol­oration, tiredness, restlessness, and swelling of the extremity. Complaints are usually pronounced after prolonged limb dependency and relieved with rest or elevation, with further progression of symptoms more notable towards the end of the day. More severe symptoms and advanced venous problems, including chronic venous skin changes and progression to venous stasis ulcers, can occur with both isolated superfi cial venous insuffi ­ciency and deep or perforator venous incompe­tence. Other pertinent history should include prior personal or family history of venous thromboem-
bolism, superfi cial thrombophlebitis, established thrombophilia, medication history (particularly oral contraceptives), smoking, pregnancies, family history of varicose veins, spontaneous rupture of varicosity, venous ulceration, and previous venous interventions. It is important to differentiate symptoms due to venous disease from other concomitant musculoskeletal, arterial, neuropathic, dermatologic, pelvic, or lymphatic etiologies.
12.2.2 Diagnostic Evaluation
Physical examination should be performed with the patient standing. On inspection, general posi­tion of telangiectases, dilated reticular veins, and varicose veins should be noted, with iden­tifi cation of location, anatomic pattern, size, and presence of infl ammation. Documentation can be greatly assisted with handwritten diagrams, electronic drawing systems, or digital photog­raphy. Palpation is performed assessing for pal­pable cord, tenderness, induration, pulses, thrill, and groin or abdominal masses. Auscultation should identify any associated bruits. Evaluation of swelling components should include unilateral vs. bilateral, standardized limb measurements, distribution of edema across the entire extrem­ity, and whether it is pitting or non-pitting, to differentiate lymphedema and other non-venous causes. Additional venous stigmata may include inframalleolar ankle fl are, corona phlebectatica, and atrophie blanche. More advanced venous skin fi ndings include hyperpigmentation, venous eczema, stasis dermatitis and other infl ammatory changes, induration, lipodermatosclerosis, and healed or active venous ulcerations.
Bedside venous examinations such as Trendelenburg, Ochsner-Mahorner, or Perthes’ tests, although occasionally useful, are often unreliable and have been largely replaced by diagnostic imaging. Venous duplex ultrasound is critically important to differentiate obstruc­tive components, presence or absence of venous thrombosis, and competency of deep, superfi cial,
12 Surgical Techniques
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Fig. 12.1 Anatomic distribution of varicose veins and
their relationship to documented source of superfi cial venous refl ux, including the great saphenous vein, ante-
and perforator venous systems (see Chap. 6 ). Identifying sources of refl ux and association to clinical patterns of venous fi ndings will help determine the best operative option (Fig. 12.1 ). Venous physiologic testing (see Chap. 8 ) and other imaging such as computed tomography (CT) venography, magnetic resonance (MR) venography, ascending and descending contrast venography, and intravascular ultrasound (see Chaps. 9 and 16 ) can be useful in selected cases when other venous problems beyond superfi cial venous insuffi ciency are a consideration, such as post-thrombotic syndrome, thrombotic or non­thrombotic iliac vein obstruction (May-Thurner syndrome), pelvic congestion syndrome, nut­cracker syndrome, vascular malformations, venous trauma, or tumors.
12.3 Classifi cation
Venous outcome assessment tools have been used to evaluate severity of venous disease, provide standardized evaluation of treatment effectiveness over time, and are important in
rior saphenous vein, pudendal vein, small saphenous vein, and posterior thigh circumfl ex vein (vein of Giacomini)
objectively assessing effectiveness of superfi cial venous operations. Clinical, etiologic, anatomic, pathophysiologic (CEAP) classifi cation system (Table 12.1 ) for chronic venous disease is widely accepted and allows patient comparison among different centers and studies but has been recog­nized to be relatively static and insensitive for determining changes in venous disease sever­ity over time. Venous Severity Scoring (VSS) which includes Venous Disability Score (VDS), Venous Segmental Disease Score (VSDS), and Venous Clinical Severity Score (VCSS) has been shown to be more useful for comparing patient groups with similar degrees of severity in regard to outcome over time and following different therapies. The VCSS system includes 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, infl ammation, induration, number of active ulcers, duration of active ulceration, size of ulcer, and compressive therapy use), scored from 0 to 3 (total possible score, 30) that may be used to assess changes in response to therapy (Table 12.2 ). VCSS, revised in 2010, has been shown to have mini­mal intraobserver and interobserver variability,