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Chapter
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14
Venoactive Drugs
Table 14.3 Levels of evidence and grades of recommendations
Recommendation Compounds RCT Meta-analyses
Grade A Micronized purified flavonoid fraction (MPFF) Gilly 1994 Coleridge-Smith 2005
Guilhou 1997
Chassignolle 1999
Danielsson 2002
Das 2003
Veverkova 2005
Pokrovsky 2007
Simsek 2007
Oxerutin Kranendonk 1993 Poynard 1994
Diebschlag 1994
Cloarec 1996
Unkauf 1996
Grossmann 1997
Calcium dobesilate Casley-Smith 1988 Espinoza 2001
Widmer 1990 Ciapponi 2004
Labs 2004
Rabe 2006
Martinez 2008
Grade B Horse chestnut seed extracts (escin) Diehm 1996 Pittler 2002
Siebert 2002
Ruscus extracts Vanscheidt 2002 Boyle 2003
Parrado 1999
Grade C Diosmin Carpentier 1994
Troxerutin Vin 1994
Rehn 1993
Troxerutin-Coumarin Vanscheidt 2002
Gingko biloba Zuccarelli 1986
Natali 1989
Proanthocyanidines Kiesewetter 2000
Petrassi 2000
Naftazone Vayssairat 1997
RCT, randomized controlled trials.
Grade A: RCT with large sample sizes, valid meta-analyses.
Grade B: RCT with small sample size.
Grade C: Other controlled trials, no RCTs.
References
1. Ramelet AA, Perrin M, Kern P.
Bounameaux H. Phlebology. 5th ed.
Paris: Elsevier; 2008.
2. Ramelet AA, Kern P, Perrin M. Varicose
veins and telangiectasias. Paris:
Elsevier; 2004.
3. Ramelet AA, Boisseau MR, Allegra C,
et al. Veno-active drugs in the
374
management of chronic venous
disease. An international consensus
statement: current medical position,
prospective views and final resolution.
Clin Hemorheol Microcirc
2005;33:309.
4. Nicolaides AN, Allegra C, Bergan J,
et al. Management of chronic venous
disorders of the lower limbs –
guidelines according to scientific
evidence. International Angiology
2008;27:1.
5. Gobin JP, Ramelet AA. Place actuelle
des médicaments veino-actifs dans le
traitement des affections veineuses
chroniques. Phlébologie 2008;61:395.
6. Ramelet AA. Management of chronic
https://t.me/med1917
venous disease: the example of Daflon
500 mg. Phlebolymphology 2009, in
press.
7. Diem C. The role of oedema
protective drugs in the treatment of
CVI: a review of evidence based and
placebo-controlled clinical trials with
regard to efficacy and tolerance.
Phlebology 1996;11:23.
8. Kurtz X. Chronic venous insufficiency
of the leg: epidemiology, outcomes,
diagnosis and management. Summary
of an evidence-based report of the
VEINES task force. Int Angiol 1999;
18:83.
9. Boada JN, Nazco GJ. Therapeutic
effect of venotonics in chronic venous
insufficiency: a meta-analysis. Clin
Drug Invest 1999;18:413.
10. Clement DL. Management of venous
edema: insights for an international
task force. Angiology 2000;51:13.
11. Frick RW. Three treatments for chronic
venous insufficiency: escin,
hydroxyethylrutoside and Daflon.
Angiology 2000;51:197.
12. Pittler MH, Ernst E. Horse chestnut
seed extract for chronic venous
insufficiency. Cochrane Database Syst
Rev Jan 2006;25(1):CD003230.
13. Martinez MJ, Bonfill X, Moreno RM,
et al. Phlebotonics for venous
insufficiency. Cochrane Database Syst
Rev 2005;(3):CD003229.
14. Vanscheidt W, Heidrich H, Jünger M,
Rabe E. Guidelines for testing drugs
for chronic venous insufficiency. Vasa
2000;29:274.
15. Gohel MS, Davies AH.
‘Pharmacological agents in the
treatment of venous disease: an
update of the available evidence.’
Curr Vasc Pharmacol 2009;7:303.
16. Sovak M. ‘Grape Extract, resveratrol,
and its analogs: a review.’ J Med Food
2001;4:93.
17. Badger C, Preston N, Seers K,
Mortimer P. Benzo-pyrones for
reducing and controlling lymphoedema
of limbs. Cochrane Database Syst Rev
2004;(2):CD003140.
18. Vanscheidt W, Rabe E, Nazer-Hijazi B,
et al. The efficacy and safety of a
coumarin-troxerutin combination
(SB-LOT) in patients with chronic
venous insufficiency: a double blind
placebo controlled randomized study.
Vasa 2000;31:185.
19. Carpentier PH, Mathieu M. Evaluation
de l’efficacité clinique d’un médicament
veinotrope: les enseignements d’un
essai thérapeutique avec la diosmine
d’hémisynthèse (Diovénor) dans le
syndrome de jambes lourdes. J Mal
Vasc 1998;28:106.
20. Biland L, Blatter P, Scheibler P, et al.
On the therapy of so-called leg pains.
Controlled double-blind study of the
therapeutic efficacy of Daflon (in
German). Vasa 1982;11:53.
21. Behar A, Lagrue G, Cohen-Boulakia F,
et al. Study of capillary filtration by
double labelling I131-albumin and
Tc99m red cells. Application to the
pharmacodynamic of Daflon 500 mg.
Int Angiol 1988;7(Suppl 2):35.
22. Cospite M, Dominici A. Double blind
study of the pharmacodynamic and
clinical activities of 5682 SE in venous
insufficiency: advantages of the new
micronized form. Int Angiol
1989;8(Suppl 4):61.
23. Barbe R, Amiel M. Pharmacodynamic
properties and therapeutic efficacy of
Daflon 500 mg. Phlebology
1992;(Suppl 2):41.
24. Galley P, Thiollet M. A double-blind
placebo-controlled trial of a new
veno-active flavonoid fraction (S
5682) in the treatment of
symptomatic capillary fragility. Int
Angiol 1992;12:69.
25. Blume I, Langenbahn H, Chamvallins
M. Quantification of oedema using
the volumeter technique: therapeutic
application of Daflon 500 mg in CVI.
Phlebology 1992;2:37.
26. Gilly R, Pillion G, Frileux C.
Evaluation of a new venoactive
micronized flavonoid fraction (S
5682) in symptomatic disturbances of
the venolymphatic circulation or the
lower limb. A double-blind placebocontrolled study. Phlebology
1994;9:67.
27. Amato C. Advantage of a micronized
flavonoidic fraction (Daflon 500) in
comparison with a micronized
diosmin. Angiology 1994;45:531.
28. Cloarec M, Clement R, Griton P. A
double-blind clinical trial of
hydroxyethylrutosides in the
treatment of the symptoms and signs
of CVI. Phlebology 1996;11:76.
29. Guilhou JJ, Dereure O, Marzin L, et al.
Efficacy of Daflon 500 mg on venous
ulcer healing: a double blind
randomized placebo controlled trial.
Angiology 1997;48:77.
30. Ibegbuna V, Nicolaides AN, Sowade
O, et al. Venous elasticity after
treatment with Daflon 500 mg.
Angiology 1997;48:45.
31. Chassignolle JF, Amiel G, Lanfranchi
G, Barbe R. Activité thérapeutique de
Daflon 500 mg dans l’insuffisance
veineuse fonctionnelle. JIM
1999;99(Suppl):32.
32. Shoab SS, Porter JB, Scurr JH,
Coleridge-Smith PD. Endothelial
activation response to oral micronised
flavonoid therapy in patients with
chronic venous disease. A prospective
study. Eur J Vasc Endovasc Surg
1999;17:313.
33. Shoab SS, Porter JB, Scurr JH,
Coleridge-Smith PD. Effect of oral
micronised purified flavonoid fraction
treatment on leucocyte adhesion
molecule expression in patients with
chronic venous disease: a pilot study.
J Vasc Surg 2000;31:456.
34. Ramelet AA. Pharmacologic aspects of
a phlebotropic drug in CVI-associated
oedema. Angiology 2000;5:19.
35. Olszewski W. Clinical efficacy of
micronized purified flavonoid fraction
(MPFF) in edema. Angiology 2000;
51:25.
36. Ramelet AA. Clinical benefits of
Daflon 500 mg in the most severe
stages of chronic venous insufficiency.
Angiology 2001;52:549.
37. Danielsson G, Jungbeck C, Peterson K,
Norgren L. A randomised controlled
trial of micronised purified flavonoid
fraction vs placebo in patients with
CVI. Eur J Vasc Endovasc Surg
2002;23:73.
38. Lyseng-Williamson KA, Perry CM.
Micronised purified flavonoid fraction:
a review of its use in CVI, venous
ulcers and haemorrhoids. Drugs
2003;63:71.
39. Nicolaides AN. From symptoms to leg
oedema: efficacy of Daflon 500 mg.
Angiology 2003;54(Suppl 1):S33.
40. Roztocyl K, Stvrtinová V, Strejcek J.
Efficacy of a 6-month treatment with
Daflon 500 mg in patients with
venous leg ulcers associated with CVI.
Int Angiol 2003;22:1.
41. Coleridge-Smith P, Lok C, Ramelet AA.
Venous leg ulcer: a meta-analysis of
adjunctive therapy with micronized
purified flavonoid fraction. Eur J Vasc
Endovasc Surg 2005;30:198.
42. Simsek M, Burak F, Taskin O. Effects
of micronized purified flavonoid
fraction (Daflon) on pelvic pain in
women with laparoscopically
diagnosed pelvic congestion
syndrome: a randomized crossover
trial. Clin Exp Obstet Gynecol
2007;34:96.
43. Pokrovsky AV, Saveljev VS, Kirienko
AI, et al. Surgical correction of
varicose vein disease under
micronized diosmin protection
(results of the Russian multicenter
controlled trial DEFANS). Angiol
Sosud Khir 2007;13:47.
44. Veverkova L, Kalac J, Jedlicka V,
Wechsler J. Analysis of surgical
procedures on the vena saphena
magna in the Czech Republic and an
effect of Detralex during its stripping,
[in Czech]. Rozhl Chir 2005;84:410.
45. Das L, Subramanyam Reddy G, Pani S.
Some observations on the effect of
daflon (micronized purified flavonoid
fraction of rutaceae aurantiae) in
bancroftian filarial lymphoedema.
Filaria J 2003;2:5.
46. Wright DD, Franks PJ, Blair SD, et al.
Oxerutins in the prevention of
recurrence in chronic venous
ulceration: a randomized controlled
trial. Br J Surg 1991;78:1269.
47. Kranendonk SE, Koster AM. A
double-blind clinical trial of the
efficacy and tolerability of O-(βhydroxyethyl)-rutosides and
compression stockings in the
treatment of leg oedema and
symptoms following surgery for
varicose veins. Phlebology 1993;
8:77.
References
375
Chapter
https://t.me/med1917
14
Venoactive Drugs
376
48. Rehn D, Golden G, Nocker W, et al.
Comparison between the efficacy and
tolerability of oxerutins and troxerutin
in the treatment of patients with CVI.
Arzneimittelforschung 1993;10:1060.
49. Vin F, Chabanel A, Taccoen A, et al.
Double blind trial of the efficacy of
troxerutin on chronic venous
insufficiency. Phlebology 1994;9:71.
50. Diebschlag W, Nocker W, Lehmacher
D, Rehn D. A clinical comparison of
two doses of O-(β-hydroxyethyl)rutosides (oxerutins) in patients with
CVI. J Pharm Med 1994;4:7.
51. Poynard T, Valterio C. Meta analysis
of hydroxyethyl rutosides in the
treatment of chronic venous
insufficiency. Vasa 1994;23:244.
52. Unkauf M, Rehn D, Klinger J, et al.
Investigation of the efficacy of
oxerutins compared to placebo in
patients with CVI treated with
compression stockings.
Arzneimittelforschung 1996;46:478.
53. Incandela L, De Sanctis MT, Cesarone
MR, et al. Efficacy of troxerutin in
patients with chronic venous
insufficiency: a double blind,
controlled study. Adv Ther 1996;
13:161.
54. Carlsson K, Patwardhan A, Poullain
JC, Gerentes I. Transport and
localization of troxerutin in the
venous wall. J Mal Vasc
1996;21(Suppl C):270.
55. Grossmann K. Vergleich der
Wirksamkeit einer kombinierten
Therapie mit Kompressionstrümpfen
und Oxerutin (Venoruton) versus
Kompressionsstrümpfe und Placebo
bei Patienten mit CVI. Phlebologie
1997;26:105.
56. Incandela L, Belcaro G, Renton S, et al.
HR (Paroven; O-(β-hydroxyethyl)rutosides) in venous hypertensive
microangiopathy: a prospective,
placebo controlled, randomized trial. J
Cardiovasc Pharmacol Ther 2002;
7(Suppl 1):S7.
57. Petruzellis V, Troccoli T, Candiani C,
et al. Oxerutins (Venoruton): efficacy
in CVI: a double blind, randomized,
controlled study. Angiology
2002;53:257.
58. Marshall M, Loew D, SchwahnSchreiber C. Hydroxyethylrutoside zur
Behandlung der chronischen
Veneninsuffizienz Grad I und II.
Phlebologie 2005;34:157.
59. Diehm C, Vollbrecht D, Amendt K,
Comberg HU. Medical edema
protection – clinical benefit in
patients with chronic deep vein
incompetence. A placebo controlled
double blind study. Vasa 1992;21:188.
60. Diehm C, Trampisch HJ, Lange S,
Schmidt C. Comparison of leg
compression stocking and oral
horse-chestnut seed extract therapy in
patients with chronic venous
insufficiency. Lancet 1996;347:292.
61. Pittler MH, Ernst E. Horse chestnut
seed extract for chronic venous
insufficiency: a criteria-based
systematic review. Arch Dermatol
1998;134:1356.
62. Koch R. Comparative study of
Venostasin and Pycnogenol in CVI.
Phytotherapy Res 2002;16:S1.
63. Siebert U, Brach M, Scrozynski G,
Berla K. Efficacy, routine effectiveness
and safety of horse chestnut seed
extract in the treatment of CVI: a meta
analysis of randomized controlled
trials and large observational studies.
Int Angiol 2002;21:305.
64. Pittler MH, Ernst E. Horse chestnut
seed extract for chronic venous
insufficiency. Cochrane Database Syst
Rev 2004;(2):CD003230.
65. Cappelli R, Nicora M, Di Perri T. Use
of extract of Ruscus aculaeatus in
venous diseases of the lower limbs.
Drugs Exp Clin Res 1988;4:277.
66. Le Devehat C, Khodabandehlou T,
Vimeux M, Dougny M. The effect of
Cyclo 3 Fort® treatment on
hemorheological disturbances during
a provoked venous stasis in patients
with chronic venous insufficiency.
Clin Hemorheol Micorocirc
1994;14:S53.
67. Parrado F, Buzzi A. A study of the
efficacy and tolerability of a
preparation containing Ruscus
aculeatus in the treatment of CVI of
the lower limbs. Clin Drug Invest
1999;18:255.
68. Jäger KA, Eichlisberger R, Jeanneret
CH, Labs KH. Pharmacodynamic
effects of Ruscus extract (Cyclo 3 Fort)
on superficial and deep veins in
patients with primary varicose veins:
assessment by duplex sonography.
Clin Drug Invest 1999;17:265.
69. Beltranimo R, Penenory A, Buceta AM.
An open label, randomized
multicenter study comparing the
efficacy and safety of Cyclo 3 fort
versus hydroxyethyl rutoside in
chronic venous lymphatic
insufficiency. Angiology 2000;51:535.
70. Bouaziz N, Michiels C, Janssens D,
et al. Effect of Ruscus extract and
hesperidin methylchalcone on
hypoxia-induced activation of
endothelial cells. Int Angiol
1999;18:306.
71. Vanscheidt W, Jost V, Wolna P, et al.
Efficacy and safety of a Butcher’s
broom preparation compared to
placebo in patients suffering from
chronic venous insufficiency.
Arzneimittelforschung 2002;52:243.
72. Boyle P. Meta-analysis of clinical trials
of Cyclo 3 Fort in the treatment of
chronic venous insufficiency. Int
Angiol 2003;22:250.
73. Lascasas Porto CL, Milhomens AL,
Pires CE, et al. Changes on venous
diameter and leg perimeter with
different clinical treatments for
moderate chronic venous disease:
evaluation using Duplex scanning and
perimeter measurements. Int Angiol
2009;28:222.
74. Guex JJ, Enriquez Vega DM, Avril L,
et al. Assessment of quality of life in
Mexican patients suffering from
chronic venous disorder – impact of
oral Ruscus aculeatus-hesperidinmethyl-chalcone-ascorbic acid
treatment – ‘QUALITY Study’.
Phlebology 2009;24:157.
75. Natali J. Gingkor Fort et maladie
veineuse. Angiologie 1989;102:3.
76. Arnould T, Michiels M, Janssens D,
et al. Effect of Ginkor Fort on hypoxia
induced neutrophil adherence to
human saphenous vein endothelium.
Int J Clin Pharmacol Res 1994;14:95.
77. Zucarelli F. Evaluation de l’efficacité
de Ginkor Fort sur la symptomatologie
fonctionnelle de l’insuffisance veineuse
chronique. Angiologie 1996;49:1.
78. Janssens D, Michiels C, Guillaume G,
et al. Increase of circulating
endothelial cells in patients with
primary chronic venous insufficiency:
protective effect of Ginkor Fort in a
randomized double-blind, placebocontrolled clinical trial. J Cardiovasc
Pharmacol 1999;33:7.
79. Allegra C, Pollari G, Criscuolo A, et al.
L’estratto di centella asiatica nelle
flebopatie degli arti inferiori. Ricorca
clinco-stratamentale conparativa con
un placebo. Clin Ter 1988;199:507.
80. Cataldi A, Gasbarro V, Viaggi R, et al.
Effectiveness of the combination of
alpha tocopherol, rutin, melitolotus
and centella asiatica in the treatment
of chronic venous insufficiency [in
Italian]. Minerva Cardioangiol
2001;49:159.
81. Kiesewetter A, Koscielny J, Kalus U,
et al. Efficacy of orally administered
extract of red wine leaf AS 195 in
chronic venous insufficiency (stages
I-II). A randomized double blind,
placebo controlled trial.
Arzneimittelforschung 2000;50:109.
82. Constantini A, Bernardi T, Gotti A.
Clinical and capillaroscopic evaluation
of chronic uncomplicated venous
insufficiency with procyanidins
extracted from vitis vinifera [in
Italian]. Minerva Cardioangiol 1999;
47:39.
83. Petrassi C, Mastromarino A, Spartera
C. Pycnogenol in CVI. Phytomedicine
2000;7:383.
84. Rohdewald P. A review of the French
maritime pine bark extract
(Pycnogenol), a herbal medication
with a diverse clinical pharmacology.
Int J Clin Pharmacol Ther 2002;40:158.
85. Arcangeli P. Pycnogenol in chronic
venous insufficiency. Fitoterapia
2000;71:236.
86. Casley-Smith JR. A double-blind trial
of calcium dobesilate in chronic
venous insufficiency. Angiology
1988;10:853.
87. Widmer L, Biland L, Barras JP.
Doxium 500 in chronic venous
insufficiency: a double blind placebo
controlled multicenter study. Int
Angiol 1990;9:105.
88. Angehrn F, on behalf of the Swiss
https://t.me/med1917
study group. Efficacy and safety of
calcium dobesilate in patients with
chronic venous insufficiency: an open
label multicenter study. Curr Ther Res
1995;56:346.
89. Arceo A, Berber A, Trevino C. Clinical
evaluation of the efficacy and safety of
calcium dobesilate in patients with
chronic venous insufficiency of the
lower limbs. Angiology 2002;53:539.
90. Allain H, Ramelet AA, Polard E,
Bentue-Ferrer D. Safety of calcium
dobesilate in chronic venous disease,
diabetic retinopathy and
haemorrhoids. Drug Saf 2004;27:649.
91. Iriz E, Vural C, Ereren E, et al. Effects
of calcium dobesilate and diosminhesperidin on apoptosis of venous
wall in primary varicose veins. Vasa
2008;37:233.
92. Flota-Cervera F, Flota-Ruiz C, Treviño
C, Berber A. Randomized, double
blind, placebo-controlled clinical trial
to evaluate the lymphagogue effect
and clinical efficacy of calcium
dobesilate in chronic venous disease.
Angiology 2008;59:352.
93. Ciapponi A, Laffaire E, Roque M.
Calcium dobesilate for chronic venous
insufficiency: a systemic review.
Angiology 2004;55:147.
94. Labs KH, Degisher S, Gamba G, Jaeger
KA, on behalf of the CVI study group.
Effectiveness and safety of calcium
dobesilate in treating chronic venous
insufficiency: randomized double
blind placebo controlled trial.
Phlebology 2004;19:123.
95. Rabe E, Jaeger K. Multicentre, double
blind, placebo-controlled, randomised
clinical study to assess the efficacy and
safety of Doxium 500 three times
daily in patients suffering from CVI
CEAP class C3,4 or 5. Phlebologie
2006;35:A37.
96. Martínez-Zapata MJ, Moreno RM,
Gich I, et al. Chronic Venous
Insufficiency Study Group. A
randomized, double-blind multicentre
clinical trial comparing the efficacy of
calcium dobesilate with placebo in
the treatment of chronic venous
disease. Eur J Vasc Endovasc Surg
2008;35:358.
97. Hautekeete ML. Severe hepatotoxicity
related to benzarone: a report of three
cases with two fatalities. Liver
1995;15:25.
98. Vayssairat M, and the French Venous
Naftazone Trial Group. Placebocontrolled trial of naftazone in
women with primary uncomplicated
symptomatic varicose veins.
Phlebology 1997;12:17.
99. Zicot M. Etude multicentrique de
l’efficacité et de la tolérance de la
Naftazone (Mediaven 10 mg).
Comparaison de deux schémas
posologiques. Rev Med Liège
1993;158:224.
100. Forconi S, Guerrini M, Pecchi S, et al.
Effect of HR(O-(beta-hydroxyl)rutosides) on the impaired venous
function of young females taking oral
contraceptives: a strain gauge
plethysmographic and clinical open
controlled study. Vasa 1980;9:324.
101. Allaert FA, Vin F, Levardon M.
Comparative study of the effectiveness
of continuous or intermittent courses
of a phlebotonic drug on venous
disorders disclosed or aggravated by
oral oestrogen-progesterone
contraceptives. Phlebologie 1992;
45:167.
102. Serfaty D, Magneron AC. Premenstrual
syndrome in France: epidemiology
and therapeutic effectiveness of
1000mg of micronized purified
flavonoid fraction in 1473
gynecological patients [in French].
Contracept Fertil Sex 1997;1997;
25:85.
103. Lefebvre G, Lacombe C. Venous
insufficiency in the pregnant woman.
Rheological correction by troxerutin.
Rev Fr Gynecol Obstet 1991;86:206.
104. Marhic C. Clinical and rheological
efficacy of troxerutin in obstetric
gynaecology. Rev Fr Gynecol Obstet
1991;86:209.
105. Young GL, Jewell D. Interventions for
varicosities and leg oedema in
pregnancy. Cochrane Database Syst
Rev 1998;(1):CD001066.
106. Gouny AM, Horovitz D, Gouny P,
et al. Etude d’efficacité et de tolérance
des Hydroxyéthyl-rutosides dans le
traitement local des symptômes
d’insuffisance veineuse survenant au
cours des transports aériens. J Mal
Vasc 1999;24:214.
107. Wetzel D, Menke W, Dieter R, et al.
Escin/diethylammonium salicylate/
heparin combination gels for the
topical treatment of acute impact
injuries: a randomised, double blind,
placebo controlled, multicentre study.
Br J Sports Med 2002;36:183.
108. Gloviczki P DM, Eklöf B, Moneta GL,
Wakefield TW. Handbook of venous
disorders: guidelines of the American
Venous Forum. 3rd ed. London:
Hodder Arnold; 2009. p. 359.
109. Kearon C, Kahn SR, Agnelli G, et al.
Antithrombotic therapy for venous
thromboembolic disease: American
College of Chest Physicians EvidenceBased Clinical Practice Guidelines, 8th
edn. Chest 2008;133(Suppl 6):
454S–545S.
110. Allegra C. Chronic venous
insufficiency: the effects of health-care
reforms on the cost of treatment and
hospitalisation – an Italian
perspective. Curr Med Res Opin
2003;19:761.
References
377
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C H A P T E R
Setting Up a Sclerotherapy Practice
Providers
Before proceeding with the practical aspects of establishing a
practice, one must decide who will deliver patient care. Most
physicians agree that a physician should perform the sclerotherapy procedure; however, some clinics use nurses to treat
spider telangiectasias. A survey of the membership of the
North American Society of Phlebology (NASP) (now the
American College of Phlebology (ACP)) found that approximately 25% of the members would allow a registered nurse
and 20% would allow a nurse practitioner to perform sclerotherapy on spider veins.
would allow a registered nurse to perform sclerotherapy on
varicose veins versus 7% who would allow nurse practitioners
to perform this procedure. Registered nurses can legally
perform intravenous therapeutic injections in most states.
Physicians should check with the state licensing board for
nursing for the specific requirements.
The arguments for allowing nurses to render such care are
both economic and procedural. An economic benefit is realized for both the patient and the physician if a lower-salaried
person performs the sclerotherapy procedure, especially in
these days of cost containment. Since the injection of spider
veins is primarily cosmetic and is rarely fully reimbursable
under most insurance plans, cost containment can be translated into economic marketing.
Because the cannulation of a blood vessel is relatively easy
to perform and few serious or life-threatening complications
can arise from sclerotherapy treatment of spider telangiectasias, an argument can be made for using nonphysicians as
sclerotherapists. On the other hand, although rare, serious
complications can result from injection of spider telangiectasias. Anaphylactic allergic reactions have occurred with many
sclerosing agents; a fatality was reported after a ‘trial’ injection
of sodium tetradecyl sulfate.
occurred from the injection of leg telangiectasias (see Chapter
8). Injection into an arteriovenous anastomosis usually produces a cutaneous ulceration, and cutaneous ulceration from
sclerotherapy injection (extravasation or arteriolar injection)
is the most common reason (in sclerotherapy) for medical
malpractice litigation. Injection into a superficial artery, especially around the malleoli, can lead to arterial emboli and
pedal gangrene. Duplex-guided injections into deep perforating veins can cause significant muscular necrosis requiring leg
amputation. Thus, as with most of medicine, sclerotherapy is
not entirely risk-free. The physician is ultimately responsible
for ensuring that the nurse is properly trained both in performing sclerotherapy and in recognizing adverse sequelae.
The physician, not the nurse, will be the one sued for
malpractice.
In addition to being skilled at sclerotherapy technique,
the sclerotherapist must have a thorough knowledge of the
anatomy and pathophysiology of venous disease and of the
mechanism of action of the procedure, including its potential
complications. The ability to appreciate these mechanisms
1
Of NASP members surveyed, 10%
2
Pulmonary emboli also have
and immediately recognize potential complications and
render preventive treatment is critical to maintaining optimal
patient care. Furthermore, a thorough understanding of vascular hemodynamics, including the relationship between
deep and superficial venous insufficiency, is imperative to
those practicing sclerotherapy. For example, venous segments
with a certain degree of incompetence are best initially treated
with endovenous ablation, which removes the source of
venous hypertension, thus reducing or eliminating progression of reflux to other surrounding veins.
to recognize when endovenous ablation is a necessary portion
of the overall treatment approach results in inadequate
improvement following sclerotherapy. Thus, clinical judgment as well as technical skill are both essential attributes in
an effective sclerotherapist.
Hallgren et al5 defined basic nursing assessment skills and
the requirements for transfer of function of the nurse in a
sclerotherapy–phlebology practice. In short, for a nurse to
function as a sclerotherapist, the following must be known:
• Nature and purpose of the procedure
• Specific conditions under which the procedure may be
performed
• Potential complications of the procedure and methods
for notifying the physician and stabilizing the patient
with immediate countermeasures
• Knowledge of the mechanism of action and potential
side effects of sclerosing solutions
• Contraindications to sclerotherapy.
This knowledge base should also include instruction so that
the nurse can do the following:
• Record appropriate physical findings such as size,
location, and type of vein and associated cutaneous
manifestations of venous hypertension
• Recognize and describe the presence and extent of
superficial and deep thrombophlebitis and venous
ulceration
• Perform a noninvasive physical examination to include
identifying the presence or absence of reflux from the
saphenofemoral or saphenopopliteal junctions and/or
perforator veins through venous Doppler and/or duplex
ultrasound examination; perform photoplethysmography
• Photograph the patient’s leg in four general views and
specific close-up views to document pre-existing cutaneous
irregularities and the specific area of telangiectasia
• Complete detailed mapping of the varicose and
telangiectatic leg veins
• Locate pedal pulses; determine the brachial and ankle
blood pressures to determine the degree of arterial
insufficiency
• Accurately measure and fit the patient with a graduated
compression stocking
• Apply a graduated compression bandage/stocking.
In conclusion, nurses who practice phlebology must be
actively involved in the practice of nursing when delivering
3,4
Not being trained
care. They should be able to prepare not only the operating
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room for the procedure, but also the patient for the procedure
by answering questions, allaying fears, and documenting pretreatment disease. In addition, follow-up treatments allow the
nurse the opportunity to reinforce patient teaching so that
preventive measures can be emphasized. For an excellent demonstration of lower extremity superficial venous examination
techniques, the reader is encouraged to refer to an educational
DVD provided by the American College of Phlebology partnered with the Society of Vascular Ultrasound.
6
Various other
comprehensive textbooks on sclerotherapy, phlebectomy, and
venous ultrasound techniques are available; we have referenced those textbooks that we feel are the most useful at the
end of this chapter.
7–10
A
B C
Equipment
Facility
Endovenous laser ablation of leg veins is best performed in a
non-facility setting, as this eliminates additional facility fees
associated with procedures performed in a hospital or ambulatory care facility. By having his/her procedure performed
in an outpatient setting, patients save money by not having
to pay facility fees, and practitioners generate more revenue
by not having to split reimbursement payments with a
11
facility.
Equipment
Relatively little specialized equipment is required to perform
successful sclerotherapy. Various types of lasers may also be
required for treating specific types of leg veins (see Chapter
13). For now, all that is required is a needle, syringe, sclerosing
solution, binocular loupe, foam pads, tape, graduated support
stockings, and camera. (See online Appendix C for information on manufacturers.) Although serious adverse events are
rarely encountered during the treatment of leg veins, appropriate resuscitation equipment must be readily accessible
throughout the procedure. Patients occasionally experience
vasovagal reactions during the treatment of leg veins; ammonium capsules as well as oxygen can help mitigate these reactions. Other equipment, including an emergency resuscitation
(crash) cart as well as an electrocardiograph, should remain
readily accessible throughout the procedures.
Ultrasound devices
A duplex ultrasound device is essential for both diagnosis and
treatment of venous disease. It can help discern superficial
and deep venous insufficiency, allow for pretreatment vein
mapping, provide imaging and guidance during the procedure, and allow for postoperative assessment of therapeutic
efficacy.
have in a sclerotherapy practice. It allows for assessment of
venous reflux and is an integral component of the work-up as
well as the preoperative mapping during endovenous laser
ablation procedures. Dopplex devices (Huntleigh Healthcare,
Luton, UK) use a probe that is three times wider and 50%
more sensitive than standard probes, making it easier for the
practitioner to locate and maintain contact with vessels. The
Mini Dopplex is a lower cost, yet still effective, hand-held
doppler device. The ‘top of the line’ hand-held Doppler is the
bi-directional Super Dopplex II, which can assess simultaneous forward and reverse venous flow, thus offering an advantage over non-directional and even most bi-directional
Dopplers.
Wash., USA) includes a durable, hand-held computer which
13
A hand-held vascular Doppler is another valuable tool to
The MicroMaxx ultrasound system (SonoSite; Bothell,
12
D
Figure 15.1 Comparison of bevels of recommended needles. A, Acuderm
needle, 30 gauge. B, Becton-Dickinson (B-D) needle, 30 gauge. C, Yale
needle (B-D), 27 gauge. D, Yale needle (B-D), 26 gauge. E, Butterfly needle
(Abbott), 25 gauge. F, Butterfly needle (Abbott), 23 gauge.
E F
uses an image enhancement algorithm to optimize the clarity
of venous imaging (vein mapping, venous reflux assessment,
and venous ablation guidance). This lightweight, portable
platform boots up in around 15 seconds, is able to send wireless images to other clinic sites, and comes with multiple
transducers.
Needles
The injection of telangiectasias requires a fine-gauge needle. A
needle with a clear plastic hub instead of a metal hub is useful
to allow visualization with aspiration. Although some physicians prefer to use a 32- to 33-gauge or 26- to 27-gauge needle,
we prefer the 30-gauge needle. There are two types of 30-gauge
needles. One is the Becton-Dickinson (B-D) Precision Glide
needle (Becton, Dickinson & Co, Rutherford, N.J.), which has
an elongated bevel on a
at the tip. The needle can be easily bent at varying angles to
penetrate telangiectasias. In addition, it is relatively sharp and
holds up well when used for multiple punctures of the skin.
The second type is a tribevel tipped needle. The Acuderm
(Acuderm, Ft Lauderdale, Fla.) and Delasco (Dermatologic
Lab & Supply, Council Bluffs, Iowa) 30-gauge needles have a
1
-inch metal hub and a silicone-coated tribevel point. This
2
type is preferred because its silicone coating and more acute
angle at the tip allow it to pierce the skin with less pain. In
addition, the length of the bevel is shorter than that of the
B-D needle. Accordingly, extravasation of solution perivascularly while the needle is in the vessel lumen is less likely.
Tribeveling of the tip also makes it harder, so it retains its
sharpness with multiple injections. A comparison of the
bevels of all of the recommended needles is shown in Figure
15.1. However, even with this magnified comparison, the dif-
ferences between the needle tips cannot be fully appreciated.
Clinical trials using each needle type are necessary to discern
the subtle differences.
In addition, the same needle may actually change from year
to year if the company chooses a different manufacturer. It is
best to try different needles from different companies at least
once yearly to determine which brand works best. The best
test is to use each needle on both a patient and yourself to
determine the ease of insertion into the skin and the feel.
One objection to the use of a 30-gauge needle has been the
perception that it dulls after multiple insertions into the skin.
Microscopic examination of tribeveled needles used to pierce
the skin up to 15 times in our patients did not show the needle
1
/
-inch needle with a 45-degree angle
2
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15
10ml987654321
Figure 15.3 Plastipak eccentric syringe by Becton-Dickinson. Note
eccentrically placed hub.
Delasco
33-gauge
Figure 15.2 Comparison of 33-gauge Delasco needle tip with a 30-gauge
tribevel point.
Setting Up a Sclerotherapy Practice
30-gauge
with
tribeveled
point
tip had dulled. What is apparent is that some needles, even
when unused, have burrs or are dull. Therefore, if the insertion
of the needle does not feel right, change to another needle
and discard the old one.
Some sclerotherapists advise the use of a 33-gauge needle
to cannulate the smallest diameter telangiectasia. Multiple
31- to 33-gauge
1
-inch needles are available (Fig. 15.2). These
2
needles have several drawbacks. They are more expensive
than 30-gauge needles and must be cleaned and sterilized
between patients if they are not disposed of (this is of concern
to patients who fear inadequate sterilization with the subsequent risk of blood-borne pathogens). Repetitive sterilization
also dulls the needle point. In addition, the tips of these
needles bend and dull more quickly than those of the 30gauge needles, and the needle shafts are thinner and thus less
stable during injections through tough skin. John Phiffer
(personal communication, 1992) reported on the construction of a rigid shaft used to support the 32-gauge needle tip
to help stabilize it. However, as mentioned previously (Chapter
12), we find these needles of little use.
Finally, some physicians prefer 26- or 27-gauge needles for
injecting telangiectasias. Again, the preference arises from a
perceived sharpness of the bevel, allowing easier, more painless insertion. The 27-gauge needle comes separately in a
inch length as either a Yale (Becton, Dickinson) hypodermic
needle or as an allergy needle–syringe combination fixed to a
1-mm syringe. The benefit of using the 1-mm syringe is the
ease of handling perceived by some sclerotherapists. The Yale
26-gauge needle also comes in a
1
-inch length and has the
2
advantage of a sturdy, nonbendable shaft. In short, all types
have their advantages and disadvantages. The best needle is
the one with which the physician is most comfortable.
Larger needles are used most often to inject varicose veins.
When injecting varicose veins, it is critical to determine the
proper placement of the needle. Therefore, the smallest recommended needle size is 25-gauge (23-gauge if there is any
doubt whether the vessel to be cannulated is an artery or vein
or if a highly caustic sclerosing solution is being used). Largerbore needles offer no additional advantage. A 25-gauge needle
easily allows retrograde blood flow through the inserted
needle, which aids in determining if placement is intravenous
or intra-arterial.
The surest method of determining proper needle placement
is to insert an open needle into the vein. With this technique,
blood flow from the needle serves as the indicator of arterial
versus venous injection. Butterfly needles are connected to
clear tubing that allows visualization of blood flow, avoiding
or minimizing blood exposure. In an effort to avoid blood
exposure, some sclerotherapists attach a syringe to the needle
and withdraw to determine flow. Still others combine the
needle with a glass syringe to ‘feel’ for proper intravascular
placement.
380
To take advantage of the safety of a large-gauge needle
without incurring the risk of blood contamination, a 23-, 25-,
or 27-gauge butterfly needle may be used. The needle length
3
is
inch, and the tubing is 30 cm. The plastic tubing on the
4
proximal end of the needle allows visualization of arterial
versus venous flow without risking blood exposure. The tubing
takes up 0.41 mL of fluid. Some physicians fill the needle
tubing with sclerosing solution to prevent clotting of blood
within the needle tubing. However, this is unnecessary if
the injection is performed within a few minutes of blood
aspiration.
Small vein infusion sets are also available. Kawasumi Laboratories have designed a 27-gauge
3
1
(
-inch) catheter tubing. The priming volume with this short
4
3
-inch needle on a short
8
length is 0.05 mL. The female Luer-Lok connector has a flange
for easy grip. STD Pharmaceuticals (Hereford, UK) have a
30-gauge needle set with the needle attached to the tubing
without wings and the other end of the tubing connected to
a standard clear plastic female Luer-Lok [0].
Syringes
Although glass syringes had been used in the past to allow
easy detection of an arterial puncture, modern plastic syringes
have a feel comparable to that of glass syringes. Disadvantages
of using a glass syringe are that it requires practice both to fill
and to use smoothly as well as the fact that it must be cleaned
and sterilized between patients.
The 3-mL plastic syringe, Luer-Lok (Becton, Dickinson), is
used exclusively in our practice. This syringe allows the use of
an ideal quantity of solution, and when filled to a 2-mL capacity, it fits easily in the palm of the hand. However, a nonLuer-Lok syringe has the advantage of possessing a needle hub
1
-
2
that is able to separate from the syringe if resistance, which
indicates noncannulation of a vessel, is encountered. Each
syringe manufacturer coats the inner portion of the syringe
with silicone to allow smooth action by the plunger. The addition of silicone to coat the barrel of the syringe has also been
shown to decrease the half-life of bubbles when foam is generated in the syringe (see Chapter 9). If using foam, one may
wish to use a syringe with the least amount of silicone coating.
The physician should evaluate different types of syringes to
determine which has the best feel for his or her use.
If one does not bend the needle to facilitate penetration of
the vein, the Plastipak eccentric syringe (Fig. 15.3) is useful.
With this syringe, the hub is eccentrically placed at the syringe
tip so that it abuts the skin surface. It is available in sizes of
1, 2, 5, and 10 mL.
Sclerosing solutions
The various sclerosing solutions available are discussed in
detail in Chapter 7. Addresses of the manufacturers and distributors of these solutions are listed online in Appendix B.
Binocular loupes
Protective eyeglasses are necessary equipment for the physician who performs any surgical procedure. These glasses
should be constructed to prevent the splatter or spray of body
fluids (blood) as well as sclerosing solution from coming
in contact with the orbital tissues, thus helping to prevent
va = ha + da
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Horizontal
Head angle
(ha)
Viewing
angle (va)
Equipment
Head erect Head tilted
Convergence angle
Working distance
Viewing angle
Depth of field
Declination
of angle
Object
Field of view
Magnification
scotoma
Object
Line of sight
Figure 15.4 Several key optical features, including working distance, working range, convergence angle, field of view, and viewing angle, are shown.
(Courtesy of General Scientific Corporation, Ann Arbor, Mich.)
the physician’s contamination with infectious, blood-borne
disease. When cannulating small diameter telangiectasia, it is
common to begin injecting solution as one enters the skin.
This allows the needle hub to enter the vessel and expand it
to allow full insertion of the needle hub and sclerosing solution. During this process a spray of sclerosing solution is possible. Protective glasses should be worn when performing
sclerotherapy.
The injection treatment of varicose veins does not require
magnification of the surgical field. However, for cannulating
venulectases or telangiectasias, magnification of the treatment
site is important. The enhanced detail that magnification
affords a more accurate placement of the needle within the
vessel lumen, which prevents extravasation of the sclerosing
solution into extravascular spaces.
Normally, to magnify the field of vision, one moves closer
to the viewed object to enlarge its field on the retina. Moving
closer to an object requires the eyes to refocus and converge
more. The consequences of maintaining this close focusing
distance are eye strain and back muscle stress. Eye tension and
muscle fatigue may then occur, which tends to reduce efficiency. Optical magnification offers an alternative to such
strain and allows maintenance of a more comfortable working
distance.
The magnifying loupe allows the focusing and converging
systems of the eye to relax. The loupe also allows switching
back and forth between normal vision and magnified vision
as necessary. This versatility is relaxing to the eyes. Viewing
through magnification for long periods is not harmful and
cannot damage vision. The only question concerns how much
magnification is necessary.
The ideal magnifier provides a wide field of view with
distortion-free magnification within a reasonably long working
distance and ergonomic viewing angle (Fig. 15.4). Unfortunately, with currently available optics, the higher the magnification, the smaller the field of view and depth of field.
Complex, multilens binocular magnifiers overcome some of
the limitations of short working distances. Some of these magnifiers are detailed online in Appendix C. An independent
evaluation of magnifiers appears in another source.
14,15
The ideal ergonomic magnifier would be comfortable to
wear (lightweight with comfortable nose pads), allow a comfortable working distance, and maintain the surgeon’s neck
and back in a neutral position (Fig. 15.5). An increase in the
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15
Setting Up a Sclerotherapy Practice
Poor
posture
A B
Table 15.1 Comparison of loupe magnification
Refractive Power
Excellent
posture
Figure 15.5 A, Some binocular loupes require
surgeon to bend the neck to see the surgical
field, putting strain on the neck and upper back.
B, Proper fitting loupes maintain good posture
while allowing the surgeon to focus on the surgical
field.
Measurement 3 Diopters 5 Diopters 8 Diopters
Magnification
Lens-to-object
distance (cm)
Eye-to-object
distance (cm)
Field of view (cm) 8 4 2
Depth of field (cm) 25 8 1
×1.75 ×2.25 ×3
8–34 13–20 10
17–45 22–36 20–25
head/neck tilt angle causes neck muscle fatigue.
with proper posture thus decreases stress and fatigue.
Two types of optics are commonly available. Gallilean
optics are shorter and lightweight but have a mild distortion
(10%) at the periphery. Prismatic optics have a narrower field
of vision but have no lateral distortion. The prismatic optics
require more light than the Gallilean optics because of their
increased length.
When choosing the proper magnification, five factors must
be addressed:
• Magnification
• Lens-to-object distance
• Eye-to-object distance
• Field of view
• Depth of field.
Table 15.1 shows a comparison of these factors in regard
to a person with normal focusing-converging ability. Note that
magnifications greater than 5 diopters decrease the field of
view and depth of focusing sufficiently to make their use
impractical for sclerotherapy. In our experience, lenses with
2× to 3× power provide the ideal combination of focal distance and magnification.
Magnifying glasses
Half-frame clip-on lenses are available in multiple powers.
The most useful is a 5-diopter, 2.25×-power lens with a 19-cm
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16
Working
Figure 15.6 Almore clip-on loupe. (Courtesy of Almore International, Inc.,
Beaverton, Oreg.)
focal distance. These lenses produce marked peripheral distortion but have a usable field of view of 7 cm for the 3-diopter
and 5 cm for the 5-diopter lens. The working distance from
lens to object is 17 cm for the 3-diopter and 12 cm for the
5-diopter lens (Fig. 15.6). This type of magnification aid is
available from most opticians and department stores.
Headband-mounted simple binocular
magnifiers
Headband-mounted magnifiers are available equipped with
interchangeable lens plates that provide a range of magnification from 1.5× to 3.5× (Fig. 15.7). These magnifiers can be
worn comfortably over prescription eyeglasses. The most
widely used magnifications with the least peripheral distortion and best working distance are 2.3× and 2.5×. An optional
Optiloupe (Donegan Optical Co, Lenexa, Kan.) attachment
lens adds 2.5× magnification to any base lens but has a very
small field of view without distortion. These magnifiers are
available from many manufacturers and vary in price, type of
headgear padding, and adjustability; Optivisor (Donegan
Optical) and Mark II Magni-Focuser (Edroy Products Co,
Nyack, N.Y.) are two examples.
Simple binocular loupes
The Precision (Almore International, Beaverton, Ore.) binocular loupe comes with varying diopter loupes fitted on a
double-hinged telescoping rod so that the eye-to-object
Figure 15.7 Magni-Focuser. (Courtesy of Edroy Products Co., Inc, Nyak, NY.)
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Figure 15.8 Almore 3-diopter loupe. (Courtesy of Almore International, Inc.,
Beaverton, Oreg.)
distance can be adjusted. It is available with 3-, 5-, or 8-diopter
17
lenses
(Fig. 15.8) and is also available as a multidistance
headband-mounted loupe. Available powers include 1.5×,
1.75×, 2.25×, and 2.75×, with working distances from 50 to
15 cm, respectively.
It also comes with an adjustable bridge-of-nose-to-lens distance of 9 to 21 cm, thus increasing the eye-to-object distance
from 19 to 44 cm depending on the diopter used. The
3-diopter lens has a 13-cm usable field of view and a working
distance of 16 cm from lens to object. The 5-diopter lens has
a 10-cm usable field of view and a working distance of 13 cm
from lens to object.
Multilens binocular magnifiers
Multilens binocular magnifiers are referred to as binocular
loupes, telescopic magnifiers, and surgical telescopes. They are
available in magnifications ranging from 2× to 8× and are
designed to provide a working distance of 25 to 40 cm. Their
drawback is their significantly higher expense and limited field
of view. However, the entire field is usually not distorted; thus,
the nondistorted portion of the field of view approaches that
of lesser-quality magnifiers. Some high-quality binocular
loupes have a field of view larger than that of other brands;
therefore one should compare many loupes prior to deciding
which to purchase. These loupes are used exclusively in our
practice and are recommended for both sclerotherapy and
multiple surgical procedures.
N.Y.) loupe best suited for dermatologic examination. The
working distance of this loupe is 35 cm for the 3.5× and
40 cm for the 2.5× magnifier. These magnifiers have the ocular
structure secured to the lenses of the glass. The viewing angle
is thus locked into position and can be customized only to
the original operator’s posture. A disadvantage of this loupe
system is a restriction of the peripheral vision to as little as
10%. This necessitates removing the loupes to view anything
outside the working area.
3.5×, 4×, and 6× power (Fig. 15.9). The most useful power for
sclerotherapy is the 2.5× model, which has a working distance
of 34 cm with a field of view of 75 mm. The Gallilean optics
are shorter than most other loupes and are lightweight (80 g).
They are available on a large or small spectacle frame. Like
many other loupes, the Heine loupe has both an asymmetric
pupil distance adjustment and two alternate height settings
for the optics.
the following advantages: optics that can flip up out of view
when not needed, lightweight frames, and optics with an
antireflection coating. The 2.5× magnification loupe (Fig. 15.10)
14
Epstein
found the Designs for Vision (Ronkonkoma,
Heine (Cary, N.C.) binocular loupes come in 2×, 2.5×,
The Keeler (Broomall, Pa.) panoramic surgical loupe has
Equipment
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