Embed Size (px)
Citation preview
http://phl.sagepub.com/Phlebology
http://phl.sagepub.com/content/29/10/688The online version of this article can be found at:
DOI: 10.1177/0268355513505506
2014 29: 688 originally published online 26 September 2013PhlebologyCaroline Williamsson, Peter Danielsson and Lennart Smith
Catheter-directed foam sclerotherapy for chronic venous leg ulcers
Published by:
http://www.sagepublications.com
can be found at:PhlebologyAdditional services and information for
http://phl.sagepub.com/cgi/alertsEmail Alerts:
http://phl.sagepub.com/subscriptionsSubscriptions:
http://www.sagepub.com/journalsReprints.navReprints:
http://www.sagepub.com/journalsPermissions.navPermissions:
What is This?
- Sep 26, 2013OnlineFirst Version of Record
- Nov 7, 2014Version of Record >>
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
Original Article
Catheter-directed foam sclerotherapyfor chronic venous leg ulcers
Caroline Williamsson, Peter Danielsson and Lennart Smith
Abstract
Objectives: This study presents the results of catheter-directed foam sclerotherapy (CDS) for chronic venous ulcer
refractory to compression treatment, four weeks and one year after treatment.
Methods: In sum, 31 patients (32 limbs) with refractory chronic venous ulcer and duplex-verified superficial insufficiency
were offered CDS. CDS was conducted with 10 ml of sclerosant foam of 3% polidocanol. Four weeks and one year after
treatment, the patients were evaluated regarding ulcer healing and ultrasound appearance of the saphenous trunk.
Results: CDS was successfully performed in all patients. After one year, 65% of the ulcers were healed. Only two (6%)
recurred. 86% of the treated saphenous trunk were completely occluded, 3% was partly occluded and 10% were
recanalised. No serious side effects occurred.
Conclusions: CDS is one alternative of eliminating superficial venous reflux when treating refractory venous leg ulcers.
This study suggests that the treatment is safe and induce a quick ulcer healing.
Keywords
Chronic venous ulcers, endovenous technique, catheter-directed foam sclerotherapy, polidocanol
Introduction
Chronic venous ulcer (CVU) requires huge health careresources, affecting approximately 1–1.5% of the adultWestern population and is estimated to 1% of totalhealth cost.1–3
Traditionally, compression therapy has been thestandard treatment showing a clear increase in ulcerhealing rates compared with no compression.4
Compression therapy demonstrates healing rates of68–83% after six months and a recurrence rate of26–28% at 12 months.5
During the last decade, there have been several stu-dies showing that correction of superficial venous insuf-ficiency in addition to compression therapy does notspeed up ulcer healing but significantly reduces recur-rence rate. Elimination of saphenous trunk refluxshould therefore be offered patients with venous legulcers.5–9
Gradually, the traditional surgical methods forvenous insufficiency have been replaced by modernendovenous techniques. Although there is no rando-mised controlled study comparing surgery and theendovenous methods, it is reasonable to believe thatsaphenous ablation achieved by any technique wouldlead to similar outcome as surgery. Several studies have
shown promising results when eliminating the saphe-nous reflux by ultrasound-guided foam sclerotherapy(UGFS).10–14
A technique similar to UGFS is catheter-directedfoam sclerotherapy (CDS), when the sclerosing foamis delivered along the incompetent vein through a cath-eter. This is a safe and simple technique of distributingfoam directly to the intended site.15–17
This is a prospective study of the first 31 patientstreated with CDS in addition to compression forchronic venous leg ulcers. The aim of the study wasto present ulcer healing, recurrence rates and occlusionrates of the treated saphenous trunk four weeks andone year after treatment.
Department of Surgery and Oncology, Hospital of Halmstad, Sweden
Corresponding author:
Peter Danielsson, Department of Surgery and Oncology, Hospital of
Halmstad, Lanssjukhuset, 301 85 Halmstad, Sweden.
Email: [email protected]
Phlebology
2014, Vol. 29(10) 688–693
! The Author(s) 2013
Reprints and permissions:
sagepub.co.uk/journalsPermissions.nav
DOI: 10.1177/0268355513505506
phl.sagepub.com
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
Materials and methods
Patients
Patients with CVU referred to the Surgical Departmentof Halmstad, Sweden, were clinically evaluated by avascular surgeon and an ultrasound (US) examinationwas performed by a vascular nurse trained in sonog-raphy. The US assessed the great saphenous vein(GSV), the small saphenous vein (SSV) and the deepvenous system with the femoral and popliteal vein.Veins with duration of reflux �0.5 s and a diameter�3mm were classified as insufficient.
All patients had regularly had compression bandagesof diverse systems applied by a community nurse for atleast three months. They had all been compliant tointensive compression therapy and were consideredrefractory due to no signs of healing.
General exclusion criteria to CDS were allergy topolidocanol, a very tortuous vein (which could makethe catheters impossible to advance), an ankle-brachialpressure index (ABPI) <0.8 or deep venous insuffi-ciency. Anticoagulants, history of thrombosis or recur-rent varicose veins were not contraindications.
The study was approved by the ethical committee ofthe University of Lund, Sweden.
Technique
The CDS technique has been described in detail previ-ously.17 The treatments were performed in an out-patient clinic. The patient was placed on theexamination table in a slightly upright position to dis-tend the vein. An ultrasound machine (LOGIQ e;General Electric, Jiangsu, China) with a 10-MHzlinear transducer was used to identify the insufficientvein. The skin was infiltrated with local anaesthesia(1ml of Mepivakain/Carbocain� 1%; AstraZeneca,Sodertalje, Sweden), the leg antisepticised and draped.
The vein was accessed by a micropuncture intro-ducer set (MPIS; COOK, Bloomington, USA) and a0.35-Fr guidewire (Fixed Core Wire Guide Straight;COOK) was advanced proximally under US surveil-lance and positioned at the saphenofemoral junction(GSV insufficiency) or saphenopopliteal junction (SSVinsufficiency). A catheter (Beacon Tip Royal Flush Plushigh-flow catheter; COOK) was introduced over theguidewire and positioned approximately 2 cm distal tothe saphenous trunk inflow to the deep system and theguidewire was removed. The table was slightly tilted toelevate the leg to empty the vein. Using a modifiedmethod of Tessari, 10ml sclerosing foam was madeby mixing 2ml chilled 3% polidocanol(Aethoxysklerol�; Inverdia, Wiesbaden, Germany)and 8ml air using two syringes (10ml; Becton-Dickinson, Canaan, USA) and a three-way
connector.18 The vein was compressed with the USprobe proximal to the catheter, to prevent inflow offoam to the deep system. The foam was then deliveredalong the vein while the catheter was steadily with-drawn. Approximately 9.2ml of foam was deliveredsince 0.8ml was left within the catheter. The superfi-cial-deep junction and site of puncture was compressedfor 5min and the extension of the vein massaged tomigrate foam in distal direction. No additional localinjection of foam was given.
Immediately after the procedure, the patients weremobilised. All patients had continuously four-layercompression bandages (Profore, multi-layer compres-sion bandaging system; Smith & Nephew, Hull,England) and continued dressing and compressiontreatment by the community nurse until ulcer healing.After healing, the patients were recommended compres-sion stockings.
Follow-up
Outcome measures were ulcer healing and eliminationof the superficial venous insufficiency in the treatedlimb. Evaluation with clinical examination and USwas performed four weeks and one year after treat-ment. Ulcer healing was defined as complete epithelia-lisation of the area distal to the knee.
All patients were seen and re-examined by the samenurses who made the first US. The saphenous trunkwas examined and classified as recanalised, occludedor partly occluded. If a segment of the vein of morethan 2 cm was circulated, it was classified as partlyoccluded. The femoral vein was examined to excludethrombosis (deep vein thrombosis, DVT) and compli-cations were registered. The community nurses wereinstructed to report ulcer healing.
Results
Between October 2008 and February 2011, 31 patients(32 limbs) underwent CDS for venous leg ulcers.Median age was 77 years (range 39–94), 10 men and21 women. All patients had active venous ulcers. Thestudied population were categorised as C6, Ep, As andPr according to CEAP classification. Of the 32 limbs,27 had insufficiency of the GSV and eight insufficiencyof the SSV. Three patients had insufficiency in bothGSV and SSV, and only one patient had bilateralulcers and saphenous insufficiency. Six patients hadrecurrent varicose veins after previous venous surgery.No patient had a ABPI <0.8 or insufficiency in the deepvenous system. All but one patient had good experienceof compression therapy in terms of relief of symptoms,but their ulcers were not healed.
Williamsson et al. 689
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
Foam delivery along the vein was technically suc-cessful in 100%. In all veins, 10ml of foam wereused. The 27 GSVs were punctured just above of theknee. In two patients, access to SSV was achieved by anantegrade puncture in the proximal part of the calf andin six patients, access were achieved by a retrogradepuncture.
Twenty-nine of the 31 patients were available forfollow-up four weeks after CDS. One patient wasdeceased due to an unrelated condition and one patientdeclined follow-up. At the US control, 28 patients hada complete occlusion in the treated part of the saphe-nous trunk. One GSV was recanalised and subject to arepeated CDS. Fifteen of 29 patients (15 limbs) werecompletely healed and five of these patients had there-fore abandoned compression.
At the one-year follow-up, 28 patients (29 limbs)were examined, since one additional patient declinedevaluation. Five patients (six limbs) reported healedulcers during the second and third months after CDS.Complete ulcer healing was reported by the communitynurse for the patients who declined follow-up, one afterfour weeks.
After three months, no additional ulcers were healedleaving nine non-healed ulcers, 29% (9/31 limbs). Six ofthese nine ulcers decreased in size. Two previouslyhealed ulcers recurred within 12 months.
This gives a total ulcer healing rate of 71% (22/31) ofthe studied limbs or 70% (21/30) of the patients. At oneyear, 65% (20/31) limbs did not have active ulcers.
US were performed in 29 of the 32 primarily treatedlimbs (91%). The one year US showed that 86% (25/29) of the examined veins were completely occluded,one was partly occluded and three were recanalised.The recanalised veins were one SSV and two GSVs,of which one was subject to the repeated CDS at thefour-week follow-up. All were offered and acceptedrepeated CDS. No additional local foam sclerotherapywere given, since all visible varicose veins disappearedafter the initial CDS. Within the group of completelyoccluded veins, 68% (17/25) were healed (Figure 1;Table 1).
At the one-year follow-up, 11 patients had activeulcers, nine were not healed and two were recurrences.The nine patients with non-healed ulcers were thor-oughly reviewed. Three of them had developed arterialdisease with a ABPI <0.8 one year after CDS. Of theother six patients, one had a recanalised GSV and onehad a partly occluded GSV. Both were subject torepeated CDS. One of the two patients with recurrentulcers had a recanalised SSV and accepted repeatedCDS.
No major complications occurred such as visual dis-turbance, pulmonary embolism, DVT or infection.Prescription-free analgesia was used by 6% (two
patients) during the first week after treatment. Nopatient had sick leave.
Discussion
This study shows that CDS is an option in the treat-ment of venous leg ulcers. Ulcers refractory to compres-sion therapy shows a healing rate at one year of 71%after CDS. Two recurred (6%), leaving a total healingrate of 65%.
Compression is the first-line treatment for venousulcers.4,6 A significant number remains refractory tocompression why other treatment modalities havebeen studied.
The ESCHAR trial showed in 2004 that surgical cor-rection of superficial venous insufficiency in addition tocompression treatment does not increase ulcer healingcompared with compression alone (65% in bothgroups) but significantly reduces 12-month recurrencerates compared with compression alone (12% vs.28%).5 These results have been confirmed in other stu-dies concluding that superficial venous surgery is effect-ive in maintaining healing of venous ulcers and shouldbe offered to patients with saphenous trunk incompe-tence.6–9 Surgical correction of superficial venous insuf-ficiency has decreased in popularity mainly due to thehigh costs, sick leave and procedural complications.Moreover, patients with venous leg ulcers may not besuitable candidates for surgery due to age and comor-bidity.5,8 Minimal invasive methods to eliminate saphe-nous trunk reflux have gained widespread support andhave gradually come to replace surgery to a largeextent. So far, no study has been published comparingmodern endovascular methods with surgical treatmentfor venous leg ulcers. Although several authors suggeststhat the elimination of saphenous reflux by any methodwould be at least as effective as surgery.6,19
This study reports healing rates comparable withother studies, both after surgical correction of superfi-cial venous incompetence (65–83%) and after UGFS(79–83%). The recurrence rate is comparable withthose reported after UGFS (4.9–17%) and slightlybetter than after surgery (12–22%).5,8,10,11,20,21 A fewstudies report higher healing rates after UGFS in add-ition to compression therapy, but they are small andtheir follow-ups are short.12,13 This study has onlyincluded patients suffering from venous ulcers notresponding intensive compression therapy. Patients suf-fering from diabetes, previously deep vein thrombosisor ongoing warfarin therapy have not been excluded.Differences in the study population might explain whythe healing rate is lower than in some studies.
The elimination of superficial venous insufficiencyseems to initiate a quick ulcer healing in many patients.As shown here, many ulcers were healed at the first
690 Phlebology 29(10)
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
follow-up four weeks after CDS and all of the healedulcers did so within three months. This phenomenonhas been reported in other studies.11–14
The CDS technique is well comparable with UGFSregarding elimination of superficial insufficiency. In this
study, the occlusion rate one year after treatment was86%.22
At the one-year follow up, 11 patients (11 limbs),including two recurrences, had active ulcers. Of thosenever healed, three patients were diagnosed with
Intended for CDS, n=32
Successfully treated, n=32
recanalized n=1
partly occl. n=0
occluded n=29
Follow-up by US, n=29
Not available for US follow-up, n=3
recanalized n=3
partly occl. n=1
occluded n=25
4 weeks
One year
Not available for US follow-up, n=2
Figure 1. Study flow diagram, ultrasound outcome. n¼ limbs.
Table 1. Ulcer status in relation to vein appearance on US.
Initial CDS
4 weeks, n (%) (n¼ 31) One year, n (%) (n¼ 31)
Available
for US Occluded
Healed
limbs
Available
for US Occluded
Healed
limbs
Ulcers
Non-healed
ulcers
Recurrent
ulcers
GSV, n¼ 24 22 (96) 21 (95) 9 (39) 21 (91) 18 (86) 15 (65) 7 (30) 1 (4)
SSV, n¼ 5 5 (100) 5 (100) 4 (80) 5 (100) 4 (80) 3 (60) 1 (20) 1 (20)
GSVþ SSV, n¼ 3 3 (100) 3 (100) 2 (67) 3 (100) 3 (100) 2 (67) 1 (33) 0
Total, n¼ 32 30 (97) 29 (97) 15 (48) 29 (94) 25 (86) 20 (65) 9 (29) 2 (6)
Thirty-two limbs were given initial CDS. At the four-week follow-up, one patient (GSV) was deceased and excluded. One GSV was not available for US
at four weeks and one additional GSV was lost at the one-year follow-up. Both had healed ulcers and are included in the ulcer status.
Williamsson et al. 691
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
arterial insufficiency and their ulcers were consideredas mixed ulcers. This might have affected their healingability. However, the treatment had improved theirulcer status and none of these patients had experi-enced any complication related to the CDS. Mixedulcers benefit from eliminating the superficial venousinsufficiency in addition of correcting the arterial com-ponent. For these patients, compression is notadvisable.7,23
Two patients had at US a partly occluded and arecanalised vein. The persisting venous reflux is a pos-sible explanation to persisting ulcers. These patientswere subject to repeated CDS treatment, performedwithout complications. The CDS method can easilybe repeated if necessary.17 The remaining four patientshad an occlusion of the treated vein and other factorsinfluencing healing must be considered.
The importance of eliminating reflux close to theulcer to achieve healing has been discussed.24 In thisstudy, all GSVs were accessed above knee. Afterfoam delivery from the catheter, the foam was mas-saged in the direction of the ulcer. This strategygives a more complete exclusion of distal veins andsimilar to a more distal puncture. New studies arenecessary to evaluate the importance of differentpuncture sites.
Shortcomings of this study are the small patientsample and the lack of surveillance of the compressiontreatment. All patients received the same treatment, i.e.there is not a control group of compression alone. Thepossible effect of different compression systems is there-fore not evaluated.
CDS is a cheap treatment modality compared withother endovenous therapies. The cost effectiveness inthe treatment of venous leg ulcers cannot be evaluateduntil larger studies with longer follow-up time havebeen made. However, in daily practice, it is importantto find a simple method to address this increasing prob-lem for an elderly population. A very strict compressionregime is usually difficult to maintain. If CDS safely cancontribute to ulcer healing for a reasonable cost ofmoney and time, it might be an attractive strategy forpublic health systems.
Conclusion
CDS is an alternative for eliminating superficialvenous reflux in refractory venous leg ulcers. Theresults of this limited study suggest that the treatmentis safe and induce a quick ulcer healing in the majorityof patients.
Acknowledgements
Special thanks to Linda Rapp and Ulrika Johansson forregistration of patient data.
Funding
This research received no specific grant from any funding
agency in the public, commercial, or not-for-profit sectors.
Conflict of Interest
None declared.
References
1. Nelzen O, Bergqvist D and Lindhagen A. The prevalence
of chronic lower-limb ulceration has been underesti-
mated: results of a validated population questionnaire.
Br J Surg 1996; 83: 255–258.2. Moffatt CJ, Franks PJ, Oldroyd M, et al. Community
clinics for leg ulcers and impact on healing. BMJ 1992;
305: 1389–1392.
3. Nelzen O. Leg ulcers: economic aspects. Phlebologie 2000;
15: 110–114.4. O’Meara S, Cullum NA and Nelson EA. Compression
for venous leg ulcers. Cochrane Database Syst Rev 2009;
1: CD000265.
5. Barwell JR, Davies CE, Deacon J, et al. Comparison of
surgery and compression with compression alone in
chronic venous ulceration (ESCHAR study): randomised
controlled trial. Lancet 2004; 363: 1854–1859.6. Coleridge-Smith PD. Leg ulcer treatment. J Vasc Surg
2009; 49: 804–808.7. Obermayer A, Gostl K, Walli G, et al. Chronic venous
leg ulcers benefit from surgery: long-term results from
173 legs. J Vasc Surg 2006; 44: 572–579.8. Howard DP, Howard A, Kothari A, et al. The role of
superficial venous surgery in the management of venous
ulcers: a systematic review. Eur J Vasc Endovasc Surg
2008; 36: 458–465.
9. Barwell JR, Taylor M, Deacon J, et al. Surgical correc-
tion of isolated superficial venous reflux reduces long-
term recurrence rate in chronic venous leg ulcers. Eur J
Vasc Endovasc Surg 2000; 20: 363–368.10. Cabrera J, Redondo P, Becerra A, et al. Ultrasound-
guided injection of polidocanol microfoam in the man-
agement of venous leg ulcers. Arch Dermatol 2004; 140:
667–673.11. Pang KH, Bate GR, Darvall KA, et al. Healing and
recurrence rates following ultrasound-guided foam
sclerotherapy of superficial venous reflux in patients
with chronic venous ulceration. Eur J Vasc Endovasc
Surg 2010; 40: 790–795.12. Bergan J, Pascarella L and Mekenas L. Venous disorders:
treatment with sclerosant foam. J Cardiovasc Surg
(Torino) 2006; 47: 9–18.13. Darvall KA, Bate GR, Adam DJ, et al. Ultrasound-
guided foam sclerotherapy for the treatment of chronic
venous ulceration: a preliminary study. Eur J Vasc
Endovasc Surg 2009; 38: 764–769.14. Hertzman PA and Owens R. Rapid healing of chronic
venous ulcers following ultrasound-guided foam sclero-
therapy. Phlebology 2007; 22: 34–39.15. Parsi K. Catheter-directed sclerotherapy. Phlebology
2009; 24: 98–107.
692 Phlebology 29(10)
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
16. Kolbel T, Hinchliffe RJ and Lindblad B. Catheter-direc-ted foam sclerotherapy of axial saphenous reflux: earlyresults. Phlebology 2007; 22: 219–222.
17. Williamsson C, Danielsson P and Smith L. Catheter-directed foam sclerotherapy for insufficiency of thegreat saphenous vein: occlusion rates and patient satis-faction after one year. Phlebology 2013; 28: 80–85.
18. Tessari L, Cavezzi A and Frullini A. Preliminary experi-ence with a new sclerosing foam in the treatment of vari-cose veins. Dermatol Surg 2001; 27: 58–60.
19. Simka M. Principles and technique of foam sclerotherapyand its specific use in the treatment of venous leg ulcers.Int J Low Extrem Wounds 2011; 10: 138–145.
20. van Gent WB, Hop WC, van Praag MC, et al.Conservative versus surgical treatment of venous leg
ulcers: a prospective, randomized, multicenter trial.J Vasc Surg 2006; 44: 563–571.
21. Nael R and Rathbun S. Effectiveness of foam sclerother-
apy for the treatment of varicose veins. Vasc Med 2010;15: 27–32.
22. Jia X, Mowatt G, Burr JM, et al. Systematic review offoam sclerotherapy for varicose veins. Br J Surg 2007; 94:
925–936.23. Treiman GS, Copland S, McNamara RM, et al. Factors
influencing ulcer healing in patients with combined arter-
ial and venous insufficiency. J Vasc Surg 2001; 33:1158–1164.
24. Bush RG. New technique to heal venous ulcers: terminal
interruption of the reflux source (TIRS). Perspect VascSurg Endovasc Ther 2010; 22: 194–199.
Williamsson et al. 693
at The University of Auckland Library on December 6, 2014phl.sagepub.comDownloaded from
