Graduated compression stockings are universally

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1 Efficacy of Graduated Compression Stockings for an Additional 3 Weeks after Sclerotherapy Treatment of Reticular and Telangiectatic Leg Veins PAVAN K. NOOTHETI, MD, KRISTIAN M. CADAG, BS, ANGELA MAGPANTAY, MPH, MT (ASCP), AND MITCHEL P. GOLDMAN, MD BACKGROUND Sclerotherapy with post-treatment graduated compression remains the criterion standard for treating lower leg telangiectatic, reticular, and varicose veins, but the optimal duration for that postsclerotherapy compression is unknown. OBJECTIVE To determine whether 3 weeks of additional graduated compression with Class I compression stockings (20 30 mmhg) improves efficacy when used immediately after 1 week of Class II (30 40 mmhg) graduated compression stockings. METHODS Twenty-nine patients with reticular or telangiectatic leg veins were treated with sclerotherapy; one leg was assigned to wear Class II compression stocking for 1 week only, and the contralateral leg was assigned an additional 3 weeks of Class I graduated compression stocking. RESULTS AND CONCLUSIONS Postsclerotherapy pigmentation and bruising was significantly less with the addition of 3 weeks of Class I graduated compression stockings. This study was supported by a grant from Sigvaris and Medi USA, who supplied the compression stockings used in this study. Dr. Goldman is a consultant and receives honoraria from Bioniche/Angiodynamics. Graduated compression stockings are universally recommended for surgical and nonsurgical treatment of varicose veins. Whereas graduated compression is thought to be particularly essential after sclerotherapy of large varicose veins, it has not been universally adopted after sclerotherapy treatment of telangiectasia. For varicose veins, less thrombus formation results in a lower incidence of postsclerosis pigmentation. 1 4 Immediate postsclerotherapy compression is thought to result in direct apposition of treated vein walls, which produces more effective sclerosis by limiting thrombus formation. In addition, limitation of thrombosis and inflammation secondary to phlebitis may minimize telangiectatic matting. 5,6 The degree and length of time for compression after sclerotherapy treatment is debatable. A trial of highversus low-compression stockings (40 vs 15 mmhg at the ankle) after varicose vein surgery demonstrated equal efficacy in controlling bruising and thrombophlebitis. 7 This same study concluded that, after varicose vein surgery, Class I (20 30 mmhg) compression stockings provided adequate support, but that after sclerotherapy, Class II (30 40 mmhg) compression stockings were necessary. Nevertheless, in terms of controlling objective and subjective parameters of venous insufficiency, no difference was found between Class I and Class II compression. 8 One of the authors (MPG) previously evaluated postsclerotherapy compression with Class II graduated compression stockings in 37 women with telangiectasia in a multicenter study. A decrease in hyperpigmentation from 40.5% to 28.5% was demonstrated. Ankle and calf edema were also decreased. 9 The same author next evaluated postsclerotherapy Class I graduated compression All authors are affiliated with Dermatology/Cosmetic Laser Associates of La Jolla, Inc., La Jolla, California & 2008 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc. ISSN: Dermatol Surg 2009;35:53 58 DOI: /j x 53

2 SCLEROTHERAPY TREATMENT OF LEG VEINS TABLE 1. Sclerosing Solutions Used for Leg Veins Based on Diameter Veins o1mm in diameter Veins 1 3 mm in diameter Veins 3 6 mm in diameter 2% glycerin mixed 2:1 with 1% lidocaine with epinephrine 0.25% sotradecol foam (1 ml solution with 4 ml of air) 0.5% sotradecol foam (1 ml solution with 4 ml of air) stockings in 40 patients with similar telangiectatic patterns. 10 These patients were randomly assigned to compression durations of 0 days, 3 days, 1 week, and 3 weeks. The three compression groups showed significantly greater improvement at 6 weeks (p =.004). There was a strong correlation between the length of time compression was applied and degree of improvement at 6, 12, and 24 weeks. The patients treated with compression for 3 days and 1 week had more improvement than the control patients, and the patients treated for 3 weeks with continuous graduated compression had the most improvement. When improvement after sclerotherapy was followed to 12 and 24 weeks, the benefits of compression were even more evident. Patients in the 3-week compression group had the greatest improvement, followed by the 1-week group, with similarly decreasing rates of improvement at 12 Patient Quality of Life Questionnaire 1- What is your current level of pain? Do you have any leg swelling? A)Yes 3- Do you have any bruising? A) Yes 4- Do you have any leg ulcerations (bleeding)? A) Yes 5- Do you have any discoloration, and if so, what grade? A) None B) Mild C) Moderate D) Severe 6- Do you have any pigmentation? a. No, none b. Mild c. Moderate d. Severe 7- Using a percentage score, please describe the amount of vein clearance that you believe you have gained since your procedure. A) 0% B) 10% C) 20% D) 30% E) 40% F) 50% G) 60% H) 70% I) 80% J) 90% K) 100% 8- Do you feel a sensation of heaviness? A) Yes Figure 1. Patient quality-of-life questionnaire. 54 DERMATOLOGIC SURGERY

3 NOOTHETI ET AL (p =.02) and 24 (p =.006), weeks of follow-up in the 3-day and control groups. There were no statistically significant differences between the four groups in the incidence of bruising, telangiectatic matting, edema, or ulceration, although trends of lessening were noted with increasing times of compression. There was a statistically significant difference, however, between the groups regarding hyperpigmentation. The 1-week and 3-week compression groups experienced the least amount of hyperpigmentation. These two studies demonstrate the benefits of postsclerotherapy treatment of leg telangiectasia with Class I and Class II graduated compression stockings. Compression for 1 to 3 weeks appears to be most beneficial. This was also confirmed in a study on the use of compression for varicose veins. 11 Materials and Methods Thirty-three patients with reticular and telangiectatic leg veins in a similar pattern, size, and extent on both legs were treated with sclerotherapy. The sclerosing solutions used were sodium tetradecyl sulfate (STS) (Angiodynamics, Buffalo, NY) and glycerin 72% mixed 2:1 with 1% lidocaine with epinephrine (University Compounding Pharmacy, San Diego, CA) as previously described. 12 The treatment regimen is outlined in Table 1. A subjective quality-of-life questionnaire was administered before treatment and at 7- to 8-week follow-up to all patients (Figure 1). After sclerotherapy treatment, patients wore Class II 30- to Physician Questionnaire Figure 2. Physician questionnaire. 1- Three (3) independent physician observers will assess pre- and post-treatment photographs to determine overall disappearance of veins by the following scale (1-5): 1 = Worse than before treatment 2 = No change 3 = Minor disappearance 4 = Moderate disappearance 5 = Complete disappearance 2- Three (3) independent physician observers will assess pre- and post-treatment photographs to determine degree of pigmentation on a scale of (1-4): 1 = no pigmentation 2 = mild pigmentation 3 = moderate pigmentation 4 = severe pigmentation 3- Three (3) independent physician observers will assess pre- and post-treatment photographs to determine degree of superficial thrombophlebitis on a scale of (1-4): 1 = no evidence of phlebitis 2 = mild phlebitis 3 = moderate phlebitis 4 = severe phlebitis 4-4. Three (3) independent physician observers will assess pre- and post-treatment photographs to determine degree of ankle/pedal edema on a scale of (1-4): 1 = no edema 2 = mild edema 3 = moderate edema 4 = severe edema 35:1:JANUARY

4 SCLEROTHERAPY TREATMENT OF LEG VEINS Sclerotherapy Study (Average Means based on Photograding) Randomized Group Non-Randomized Group 0.00 Overall Disappearance of Veins Degree of Pigmentation Degree of Superficial Thrombosis Figure 3. Sclerotherapy study (average means based on photograding). 40-mmHg graduated compression stockings for 1 week, 24 hours a day (Sigvaris 860 series, thigh high, Sigvaris Inc., Peachtree City, GA, or Mediven Plus, Medi USA, Whitsett, NC). Patients legs were then randomized so that one leg had no stocking, and the other leg had a Class I 20- to 30-mmHg graduated compression stocking (Sigvaris 860 series, thigh high, or Mediven Plus) while ambulatory for an additional 3 weeks. Two physicians (PKN and MPG) assessed photographs in a blinded manner taken before treatment and 7 to 8 weeks post-treatment. Overall disappearance of leg veins, degree of pigmentation, and degree of superficial thrombophlebitis was graded on a 1 to 4 scale (Figures 2 and 3). Interrater reliability was calculated using the Spearman rank coefficient (n = 22, alpha = 2-tailed). We found that the measure of agreement in the rating estimates of our two physicians (calculated rho = 0.40) was stable and consistent (po.05). Results Of the 33 subjects initially enrolled, 29 completed participation. The four subjects who dropped out of the study did not return for follow-up at all of the time periods. There did not appear to be any adverse effects in the four subjects who dropped out of the study. Statistical analysis showed a significant difference in the degree of post-treatment pigmentation between the 1-week and 4-week compression groups (p =.01), but no difference was observed in the overall disappearance of leg veins (p =.52) or degree of superficial thrombophlebitis (p =.32) (Figure 3). The Mann-Whitney test was used for statistical analysis of photograding, with an alpha = 0.05 (two-tailed) with 95% confidence limits. Immediately after treatment and during each followup visit, subjects were questioned regarding current level of pain, swelling, bruising, ulceration, discoloration, pigmentation, vein clearance percentage, and sensation of heaviness. At the final visit, 45% and 5% of the 4-week compression group reported the presence of swelling and bruising, respectively, compared with the 1-week compression group, who developed swelling in 25% and bruising in 15%. Conclusion There was a statistically significant difference in the degree of post-treatment pigmentation between 1 56 DERMATOLOGIC SURGERY

5 NOOTHETI ET AL and 4 weeks of graduated compression stocking wear. No statistical significant difference was evident in the overall disappearance of veins and degree of superficial thrombophlebitis. There was less pigmentation and telangiectatic matting in patients who wore Class I graduated compression stockings for an additional 3 weeks versus wearing Class II graduated compression stockings for 1 week after sclerotherapy treatment. Patients who wore the Class I graduated stockings for an additional 3 weeks reported feelings of leg comfort while wearing the stockings during full motion and at rest. Limitations to our study include small sample size. Although the debate will continue with regard to the length of time compression is needed after sclerotherapy, we have demonstrated that an additional 3 weeks of postsclerotherapy compression can hasten the disappearance of post-treatment pigmentation or bruising, thereby improving overall appearance of the legs faster. References 1. Goldman MP. Postsclerotherapy hyperpigmentation. Treatment with a flashlamp-excited pulsed dye laser. J Dermatol Surg Oncol 1992;18: Goldman MP, Bennett RG. Treatment of telangiectasia: a review. J Am Acad Dermatol 1987;17: Goldman MP, Kaplan RP, Duffy DM. Postsclerotherapy hyperpigmentation: a histologic evaluation. J Dermatol Surg Oncol 1987;13: Duffy D. Techniques of Small Vessel Sclerotherapy. In: Goldman M, Weiss R, Bergan J., editors. Varicose Veins and Telangiectasia: Diagnosis and Treatment. 2nd ed. St. Louis: Quality Medical Publishing; 1999: Ouvry PA, Davy A. The sclerotherapy of telangiectasia. Phlebologie 1982;35: Davis L., Duffy DM. Determination of incidence and risk factors for postsclerotherapy telangiectatic matting of the lower extremity: A retrospective analysis. J Dermatol Surg Oncol 1990;16: Shouler PJ, Runchman PC. Varicose veins: optimum compression after surgery and sclerotherapy. Ann R Coll Surg Engl 1989;71: Spence RK, Cahall E. Inelastic versus elastic leg compression in chronic venous insufficiency: a comparison of limb size and venous hemodynamics. J Vasc Surg 1996;24: Goldman MP, Beaudoing D, Marley W, et al. Compression in the treatment of leg telangiectasia: a preliminary report. J Dermatol Surg Oncol 1990;16: Weiss RA, Sadick NS, Goldman MP, Weiss MA. Post-sclerotherapy compression: controlled comparative study of duration of compression and its effects on clinical outcome. Dermatol Surg 1999;25: Tazelar DJ, Neumann HA, De Roos KP. Long cotton wool rolls as compression enhancers in macrosclerotherapy for varicose veins. Dermatol Surg 1999;25: Goldman MP, Bergan JB, Guex JJ, editors. Sclerotherapy Treatment of Varicose and Telangiectatic Leg Veins. 4th ed. London: Mosby/Elsevier; Address correspondence and reprint requests to: Mitchel P. Goldman, MD, Dermatology/Cosmetic Laser Associates of La Jolla, Inc., 7630 Fay Ave., La Jolla, CA 92037, or mgoldman@spa-md.com COMMENTARY This small and carefully crafted study deserves analysis at three levels: proof of concept, practicality or utility value, and issues that have not been directly addressed. PROOF OF CONCEPT It is becoming increasingly apparent that by increasing the duration and degree of compression, a linear decline is noted in certain types of postsclerotherapy complications. In this report, the authors note a statistically significant difference in post-treatment pigmentation. Bruising and telangiectatic matting may also be reduced with more-aggressive compression protocols. 35:1:JANUARY

6 SCLEROTHERAPY TREATMENT OF LEG VEINS UTILITY VALUE Implicit in this article is the notion that all patients undergoing sclerotherapy for vessels large and small would benefit from one week of around-the-clock Class II hosiery followed by another three weeks of around-the-clock Class I hosiery. Whether we should recommend patients to routinely employ this expensive, difficult-to-put-on, and uncomfortable hosiery to avoid minor temporary complications is problematic. When treating telangiectasia or very small reticular veins, it might be worthwhile to discuss the benefits and drawbacks of compression therapy and leave the decision up to the patient. ISSUES THAT WERE NOT DIRECTLY ADDRESSED Class II hosiery, which is ordinarily used to treat severe varicosities, may impair calf muscle and cutaneous blood flow in recumbent patients. 1 For patients with pre-existing circulatory problems, diabetes mellitus, and certain kinds of podiatric problems, the risk of vascular compromise may outweigh the benefits. Although the authors seem convinced that aggressive compression protocols may be a panacea for a wide range of complications, personal experience suggests that pigmentation, matting, bruising, and swelling can occur on a highly variable individual and not completely predictable basis; 2 4 no matter what treatment protocols are employed. CONCLUSION Although some of the benefits ascribed to compression may be artifacts related to individual patient variability, a study of this sort underscores the increasingly appreciated benefits of postsclerotherapy compression. DAVID DUFFY, MD Torrance, CA Dr. Duffy has no conflicts to disclose. References 1. Goldman MP, Bergan JJ, Guex JJ. SclerotherapyFTreatment of Varicose and Telangiectatic Leg Veins. 4th ed. London: Mosby; Duffy D. Techniques of small vessel sclerotherapy. In: Goldman M, Weiss R, Bergan J., editors. Varicose Veins and Telangiectasia: Diagnosis and Treatment. 2nd ed. St. Louis: Quality Medical Publishing; p Davis LT, Duffy DM. Determination of incidence and risk factors for postsclerotherapy telangiectatic matting of the lower extremity: A retrospective analysis. J Dermatol Surg Oncol 1990;16: Alam M, Tri H, Nguyen DD. Procedures in cosmetic dermatology; treatment of leg veins. In: Sclerotherapy. St. Louis: Elsevier Inc.; Ch 5, p DERMATOLOGIC SURGERY