¹Associate professor, ²Professor of Radiology, Department of Radiology, Bharati Vidyapeeth medical college, Pune-411043, INDIA.

³Managing Director, Institute-Indocare Diagnostics, Pune, INDIA.

⁴Associate consultant, Department Of Interventional Radiology, Ruby Hall Clinic, Pune, INDIA.

Email: yadavmunde@gmail.com , pragyadixit2810@gmail.com

RESULTS

During study period 70 patients (79 legs) underwent EVLA for active and healed venous ulcers. 59 % patients had healed venous ulcer (CEAP clinical class 5) while 41 % patients had active venous ulcer (CEAP clinical class 6). Female patients (56%) were more than male (44%). Cardiovascular disease (33%), history of DVT (33%), smoking 14 (20%) and diabetes mellitus (16%) were common co-morbid conditions.

Table 1: Demographics and characteristics of patients with healed and active ulcer at the time of EVLA treatment.

Postoperative complications such as pain, bruising and tightness (23%), paresthesia (20%), induration (11%), superficial vein thrombophlebitis (5%), hematoma (4%), puncture site infection (4%) and DVT (1%) were noted in present study.

Table 2: Percentage of postoperative complications

In present study at the end of 1 year 68% healed ulcers were noted while ulcer area was reduced in 23% patients. 9% were unchanged and 6 % recurrence rate was noted.

Table 3: Ulcer outcome.

Case-1: 27 yrs shop keeper with large varicosities in GSV territory with dilated GSV.

The GSV was treated with LASER therapy and varicosities were treated with foam sclerotherapy by using sodium tetradecyl acetate (setrol). Post treatment the varicose veins were completely ablated and disappeared in 1 month. A- Pre Laser, B-one month post LASER.

Case-2: This is a 45 yrs clerk with non healing venous ulcer since a year. All conservative treatments were tried but failed. There was reflux in GSV with a incompetent perforator under the ulcer. The GSV and the incompetent perforator were treated by LASER and the ulcer started healing in a weeks time. A: Venous ulcer before LASER treatment; B: Healed venous ulcer after a week of LASER therapy.

Case 3: 45 yrs female with nonhealing venous ulcer just above the medial malleolus. Doppler s/o SFJ reflux with dilated GSV till lower leg. Treated with LASER and ulcer healed in 4 weeks time. A-Pre laser, B-4 weeks post LASER.

DISCUSSION

Active ulceration is known to have a profoundly detrimental effect upon quality of life, including significant pain and restriction in mobility, which result in limitations of physical and social roles.⁸ The socioeconomic impact of these non-healing ulcers and wounds is immense and may result in significant morbidity in affected individuals. Venous ulcer disease describes the most severe end of a spectrum of chronic venous insufficiency, as categorized by the CEAP (Clinical severity, Etiology, Anatomy and Pathophysiology) classification system. Clinical severity is scored from C0 (no disease) to C6 (active ulceration); C5 describes a healed ulcer. ⁹ Elevated venous pressure, turbulent flow and insufficient venous return due to venous occlusion or venous reflux are the proposed aetiologies for venous ulcers, which activate inflammatory processes, triggering leukocyte activation, endothelial damage, platelet aggregation and intracellular edema. Older age, obesity, previous leg injuries, deep venous thrombosis and phlebitis are the various risk factors aggravating this complication.¹⁰ Clinically venous ulcers occur as “pure” venous causes, when there is directed axial great saphenous vein reflux or incompetent perforator reflux directly into the ulcer bed, or as “mixed” venous plus other causes, as in cases in which arterial ischemia, scarred tissue of the gaiter area, hypersensitive skin, lymphedema, autoimmune disease, local trauma, infection, and other processes coexist with the venous hypertension. Conservative therapy of venous ulcers and the prevention of new ulcers includes control of edema and venous hypertension by adequate compression therapy, wound cleaning or surgical debridement and systemic antibiotic therapy.¹¹ A large Indian study revealed that CVD is more prevalent at an average age of 43 years and it affects women more than men.¹² In present study women were more than men. Abhinav Mohan studied 72 patients with peripheral chronic venous insufficiency, males were found to be affected predominantly with an M: F ratio of 1:0.53. ¹³ It is a well-known fact that minimally invasive interventional radiology procedures for management of chronic venous insufficiency are associated with decrease morbidity and excellent outcomes even in patients having co-morbid conditions.¹⁴ In clinical practice EVLA and RFA are increasingly used to treat patients with venous ulcers and there are several reports of low recurrence rates but with small groups and short follow-up. ^15,16 The ’walk-in, walk-out’ local anaesthetic technique that can be used with endovenous thermal ablation may be more acceptable to patients with venous ulcers, avoiding the difficulties associated with general anaesthesia and minimising the morbidity, recovery time and even early recurrence following intervention.¹⁷ In a comparative study, Viarengo et al.., ¹⁸ noted 82% of EVLA treated patients and 24% of the compression group had healed ulcers after 1 year follow up. EVLA of incompetent saphenous trunks promotes venous ulcer healing. ¹⁸ In present study at the end of 1 year, 68% patients had healed ulcers. In study by Sharif et al., ¹⁹ endovenous laser ablation in CEAP: C4-C6 patients, cumulative healing rates after 3 months was 87%; after 1 year was 100% and after 22 months was 95%. They noted that EVLA is effective in the treatment and prevention of venous ulcers. ¹⁹ In the Effect of Surgery and Compression on Healing and Recurrence (ESCHAR) study showed that when VU patients were treated by compression and superficial venous surgery, the recurrence rate of VU was reduced with an absolute risk reduction of 25% compared with compression only.²⁰ When endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) were compared with high ligation and stripping in treating varicose veins (VVs), treatments were found to be as effective and safe 5 years after treatment.²¹ Rueda et al..,²² noted that, during a mean patient follow-up of 37 months, 41 patients treated with SEPS and 23 with radiofrequency ablation had ulcer healing in 88% and 100%, respectively. The authors concluded that they support an “aggressive approach to patients with C5/C6 disease,” which would include treatment of incompetent perforating veins when appropriate.²² Gohel et al. in their study noted that 84% of the treated legs (still) had a healed ulcer without recurrence after 3.5 years in a group of 170 patients where 16% were lost to follow-up. Complications were mostly minor and 15% had undergone repeat treatment of VVs.²³ Recently, another clinical trial ( EVRA Trial) evaluated the role of early endovenous treatment of superficial venous reflux as an adjunct to compression therapy in patients with venous leg ulcers and they concluded that compression therapy combined with early endovenous ablation treatment could promote ulcer healing, reduce ulcer recurrence and prolong the patients’ ulcer-free time within 1 year after the intervention.²⁴ Results of large randomized studies have suggested that the rate of technical success (i.e., complete venous occlusion) may be lower with foam sclerotherapy than with endovenous thermal ablation.^21,25 Deep venous reflux, large ulcer area and reduced ankle mobility are considered risk factors for ulcer recurrence.²⁶ Factors associated with ulcer nonhealing and recurrence are overweight body mass index, history of deep venous thrombosis, large ulcer area, noncompliance with compression therapy, and triple-system venous disease involving superficial, perforating, and deep veins.²⁷ In present study 6% recurrence was noted. Present study had small sample size; institution based with 1 year follow up. Large scale, multicentric, randomised controlled studies about the efficacy of endovenous methods in treating patients with healed or active venous ulcers are needed for definitive results.

CONCLUSION

Endovenous laser ablation is useful treatment modality in patients with healed or active venous ulcers associated with better ulcer healing, low recurrence rates and a low rate of complications.

REFERENCES

1. Gloviczki P. Handbook of venous disorders: Guidelines of the American Venous Forum. 3rd ed. London: Hodder Arnold; 2009.
2. Lee AJ, Robertson LA, Boghossian SM, Allan PL, Ruckley CV, Fowkes FG. Progression of varicose veins and chronic venous insufficiency in the general population in the Edinburgh Vein Study. J Vasc Surg Venous Lymphat Disord 2015;3:18-26.
3. Abdul-Haqq R, Almaroof B, Chen BL, Panneton JM, Parent FN. Endovenous laser ablation of great saphenous vein and perforator veins improves venous stasis ulcer healing. Ann Vasc Surg 2013;27(7):932e9.
4. Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, et al.. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ 2007;335(7610): 83.
5. O’Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2014;60(Suppl):c3S-59S.
6. Andrej Šikovec, Saphenous Vein Occlusion by Endovenous Laser Ablation (EVLA) with a 1064 nm VSP Nd:YAG Laser. LAandHA - J Laser Heal Acad ,2010, 1: 19–23.
7. Marrocco CJ, Atkins MD, Bohannon WT, Warren TR, Buckley CJ, et al.. (2010) Endovenous ablation for the treatment of chronic venous insufficiency and venous ulcerations. World J Surg 34: 2299–2304.
8. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. British Journal of Surgery 2011;98(8): 1117–23.
9. Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, et al..Revision of the CEAP classification for chronic venous disorders: consensus statement. Journal of Vascular Surgery 2004;40(6):1248–52.
10. Collins L, Seraj S (2010) Diagnosis and treatment of venous ulcers. Am Fam Physician 81(8):989–996
11. Mekkes JR, Loots MAM, Van Der Wal AC, Bos JD (2003) Causes, investigation and treatment of leg ulceration. Br J Dermatol 148: 388–401.
12. Dekiwadia DB, Jindal R, Varghese R, Bedi HS, Padaria S, Patel MD, Agarwal S, Saravanan S, Rao UV, Pinjala R, Singh G, Executive summary: a consensus statement—part I: recommendations for the management of chronic venous disease (CVD) in India and key role of primary care doctors. J Assoc Physicians India, 2016, 64(8):53–56
13. Abhinav Mohan, Pankaj Banode, Gaurav Sharma, Chronic venous insufficiency: a study of clinical presentation at A rural hospital and its management in interventional radiology Clinic. International Journal Of Scientific Research, Volume-7, Issue-6, June-2018
14. Hardman RL, Rochon PJ. Role of Interventional Radiologists in the Management of Lower Extremity Venous Insufficiency. Seminars in Interventional Radiology. 2013;30(4):388-393.
15. Samuel N, Carradice D, Wallace T, Smith GE, Chetter IC. Endovenous thermal ablation for healing venous ulcers and preventing recurrence. Cochrane Database Syst Rev 2013;(10): CD009494.
16. Wysong A, Taylor BR, Graves M, Mishra V, Gilbertson R, Greenway HT, et al.. Successful treatment of chronic venous ulcers with a 1,320-nm endovenous laser combined with other minimally invasive venous procedures. Dermatol Surg 2016;42(8):961e6
17. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. British Journal of Surgery 2011;98 (4):501–10.
18. Viarengo LM, Potério-Filho J, Potério GM, Menezes FH, Meirelles GV. Endovenous laser treatment for varicose veins in patients with active ulcers: measurement of intravenous and perivenous temperatures during the procedure. Dermatol Surg 2007;33:1234-42.
19. Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. Role of endovenous laser treatment in the management of chronic venous insufficiency. Ann Vasc Surg 2007;21:551-5.
20. Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, et al.. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet 2004;363(9424):1854e9.
21. Rasmussen L, Lawaetz M, Serup J, et al.. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up. J Vasc Surg Venous Lymphat Disord 2013; 1: 349-56.
22. Rueda CA, Bittenbinder EN, Buckley CJ, Bohannon WT, Atkins MD, Bush RL, et al.. The management of chronic venous insufficiency with ulceration: the role of minimally invasive perforator interruption. Ann Vasc Surg 2013;27: 89-95.
23. H. Sinabulya, R. Östmyren, L. Blomgren , Mid-term outcomes of endovenous laser ablation in patients with active and healed venous ulcers: a follow-up study, Eur J Vasc Endovasc Surg, 2017, 53, 710-716
24. Gohel, M. S. et al.. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med 2018, 378, 2105–2114.
25. Tzaneva S, Heere-Ress E, Kittler H, Bohler K. Surgical treatment of large vascular leg ulcers: a retrospective review evaluating risk factors for healing and recurrence. Dermatol Surg 2014;40(11):1240e8.
26. Brittenden J, Cotton SC, Elders A, et al.. A randomized trial comparing treatments for varicose veins. N Engl J Med 2014; 371: 1218-27.
27. Labropoulos N, Wang ED, Lanier ST, Khan SU. Factors associated with poor healing and recurrence of venous ulceration. Plast Reconstr Surg 2012;129:179-86.