Randomized clinical comparison of short term outcomes following endogenous laser ablation and stripping in patients with saphenous vein insufficiency

Transcription

1 Original Research 12 endogenous laser ablation and stripping in patients with saphenous vein Ozgur Bulut*, Umit Halici, Serdar Menekse Department of Cardiovascular Surgery Education and Research Hospital, Samsun, Turkey *Corresponding Author: Department of Cardiovascular Surgery Education and Research Hospital, Baris Bulvari, Kadıkoy Mahallesi, No:199, Ilkadim, 55100, Samsun/Turkey Tel: , Key words: Catheter ablation; quality of life; saphenous vein; surgery; venous Received: Accepted: e-published: Abstract Objectives: The aim was to compare the effects of endovenous laser ablation () and saphenous vein stripping on the quality of life of the patients and their short-term clinical outcomes in the treatment of isolated, symptomatic, unilateral greater saphenous vein (GSV). Materials and Methods: A total of 65 patients undergoing GSV stripping (n = 35) or (n = 30) for GSV (patients demonstrating backflow lasting more than 5 s during Valsalva maneuvers and those with a saphenous vein diameter more than 5 mm) between May 2013 and September 2013 were prospectively included in the study. Groups were compared for differences in clinical, etiological, anatomical and pathophysiological characteristics classification, venous clinical severity scores, and Short Form-36 (SF-36) quality of life scale. Results: Pre-operative and post-operative SF-36 scale scores in both groups were compared statistically and quality of life scores were found to be better in group with lesser number of complaints (P < 0.01). Despite the initial increase in the 1 st week, the venous clinical severity score significantly declined in both groups after treatment, and it was significantly lower in the group at 1 st month. Discussion: In GSV insufficiencies, is an efficient and safe treatment modality with better quality of life outcomes when compared with the stripping method. It offers better short-term relief of symptoms than stripping. Introduction Saphenous vein is an important health problem with its higher prevalence, apparent labor loss and its unfavorable impact on quality of life of the patient, together with its epidemiological and socioeconomical outcomes [1]. In cases of venous ; pain, feeling of heaviness on legs, superficial thrombophlebitis, pigmentation at ankles, formation of white atrophy and ulcerations are symptoms and signs which constitute indications of surgical treatment [2]. Due to the simultaneous involvement of various anatomical and pathophysiological mechanisms in the development of the clinical manifestations of venous, its clinical signs vary greatly. To this end, American Venous Forum organized an international forum in 1994 in order to formulate a comprehensive definition of the condition and use the same terminology for the diagnosis, evaluation and classification of the venous insufficiencies. The forum approved a clinical (C), etiological (E), anatomical (A) and pathological (P) classification of the condition [3,4]. As a complementary to CEAP classification, venous clinical severity scoring system (VCSS) was introduced in order to facilitate its treatment and monitorization of the characteristics of clinical changes occurring during the course of this disease, which is required for the determination of the severity of the disease and proper treatment approach [5,6]. In this study, in the treatment of isolated, symptomatic, unilateral greater saphenous vein (GSV), the effects of endovenous laser ablation () and saphenous vein stripping on the quality of life of the patients and their short-term clinical outcomes were compared. Materials and Methods Study design This study was approved by the local Institutional Review Board. Written informed consent was obtained from all subjects. A total of 65 patients undergoing stripping or

2 Original Research 13 in our clinic between May 2013 and September 2013 with the diagnosis of GSV were included in the study. CEAP classifications and venous clinical severity scores of the patients were evaluated and analyzed prospectively. The age of patients ranged from 18 to 62. The patients were assessed pre-operatively and on post-operative 1 st week and 1 st month. Consecutive patients with symptomatic varicose veins and GSV incompetence, CEAP C2-4EpAsPr, were randomized using sealed envelopes to either surgery or. Inclusion criteria were of GSV and sapheno-femoral junction with reflux at least up to the knee, symptoms of GSV, C2-5, Ep-En, As 1-5 and Pr-Pn. Exclusion criteria; pregnancy, active malignancy, arterial occlusive disease, acute deep vein thrombosis, high risk of pulmonary thromboemboli and deep venous. Outcome parameters All patients underwent venous Doppler ultrasonographic examinations, their vein maps were obtained, source and level of the venous reflux and distribution of the varicose veins were recorded. Before the procedure the patients were classified with respect to their clinical, etiological, anatomical and pathophysiological characteristics. Their VCSS based on scoring of clinical complaints, symptoms and signs were recorded. Short Form-36 (SF-36) quality of life scale was used for the evaluation and comparison of quality of life scores. Pre-operative decision to include patients in the stripping or groups was made upon severity of GSV and diameter of the GSV as detected during diagnostic Doppler examination of the patients. Patients demonstrating backflow lasting more than 5 s during Valsalva maneuvers and those with a saphenous vein diameter more than 5 mm were included in the study. Patients with deep venous were not included in the study. As an outcome of all assessments, patients with established symptomatic GSV, those without any contraindication to these treatment modalities were included in the analysis after they were subjected to CEAP classification and VCSS evaluation. The patients were symptomatic and chosen among those who met the criteria of C2-6, Ep-En, As 1-5 and Pr-Pn classification. In assigned patients, SF-36 questionnaire surveys were performed pre-operatively and on post-operative and in order to evaluate their quality of life. This scale which evaluates both favorable and unfavorable aspects of the health state and consists of subscales of physical function, power of the physical role, physical function, bodily pain, general health state, energy/vitality, social function, role of emotional power, mental health and summary of the physical components [7]. For each subscale, total scores were estimated individually. Health state was evaluated between 0 and 100 points. 0 and 100 pts indicated poor and improved health states, respectively. In every phase, CEAP and VCSS data were retrieved and clinical outcomes were compared. VCSS was evaluated between 0 and 3 points [6]. Statistical analyses Data were analyzed using the Statistical Package for Social Sciences 15.0 for windows (SPSS Inc., Chicago, IL). Parametric tests were applied to data of the normal distribution, and non-parametric tests were applied to data of questionably normal distribution. Repeated-measures analysis of variance was used to compare variable parameters. The distribution of categorical variables in both groups was compared using Pearson Chi-square test. To calculate correlation coefficients Pearson s r, and Kendall s taub was used. Spearman correlation co-efficient followed by the Tukey post hoc test were used to determine correlations between different variables. All differences associated with a chance probability of.05 or less were considered statistically significant. RESULTS A total of 65 consecutive patients (85 legs) were randomized to surgery or. Thirty-seven (56.9%) female and 28 (43.1%) male patients were included in the study. The number of patients and legs treated and examined at follow-up is shown in the consort Diagram 1. Endovenous treatment was applied on GSVs of 20 female (54.0%) and 10 (35.7%) male patients and the remaining patients underwent stripping. Age of the patients ranged between 18 and 62 years. Mean age of the patients in the and surgery groups was 37.8 ± 14.7 and 42.3 ± 11.6 years, respectively. Gender and age were not statistically significant variables in the process of the study. All of the patients were symptomatic at the onset. Clinically the patients were classified in (n = 26; 40%), (n = 18, 27.9%), C 4 (n = 17; 26.1%), and C 5 (n = 4; 6%) categories. Pre-operative venous clinical severity score indicated severe (n = 22; 33.8%), moderate (n = 22; 33.8%) and mild (n = 21; 32.3%) degrees of GSV. Pre-operative evaluation of the patients in the group, venous VCSS indicated severe [3] venous in 12 (40%) patients, however in the post-procedural 1 st week 18 (60%) patients had clinical venous severity score of 0 point, while 12 (40%) patients had mild degrees of [1]. On the 1st month evaluation, VCSS indicated mild (1) degrees of in 4 (13.4%) patients and 26 (96.6%) patients had a VCSS of 0 (e.g., they were asymptomatic). Still in pre-operative

3 Original Research 14 evaluations among 35 patients who underwent stripping, 12 (34.3 %) patients had severe (3) venous at post-operative 1 st week, VCSS pointed out to moderate (2) (n = 12; 34.3%) and mild (1) (n = 23; 65.7%) degrees of venous. On post-operative 1 st month, VCSS represented mild (1) (n = 20; 57.2%) degrees of. While 15 (42.8%) patients were asymptomatic (0). VCSS data were found to be statistically significant (P < 0.01) (Table 1). During post-operative monitorization recanalized flow and thrombophlebitis were observed in 4 (13.3%) patients in the study group. Reintervention and medical therapy were performed. Surgical wound site infection was detected in 3 (8.5%) patients in the stripping group. Signs of venous disappeared in 8 patients (26.6%) in the group at the end of the 1st post-operative month ( ), in 22 (73.4%) patients telengiectasia and partially varicose veins ( ) were observed. At the end of the 1st month among patients who underwent surgical interventions one (2.8%) patient was asymptomatic, while reticular and varicose veins ( ) were observed in 34 (97.2%) patients (Table 2). Pre-operatively and on post-operative 1 st week and 1 st month, patients were evaluated based on SF-36 quality of life scale scoring system and statistically lower pre-operative mental and physical domain scores were detected, while post-operative SF-36 scores were higher and directly proportional to duration of the post-operative period (P < 0.01). In the study group mean pre-operative SF-36 mental component summary score was ± 5.5 pts, while at the 1st week and the 1 st month estimated mean values were ± 4.0 and ± 3.4 pts, respectively. Mean Table 1: VCSS score before and after intervention (P<0.01) VCSS Pre treatment Absent: 0 18 (60) 26 (96.6) Mild: 1 6 (20) 12 (40) 4 (13.4) Moderate: 2 12 (40) 0 (0) Severe: 3 12 (40) 0 (0) Stripping Absent: 0 15 (42.8) Mild: 1 8 (22.8) 23 (65.7) 20 (57.2) Moderate: 2 15 (42.8) 12 (34.3) Severe: 3 12 (34.3) VCSS: Venous clinical severity scoring system, : Endovenous laser ablation pre-operative SF-36 physical component summary score was ± 5.7 pts and on post-operative 1 st week and 1 st month, it was ± 3.8 and 59.9 ± 2.6 pts, respectively. In the stripping group, mean pre-operative SF 36 mental component summary score was ± 5.5 pts, while it was ± 4.1 and ±3.5 pts on post-operative 1 st week and 1 st month, respectively. Mean pre-operative SF-36 physical component summary score was ± 5.7 pts and on post-operative 1 st week and 1 st month it was ± 3.7 and ± 3.0 pts, respectively (Table 3). All of these findings were statistically significant (P < 0.01). Pre-operative and, post-operative SF 36 scale scores in both groups were compared statistically and quality of life scores were found to be better in group with lesser number of complaints (P < 0.01). Graphical distribution of SF- 36 quality of life scale scores is shown in Figures 1 and 2. Table 2: Frequency of CEAP score before and after intervention CEAP Pre treatment 4 (13.3) 8 (26.6) 20 (6.60) 22 (73.4) 15 (50) 6 (20) 10 (33.3) C 4 5 (16.6) C 5 Median Strıppıng 1 (2.8) 11 (31.4) 22 (62.8) 34 (97.2) 8 (22.8) 13 (37.1) C 4 12 (34.3) C 5 4 (11.4) Median Table 3: Quality of life before and after intervention (P<0.01) Quality of life (SF 36) Mental component summary Physical component summary Group stripping stripping Pre operative 37.86± ± ± ±3.3 : Endovenous laser ablation, SF 36: Short Form ± ± ± ± ± ± ± ±3.0

4 Original Research 15 DISCUSSION During the last 10 years, management of varices and venous has seen very important changes. Number of patients treated with methods alternative to stripping is rapidly increasing [8]. New treatment methods replacing classical surgical treatment are ultrasound guided liquid or foam sclerotherapy, radiofrequency ablation, therapy, trans illuminated powered phlebectomy, subfascial endoscopic perforator vein surgery, ambulatory conservative hemodynamic interventions and cryotherapy [9,10]. Mekako et al. compared short-term quality of life and venous severity scores in their venous patients who were treated with stripping or and observed that patients had lower short-term venous clinical severity scores and higher quality of life scores [11]. We also observed that is superior to stripping with respect to short-term outcomes and quality of life scores in that has shorter operative times with lower risk of bleeding and thrombus formation without operative scar tissue, in addition to higher SF36 scale and lower venous clinical severity scores. Kavaus et al. performed on 46 patients with venous in their medical center using laser at a wavelength of 940 nm and published their clinical outcomes [12]. Figure 1. Intergroup comparisons of Short Form-36 quality of life scale mental component data in the post-operative 1 st month. Mental component data in patients in the endovenous laser ablation group were more favorable Figure 2. Intergroup comparisons of Short Form-36 quality of life scale physical component data in the post-operative 1 st month. Physical component data in patients in the endovenous laser ablation group were more favorable Diagram 1. Consort diagram for process from eligibility to analysis

5 Original Research 16 Outcomes of this clinic indicated that the treatment of varices using endovascular laser is a safe and effective treatment modality. In our clinic, we performed at a wavelength of 1470 nm using laser catheter with fiber optic radial tip. Dependent on the diameter of the vein, we used w diode laser. In two patients recanalized blood flow was noted. In 13 patients, we didn t encounter any additional pathology and procedural complication. Since saphenous veins were ablated from 1 cm to 2 cm distal to saphenofemoral junction down to the knee level and adequate amounts of tumescent anesthetic agent were used, nerve and tissue damage were not seen. Pannier et al. indicated that 1470 nm wavelength is more effective than all other wavelengths [12]. In a non-randomized study, Leopardi et al. compared and classical surgery and observed inguinal hematoma in 3.1% the cases who had undergone classical surgery [13]. Thermal burns related to were observed in 2.5% of the cases and in both groups most frequently ecchymosis, paresthesis and induration were seen. Post-operative analgesic use was indicated to be more frequent in the group relative to the classical surgery. During 4 weeks of the follow-up period, saphenous vein was seen in 0.8% of the cases. It has been demonstrated that in the group, quality of life data are more favorable and SF-36 scale scores were higher during the 1 st and 6 th weeks of the follow-up period. In our study, in both groups, though not statistically significant, minor complications (ecchymosis, induration and paresthesias) were observed. In the group of patients, VCSSs estimated at the 1 st and 4 th weeks were statistically significantly lower in the group. In both groups SF-36 quality of life scale scores increased, while in the group they were higher relative to the classical surgery group with better patient satisfaction. CONCLUSION In saphenous vein insufficiencies, which is one of the alternative methods to stripping, is an efficient and safe treatment modality with its shorter procedural time, lack of development of surgical scar, lower bleeding risk and better quality of life outcomes when compared with the stripping method. REFERENCES 1) Nicolaides AN, Allegra C, Bergan J, et al. Management of chronic venous disorders of the lower limbs: Guidelines according to scientific evidence. Int Angiol 2008;27: ) Howard A, Howard DP, Davies AH. Surgical treatment of the in competent saphenous vein. In: Gloviczki P, Dalsing MC, Eklöf B, Moneta GL, Wakefield TW, editors. Handbook of Venous Disorder. 3 rd ed., Vol. 35. London: American Venous Forum, Edward Arnold; p ) Porter JM, Moneta GL. Reporting standards in venous disease: An update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg 1995;21: ) Padberg FT Jr. CEAP classification for chronic venous disease. Dis Mon 2005;51: ) Lozano Sánchez FS, Sánchez Nevarez I, González- Porras JR, et al. Quality of life in patients with chronic venous disease: Influence of the socio-demographical and clinical factors. Int Angiol 2013;32: ) Yang L, Wang XP, Su WJ, Zhang Y, Wang Y. Randomized clinical trial of endovenous microwave ablation combined with high ligation versus conventional surgery for varicose veins. Eur J Vasc Endovasc Surg 2013;46: ) Koçyiğit H, Aydemir Ö, Fişek G, Ölmez N, Memiş A. Knee ınjury and osteoarthritis outcome score: Reliability and validation of the Turkish version. Turkiye Klinik J Med Sci 2007;27: ) Stirling M, Shortell CK. Endovascular treatment of varicose veins. Semin Vasc Surg 2006;19: ) Subramonia S, Lees TA. The treatment of varicose veins. Ann R Coll Surg Engl 2007;89: ) Uncu H. Patient Selection for Endovenous Treatments of the Varicose Veins of Lower Extremity. Turkiye Klinik J Cardiovasc Surg Spec Top 2009;2: ) Mekako AI, Hatfield J, Bryce J, Lee D, McCollum PT, Chetter I. A nonrandomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins. Ann Vasc Surg 2006;20: ) Firouznia K, Ghanaati H, Hedayati M, et al. Endovenous laser treatment (EVLT) for the saphenous reflux and varicose veins: a follow-up study. J Med Imaging Radiat Oncol 2013;57: ) Pannier F, Rabe E, Maurins U. First results with a new 1470-nm diode laser for endovenous ablation of incompetent saphenous veins. Phlebology 2009;24:26-30.