1. Implementation of a new two-ring radial-fiber combined with
1470 nm diode laser as promising standard treatment for
great saphenous vein insufficiency of more than 8mm
Aljoscha Greiner; Knuth Rass; Norbert Frings; Andreas Fiebig
Background
Endovenous laser treatment (ELT) by intraluminal laser administration is a promising standard treatment for great saphenous vein (GSV) insufficiency. Duplex ultrasound (DUS) is the most frequently used investigation to evaluate the ELT outcome. DUS imaging is the ideal non-invasive follow-up method as it provides anatomical and haemodynamic information about the treated veins. Effective treatment of the vein includes the optimal amount of energy for a certain size of the vein diameter to ensure perfect vein ablation and to reduce any effect of carbonization or pain. Due to the fact that veins are long tubes a radial emitting laser probe is suitable for any bionic concept for the perfect treatment of any vascular organic system. The last step in the recent development of radial emitting laser probes is the new two-ring radial-fiber in combination with a 1470 nm diode laser.
Main-study data analysis (n=50): Patients with an average age of 47.1 years with a range from 20 to 71 years (SD = 15.45). Observation subgroup A (n=10) mean (SD) diameter = 9.0 mm (1.2) and subgroup B (n=40) mean (SD) diameter = 6.0 mm (1.6). Occlusion-rate of 100 % for both subgroups. The length of the treated GSV was 43.9 cm (SD=10.3). Laser treatment was continuously carried out with a power of 13.4 watts (10-15: SD=1.21) 3cm around the SFJ resulting in a LEED of 91.5 J/cm (SD= 8.49) and an EFE of 53.3 J/cm2 (SD=14.3). In regard of the vein trunk 13.2 watts (10-15:SD= 1,23) have been applied until the end. The average LEED was 90.5 J/cm (SD=8.6) and EFE was J/cm2 (SD=14.9). No significant differences could be observed between male and female subjects. After the laser treatment the average diameter was 4.7 mm (52.2%) and 2.6 mm (48.1%) for subgroup A and B respectively 3cm from the SVJ. Data result from 1.2 days after the ELT. Modified CEAP severity score dropped down from 2.04 C classes to 0.45 C classes. In 35 cases of the main study (70%) the patients were very satisfied with the chosen method and 34 patients (68%) would choose it again. Just 10 patients (20%) would probably choose the method again and 6 patients (12%) were uncertain about a potential choice 1.2 days after treatment.
Objective
The purpose of this project is to implement the new two-ring radial-fiber in combination with a 1470 nm diode laser as promising standard treatment for great saphenous vein insufficiency (diameter 3 cm distal to junction) of more than 8 mm. Our study aims to improve an effective treatment of the vein by defining the ideal biometric data for best practice. Second we combine in our study good clinical practice and patient focus evaluation such as Clinical, Etiologic, Anatomic and Pathophysiologic Data (CEAP), Venous Clinical Severity Score (VCSS) and CIVIQ1. 1
Conclusion
We demonstrated an effective method to treat large insufficient GSV (diameter above 8 mm) by using the new developed two-ring radial-fiber laser (Biolitec). This new design needs less energy and results in an optimal homogenous radiation. The patient satisfaction was high. In our main-study we could and will still demonstrate additional results: modified CEAP severity was much better after 1.2 days, but of course this has to be verified at least after 3 and 6 month. Patient satisfaction rate was high but will be evidenced again. We finally would like to mention that no significant difference in the occlusion-rate between subgroup A and B could be observed in both studies. The recruitment of 250 additional patients has to be completed. The study staff will continue to perform follow-up visits every three month. The return visit data are of critical importance as they will allow us to examine the process of vein degradation over time.
Methods / Subjects
Patients suffering from a great saphenous vein insufficiency were assigned to ELT using the new developed two-ring radial-fiber (Biolitec) in combination with a 1480 nm diode laser. All interventions were performed on ambulatory patients in a specialized vein center in Germany. A pre-study with 226 patients has been performed. The main-study with a planned examination of 300 additional patients has started in March this year. Up to now, we have enrolled further 50 patients into the main study. Main outcome measures include occlusion-rate, venous clinical severity scoring, quality of life, biometric data, energy density data and compression therapy. Performance characteristics of each ELT are evaluated, including length of the treated vein diameter of the vein and LEED. Each patient is asked to return for clinical evaluation approximately every 3 months. Duplex examination was done in line towards the UIP consensus document 2. 2
References
1. Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. (1999) Evaluating and improving health-related quality of life in patients with varicose veins. J Vasc Surg. 30(4):710-9.
2 = De Maeseneer M, et al., Duplex Ultrasound Investigation of the Veins of the Lower Limbs after Treatment for Varicose Veins UIP Consensus Document, Eur. J. Vasc. Endovasc. Surg. (2011), doi: /j.ejvs
Acknowledgements
Special thank you to the clinical staff at the Capio MVZ at Bad Bertrich / Germany and the team of the KN-CVK / at Kiel & Berlin / Germany. to Andreas Fiebig:
Results
Pre-study data analysis (n=226): Observation of 226 patients with a mean (SD) diameter of 7.2 mm (1.8) 3 cm distal to the junction of the great saphenous vein.
Sex specific analysis: females (n=166) mean = (SD) 7.1 mm (1.7) and males (n=60) mean (SD) = 7.5 mm (2.0). Comparison of patients with a diameter ≥ 8mm (subgroup A) versus < 8mm (subgroup B). Observation of subgroup A (n=72): mean (SD) diameter = 9.2 mm (1.0) and of subgroup B (n=154): 6.3 mm (1.3). Occlusion-rate ≥ 99.1 % for all patients. No difference between subgroup A and B in terms of occlusion.
Pictures
Picture 1: Endovenous laser procedure
Picture 2: Patient 005 (examination on ) cross section of V. saphena magna 3cm to SFJ before laser treatment. Calculated with a venous diameter of 10.41mm (calculated with value C of ellipse perimeter). ELT treatment was performed on the same day.
Picture 3: Patient 005 (follow-up on ) cross section of V. saphena magna after ablation. Calculated mean venous diameter of 6.14mm. Vein contracts to 58.98% of the baseline value. 3