To evaluate the safety, efficacy and ≥36 months outcomes of endovenous laser ablation (EVLA) by means of 1940 nm laser with radial fiber for the treatment of truncal vein insufficiency and compare the results to a historical cohort, obtained via reviewing the literature. Methods: This prospective, non-randomized, single-center clinical study included 139 consecutive patients with 177 incompetent great saphenous (GSV, n = 135) and short saphenous veins (SSV, n = 42). The maximum laser power (Pmax. 10 W) and pullback velocity were adjusted individually (V max = 1 mm/s). The laser fiber was placed at the junction to the deep vein under duplex monitoring. Simultaneous phlebectomies were performed on all the patients. Regular follow up with clinical and duplex ultrasound examination (DUS) were carried out postoperatively at 1 month (1 M), 6 months (6 M), 12 months (12 M), 24 months (24 M), 36 months, and after that (≥36 M). The results were compared with three cohorts (total 616 EVLA procedures with 1470 nm laser and radial fiber) from literature (criteria: >100 procedures, follow-up of ≥2 years). Results: The follow-up rate was 100%, 91%, 73%, 48%, and 23% of the truncal veins at 1, 6, 12, 24, and ≥36 M, respectively. In comparison to the literature using 1470, a lower average linear endovenous energy density (LEED) (53 vs. 77-82 J/cm) resulted in 100% (6 M) and 96.5% (24 M) occlusion rates, reduced local ecchymosis (2.2% vs. 3.2%-18.7%) and reduced average postoperative pain levels (1.3 vs. 2.18). Regarding adverse events, induration (1.1% vs. 1.8%), skin burns (0% vs. 0.45%), endovenous heat-induced thrombus propagation (EHIT) in the deep veins (2.3% vs. 1.8%) and laser-induced persistent paresthesia (2.2% vs. 0.5%-2.9%) were comparable. Recanalizations observed in this study (GSV 0, SSV 3) were asymptomatic and required no treatment. At ≥36 M reflux in the accessory veins was observed in 5% versus 10.5% of patients. Reintervention was required in none (0% vs. 21%). At >36 M, short average stump lengths of 1 cm (GSV) and 0.3 cm (SSV) were observed. Conclusion: EVLA with 1940 nm laser with radial emitting fiber is as safe and effective as 1470 nm laser for the treatment of truncal vein insufficiency. Lower postoperative pain, low analgesic requirements, short convalescence add to patients' comfort. EVLA with 1940 nm laser-guided by intraoperative DUS permits reproducible placement of the radial fiber at the saphenofemoral and saphenopopliteal junction, enabling further studies to assess the effect of shorter stump length on patterns and frequency of recurrence without increased risk of EHIT.
Objective:Several studies indicate that ELT using wavelengths of high water absorption showed advantages compared to conventional ELT. Thulium-Lasers emit nearby the local absorption maximum of water at 1940nm. In this clinical study the effectiveness, safety and the feasibility of 1940nm-ELT is proven. Materials and Method:A single centric, prospective observational study was performed. 1940nm-laserenergy was applied using radial emitting fibres with continuous pullback (1mm/s). Treatment was performed under anesthesia (general, spinal, tumescent) thus simultaneous miniphlebectomy and ligation of perforators could be applied. Patient and technical details were systematically collected. Evaluation included: standardized questionnaire, clinical examination, color-duplex ultrasonography preoperatively, 3d, 4w, 6m postoperatively, statistic. Results:The 1940nm-ELT study include 55 patients (female/men=34/21, mean age 55y, range 23-90y) treating n=72 vessels. The mean maximum diameter of great saphenous veins (GSV, n=59) was 7.5mm (range 3.7-11.3mm) and of small saphenous veins (SSV, n=13) was 5.3mm (3.0-10.0mm). The mean applied longitudinal endovenous energy density (LEED) was 64.3J/cm (40.3-98.2J/cm) in GSVs and 51.0J/cm (37.6-72.7J/cm) in SSVs. Complete occlusion of the vein without sign of reflux was achieved in 100%. The mean length of non-occluded stump at the sapheno-femoral junction was 6.0mm (1.0-20.0mm). Postoperative reduction of the diameter of GSV was 1.6mm (21.3%) and 2.0mm (37.7%) in SSV. One (1.4%) endovenous heat induced thrombus (EHIT) was observed. Further adverse events were: paresthesia 10/72 (13.9%), ecchymosis 1/72 (1.4%), lymphocele 1/72 (1.4%), hyperpigmentation 1/72 (1.4%). The mean postoperative pain intensity was 1.3 and 1.8 single doses of analgesics were administered. Normal physical activity was reached after 3d (1-21d).Conclusion: 1940nm-ELT using radial light application effectively eliminates the reflux in insufficient saphenous veins by a significant diameter reduction. The risk profile correlates with other endothermal treatment options. Low postoperative pain and analgesic requirements with rapid convalescence indicate a high level of patient comfort.
rate within the first year from 30% to 10% of the patient population. A secondary objective is a non-inferiority of MonoMax suture material (group C) in comparison to MonoPlus (group A). Results: 108 patients were randomized between February 2011 and July 2013. The compare of demographic data, risk factors and co-morbidities did not reveal structural differences between the study groups. After 12 months 4.55% of the patients with an additional implanted mesh in onlay position (group B) had developed an incision hernia versus 21.74% undergoing midline closure using two monofilaments suture loops (group A). In group C 18.18% of patients with 12-months-follow-up had an incision hernia. Non-parametric binomial testing assuming a hernia rate of 20% or 30% after 12 months was performed. For group A and C, herniation significantly differing from 20% (p ¼ 0.499 respectively p ¼ 0.543) or 30% (p ¼ 0.269 respectively p ¼ 0.165) could be refused, while the number of hernias in group B significantly differed from 20% (p ¼ 0.048) and 30% (p ¼ 0.004). Wound healing disorders occurred in15.19%. Notable differences were visible in formation of seromas which were exclusively found in patients of group B (19.23%) but not in group A or C. In total, re-surgery of the abdominal wall was performed in n ¼ 11 patients (10.68%). This number also includes n ¼ 4 non-emergency interventions (revision of the abdominal wall because of persistent seroma or repair of incision hernia). Conclusion: Additional mesh in onlay position after median laparotomy for AAA can reduce hernia rate significantly.
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