Homogeneously Emitting, Mechanically Stable, and Efficient fs-Laser-Machined Fiber Diffusers for Medical Applications.

BACKGROUND AND OBJECTIVES: Light delivery is an essential part of therapy forms like photodynamic therapy (PDT), laser-induced thermotherapy, and endovenous laser therapy. While there are approaches to the light application for all three therapies, there is no diffuser that can be used for all three approaches. This diffuser must meet the following criteria: Homogeneous radiation profile over a length of 40 mm, efficient light extraction in the diffuser area, mechanical breakage resistance as well as thermal stability when applying high power. STUDY DESIGN/MATERIALS AND METHODS: An ultrashort pulse laser was used to inscribe inhomogeneities into the core of a fused-silica fiber core while scanning the laser focus within a linear arrangement of cuboids centered around the fiber axis. The manufactured diffuser was optically and mechanically characterized and examined to determine the maximum power that can be applied in a tissue environment. RESULTS: Based on the analysis of all examined diffusers, the manufactured diffuser exhibits an emission efficiency ε = (81.5 ± 5.9)%, an intensity variability of (19 ± 5)% between distal and proximal diffuser end, and a minimum bending radius Rb = (15.4 ± 1.5) mm. It was taken advantage of the fact that the outer areas of the fiber core do not undergo any structural changes due to the machining and therefore do not suffer a major loss of stability. Tissue experiments revealed that a maximal power of 15 W was deliverable from the diffuser without harming the diffuser itself. CONCLUSIONS: It could be shown that a diffuser manufactured by ultrafast-laser processing can be used for low power applications as well as for high power applications. Further tests have to show whether the mechanical stability is still maintained after the application of high power in a tissue environment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Perioperative quality assessment of varicose vein surgery : Commission for quality assessment of the German Society for Vascular Surgery.

PURPOSE: An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). METHODS: Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15-96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists' (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. RESULTS: Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) CONCLUSIONS: Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.

Surgical management of great saphenous vein varicose veins: A meta-analysis.

PURPOSE: The purpose of this systematic review and meta-analysis is to synthesise the available evidence of randomised controlled trials comparing endovenous laser therapy to traditional open surgery, high ligation and stripping, for the treatment of great saphenous vein varicose veins in terms of clinical effectiveness, patient satisfaction and peri-operative complications. METHODS: MEDLINE, CINAHL, EMBASE and the Cochrane library were searched to identify eligible studies. All randomised controlled trials comparing endovenous laser therapy to high ligation and stripping that used ultrasound examination as an outcome measure and had follow up of one year or more were included. The Cochrane Collaboration's tool for assessing risk of bias was also used to assess the methodological quality of the included studies. Pooled risk ratios with 95% confidence intervals were used as the measure of effect for each dichotomous outcome. FINDINGS: Nine eligible publications relating to six randomised controlled trials were identified. The total enrolment of the studies was 1289 limbs. The clinical efficacy of endovenous laser therapy is comparable to that of surgery in the relatively short follow up period described in the studies. Meta-analysis revealed a trend towards a higher risk of ultrasound recurrence after endovenous laser therapy at 12 months. Quality of life questionnaires reveal similar outcomes for endovenous laser therapy and surgery. There is low quality evidence to suggest surgery is associated with more pain, sensory complications and infection. CONCLUSION: Endovenous laser therapy is a safe alternative to traditional open surgery. There is some weak evidence to suggest that endovenous laser therapy has a higher risk of ultrasound-detected recurrence at 12 months following treatment compared to open surgery. However, it may be associated with less sensory complications, pigmentation and infection.

Endovenous laser ablation of the great and short saphenous veins with a 1320-nm neodymium:yttrium-aluminum-garnet laser: retrospective case series of 1171 procedures.

BACKGROUND: Venous insufficiency is a common medical condition affecting up to 50.5% of women and 30.1% of men. Endovenous laser ablation is a minimally invasive procedure that safely and effectively treats reflux involving the great and short saphenous veins. OBJECTIVE: We sought to present safety and efficacy data of 1171 endovenous laser ablations using the Scripps Clinic endovenous laser therapy (EVLT) protocol. METHODS: We conducted an institutional review board-approved, retrospective chart analysis of 1171 endovenous laser ablations performed from March 2007 until February 2011 treated at Scripps Clinic with the 1320-nm neodymium:yttrium-aluminum-garnet laser with 1-month, 6-month, 1-year, and 2-year follow-up data. RESULTS: Our current overall experience is greater than 2000 EVLT procedures. The mean follow-up for this case series of 1171 EVLT procedures (1066 great saphenous veins and 105 short saphenous veins) is 11.4 months with an overall closure success rate of 99.9% for patients not lost to follow-up. There has been no incidence of deep vein thrombosis, permanent nerve damage, or pulmonary embolism related to laser ablation. LIMITATIONS: Retrospective chart analysis, investigator bias, patients lost to follow-up, and lack of quality-of-life assessment are limitations. CONCLUSION: EVLT using a 1320-nm neodymium:yttrium-aluminum-garnet laser appears to be a viable option for venous insufficiency and venous ulceration unresponsive to conservative treatment.

Delineating the durability outcome differences after saphenous ablation with laser versus radiofrequency.

OBJECTIVE: The mechanism of delivering thermal energy to the vein wall differs between endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). Different mechanisms of ablation may have different effects on the durability of these procedures typically performed for saphenous vein insufficiency. Whether there is a difference in long-term durability outcomes between these two techniques remains uncertain. This study aimed to delineate the durability outcome differences in terms of recurrence rate and pattern. METHODS: A retrospective review identified 270 consecutive patients who underwent saphenous ablation using EVLA or RFA between July 2013 and October 2016. The primary end points were clinical symptom recurrence and anatomic recurrence of reflux. RESULTS: Overall, 343 limbs were included in the study; 246 limbs (183 patients) underwent EVLA and 97 limbs (87 patients) underwent RFA. The mean follow-up time was 112 days for EVLA (range, 2-1153 days) and 106 days for RFA (range, 3-735 days; P = .786). No significant differences were observed between the groups with respect to demographic data, Clinical, Etiological, Anatomical, Pathophysiological classification, or ratio of great saphenous vein to small saphenous vein treated. The mean time to recurrence of symptoms was 219 days longer with EVLA (n = 8; mean, 774 days; range, 187-1042 days) than RFA (n = 4; mean 555 days; range, 341-616 days). Kaplan-Meier estimates for 1- and 3-year freedom from clinical recurrence were 100% and 96% for EVLA and 97% and 93% for RFA, respectively. There was no difference between the two groups (log rank, P = .0666). In cases with recurrent reflux documented on duplex (four in the EVLA group and three in the RFA group), the thigh segment was the most frequently involved site (75% in EVLA, 67% in RFA). Same site recanalization was significantly less frequent in EVLA (0.82% in EVLA vs 2.06% in RFA; P = .0388). New areas of reflux developed at a similar rate between the groups, in 0.82% of EVLA limbs in the anterior accessory saphenous vein and the calf great saphenous vein, and in 1.03% of RFA limbs in the anterior accessory saphenous vein (P = .8436). CONCLUSIONS: The results of our study suggest that the outcomes of EVLA and RFA performed for saphenous vein insufficiency may differ in the long term. The clinical recurrence rates are similar, but the anatomic recurrence patterns may differ, with more frequent treated site recurrence in the RFA group.

A rare anatomical variation of great saphenous vein at the level of saphenofemoral junction.

The saphenofemoral junction is one of the major connections between the superficial and deep venous system in the leg. It is important to understand the anatomic variations in the lower extremity for treatment of venous disorders. There are many variations of the superficial system, most of them are with the great saphenous vein. A rare anatomic variant where the great saphenous vein is located between the superficial femoral and profunda arteries at the level of saphenofemoral junction is discussed in our case report.

The role of compression after endovenous ablation of varicose veins.

OBJECTIVE: The aim of this review was to identify the evidence regarding the optimal duration of compression therapy after endovenous ablation of varicose veins. METHODS: Electronic databases were searched for studies assessing the use of compression after endovenous ablation in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The primary outcomes for this study were pain score and complications. Secondary outcomes were time to full recovery, quality of life score, leg circumference, bruising score, and compliance rates. RESULTS: Following strict inclusion and exclusion criteria, five studies were included in our review, including a total of 734 patients. The short-duration compression therapy ranged from 4 hours to 2 days, whereas the longer duration ranged from 3 to 15 days. A single study showed a better outcome in terms of complications with a short compression therapy. A single study showed a benefit to pain and quality of life with extended compression therapy, whereas the others did not. There was no significant difference in terms of bruising, recovery time, and leg swelling. CONCLUSIONS: Our review showed that there is no evidence for the extended use of compression after endovenous ablation of varicose veins.

The Outcome of Anticoagulation on Endovenous Laser Therapy for Superficial Venous Incompetence.

OBJECTIVES: The purpose of this study was to evaluate whether anticoagulation (warfarin or direct oral inhibitors) affected the success of endovenous treatment. METHODS: Patients taking anticoagulation (warfarin or direct oral inhibitors) undergoing endovenous treatment in the form of endovenous laser ablation (EVLA) were matched against controls for sex, age, leg, and vein. Data were collected prospectively between January 2012 and March 2017. The primary endpoint was failure of treatment at 6-week postoperative duplex scan. The rates of major bleeding, hematoma, endothermal heat-induced thrombosis, venous thromboembolism, or pulmonary embolism were also compared between groups. RESULTS: Two hundred eighty-four limbs underwent EVLA during the study period. Of this, 23/284 (8.1%) procedures were done in patients on anticoagulation. 21/23 (91.3%) limbs had venous occlusion at follow-up compared with 23/23 (100%) of controls ( P = .49). The patient who failed treatment in the anticoagulation group had undergone small saphenous vein (SSV) ablation. There was no difference in the complication rates between groups. DISCUSSION: This study demonstrates that anticoagulation does not affect success rates of EVLA though there was higher recanalization rate in patients undergoing SSV ablation. Anticoagulation can be continued safely in patients undergoing this procedure.

Chronic Venous Insufficiency: Novel Management Strategies for an Under-diagnosed Disease Process.

Chronic venous insufficiency is an often-missed diagnosis that results in a variety of clinical manifestations that may severely compromise quality of life. Prompt recognition is important to provide symptomatic relief and prevent disease progression. Most patients can be treated with a comprehensive plan of conservative measures. However, it is important for providers to recognize those patients who require referral to a vascular specialist for more invasive therapies. Over the past 2 decades, a variety of endovenous strategies have demonstrated effective and lasting results in treatment of severe symptomatic venous insufficiency. [Full article available at http://rimed.org/rimedicaljournal-2017-05.asp].

Ozone Gas Bath Combined with Endovenous Laser Therapy for Lower Limb Venous Ulcers: A Randomized Clinical Trial.

BACKGROUND: Endovenous laser therapy (EVLT) is safe and effective for lower limb venous ulcers. However, severe necrosis and infection in the ulcer area are contraindications of puncture and EVLT. Local bath with ozone gas has been shown to improve the condition of ulcer areas. The aim of this study was to evaluate the clinical efficacy of ozone gas bath combined with EVLT in comparison with EVLT alone for the treatment for lower limb venous ulcers. PATIENTS AND METHODS: Ninety-two patients with venous ulcers were randomized to receive ozone gas bath combined with EVLT (OEVLT group) or EVLT alone (EVLT group). In the OEVLT group, the venous ulcers were preconditioned with ozone gas bath prior to EVLT. The minimum follow-up time was 12 months. The two groups were compared in terms of complete occlusion of the treated veins, ulcer healing ratio, ratio of ulcer recurrence, patient satisfaction, complications, and side effects. RESULTS: There was no significant difference in venous occlusion between the two groups. The ratio of ulcer healing in the OEVLT group was significantly higher than the EVLT group at 12 months follow-up. Patients in the OEVLT group showed better satisfaction and a lower recurrence ratio than the OEVLT group. No severe complications or side effects occurred in either groups. CONCLUSIONS: Ozone gas bath combined with EVLT showed improved efficacy for the treatment of lower limb venous ulcers and lower recurrence ratio comparison with EVLT alone. This procedure is a safe and technically feasible.

Volumetric optoacoustic imaging feedback during endovenous laser therapy - an ex vivo investigation.

Endovenous laser therapy (ELT) was introduced in clinical practice for treating incompetent veins about fifteen years ago. Despite the considerable clinical evidence collected so far, no rigorous guidelines are yet available regarding the optimal energy deposition protocols while incidence of recanalization, lack of vessel occlusion and collateral damage remains variable among patients. Online monitoring and feedback-based control over the lesion progression may improve clinical outcomes. Yet the currently employed monitoring tools, such as Doppler ultrasound, often do not provide sufficient contrast as well as three-dimensional imaging capacity for accurate lesion assessment during thermal treatments. Here we investigate on the utility of volumetric optoacoustic tomography for real-time monitoring of the ELT procedures. Experiments performed in subcutaneous veins of an ox foot model revealed the accurate spatio-temporal maps of the lesion progression and characteristics of the vessel wall. Optoacoustic images further correlated with the temperature elevation measured in the area adjacent to the coagulation spot and made it possible to track the position of the fiber tip during its pull back in real time and in all three dimensions. Overall, we showcase that volumetric optoacoustic tomography is a promising tool for providing online feedback during endovenous laser therapy.

Comparative Study of Cryostripping and Endovenous Laser Therapy for Varicose Veins: Mid-Term Results.

BACKGROUND: Conventional stripping is considered to be the standard procedure for great saphenous vein (GSV) varicosities, but many other alternative treatments such as cryostripping, endovenous laser therapy (EVLT), radio-frequency ablation, and ultrasound-guided foam sclerotherapy have been developed. Among them, both cryostripping and laser therapy have been reported to be less traumatic, with lower rates of complications and recurrences when compared to conventional stripping. To compare the efficacy of these treatments, we have analyzed and compared the mid-term clinical outcomes of cryostripping and EVLT. METHODS: Patients diagnosed with varicose veins of the GSV and treated with cryostripping or laser therapy between September 2008 and April 2013 were enrolled in this study. Duplex ultrasonography was used for the diagnosis and evaluation of varicosity and reflux, and the clinical-etiology-anatomy-pathophysiology classification was used to measure the clinical severity. The symptoms, Venous Clinical Severity Score (VCSS), recurrence rates, and complication rates of the cryostripping and laser therapy groups were analyzed and compared. RESULTS: A total of 68 patients were enrolled in this study. 32 patients were treated with cryostripping, and 36 patients were treated with laser therapy. The median follow-up period was 29.6 months. Recurrence was noted in three patients from the cryostripping group and in two patients from the EVLT group. There was no difference in the VCSS score, operative time, duration of hospital stay, and complication rate between the cryostripping group and the EVLT group. CONCLUSION: The mid-term clinical outcomes of cryostripping were not inferior to those of EVLT. Further, considering its cost-effectiveness, cryostripping seems to be a safe and feasible method for the treatment of varicose veins.

Anatomical and clinical factors favoring the performance of saphenous ablation and microphlebectomy or sclerotherapy as a single-stage procedure.

OBJECTIVE: To identify the anatomical and clinical parameters that predict lack of regression of superficial varicosities after ablation of the great saphenous vein. METHODS: Symptomatic patients treated with endovenous ablation from August 2006 to July 2013, by a single surgeon, were included. Recorded parameters included age, sex, size, and extent of varicosities (class I-IV) (patient standing), and diameter and length (patient supine) of treated great saphenous vein. Varicose vein classification was defined as: class I ≤6 mm and localized to thigh or leg, class II ≤6 mm and present in the thigh and leg (extensive), class III >6 mm and localized to the thigh or leg, and class IV >6 mm and extensive. "Excellent" results were defined as complete resolution of varicosities, "good" results as incomplete resolution, and "poor" results as no improvement. RESULTS: A total of 267 patients and 302 consecutive limbs were included in the study. There were 175 females (65.5%), and the mean age was 54 years old (22-92). The CEAP classification was as follows: C2 (81.5%), C3 (6.3%), C4 (7.9%), C5 (2.0%), and C6 (2.3%). Great saphenous vein diameters was significantly larger in patients with C3-C6 (proximal 0.84 ± 0.25 versus 0.65 ± 0.21, p = < 0.0001, distal 0.58 ± 0.18 versus 0.44 ± 0.13, p < 0.0001) or class III-IV varicose veins (proximal 0.85 ± 0.25 versus 0.75 ± 0.27, p = 0.012, distal 0.62 ± 0.62 versus 0.50 ± 0.17, p < 0.0001). Class III-IV limbs had a "good/poor" result 69.8% of the time, as compared to 51.9% of the limbs class I-II varicose veins (p = 0.002). CONCLUSIONS: Advanced chronic venous disease (C3-C6) patients have larger diameter great saphenous veins, reflecting the progressive nature of the disease. Patients with more severe varicosities regardless of CEAP class were more likely to require a secondary procedure. The severity of the varicosities may not correlate with the degree of venous disease, but it is an indication of which patients should undergo secondary procedures, possibly with a one-stage approach.

Two cases of arteriovenous fistula formation between the external iliac vessels following endovenous laser therapy.

Minimally invasive treatment of varicose veins is becoming increasingly popular with both patients and physicians. Endovenous laser therapy has been shown to be safe and effective but the rare complication of iatrogenic creation of arteriovenous fistulas has been described. One case of fistulation between the external iliac artery and vein has been published. We report two further cases and describe their management.

Primary care trust commissioning of varicose vein intervention--new guidance needed?

OBJECTIVES: In light of evidence of national variability in service commissioning of varicose vein intervention, our aim was to evaluate the current state of primary care trust commissioning for all forms of varicose vein intervention in England. We also sought to clarify the extent to which access to endovenous and surgical varicose vein services is being restricted. METHODS: Under the Freedom of Information Act (2001), a structured email survey was sent to 108 primary care trusts in England. Trusts were asked how many elective endovenous laser therapy and open procedures were commissioned from 2008 to 2011 and they were asked to submit their commissioning policy for analysis. The 'qualifying criteria' expressed in each policy were analysed by theme and geographical region. RESULTS: Of 108 surveys, 95 (88%) were completed and returned. Of these, 91 (96%) stated that varicose vein interventions were actively commissioned. Eighty-eight (97%) of primary care trusts that commissioned varicose vein interventions stated that access was restricted. Qualifying criteria varied considerably between regions. CONCLUSIONS: Access to varicose vein intervention appears to be restricted, with national variation in commissioning across England. This might have an impact on patient care and surgical training. We propose that a national decision be made about which varicose vein patients should be offered funding for treatment on the National Health Service.