Efficacy and safety of endovenous laser ablation with the 1470 nm diode laser using a novel optical probe.

Objectives: Outcome assessment of a novel optical fiber probe for the 1470 nm diode laser under real-world conditions. Methods: Prospective clinical pilot study in 10 patients undergoing endovenous laser ablation with a follow-up period of 1 year. Primary endpoints were efficacy and safety. Secondary endpoints include, inter alia, quality of life and patient satisfaction. Results: After a follow-up period of 1 year all treated vein segments were still occluded. Only mild and short-term side effects (hematoma, ecchymosis and hyperpigmentation) were observed. No intake of pain medication was needed and a quick return to normal activity was documented (0.9 days). Clinical hallmarks of the venous disease (VCSS) improved significantly (p= .003). All patients were very satisfied with the treatment and quality of life (AVVQ) was significantly improved after the procedure (p=.008). Conclusions: The study demonstrates that the endoluminal treatment with the novel fiber probe is highly effective and safe.

Endovenous (minimally invasive) procedures for treatment of varicose veins : The gentle and effective alternative to high ligation and stripping operations.

Thermal ablation of saphenous vein varicosis has developed into a standard procedure for treatment of varicose veins. The clinical success of the endovenous thermal procedure is comparable to high ligation and stripping operations and a significant difference between these groups could not be detected in long-term analyses. The only difference is in the genesis of saphenofemoral recurrence detected by duplex ultrasound: neoangiogenesis occurs after high ligation and stripping operation and after endovenous ablation of the great saphenous vein a recurrence occurs predominantly via a residual anterior accessory saphenous vein (AASV). Reduction of costs by an increase in endovenous procedures carried out in an outpatient setting in comparison to stripping operations, which are still frequently carried out in Germany (in comparison to other countries) as an inpatient procedure, have meanwhile been confirmed. An endovenous crossectomy (i.e., high ligation) should be strived for. Nonthermal endoluminal catheter procedures are predominantly reserved for treatment of the short saphenous vein.

[Endovenous (minimally invasive) procedures for treatment of varicose veins : The gentle and effective alternative to high ligation and stripping operations]. / Endovenöse (minimalinvasive) Verfahren zur Therapie der Varikose : Schonende und effektive Alternative zur Stripping-Operation.

Thermal ablation of saphenous vein varicosis has developed into a standard procedure for treatment of varicose veins. The clinical success of the endovenous thermal procedure is comparable to high ligation and stripping operations and a significant difference between these groups could not be detected in long-term analyses. The only difference is in the genesis of saphenofemoral recurrence detected by duplex ultrasound: neoangiogenesis occurs after high ligation and stripping operation and after endovenous ablation of the great saphenous vein a recurrence occurs predominantly via a residual anterior accessory saphenous vein (AASV). Reduction of costs by an increase in endovenous procedures carried out in an outpatient setting in comparison to stripping operations, which are still frequently carried out in Germany (in comparison to other countries) as an inpatient procedure, have meanwhile been confirmed. An endovenous crossectomy (i.e. high ligation) should be strived for. Nonthermal endoluminal catheter procedures are predominantly reserved for treatment of the short saphenous vein.

Safety of synchronous prophylactic ablation of the anterior saphenous vein in patients undergoing great saphenous vein thermal ablation- 6 months follow-up data of the SYNCHRONOUS study.

BACKGROUND: The SYNCHRONOUS-study investigates simultaneous ASV-ablation with great saphenous vein (GSV) treatment in endovenous laser ablation (EVLA) for preventing varicose vein recurrence. This sub-study examines complication rates associated with prophylactic ASV-ablation. METHODS: Among 1173 patients with refluxing GSV, 604 underwent GSV-ablation only, and 569 received additional ASV-ablation. Complication rates were compared over 6 months. RESULTS: Approximately 80% of patients were complication-free with minor bruising and dysesthesia being most common complications. After 6 months, additional prophylactic ASV-ablation did not increase the rate of complications compared to GSV-only treatment. CONCLUSION: The 6-months follow-up data suggests that prophylactic ASV-closure, alongside GSV-treatment, is safe, with similar complication rates to GSV-only EVLA.

Compression therapy after endovenous laser ablation: Patient compliance and impact on clinical outcome.

OBJECTIVES: This study aimed to investigate the impact of post-interventional compression therapy on clinical outcomes after endovenous laser ablation (EVLA) of incompetent saphenous veins. METHODS: This prospective, controlled, multicenter study in Germany involved 493 varicose vein patients followed-up for 6 months. RESULTS: Compression therapy significantly reduced symptoms compared to no compression (VCSS: 1.4 ± 1.6 vs 2.2 ± 2.2; p = .007). Post-interventional therapy duration of up to 14 days was found to be most effective for improving patient-reported disease severity (p < .001) and higher quality of life (p = .001). Patient compliance was high (82%), and non-compliance was linked to worse disease severity (VCSS 1.4 ± 1.5 vs 2.1 ± 2.3, p = .009). CONCLUSION: In conclusion, post-interventional compression therapy is beneficial by reducing symptoms and improving quality of life. High patient compliance with the therapy is observed, and non-compliance is associated with worse disease severity.

Impact of a synchronous prophylactic treatment of the anterior accessory saphenous vein on the recurrent varicose vein rate in patients undergoing thermal ablation of an insufficient great saphenous vein (SYNCHRONOUS-Study): study protocol for a prospective, multicentre, controlled observational study.

INTRODUCTION: To date, there are no prospective studies evaluating the prevention of recurrent veins by the simultaneous treatment of a sufficient anterior accessory saphenous vein (AASV) in patients undergoing endovenous laser ablation (EVLA) of an insufficient great saphenous vein (GSV). This study will provide important information about the impact of the AASV on the development of recurrent veins after EVLA of the GSV. Additionally, it will be clarified whether patients benefit from a preventive ablation of a sufficient AASV. METHODS AND ANALYSIS: This is a multicentre, prospective, controlled, exploratory clinical study in 1150 patients with a medical indication for EVLA of a refluxing great saphenous vein. Patients will be enrolled into two study groups: in half of the patients EVLA will be performed on the insufficient GSV only. In the other half of the patients EVLA will be performed on the insufficient GSV and additionally on the sufficient AASV. Within seven study visits, patients will be followed-up over a time period of 5 years. Primary study endpoint is the recurrence rate; secondary endpoints include inter alia, complication rate, postoperative pain intensity, quality of life and patient satisfaction. ETHICS AND DISSEMINATION: Before initiation of the study, the protocol was presented and approved by the independent ethics committee of the medical faculty of the University of Heidelberg (Ethics approval number S-596/2018). This study was prospectively registered at the German Clinical Trial Register (https://www.germanctr.de/). Research findings will be disseminated in a peer-reviewed journal and at relevant conferences. TRIAL REGISTRATION NUMBER: German Clinical Trial Registry (DRKS00015486).