Feasibility and potential significance of prophylactic ablation of the major ascending tributaries in endovenous laser ablation (EVLA) of the great saphenous vein: A case series.

BACKGROUND: Recurrent varicosities after endovascular laser ablation (EVLA) of the great saphenous vein (GSV) are frequently due to varicose transformed, initially unsealed major ascending tributaries of the saphenofemoral junction (SFJ). Preventive ablation of these veins, especially the anterior accessory saphenous vein, is discussed as an option, along with flush occlusion of the GSV. However, few related data exist to date. METHODS: A consecutive case series of 278 EVLA procedures of the GSV for primary varicosis in 213 patients between May and December 2019 was retrospectively reviewed. The ablations were performed with a 1470 nm dual-ring radial laser and always included flush occlusion of the GSV, and concomitant ablation of its highest ascending tributaries by additional cannulation and ablation when this seemed anatomically appropriate. The initial technical success, comprising occlusion of the GSV and its major tributaries, was set as the primary endpoint. Possible determinants were explored using downstream multiple logistic regression analysis. RESULTS: The early technical success was 92.8%, with the GSV occluded in 99.6% and the highest ascending SFJ tributary, if present, in 92.4%. Additional ablations of ascending tributaries were performed in 171 cases (61.5%), the latter being associated with success (OR 10.39; 95% CI [3.420-36.15]; p < 0.0001). Presence of anterior as opposed to posterior accessory saphenous vein was another positive predictor (OR 3.959; 95% CI [1.142-13,73]; p = 0.027), while a confluence of the tributary in the immediate proximity to the SFJ had a negative impact (OR 0.2253; 95% CI [0.05456-0.7681]; p = 0.0253). An endothermal heat-induced thrombosis (EHIT) ≥ grade 2 was observed in three cases (1.1%). CONCLUSIONS: A co-treatment of the tributaries is feasible and could improve the technical success of EVLA if a prophylactic closure of these veins is desired, especially if their distance to the SFJ is short. Its effect on the recurrence rate needs further research.

Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins.

OBJECTIVE: Cyanoacrylate closure of refluxing saphenous veins has demonstrated excellent safety and effectiveness results in feasibility and pivotal studies. This article provides the 36-month follow-up results of a prospective, multicenter, nonrandomized cohort study. METHODS: A total of 70 patients were enrolled in a prospective, multicenter study conducted at seven centers in four European countries and underwent treatment of a solitary refluxing great saphenous vein with endovenous cyanoacrylate embolization without the use of tumescent anesthesia or postprocedure compression stockings. The primary effectiveness end point was freedom from recanalization (closure rate) of the great saphenous vein at 6 months. Safety was assessed by occurrence of adverse events after the procedure and during the 6-month follow-up period. Quality of life and clinical improvement parameters were measured before and after the procedure and through a 12-month follow-up period. Anatomic success and clinical improvement were assessed through 36 months after the procedure. RESULTS: Of 70 treated patients, 64 (91%) were available for the 3-year follow-up. The closure rates by Kaplan-Meier life table methods at 6-, 12-, 24-, and 36-month time points were 91.4%, 90.0%, 88.5%, and 88.5%, respectively. Through 36 months, the improvement in change of the mean venous clinical severity score over time was statistically significant by dropping from 4.3 at baseline to 0.9 at the 36-month follow-up (P < .001). CONCLUSIONS: The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued anatomic and clinical effectiveness of cyanoacrylate embolization over an extended follow-up period.

Feasibility and technique of endovenous laser ablation (EVLA) of recurrent varicose veins deriving from the sapheno-femoral junction-A case series of 35 consecutive procedures.

AIM: To assess the feasibility and technical success of endovenous laser ablation (EVLA) of recurrent varicose veins arising from the former sapheno-femoral junction (SFJ). METHODS: We retrospectively analyzed all EVLA procedures treated in our institution by one surgeon between March 2019 and April 2020 and selected all consecutive cases with SFJ recurrence occuring after surgical high ligation and stripping or endovenous thermal ablation for incompetence of the great saphenous vein (GSV) in superficial venous insufficiency. The feasibility, technical success as determined by duplex ultrasound on the postoperative visit, complications and rate of endothermal heat-induced thrombosis (EHIT) were recorded. A subgroup definition was performed based on sonographic morphology of the recurrence and resulting strategy of ablation. RESULTS: Thirty-five limbs with SFJ recurrence in 34 patients were treated with EVLA in order to shut down the highest refluxing point. In 22 interventions, it was required to switch off a short stump or a neovascularization by direct puncture (Subgroup 1). In 13 treatments, the presence of residual GSV segments, or persistent, varicose transformed major tributaries like the anterior accessory great saphenous vein, enabled cannulation and advancing the laser fiber from distal to the former SFJ (Subgroup 2). The EVLA procedures could be successfully carried out in all 35 cases. There were no major complications, no thromboembolism or EHIT, and no local groin complications. In one case, the patient developed a phlebitic response that required temporary medication. Technical success was achieved with 34/35 treatments (97.1%). When comparing the subgroups, the morphological pattern of the SFJ recurrence and the resulting technique of puncture, cannulation and ablation did not influence the result. CONCLUSIONS: The results of this case series suggest that SFJ recurrences can also be successfully treated in situations where there are tortuous or short stumps that require direct puncture and ablation.

The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins.

OBJECTIVE: Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. METHODS: A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither tumescent anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. RESULTS: In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P < .0001). Side effects were generally mild; a phlebitic reaction occurred in eight cases (11.4%) with a median duration of 6.5 days (range, 2-12 days). Pain without a phlebitic reaction was observed in five patients (8.6%) for a median duration of 1 day (range, 0 -12 days). No serious adverse event occurred. Paresthesia was not observed. CONCLUSIONS: Endovenous CA embolization of refluxing GSVs is safe and effective without the use of tumescent anesthesia or compression stockings.

A novel panel of biomarkers predicts radioresistance in patients with squamous cell carcinoma of the head and neck.

PURPOSE: Global gene expression analysis was performed on pre-treatment biopsies from patients with squamous cell carcinoma of the head and neck (SCCHN) to discover biomarkers that can predict outcome of radiation based therapy. METHODS: We initially evaluated RNA expression using cDNA microarray analysis of 38 patients that received radiotherapy (RT). The five strongest candidates (VEGF, BCL-2, CLAUDIN-4, YAP-1 and c-MET) were then analysed in pre-treatment biopsies in a second group of 86 patients who received radiation based treatment using immunohistochemical staining (IHC), prepared by tissue microarray. RESULTS: In the first population, 13 of 38 (34%) had no (NR) or partial response (PR) to RT. cDNA microarrays revealed 60 genes that were linked to response to therapy. In the second series, 12 of 86 patients (14%) experienced NR or PR to CRT. Cause specific survival (CSS) and recurrence free survival (RFS) at 2 years was 85% and 90% and at 3 years 81% and 84%, respectively. Biomarkers predictive for NR/PR were increased expression of vascular endothelial growth factor (VEGF) (p=0.02), Yes-associated protein (YAP-1) (p<0.01), CLAUDIN-4 (p<0.01), c-MET (p<0.01) and BCL-2 (p=0.02). Biomarkers predictive of poor RFS were YAP-1 (p=0.01) and BCL-2 (p<0.01). Biomarkers predictive of poor CSS were YAP-1 (p=0.04), VEGF (p=0.03) and CLAUDIN-4 (p=0.03). Furthermore, when YAP-1 and c-MET expression levels were combined the prediction of radio-resistance was increased. CONCLUSION: All five biomarkers were predictive of poor response to radiation based therapy. In particular, YAP-1 and c-MET have synergistic power and could be used to make treatment decisions.

Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities.

BACKGROUND: Radiofrequency segmental thermal ablation (RSTA) has become a commonly used technology for occlusion of incompetent great saphenous veins (GSVs). Midterm results and data on clinical parameters are still lacking. METHODS: A prospective multicenteral trial monitored 295 RSTA-treated GSVs for 36 months. Clinical control visits included flow and reflux analysis by duplex ultrasound imaging and assessment of clinical parameters according to the CEAP classification and Venous Clinical Severity Score (VCSS). RESULTS: A total of 256 of 295 treated GSVs (86.4%) were available for 36 months of follow-up. At 36 months, Kaplan-Meier survival analysis showed the probability of occlusion was 92.6% and the probability of no reflux was 95.7%, and 96.9% of legs remained free of clinically relevant axial reflux. If complete occlusion was present at the 12-month follow-up, the risk of developing new flow by 24 and 36 months of follow-up was 3.7% and 4.1%, respectively. Diameters of the GSV measured 3 cm distal to the saphenofemoral junction reduced from 5.8 ± 2.1 mm at screening to 2.2 ± 1.1 mm at 36 months. The average VCSS score improved from 3.9 ± 2.1 before treatment to 0.9 ± 1.5 at 3 months (P < .0001) and stayed at an average <1.0 during the complete 36 months of follow-up. Only 41.1% of patients were free of pain before treatment; at 36 months, 251 (98.0%) reported no pain and 245 (95.7%) did not experience pain during the 24 months before. At 36 months, 189 of 255 legs (74.1%) showed an improvement in CEAP class compared with the clinical assessment before treatment (P < .001). Stages C(3) and C(4) combined to 46% before treatment and dropped constantly to a combined level of 8% at 36 months. However, the proportion of C(2) legs that dropped from 52.3% before treatment to <10% at 12 months showed a constant increase thereafter, reaching 33.3% at 36 months. CONCLUSION: RSTA showed a high and durable success rate in vein ablation in conjunction with sustained clinical efficacy.

Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience.

BACKGROUND: Radiofrequency ablation of saphenous veins has proven efficacy with an excellent side effect profile but has the disadvantage of a lengthy pullback procedure. This article reports a new endovenous catheter for radiofrequency-powered segmental thermal ablation (RSTA) of incompetent great saphenous veins (GSVs). METHODS: A prospective, nonrandomized, multicenter study was conducted to evaluate the safety, feasibility, and early clinical outcomes of RSTA of the GSV. RESULTS: A total of 194 patients with 252 GSVs with an average diameter of 5.7 +/- 2.2 mm (range, 2.0 to 18.0 mm) received RSTA under tumescent local anesthesia. In 58 patients (29.9%), bilateral treatment (average length treated, 36.7 +/- 10.8 cm) was done. The average total endovenous procedure time was 16.4 +/- 8.2 minutes, and the average total energy delivery time was 2.2 +/- 0.6 minutes. The corresponding endovenous fluence equivalent delivered to the proximal 7-cm vein segment was 82 +/- 25 J/cm(2) (range, 38 to 192). Follow-up at 3 days, 3 months, and 6 months was obtained from 250, 164, and 62 limbs, respectively. Occlusion rates were 99.6% for all three follow-up dates according to life-table analysis. The average Venous Clinical Severity Score was 3.4 +/- 1.2 at 3 days, 0.9 +/- 1.6 at 3 months, and 1.5 +/- 1.8 at 6 months compared with 3.9 +/- 2.0 at baseline. CONCLUSION: Radiofrequency segmental thermal ablation is feasible, safe, and well tolerated.