Ten-year follow-up of a randomized controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia.

OBJECTIVE: The long-term results of saphenofemoral ligation and stripping (SFL/S) were compared with 980-nm bare fiber endovenous laser ablation (EVLA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: This was a single-center, randomized, controlled trial with a follow-up time of 10 years. Patients with GSV incompetence were randomized to undergo SFL/S or EVLA under tumescent anesthesia. The primary outcome was recurrence of groin-related varicose veins seen on duplex ultrasound imaging and clinical examination. The secondary outcomes were (changes or improvement in) CEAP clinical class, venous symptoms, cosmetic results, quality of life, reinterventions, and complications. RESULTS: Between June 2007 and December 2008, 122 patients (130 limbs) were included; of these, 68 limbs were treated with SFL/S and 62 limbs with EVLA. The 10-year estimated freedom from groin recurrence as seen on duplex ultrasound imaging was higher in the SFL/S group (73% vs 44% in the EVLA group; P = .002), and the same trend was seen for clinically evident recurrence (77% vs 58%, respectively; P = .034). Nine reinterventions (17%) were deemed necessary in the SFL/S group vs 18 (36%) in the EVLA group (P = .059). All reinterventions in the SFL/S group consisted of foam sclerotherapy. Reinterventions in the EVLA group included foam sclerotherapy (n = 5), crossectomy (n = 2), and endovenous procedures (n = 11). There was no significant differences in quality of life and relief of venous symptoms. Cosmetic appearance improved, with a better cosmetic rating in the SFL/S group compared with the EVLA group (P = .026). One patient in the SFL/S group had a persisting neurosensory deficit remaining at 10 years. CONCLUSIONS: This study showed no clear long-term advantage of EVLA with a 980-nm wavelength and bare-tip fiber over high ligation and stripping of the GSV under local tumescent anesthesia.

Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radiofrequency-powered segmental ablation or 1470-nm endovenous laser ablation with radial-tip fibers (Varico 2 study).

BACKGROUND: Endovenous laser ablation (EVLA) and radiofrequency-powered segmental ablation (RPSA) of the incompetent great saphenous vein (GSV) are both known for their excellent technical and clinical outcomes for the treatment of varicose veins. RPSA has reduced postprocedural pain and morbidity with shorter recovery time for the patient compared with EVLA using bare-tip fibers. However, new-generation EVLA devices with less traumatic radial-tip fibers (RTFs) operating at longer wavelengths up to 1470 nm also reduce postprocedural pain. The objective of this study was to compare long-term effectiveness of GSV thermal ablation and postprocedural recovery using RPSA or 1470-nm EVLA with RTF (EVLA-RTF). METHODS: In a comparative prospective monthly altering-treatment cohort study of 311 patients (346 treated legs), each leg with incompetence of the GSV was treated with either RPSA (158 patients, 175 legs) or EVLA-RTF (153 patients, 171 legs). The primary outcome was anatomic occlusion of the GSV, assessed at 12, 24, 36, 48, and 60 months using Kaplan-Meier statistics and compared using the log-rank test. Secondary outcomes included freedom of varicose vein recurrence, clinical success measured by Venous Clinical Severity Score (VCSS), disease-specific quality of life determined using the Aberdeen Varicose Vein Questionnaire (AVVQ), postoperative pain scores, and time to return to work. RESULTS: The total primary obliteration rate after 36 and 60 months was 96.2% with RPSA and 96.7% with EVLA-RTF (P = .81). Freedom of symptomatic anterior accessory vein recurrence after 5 years was 85% after RPSA and 87% after EVLA-RTF (P = .50). VCSS and AVVQ score presented similar and durable improvements in both groups between 6 weeks and 60 months. There was no difference in postoperative pain scores after both treatments during the first 14 days (mean visual analog scale score, 0.54-2.19). The median time for return to work was 1 day after both treatments. No severe adverse events were observed. CONCLUSIONS: RPSA and EVLA-RTF have similarly high GSV obliteration rates in the long term, and the treatments are equally effective clinically. Both treatments are associated with similar minimal postprocedural pain scores and short recovery times.

Five-year follow-up of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia.

OBJECTIVE: The objective of this study was to compare the long-term results (groin-related recurrence, great saphenous vein [GSV] occlusion rate, Clinical class, Etiology, Anatomy, and Pathophysiology [CEAP] staging, and quality of life [QoL]) after the treatment of a GSV incompetence by saphenofemoral ligation and stripping (SFL/S) with endovenous laser ablation bare fiber, 980 nm (EVLA). METHODS: Patients with GSV insufficiency and varicose veins were randomized to either undergo SFL/S or EVLA, both of which were performed under tumescent anesthesia. The long-term results, which included the anatomic occlusion rate, varicose vein recurrence at the saphenofemoral junction (SFJ), relief of venous symptoms and QoL, were compared up to 5 years after treatment. RESULTS: A total of 130 legs of 121 patients were treated with either SFL/S (n = 68) or EVLA (n = 62). In the first 12 months, three recanalizations of the GSV were observed after EVLA. Up to 5 years later, more recurrent varicose veins caused by neoreflux in incompetent tributaries of the SFJ were observed in after EVLA (31%; 19/61) compared with SFL/S (7%; 4/60; P < .01). Neovascularization in the groin with clinically visible recurrence identified at 3 and 5 years post-treatment follow-up was only observed in the SFL/S group (n = 6). After 5 years, clinically visible recurrences originating from the SFJ region after EVLA were observed 33% (20/61) compared with 17% of patients (10/60) after SFL/S (P < .04). In both treatment groups, venous symptoms improved significantly. Patients in both groups reported a continuing significant cosmetic improvement measured on a visual analog scale of 1 to 10 (mean, 7.49; P < .01). There was no difference in the CEAP staging and a standardized, non-disease-specific instrument for describing and valuing health states (EuroQol-5D), between the groups up to 5 years after follow-up. CONCLUSIONS: At the 5-year follow-up, a significantly higher varicose vein recurrence rate originated at the SFJ region after EVLA compared with SFL/S. There were no differences in the relief of venous symptoms, CEAP staging, or general QoL between the groups.

Patient Perception of Imiquimod Treatment for Actinic Keratosis and Superficial Basal Cell Carcinoma in 202 Patients.

OBJECTIVE: To document the impact on patient-reported outcomes and health-related quality of life (HRQoL) of treatment with imiquimod cream in patients with actinic keratosis (AK) and superficial basal cell carcinoma (sBCC). METHODS: This open-label, multicenter study included AK and sBCC patients eligible for treatment with imiquimod 5% cream. HRQoL was measured by the Skindex-17 and the Skin Cancer Index (SCI) and treatment satisfaction by the Treatment Satisfaction Questionnaire for Medication. RESULTS: 118 AK patients and 84 patients with sBCC were included. Low baseline HRQoL impairment was found on both questionnaires, which remained low after treatment, except for a small dip at the end of the application period. CONCLUSION: Imiquimod 5% cream treatment has no clinically relevant HRQoL impact in AK and sBCC patients according to the Skindex-17 and SCI. The effect of imiquimod treatment on HRQoL may be limited or these questionnaires do not fully capture relevant issues, such as fear of recurrence.

To dive or not to dive with bleomycin: a practical algorithm.

BACKGROUND: Bleomycin is used in the treatment of different cancers, but possible side effects of interstitial pneumonitis and fibrosis are associated with increased concentrations of oxygen. Therefore, clinicians are reluctant to declare young people fit for scuba diving after bleomycin treatment, because scuba divers might be exposed to high partial pressures of oxygen. METHODS: Based on a survey, 16 patients treated with bleomycin for either testicular/germ cell cancer or Hodgkin's disease were evaluated according to an algorithm to assess their fitness to dive. The algorithm is based on a review of the literature related to oncology, anesthesiology, and diving medicine. RESULTS: According to our protocol, 12 of the 16 patients were fit for scuba diving. However, the two groups of cancer patients showed considerable difference with regard to fitness for diving, i.e., 10 of 11 patients with testicular/germ cell cancer compared with 2 of 5 patients with Hodgkin's disease. CONCLUSIONS: The algorithm can be used by physicians and diving organizations to assess fitness for scuba diving after bleomycin treatment. However, patients with Hodgkin's disease treated with a combination of bleomycin and radiation may be at higher risk of radiation-induced pulmonary problems and are therefore more likely to be unfit for scuba diving.