Danish Nationwide Study on Surgical Treatment of Infective Native Abdominal Aortic Aneurysms.

OBJECTIVE: This study aimed to describe surgical trends, survival, and infection related complications (IRC) in a Danish cohort of patients with infective native aortic aneurysms (INAAs). METHODS: A retrospective nationwide cohort study including all patients in Denmark who were surgically treated for abdominal INAA between 2000 and 2020 was conducted. Patients were identified through the Danish vascular registry, Karbase, which is a database registering all patients treated with vascular surgery in Denmark. Subsequent data on clinical presentation, treatment, all cause mortality, and complications were obtained from the electronic patient charts. RESULTS: Seventy-five patients were included in the study, of whom 60 (80%) were male, with a median age of 69 (IQR 64, 75) years. Open surgical repair (OSR) was performed in 54 (72%) patients and endovascular aortic repair (EVAR) in 21 (28%). Median follow up was 52 (IQR 32, 103) months. Open repair was consistently the most frequent treatment modality throughout the study period, but EVAR became more frequent over time. The 30 day survival of the total cohort was 97% (94 - 100%). Kaplan-Meier survival estimates for the cohort were 92% (95% CI 85 - 98%), 80% (95% CI 71 - 91%), 63% (95% CI 52 - 78%), and 48% (95% CI 35 - 66%) at one, three, five and 10 years, respectively. Patients treated by EVAR had comparable long term survival to patients treated by OSR, with a hazard ratio of 0.35 (95% CI 0.10 - 1.22), but was associated with better short term survival up to five years. The most common cause of death was sepsis. Five (9%) OSR patients had IRC compared with one (5%) EVAR patient. CONCLUSION: In this nationwide study of patients treated for abdominal INAA, an increasing number of patients were surgically treated during the study period. Patients treated by EVAR demonstrated long term survival comparable to OSR. The incidence of post-operative IRC was low. These results should be interpreted with caution and prospective registries are needed.

Editor's Choice - Infective Native Aortic Aneurysms: A Delphi Consensus Document on Terminology, Definition, Classification, Diagnosis, and Reporting Standards.

OBJECTIVE: There is no consensus regarding the terminology, definition, classification, diagnostic criteria, and algorithm, or reporting standards for the disease of infective native aortic aneurysm (INAA), previously known as mycotic aneurysm. The aim of this study was to establish this by performing a consensus study. METHODS: The Delphi methodology was used. Thirty-seven international experts were invited via mail to participate. Four two week Delphi rounds were performed, using an online questionnaire, initially with 22 statements and nine reporting items. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements revised, and results presented in iterative rounds. Consensus was defined as ≥ 75% of the panel selecting "strongly agree" or "agree" on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha coefficient > .80. RESULTS: All 38 panellists completed all four rounds, resulting in 100% participation and agreement that this study was necessary, and the term INAA was agreed to be optimal. Three more statements were added based on the results and comments of the panel, resulting in a final 25 statements and nine reporting items. All 25 statements reached an agreement of ≥ 87%, and all nine reporting items reached an agreement of 100%. The Cronbach's alpha increased for each consecutive round (round 1 = .84, round 2 = .87, round 3 = .90, and round 4 = .92). Thus, consensus was reached for all statements and reporting items. CONCLUSION: This Delphi study established the first consensus document on INAA regarding terminology, definition, classification, diagnostic criteria, and algorithm, as well as reporting standards. The results of this study create essential conditions for scientific research on this disease. The presented consensus will need future amendments in accordance with newly acquired knowledge.

Cancer should not contravene the revascularization of chronic limb-threatening ischaemia.

OBJECTIVES: This study aimed to examine the frequency of cancer among patients with chronic limb-threatening ischaemia (CLTI) due to peripheral artery disease (PAD) and to determine how active cancer affected outcomes after open or endovascular revascularization. In addition, we aimed to investigate all-cause mortality and cause of death in the PAD population. DESIGN: Observational single-centre cohort study based on a retrospective analysis of prospectively entered registry data. MATERIALS: All consecutive patients treated for CLTI due to PAD at a single university centre between the 1st of January 2011 and the 31st of December 2015 were included. Data from the Danish Vascular Registry (Karbase) regarding demographics, surgical procedure, and complications were linked with data from the Danish Cancer Registry and Cause of Death Registry. METHODS: The primary endpoint was major amputation-free survival. Secondary endpoints were postoperative complications within 30 days, cancer-free survival, all-cause mortality and cause of death in the cohort. Major amputation-free survival, cancer-free survival and mortality were described with Kaplan-Meier (KM) survival estimates. RESULTS: We included 920 patients, of which 116 (13%) were in the active cancer group at the time of revascularization. There was no difference in amputation-free survival between those with cancer (86.8% 1-year KM estimate) and those without cancer (85.2% 1-year KM estimate) (p = 0.50). Likewise, we found no difference in 30-day postoperative complication rate. The risk of developing cancer in the included CLTI cohort was similar to the age-matched background population (6.1% vs 6.4%) (p = 0.69). All-cause mortality was higher in CLTI patients with cancer, mainly due to cancer, compared with CLTI patients without cancer who mainly died from cardiovascular disease. Three-year KM survival estimates were 48.3% (95% CI 40.0%-58.3%) and 64.4% (95% CI 61.2%-67.8%) (p = 0.014) for cancer and non-cancer patients, respectively. CONCLUSIONS: Although cancer in patients with CLTI is related to higher medium- to long-term mortality, active cancer per se should not contravene revascularization, as postoperative complications and risk of amputation are not overrepresented.

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.

OBJECTIVE: Outcome reports after endovascular aneurysm repair (EVAR) using the low-profile Zenith Alpha Abdominal Endovascular grafts (Cook Medical, Bjæverskov, Denmark) are sparse. We present results from a single-center cohort treated with the Zenith Alpha, from a period where the graft was the primary EVAR device choice. The aim of the study was to evaluate short- and midterm outcomes of patients treated with the Zenith Alpha. METHODS: A retrospective single-center study was performed including all patients treated with the Zenith Alpha graft from October 1, 2015 to September 30, 2018. All patients underwent computed tomography angiography (CTA) imaging preoperatively as well as at 3 and 12 months postoperatively. Hereafter, patients were followed yearly with duplex ultrasound and clinical exams. Additional imaging was performed on indication. All CTAs were analyzed using three-dimensional reconstruction software (Aquarius, TeraRecon, Durham, NC). Data was extracted from electronic charts according to a protocol that remained unchanged until the end of the study (December 31, 2020). The following outcomes were assessed according to Society for Vascular Surgery/International Society of Cardiovascular Surgeons reporting criteria: aortic-related and all-cause mortality, reinterventions, instruction for use (IFU) violations, endoleaks (ELs), and aneurysm shrinkage. RESULTS: A total of 241 patients were treated with the Zenith Alpha, and 214 (89%) were asymptomatic repairs. Technical success was achieved in 238 patients (99%). One hundred fifty-seven patients (65%) received implantation outside IFU. The median hospital length of stay was 2 days (interquartile range, 2-3 days). The median clinical follow-up was 35.1 months (interquartile range, 28.8-47.5 months). The 4-year Kaplan-Meier estimate of freedom from reintervention was 66% (95% confidence interval, 59%-73%). The main reasons for reinterventions were iliac limb stenosis and occlusion (n = 30; 12%) and type 2 EL (n = 13; 5%). Overall, significantly more patients with grafts implanted outside distal IFU developed type 1B ELs (n = 10/11; P = .009). Aneurysm sac shrinkage was observed in 48 patients (25%) 1 year postoperatively. The Kaplan-Meier estimate of freedom from aortic-related mortality was 99% (95% confidence interval, 98%-100%) 4 years postoperatively. CONCLUSIONS: EVAR with the Zenith Alpha shows acceptable freedom from aortic-related mortality up to 4 years postoperatively. The majority of patients were treated outside IFU, and significantly more type 1B ELs appeared in this subgroup of patients. The leading cause for reintervention was impaired limb patency. The root cause for impaired limb patency requires further investigation.

Low Risk of Neurological Recurrence while Awaiting Carotid Endarterectomy: Results From a Danish Multicentre Study.

OBJECTIVE: The risk of ipsilateral neurological recurrence (NR) was assessed in patients awaiting carotid endarterectomy (CEA) due to symptomatic carotid artery stenosis and whether current national guidelines of performing CEA within 14 days are adequate in present day practice. METHODS: This was a retrospective multicentre observational cohort study. Patients scheduled for CEA due to symptomatic carotid artery stenosis in a five year period, 1 January 2014 to 31 December 2018, from four centres were included. Data from the Danish Vascular Registry (www.karbase.dk), operative managing systems, and electronic medical records were reviewed. RESULTS: In total, 1 125 patients scheduled for CEA were included and 1 095 (97%) underwent the planned surgery. During a median delay from index event to CEA of 11 days (interquartile range 8-16 days), 40 patients (3.6%; 95% confidence interval [CI] 2.5%-5%) experienced a NR. One third were minor strokes (n = 12, 30%); half were transient ischaemic attacks (TIA) (n = 22, 55%); and amaurosis fugax accounted for 15% (n = 6). Twenty-six (2%) CEA procedures was cancelled, of which one was due to a disabling recurrent ischaemic event (aphasia). There were no deaths or major strokes in the waiting time for CEA. Best medical treatment (BMT) with platelet inhibitory or anticoagulation drugs and a statin was initiated in nearly all patients (98%) at first assessment. The overall 30 day risk of a post-operative major event (death or stroke) was (Kaplan-Meier [KM] estimate) 2.7% (95% CI 1.8-3.8), and not significantly correlated with the timing of surgery. Most (69%) occurred within the first three days. One, two, and three year mortality rate for CEA patients was (KM estimate) 4.8%, 7.8%, and 11.5% respectively. CONCLUSION: In symptomatic carotid artery stenosis patients awaiting CEA, very few NRs occurred within 14 days. Institution of immediate BMT in specialised TIA/stroke units followed by early, but not necessarily urgent, CEA is a reasonable course of action in patients with high grade symptomatic carotid artery stenosis.

Endovascular Treatment of Chronic and Acute on Chronic Mesenteric Ischaemia: Results From a National Cohort of 245 Cases.

OBJECTIVE: Endovascular treatment of chronic mesenteric ischaemia (CMI) is linked to low early morbidity and mortality but a higher risk of recurrence than open repair. Mid and long term outcomes after endovascular treatment remain to be proven in larger series. The aim of this study was to assess short and mid term outcome after first line endovascular revascularisation of CMI and acute on chronic mesenteric ischaemia (AoCMI). METHODS: This was a prospective population and registry based cohort study supplemented by a retrospective review of medical records and imaging files. A national cohort was created based on data extracted from the Danish National Registry for Vascular Surgery (Karbase) for all patients treated endovascularly for CMI or AoCMI between 2011 and 2015 in Denmark. Survival data, bowel resection, complications, re-intervention rate, and improvement of clinical symptoms were analysed, as were potential risk factors. RESULTS: In total, 245 patients had an endovascular intervention for CMI (n = 178; 72.6%) and AoCMI (n = 67; 27.3%). One and three year survival estimates were 85% (95% confidence interval [CI] 79 - 90) and 74% (95% CI 67 - 80) in the CMI-group, and 67% (95% CI 54 - 77) and 54% (95% CI 41 - 65) in the AoCMI group. The hazard ratio for death was 1.89 (95% CI 1.23 - 2.9) for AoCMI, relative to patients with CMI. Superior mesenteric artery (SMA) stenosis, rather then occlusion, significantly increased the success of SMA recanalisation: OR 19.4 (95% CI 6.2 - 61.4) and 9.3 (95% CI 1.6 - 53.6) in the CMI and AoCMI groups, respectively. The proportion of patients reporting clinical improvement was 71% (n = 127) in the CMI group and 59% (n = 39) in the AoCMI group. Five patients (3%) in the CMI and 30 (45%) in the AoCMI groups underwent bowel resection (p < .001), and the overall length of hospital stay (LoS) was a median of two days (interquartile range [IQR] 1 - 3 days) in the CMI group and seven days (IQR 3 - 23 days) in the AoCMI group. Within the first year, re-intervention was performed in 14 patients (5.7%). CONCLUSION: First line endovascular treatment of CMI carries a three year mortality rate of 25%, and low risk of re-occurrence of symptomatic ischaemia. Relative to CMI, patients suffering AoCMI have significantly higher morbidity and mortality, more bowel resections, and longer LoS.

European Society for Vascular Surgery (ESVS) Certification of Theoretical and Practical Competences in Basic Vascular Ultrasound: Validity Investigation of the Assessment Tools.

OBJECTIVE: The aim of this study was to gather validity evidence for the Assessment of basic Vascular Ultrasound Expertise (AVAUSE) tool, and to establish a pass/fail score for each component, to support decisions for certification. METHODS: A cross sectional validation study performed during the European Society for Vascular Surgery's annual meeting. Validity evidence was sought for the theoretical test and two practical tests based on Messick's framework. The participants were vascular surgeons, vascular surgical trainees, sonographers, and nurses with varying experience levels. Five vascular ultrasound experts developed the theoretical and two practical test components of the AVAUSE tool for each test component. Two stations were set up for carotid examinations and two for superficial venous incompetence (SVI) examinations. Eight raters were assigned in pairs to each station. Three methods were used to set pass/fail scores: contrasting groups' method; rater consensus; and extended Angoff. RESULTS: Nineteen participants were enrolled. Acceptable internal consistency reliability (Cronbach's alpha) for the AVAUSE theoretical (0.93), carotid (0.84), and SVI (0.65) practical test were shown. In the carotid examination, inter-rater reliability (IRR) for the two rater pairs was good: 0.68 and 0.78, respectively. The carotid scores correlated significantly with years of experience (Pearson's r = 0.56, p = .013) but not with number of examinations in the last five years. For SVI, IRR was excellent at 0.81 and 0.87. SVI performance scores did not correlate with years of experience and number of examinations. The pass/fail score set by the contrasting groups' method was 29 points out of 50. The rater set pass/fail scores were 3.0 points for both carotid and SVI examinations and were used to determine successful participants. Ten of 19 participants passed the tests and were certified. CONCLUSION: Validity evidence was sought and established for the AVAUSE comprehensive tool, including pass/fail standards. AVAUSE can be used to assess competences in basic vascular ultrasound, allowing operators to progress towards independent practice.

In Situ Vein Bypass Is Superior to Endovascular Treatment of Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia.

BACKGROUND: The objective of the study was to compare bypass surgery and endovascular revascularization of the femoropopliteal segment in patients with peripheral arterial disease and critical limb-threatening ischemia (CLTI). METHODS: This is a single-center study including patients undergoing first-time lower extremity intervention with peripheral bypass surgery or percutaneous transluminal angioplasty with or without stenting (PTA/S) of the femoropopliteal segment because of CLTI from 2011 to 2015. Based on prospective entered data from the Danish Vascular Registry, the primary end points were amputation-free survival, overall mortality, and reinterventions. RESULTS: A total of 679 patients with CLTI were included of which 35% (n = 239) were treated with PTA/S, 54% (n = 363) with vein bypass, and 11% (n = 77) with synthetic bypass. After 3 years, amputation-free survival was significantly better with a vein bypass (41.8% [95% CI: 35-48.4]) than both PTA/S (29.7% (95% CI: 22.7-37)) and synthetic bypass (31.7% [95% CI: 19-45.1]). Overall, the endovascular-treated patients faced more than 50% increased risk of major amputation or death than that of a vein bypass, after adjusting for comorbidity and Trans-Atlantic Inter-Society Consensus (TASC) classification (HR: 1.56 [95% CI: 1.21-2.05]). As expected, postoperative complications, length of hospital stay, and reinterventions were more frequent in the bypass groups. CONCLUSIONS: In this nonrandomized study, autologous vein bypass was superior to both PTA/S and synthetic bypass in regard to amputation-free survival and overall mortality. Despite the increased frequency of surgical complications, a vein bypass appears justified in both shorter (TASC B-C) and longer (TASC D) femoropopliteal lesions.

The Role of Routine Ultrasound Surveillance after In Situ Infrainguinal Peripheral Vein Bypass for Critical Limb-Threatening Ischemia.

BACKGROUND: To evaluate systematic duplex ultrasound (DUS) surveillance of patients treated with in situ great saphenous vein bypass (ISSVB) due to critical limb-threatening ischemia (CLTI) we performed a retrospective analysis of prospectively entered registry data. METHODS: Single-center study including consecutive patients undergoing elective ISSVB surgery due to CLTI between 2011 and 2015. Postoperative graft surveillance program included clinical examination, ankle-brachial indices (ABIs), and DUS at 6 weeks and 3 and 12 months. All DUS scans were performed by trained nurse sonographers. Patient data were extracted from the Danish Vascular Registry, electronic medical records and Picture Archiving and Communication System (PACS). Primary outcomes were reintervention rate, patency, and survival. RESULTS: In total, 363 consecutive and treatment-naive CLTI patients were revascularized with ISSVB and included in the study. Of those, 310 patients had minimum one follow-up visit and in total 1,199 DUS examinations. During the study period, 84 (23%) patients received 125 graft preserving reinterventions of which 20 were indicated solely on routine DUS without concurrent ischemic symptoms and/or significant (>15%) decrease in ABI. Hence, to find one asymptomatic graft stenosis requiring reintervention, we needed to scan 60 patients. After 1, 2, and 3 years, assisted primary patency was (Kaplan-Meier estimate) 79.4% (95% CI: 74.4, 83.5), 76.3% (95% CI: 70.7, 81.0), and 73.6% (95% CI: 66.9, 79.2), respectively. Survival rates were 82.6% (95% CI: 78.1, 86.3), 64.2% (95% CI: 57.8, 69.9) and 47.7% (95% CI: 40.6, 54.4) at 1, 2, and 3 years, respectively. CONCLUSIONS: In this study, one in four patients received a graft preserving intervention, but very few were driven by routine DUS and most graft lesions were detected on clinical findings. These findings suggest that development of a more individualized surveillance program differentiating between high- and low-risk infrainguinal bypass patients may increase cost-effectiveness.

Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT.

BACKGROUND: This study compares the outcome 5 years after treatment of varicose veins with endovenous radiofrequency ablation (RFA), endovenous laser ablation (EVLA), ultrasound guided foam sclerotherapy (UGFS) or high ligation and stripping (HL/S) by assessing technical efficacy, clinical recurrence and the rate of reoperations. METHODS: Five hundred patients (580 legs) with Great Saphenous Vein (GSV) reflux and varicose veins were randomized to one of the 4 treatments. Follow-up included clinical and duplex ultrasound examinations. RESULTS: During 5 years there was a difference in the rate of GSV recanalization, recurrence and reoperations across the groups, KM P<0.001, P<0.01, P<0.001 respectively. Thus 8 in the RFA group (Kaplan Meier [KM] estimate 5.8%), 8 in the EVLA group (KM estimate 6.8%), 37 (KM estimate 31.5%) in the UGFS group and 8 in the HL/S group (KM estimate 6.3%) of GSVs recanalized or had a failed stripping procedure. Nineteen (RFA) (KM estimate 18.7%), 42 (EVLA) (KM estimate 38.6%), 28 (UGFS) (KM estimate 31.7%) and 38 (HL/S) (KM estimate 34.6%) legs developed recurrent varicose veins. Within 5 years after treatment, 19 (RFA) (KM estimate 17%), 19 (EVLA) (KM estimate 18.7%), 43 (UGFS) (KM estimate 37.7%) and 25 (HL/S) (KM estimate 23.4%) legs were retreated. CONCLUSIONS: More recanalization's of the GSV occurred after UGFS and no difference in the technical efficacy was found between the other modalities during 5-year follow-up. The higher frequency of clinical recurrence after EVLA and HL/S cannot be explained and requires confirmation in other studies.

[No effect of the use of varicose vein treatment compression after more than seven days]. / Ingen effekt af kompressionsbehandling i mere end syvdage efter behandling af varicer

The aim of this article is to review the current use of compression after varicose vein treatment. Five randomized controlled trials and one systematic review was chosen for evaluation. No benefit was found when comparing either long duration compression with short duration, or compression with no compression. Additionally, patient compliance was low. The evidence is based on underpowered and heterogeneous groups. Thus, no contribution to a consensus regarding the use of post varicose vein treatment compression can be made.

Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years.

OBJECTIVE: This is the first randomized controlled trial with a 5-year follow-up comparing endovenous laser ablation (EVLA) with high ligation and pin-stripping in patients with great saphenous vein (GSV) incompetence. METHODS: One hundred twenty-one consecutive patients (137 legs) with GSV incompetence were randomized to EVLA (980 nm bare fiber) or high ligation and stripping using tumescent local anesthesia with light sedation. Mini-phlebectomies were performed in all patients. The patients were examined with duplex scanning before treatment and after 12 days, and then after 1, 3, and 6 months, and yearly thereafter for up to 5 years. The primary end point was open refluxing GSV. Secondary end points were recurrent varicose veins, frequency of reoperations, Venous Clinical Severity Score, and quality of life scores (Aberdeen Varicose Vein Symptoms Severity Score and Short Form-36). RESULTS: In the EVLA and stripping group, nine (Kaplan-Meier [KM] estimate, 17.9%) and four (KM estimate, 10.1%) of GSVs had open refluxing segments of 5 cm or more (ns). Clinical recurrence was recorded in 24 (KM estimate, 46.6%) and 25 (KM estimate, 54.6%), whereas reoperations were performed in 17 (KM estimate, 38.6%) and 15 (KM estimate, 37.7%) legs (ns). Venous Clinical Severity Score and Aberdeen Varicose Vein Symptoms Severity Score improved whereas Medical Outcomes Study Short Form-36 quality of life score improved in several domains in both groups with no difference between the groups. CONCLUSIONS: Five-year follow-up of our randomized controlled trial comparing EVLA with open surgery in patients with GSV incompetence did not show any significant difference between the two groups in primary or secondary end points, perhaps because of the small sample size. EVLA seems to be a valid alternative to open surgery.

Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up.

INTRODUCTION: This study compares the outcome 3 years after treatment of varicose veins by endovenous laser ablation (EVLA), radiofrequency ablation, ultrasound-guided foam sclerotherapy (UGFS), or surgery by assessing recurrence, Venous Clinical Severity Score (VCSS), and quality of life (QOL). METHODS: A total of 500 patients (580 legs) were randomized to one of the three endovenous treatments or high ligation and stripping of the great saphenous vein (GSV). Follow-up included clinical and duplex ultrasound examinations and VCSS and QOL questionnaires. Kaplan-Meier (KM) life-table analysis was used. P values below .05 were considered statistically significant. RESULTS: At 3 years, eight (KM estimate, 7%), eight (KM estimate, 6.8%), 31 (KM estimate, 26.4%), and eight (KM estimate, 6.5%) of GSVs recanalized or had a failed stripping procedure (more than 10 cm open refluxing part of the treated GSV; CLF, EVLA, UGFS, and stripping, respectively; P < .01). Seventeen (KM estimate, 14.9%), 24 (KM estimate, 20%), 20 (KM estimate, 19.1%), and 22 (KM estimate, 20.2%) legs developed recurrent varicose veins (P = NS). The patterns of reflux and location of recurrent varicose veins were not different between the groups. Within 3 years after treatment, 12 (KM estimate, 11.1%), 14 (KM estimate, 12.5%), 37 (KM estimate, 31.6%), and 18 (KM estimate, 15.5%) legs were retreated in the CLF, EVLA, UGFS, and stripping groups, respectively (P < .01). VCSS, SF-36, and Aberdeen QOL scores improved significantly in all the groups with no difference between the groups. CONCLUSIONS: All treatment modalities were efficacious and resulted in a similar improvement in VCSS and QOL. However, more recanalization and reoperations were seen after UGFS.

Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results.

BACKGROUND: Endovenous laser (EVL) ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity and reduce work loss compared with high ligation and stripping (HL/S). However, the procedures have not previously been compared in a randomized trial with parallel groups where both treatments were performed in tumescent anesthesia on an out-patient basis. METHODS: Patients with varicose veins due to GSV insufficiency were randomized to either EVL (980 nm) or HL/S in tumescent anesthesia. Miniphlebectomies were also performed. Patients were examined preoperatively and at 12 days, and 1, 3, and 6 months postoperatively. Sick leave, time to normal physical activity, pain score, use of analgesics, Aberdeen score, Medical Outcomes Study Short Form-36 quality-of-life score, Venous Clinical Severity Score (VCSS), and complication rates were investigated. The total cost of the procedures, including lost wages and equipment, was calculated. Cost calculations were based on the standard fee for HL/S with the addition of laser equipment and the standard salary and productivity level in Denmark. RESULTS: A follow-up of 6 months was achieved in 121 patients (137 legs). The groups were well matched for patient and GSV characteristics. Two HL/S procedures failed, and three GSVs recanalized in the EVL group. The groups experienced similar improvement in quality-of-life scores and VCSS score at 3 months. Only one patient in the HL/S group had a major complication, a wound infection that was treated successfully with antibiotics. The HL/S and EVL groups did not differ in mean time to resume normal physical activity (7.7 vs 6.9 calendar days) and work (7.6 vs 7.0 calendar days). Postoperative pain and bruising was higher in the HL/S group, but no difference in the use of analgesics was recorded. The total cost of the procedures, including lost wages, was euro 3084 ($3948 US) in the HL/S and euro 3396 ($4347 US) in the EVL group. CONCLUSIONS: This study suggests that the short-term efficacy and safety of EVL and HL/S are similar. Except for slightly increased postoperative pain and bruising in the HL/S group, no differences were found between the two treatment modalities. The treatments were equally safe and efficient in eliminating GSV reflux, alleviating symptoms and signs of GSV varicosities, and improving quality of life. Long-term outcomes, particularly with respect to recurrence rates, shall be investigated in future studies, including the continuation of the present.