Perfusion increase in foot angiosomes: Comparison between direct and indirect revascularization of crural arteries.

BACKGROUND AND AIMS: In retrospective studies, wound healing and leg salvage have been better if revascularization is targeted to the crural artery supplying arterial flow to the wound angiosome. No data exist on how revascularization changes the blood flow in foot angiosomes. The aim of this study was to evaluate the change in perfusion after infrapopliteal artery revascularization in all foot angiosomes and to compare directly revascularized (DR) angiosomes to the indirectly revascularized (IR) angiosomes. METHODS: In this prospective study, foot perfusion was measured with indocyanine green fluorescence imaging (ICG-FI) before and after either surgical or endovascular below-knee revascularization. According to angiograms, we divided the foot angiosomes into DR and IR angiosomes. Furthermore, in a subanalysis, the IR angiosomes were graded as IR_Coll+ angiosomes if there were strong collaterals arising from the artery which was revascularized, and as IR_Coll- angiosomes if strong collaterals were not seen. RESULTS: A total of 72 feet (28 bypass, 44 endovascular revascularizations) and 282 angiosomes were analyzed. Surgical and endovascular revascularization increased perfusion significantly in both DR and IR angiosomes. After bypass surgery, the increase in DR angiosomes was 55 U and 53 U in IR angiosomes; there were no significant difference in the perfusion increase between IR and DR angiosomes. After endovascular revascularization, perfusion increased significantly more, 40 U, in DR angiosomes compared to 26 U in IR angiosomes (p < 0.05). In the subanalysis of IR angiosomes, perfusion increased significantly after surgical bypass regardless of whether strong collaterals were present or not. After endovascular revascularization, however, a significant perfusion increase was noted in the IR_Coll+ but not in the IR_Coll- subgroup. CONCLUSION: Open revascularization increased perfusion equally in DR and IR angiosomes, whereas endovascular revascularization increased perfusion significantly more in DR than in IR angiosomes. Strong collateral network may help increase perfusion in IR angiosomes.

Reversed Gore Excluder conformable main body as a conduit between branched stent graft limb, common iliac artery, and renal artery.

Renal artery access might not always be achieved due to anatomical reasons during the deployment of a branched stent graft in thoracoabdominal or juxtarenal abdominal aortic aneurysms. Renal perfusion is maintained through the aneurysm sac until the iliac limbs are deployed. To preserve renal perfusion, a branched iliac limb would be needed. Such limbs with a side branch, a narrow (12-14 mm) proximal end, and a wide (16-20 mm) distal end are not commercially available. Due to the nature of their deployment mechanism, Gore Excluder distal limbs (W.L. Gore & Associates) have been used outside the instructions for use in reversed position. A traditional Gore Excluder main body can be reversed; however, the smallest proximal diameter is 23 mm, which could be too large to be deployed in a typically 16- to 18-mm common iliac artery. However, the smallest Gore Excluder Conformable endoprosthesis (W.L. Gore & Associates, Inc) main body is 20 mm in diameter, and the distal limb is 14.5 mm. This allows for a perfect fit when deployed in reversed position between an 11-mm unibody limb (Cook Medical Inc) and the common iliac artery, resulting in access to the renal artery from the side branch. We used a Gore Excluder Conformable main body graft in two such cases successfully. In these two patients, the iliac limbs and renal artery have stayed patent during a follow-up of 24 and 3 months. A Gore Excluder Conformable graft can be deployed in reversed position, using it as a conduit between the branched stent graft limb, common iliac artery, and renal artery.

Exercise Therapy for Chronic Symptomatic Peripheral Artery Disease: A Clinical Consensus Document of the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases in Collaboration With the European Society of Vascular Medicine and the European Society for Vascular Surgery.

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.

Outcomes Following Intact and Ruptured Aneurysm Repair across Nations: Analysis of International Registry Data from the VASCUNET Collaboration 2014 - 2019.

OBJECTIVE: To determine the peri-operative mortality rate for intact and ruptured abdominal aortic aneurysm (AAA) repair in 10 countries and to compare practice and outcomes over a six year period by age, sex, and geographic location. METHODS: This VASCUNET study used prospectively collected data from vascular registries in 10 countries on primary repair of intact and ruptured AAAs undertaken between January 2014 and December 2019. The primary outcome was peri-operative death (30 day or in hospital). Logistic regression models were used to estimate the association between peri-operative death, patient characteristics, and type of procedure. Factors associated with the use of endovascular aortic aneurysm repair (EVAR) were also evaluated. RESULTS: The analysis included 50 642 intact and 9 453 ruptured AAA repairs. The proportion of EVARs for intact repairs increased from 63.4% in 2014 to 67.3% in 2016 before falling to 62.3% in 2019 (p < .001), but practice varied between countries. EVAR procedures were more common among older patients (p < .001) and men (p < .001). Overall peri-operative mortality after intact AAA repair was 1.4% (95% confidence interval [CI] 1.3 - 1.5%) and did not change over time. Mortality rates were stable within countries. Among ruptured AAA repairs, the proportion of EVARs increased from 23.7% in 2014 to 35.2% in 2019 (p < .001). The average aortic diameter was 7.8 cm for men and 7.0 cm for women (p < .001). The overall peri-operative mortality rate was 31.3% (95% CI 30.4 - 32.2%); the rates were 36.0% (95% CI 34.9 - 37.2%) for open repair and 19.7% (95% CI 18.2 - 21.3%) for EVAR. This difference and shift to EVAR reduced peri-operative mortality from 32.6% (in 2014) to 28.7% (in 2019). CONCLUSION: The international practice of intact AAA repair was associated with low mortality rates in registry reported data. There remains variation in the use of EVAR for intact AAAs across countries. Overall peri-operative mortality remains high after ruptured AAA, but an increased use of EVAR has reduced rates over time.

Acute kidney injury in patients undergoing endovascular or open repair of juxtarenal or pararenal aortic aneurysms.

BACKGROUND: The aim of this cohort study was to report the proportion of patients who develop periprocedural acute kidney injury (AKI) after endovascular repair (ER) and open surgery (OS) in patients with juxta/pararenal abdominal aortic aneurysm and to assess potential risk factors for AKI. The study also aimed to report the short- and long-term outcomes of patients with and without AKI. METHODS: This was a multicenter cohort study of five European academic high-volume centers (>50 OS or 50 ER infrarenal AAA repairs, plus >15 complex AAA repairs per year). All consecutively treated patients were extracted from a prospective vascular surgical registry and the data were scrutinized retrospectively. The primary end point for this study was the development of AKI. AKI was diagnosed when there is a two-fold increase of serum creatinine or decrease of glomerular filtration rate of >50% within 1 week of AAA repair. Secondary end points included long-term mortality and end-stage renal disease (ESRD). RESULTS: AKI occurred in 16.6% of patients in the ER group vs 30.3% in the OS group (P < .001). The 30-day mortality rate was higher among patients with AKI in both ER (15.4% vs 3.1%; P = .006) and OS (13.2% vs 5.3%; P = .001) groups. Age, chronic kidney disease, presence of significant thrombus burden in the pararenal region, >1000 mL blood loss in ER group were associated with development of AKI. Age, diabetes mellitus, chronic kidney disease, presence of significant thrombus burden in the pararenal region, and a proximal clamping time of >30 minutes in the OS group were associated with the development of AKI, whereas renal perfusion during clamping was the protective factor against AKI development. After a median follow-up of 91 months, AKI was associated with higher mortality rates in both the ER group (58.9% vs 29.7%; P < .001) and the OS group (61.5% vs 27.3%; P < .001). After the same follow-up period, AKI was associated with a higher incidence of ESRD in both the ER group (12.8% vs 3.6%; P = .009) and the OS group (9.9% vs 2.9%; P < .001). CONCLUSIONS: The current study identified important pre and postoperative factors associated with AKI after juxta/pararenal abdominal aortic aneurysm repair. Patients with postoperative AKI had significantly higher short- and long term mortality and higher incidence of ESRD than patients without AKI.

Low and Borderline Ankle-Brachial Index Is Associated With Intracranial Aneurysms: A Retrospective Cohort Study.

BACKGROUND AND OBJECTIVES: A low ankle-brachial index (ABI) has been linked to systemic inflammation and an elevated risk of cardiovascular events, most notably myocardial infarction and stroke. Intracranial aneurysms (IAs) share similar risk factors with other cardiovascular diseases. However, the association between low ABI and IAs has not been sufficiently investigated. Our objective was to investigate the potential connection between ABI values and the prevalence of unruptured IAs. METHODS: This retrospective cohort study reviewed 2751 patients who had ABI measurements at a public tertiary hospital from January 2011 to December 2013. Patients with available cerebrovascular imaging or a diagnosis of ruptured IA were included in the study (n = 776) to examine the association between ABI and saccular IAs. The patients were classified into 4 groups: low ABI (≤0.9, n = 464), borderline ABI (0.91-0.99; n = 47), high ABI (>1.4, n = 57), and normal ABI (1.00-1.40; n = 208). RESULTS: The prevalence of IAs was 20.3% (18.1% unruptured IAs) in the low ABI group, 14.9% (12.8% unruptured IAs) in the borderline ABI group, 7.0% (5.3% unruptured IAs) in the high ABI group, and 2.4% (1.9% unruptured IAs) in the normal ABI group (P < .001). There were no significant differences in the prevalence of ruptured IAs between the ABI groups (P = .277). Sex- and age-adjusted multinomial regression, including clinically relevant variables, revealed that low ABI (odds ratio [OR], 13.02; 95% CI, 4.01-42.24), borderline ABI (OR, 8.68; 95% CI, 2.05-36.69), and smoking history (OR, 2.01; 95% CI, 1.07-3.77) were associated with unruptured IAs. CONCLUSION: The prevalence of unruptured IAs was 9-fold higher in the low ABI group and nearly 7-fold higher in the borderline ABI group when compared with the normal ABI group. ABI measurements could be clinically relevant for identifying individuals at higher risk of IAs and may help guide screening and preventive strategies.

The Effect of a Suspended Radiation Protection System on Occupational Radiation Doses During Infrarenal EVAR Procedures: A Randomised Controlled Study.

OBJECTIVE: To compare the protective effect of Zero Gravity (ZG) with conventional radiation protection during endovascular aneurysm repair (EVAR). Secondly, user experience was surveyed with a questionnaire on ergonomics. METHODS: This was a single centre, prospective, randomised, two arm trial where 71 consecutive elective infrarenal EVAR procedures were randomised into two groups: (1) operator using ZG and assistant using conventional protection (n = 36), and (2) operator and assistant using conventional radiation protection (n = 35). A movable floor unit ZG system consists of a lead shield (1.0 mm Pb equivalent) for the front of the body and 0.5 mm Pb equivalent acrylic shielding for the head and neck. The ZG also includes arm flaps of 0.5 mm Pb equivalent covering the arm up to the elbow. Deep dose equivalent values, Hp(10) were measured with direct ion storage dosimeters (DIS) placed on various anatomical regions of the operator (axilla, chest, abdomen, and lower leg). Personal dose equivalent values, Hp(3) to eye lenses were measured in the operating and assisting surgeon using thermoluminescence dosimeters. The study was registered at the US National Institute of Health #NCT04078165. RESULTS: Protection with the standard protection was superior in chest (0.0 vs. 0.1 µSv), abdomen (0.0 vs. 0.6 µSv), and lower leg (0.4 vs. 2.2 µSv) (p < .001). On the other hand, the ZG system yielded better shielding for the axilla (1.5 vs. 0.0 µSv) and eyes (6.3 vs. 1.1 µSv) of the operator. The use of ZG hampered the deployment of ancillary shields, which is particularly relevant for protection of the assisting surgeon. Users found ZG more cumbersome than conventional garments, it also impaired communication and reduced field of view. CONCLUSION: Both ZG and conventional radiation protection reduced radiation exposure. Conventional protection allows better manoeuvrability at the price of wider exposure of the upper arm and axilla. ZG indirectly impaired protection of the assistant.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

The association of ruptured abdominal aortic aneurysm diameter with mortality in the International Consortium of Vascular Registries.

BACKGROUND: The mortality after ruptured abdominal aortic aneurysm (rAAA) repair is high, despite improvements in perioperative care, centralization of emergency vascular surgical services, and the introduction of endovascular aneurysm repair (EVAR). The diameter of intact AAA has been shown to be a predictor of short- and long-term survival. The aim of this study was to analyze the impact of AAA diameter on mortality for rAAA repair using contemporary data collected from the International Consortium of Vascular Registries and compare outcomes by sex and the type of repair patients received. METHODS: Prospective registry data on repair of rAAA from seven countries were collected from 2010 to 2016. The primary outcome was perioperative mortality after EVAR and open surgical repair (OSR). Data were stratified by type of repair and sex. Logistic regression models were used to estimate odds ratio (OR) for the association between AAA diameter and perioperative mortality and the association between type of repair and mortality. Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: The study population consisted of 6428 patients with a mean age ranging from 70.2 to 75.4 years; the mean AAA diameter was 7.7 ± 1.8 cm. Females had a significantly smaller AAA diameter at presentation compared with males (6.9 ± 1.6 cm vs 7.9 ± 1.8 cm; P < .001). who underwent OSR had larger AAA diameters compared with those who underwent EVAR (P < .001). Females who underwent repair were significantly older (P < .001). Males were more likely to have cardiac disease, diabetes mellitus, and renal impairment. Overall, AAA diameter was a predictor of mortality in univariate and multivariate analysis. When analyzing EVAR and OSR separately, the impact of AAA diameter per cm increase on mortality was apparent in both males and females undergoing EVAR, but not OSR (EVAR: male OR, 1.09 [95% confidence interval, 1.03-1.16] and EVAR: female OR, 1.17 [95% confidence interval, 1.02-1.35]). The early mortality rate for males and females who underwent EVAR was 18.9% and 25.9% (P < .001), respectively. The corresponding mortality for males and females who underwent OSR was 30.2% and 38.6% (P < .001), respectively. CONCLUSIONS: In these real-world international data, there is a significant association between rAAA diameters and early mortality in males and females. This association was more evident in patients undergoing EVAR, but not shown in OSR. Despite improvements in overall AAA repair outcomes, the risk of mortality after rAAA repair is consistently higher for females.

Ultrasound Surveillance is Feasible After Endovascular Aneurysm Repair.

BACKGROUND: Surveillance after endovascular aneurysm repair (EVAR) is traditionally done with computed tomography angiography (CTA) scans that exposes patient to radiation, nephrotoxic contrast media, and potentially increased risk for cancer. Ultrasound (US) is less labor intensive and expensive and might thus provide a good alternative for CTA surveillance. The aim of this study was to evaluate in real-life patient cohorts whether US is able to detect post-EVAR aneurysm-related complications similarly to CTA. METHODS: This retrospective study compared the outcome of consecutive patients who underwent EVAR for intact abdominal aortic aneurysm and were surveilled solely by CTA (CTA-only cohort, n = 168) in 2000-2010 or by combined CTA and US (CTA/US cohort, n = 300) in 2011-2016, as a standard surveillance protocol in the department of vascular surgery, Helsinki University Hospital. The CTA-only patients were imaged at 1, 3, and 12 months and annually thereafter. The CTA/US patients were imaged with CTA at 3 and 12 months, US at 6 months and annually thereafter. If there were suspicion of >5 mm aneurysm growth, CTA scan was performed. The patients were reviewed for imaging data, reinterventions, aneurysm ruptures, and death until December 2018. The 2 groups were compared for secondary rupture, aneurysm-related and cancer-related death, reintervention related to abdominal aortic aneurysm, and maximum aneurysm diameter increase ≥5 mm. The mean follow-up in the CTA-only cohort was 67 months and in CTA/US cohort 43 months. RESULTS: The 2 cohorts were alike for basic characteristics and for the mean aneurysm diameter. The total number of CT scans for detecting aneurysm was 84.1/100 patient years in the CTA-only cohort compared to 74.5/100 patient years for US/CTA cohort. Forty percent of patients under combined CTA/US surveillance received 1 or more additional CTA scans. The 2 cohorts did not differ for 1-year, 5-year and 8-year freedom from aneurysm related death, secondary sac rupture, nor the incidence of rupture preventing interventions. CONCLUSIONS: Based on the follow-up data of this real-life cohort of 468 patients, combined surveillance with US and additional CTA either per protocol or due to suspicion of aneurysm-related complications had comparable outcome with sole CTA-surveillance. Thus, US can be considered a reasonable alternative for the CTA. However, our study showed also that the need of additional CTAs due to suspicion of endoleak or aneurysm nonrelated reasons is substantial.

External Validation of a Prognostic Model for Survival of Patients With Abdominal Aortic Aneurysms Treated by Endovascular Aneurysm Repair.

OBJECTIVE: Current guidelines recommend diameter monitoring of small and asymptomatic abdominal aortic aneurysms (AAAs) due to the low risk of rupture. Elective AAA repair is recommended for diameters ≥ 5.5 cm in men and ≥ 5.0 cm in women. However, data supporting the efficacy of elective treatment for all patients above these thresholds are diverging. For a subgroup of patients, life expectancy might be very short, and elective AAA repair at the current threshold may not be justified. This study aimed to externally validate a predictive model for survival of patients with an asymptomatic AAA treated by endovascular aneurysm repair (EVAR). METHODS: This was a multicentre international retrospective observational cohort study. Data were collected from four European aortic centres treating patients between 2001 and 2021. The initial model included age, estimated glomerular filtration rate (eGFR), and chronic obstructive pulmonary disease (COPD) as independent predictors for survival. Model performance was measured by discrimination and calibration. RESULTS: The validation cohort included 1 500 patients with a median follow up of 65 months, during which 54.6% of the patients died. The external validation showed slightly decreased discrimination ability and signs of overfitting in model calibration. However, a high risk subgroup of patients with impaired survival rates was identified: octogenarians with eGFR < 60 OR COPD, septuagenarians with eGFR < 30, and septuagenarians with eGFR < 60 and COPD having survival rates of only 55.2% and 15.5% at five and 10 years, respectively. CONCLUSION: EVAR is a valuable treatment option for AAA, especially for patients unsuitable for open repair. Nonetheless, not all these patients will benefit from EVAR, and an individualised treatment recommendation should include considerations on life expectancy. This study provides a risk stratification to identify patients who may not benefit from EVAR using the present diameter thresholds.

The Intersocietal IWGDF, ESVS, SVS Guidelines on Peripheral Artery Disease in People With Diabetes Mellitus and a Foot Ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes mellitus and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

Editor's Choice - Long Term Outcomes After Invasive Treatment of Carotid Artery Stenosis: a Longitudinal Study of German Health Insurance Claims.

OBJECTIVE: There is a paucity of observational data including long term outcomes after invasive treatment for carotid artery stenosis. METHODS: This retrospective study used nationwide insurance claims from the third largest provider in Germany, DAK-Gesundheit. Patients who underwent inpatient carotid endarterectomy (CEA) or carotid artery stenting (CAS) between 1 January 2008 and 31 May 2017 were included. The Elixhauser comorbidity scores from longitudinally linked hospital episodes were used. Kaplan-Meier analysis and the log rank test were used to determine long term stroke free survival. Multivariable regression models were developed to adjust for confounding. RESULTS: A total of 22 637 individual patients (41.6% female, median age 72.5 years) were included, of whom 15 005 (66.3%) were asymptomatic and 17 955 (79.3%) underwent CEA. After a median of 48 months, 5 504 any stroke or death events were registered. The mortality rate varied between 0.4% (CEA for asymptomatic stenosis) and 2.1% (urgent CAS for acute stroke patients) at 30 days, and between 4.1% and 8.4% at one year, respectively. The rate for any stroke varied between 0.6% (CEA for asymptomatic stenosis) and 2.5% (CAS for symptomatic patients) at 30 days, and between 2.5% and 6.4% at one year, respectively. The combined rate for any stroke and mortality at one year was 6.3% (CEA for asymptomatic stenosis), 8.7% (CAS for asymptomatic stenosis), and 12.5% (urgent CAS for acute stroke patients). After five years, the overall stroke rate was 7.4% after CEA and 9.0% after CAS. In adjusted analyses, both older age and van Walraven comorbidity score were associated with events, while treatment of asymptomatic stenosis was associated with lower event rates. CONCLUSION: The current study revealed striking differences between previous landmark trials and real world practice. It further suggested excess deaths among invasively treated asymptomatic patients.

Femoral nerve blockade during endovenous laser ablation of great saphenous vein decreases pain but does not affect the use of opioids during the procedure.

BACKGROUND: Endovenous laser ablation (EVLA) using tumescent anesthesia for treatment of an insufficient great saphenous vein (GSV) can be painful and require intravenous pain management and, sometimes, sedation with propofol. Femoral nerve blockade (FNB) anesthetizes the femoral nerve distribution and is usually used for anterior thigh and knee procedures. It is easy to inject with ultrasound guidance because the nerve is easy to visualize in the groin. The aim of the present double-blind, randomized controlled trial was to determine whether FNB before tumescent anesthesia decreases the pain of GSV EVLA combined with local phlebectomy. METHODS: Eighty patients who underwent GSV EVLA combined with local phlebectomy under tumescent anesthesia were randomized into two groups. The placebo group (control group; 40 patients) was given placebo FNB with 0.9% saline before tumescent injection. The FNB group (intervention group; 40 patients) received 1% lidocaine with adrenaline for FNB before tumescent injection. Only the study nurse, who performed the randomization, knew which patients were in which group. The patients and operating surgeon were unaware of the randomization group. FNB was performed under ultrasound guidance. The effectiveness of anesthesia was tested 10 minutes after injection using the pin-prick test and a numeric rating scale (NRS). The NRS was completed before and during tumescent anesthesia and during EVLA ablation and local phlebectomy. The motor function of the femoral nerve was tested at the end of the procedure and 1 hour after using the Bromage method. Patients had a follow-up visit 1 month after the procedure, and their need for pain medication and the duration of sick leave were recorded. RESULTS: No differences were found in the gender distribution, age, or GSV dimensions at baseline. The mean length of the treated GSV segment was 28 cm and 30 cm and the mean energy used was 1911 J and 2059 J in the placebo and FNB groups, respectively. The median NRS score for pain during tumescent injection around the GSV was 2 (interquartile range [IQR], 1-4) in the placebo group compared with 1 (IQR, 1-3) in the FNB group. Very little pain was experienced during laser ablation. The median NRS score was 0 (IQR, 0-0) and 0 (IQR, 0-0.75) in the placebo and FNB groups, respectively. The most painful stage was injection of tumescence to the local phlebectomy sites in both groups. The median NRS score was 4 (IQR, 3-7) in the placebo group and 2 (IQR, 1-4) in the FNB group (P = .01). During local phlebectomy, the NRS score was 2 (IQR, 0-4) vs 1 (IQR, 0-3) in the placebo and FNB groups, respectively. Only the difference in pain during injection of tumescence before local phlebectomy was significant. CONCLUSIONS: FNB seems to decrease pain during EVLA combined with local phlebectomy. Patients experienced the highest pain when tumescence was injected before local phlebectomy, and those in the FNB group experienced significantly less pain than the placebo group. No indication for routine use of FNB is indicated. However, it could be used to decrease the pain for patients who experience strong pain during varicose vein surgery, especially if extensive local phlebectomies are required.

A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study.

BACKGROUND: Opinions on the treatment of varicose tributaries in relation to saphenous ablation in varicose disease vary. Moreover, the possible role of the tributaries regarding the recurrence of varicose disease remains unclear. The aim of the FinnTrunk study is to compare two different treatment strategies for varicose disease in a randomized setting. In group one, the initial treatment will entail endovenous laser ablation (EVLA) of the incompetent saphenous trunk without tributary treatment. In group two, the varicose tributaries will be treated with ultrasound-guided foam sclerotherapy (UGFS) concomitantly with truncal ablation. The primary outcome measure is the need for additional procedures during the follow-up. The secondary outcome measures are the cost of treatment and recurrence of varicose disease. METHODS: Consecutive patients with symptomatic varicose disease (CEAP clinical class C2-C3) will be screened for the study. Patients who fulfil the study criteria and give their informed consent will be scheduled for the procedure and randomized to either study group. Patients will be followed-up at 3 months, 1 year, 3 years, and 5 years. The post-procedure pain score based on a numeric rating scale (NRS) and also the use of analgesics, as well as possible procedure-related complications will be recorded at 3 months. Patient-reported outcome measures (PROMs) will be recorded at 1 year. Data pertaining to the additional treatment of varicose tributaries, the Aberdeen Varicose Vein Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and the health-related quality of life (EQ-5D-5L) will be collected at each follow-up visit. A duplex ultrasound (DUS) examination will be performed at each visit, and data on varicose tributaries and the need for additional treatment will be recorded. TRIAL REGISTRATION: Registered on ClinicalTrials.gov, ID NCT04774939.