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Background Gun violence is a global health problem. Population-based research on firearm-related injuries has been relatively limited considering the burden of disease. The aim of this study was to analyze nationwide epidemiological trends of firearm injuries. Methods This is a retrospective nationwide epidemiological study including all patients with firearm injuries from the Swedish Trauma Registry (SweTrau) during the period 2011 and 2019. Registry data were merged with data from the Swedish National Council for Crime Prevention and the Swedish Police Authority. Results There were 1010 patients admitted with firearm injuries, 96.6% men and 3.4% women, median age 26.0 years [IQR 22.0–36.3]. The overall number of firearm injuries increased on a yearly basis (P Conclusions This nationwide study shows an annual increase of firearm-related injuries and fatalities. Firearm injuries affect people of all ages but more frequently young males in major cities. One in six patients succumbed from their injuries within 30 days with most deaths occurring within 24 h of hospital admission. Given the impact of firearm-related injuries on society additional research on a national level is critical.

Objective The aim was to describe the microbiology of surgically treated infective native (mycotic) aortic aneurysms (INAAs), and associated survival and development of infection-related complications (IRCs). Methods Data were pooled from 2 nationwide studies on surgically treated patients with INAAs in Sweden, between 1994 – 2016. Patients were grouped and analyzed according to culture results: 1) Staphylococcus aureus, 2) Streptococcus species (sp.), 3) Salmonella sp., 4) Enterococcus sp., 5) Gram-negative intestinal bacteria, 6) Other sp. (all other species found in culture), and 7) Negative cultures. Results A sum of 182 patients were included, mean age 71 years (standard deviation; SD: 8.9). The median follow-up was 50.3 months (range 0 – 360). 128 (70.3%) patients had positive blood and/or tissue culture; Staphylococcus aureus n = 38 (20.9%), Streptococcus sp. n = 37 (20.3%), Salmonella sp. n = 19 (10.4%), Enterococcus sp. n = 16 (8.8%), Gram-negative intestinal bacteria n = 6, (3.3%), Other sp. n = 12 (6.6%) and Negative cultures n = 54 (29.7%). The estimated survival for the largest groups at 2-years after surgery was: Staphylococcus aureus 62% (95% Confidence interval 53.9 – 70.1), Streptococcus sp. 74.7% (67.4 – 82.0), Salmonella sp. 73.7% (63.6 – 83.8), Enterococcus sp. 61.9% (49.6 – 74.2), and Negative cultures 89.8% (85.5 – 94.1), P = .051. There were 37 IRCs (20.3%), and 19 (51.4%) were fatal, the frequency was insignificant between the groups. The majority of IRCs, 30/37 (81%), developed during the first postoperative year. Conclusion In this assessment of microbiological findings of INAAs in Sweden, 50% of the pathogens were Staphylococcus aureus, Streptococcus sp., or Salmonella sp.. The overall 20%-frequency of IRCs, and its association with high mortality, motivates long-term antibiotic treatment regardless of microbial findings.

Background The objective of this clinical study was to investigate the anticoagulant effect of standard fixed dose of heparin during endovascular intervention in the lower extremity arteries. Methods A prospective clinical pilot study was completed with retrospective quality review of patients between 2015 and 2017 (n = 61). Patients undergoing elective endovascular intervention for arterial insufficiency in the lower extremities were enrolled. A standard fixed intra-arterial dose of 5000 IU of unfractionated heparin (UFH) was administered during the procedure without adjustment for weight or monitoring. Activated clotting time (ACT) was measured before and ten minutes after heparin administration and at the end of the procedure. The primary study end point was the level of heparin anticoagulation after standard perioperative administration. Results Mean age was 74 ± 9 years, 48% women. Mean weight was 74 ± 15 kg, and mean BMI, 25.6 ± 4.7 kg/m2. The endovascular interventions were performed at the iliac arteries 19.7% (12/61), at the femoral popliteal segment 50.8 % (31/61), below the knee arteries 6.6% (4/61), and at multiple levels 13% (8/61). The perioperative mean ACT increased from baseline 155 ± 43 s (n = 31) to ten minutes after heparin administration 290 ± 70 s (n = 60) (P 350 (P = 0.0095). The same pattern was seen for heparin dose per BMI and DuBois. In univariate logistic regression analysis, ACT ≥350 s was associated with lower body weight (OR 0.92; 95% CI 0.87–0.98; P = 0.008), lower BMI (OR 0.80; 95% CI 0.67–0.96; P = 0.014), and lower body surface area DuBois (OR 0.53; 95% 0.32–0.85; P = 0.009). In multivariable regression, the ACT association with body weight remained (OR 0.92; 95% 0.87–0.98; P = 0.008). There were no perioperative or immediate postoperative bleeding complications requiring blood transfusion or surgical intervention in this study cohort. Conclusions The standard heparin dosing of 5000 IU during endovascular intervention for arterial insufficiency in the lower extremities helps achieve ACT >200 s in almost all patients, but most patients were outside recommended target interval. To provide a more consistent and predictable heparinization, a weight-based bolus dose of 70 IU heparin/kg is recommended.

Background There is a concern that civilian gunshot injuries in Europe are increasing but there is a lack of contemporary studies. The purpose of this study was to investigate the current epidemiology and outcome of firearm injuries. Methods Retrospective cohort study of all patients (n = 235) treated for firearm injuries admitted to a Scandinavian trauma center between 2005 and 2016. Local and national trauma registries were used for data collection. Results Mean age was 31.3 years (SD ± 12.9; range 16–88 years); 93.6% males; mean ISS was 14.3 (SD ± 15.9); 31.9% (75/235) had ISS > 15. There was a significant increase in penetrating trauma (P

The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality.No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively).In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

BACKGROUND: Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS: This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION: Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding.FUNDING: Bayer AG.

Objectives The aim was to study blood transfusions and blood product ratios in massively transfused patients treated for ruptured abdominal aortic aneurysms (rAAAs). Methods This was a registry based cohort study of rAAA patients repaired at three major vascular centres between 2008 and 2013. Data were collected from the Swedish Vascular Registry, hospitals medical records, and local transfusion registries. The transfusion data were analysed for the first 24 h of treatment. Massive transfusion (MT) was defined as 4 or more units of red blood cell (RBC) transfused within 1 h, or 10 or more RBC units within 24 h. Logistic regression was used to calculate the odds ratio of 30 day mortality associated with the ratios of blood products and timing of first units of platelets (PLTs) and fresh frozen plasma (FFP) transfused. Results Three hundred sixty nine rAAA patients were included: 80% men; 173 endovascular aneurysm repairs (EVARs) and 196 open repairs (ORs) with median RBC transfusion 8 units (Q1–Q3, 4–14) and 14 units (Q1–Q3, 8–28), respectively. A total of 261 (71%) patients required MT. EVAR patients with MT (n = 96) required less transfusion than OR patients (n = 165): median RBC 10 units (Q1–Q3, 6–16.5) vs. 15 units (Q1–Q3, 9–26) (p = .002), FFP 6 units (Q1–Q3, 2–14.5) vs. 13 units (Q1–Q3, 7–24) (p < .001), and PLT 0 units (Q1–Q3, 0–2) vs. 2 units (Q1–Q3, 0–4) (p = .01). Median blood product ratios in MT patients were FFP/RBC (EVAR group 0.59 [0.33–0.86], OR group 0.84 [0.67–1.2]; p < .001], and PLT/RBC (EVAR 0 [0–0.17], OR 0.12 (0–0.18); p < .001]. In patients repaired by OR a FFP/RBC ratio close to 1 was associated with reduced 30 day mortality (p = .003). The median PLT/RBC ratio was higher during the later part of the study period (p < .001, median test), whereas there was no significant difference in median FFP/RBC ratio (p = .101, median test). Conclusion The majority of rAAA patients undergoing EVAR required MT. EVAR patients treated with MT had lower FFP/RBC and PLT/RBC ratios than OR patients with MT. The mortality risk was lower with FFP/RBC ratio close to 1:1 in open repaired patients requiring MT. The 24 h PLT/RBC ratio increased over the study period. (Less)

Purpose Hemorrhage is the most common cause of preventable death after trauma. Coagulopathy plays a central role in uncontrolled bleeding and is caused by multiple factors. Extracorporeal Membrane Oxygenation (ECMO) is an established treatment for patients with respiratory failure and has in recent years also been used in severely injured trauma patients with cardiopulmonary failure and coexisting bleeding shock. The aim of this study was to evaluate the effect of ECMO on hypothermia, acidosis, and coagulopathy in a traumatic hemorrhagic rabbit model. Methods After anesthesia and tracheostomy, ten New Zealand White rabbits sustained laparotomy, bilateral femur fractures and were hemorrhaged 45% of their estimated blood volume. After 90 min of hemorrhagic shock they were resuscitated with a standard transfusion protocol together with venoarterial ECMO (n = 5) or with a standard transfusion protocol only (n = 5) for 60 min. No systemic heparin was administered. Results ECMO during 60 min of resuscitation significantly increased heart rate (p = 0.01), mean arterial pressure (p = 0.01), body temperature (p = 0.01) and improved the metabolic acidosis, pH (p = 0.01), and lactate (p = 0.01). ECMO also improved the coagulation capacity measured in vitro by Rotational Thromboelastometry with a significant decrease in clot formation time (p

In a recent publication in The Lancet Johansson and colleagues claim no effect on aneurysm mortality among men participating in the Swedish AAA screening program, and question its justification. The study is, however, limited by a corrupt study design and incorrect data, making the publication misleading. On the contrary, several RCTs and contemporary nationwide data with sufficient follow-up clearly show that AAA screening saves lives and is highly cost-effective. The program has so far identified about 6000 men with an AAA, of whom 1500 have been operated on to prevent rupture. Thus, more than 750 men have experienced a longer life (by a mean of 8 years) as a result of the program. Continuous evaluation of the program is important but requires a scientifically sound methodology.

Mycotic aortic aneurysms are rare, life threatening, and complex. This nationwide study aimed to assess outcome after repair of mycotic thoracic aortic aneurysms (MTAAs).Patients treated in Sweden for MTAAs between 2000 and 2016 were identified in the Swedish vascular registry (2010-16) and local patient registries (2000-09). Primary outcome was survival, and secondary outcomes included surgical strategy, rate of infection related complications (IRC), and re-operations.Fifty-two patients (median age 71 ± 8.1 years; 28 [54%] men, 13 [25%] ruptured) were identified (3.6% of all thoracic aortic aneurysm repairs in Sweden). Aneurysm location was aortic arch (n = 6; 11%), descending aorta (n = 42; 81%), and multiple locations (n = 4; 8%). Twenty-nine (56%) patients had positive cultures; the most prevalent agent was Staphylococcus aureus (n = 16; 31%). Operative techniques included thoracic endovascular aortic repair (TEVAR; n = 35 [67%]), fenestrated/branched TEVAR (n = 8; 15%), hybrid repair (n = 7; 14%), and open patch repair (n = 2; 4%). Survival was 92% (95% confidence interval [CI] 88-96) at 30 days, 88% (95% CI 84-93) at three months, 78% (73-84) at one year, and 71% (64-77) at five years. The mean follow up among survivors (90 days) was 45 months (range 4-216 months). Antibiotics were administered for a median of 15 weeks (range 0-220 weeks). IRCs occurred in nine patients (17%): sepsis (n = 3), graft infection (n = 3), recurrent mycotic aneurysm (n = 1), aorto-oesophageal/bronchial fistula (n = 2). Six (67%) IRCs were fatal; 80% occurred within the first year. Re-operations were performed in nine patients (17%).TEVAR was often used as treatment for MTAAs, with acceptable short- and long-term survival when compared with open cohorts in the literature. IRCs are of concern and warrant follow up and long-term antibiotic treatment.

Introduction: Acute compartment syndrome (ACS) is a challenging and recognized complication to vascular surgery revascularization. The aim of this study was to investigate the current epidemiology, management, and early outcomes of fasciotomy in vascular surgery. Methods: Retrospective cohort study of all patients undergoing lower extremity fasciotomy at a single university center between January 2008 and December 2014. Patient demographics, operative techniques, and outcomes were analyzed. Results: The cohort (n = 113 limbs; 107 patients; 48% women; mean age was 74 (12) years [range, 50-97 years]) included 81 (72%) limbs undergoing revascularization for acute limb ischemia, 7 (6.2%) limbs related to acute aortic disease, and 23 (20%) limbs undergoing elective vascular surgery. Five patients underwent bilateral lower extremity fasciotomy. In all, 64 (57%) limbs had signs of ACS and underwent a therapeutic fasciotomy, while 49 (43%) fasciotomies were prophylactic. There were 20 (18%) fasciotomies performed after endovascular interventions. A 4-compartment fasciotomy was performed in 82% (n = 93) of limbs with a double incision technique. Split thickness skin graft was required in 11% (12/112) and vacuum-assisted closure treatment in 11% (12/111). The mean length of stay in hospital was 11 (9) days. Most common complication was lower extremity nerve deficit 32% (33/104) followed by wound infection 30% (32/108). At 30-day follow-up, amputation rate was 13% (14/107 limbs) and mortality 23% (25/107 patients). In the multivariate logistic regression analysis, prophylactic fasciotomy was associated with amputation (odds ratio: 28.9; 95% confidence interval: 1.96-425; P = .014). Conclusion: Acute compartment syndrome is primarily related to acute ischemic conditions but occurs after both aortic or elective vascular procedures and endovascular treatments. There are significant complications related to lower extremity fasciotomy in vascular surgery.

Objective The purpose of this multicentre study was to analyse the outcome of thoracic endovascular aortic repair (TEVAR) in patients with ruptured descending thoracic aortic aneurysm (rDTAA). Methods This is a nationwide retrospective study including all patients who underwent TEVAR for rDTAA at six major vascular university centres in Sweden between January 2000 and December 2015. Outcome measures were analysed using Kaplan–Meier estimator and multivariable Cox regression. Results There were 140 patients (age [mean ± SD] 74.1 ± 8.8 years; 56% men; aneurysm size 64.8 ± 19 mm), with rDTAA. In 53 patients (37.9%), the left subclavian artery was covered, and in 25 patients (17.9%) arch vessel revascularisation was performed. In total, 61/136 patients (45%) had a major complication within 30 days post TEVAR. Stroke (n = 20; 14.7%) was the most common complication, followed by paraplegia (n = 13; 9.6%) and major bleeding (n = 13; 9.6%). TEVAR related complications during follow up included endoleaks 22.1% (30/136; 14 type 1a, six type 1b, 10 not defined). In total, re-interventions (n = 31) were required in 27/137 (19.7%) patients. The median follow up time was 17.0 months (range 0–132 months). The Kaplan–Meier estimated survival was 80.0% at one month, 71.7% at three months, 65.3% at one year, 45.9% at three years, and 31.9% at five years. Age (HR 1.03; 95% CI 1.00–1.07; p = .046), history of stroke (HR 2.35; 95% CI 1.19–4.63; p = .014), previous aortic surgery (HR 2.11; 95% CI 1.15–3.87; p = .016) as well as post-operative major bleeding (HR 4.40; 95% CI 2.20–8.81; p = .001), stroke (HR 2.63; 95% CI 1.37–5.03; p = .004), and renal failure (HR 8.25; 95% CI 2.69–25.35; p = .001) were all associated with mortality. Conclusions This nationwide multicentre study of patients with rDTAA undergoing TEVAR showed acceptable short- but poor long-term survival. Adequate proximal and distal aortic sealing zones are important for technical success. High risk patients and post-operative complications need to be further addressed in an effort to improve outcome.

BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, pINTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.FUNDING: Bayer AG.

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

Background and Purpose— Early carotid surgery or stenting after thrombolytic treatment for stroke has become more common during recent years. It is unclear whether this carries an increased risk of postoperative complications and death. The aim of this nationwide population-based study was, therefore, to investigate the safety of urgently performed carotid procedures in patients treated with thrombolysis for stroke. Methods— Using the national Vascular and Stroke registries, we identified 3998 patients who had undergone carotid endarterectomy or carotid artery stenting for symptomatic carotid stenosis between May 2008 and December 2012. Among these, 2% (79 of 3998) had undergone previous thrombolysis for stroke. We conducted a retrospective review of registry data and individual case records with regard to postoperative complications, including surgical-site bleeding, stroke, and death. The outcome was compared with the results for the remaining patient cohort (3919 of 3998) undergoing carotid surgery and stenting during the study period. Results— The median time between thrombolysis and the carotid procedure was 10 days. Seventy-one patients underwent carotid endarterectomy, and 6 patients underwent carotid artery stenting. The 30-day death and stroke rate for the thrombolysis cohort was 2.5% (2 of 79), and for the whole cohort, it was 3.8% (139 of 3626; P =0.55). The postoperative bleeding rates requiring reoperation were not significantly different between the groups (3.8% [3 of 79] in the thrombolysis group versus 3.3% [119 of 3626] in the whole cohort; P =0.79). There was no correlation between time from lysis to surgery or stenting and complications at 30 days postoperatively. Conclusions— Urgent carotid endarterectomy or carotid artery stenting after thrombolysis for stroke may be safe without increased risk of serious complications.

Objectives To compare early (30 day mortality and major complications) and midterm (survival) outcomes in elective open surgical descending and thoraco-abdominal aortic repair using left heart bypass (LHB) versus hypothermic circulatory arrest (HCA) for organ protection, hypothesising non-inferiority of HCA management. Method This was a retrospective clinical cohort study with cross sectional follow-up. All elective ( n = 90) descending or thoraco-abdominal aortic repairs performed between 2004 and 2015 using either LHB ( n = 57) or HCA ( n = 33) were included. Pre- and intra-operative variables were evaluated by univariate statistical analysis. Thirty day and follow-up mortality were primary endpoints; major complications were secondary endpoints. Propensity score matching was employed to adjust for selection bias. Kaplan–Meier methods were used to estimate midterm survival. Results Overall 30 day mortality was 8/90 (8.9%): 6/57 (10.5%) using LHB vs. 2/33 (6.1%) using HCA, p = .47. Five patients (5.6%) suffered paraplegia: 3/57 (5.3%) using LHB vs. 2/33 (6.1%) using HCA, p = .87. Stroke occurred in 6/57 (11%) vs. 2/33 (6.1%), p = .76; renal failure in 27/57 (47%) vs. 19/33 (58%), p = .90; and respiratory failure in 17/57 (30%) vs. 11/33 (33%), p = .68. In 26 propensity score matched pairs, findings remained unaltered. Total follow-up was 443 patient years (median 4.9 years). Estimated survival was 78% at 1 year and 77% at 5 years in LHB vs. 72% and 67%, respectively, with HCA; there were no significant inter-group differences, before or after propensity score matching. Conclusions In elective descending or thoraco-abdominal aortic repair, no statistically significant differences in 30 day mortality, major complications, or follow-up survival were found when LHB and HCA were compared. These findings remained after propensity score matching.

ObjectiveThis study aimed to evaluate the outcome and predisposing factors related to perioperative bleeding in patients treated with endovascular aneurysm repair (EVAR) for ruptured and non-ruptured abdominal aortic aneurysm (AAA).DesignThis was a retrospective cohort study.MethodsA total of 525 consecutive patients (73% elective) with AAA underwent EVAR at two vascular centres from 2008 to 2011. From registry data perioperative bleeding was analysed in relation to outcome and preoperative data.ResultsA total of 453 (86%) patients presented with a perioperative bleeding 5000 ml. Other than ruptured AAA (n = 90), no preoperative risk factors for increased perioperative bleeding were found. Open femoral artery access (n = 101), branched (n = 18) and uni-iliacal endografts (n = 18) and introducer size were associated with increased perioperative bleeding (P 2000 ml were significantly related to 30-day mortality (odds ratio 10.6 (range 3.8–29.6) and 13.4 (range 4.8–37.4), respectively). Postoperative renal failure, multi-organ failure, >5 days at intensive care unit, bowel ischaemia and abdominal compartments syndrome were significantly related to perioperative bleeding >2000 ml (P

The proportion of women with abdominal aortic aneurysm (AAA) treated with endovascular aortic repair (EVAR) is lower than for open repair (OR). Unfavorable morphologic features for EVAR in women with AAA may explain this disproportion. The objective of this study was to identify morphologic features in AAA patients undergoing elective repair with special emphasis on gender differences.Patients undergoing elective repair from January 1, 2006 to December 31, 2008 at our university's vascular unit were included in this study. Computed tomography (CT) angiograms were analyzed. Morphologic features considered unfavorable for EVAR rather than open repair (OR) included: infrarenal aortic neck15 mm; angulation60°; circumferential neck thrombus; neck width32 mm; iliac arteries7.5 mm; or presence of bi-iliac aneurysms. Complex aortic neck was defined as a neck length of15 mm and one or more of the other aortic neck exclusion criteria.One hundred seventy-two patients, including 140 men and 32 women, were treated during the study period, which included 99 with OR (21 women, 78 men) and 73 with EVAR (11 women, 62 men). Morphologic unsuitability for EVAR was 44% (75 of 172) and was not statistically different between women and men [47% (15 of 32) vs. 43% (60 of 140), P = 0.70]. Aortic neck pathology was the dominating feature for unsuitability for EVAR (69 of 75, 92%), and 85 of 172 patients had an unsuitable aortic neck. This rate was not different between women and men [19 of 32 (59%) vs. 66 of 140 (47%), P = 0.24]. Iliac unsuitability rates were 11% (19 of 172) and were not different between women and men [4 of 32 (12%) vs. 15 of 140 (11%), P = 0.76]. In patients unsuitable for EVAR, the proximal aortic necks showed more extensive aortic neck pathology in women than in men [8 of 15 (53%) vs. 13 of 60 (22%), P = 0.02]. More men had only short neck pathology [22 of 60 (37%) vs. 1 of 15 (7%), P = 0.03].Aortic neck pathology is the dominating cause of EVAR exclusion in both genders. A higher proportion of women have more pathologic neck anatomy. Future development of EVAR devices should focus on the complexity of the aortic neck, which will benefit all AAA patients, but especially women.

Background: No reliable comparative data exist between open repair (OR) and endovascular aneurysm repair (EVAR) for mycotic abdominal aortic aneurysms (MAAAs). This nationwide study assessed outcomes after OR and EVAR for MAAA in a population-based cohort. Methods: All patients treated for MAAAs in Sweden between 1994 and 2014 were identified in the Swedish vascular registry. The primary aim was to assess survival after MAAA with OR and EVAR. Secondary aims were analyses of the rate of recurrent infections and reoperations, and time trends in surgical treatment. Survival was analyzed using Kaplan-Meier and log-rank tests. A propensity score–weighted correction for risk factor differences in the 2 groups was performed, including the operation year to account for differences in treatment and outcomes over time. Results: We identified 132 patients (0.6% of all operated abdominal aortic aneurysms in Sweden). Mean age was 70 years (standard deviation, 9.2), and 50 presented with rupture. Survival at 3 months was 86% (95% confidence interval, 80%–92%), at 1 year 79% (72%–86%), and at 5 years 59% (50%–68%). The preferred operative technique shifted from OR to EVAR after 2001 (proportion EVAR 1994–2000 0%, 2001–2007 58%, 2008–2014 60%). Open repair was performed in 62 patients (47%): aortic resection and extra-anatomic bypass (n=7), in situ reconstruction (n=50), and patch plasty (n=3); 2 patients died intraoperatively. EVAR was performed in 70 patients (53%): standard EVAR (n=55), fenestrated/branched EVAR (n=8), and visceral deviation with stent grafting (n=7); no deaths occurred intraoperatively. Survival at 3 months was lower for OR than for EVAR (74% versus 96%, P P =0.054). A propensity score–weighted risk-adjusted analysis confirmed the early better survival associated with EVAR. During median follow-up of 36 and 41 months for OR and EVAR, respectively, there was no difference in long-term survival (5 years 60% versus 58%, P =0.771), infection-related complications (18% versus 24%, P =0.439), or reoperation (21% versus 24%, P =0.650). Conclusion: This study demonstrates a paradigm shift in treatment of MAAA in Sweden, with EVAR being the preferred treatment modality. EVAR was associated with improved short-term survival in comparison with OR, without higher associated incidence of serious infection-related complications or reoperations.

The purpose of this study was to analyse the effect of dual antiplatelet therapy (DAPT) compared to aspirin on outcome after endovascular interventions in patients with CLI.This was a population based retrospective nationwide cohort analysis. Several linked national databases in Sweden: Swedish National Vascular Registry, Prescribed Drug Registry and National Discharge Registry. A total of 1941 patients (median age 79; range 43-103 years; women 58%) were identified with CLI who had undergone primary femoropopliteal endovascular intervention between 2006 and 2012. Of these, 599 (31%) patients were treated after the intervention with DAPT (aspirin and clopidogrel) and 1342 (69%) patients were treated with aspirin only. Percutaneous transluminal angioplasty (PTA) was performed in 1131 patients (58%), stenting in 633 patients (33%), and subintimal angioplasty (SAP) in 177 patients (9%).DAPT was given after PTA, stenting, and SAP to 17% (n = 188), 53% (n = 334), and 44% (n = 77) of the patients, respectively. During the study period, 77 patients (13%) with DAPT and 228 patients (17%) with aspirin underwent a major amputation. Patients receiving DAPT after stenting had a lower rate of amputation (HR 0.56; 95% CI 0.36-0.86) than patients receiving aspirin alone. In the subgroup analysis, the protective effect of DAPT on amputation seemed to be confined to patients with diabetes mellitus receiving a stent (HR 0.26; 95% CI 0.13-0.52; p .001). DAPT after PTA or SAP did not influence limb salvage, and there was no overall difference in mortality. There was no significant difference in bleeding complications between DAPT and aspirin.DAPT with aspirin and clopidogrel compared to aspirin alone was associated with a lower amputation rate but not a higher bleeding rate in patients with diabetes and CLI after endovascular femoropopliteal stenting.

Purpose: To describe a heretofore unreported complication involving the Zenith Low Profile (LP) stent-graft. Case Report: Two men, aged 75 and 67 years, respectively, underwent abdominal aortic aneurysm repair with a Zenith LP device. At 4 and 3 years, respectively, computed tomography angiography revealed separation of the proximal fixation stent from the stent-graft. In the first patient, there was stent-graft migration but no evidence of an endoleak; however, the aneurysm had grown. A fenestrated cuff was placed, sealing distally in the previous LP graft. The second patient had a type I endoleak. Open surgery was performed, and the main body of the graft was explanted. Postoperative examination of the device revealed that the fixation sutures on the suprarenal stent were still attached to the stent and had eroded through the graft material. Conclusion: Physicians should be aware of the potential for top stent separation from the Zenith LP stent-graft as a cause of endoleak and migration.

Objective— To analyze the contribution of genetic and environmental factors to the development of peripheral arterial disease (PAD) in a large population-based sample of twins. Methods and Results— The understanding of genetics in PAD is still limited. From the Swedish Twin Registry and the national patient discharge registry, 1464 twins with PAD were identified, including 33 monozygotic (MZ) and 42 dizygotic (DZ) concordant pairs and 298 MZ and 1008 DZ discordant pairs. Traditional cardiovascular risk factors were significantly more prevalent in twins with PAD than in those without PAD. Concordances and correlations were higher in MZ compared with DZ twins, indicating genetic influences in PAD. The risk of PAD for persons whose twin had PAD compared with persons whose twin did not have PAD, estimated as an odds ratio, was 17.7 (95% CI, 11.7 to 26.6) for MZ twins and 5.7 (95% CI, 4.1 to 7.9) for DZ twins. In the structural equation models, Mx analyses, genetic effects accounted for 58% (95% CI, 50% to 64%) and nonshared environmental effects for 42% (95% CI, 36% to 50%) of the phenotypic variance among twins. Conclusion— Heritability is an important component, along with unique environmental factors, for the development of PAD. The proportion of the overall PAD heritability attributed to the heritability of cardiovascular risk factors needs to be resolved. Traditional risk factors could explain a major proportion of PAD heritability. A better understanding of the genetics in PAD could identify individuals at increased risk who may benefit from targeted therapies.

Background The contribution of hereditary and environmental factors to the development of abdominal aortic aneurysms (AAAs) is still partly unknown. The aim of this study was to analyze the role of these factors in a large population-based sample of twins. Methods The Swedish Twin Registry, containing data on twins born in the country since 1886, was cross-linked with the Inpatient Registry, providing national coverage of discharge diagnoses coded according to the International Classification of Diseases (ICD). All twins with an infrarenal AAA were identified. Concordance rates and tetrachoric correlations were calculated for monozygotic (MZ) and dizygotic (DZ) twins. Tetrachoric correlations were calculated assuming an underlying normal distribution of liability, with multiple factors contributing additively and a threshold value that discriminates between AAA and no AAA. Higher concordance rates and correlations of liability in MZ twins than in DZ twins suggest that genetic factors influence disease development. Structural equation modeling techniques, Mx-analyses, were used to estimate the contributions of genetic effects as well as shared and nonshared environmental factors for development of AAA. Results There were 172,890 twins registered at the time of the study including 265 twins (81% men; mean age 72 years; range, 48-94) with AAA. There were 7 MZ and 5 DZ concordant pairs as well as 44 MZ and 197 DZ discordant pairs with AAA. The probandwise concordance rates for MZ and DZ pairs were 24% and 4.8%, respectively. The tetrachoric correlations were 0.71 in MZ pairs and 0.31 in DZ pairs. The odds ratio (OR) was 71 (95% confidence interval [CI] 27-183) for MZ twins and 7.6 (95% CI 3.0-19) for DZ twins. In the structural equation models, genetic effects accounted for 70% (95% CI 0.33-0.83), shared environmental effects for 0% (95% CI 0-0.27), and nonshared environmental effects for 30% (95% CI 0.17-0.46) of the phenotypic variance among twins. Conclusion These data provide robust epidemiologic evidence that heritability contributes to aneurysm formation. Concordances and correlations were higher in MZ compared with DZ twins, indicating genetic effects. There was a 24% probability that an MZ twin of a person with AAA will have the disease. The twin of an MZ twin with AAA had a risk of AAA that was 71 times that of the MZ twin of a person without AAA. A heritability of 70% of the total trait variance was estimated. The remaining variance was explained by nonshared environmental factors with no support for a role of shared environmental influences.

Objective: To determine the efficacy of atherectomy for limb salvage compared with open bypass in patients with critical limb ischemia. Methods: Ninety-nine consecutive bypass and atherectomy procedures performed for critical limb ischemia between January 2003 and October 2006 were reviewed. Results: A total of 99 cases involving TASC C (n = 43, 44%) and D (n = 56, 56%) lesions were treated with surgical bypass in 59 patients and atherectomy in 33 patients. Bypass and atherectomy achieved similar 1-year primary patency (64% vs 63%; P = .2). However, the 1-year limb salvage rate was greater in the bypass group (87% vs 69%; P = .004). In the tissue loss subgroup, there was a greater limb salvage rate for bypass patients versus atherectomy (79% vs 60%; P = .04). Conclusions: Patients with critical limb ischemia may do better with open bypass compared with atherectomy as first-line therapy for limb salvage.

This register based study aimed to investigate the rate and pattern of healthcare associated infections (HCAI) in patients treated for lower extremity arterial disease, using antibiotic prescription as a surrogate for post-operative HCAI.A retrospective analysis of prospectively registered data on all patients treated with primary elective, open or endovascular, surgery for lower extremity arterial disease in Sweden between 2005 and 2010, was carried out. Antibiotic prescriptions were determined for three time periods (6 months pre-operative; 30 day post-operative, and 5 months extended post-operative).The cohort (n = 9894) included patients with claudication (27%, n = 2659), critical limb ischemia (rest pain without ulceration; 17%, n = 1681), and ulceration/gangrene (56%, n = 5552). Fifty-nine percent (n = 5865) of the procedures were endovascular interventions. The incidence of 30 day post-operative antibiotic prescriptions was 33% (n = 3294). These were comprised of antibiotics for skin and soft tissue infections (67%, n = 2199); urinary tract infections (UTIs; 21%, n = 703); and respiratory tract infections (12%, n = 383). There was a 92% increase in the antibiotic prescription incidence rate for the 1 month post-operative period compared with the pre-operative period (p .001). In the endovascular group, UTI antibiotics dominated the 30 day post-operative period for patients with claudication (p .001).Antibiotic treatment can be a useful marker for post-discharge surveillance of HCAI in patients with lower extremity arterial disease. The incidence of post-operative HCAI after lower extremity revascularization may have previously been underestimated.

Background Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. Methods Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470. Findings 1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0–5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72–1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28–2·30, p Interpretation Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis. Funding Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.

Background— Mycotic aortic aneurysm (MAA) is a rare and life-threatening disease. The aim of this European multicenter collaboration was to study the durability of endovascular aortic repair (EVAR) of MAA, by assessing late infection–related complications and long-term survival. Methods and Results— All EVAR treated MAAs, between 1999 and 2013 at 16 European centers, were retrospectively reviewed. One hundred twenty-three patients with 130 MAAs were identified. Mean age was 69 years (range 39–86), 87 (71%) were men, 58 (47%) had immunodeficiency, and 47 (38%) presented with rupture. Anatomic locations were ascending/arch (n=4), descending (n=34), paravisceral (n=15), infrarenal aorta (n=63), and multiple (n=7). Treatments were thoracic EVAR (n=43), fenestrated/branched EVAR (n=9), and infrarenal EVAR (n=71). Antibiotic was administered for mean 30 weeks. Mean follow-up was 35 months (range 1 week to 149 months). Six patients (5%) were converted to open repair during follow-up. Survival was 91% (95% confidence interval, 86% to 96%), 75% (67% to 83%), 55% (44% to 66%), and 41% (28% to 54%) after 1, 12, 60, and 120 months, respectively. Infection-related death occurred in 23 patients (19%), 9 after discontinuation of antibiotic treatment. A Cox regression analysis demonstrated non-Salmonella–positive culture as predictors for late infection–related death. Conclusions— Endovascular treatment of MAA is feasible and for most patients a durable treatment option. Late infections do occur, are often lethal, and warrant long-term antibiotic treatment and follow-up. Patients with non-Salmonella–positive blood cultures were more likely to die from late infection.

Purpose To evaluate the long-term outcome of infrainguinal percutaneous transluminal angioplasty (PTA). Methods Between 1991 and 1994, 77 patients (45 men; mean age 70 years, range 41-85) underwent infrainguinal PTA for occlusive disease. Patient records and angiographic examinations were reviewed to extract data to a patient register. A long-term (mean 9.3 years) follow-up examination of survivors was performed, including physical evaluation, walking impairment questionnaire (WIQ), and duplex ultrasound. Results Cumulative primary and secondary patency rates, respectively, were 81% and 86% at 1 year, 65% and 73% at 5 years, and 12% and 17% at 10 years. Patency rates were better for patients with claudication than critical ischemia (p=0.02). Stenoses had better primary patency than occlusions (p=0.001), but there was no difference between stenoses /=2 cm. At long-term follow-up, patients with patent vessels (50%) had better ankle-brachial indices (p=0.01) and less pain in their calves (p=0.04) compared to patients with non-patent vessels, but there was no difference in walking capacity or quality of life. Generalized femoral artery disease (p=0.03) and diabetes mellitus (p=0.03) predicted poor survival. Conclusions Although the overall long-term patency of infrainguinal PTA is poor, the technique has a low morbidity and can be performed in selected patients with a reasonable long-term result.

Ruptured abdominal aortic aneurysm (rAAA) is associated with coagulopathy and intraabdominal hemorrhage. Fibrinogen acts as a key coagulation factor and has previously been suggested as a biomarker for increased perioperative bleeding in other surgical areas. The aim of the present study was to investigate fibrinogen and standard laboratory parameters and their association to preoperative hemodynamic status, intraoperative bleeding (IOB), and outcome in treatment of rAAA.This is a single university center retrospective cohort study of 91 consecutive patients with rAAA undergoing open surgery or endovascular aneurysm repair (EVAR) between 2008 and 2013. Patients were analyzed using the Swedish Vascular Registry (Swedvasc), and local hospital medical and laboratory records. Laboratory data analyzed included fibrinogen, hemoglobin, platelet count, prothrombin time ratio, activated partial thrombin time, and creatinine. Odds ratios (OR) with 95% confidence intervals (CI) were calculated in a logistical regression model.In the study cohort (n = 91), median age was 74 (57-91) years; 80 % men; open surgical repair (n = 72; 77%); EVAR (n = 19; 23%). Median preoperative fibrinogen concentration was 1.8 g/L (IQR = 1.4) and varied significantly across bleeding groups: ≤1999 ml 2.3g/L, IQR = 1.4 (n = 35); 2000-4999 ml 1.6 g/L, IQR = 1.5 (n = 33); ≥5000 ml 1.4 g/L, IQR = 1.0 (n = 23) (P0.001). Preoperative fibrinogen concentration showed a linear relationship with preoperative blood pressure (r = .447, P = 0.01). When analyzing other preoperative laboratory values, only platelets showed a similar linear relationship with preoperative blood pressure (r = .247, P = 0.05). Patients with blood pressure70 mmHg had an associated median fibrinogen concentration of less than 1.5 g/L (P = 0.001). In the multivariable logistic regression analysis, preoperative fibrinogen1.5 g/L [OR 10.0, CI (1.8-57.1), P = 0.009] was associated with IOB2000 ml and preoperative blood pressure70 mmHg was associated with IOB2 000 ml [OR 3.7, CI (1.1-12.6), P = 0.03] and5000 ml [OR 5.2, CI (1.3-21.1), P = 0.02]. Low fibrinogen concentration (1.5 g/L) was associated with 30-day mortality in the univariate analysis but not in the multivariable logistic regression analysis.Low preoperative fibrinogen concentration was significantly associated with preoperative hypotension and increased intraoperative bleeding in patients with rAAA. Patients in hemodynamic shock with blood pressure70 mmHg had an associated fibrinogen concentration of less than 1.5 g/L. A fibrinogen concentration less than 1.5 g/L was associated with a ten-fold increased risk of intraoperative hemorrhage of more than 2000 ml.

WHAT THIS PAPER ADDS The literature on the safety of carotid endarterectomy (CEA) after intravenous thrombolysis (IVT) consists of relatively small series. This study presents the first very large registry based case controlled study on a consecutive series of patients having CEA with or without previous IVT for acute stroke. Equally low procedure related stroke and death rates were found in the two groups. Despite weaknesses in this study, including lack of data on the interval from symptoms to CEA in the control group, the results support the indication that CEA can also be performed within the recommended 2 weeks in patients having had IVT. Objective: Few studies have been published on the safety of carotid endarterectomy (CEA) after intravenous thrombolysis (IVT). Registry reports have been recommended in order to gather large study groups. Design: A retrospective, registry based, case controlled study on prospectively gathered data from Sweden, the capital region of Finland, and from Denmark, including 30 days of follow up. Methods: The study group was a consecutive series of 5526 patients who had CEA for symptomatic carotid artery stenosis during a 4.5 year period. Among these, 202 (4%) had IVT prior to surgery, including 117 having CEA within 14 days, and 59 within 7 days of thrombolysis. IVT as well as CEA were performed following established guidelines. The median time from index symptom to CEA was 12 days (range 0e130, IQR 7e21). Results: The 30 day combined stroke and death rate was 3.5% (95% CI 1.69e6.99) for those having IVT þ CEA, 4.1% (95% CI 3.46e4.39) for those having CEA without previous IVT (odds ratio 0.84 [95% CI 0.39e1.81]), 3.4% (95% CI 1.33e8.39) for those having IVT þ CEA within 14 days, and 5.1% (95% CI 1.74e13.91) for those having IVT þ CEA within 7 days. Conclusion: Data on the time from symptoms to CEA in patients not having IVT, Rankin score, degree of stenosis, and cerebral imaging were not available. Despite its weaknesses, this study reasserts that CEA can be performed within the recommended 2 weeks of the onset of symptoms and IVT without increasing the risk of peri-operative stroke or death. Centres and vascular registries are recommended to continue monitoring changes in patient characteristics, lead times, and major complications after CEA in general, with a special focus on those who have undergone a prior thrombolysis.

Item does not contain fulltext BACKGROUND: Findings from randomised trials have shown a higher early risk of stroke after carotid artery stenting than after carotid endarterectomy. We assessed whether white-matter lesions affect the perioperative risk of stroke in patients treated with carotid artery stenting versus carotid endarterectomy. METHODS: Patients with symptomatic carotid artery stenosis included in the International Carotid Stenting Study (ICSS) were randomly allocated to receive carotid artery stenting or carotid endarterectomy. Copies of baseline brain imaging were analysed by two investigators, who were masked to treatment, for the severity of white-matter lesions using the age-related white-matter changes (ARWMC) score. Randomisation was done with a computer-generated sequence (1:1). Patients were divided into two groups using the median ARWMC. We analysed the risk of stroke within 30 days of revascularisation using a per-protocol analysis. ICSS is registered with controlled-trials.com, number ISRCTN 25337470. FINDINGS: 1036 patients (536 randomly allocated to carotid artery stenting, 500 to carotid endarterectomy) had baseline imaging available. Median ARWMC score was 7, and patients were dichotomised into those with a score of 7 or more and those with a score of less than 7. In patients treated with carotid artery stenting, those with an ARWMC score of 7 or more had an increased risk of stroke compared with those with a score of less than 7 (HR for any stroke 2.76, 95% CI 1.17-6.51; p=0.021; HR for non-disabling stroke 3.00, 1.10-8.36; p=0.031), but we did not see a similar association in patients treated with carotid endarterectomy (HR for any stroke 1.18, 0.40-3.55; p=0.76; HR for disabling or fatal stroke 1.41, 0.38-5.26; p=0.607). Carotid artery stenting was associated with a higher risk of stroke compared with carotid endarterectomy in patients with an ARWMC score of 7 or more (HR for any stroke 2.98, 1.29-6.93; p=0.011; HR for non-disabling stroke 6.34, 1.45-27.71; p=0.014), but there was no risk difference in patients with an ARWMC score of less than 7. INTERPRETATION: The presence of white-matter lesions on brain imaging should be taken into account when selecting patients for carotid revascularisation. Carotid artery stenting should be avoided in patients with more extensive white-matter lesions, but might be an acceptable alternative to carotid endarterectomy in patients with less extensive lesions. FUNDING: Medical Research Council, the Stroke Association, Sanofi-Synthelabo, the European Union Research Framework Programme 5.

BACKGROUND: Thrombin potently activates platelets through the protease-activated receptor PAR-1. Vorapaxar is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin through antagonism of PAR-1. METHODS: We randomly assigned 26,449 patients who had a history of myocardial infarction, ischemic stroke, or peripheral arterial disease to receive vorapaxar (2.5 mg daily) or matching placebo and followed them for a median of 30 months. The primary efficacy end point was the composite of death from cardiovascular causes, myocardial infarction, or stroke. After 2 years, the data and safety monitoring board recommended discontinuation of the study treatment in patients with a history of stroke owing to the risk of intracranial hemorrhage. RESULTS:At 3 years, the primary end point had occurred in 1028 patients (9.3%) in the vorapaxar group and in 1176 patients (10.5%) in the placebo group (hazard ratio for the vorapaxar group, 0.87; 95% confidence interval [CI], 0.80 to 0.94; P

BackgroundThrombolysis is a common method in the treatment of lower extremity bypass graft occlusion. The purpose of this study was to investigate the results of thrombolytic therapy in the management of acute bypass graft occlusion and to identify risk factors for technical failure and amputation.MethodsAll patients at two tertiary referral centers undergoing thrombolysis for acute graft occlusion in the lower limb between January 1, 2000 and December 31, 2008 were retrospectively reviewed. Factors associated with technical failure of thrombolytic therapy, major amputation, and mortality were determined with multivariate analysis, and long-term outcomes were assessed with the Kaplan-Meier method and log-rank test.ResultsDuring the study period, 123 patients underwent thrombolysis for acute bypass graft occlusion. Mean age was 69 years (range, 27-91 years); 38% were women. Sixty-seven percent had synthetic grafts. Acute critical leg ischemia (74%) was the dominating symptom preceding thrombolytic treatment. In 29% of cases, no adjunctive interventions were required, whereas 21% underwent open surgery, 39% endovascular intervention, and 11% underwent a hybrid procedure. Technical failure of thrombolysis occurred in 18 patients. Presence of ischemic heart disease (P = .013), older grafts (P = .014), and synthetic grafts (trend; P = .092) were associated with success of thrombolysis, and ischemic heart disease remained as an independent factor in the multivariate analysis for technical success of thrombolysis (P = .04; odds ratio 4.0; 95% confidence interval [CI; 1.1-15.1]), whereas there was a trend for older grafts (P = .089). Mean follow-up was 38 months (range, 0-119 months). The major amputation rate was 11% (14/123) at 1 month and 25% (31/122) at 1 year. In a Cox regression model, technical failure (P = .031; hazard ratio [HR] 2.58, 95% CI [1.0-6.08]), higher age (P = .004; HR 1.06, 95% CI [1.02-1.10]), and synthetic graft as opposed to vein graft (P = .050; HR 2.63, 95% CI [1.0-6.9]) remained as independent factors associated with major amputation. The amputation-free survival rate was 89% and 75% at 1 and 12 months, respectively. Higher age (P < .001; HR 1.06, 95% CI [1.03-1.09]) and acute limb ischemia (P = .007; HR 2.40, 95% CI [1.26-4.56]) remained as independent adverse factors associated with amputation-free survival.ConclusionsOur findings support the use of thrombolysis in the treatment of acute bypass graft occlusion in the lower limb given its acceptable short- and long-term amputation-free survival rates. Technical failure and higher age were factors associated with major amputation. Synthetic grafts appeared to have a somewhat increased likelihood of technically successful thrombolysis compared with vein grafts, but on the other hand, they exhibited an increased risk of amputation during follow-up.

Background: The postthrombotic syndrome is a chronic complication of deep venous thrombosis that leads to considerable pain and suffering to patients. We evaluated our experience of endovascular treatment for patients with chronic postthrombotic femoroiliocaval venous disease. Materials and Methods: From January 2003 through December 2007, 50 patients (51 limbs; 60% women; mean age 45 years; range: 24-74 years) with chronic postthrombotic venous disease were referred to our institution for interventional assessment. All patients underwent duplex ultrasonography as well as ascending and descending venography. The CEAP (clinical, etiologic, anatomic, and pathophysiologic classification) clinical scores were class 0 (no signs) in 2% of limbs, class 3 (edema) in 63%, class 4a (pigmentation or eczema) in 18%, class 5 (healed venous ulcer) in 14%, and class 6 (active venous ulcer) in 4%. The etiology was secondary (postthrombotic) in all patients. The anatomical distribution of reflux and obstruction were deep veins in 63% and a combination of deep and superficial veins in 37%. The underlying pathophysiology due to obstruction of the deep venous outflow with no reflux was found in 25% of limbs, only reflux was found in 14%, and a combination of obstruction and reflux was found in 61%. Results: There were 21 limbs in 20 (38%) patients that underwent endovascular and/or surgical treatment. One limb underwent femoral endovenectomy and 1 limb superficial femoral vein to deep femoral vein transposition. In all, 19 limbs were scheduled for endovascular treatment. The technical success rate was 84%, 3 limbs with iliac vein occlusions could not be recanalized. A total of 11 patients (11 limbs) underwent solely endovascular intervention and 4 patients (5 limbs) underwent endovascular intervention combined with femoral endovenectomy. The endovascular and surgical procedures were performed with no perioperative or postoperative mortality as well as no major bleeding or cardiac, pulmonary, or renal 30-day complications. Early thrombosis (

Incidental arterial injury is one of the main mechanical complications associated with central venous catheter placement. These injuries can result in significant morbidity and mortality. The use of arterial closure devices to repair these injuries offers a less invasive alternative than open repair and a safer approach than manual compression. We present 3 cases of critically ill patients treated with arterial closure devices when attempted central venous catheterization failed and inadvertent arterial cannulation occurred. A brief review of the various closure devices and there indications is discussed.

Background The management of infrarenal aortic aneurysms in high-risk patients remains a challenge. Endovascular aneurysm repair (EVAR) is associated with superior short-term mortality rates but unclear long-term results and has not been shown to improve survival in patients unfit for open repair (OR). The aim of this population-based study was to evaluate the outcome after elective EVAR compared with OR in a high-risk patient cohort. Methods Prospectively collected data from January 2000 to December 2006 were retrieved from the Swedish Vascular Registry. The high-risk cohort was defined as age ≥60 years, American Anesthesiologists Association (ASA) class 3 or 4, and at least one cardiac, pulmonary, or renal comorbidity. These criteria were met by 217 of 1000 EVAR patients and 483 of 2831 OR patients. Primary end points were 30-day and 1-year all-cause mortality. Kaplan-Meier curves for survival and multivariate Cox regression analyses were performed. Results The crude 30-day and 1-year all-cause mortality rates for EVAR vs OR for the whole treatment group (n = 3831) were 1.8% vs 2.8% and 8.0% vs 7.2%, respectively. In the high-risk cohort (n = 700), EVAR patients were approximately 2 years older and renal insufficiency and diabetes mellitus were more common, and smoking was more prevalent in the OR group. About two-thirds of EVAR procedures were performed at university hospitals and one-half of OR procedures were performed at county hospitals. In the high-risk cohort, there was no difference in mortality at 30-days (EVAR, 4.6% vs OR, 3.3%), but OR had lower 1-year mortality (8.5% vs 15.9%; P = .003). More bleeding complications occurred in the EVAR group, but more pulmonary complications occurred in the OR group; however, there was no difference in cardiac, cerebrovascular, or renal complications. The mean follow-up was 3.4 years. EVAR was associated with increased mortality risk after adjusting for age, ASA class, and comorbidities (hazard ratio, 1.50; 95% confidence interval, 1.07-2.12; P = .02). Kaplan-Meier survival analysis showed a lower mortality rate for patients undergoing OR, which remained during follow-up ( P = .001). Conclusions Elective OR of aortic aneurysms seems to have a better outcome compared with EVAR in this specific, population-based, high-risk patient cohort after adjusting for covariates. We cannot confirm the benefit of EVAR from previous registry studies with a similar high-risk definition. In clinical practice, OR may be at least as good as EVAR in high-risk patients fit for surgery.

The use of an inferior vena cava filter has an important role in the management of patients who are at high risk for development of pulmonary embolism. Migration is a rare but known complication of inferior vena cava filter placement. We herein describe a case of a prophylactic retrievable vena cava filter migrating to the right ventricle in a bariatric patient. The filter was retrieved percutaneously by transjugular approach and the patient did well postoperatively. A review of the current literature is given.

Infrarenal abdominal aortic aneurysms (AAAs) with a hostile infrarenal aortic neck unfit for endovascular aneurysm repair (EVAR) are more likely to require open repair with suprarenal aortic cross-clamping. We compared the results of the transperitoneal versus retroperitoneal approaches for repair of infrarenal AAA requiring suprarenal cross-clamping and the relative frequency of such techniques after incorporating EVAR into our clinical practice. From January 1998 through September 2005, 478 elective infrarenal aortic aneurysms were repaired. There were 160 (33%) open repairs (71% transperitoneal and 29% retroperitoneal) and 318 (67%) endovascular repairs. In 38 cases (24%) suprarenal cross-clamping was performed (47% transperitoneal and 53% retroperitoneal incisions) for a hostile infrarenal neck. A hostile aortic neck was defined as severe angulation (60 degrees ), short neck (15 mm), extensive calcification, or circumferential thrombus. The median age was 70 years; 47% were men; 16% had diabetes mellitus, 29% pulmonary disease, 53% coronary artery disease, and 11% renal insufficiency. The median aneurysm size was 6.0 cm. A retrospective analysis was performed to compare 30-day postoperative outcomes between the trans- and retroperitoneal patient cohorts. The results were determined for two time periods to assess whether open repair with suprarenal cross- clamping was being performed more frequently as a result of increased utilization of EVAR in the contemporary period. After 2002, EVAR increased from 60% to 71% (p = 0.04) while open repair declined from 40% to 29% (p = 0.01). The retroperitoneal approach doubled from 19% to 39%, while the transperitoneal approach decreased from 81% to 61% (p = 0.02). Suprarenal cross-clamping increased by 11% after 2002. There was no significant difference in age, sex, aneurysm size, or comorbidities between the trans- and retroperitoneal groups with suprarenal cross-clamping. The 30-day mortality was 2/38 (5%) and occurred only in the transperitoneal group. The transperitoneal approach was associated with significantly greater blood loss and longer suprarenal cross-clamp times (2,400 vs. 1,800 mL and 38.0 vs. 29.5 min; p = 0.03), but there were no significant differences in 30-day postoperative complications. In our 7 years' experience, there has been a gradual increase in the utilization of EVAR for infrarenal AAAs. At the same time, more infrarenal AAAs with hostile aortic necks requiring suprarenal aortic cross-clamping were encountered. In such instances, the retroperitoneal approach is safer, with less perioperative blood loss and shorter suprarenal cross-clamp time. This is likely attributed to better exposure of the suprarenal abdominal aorta, allowing a more secure proximal anastomosis.

Restenosis remains a frequent complication after angioplasty in peripheral arterial disease. Inflammation plays a critical role in the vascular response to injury. Effective medical treatment to improve patency after angioplasty is still elusive. The aims of this prospective clinical study were to investigate changes in blood coagulation and inflammatory markers after angioplasty and their significance for restenosis. Thirty-four patients with peripheral arterial disease underwent angioplasty of the iliac and superficial femoral arteries. Ten patients undergoing diagnostic angiography were included in the study as controls. Plasma levels of tissue factor, prothrombin fragment 1 + 2, D-dimer, P-selectin, C-reactive protein (CRP), and fibrinogen were analyzed before and after angioplasty. Patients were followed up with angiography after 6 months to assess restenosis. CRP was elevated the day after angioplasty (6.6 mg/l, p = 0.0001) and tended to peak after 1 week (11 mg/l, p = 0.09). There was a significant increase of D-dimer and P-selectin 1–4 hr after angioplasty (0.4 mg/l, p = 0.001 and 68 ng/ml, p = 0.05, respectively). None of the biochemical markers was a statistically significant predictor of restenosis. We have observed a much more prolonged inflammatory response than previously noted, but only minor changes in coagulation activity after angioplasty. The biochemical markers, before and after angioplasty, were not related to restenosis. Further studies are needed to delineate the molecular mechanisms behind these observations and their involvement in thrombosis and restenosis. If these pathways are further defined, improved treatment strategies, including antithrombotic treatments and statins, could be tailored to modulate postprocedural inflammation.

Objective Oxidative stress and inflammation in the vessel wall may play important roles in the development of restenosis after angioplasty. Reactive oxygen species have been suggested to mediate the proliferative phenotype in smooth muscle cells. The role of the redox-active proteins, thioredoxin and glutaredoxin, after angioplasty in patients with peripheral arterial disease has never been assessed before. Circulating thioredoxin impairs the chemotactic response to local sites of inflammation and administration of human recombinant Trx has been shown to attenuate ischemic reperfusion injury. Methods and results Patients with peripheral arterial disease undergoing angioplasty were included in this observational study. Plasma levels of thioredoxin and glutaredoxin were analysed before and 1, 4 and 24h, and 1 week after angioplasty. Plasma levels of thioredoxin were significantly elevated 4h after angioplasty [2.3ng/ml (0.5–14), p =0.02] and returned to baseline within 24h [1.1ng/ml (0.5–3.1), p =0.02]. There may also exist an association between patients with elevated levels of thioredoxin after angioplasty and decreased rate of restenosis at follow-up angiography after 6 months. There were no changes in plasma levels of glutaredoxin after angioplasty. Conclusion These findings provide a new insight to the role of thioredoxin in the complex process of vascular injury and restenosis in patients with peripheral arterial disease, suggesting thioredoxin both as a marker of oxidative stress and as a therapeutic agent.

Restenosis secondary to neointimal hyperplasia remains the major limiting factor after vascular interventions. Thrombin generated in high concentrations at the site of vascular injury plays a central role in thrombosis and hemostasis. Thrombin has also been implicated as a mitogen for smooth muscle cell proliferation that contributes to restenosis. This study was designed to determine the effects of a specific thrombin inhibitor on neointimal hyperplasia after balloon injury in a rat carotid artery model.A total of 47 male Sprague-Dawley rats were divided into five groups. All groups underwent balloon injury of the left carotid artery. A specific thrombin inhibitor, inogatran, was given in four different regimens: low and high dose injections, short-term infusion for 3 h, and long-term infusion for 1 week. After 2 weeks the animals were killed and the carotid neointima/media area ratio and the luminal narrowing were calculated.All treatments significantly reduced the neointimal hyperplasia. Inogatran given as a long-term infusion for 1 week had the lowest neointima/media ratio compared with the other groups. The percentage of lumen narrowing was also significantly lower in all treatment groups compared with the control group.A specific direct thrombin inhibitor, inogatran, reduces neointimal hyperplasia after arterial injury in rats. A more prolonged administration of the thrombin inhibitor gave a further reduction of the neointimal hyperplasia. It seems that inhibition of thrombin activity is not only important early after injury, but also later. This could have clinical implications in the treatment of restenosis and needs to be further evaluated.

Recombinant activated factor VII (rFVIIa) was first used to control bleeding in haemophilia patients. More recently, it has been used to prevent severe bleeding in patients without pre-existing coagulopathy. We report a case where rFVIIa was used to successfully control postoperative bleeding in a patient undergoing suprarenal abdominal aortic aneurysm (AAA) repair. Eur J Vasc Endovasc Surg 26 , 221-222 (2003)