Administration of platelets to ruptured abdominal aortic aneurysm patients before open surgery: a prospective, single-blinded, randomised study.

BACKGROUND: In patients undergoing open surgery for a ruptured abdominal aortic aneurysm (rAAA), survivors demonstrate a high platelet count, and proactive administration of platelets (and fresh frozen plasma) appears to influence mortality. OBJECTIVES: This trial investigated the effect of platelets administered before transport to surgery. METHODS: In a prospective study design, patients were randomised to receive platelets (intervention; n = 61) or no platelets (control; n = 61) before transport to vascular surgery from 11 local hospitals. The study was terminated when one of the vascular surgical centres implemented endovascular repair for rAAA patients. RESULTS: Thirty days after surgery, mortality was 36% for patients with intervention vs 31% for controls (P = 0·32). Post-operative thrombotic events (14 vs 15; P = 0·69), renal failure (11 vs 10; P = 0·15) and pulmonary insufficiency (34 vs 39; P = 0·15) were similar in the two groups of patients. No adverse reactions to platelet administration were observed. In addition, length of stay in the intensive care unit was unaffected by intervention. CONCLUSIONS: For patients planned for open repair of a rAAA, we observed no significant effect of early administration of platelets with regard to post-operative complications and stay in the ICU or in hospital and also no significant effect on mortality.

Editor's Choice - Factors Associated with Long-Term Outcome in 191 Patients with Ilio-Femoral DVT Treated With Catheter-Directed Thrombolysis.

OBJECTIVE: To identify factors associated with long-term treatment success after catheter-directed thrombolysis (CDT) for acute deep venous thrombosis (DVT) involving the ilio-femoral vein. MATERIAL AND METHODS: This was a non-randomised observational cohort study. From 1999 to 2013, 191 consecutive patients (203 limbs) attending a tertiary vascular centre at Gentofte University Hospital, Denmark underwent CDT. All patients had ultrasonically verified acute ilio-femoral DVT with open distal popliteal vein and calf veins. Patients were seen in the outpatient clinic 6 weeks, 3, 6, and 12 months, and annually thereafter following the DVT. Successful outcome was defined as patent deep veins without reflux on Duplex ultrasound scanning (DUS). Data were collected prospectively as per protocol and analysed retrospectively. RESULTS: Median age was 27 years (range 14-74 years) and overall median lysis time was 56 h (range 22-146 h). A stent was placed in 106 limbs (52%). Six patients had major bleeding. The median follow-up was 5 years (range 1 month-14.3 years). The cumulative rate of patients with deep patent veins without reflux at 7 years was 79%. Multivariate Cox regression analyses showed that symptom duration >2 weeks (hazard ratio (HR) 2.78, 95% CI 1.14-6.73) and chronic post-thrombotic lesions (HR 19.3, 95% CI 7.29-51.2) were significantly associated with poorer outcome, while the pulse-spray technique (HR 0.15, 95% CI 0.05-0.48) was associated with better outcome. Age, gender, side, IVC atresia, stenting, and lysis duration did not affect outcome. CONCLUSION: In this observational study of CDT for ilio-femoral DVT it was demonstrated that symptom duration less than 2 weeks, absence of chronic post-thrombotic lesions and use of the pulse-spray technique for CDT resulted in better primary patency including normal valve function in the long term.

Editor's choice - Safety of carotid endarterectomy after intravenous thrombolysis for acute ischaemic stroke: a case-controlled multicentre registry study.

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 0-130, IQR 7-21). RESULTS: The 30 day combined stroke and death rate was 3.5% (95% CI 1.69-6.99) for those having IVT + CEA, 4.1% (95% CI 3.46-4.39) for those having CEA without previous IVT (odds ratio 0.84 [95% CI 0.39-1.81]), 3.4% (95% CI 1.33-8.39) for those having IVT + CEA within 14 days, and 5.1% (95% CI 1.74-13.91) for those having IVT + 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.

Endograft limb occlusion in EVAR: iliac tortuosity quantified by three different indices on the basis of preoperative CTA.

OBJECTIVE: To assess the incidence and outcome of graft limb occlusions after endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) in a high volume single centre. To quantify iliac artery tortuosity in patients with AAA and correlate this with limb occlusion. DESIGN: Data were collected consecutively and prospectively, and analyzed retrospectively. MATERIALS: Patients treated with Zenith bifurcated stent grafts from January 2000 to December 2010 at a tertiary referral vascular unit were analyzed. Routine regular office follow-up with computed tomography angiography (CTA) and, subsequently, duplex ultrasound imaging was performed. Patients with limb occlusions were identified. For each index patient, two controls were obtained, one immediately preceding and one following the index patient in the consecutive cohort of EVAR patients. METHODS: Demographics and CTA data on limb graft occlusions were recorded and compared with a defined control group. Three different indices were used to describe the tortuosity of the iliac vessels based on preoperative CTA: pelvic artery index of tortuosity (PAI), common iliac artery index of tortuosity (CAI), and a visual description of vessel tortuosity - the double iliac sign (DIS). Demographic data and indices were correlated for later occurring limb occlusion. RESULTS: 504 patients underwent EVAR and 18 patients experienced graft limb occlusion during a median follow-up of 28 months (range 0-133). Primary graft patency was 97% at 1 year and 96% at 3 years. Logistic regression showed that iliac artery tortuosity (DIS) (p = .001) and body mass index (p = .007) had a significant impact on graft patency. CONCLUSION: A tortuous vessel on the preoperative CTA is associated with an increased risk of limb occlusion after EVAR. Adjunctive stenting of iliac segments deemed at risk is suggested, which is achieved without compromise of the aneurysm repair.

Beta-blocker use and clinical outcomes after primary vascular surgery: a nationwide propensity score-matched study.

OBJECTIVE: To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction. METHODS: Patients who had primary vascular surgical or endovascular reconstruction due to symptomatic peripheral arterial disease, in Denmark between 1996 and 2007 were included. We obtained data on filled prescriptions, clinical outcomes and confounding factors from population-based healthcare registries. Beta-blocker users were matched to non-users by propensity score, and Cox-regression was performed. All medications were included as time-dependent variables. RESULTS: We studied 16,945 matched patients (7828 beta-blocker users and 9117 non-users) with a median follow-up period of 582 days (range, 30-4379 days). The cumulative risks were as follows: all-cause mortality, 17.9%; MI, 5.3%; stroke, 5.6%; major amputation, 9.1%; and recurrent vascular surgery, 23.1%. When comparing beta-blocker users with non-users: adjusted hazard ratio: MI, 1.52 (95% CI, 1.31-1.78); stroke, 1.21 (95% CI, 1.03-1.43); and major amputation, 0.80 (95% CI, 0.70-0.93). CONCLUSION: Beta-blocker use after primary vascular surgery was associated with a lower risk of major amputation but an increased risk of hospitalisation with MI and stroke. No associations were found between beta-blocker use and all-cause mortality or the risk of recurrent vascular surgery. However, our results are not sufficient to alter the indication for beta-blocker use among symptomatic peripheral arterial disease patients.

Outcomes after elective aortic aneurysm repair: a nationwide Danish cohort study 2007-2010.

OBJECTIVE: To assess outcomes after treatment for asymptomatic abdominal aortic aneurysm (AAA) in Denmark in a period when both open surgery (OR) and endoluminal repair (EVAR) have been routine procedures. METHODS: We performed a retrospective nationwide cohort study of patients treated for asymptomatic AAA between 2007 and 2010. Data on demographics, procedural data, perioperative complications, length of stay (LOS), 30-day reinterventions and readmissions, late aneurysm and procedure-related complications and mortality were obtained from the Danish Vascular Registry and the Danish National Patient Register. RESULTS: 525 EVAR and 1176 OR for asymptomatic AAA were identified. LOS was shorter after EVAR than OR (4 vs. 7 days, p < .001). During primary hospitalization procedure-related complications (12% vs. 6%) and general complications (21% vs. 8%) were more common after OR than EVAR (p < 0.001). The 30-day reintervention rate was higher for OR than EVAR (18% vs. 6%, p < 0.001), but there was no difference in readmissions within 30 days. During follow-up (mean 29 ± 15 months) aneurysm-related complications after EVAR were outweighed by procedure-related complications after OR. CONCLUSION: Elective AAA repair in Denmark is overall comparable with international results and both perioperative and late outcomes after EVAR of elective AAA are better than the results after OR.

Carotid endarterectomy after intravenous thrombolysis for acute cerebral ischaemic attack: is it safe?

OBJECTIVES: Intravenous thrombolysis (IVT) has proven effective in the treatment of acute cerebral ischaemic attack in selected cases. In the presence of a carotid artery stenosis, such patients may be candidates for carotid endarterectomy (CEA). Few studies have been made on the safety of CEA performed after IVT. DESIGN: This was a retrospective study. Data including 30 days' follow-up were obtained from medical records and from a vascular registry. MATERIALS: A consecutive series of 306 patients were operated on for symptomatic carotid artery stenosis during a 5-year period. Among these, 22 (7%) patients had been treated with IVT for an acute cerebral ischaemic attack prior to CEA and 284 (93%) patients had CEA only. METHODS: IVT as well as CEA was performed following established guidelines. CEA was performed in median 11 days (25 and 75% percentiles: 7-13 days) after the neurological index event in patients having undergone IVT and 12 days (25 and 75% percentiles: 8-21 days) in patients undergoing CEA only. RESULTS: The 30 days' stroke and death rate was 0% (95% confidence interval (CI): 0-15%) in patients who had IVT before CEA and 2.4% (95% CI: 0.9-4.7%) in patients who underwent CEA only. CONCLUSION: Our experience indicates that CEA performed after IVT for acute cerebral ischaemic attack is safe, confirming existing but sparse publications. However, our series is small and our study possesses a number of limitations. Thus, our results cannot necessarily be transferred to other units, who instead should perform similar studies, preferably together.

International variations in infrainguinal bypass surgery - a VASCUNET report.

OBJECTIVES: To compare practice in lower limb bypass surgery in nine countries. DESIGN: A prospective study amalgamating and analysing data from national and regional vascular registries. METHODS: A table of data fields and definitions was agreed by all member countries of the Vascunet Collaboration. Data from January 2005 to December 2009 was submitted to a central database. RESULTS: 32,084 cases of infrainguinal bypass (IIB) in nine countries were analysed. Procedures per 100,000 population varied between 2.3 in the UK and 24.6 in Finland. The proportion of women varied from 25% to 43.5%. The median age for all countries was 70 for men and 76 for women. Hungary treated the youngest patients. IIB was performed for claudication for between 15.7% and 40.8% of all procedures. Vein grafts were used in patients operated on for claudication (52.9%), for rest pain (66.7%) and tissue loss (74.1%). Italy had the highest use of synthetic grafts. Among claudicants 45% of bypasses were performed to the below knee popliteal artery or more distally. Graft patency at 30 days varied between 86% and 99%. CONCLUSIONS: Significant variations in practice between countries were demonstrated. These results should be interpreted alongside the known limitations of such registry data with respect to quality and completeness of the data. Variation in data completeness and data validation between countries needs to be improved for useful international comparison of outcomes.

Variation in clinical practice in carotid surgery in nine countries 2005-2010. Lessons from VASCUNET and recommendations for the future of national clinical audit.

OBJECTIVES: The aim of the study was to analyse variation in carotid surgical practice, results and effectiveness in nine countries. PATIENTS AND METHODS: A total of 48,185 carotid endarterectomies (CEAs) and 4602 carotid artery stenting (CAS) procedures were included in the comparison. A theoretical effectiveness of CEA provision for each country was estimated. RESULTS: 92.6% of the CEAs were performed according to the inclusion criteria based on the current European recommendations and had a theoretical benefit for the patient. The indication for surgery was symptomatic stenosis in 60.1% and this proportion varied between 31.4% in Italy and 100% in Denmark. The overall combined stroke and death rate in symptomatic patients was 2.3%. This varied between rates of 0.9% in Italy and 3.8% in Norway. The overall combined stroke and death rate in asymptomatic patients was 0.9%. It was lowest in Italy at 0.5%, and highest in Sweden at 2.7%. We estimated that the stroke prevention rate per 1000 CEAs varied from 72.9 in Italy to 130.8 in Denmark. CONCLUSIONS: There is significant variation in clinical practice across the participating countries. The theoretical stroke prevention potential of CEA seems to vary between participating countries due to differences in the inclusion criteria.

Age- and gender-related differences in the use of secondary medical prevention after primary vascular surgery: a nationwide follow-up study.

OBJECTIVE: This study examined the possible age- and gender-related differences in the use of secondary medical prevention following primary vascular reconstruction in a population-based long-term follow-up study. METHODS: Using information from nationwide Danish registers, we identified all patients undergoing primary vascular reconstruction in-between 1996 and 2006 (n = 20,761). Data were obtained on all filled prescriptions 6 months and 3, 5 and 10 years after primary vascular reconstruction. Comparisons were made across age and gender groups, using men 40-60 years old as a reference. RESULTS: Compared to current guidelines the overall use of secondary medical prevention was moderate to low (e.g., lipid-lowering drugs 49.5%, angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists (ACE/ATII) 43.4%, combination of lipid-lowering drugs and anti-platelet therapy and any anti-hypertensive therapy 44.7%). A decline was observed between 6 months and 3 years after surgery. Patients >80 years old were less likely to be prescribed lipid-lowering drugs and combination therapy (e.g.: adjusted risk ratio (RR) 5 years after surgery for men and women 0.63 (95% confidence interval (CI): 0.39-1.02) and 0.48 (95%CI: 0.31-0.75), respectively, whereas smaller and statistical non-significant gender-related differences were observed. The age- and gender-related differences appeared eliminated or substantially reduced in the latest part of the study period (2001-2007). CONCLUSION: We found moderate to low use of secondary medical prevention in Denmark compared with recommendations from clinical guidelines. However, the use has increased in recent years and age- and gender-related differences have been reduced or even eliminated.

Treatment of abdominal aortic aneurysm in nine countries 2005-2009: a vascunet report.

OBJECTIVES: To study contemporary treatment and outcome of abdominal aortic aneurysm (AAA) repair in nine countries. DESIGN AND METHODS: Data on primary AAA repairs 2005-2009 were amalgamated from national and regional vascular registries in Australia, Denmark, Finland, Hungary, Italy, Norway, Sweden, Switzerland and the UK. Primary outcome was in-hospital or 30-day mortality. Multivariate logistic regression was used to assess case-mix. RESULTS: 31,427 intact AAA repairs were identified, mean age 72.6 years (95% CI 72.5-72.7). The rate of octogenarians and use of endovascular repair (EVAR) increased over time (p < 0.001). EVAR varied between countries from 14.7% (Finland) to 56.0% (Australia). Overall perioperative mortality after intact AAA repair was 2.8% (2.6-3.0) and was stable over time. The perioperative mortality rate varied from 1.6% (1.3-1.8) in Italy to 4.1% (2.4-7.0) in Finland. Increasing age, open repair and presence of comorbidities were associated with outcome. 7040 ruptured AAA repairs were identified, mean age 73.8 (73.6-74.0). The overall perioperative mortality was 31.6% (30.6-32.8), and decreased over time (p = 0.004). CONCLUSIONS: The rate of AAA repair in octogenarians as well as EVAR increased over time. Perioperative outcome after intact AAA repair was stable over time, but improved after ruptured repair. Geographical differences in treatment of AAA remain.

Outcome following carotid endarterectomy: lessons learned from a large international vascular registry.

OBJECTIVES: The aim of the study was to assess if technical and patient-related factors are related to outcome after carotid surgery. DESIGN: Vascunet is a collaboration of national and regional registries with 10 contributing countries. PATIENTS AND METHODS: Data from 48,035 carotid endarterectomies (CEAs) performed in 383 centres, during 2003-2007, were merged into a common database. RESULTS: CEA was performed without patch (34%), with patch (40%) or with eversion (26%) in 74% for symptomatic and in 26% for asymptomatic disease. Overall (in-hospital and 30-day) mortality was 0.45%. Type of CEA or anaesthesia did not affect mortality, nor did contralateral occlusion. Mortality was higher in patients above the age of 75 years, for both genders (p < 0.05). The overall (in-hospital) stroke rate was 1.9%, the method of anaesthesia did not affect stroke rate. It was higher in patients with contralateral occlusion (4.6% vs. 2.5%, p = 0.002). Standard CEA without patch had a higher stroke rate than when a patch was used (2.3 vs. 1.7%, p = 0.015). Female patients >75 years had a higher stroke rate than younger women (2.0% vs. 1.6%, p = 0.078); this difference was not observed in men. CONCLUSIONS: Although there are limitations with registry data, the large number of cases involved provides useful information on outcomes, supplementing data from the randomised clinical trials (RCTs).

Long-term results using catheter-directed thrombolysis in 103 lower limbs with acute iliofemoral venous thrombosis.

OBJECTIVES: The long-term outcome of catheter-directed thrombolysis (CDT) in patients with acute iliofemoral venous thrombosis (IFVT) is evaluated in this study. MATERIAL AND METHODS: Patients presenting for treatment with IFVT between June 1999 and May 2007 were considered for treatment using CDT. The following inclusion criteria were used: first episode of IFVT, age below 60 years, age of thrombus <14 days and open distal popliteal vein. Ultrasonography (US) was used to verify the diagnosis. The popliteal vein was punctured under local anaesthesia using US guidance, and a multi-side-hole catheter with tip occlusion was placed in the thrombus. A solution of r-TPA was infused either continuously or using the pulse spray technique together with heparin. Any occlusion or residual stenosis in the iliac vein system was treated by stenting. Compression stockings and anticoagulation treatment were given for at least 12 months. Patients with severe thrombophilias were treated for longer periods. The patients were assessed by colour-duplex US for assessment of patency and valve function after 6 weeks, 3, 6 and 12 months and afterwards on a yearly basis. RESULTS: A total of 101 patients with 103 extremities affected by iliofemoral venous thrombosis were included (median age; 29 years, 78 women, and 79 had left-sided thrombosis). A stent was inserted in 57 limbs. The median follow-up time was 50 months (range 3 days-108 months). At 6 years, 82% of the limbs had patent veins with competent valves and without any skin changes or venous claudication. CONCLUSION: Treatment with CDT for IFVT achieves good patency and vein function after 6 years of follow-up in this highly selected group of patients. We suggest that results from future studies should be presented as Kaplan-Meier plots using venous patency without reflux as the main outcome, since it is an early indicator of the clinical outcome.

Intraoperative platelet and plasma improves survival in patients operated for a rAAA: a follow-up evaluation.

OBJECTIVES: Continued haemorrhage remains a significant contributor to mortality in massively transfused patients. We found that early administration of platelets and plasma reduced mortality from 54% to 36% in rAAA patients. The aim of the present evaluation was to evaluate whether reduced mortality in rAAA patients related to a pro-active transfusion therapy is maintained. DESIGN: Single-centre observational study. METHODS: Mortality of patients operated for rAAA 2006-07 was compared to that of patients operated 2004-05 (intervention group; n=50) and 2002-04 (control group, n=82). RESULTS: 64 consecutive patients with rAAA received, similar to the intervention group, more platelets (5 and 4 vs. 0 units, P<0.05) and plasma (12 and 11 vs. 7 units, P<0.05) intraoperatively and had a higher platelet count (158 and 155 vs. 69 x 10(9)/L, P<0.0001) upon arrival at the intensive care unit and the 30-day mortality remained reduced (24% and 36% vs. 56%, P<0.01 and P=0.02, respectively) as compared to the control patients. CONCLUSIONS: Early administration of platelets and plasma, together with red blood cells maintained reduced mortality in patients operated for rAAAin a 18 month period.

Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study.

OBJECTIVES: To compare polytetrafluorethylene (PTFE) and polyester grafts (Dacron) for above knee femoropopliteal bypass. DESIGN: Multicenter randomised clinical trial. MATERIAL AND METHODS: 427 patients were randomised between 6mm Dacron (Uni-Graft, B. Braun Melsungen AG, 34212 Melsungen, Germany) and PTFE (Goretex, W. L. Gore & Ass. Inc., Newark DE 19711, USA) above-knee femoropopliteal bypass grafts within 13 centres in Denmark (n=261), Norway (n=113) & Finland (n=53) between 1993 and 1998. Fourteen (3%) patients were excluded, leaving 413 patients with 208 Dacron and 205 PTFE grafts for analysis. Age, gender, indication (claudication: 65%), run-off (2 or 3 vessels: 76%), diabetes (17%) and hypertension (31%) as well as cerebrovascular (9%) and cardiac (33%) risks were evenly distributed. Patients were followed postoperatively at 1, 12 and 24 months. Patency assessment was based on ankle-brachial pressures or imaging in case of doubt. RESULTS: The two-year primary patency rates for Dacron and PTFE were 70% and 57% (p=0.02), whereas the secondary patency rates were 76% and 65% (p=0.04), respectively. Primary patency at two years was significantly influenced by the number of patent crural vessels (two or three 67%, one 50%, p=0.01). Amputations at two years, major in 4% and minor in 3%, 30-days mortality and complications (wound infections: 3% and other wound complications: 13%) occurred equally frequent in both groups. At two years, patients treated for critical limb ischemia had a major amputation more often than patients operated on for intermittent claudication, 10 and 3 respectively (p=0.003), and had higher mortality rates, 20% and 8% respectively (p=0.001). CONCLUSION: This trial confirms that Dacron is at least as durable as PTFE for above-knee bypass procedures, and might even be superior.

Accuracy of clinical data in a population based vascular registry.

INTRODUCTION: Clinical databases are increasingly being employed to evaluate the quality of treatments, including patients with peripheral vascular disease. Valid data is vital to the value of these analyses. OBJECTIVE: To assess the validity of clinical data in a population-based national vascular registry. DESIGN: Traditional reproducibility study was supplemented by refilling of data by an independent observer, thereby creating three data sets for comparison. MATERIALS AND METHODS: Twenty prospectively recorded electronic forms from each department were selected randomly from the Danish National Vascular Registry. Data forms were refilled by the surgeons of the department concerned, and by an independent member of the board of the Danish National Vascular Registry. Refilling was performed blinded to the original forms. CONCLUSIONS: A high degree of accuracy of clinical data can be achieved. An independent observer makes it possible to evaluate the classification of observer dependent parameters and explain differences in the reproducibility of data.