Gábor Menyhei

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.

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).

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.

Editor's Choice: Contemporary Treatment of Popliteal Artery Aneurysm in Eight Countries: A Report from the Vascunet Collaboration of Registries

OBJECTIVES To study contemporary popliteal artery aneurysm (PA) repair. METHODS Vascunet is a collaboration of population-based registries in 10 countries: eight had data on PA repair (Australia, Finland, Hungary, Iceland, New Zealand, Norway, Sweden, and Switzerland). RESULTS From January 2009 until June 2012, 1,471 PA repairs were registered. There were 9.59 operations per million person years, varying from 3.4 in Hungary to 17.6 in Sweden. Median age was 70 years, ranging from 66 years in Switzerland and Iceland to 74 years in Australia and New Zealand; 95.6% were men and 44% were active smokers. Elective surgery dominated, comprising 72% of all cases, but only 26.2% in Hungary and 39.7% in Finland, (p < .0001). The proportion of endovascular PA repair was 22.2%, varying from 34.7% in Australia, to zero in Switzerland, Finland, and Iceland (p < .0001). Endovascular repair was performed in 12.2% of patients with acute thrombosis and 24.1% of elective cases (p < .0001). A vein graft was used in 87.2% of open repairs, a synthetic or composite graft in 12.7%. Follow-up was until discharge or 30 days. Amputation rate was 2.0% overall: 6.5% after acute thrombosis, 1.0% after endovascular, 1.8% after open repair, and 26.3% after hybrid repair (p < .0001). Mortality was 0.7% overall: 0.1% after elective repair, 1.6% after acute thrombosis, and 11.1% after rupture. CONCLUSIONS Great variability between countries in incidence of operations, indications for surgery, and choice of surgical technique was found, possibly a result of surgical tradition rather than differences in case mix. Comparative studies with longer follow-up data are warranted.

Regional Differences in Case Mix and Peri-operative Outcome After Elective Abdominal Aortic Aneurysm Repair in the Vascunet Database

OBJECTIVE/BACKGROUND National differences exist in the outcome of elective abdominal aortic aneurysm (AAA) repair. The role of case mix variation was assessed based on an international vascular registry collaboration. METHODS All elective AAA repairs with aneurysm size data in the Vascunet database in the period 2005-09 were included. AAA size and peri-operative outcome (crude and age adjusted mortality) were analysed overall and in risk cohorts, as well as per country. Glasgow Aneurysm Score (GAS) was calculated as risk score, and patients were stratified in three equal sized risk cohorts based on GAS. Predictors of peri-operative mortality were analysed with multiple regression. Missing data were handled with multiple imputation. RESULTS Patients from Australia, Finland, Hungary, Norway, Sweden and the UK (n = 5,895) were analysed; mean age was 72.7 years and 54% had endovascular repair (EVAR). There were significant variations in GAS (lowest = Finland [75.7], highest = UK [79.4], p for comparison of all regions < .001), proportion of AAA < 5.5 cm (lowest = UK [6.4%], highest = Hungary [29.0%]; p < .001), proportion undergoing EVAR (lowest = Finland [10.1%], highest = Australia [58.9%]; p < .001), crude mortality (lowest = Norway [2.0%], highest = Finland [5.0%]; p = .006), and age adjusted mortality (lowest = Norway [2.5%], highest = Finland [6.0%]; p = .048). Both aneurysm size and peri-operative mortality were highest among patients with a GAS >82. Of those with a GAS >82, 8.4% of men and 20.8% of women had an AAA <5.5 cm. CONCLUSION Important regional differences exist in case selection for elective AAA repair, including variations in AAA size and patient risk profile. These differences partly explain the variations in peri-operative mortality. Further audit is warranted to assess the underlying reasons for the regional variation in case-mix.

Validation of the VASCUNET registry - pilot study

BACKGROUND VASCUNET is an international registry of vascular surgical (open and endovascular) procedures since 1997. The aim of this paper is to describe a pilot validation performed at three hospitals in Hungary in September 2012. PATIENTS AND METHODS Three core indications were checked: abdominal aortic aneurysm, carotid artery disease and limb ischemia with infrainguinal treatment. RESULTS 2439 registered procedures had been reported with between 94 and 109 per cent agreement with hospital administrative numbers. In a random sample of 29 patients the VASCUNET data were compared with the patient records regarding risk factors, procedures performed and in hospital results. Only few discrepancies were found. CONCLUSIONS The conclusions are that validation is feasible, that this pilot project in Hungary showed good agreement between registry and local patient records. For a registry to be accepted and used both for practical and scientific purposes regular validation by senior surgeons should be undertaken and the vascular surgical community must have a budget for such a process.

The Safety and Efficacy of a Paclitaxel-eluting Wrap for Preventing Peripheral Bypass Graft Stenosis: A 2-Year Controlled Randomized Prospective Clinical Study

OBJECTIVES To compare the safety and efficacy of a bioresorbable paclitaxel-eluting wrap implanted with a synthetic vascular graft (treatment) versus the graft implanted alone (control). DESIGN Prospective, randomized, controlled, multicentre, 2-year clinical study conducted in adults scheduled to undergo femoropopliteal peripheral bypass surgery with a polytetrafluoroethylene (PTFE) graft. MATERIALS AND METHODS Hundred and nine subjects were randomized 2:1 to treatment or control. All subjects were implanted with a 6mm expanded PTFE vascular graft; in addition, treated subjects had a 2.5 cm x 4 cm paclitaxel-eluting wrap (1.6 microg/mm(2)) placed around the distal graft anastomosis. RESULTS The overall incidence of adverse events was similar in both groups. Treated subjects required fewer limb amputations than controls (15.5% vs 18.4%) and time to amputation for those that required amputation was twice as long (153 days vs 76 days). Among diabetics, this effect was pronounced with 13.8% of treated subjects requiring limb amputations compared with 23.5% of controls. Over the course of study, the diameter at the distal graft anastomosis was greater in treated subjects than in controls (difference of 2.1mm at 2 yr, p=0.03). CONCLUSIONS The paclitaxel-eluting wrap maintained graft patency at the distal anastomosis and was safe to use in patients who had received a peripheral bypass PTFE graft.

Effect of vitamin E on reperfusion injuries during reconstructive vascular operations on lower limbs.

INTRODUCTION The challenge against reperfusion injury and tissue oxidative stress, especially in vascular surgical interventions has an essential importance to reach the optimal clinical result. Numerous experimental attempts have proved the positive antioxidant effect of vitamin E in both chronic and acute phase models. In our study we monitored the effect of continuous preoperative treatment with vitamin E, on oxidative stress and tissue inflammation reactions developed after reconstructive operations. PATIENTS AND METHODS 32 patients have been involved in a randomized, prospective study, all suffering from AFS occlusion proved by angiography, and all undergone supragenual reconstruction. Duration of ischemia and amount of tissues under vascular clamping were almost the same in all patients. In the group treated with E-vitamin, we administered 1 x 200 mg of vitamin E p/o from the preoperative day till the 7th post operative day. Patients of the second group did not receive vitamin E. MATERIALS AND METHODS Peripheral blood samples were collected immediately before operation and at the end of the second reperfusion hour (early reperfusion period). Late reperfusion period has been monitored by analyzing blood samples taken at 24th hour and 7th day next to the operative ischemia. Among oxidative stress parameters, direct measurement of reactive oxygen intermediator (ROI) and determination of antioxidant state (GSH, Total-SH group, SOD) have been performed. Malondialdehyde was chosen as marker for lipidperoxidation. Inflammation reactions were monitored up on expression of adhesion molecules (CD11a and CD18). We also controlled the oscillation of myeloperoxidase (MPO) activity. RESULTS Our study has proved that preoperative (from the preoperative day till the 7th post operative day) administration of 200 mg vitamin E could reduce the level of oxidative stress developed after ischemic-reperfusion insult (lipidproxidation, antioxidant enzymes). According to our results, the prooxidant-antioxidant imbalance also diminished in the group with E-vitamin treatment. We proved that elective administration of vitamin E could decrease the WBC activity (MPO activity, free radicals production, expression of adhesion molecules) and its consequential local inflammation process, during early reperfusion.

Trends in Major Lower Limb Amputation Related to Peripheral Arterial Disease in Hungary: A Nationwide Study (2004-2012)

OBJECTIVES To assess the trends of peripheral arterial disease associated major lower limb amputation in Hungary over a 9 year period (2004-2012) in the whole Hungarian population. METHODS This was a retrospective cohort study employing administrative health care data. Major amputations were identified in the entire Hungarian population during a 9 year period (2004-2012) using the health care administrative data. Direct standardization was used to eliminate the potential bias induced by the different age and sex structure of the compared populations. For external direct standardization, the ESP 2013 was chosen as reference. RESULTS 76,798 lower limb amputations were performed. The number of major amputations was 38,200; these procedures affected 32,084 patients. According to case detection, 50.4% of the amputees were diabetic. The overall primary amputation rate was 71.5%. The annual crude and age adjusted major amputation rates exhibited no significant long-term pattern over the observation period. The major lower limb amputation incidence for the overall period was 42.3/10(5) in the total population and 317.9/10(5) in diabetic population. CONCLUSION According to this whole population based study from Hungary, the incidence of lower limb major amputation is high with no change over the past 9 years. An explanation for this remains to be determined, as the traditional risk factors in Hungary do not account for it. The characteristics of major amputation (the rate of primary amputation, the ratio of below to above knee amputation and the age of the affected population) underline the importance of screening, early detection, improved vascular care and an optimal revascularization policy. Standardization and validation of amputation detection methods and reporting is essential.

Editor's Choice - Carotid Stenosis Treatment: Variation in International Practice Patterns.

OBJECTIVES The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR). METHODS Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country. RESULTS Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7). CONCLUSIONS Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world.