Editor's Choice - The Impact of Centralisation and Endovascular Aneurysm Repair on Treatment of Ruptured Abdominal Aortic Aneurysms Based on International Registries.

OBJECTIVES: Current management of ruptured abdominal aortic aneurysms (RAAA) varies among centres and countries, particularly in the degree of implementation of endovascular aneurysm repair (EVAR) and levels of vascular surgery centralisation. This study assesses these variations and the impact they have on outcomes. MATERIALS AND METHODS: RAAA repairs from vascular surgical registries in 11 countries, 2010-2013, were investigated. Data were analysed overall, per country, per treatment modality (EVAR or open aortic repair [OAR]), centre volume (quintiles IV), and whether centres were predominantly EVAR (≥50% of RAAA performed with EVAR [EVAR(p)]) or predominantly OAR [OAR(p)]. Primary outcome was peri-operative mortality. Data are presented as either mean values or percentages with 95% CI within parentheses, and compared with chi-square tests, as well as with adjusted OR. RESULTS: There were 9273 patients included. Mean age was 74.7 (74.5-74.9) years, and 82.7% of patients were men (81.9-83.6). Mean AAA diameter at rupture was 7.6 cm (7.5-7.6). Of these aneurysms, 10.7% (10.0-11.4) were less than 5.5 cm. EVAR was performed in 23.1% (22.3-24.0). There were 6817 procedures performed in OAR(p) centres and 1217 performed in EVAR(p) centres. Overall peri-operative mortality was 28.8% (27.9-29.8). Peri-operative mortality for OAR was 32.1% (31.0-33.2) and for EVAR 17.9% (16.3-19.6), p < .001, and the adjusted OR was 0.38 (0.31-0.47), p < .001. The peri-operative mortality was 23.0% in EVAR(p) centres (20.6-25.4), 29.7% in OAR(p) centres (28.6-30.8), p < .001; adjusted OR = 0.60 (0.46-0.78), p < .001. Peri-operative mortality was lower in the highest volume centres (QI > 22 repairs per year), 23.3% (21.2-25.4) than in QII-V, 30.0% (28.9-31.1), p < .001. Peri-operative mortality after OAR was lower in high volume centres compared with the other centres, 25.3% (23.0-27.6) and 34.0% (32.7-35.4), respectively, p < .001. There was no significant difference in peri-operative mortality after EVAR between centres based on volume. CONCLUSIONS: Peri-operative mortality is lower in centres with a primary EVAR approach or with high case volume. Most repairs, however, are still performed in low volume centres and in centres with a primary OAR strategy. Reorganisation of acute vascular surgical services may improve outcomes of RAAA repair.

International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection.

OBJECTIVE/BACKGROUND: To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries. METHODS: A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions. RESULTS: Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up. CONCLUSION: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.

Variations in Abdominal Aortic Aneurysm Care: A Report From the International Consortium of Vascular Registries.

BACKGROUND: This project by the ICVR (International Consortium of Vascular Registries), a collaboration of 11 vascular surgical quality registries, was designed to evaluate international variation in the contemporary management of abdominal aortic aneurysm (AAA) with relation to recommended treatment guidelines from the Society for Vascular Surgery and the European Society for Vascular Surgery. METHODS: Registry data for open and endovascular AAA repair (EVAR) during 2010 to 2013 were collected from 11 countries. Variations in patient selection and treatment were compared across countries and across centers within countries. RESULTS: Among 51 153 patients, 86% were treated for intact AAA (iAAA) and 14% for ruptured AAA. Women constituted 18% of the entire cohort (range, 12% in Switzerland-21% in the United States; P<0.01). Intact AAAs were repaired at diameters smaller than recommended by guidelines in 31% of men (<5.5 cm; range, 6% in Iceland-41% in Germany; P<0.01) and 12% of women with iAAA (<5 cm; range, 0% in Iceland-16% in the United States; P<0.01). Overall, use of EVAR for iAAA varied from 28% in Hungary to 79% in the United States (P<0.01) and for ruptured AAA from 5% in Denmark to 52% in the United States (P<0.01). In addition to the between-country variations, significant variations were present between centers in each country in terms of EVAR use and rate of small AAA repair. Countries that more frequently treated small AAAs tended to use EVAR more frequently (trend: correlation coefficient, 0.51; P=0.14). Octogenarians made up 23% of all patients, ranging from 12% in Hungary to 29% in Australia (P<0.01). In countries with a fee-for-service reimbursement system (Australia, Germany, Switzerland, and the United States), the proportions of small AAA (33%) and octogenarians undergoing iAAA repair (25%) were higher compared with countries with a population-based reimbursement model (small AAA repair, 16%; octogenarians, 18%; P<0.01). In general, center-level variation within countries in the management of AAA was as important as variation between countries. CONCLUSIONS: Despite homogeneous guidelines from professional societies, significant variation exists in the management of AAA, most notably for iAAA diameter at repair, use of EVAR, and the treatment of elderly patients. ICVR provides an opportunity to study treatment variation across countries and to encourage optimal practice by sharing these results.

The influence of obesity on chronic venous disease.

The authors investigate the impact of overweight in patients with chronic venous disease and determine if the eventual effect can be explained by increased venous reflux alone. Patients with chronic venous disease who underwent duplex-ultrasound scanning at the Vascular Center, Straub Clinic and Hospital during 1999 were classified according to the clinical, etiologic, anatomic, and pathophysiologic (CEAP) system and body mass index (kg/m(2)) was calculated. Reflux duration was measured in seconds and peak reverse flow velocity in cm/second. Multi-segment reflux score (total score) was calculated for both reflux duration and peak reverse flow velocity. The reflux pattern and body mass index were correlated to the clinical presentation. Four hundred and one lower extremities (204 right, 197 left) in 272 patients (173 female) with a mean age of 60 years (range 14-90) were investigated. The mean body mass index was 28.9 (+/-7.76). One hundred sixty-seven patients (61%) were overweight (body mass index 25 kg/m(2) or more). There was a significant association between body mass index and the clinical severity (p<0.001). This association persisted after adjustments for total peak reverse flow velocity and total reflux score were made (p<0.001). Overweight patients were more likely to have skin changes and ulceration (p<0.001) than patients with a body mass index less than 25 kg/m(2), despite similar values for total reflux time (p=0.92) and total peak reverse flow velocity (p=0.98). There was an ethnic difference, with Pacific Islanders being significantly heavier and younger compared to patients of white, Asian and Filipino ancestries. The variations in the frequency of skin changes were consistent with ethnic differences in body mass index. The correlation of body mass index with clinical severity independent of reflux measurements indicates that the effect of overweight may involve a mechanism separate from local effects on venous flow. Overweight appears to be a separate risk factor for increased severity of skin changes in patients with chronic venous disease.

Reflux from thigh to calf, the major pathology in chronic venous ulcer disease: surgery indicated in the majority of patients.

The aim of this study was to define the underlying anatomical and pathophysiological conditions in limbs with venous ulcers in order to get information for the most appropriate treatment selection. Ninety-eight limbs (83 patients, 59 men), with active chronic venous ulcers, were analyzed retrospectively and classified according to the CEAP (clinical, etiological, anatomical, and pathophysiological) classification. Duplex-ultrasound was performed in all patients, while air-plethysmography and venography were performed selectively on potential candidates for deep venous reconstruction. Sixty-six ulcers were primary in origin and 32 were secondary. Reflux was present in all limbs except 1. Isolated reflux in 1 system (superficial = 3, deep = 4, perforator = 3) was seen in 10 legs (10%), while incompetence in all 3 systems was seen in 51 legs (52%). Superficial reflux with or without involvement of other systems was seen in 84 legs (86%), 72 legs (73%) had deep reflux with or without involvement of other systems, and incompetent perforator veins were identified in 79 limbs (81%). Axial reflux (continuous reverse flow from the groin region to below knee) was found in 77 limbs (79%). The femoral vein was the single most common deep venous segment in which either reflux or obstruction was found. Axial distribution of disease was found in the majority of cases and no patient had isolated deep venous incompetence below knee. Primary disease was the predominant etiologic cause and reflux was the main pathophysiological finding. Practically all patients were found to have 1 or more sites of reflux or obstruction that could benefit from operative treatment.

Venous function after restoring valve competence of the great saphenous vein.

PURPOSE: To measure changes in venous function after elimination of great saphenous vein reflux using endovenously-applied heat with a specially designed catheter. METHODS: In a prospective clinical study, 13 patients (8 women; mean age 39 years, range 25-59) with symptomatic chronic venous insufficiency were treated for reflux at the saphenofemoral junction. A radiofrequency catheter (Restore) with expandable electrodes that shrinks the vein by controlled constriction of subendothelial collagen was used to restore valve competence. Extirpation of local varicosities was performed simultaneously. Main outcome was change in venous function as measured by plethysmography (foot volumetry) and change in diameter and reflux time at the saphenofemoral junction after 6 and 12 months. RESULTS: Reflux in the greater saphenous vein was eliminated or reduced to below 0.5 seconds in all patients. The venous function was significantly improved after 6 months' follow-up, with decreased refilling rate/expelled volume related to foot volume (p=0.019). The patients were clinically improved, although only 7 (54%) were entirely free from reflux. Three (21%) patients had thrombus in the vein the day after the treatment, 2 at the treatment site and 1 at the entry site of the introducer. After 1 year, the patients are still satisfied with the results, although venous function is no longer significantly improved compared to baseline. CONCLUSIONS: It is possible to safely restore valvular competence by means of internally shrinking the vein diameter. The venous function is improved, although the vein has a tendency to increase in width with time; limited reflux reappears, with deterioration of venous function.

Intraoperative angioscopy may improve the outcome of in situ saphenous vein bypass grafting: a prospective study.

OBJECTIVE: To find out whether intraoperative angioscopic assistance has any effect on graft outcome in patients with critical leg ischemia. MATERIAL AND METHODS: One hundred one patients requiring a below-knee bypass were assigned to undergo in situ saphenous vein bypass with or without intraoperative angioscopic assistance; otherwise treated similarly including preoperative duplex vein mapping, intraoperative graft flow measurements, and angiography. Data on operative details, morbidity, hospital stay, and graft patency were collected prospectively and compared. All patients were followed up for 12 months. RESULTS: The group that underwent angioscopy (A) and the control group (B) were similar in all respects, except for the number of patients enrolled in the groups (32 and 69, respectively). Angioscopy revealed incompletely destructed valves in 34 patients (range, 0 to 5; mean 1), undiagnosed vein branches in 111 patients (mean 4.3), and partly occluding thrombus in 5 patients. The number of postoperative arteriovenous fistulas with signs of failing graft and a need for angiographic or surgical reintervention were significantly higher in group B (P <.0001). The 1-year primary patency rate was significantly better in group A (P <.01), but the primary assisted and secondary patency rates did not differ between the groups. CONCLUSIONS: Angioscopic assistance has an impact on primary graft patency, minimizes the risk for graft failure and thus reduces the need for reintervention by allowing identification of persistent saphenous vein branches, incomplete valve destruction, and partly occluding graft thrombus without adding extra operative time.

Deep axial reflux, an important contributor to skin changes or ulcer in chronic venous disease.

OBJECTIVE: We undertook this cross-sectional study to investigate the distribution of venous reflux and effect of axial reflux in superficial and deep veins and to determine the clinical value of quantifying peak reverse flow velocity and reflux time in limbs with chronic venous disease. PATIENTS AND METHODS: Four hundred one legs (127 with skin changes, 274 without skin changes) in 272 patients were examined with duplex ultrasound scanning, and peak reverse flow velocity and reflux time were measured. Both parameters were graded on a scale of 0 to 4. The sum of reverse flow scores was calculated from seven venous segments, three in superficial veins (great saphenous vein at saphenofemoral junction, great saphenous vein below knee, small saphenous vein) and four in deep veins (common femoral vein, femoral vein, deep femoral vein, popliteal vein). Axial reflux was defined as reflux in the great saphenous vein above and below the knee or in the femoral vein to the popliteal vein below the knee. Reflux parameters and presence or absence of axial reflux in superficial or deep veins were correlated with prevalence of skin changes or ulcer (CEAP class 4-6). RESULTS: The most common anatomic presentation was incompetence in all three systems (superficial, deep, perforator; 46%) or in superficial or perforator veins (28%). Isolated reflux in one system only was rare (15%; superficial, 28 legs; deep, 14 legs; perforator, 18 legs). Deep venous incompetence was present in 244 legs (61%). If common femoral vein reflux was excluded, prevalence of deep venous incompetence was 52%. The cause, according to findings at duplex ultrasound scanning, was primary in 302 legs (75%) and secondary in 99 legs (25%). Presence of axial deep venous reflux increased significantly with prevalence of skin changes or ulcer (C4-C6; odds ratio [OR], 2.7; 95% confidence interval [CI], 1.56-4.67). Of 110 extremities with incompetent popliteal vein, 81 legs had even femoral vein reflux, with significantly more skin changes or ulcer, compared with 29 legs with popliteal reflux alone (P =.025). Legs with skin changes or ulcer had significantly higher total peak reverse flow velocity (P =.006), but the difference for total reflux time did not reach significance (P =.084) compared with legs without skin changes. In contrast, presence of axial reflux in superficial veins did not increase prevalence of skin changes (OR, 0.73; 95% CI, 0.44-1.2). Incompetent perforator veins were observed as often in patients with no skin changes (C0-C3, 215 of 274, 78%) as in patients with skin changes (C4-C6, 106 of 127, 83%; P =.25). CONCLUSION: Continuous axial deep venous reflux is a major contributor to increased prevalence of skin changes or ulcer in patients with chronic venous disease compared with segmental deep venous reflux above or below the knee only. The total peak reverse flow velocity score is significantly higher in patients with skin changes or ulcer. It is questionable whether peak reverse flow velocity and reflux time can be used to quantify venous reflux; however, if they are used, peak reverse flow velocity seems to reflect venous malfunction more appropriately.

Flavonoid treatment in patients with healed venous ulcer: flow cytometry analysis suggests increased CD11b expression on neutrophil granulocytes in the circulation.

The objective was to determine the activation of white blood cells (WBCs) and endothelial cells in patients with healed venous ulcer and the influence of the standing position and of treatment with flavonoids. Ten patients with a healed venous ulcer were treated with flavonoid substance (90% diosmin), 1000 mg three times daily for 30 days. Blood samples were taken from arm and dorsal foot veins before and after standing for 30 minutes. Blood sampling was performed before treatment, after three days, one month and three months. The activation of WBCs was determined by measuring adhesion molecule CD11b and CD18 expression on the surface of granulocytes and monocytes. In addition, interleukin 6 (IL-6), IL-8, soluble E-selectin (sE-selectin), sL-selectin and sICAM-1 levels in serum were quantified. The results showed that standing did not influence any of the measured parameters significantly. Expression of CD11b adhesion molecules on granulocytes was significantly up-regulated (p = 0.044) after treatment with flavonoids for one month, but this increase was not significant (p = 0.056) two months after the treatment period compared with the baseline level. The expression of CD18 remained unchanged. Baseline expression of CD11b or CD18 on monocytes did not change significantly during the study period. Neither was any significant change observed in the levels of IL-6, IL-8 or the soluble adhesion molecules. It was concluded that flavonoid treatment for 30 days increased the expression of CD11b adhesion molecules on circulating granulocytes. No general effect on the inflammatory process could be observed as assessed by levels of cytokines and soluble adhesion molecules. Possible explanations for these findings could be that a decreased number of primed granulocytes leave the circulation due to a changed WBC/endothelial cell interaction or that flavonoids have a direct effect on granulocytes. Further studies are needed to clarify the mode of action of flavonoids in chronic venous disease.