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Contains fulltext : 288457.pdf (Publisher’s version ) (Closed access) OBJECTIVE: The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan (ODYSSEUS) study was conducted to assess differences in outcomes of patients with continued or discontinued yearly follow up after endovascular abdominal aortic aneurysm repair (EVAR). Earlier results of this study showed that discontinued follow up was not associated with poor outcomes. Therefore, an incremental cost analysis and budget impact analysis of de-implementation of yearly imaging following EVAR was performed. METHODS: In total, 1 596 patients from the ODYSSEUS study were included. The expected cost savings were assessed if yearly imaging was reduced in patients with a post-operative computed tomography angiogram without abnormalities made around 30 days after EVAR. Costs were derived from the Dutch costs manual, benchmark cost prices, and literature review. Costs were expressed in euros (€) and displayed at 2019 prices. Sensitivity analysis was performed by varying costs. RESULTS: A difference of 24% in cost was found between patients with continued and discontinued imaging follow up. The cost per patient was €1 935 in the continued group vs. €1 603 per patient in the discontinued group at five years post-EVAR, with a mean difference of €332 (95% bias corrected and accelerated bootstrap confidence interval -741 to 114). De-implementation of yearly imaging would result in an annual nationwide cost saving of €678 471. Sensitivity analysis with variation in adherence rates, imaging, or secondary intervention costs resulted in a saving of at least €271 388 per year. CONCLUSION: This study provided an in depth analysis of hospital costs for post-EVAR patients in the Netherlands with a modest impact on the Dutch healthcare budget.

Objective Patients with intermittent claudication (IC) are initially treated with supervised exercise therapy (SET), as advised by national and international guidelines. Dutch health insurance companies and the Dutch National Health Care Institute suggested an 87% compliance rate with these guidelines in the Netherlands in 2017 and judged this to be undesirably low. The aim of this study was to evaluate compliance with IC guidelines and to elaborate on the reasons for deviating from them (practice variation) in a large teaching hospital. Methods A retrospective single centre cohort study was conducted at a large teaching hospital in the Netherlands. In total, 420 patients with newly diagnosed IC between 1 January 2017 and 31 December 2018 were analysed. Data included risk profiles and prescribed therapies. Results For all 420 included patients, the compliance rate with the guidelines for SET was 80.5%. The rate of adequately motivated and defensible practice variation was 15.7%; the rate of unjustified practice variation was 3.8%. Meaningful care was seen in 96.2% of cases. Conclusion Deviation from IC guidelines was found in 19.5% of patients. Almost three quarters of this deviation can be explained by the decision to provide personalised, meaningful care.

BACKGROUND: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah).METHODS: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications.RESULTS: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033).CONCLUSIONS: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

Background: Evidence to guide management of postdissection abdominal aortic aneurysms (PDAAA) is lacking. This study describes the outcomes of open repair of PDAAA. Methods: A retrospective cohort study was conducted of all consecutive patients treated with open repair for PDAAA after a Stanford type A or type B thoracic aortic dissection between January 2006 and December 2017 in two vascular referral centers. Preceding type B dissection treatment could include conservative or surgical management. Primary outcomes were 30-day mortality, complication rates, survival, and reintervention-free survival. Survival and reintervention-free survival were analyzed using the Kaplan-Meier method. Reintervention was defined as any endovascular or surgical intervention after the index procedure. Results: Included were 36 patients (27 men [75%]) with a median age of 64 years (range, 35-81 years). The 30-day mortality was 2.7%. The median follow-up was 16 months (range, 0-88 months). The postoperative course was uneventful in 21 patients (58%). The most frequent complications were postoperative bleeding requiring repeat laparotomy (n = 4), pneumonia (n = 3), congestive heart failure (n = 2), new-onset atrial fibrillation (n = 2), mesenteric ischemia requiring left hemicolectomy (n=1), and ischemic cerebrovascular accident (n = 1). Renal failure requiring hemodialysis developed in one patient. The overall survival at 1 year was 88.8%. Reintervention-free survival was 95.5% after 1 year and 88.6% after 2 years. Conclusions: Open repair of PDAAA can be performed with a low mortality rate and an acceptable complication rate, comparable with elective open repair of abdominal aortic aneurysms without dissection.

Background: Juxtarenal abdominal aortic aneurysms (JRAAAs) can be treated either with open surgical repair (OSR) including suprarenal clamping or by complex endovascular aneurysm repair (cEVAR). In this study, we present the comparison between the short-term mortality and complications of the elective JRAAA treatment modalities from a national database reflecting daily practice in the Netherlands.Methods: All patients undergoing elective JRAAA open repair or cEVAR (fenestrated EVAR or chimney EVAR) between January 2016 and December 2018 registered in the Dutch Surgical Aneurysm Audit (DSAA) were eligible for inclusion. Descriptive perioperative variables and outcomes were compared between patients treated with open surgery or endovascularly. Adjusted odds ratios for short-term outcomes were calculated by logistic regression analysis.Results: In all, 455 primary treated patients with JRAAAs could be included (258 OSR, 197 cEVAR). Younger patients and female patients were treated more often with OSR vs cEVAR (72 ± 6.1 vs 76 ± 6.0; P < .001 and 22% vs 15%; P = .047, respectively). Patients treated with OSR had significantly more major and minor complications as well as a higher chance of early mortality (OSR vs cEVAR, 45% vs 21%; P < .001; 34% vs 23%; P = .011; and 6.6% vs 2.5%; P = .046, respectively). After logistic regression with adjustment for confounders, patients who were treated with OSR showed an odds ratio of 3.64 (95% confidence interval [CI], 2.25-5.89; P < .001) for major complications compared with patients treated with cEVAR, and for minor complications, the odds ratios were 2.17 (95% CI, 1.34-3.53; P = .002) higher. For early mortality, the odds ratios were 3.79 (95% CI, 1.26-11.34; P = .017) higher after OSR compared with cEVAR.Conclusions: In this study, after primary elective OSR for JRAAA, the odds for major complications, minor complications, and short-term mortality were significantly higher compared with cEVAR.

OBJECTIVE: Endothermal techniques have proved to be effective for treatment of incompetent truncal veins. The tumescentless mechanochemical ablation (MOCA) technique has become an alternative treatment modality, but its outcome with regard to endothermal techniques is still unclear.METHODS: A multicenter prospective randomized controlled trial was designed comparing MOCA with radiofrequency ablation (RFA) to treat great saphenous vein incompetence with the hypothesis that MOCA is associated with less postprocedural pain and a comparable anatomic and clinical success rate at 1-year follow-up. Disease-specific quality of life and general health-related quality of life (HRQoL) were measured using questionnaires. Inclusion was terminated prematurely because reimbursement was suspended.RESULTS: A total of 213 patients (46.3% of intended number of patients) were randomized, of whom 209 were treated (105 in the MOCA group and 104 in the RFA group). Overall median pain scores during the first 14 days were lower after MOCA (0.2 vs 0.5 after RFA; P = .010), although the absolute difference was small. At 30 days, similar complication numbers (MOCA, n = 62; RFA, n = 63) and HRQoL scores (Aberdeen Varicose Vein Questionnaire: MOCA, 8.9; RFA, 7.6; P = .233) were observed. Hyperpigmentation was reported in seven patients in the MOCA group and two patients in the RFA group (P = .038). In the MOCA group, there were four complete failures (3.8%) compared with none in the RFA group (P = .045), although in one patient at 1 year, the vein showed occlusion. Median 30-day Venous Clinical Severity Score (VCSS) was significantly lower at 30 days after MOCA (1.0 vs 2.0 in the RFA group; P = .001), whereas VCSS was comparable at baseline (MOCA, 4.0; RFA, 5.0; P = .155). The 1- and 2-year anatomic success rate was lower after MOCA (83.5% and 80.0%) compared with RFA (94.2% and 88.3%; P = .025 and .066), mainly driven by partial recanalizations. After 2 years of follow-up, no differences were observed in the number of complete failures. Similar clinical success rates at 1 year (MOCA, 88.7%; RFA, 93.2%; P = .315) and 2 years (MOCA, 93.0%; RFA, 90.4%; P = .699) and no differences in HRQoL scores on the Aberdeen Varicose Vein Questionnaire at 1 year (MOCA, 7.5; RFA, 7.0; P = .753) and 2 years (MOCA, 5.0%; RFA, 4.8%; P = .573) were observed. There were two cardiac serious adverse events, a ventricular fibrillation in the MOCA group (1 year) and an unstable angina in the RFA group (2 years). One deep venous thrombosis occurred in the RFA group on 1-year duplex ultrasound, without clinical sequelae.CONCLUSIONS: Unilateral treatment with MOCA in the short term resulted in less postoperative pain but more hyperpigmentation compared with RFA and a faster improvement in VCSS. More anatomic failures were reported after MOCA, mostly driven by partial recanalizations, but both techniques were associated with similar clinical outcomes at 1 year and 2 years.

Background Early morbidity and mortality are low after endovascular abdominal aneurysm repair (EVAR), but secondary interventions and late complications are common. The aim of the present multicenter cohort study is to detail the frequency and indication for interventions after EVAR and the impact on long-term survival. Methods A retrospective multicenter cohort study of secondary interventions after elective EVAR for an infrarenal abdominal aortic aneurysm was conducted. Consecutive patients (n = 349) undergoing EVAR between January 2007 and January 2012 were analyzed, with long-term follow-up until December 2018. Those requiring intervention were classified in accordance with the indications and specific nature of the intervention and treatment. The primary study end point was overall survival classified for patients with and without intervention. Kaplan-Meier analysis was used to estimate overall survival for those who did and who did not undergo secondary interventions. Univariable and multivariable Cox regression were performed to identify independent variables associated with mortality. Results Some 56 patients (16%) underwent 72 secondary interventions after EVAR during a median (interquartile range) follow-up period of 53.2 months (60.1). Some 45 patients (80.4%) underwent one intervention. Indications for intervention included mainly endograft kinking/outflow obstruction and type II endoleak. An endovascular technique was used in 40.3% of interventions. Median time to secondary intervention was 24.1 months. In 93 patients with abnormalities on imaging, no intervention was performed mainly because the abnormality had disappeared on follow-up imaging (43%). Kaplan-Meier curves showed no difference in survival for patients with and without secondary interventions (P = 0.153). Age (hazard ratio [HR]: 1.089, 95% confidence interval [CI]: 1.063–1.116), ASA classification (ASA III, IV HR: 1.517, 95% CI: 1.056–2.178) were significantly related to mortality. Conclusions Secondary intervention rates are still considerable after EVAR. Endograft kinking/outflow obstruction and endoleak type II are the most common indications for a secondary intervention. Secondary interventions did not adversely affect long-term overall survival after EVAR.

Contains fulltext : 226467.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Composite measures may better objectify hospital performance than individual outcome measures (IOM). Textbook outcome (TO) is an outcome measure achieved for an individual patient when all undesirable outcomes are absent. The aim of this study was to assess TO as an additional outcome measure to evaluate quality of care in symptomatic patients treated by carotid endarterectomy (CEA). METHODS: All symptomatic patients treated by CEA in 2018, registered in the Dutch Audit for Carotid Interventions, were included. TO was defined as a composite of the absence of 30 day mortality, neurological events (any stroke or transient ischaemic attack [TIA]), cranial nerve deficit, haemorrhage, 30 day readmission, prolonged length of stay (LOS; > 5 days) and any other surgical complication. Multivariable logistic regression was used to identify covariables associated with achieving TO, which were used for casemix adjustment for hospital comparison. For each hospital, an observed vs. expected number of events ratio (O/E ratio) was calculated and plotted in a funnel plot with 95% control limits. RESULTS: In total, 70.7% of patients had a desired outcome within 30 days after CEA and therefore achieved TO. Prolonged LOS was the most common parameter (85%) and mortality the least common (1.1%) for not achieving TO. Covariates associated with achieving TO were younger age, the absence of pulmonary comorbidity, higher haemoglobin levels, and TIA as index event. In the case mix adjusted funnel plot, the O/E ratios between hospitals ranged between 0.63 and 1.27, with two hospitals revealing a statistically significantly lower rate of TO (with O/E ratios of 0.63 and 0.66). CONCLUSION: In the Netherlands, most patients treated by CEA achieve TO. Variation between hospitals in achieving TO might imply differences in performance. TO may be used as an additive to the pre-existing IOM, especially in surgical care with low baseline risk such as CEA.

Objective: To evaluate reasons to deviate from aneurysm diameter thresholds, and focus on the difference in how Dutch vascular surgical units (VSUs) perceive their deviation and their actual deviation. Background: Guidelines recommend surgical treatment for asymptomatic abdominal aortic aneurysms (AAAs) with a diameter of at least 55 mm for men and 50 mm for women. We evaluate reasons to deviate from these guidelines, and focus on the difference in how Dutch vascular surgical units (VSUs) perceive their deviation and their actual deviation. Methods: All patients undergoing elective AAA repair between 2013 and 2016 registered in the Dutch Surgical Aneurysm Audit (DSAA) were included. Surgery at diameters of

Background Increased use of endovascular aneurysm repair (EVAR) and reduced open surgical repair (OSR), has decreased postoperative mortality after elective repair of abdominal aortic aneurysms (AAAs). The choice between EVAR or OSR depends on aneurysm anatomy, and the experience and preference of the vascular surgeon, and therefore differs between hospitals. The aim of this study was to investigate the current mortality risk difference (RD) between EVAR and OSR, and the effect of hospital preference for EVAR on overall mortality. Methods Primary elective infrarenal or juxtarenal aneurysm repairs registered in the Dutch Surgical Aneurysm Audit (2013–2017) were analysed. First, mortality in hospitals with a higher preference for EVAR (high-EVAR group) was compared with that in hospitals with a lower EVAR preference (low-EVAR group), divided by the median percentage of EVAR. Second, the mortality RD between EVAR and OSR was determined by unadjusted and adjusted linear regression and propensity-score (PS) analysis and then by instrumental-variable (IV) analysis, adjusting for unobserved confounders; percentage EVAR by hospital was used as the IV. Results A total of 11 997 patients were included. The median hospital rate of EVAR was 76.6 per cent. The overall mortality RD between high- and low-EVAR hospitals was 0.1 (95 per cent −0.5 to 0.4) per cent. The OSR mortality rate was significantly higher among high-EVAR hospitals than low-EVAR hospitals: 7.3 versus 4.0 per cent (RD 3.3 (1.4 to 5.3) per cent). The EVAR mortality rate was also higher in high-EVAR hospitals: 0.9 versus 0.7 per cent (RD 0.2 (−0.0 to 0.6) per cent). The RD following unadjusted, adjusted, and PS analysis was 4.2 (3.7 to 4.8), 4.4 (3.8 to 5.0), and 4.7 (4.1 to 5.3) per cent in favour of EVAR over OSR. However, the RD after IV analysis was not significant: 1.3 (−0.9 to 3.6) per cent. Conclusion Even though EVAR has a lower mortality rate than OSR, the overall effect is offset by the high mortality rate after OSR in hospitals with a strong focus on EVAR., Mortality after abdominal aortic aneurysm surgery may have changed owing to the increased application of endovascular aneurysm repair (EVAR) at the expense of open surgical repair (OSR), along with hospital preference. This study investigated the effect of hospital preference for EVAR on mortality by using an instrumental variable (IV): a hospital’s preference for EVAR. Although overall mortality rates were similar in hospitals carrying out a high and low percentage of EVAR procedures, the mortality rate following OSR was significantly higher in high-EVAR than in low-EVAR hospitals. This will need special attention in the future. Too many EVARs?

Objectives Stent grafts for endovascular repair of infrarenal aneurysms are commercially available for aortic necks up to 32 mm in diameter. The aim of this study was to evaluate the feasibility of endovascular repair with large thoracic stent grafts in the infrarenal position to obtain adequate proximal seal in wider necks. Methods All patients who underwent endovascular aneurysm repair using thoracic stent grafts with diameters greater than 36 mm between 2012 and 2016 were included. Follow-up consisted of CT angiography after six weeks and annual duplex thereafter. Results Eleven patients with wide infrarenal aortic necks received endovascular repair with thoracic stent grafts. The median diameter of the aneurysms was 60 mm (range 52–78 mm) and the median aortic neck diameter was 37 mm (range 28–43 mm). Thoracic stent grafts were oversized by a median of 14% (range 2–43%). On completion angiography, one type I and two type II endoleaks were observed but did not require reintervention. One patient experienced graft migration with aneurysm sac expansion and needed conversion to open repair. Median follow-up time was 14 months (range 2–53 months), during which three patients died, including one aneurysm-related death. Conclusions Endovascular repair using thoracic stent grafts for patients with wide aortic necks is feasible. In these patients, the technique may be a reasonable alternative to complex endovascular repair with fenestrated, branched, or chimney grafts. However, more experience and longer follow-up are required to determine its position within the endovascular armamentarium.

Objective/Background: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period.Methods: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort.Results: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; +22% [p Conclusion: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system. (C) 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Background The introduction of endovascular aneurysm repair (EVAR) has reduced perioperative mortality after abdominal aortic aneurysm (AAA) surgery. The objective of this systematic review was to assess existing mortality risk prediction models, and identify which are most useful for patients undergoing AAA repair by either EVAR or open surgical repair. Methods A systematic search of the literature was conducted for perioperative mortality risk prediction models for patients with AAA published since 2006. PRISMA guidelines were used; quality was appraised, and data were extracted and interpreted following the CHARMS guidelines. Results Some 3903 studies were identified, of which 27 were selected. A total of 13 risk prediction models have been developed and directly validated. Most models were based on a UK or US population. The best performing models regarding both applicability and discrimination were the perioperative British Aneurysm Repair score (C-statistic 0·83) and the preoperative Vascular Biochemistry and Haematology Outcome Model (C-statistic 0·85), but both lacked substantial external validation. Conclusion Mortality risk prediction in AAA surgery has been modelled extensively, but many of these models are weak methodologically and have highly variable performance across different populations. New models are unlikely to be helpful; instead case-mix correction should be modelled and adapted to the population of interest using the relevant mortality predictors.

Background Critical limb ischaemia (CLI) is the end stage of peripheral artery disease (PAD) and is associated with high amputation and mortality rates and poor quality of life. For CLI patients with no revascularisation options, venous arterialisation could be a last resort for limb salvage. Objective To review the literature on the clinical effectiveness of venous arterialisation for lower limb salvage in CLI patients with no revascularisation options. Method Different databases were searched for papers published between January 1966 and January 2016. The criteria for eligible articles were studies describing outcomes of venous arterialisation, published in English, human studies, and with the full text available. Additionally, studies were excluded if they did not report limb salvage, wound healing or amputation as outcome measures. The primary outcome measure was post-operative limb salvage at 12 months. Secondary outcome measures were 30 day or in-hospital mortality, survival, patency, technical success, and wound healing. Results Fifteen articles met the inclusion criteria. The included studies described 768 patients. According to the MINORS score, methodological quality was moderate to poor. The estimated pooled limb salvage rate at one year was 75% (0.75, 95% CI 0.70–0.81). Thirty day or in-hospital mortality was reported in 12 studies and ranged from 0 to 10%. Overall survival was reported in 10 studies and ranged from 54% to 100% with a mean follow-up ranging from 5 to 60 months. Six studies reported on patency of the venous arterialisations performed, with a range of 59–71% at 12 months. Conclusion In this systematic review on venous arterialisation in patients with non-reconstructable critical limb ischaemia, the pooled proportion of limb salvage at 12 months was 75%. Venous arterialisation could be a valuable treatment option in patients facing amputation of the affected limb; however, the current evidence is of low quality.

Objective: A stepped care model, in which patients are primarily treated with supervised exercise therapy (SET), is recommended as the optimal strategy for intermittent claudication (IC). The aim of this study was to determine the primary treatment (SET, endovascular revascularisation [ER], or open surgery) in relation to secondary lower limb revascularisation and survival in patients with IC.Methods: This study was a nationwide retrospective data analysis of health insurance claims of patients newly diagnosed with IC between January 2013 and December 2017. Exclusion criteria were the presence of diagnostic codes for critical limb ischaemia or for a diabetic foot. Study outcomes were distribution of primary treatment modalities, freedom from secondary lower limb revascularisation, and overall five year survival. Analysis included Kaplan-Meier method and Cox proportional hazards regression models with adjustment for multiple confounders (age, gender, socioeconomic status, use of diabetes medication, statins, platelet aggregation inhibitors or anticoagulants, presence of cardiac disease, chronic obstructive pulmonary disease, and pre-dialysis).Results: The five year cohort included 54 504 patients with IC (primary SET n = 39 476, primary ER n = 11 769, and primary open surgery n = 3 259). SET as primary treatment increased from 63% in 2013 to 87% in 2017. Patients who underwent ER or open surgery as a primary treatment had a higher risk of secondary revascularisations (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.37-1.51; p Conclusion: Guideline adherence improved to 87% in Dutch patients with IC. Patients receiving primary SET had fewer lower limb revascularisations and demonstrated better survival than patients undergoing primary ER or open surgery.

Objectives As the risk of a recurrent neurological event in patients with symptomatic carotid stenosis requiring carotid endarterectomy (CEA) is highest in the early phase after the first neurological event, guidelines recommend operating on these patients as soon as possible or at least within 14 days of their initial event. However, in real world practice this is often not met. The aim of this study is to identify factors that cause hospital dependent delay to CEA. Methods All consecutive patients with symptomatic carotid stenosis undergoing CEA registered in the mandatory Dutch Audit for Carotid Interventions from January 2014 up to and including December 2017 were included in the current analysis. Univariable followed by multivariable logistic regression was used to identify independent factors associated with hospital dependent waiting time, defined as time from the first consultation at any hospital to CEA of more than 14 days. Results A total of 8620 patients were included. The median time to CEA was 11 days (IQR 8–14). Seventy-eight per cent of patients underwent CEA within 14 days of first hospital consultation. Factors associated with a hospital dependent waiting time longer than 14 days were age (OR 0.99 per year, 95% CI 0.98–0.99), any previous CEA (OR 1.67, 95% CI 1.32–2.09), ocular symptoms as index event (OR 1.31, 95% CI 1.15–1.50), and indirect referral (OR 1.53, 95% CI 1.34–1.73). Hospital surgical volume was not identified as a factor for delay, except for the delay of indirectly referred patients where high volume hospitals reported the shortest delay. Conclusion This cohort derived from a validated nationwide prospective audit identified younger age, previous CEA, ocular symptoms, and indirect referral as hospital dependent factors for delay. High volume hospitals had a similar hospital dependent waiting time to middle and low volume hospitals. However, high volume hospitals had more indirect referrals, implying that their logistics are more efficiently organised.

Purpose: To evaluate the total midterm costs and cost-effectiveness of percutaneous transluminal angioplasty with optional stenting (PTA/S) as initial treatment compared with femoropopliteal bypass (FPB) surgery in patients with medium-length TransAtlantic Inter-Society Consensus II (TASC) B and C femoropopliteal lesions. Materials and Methods: Over a period of 3 years, all hospital health care costs for 226 consecutive patients were calculated: 170 patients with a TASC B lesion and 56 patients with a TASC C lesion. In the 135-patient PTA/S group (mean age 69.9±10.9 years; 83 men), 108 (63.5%) patients had TASC B lesions and 27 (48.2%) patients had TASC C lesions. Ninety-one patients (mean age 68.4±10.9 years; 60 men) were treated with FPB for 62 TASC B and 29 TASC C femoropopliteal lesions. The main outcome measure was the primary patency rate at 3-year follow-up. Multiple imputation and bootstrapping techniques were used to analyze the data. The adjusted incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in total costs by the difference in 3-year primary patency rate. Costs were expressed in euros (€), and cost differences are presented with the 95% confidence interval (CI). Results: Mean total costs per patient were €29,058 in the PTA/S treatment group vs €42,437 in the FPB group (mean adjusted difference –€14,820, 95% CI –€29,044 to −€5976). Differences in 3-year primary patency between PTA/S and FPB were small and nonsignificant (68.9% and 70.3%, respectively). An ICER of 563,716 was found, indicating that FPB costs €563,716 more per one extra patient reaching 3-year primary patency in comparison with PTA/S treatment. Conclusion: FPB in medium-length femoropopliteal lesions involved higher total costs when evaluated over a 3-year follow-up period. An endovascular-first approach is recommended, as this will result in cost minimization for patients with medium-length femoropopliteal disease.

Objectives This study was designed to compare clinical outcomes of percutaneous transluminal angioplasty with optional stenting (PTA/s) and femoropopliteal bypass (FPB) surgery as primary invasive treatment in patients with medium-length superficial femoral artery (SFA) lesions. Methods We performed a single-center retrospective, observational analysis in all consecutive patients who had undergone initial invasive treatment for medium-length, TASC II B and TASC II C, SFA lesions from 2004 to 2015. Primary endpoints were primary and secondary clinical patency. Secondary endpoints were complication rates and number of amputations. Kaplan–Meier curves were used to compare patency rates in the two treatment groups. Multivariate Cox regression analysis was performed to adjust for confounding variables and propensity score matching analysis was used to balance treatment groups. Results A total of 362 patients with a mean observation period of 4.0 years (SD ± 2.6) were analyzed. In this group, 231 patients (64%) underwent PTA/s and 131 patients (36%) FPB surgery. There was no difference in primary clinical patency at one-, three- and five-year follow-up between the PTA/s and FPB group, with rates of 79% vs. 63%, 53% vs. 78% and 71% vs. 66%, respectively ( P = 0.46). Secondary clinical patency estimates were comparable, resulting in one-, three- and five-year secondary clinical patency rates of 88%, 76% and 67% in the PTA/s group versus 88%, 80% and 79% in the bypass group ( P = 0.40). Multivariate analysis revealed no significant differences between the PTA/s and FPB groups in terms of primary clinical patency (HR 1.4; 95% CI 0.9–2.2) and secondary clinical patency (HR 1.7; 95% CI 0.9–2.9). This was confirmed in the propensity score analysis. Hospital stay (4.8 vs. 10.3 days) and complication rate (2.6% vs. 18.3%) were significantly lower in the PTA/s group ( P = 0.00). The number of amputations was comparable ( P = 0.75). Conclusions The clinical success of endovascular therapy and surgery for medium-length SFA lesions is comparable. Taking into account the lower morbidity rate, shorter length of hospital stay and the less invasive character of PTA/s compared with bypass surgery, patients with medium-length SFA lesions are ideally treated by an endovascular-first approach.

Objectives: Diagnosing colonic ischaemia (CI) after ruptured abdominal aortic aneurysm (RAAA) repair is challenging. This study determined the diagnostic value of sigmoidoscopy in patients suspected of CI after RAAA repair. Methods: This was a retrospective multicentre cohort study. Patients who underwent RAAA repair in three hospitals in Amsterdam, the Netherlands, between 2004 and 2011 (AJAX cohort) were included. Sigmoidoscopies were carried out based on clinical judgment. Endoscopy results were classified as “no ischaemia,” “mild CI,” or “moderate to severe CI.” The surgical diagnosis was classified as “transmural” or “no transmural” CI. The value of sigmoidoscopy was assessed with calculation of positive and negative predictive values (PPV, NPV) with 95% CI for transmural CI. Logistic regression analysis was used to express the association of risk factors with CI as adjusted OR. Results: Transmural CI was diagnosed in 23 of 351 patients (6.6%). Thirteen of sixteen patients (81%) who underwent direct laparotomy for high suspicion of CI indeed had transmural CI. Forty-six patients (13%) underwent sigmoidoscopy. The prevalence of transmural CI was 22% (10/46; 95% CI 12–36%) in these patients. The PPV for transmural CI of “moderate to severe CI” on sigmoidoscopy was 73% (8/11; 95% CI 43–90%). The PPV of “mild CI” on sigmoidoscopy was 11% (2/19; 95% CI 2.9–31%). The NPV of “no ischaemia” on sigmoidoscopy was 100% (95% CI 78–100%). Cardiac comorbidity (OR 3.1, 95% CI 1.19–7.97), low first haemoglobin (OR 0.6, 95% CI 0.47–0.87), and high vasopressor administration (OR 9.4, 95% CI 1.99–44.46) were independently associated with CI. Conclusions: Sigmoidoscopy increases the likelihood of correctly identifying the presence or absence of transmural CI, especially in patients with a moderate clinical suspicion for CI after RAAA repair.

Objective: Supra- and infrarenal aortic neck angulation have been associated with complications after endovascular aortic aneurysm repair. However, a uniform angulation measurement method is lacking and the concept of angulation suggests a triangular oversimplification of the aortic anatomy. (Semi-)automated calculation of curvature along the center luminal line describes the actual trajectory of the aorta. This study proposes a methodology for calculating aortic (neck) curvature and suggests an additional method based on available tools in current workstations: curvature by digital calipers (CDC). Methods: Proprietary custom software was developed for automatic calculation of the severity and location of the largest supra- and infrarenal curvature over the center luminal line. Twenty-four patients with severe supra- or infrarenal angulations (≥45°) and 11 patients with small to moderate angulations (

The aim was to compare peri-operative (30 day and/or in hospital) mortality between women and men in the Netherlands after elective repair of an asymptomatic abdominal aortic aneurysm (AAA).This was a retrospective study using data from the Dutch Surgical Aneurysm Audit (DSAA), a mandatory nationwide registry of patients undergoing AAA repair in the Netherlands. Patients who underwent elective open surgical (OSR) or endovascular aneurysm repair (EVAR) of an asymptomatic abdominal aortic aneurysm (AAA) between 2013 and 2018 were included. Absolute risk differences (ARDs) with 95% confidence intervals (CIs) in peri-operative mortality between women and men were estimated. Logistic regression analyses were performed to estimate adjusted odds ratios (ORs) for mortality. Confounders included pre-operative cardiac and pulmonary comorbidity, serum haemoglobin, serum creatinine, type of AAA repair, and AAA diameter.Some 1662 women and 9637 men were included, of whom 507 (30.5%) women and 2056 (21.3%) men underwent OSR (p.001). Crude peri-operative mortality was 3.01% in women and 1.60% in men (ARD = 1.41%, 95% CI 0.64-2.37). This significant difference was also observed for OSR (ARD = 2.63%, 95% CI 0.43-5.36), but not for EVAR (ARD = 0.36%, 95% CI -0.16 to 1.17). Female sex remained associated with peri-operative mortality after adjusting for confounders (OR = 1.79, 95% CI 1.20-2.65, p = .004), which was similarly observed for OSR (OR = 1.85, 95% CI 1.16-2.94, p = .01), but not for EVAR (OR = 1.46, 95% CI 0.72-2.95, p = .29).Peri-operative mortality after elective repair of an asymptomatic AAA in the Netherlands is higher in women than in men. This disparity might be explained by the higher peri-operative mortality in women undergoing OSR, because no such difference was found in patients undergoing EVAR. Yet, it is likely that there are unaccounted factors at play since female sex remained significantly associated with mortality after adjusting for type of repair.

Objective An evidence-based consensus for a female-specific intervention threshold for abdominal aortic aneurysms (AAAs) is missing. This study aims to analyze sex-related differences in the epidemiology of ruptured AAA to establish an intervention threshold for women. Methods The Dutch Surgical Aneurysm Audit (DSAA) is a compulsory, nation-wide registry of AAA repairs in The Netherlands. All patients with emergency or elective AAA repair between January 1, 2013, and December 31, 2015, were included in the analysis. The main outcomes were age, sex, AAA diameter at time of rupture, and 30-day postoperative mortality. Results A total of 1561 ruptured AAA repairs (14.7% women) and 7063 cases of elective AAA repair (13.7% women) were included in the analysis. Women had significantly smaller mean ± standard deviation AAA diameter at time of rupture than men; 70.5 ± 14.4 mm and 78.6 ± 17.5 mm, respectively. In male patients, 8% of ruptures occurred at diameters below the 55 mm intervention threshold. The female equivalent of this eighth percentile is 52 mm. Female patients had significantly higher 30-day mortality after emergency repair, namely, 33% for women versus 24.2% for men, but were also significantly older, mean ± standard deviation age 76.7 ± 7.1 years and 73.9 ± 8.3 years for women and men, respectively. Correcting for age reduced the 30-day mortality risk for women after ruptured AAA repair from 1.53 (95% confidence interval, 1.14-2.04) to 1.27 (95% confidence interval, 0.92-1.73). Outcome after open elective repair was significantly worse for women compared with men, with a 30-day mortality of 7.97% 30 for women and 4.27% for men ( P Conclusions The equivalent of the 55-mm intervention threshold for elective endovascular AAA repair in men is 52 mm in women. The almost doubled mortality risk for elective open repair in women implies that the optimal point for open repair is at higher diameters, very possibly at least 55 mm.

Peripheral arterial disease (PAD) is associated with a substantial cardiovascular risk and secondary prevention is recommended for all patients. In this report, the literature on anticoagulant and antiplatelet drugs for patients with PAD in the femoro-popliteal segment is reviewed. PubMed/MEDLINE and Cochrane Database was searched for studies published between January 1966 and August 2017. Meta-analyses and randomized controlled trials describing outcome of anticoagulants or antiplatelet drugs for secondary prevention or following vascular interventions in patients with PAD were included. All patients with PAD should receive antiplatelet therapy to reduce cardiovascular risk with a slight preference for clopidogrel monotherapy. Following intervention, most patients will continue to benefit from this treatment. Patients receiving a venous bypass graft will benefit from VKA treatment and those with a below-knee prosthetic bypass graft should receive dual antiplatelet therapy (acetylsalicylic acid combined with clopidogrel). Further sufficiently powered studies are needed to further explore the optimal medical treatment for patients that undergo vascular interventions.

Objective Endovascular aortic sealing (EVAS) with the Nellix endosystem (Endologix, Irvine, CA, USA) is a new concept to treat infrarenal abdominal aortic aneurysms (AAAs). By sealing the aneurysm, potential endoleaks may be avoided. Early results of EVAS are good, but no data have been published regarding peri-procedural changes in aortoiliac anatomy. In this study, 27 consecutive patients who underwent elective EVAS repair of an AAA were reviewed. Method Specific AAA (diameter, length from renal arteries to aortic bifurcation, supra- and infrarenal neck angulation, AAA volume, thrombus volume, and flow lumen volume), and iliac artery characteristics (length, angulation, location of most severe angulation with reference to the origin of the common iliac artery) were determined from pre- and post-procedural reconstructed computed tomography angiograms. Results No type I or II endoleaks were seen at 30 day follow up. Total AAA volume, suprarenal and infrarenal angulation, as well as aortic neck diameter did not change significantly post-EVAS. AAA flow lumen increased significantly (mean difference −4.4 mL, 95% CI 2.0 to −8.6 mL) and AAA thrombus volume decreased (mean difference 3.2 mL, 95% CI 2.0 to −1.1 mL). AAA length (125.7 mm vs. 123.1 mm), left common iliac artery length (57.6 mm vs. 55.3 mm), and right and left maximum iliac artery angulation (right 37.4° vs. 32.2°; left: 43.9° vs. 38.4°) were reduced significantly and the location of maximum angulation was further from the iliac artery origin post-EVAS, suggesting slight straightening of the aortoiliac anatomy. Conclusion Most aortoiliac anatomic characteristics remained unchanged post-EVAS. Filling of the endobags to a pressure of 180 mmHg may lead to lost thrombus volume in some patients, probably because liquid is squeezed into lumbar or the inferior mesenteric artery. The absolute differences in pre- and post-EVAS aortoiliac lengths were small, so pre-operative sizing is accurate for determining stent length.

Background and objective The recent ESC guideline advises primary stent placement in superficial femoral arterial disease (SFAD). The aim of this study was to compare clinical outcomes of SFAD patients selected for stent placement with plain percutaneous transluminal angioplasty (PTA). Materials and methods A single centre retrospective, observational analysis was performed of all consecutive patients undergoing endovascular treatment for SFAD from 2004 to 2015. Primary endpoints were primary and secondary clinical patency rates in patients with or without stent placement. Secondary endpoints were recurrence rates and number of amputations. Kaplan–Meier curves were used to compare patency rates. Multivariable Cox regression analysis was performed to adjust for confounding variables and to identify variables associated with loss of patency. Results A total of 389 patients were analysed with a median follow up of 42 months. Two hundred and fifty one patients (64.5%) were stented. Primary clinical patency rates at 1, 3, and 5 years were 82.8%, 71.0%, and 65.6% after PTA and 76.3%, 65.7%, and 58.1% after stent placement (PTA-S), respectively (p = .30). Secondary patency rates were also comparable for the PTA and PTA-S group resulting in 1, 3 and 5 year clinical secondary patency of 89.1%, 81.0%, and 76.3% in the PTA group versus 87.8%, 78.5%, and 71.9% in the PTA-S group (p = .58). Multivariable analysis revealed equal primary and secondary clinical patency between the treatment groups. The absolute re-intervention rate was 29.3%. The number of re-interventions and amputation rate did not significantly differ between the two groups (p = .41 and p = .75). Conclusions Selective stenting in patients with SFAD shows comparable results in long-term clinical outcomes in patients who were treated with plain PTA as well as patients who are selected for stent placement. An approach of selective stenting is justified.

Background: Different factors contribute to infection after arterial reconstructive surgery. Prophylactic antibiotic use during surgery is widespread, however, there is insufficient evidence to support the use of prophylactic antibiotics with autologous vein grafting. The aim of our study was to assess the effect of single-dose prophylactic antibiotics in patients undergoing autologous vein grafting. Methods: Patients undergoing arterial bypass reconstruction in the lower extremity between 2004 and 2012 were retrospectively screened for use of vein grafts. Patients receiving single-dose antibiotic prophylaxis (group 1) were compared with those not receiving prophylaxis (group 2). Results: Primary outcome was surgical site infection (SSI), and 142 patients were included. The SSI occurred in 22% of patients in group 1 and in 29% of patients in group 2 ( P = .39; odds ratio: 1.46 confidence interval 95%: 0.61-3.47). Conclusions: Results showed no significant effect from single-dose antibiotic prophylaxis on lowering the incidence of SSI.

ObjectiveTo compare the midterm re-intervention and survival rates after EVAR and OR for ruptured abdominal aortic aneurysms (RAAA).MethodsObservational cohort study including all consecutive RAAA patients between 2004 and 2011 in 10 hospitals in the Amsterdam ambulance region. The primary end point was re-interventions within 5 years of the primary intervention. The secondary end point was death. The outcomes were estimated by survival analyses, compared using the logrank test, and subsequently adjusted for possible confounders using Cox proportional hazard models. Re-interventions were estimated in all patients and in patients who survived their hospital stay.ResultsOf 467 patients with a RAAA, 73 were treated by EVAR and 394 by OR. Five years after the primary intervention, the rates of freedom from re-intervention were 55% for EVAR (26/73, 95% CI: 41–69%) and 60% for OR (130/394, 95% CI: 55–66%) (p = .96). After adjustment for age, sex, comorbidity, and pre-operative hemodynamic stability, the risk of re-intervention was similar (HR 1.01, 95% CI: 0.65–1.55). The survival rates were 36% for EVAR (45/73, 95% CI: 24–47%) and 38% for OR (235/394, 95% CI: 33–43%) (p = .83). In 297 patients who survived their hospital stay, the rates of freedom from re-intervention were 66% for EVAR (15/54, 95% CI: 52–81%) and 90% for OR (20/243, 95% CI: 86–95%) (p

Objective: Acute kidney injury (AKI) is a major complication of ruptured abdominal aortic aneurysm (RAAA). Severe AKI is associated with high morbidity and mortality in the short term. The objective of this study was to determine the association between AKI after RAAA repair and long-term survival. Methods: We conducted a retrospective cohort study of all patients undergoing RAAA repair in three hospitals between 2004 and 2011. Outcomes were long-term survival after RAAA repair, incidence of postoperative AKI, and chronic dialysis rates. Survival rates were compared between different AKI groups (no AKI, Risk, Injury, Failure) with Kaplan-Meier survival analyses and log-rank tests. Univariable and multivariable Cox regression analyses were carried out to assess the association of survival with AKI, preoperative shock, postoperative shock, and sex. The main analysis focused on the group of patients surviving initial hospital stay. Results: Our study encompassed 362 patients with RAAA. AKI occurred in 267 of 362 patients (74%). At discharge, 267 patients were alive (74%). Median survival in this group was 7.2 years. Survival was not significantly different between the four AKI groups (P = .07). However, the univariable Cox regression analysis demonstrated a significant association between Failure and reduced long-term survival compared with having no AKI (hazard ratio, 1.85; 95% confidence interval, 1.15-2.97). This association did not remain significant after multivariable adjustment. Four patients were discharged with chronic dialysis, and four other patients needed chronic dialysis later after discharge. Conclusions: This study demonstrates no significant independent association between AKI after RAAA repair and long-term survival. Only a small proportion of patients developed end-stage renal disease at a later stage in life.

BACKGROUND: Endovascular aortic sealing (EVAS) with a sac anchoring endoprosthesis excludes abdominal aortic aneurysms based on polymer filling of endobags. Primary objective was to assess the reliability of pre-procedural computed tomography (CT) scans based calculations of required endobag volume in relation to intraoperative volume of the endobags. METHODS: Forty elective EVAS patients were included. Pre-procedural estimations of endobag volume were based on CT segmentations of aortic flow lumen volume, including both automated and manually-adjusted segmentations, performed by two experienced users. Additionally, changes in maximum AAA diameter, thrombus volume and total AAA volume were calculated from pre- and post-procedural CT scans. RESULTS: Automatically determined volumes were comparable to manually-adjusted calculations (75.3 vs. 75.7 mL) and inter-observer agreement regarding pre-EVAS calculations of prefill volume appeared almost perfect with an intra-class correlation coefficient of 0.98 (95% CI: 0.96-0.99). The mean pressure of the endobags was 185 mmHg. Manually-adjusted pre-procedural volume calculations underestimated procedural volume of the endobags (-11.3±9.9 mL). Differences between pre-EVAS and procedural volume measurements were independent from endobag pressure (r=-0.06, P=0.72), prepocedural thrombus volume (r=-0.303, P=0.057) and changes in total AAA volume (r=0.02, P=0.91). A significant association was determined between differences in pre-EVAS and endobag volume versus changes in thrombus volume pre- and post-procedural (r=0.39, P=0.01). CONCLUSIONS: In this validation study, pre-procedural volume measurements underestimate the actual fill volume of the endobags. It should be advised to perform a prefill of the endobags during the EVAS procedure.

WHAT THIS PAPER ADDS The aim of this study was to perform a cost-analysis of a recommended but largely underutilized SET first treatment strategy in intermittent claudication (IC). Until now no study has been performed to investigate the overall economic consequences of a nationwide SET first approach (stepped care). As the study used a large database (3.4 million people), daily practice is reflected well in the results. Implementation of a stepped care treatment for patients with IC may lead to significant savings of healthcare resources. These findings may be generalizable to other European healthcare systems. Objectives: International guidelines recommend supervised exercise therapy (SET) as primary treatment for intermittent claudication (IC). The aim of this study was to calculate treatment costs in patients with IC and to estimate nationwide annual savings if a stepped care model (SCM, primary SET treatment followed by revascularization in case of SET failure) was followed. Methods: Invoice data of all patients with IC in 2009 were obtained from a Dutch health insurance company (3.4 millionmembers).Patientsweredividedintothreegroupsbasedoninitialtreatmentafterdiagnosis(t0).TheSETgroup receivedSETinitiatedatanytimebetween12monthsbeforeandupto3monthsaftert0.Theinterventiongroup(INT) underwentendovascularoropenrevascularizationbetweent0andtþ 3m onths.Thethirdgroup(REST)receivedneither SET nor any intervention. All peripheral arterial disease related invoices were recorded during 2 years and average costs per patient were calculated. Savings following use of a SCM were calculated for three scenarios. Results: Data on 4954 patients were analyzed. Initial treatment was SET (n ¼ 701, 14.1%), INT (n ¼ 1363, 27.5%), or REST (n ¼ 2890, 58.3%). Within 2 years from t0, invasive revascularization in the SET group was performed in 45 patients (6.4%). Additional interventions (primary at other location and/or re-interventions) were performed in 480 INT patients (35.2%). Some 431 REST patients received additional SET (n ¼ 299, 10.3%) or an intervention (n ¼ 132, 4.5%). Mean total IC related costs per patient were V2,191, V9851 and V824 for SET, INT, and REST, respectively. Based on a hypothetical worst, moderate, and best case scenario, some 3.8, 20.6, or 33.0 million euros would have been saved per annum if SCM was implemented in the Dutch healthcare system. Conclusion: Implementation of a SCM treatment for patients with IC may lead to significant savings of health care resources.

Background Contrast-enhanced magnetic resonance angiography (MRA) and intra-arterial digital subtraction angiography (DSA) both have a high diagnostic performance in the imaging of peripheral arterial occlusive disease (PAOD). However, little is known about the effects of initial, preoperative imaging using MRA or DSA on quality of life (QoL) in relation to costs (cost-utility). Purpose To compare cost-utility of treatment strategies using either MRA or DSA as the principal imaging tool, related to QoL, in patients with PAOD. Material and Methods In a prospective subgroup analysis of patients randomized between MRA and DSA ( n = 79) for preoperative imaging, QoL questionnaires (SF-36) were obtained at randomization and at 4-month follow-up. Cost-effectiveness from hospital perspective was subsequently compared between groups and the difference in gained or lost QoL per € spent assessed using bootstrap analysis. Results No difference in quality of life was found. A treatment trajectory employing MRA as the principal imaging modality was almost 20% cheaper, leading to a better cost-utility ratio in favor of MRA. Conclusion A treatment plan for peripheral arterial occlusive disease employing MRA versus DSA as the principal imaging modality yields a better cost/QoL ratio for MRA.

Background Minimally invasive endovascular aneurysm repair (EVAR) could be a surgical technique that improves outcome of patients with ruptured abdominal aortic aneurysm (rAAA). The aim of this study was to analyse the cost-effectiveness and cost–utility of EVAR compared with standard open repair (OR) in the treatment of rAAA, with costs per 30-day and 6-month survivor as outcome parameters. Methods Resource use was determined from the Amsterdam Acute Aneurysm (AJAX) trial, a multicentre randomized trial comparing EVAR with OR in patients with rAAA. The analysis was performed from a provider perspective. All costs were calculated as if all patients had been treated in the same hospital (Onze Lieve Vrouwe Gasthuis, teaching hospital). Results A total of 116 patients were randomized. The 30-day mortality rate was 21 per cent after EVAR and 25 per cent for OR: absolute risk reduction (ARR) 4·4 (95 per cent confidence interval (c.i.) –11·0 to 19·7) per cent. At 6 months, the total mortality rate for EVAR was 28 per cent, compared with 31 per cent among those assigned to OR: ARR 2·4 (−14·2 to 19·0) per cent. The mean cost difference between EVAR and OR was €5306 (95 per cent c.i. –1854 to 12 659) at 30 days and €10 189 (−2477 to 24 506) at 6 months. The incremental cost-effectiveness ratio per prevented death was €120 591 at 30 days and €424 542 at 6 months. There was no significant difference in quality of life between EVAR and OR. Nor was EVAR superior regarding cost–utility. Conclusion EVAR may be more effective for rAAA, but its increased costs mean that it is unaffordable based on current standards of societal willingness-to-pay for health gains.

Background The purpose of this study was to assess the effect of revascularization (bypass surgery, angioplasty) and primary amputation on health-related quality of life (QoL) in patients with critical limb ischemia (CLI; resting pain or tissue loss). Methods A systematic review of the literature was performed through an electronic search of PubMed (from 1985 to 2012) and Embase (from 1985 to 2012) by two independent investigators to identify English-language articles investigating health-related QoL in regard to CLI. Results Three observational studies were identified describing a comparison between primary amputation and revascularization and their effects on QoL in patients with CLI, all concluding that revascularization should be attempted. Data pooling was omitted due to the impossibility of combining outcome parameters. A separate analysis of each article is presented. Conclusions Patients with CLI have poor health prospects and life expectancy, irrespective of treatment administered. Randomized trials of health-related QoL after revascularization versus primary amputation are nonexistent. Also, the available observational studies do not allow sound conclusions, due to small numbers and methodologic imperfections. Therefore, no recommendations of either therapy in patients with CLI can be made with respect to an anticipated improvement in QoL.

Introduction: Phantom limb pain (PLP) is a painful sensation perceived in the missing limb after amputation. The underlying pathophysiology remains unclear. Until recently, only opioid analgesics have been proven to be effective in prospective studies. Anecdotally, patients with PLP employ self-help measures, sometimes including ‘wrapping up’ or rubbing their stump with aluminium foil for relief. Our hypothesis is that wrapping an amputation stump with aluminium foil perioperatively will prevent PLP in the postoperative period. Methods: From September 2007 to September 2009, 32 consecutive patients were included in a crossover, double-blinded, randomised clinical trial. Perioperative fitting of an aluminium stump bandage was compared with a placebo paper foil. Scores were noted daily in a variable diary. The observation period was 2 weeks: in the first week participants were double blinded, and in the second week there was a change of bandage from aluminium to placebo or vice versa. A visual analogue scale (VAS) score was used as primary research variable. Secondary variables were use of analgesics, VAS measures of wound pain and the incidence of wound infections. Statistical analysis was done by means of Student’s t-test for non-paired observations. Results: Baseline characteristics were similar between groups. A period effect ( p= 0.84) and treatment–period interaction ( p = 0.79) were not present. There was no significant difference (mean difference 0.42) between both treatments in PLP VAS scores (95% CI −2.56 to −1.81, p = 0.71). VAS measure of wound pain showed no significant difference between both groups (mean difference 0.34, 95% CI −2.32 to −1.66, p = 0.72). Also, the other secondary endpoints did not differ. Conclusion: Patients receiving an aluminium foil stump wrapping do not experience less phantom pain than with a placebo.

Objective: The decision whether or not to proceed with surgical intervention of a patient with a ruptured abdominal aortic aneurysm (rAAA) is very difficult in daily practice. The primary objective of the present study was to develop and to externally validate a new prediction model: the Dutch Aneurysm Score (DAS).Methods: With a prospective cohort of 10 hospitals (n = 508) the DAS was developed using a multivariate logistic regression model. Two retrospective cohorts with rAAA patients from two hospitals (n = 373) were used for external validation. The primary outcome was the combined 30 day and in-hospital death rate. Discrimination (AUC), calibration plots, and the ability to identify high risk patients were compared with the more commonly used Glasgow Aneurysm Score (GAS).Results: After multivariate logistic regression, four pre-operative variables were identified: age, lowest in hospital systolic blood pressure, cardiopulmonary resuscitation, and haemoglobin level. The area under the receiver operating curve (AUC) for the DAS was 0.77 (95% CI 0.72-0.82) compared with the GAS with an AUC of 0.72 (95% CI 0.67-0.77). The DAS showed a death rate in patients with a predicted death rate >80% of 83%.Conclusions: The present study shows that the DAS has a higher discriminative performance (AUC) compared with the GAS. All clinical variables used for the DAS are easy to obtain. Identification of low risk patients with the DAS can potentially reduce turndown rates. The DAS can reliably be used by clinicians to make a more informed decision in dialogue with the patient and their family whether or not to proceed with surgical intervention. (C) 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Objective: Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). Background: Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. Methods: All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. Results: Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. Conclusions: This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertise

Objectives Shared decision making (SDM) is a process in which patients and their doctors collaborate in choosing a suitable treatment option by incorporating patient values and preferences, as well as the best available evidence. Particularly in vascular surgery, several conditions seem suitable for SDM because there are multiple treatment options. The objective of this study was to assess the degree of SDM behaviour in vascular surgery. Methods Vascular surgeons of four Dutch hospitals selected consultations with patients who were facing a treatment decision. Immediately after the consultation, patients and surgeons completed the (subjective) SDM Q-9 and SDM Q-doc questionnaires respectively, to appreciate the perceived level of SDM behaviour. Two evaluators independently and objectively rated SDM behaviour in the audiotaped consultations, using the Observing Patient Involvement (OPTION-12) scale. Results Nine vascular surgeons and three vascular surgeons in training conducted 54 consultations. The patients' median SDM Q-9 score was high, 93% (IQR 79–100%), and 16/54 (29.6%) of them gave the maximum score. The surgeons' median score was also high, 84% (IQR 73–92%), while 4/54 (7.4%) gave the maximum score. In contrast, mean OPTION score was 31% (SD 11%). Surgeons hardly ever asked the patients for their preferred approach to receive information, whether they had understood the provided information, and how they would like to be involved in SDM. Conclusions Currently, objective SDM behaviour among vascular surgeons is limited, even though the presented disorders allow for SDM. Hence, SDM in vascular surgical consultations could be improved by increasing the patients' and surgeons' awareness and knowledge about the concept of SDM.

Background Multiple studies have addressed above-the-knee femoral artery bypass grafting; however, information on late quality of life (QoL) and mobility is scarce. We studied long-term QoL and mobility after above-the-knee bypass surgery. Methods Consecutive patients presenting with claudication, ischemic rest pain, or gangrene who received above-the-knee prosthetic bypass grafting between December 1997 and January 2003 were included in this observational study. Data used were recorded in a prospectively collected database of patients receiving Dacron and polytetrafluoroethylene (PTFE) supragenicular bypasses for lower limb ischemia. Primary outcomes were QoL and mobility, and secondary outcomes were patency and patient survival. QoL was measured with the EuroQol questionnaire (EQ-5D/EQ-VAS). Mobility was assessed with the Walking Impairment Questionnaire (WIQ) and analyzed in univariate and multivariate models. Patency and survival were computed with Cox regression. Results One hundred forty patients were treated during the study period. Sixty-nine patients (50%) died during follow-up, leaving 71 survivors who were asked (63 [89%] complied) to complete the EQ-5D/EQ-VAS and WIQ questionnaires. None of the primary outcome parameters (WIQ, EQ-5D, EQ-VAS) were affected by primary bypass occlusion ( p = 0.34, p = 0.44, and p = 0.27, respectively) or long-term patency ( p = 0.07, p = 0.54, and p = 0.36, respectively). Male sex was significantly associated with a better outcome on all primary outcome parameters. Patients with Dacron versus PTFE grafts had WIQ scores of 0.49 and 0.26, respectively ( p = 0.01). EQ-5D scores of patients with Dacron and PTFE were 0.576 and 0.409 ( p = 0.08) and EQ-VAS scores were 61 and 54, respectively ( p = 0.24). Graft type was not independently associated with occlusion, but runoff was. The 5-year and 10-year patient survival rates were 58% and 51%, respectively. Conclusions In this study, long-term QoL and mobility did not seem to be associated with bypass patency, as assessed in a single late follow-up. Revision of bypasses did not contribute to long-term QoL and walking ability. Therefore, the necessity of graft surveillance and subsequent revision and/or thrombectomy in case of synthetic bypass failure in absence of critical limb ischemia seems to be questionable.

We aimed to compare the long-term results of three different strategies for treatment of patients with primary (spontaneous or effort related) subclavian vein thrombosis (PSVT). We followed 45 consecutive patients who had been treated for PSVT receiving either oral anticoagulant therapy only ( n = 14, group 1); thrombolysis followed by anticoagulant therapy ( n = 14, group 2); or thrombolysis, transaxillary first rib resection and anticoagulant therapy ( n = 17, group 3). Endpoints were persisting symptoms and quality of life (QoL). The latter was assessed with the EuroQol (EQ-5D) questionnaire at the end of follow-up. The design is a case-control study with three different groups. Predictors for residual symptoms and QoL were analyzed with logistic and linear regression analysis. Patients in groups 2 and 3 had significantly less pain, swelling and fatigue in the afflicted limb at six weeks. There was no difference in pain ( P = 0.90), swelling ( P = 0.58), fatigue ( P = 0.61), functional impairment ( P = 0.61), recurrence ( P = 0.10) or QoL ( P = 0.25) between groups at the end of follow-up (mean follow-up 57 months [range 2–176, SD ± 46]). Treatment strategy was not predictive of QoL ( P = 0.91, analysis of variance). No differences in long-term symptoms or QoL between patients with successful and unsuccessful thrombolysis were present. In conclusion, thrombolysis with or without first rib resection does not appear to contribute to lasting symptom reduction and improvement of QoL in this study. The effect of thrombolysis may be limited to short-term symptom relief. Transaxillary first rib resection was not associated with improved late outcome (symptoms, QoL) and did not reduce recurrence rate.

Objectives To compare the diagnostic and therapeutic confidence, patient outcome and costs between MRA and DSA as the initial diagnostic imaging test, in patients with symptomatic arterial disease of the leg. Design Randomised controlled diagnostic trial. Materials and methods Patients were randomly allocated to MRA (n = 97) or DSA (n = 100). Primary outcomes were: ability to make treatment plan and patients satisfaction. Secondary endpoints were: type of treatment and costs. Results A treatment plan was determined for each included patient. Additional imaging was necessary in 11% of patients in the MRA group compared to 10% in the DSA group (p = 0.5). 84% of the patients who received MRA judged the diagnostic work up as comfortable compared to 57% who had DSA (p = 0.013). Within 4 months of randomization 30 patients in the MRA group compared to 34 patients in de DSA group underwent operative procedures; 39 versus 36 patients respectively underwent angioplasty. The mean total in-hospital costs during the first 4 months were €4768,- in the MRA group compared to €4697,- in the DSA group (95% CI of difference −1331;1472). Conclusions In patients with peripheral arterial disease of the leg an adequate treatment plan can be made with MRA. This diagnostic strategy was experienced as more comfortable and less painful compared to DSA. Total diagnostic and treatment costs of both strategies were comparable.