A comparison of patient-reported outcome measures following technical success and technical failure in the treatment of great saphenous vein incompetence using ClariVein: A subanalysis of a multicenter randomized controlled trial comparing 2% and 3% polidocanol.

OBJECTIVE: This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. METHODS: A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). RESULTS: Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. CONCLUSION: This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

Cost of Follow Up After Endovascular Abdominal Aortic Aneurysm Repair in Patients With an Initial Post-Operative Computed Tomography Angiogram Without Abnormalities.

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.

Editor's Choice - Post-operative Surveillance and Long Term Outcome after Endovascular Aortic Aneurysm Repair in Patients with an Initial Post-operative Computed Tomography Angiogram Without Abnormalities: the Multicentre Retrospective ODYSSEUS Study.

OBJECTIVE: Lifelong imaging surveillance is recommended following endovascular aneurysm repair (EVAR). This study aimed to examine the association between adherence to post-operative surveillance and survival and secondary interventions in patients with an initial post-operative computed tomography angiogram (CTA) without abnormalities. METHODS: All consecutive patients undergoing EVAR for intact abdominal aortic aneurysm (AAA) in 16 hospitals between 2007 and 2012 were identified retrospectively, with follow up until December 2018. Patients were included if the initial post-operative CTA showed no types I - III endoleak, kinking, infection, or limb occlusion. Discontinued follow up was defined as at least one 16 month period in which no imaging surveillance was performed. Primary outcomes were aneurysm related mortality and secondary interventions, and secondary outcome all cause mortality. Kaplan-Meier analysis was used to estimate survival, and Cox regression analyses to identify the association between independent variables and outcome. Sensitivity analyses were performed by varying the definition of continued yearly follow up. The study protocol was published (bmjopen-2019-033584). RESULTS: 1 596 patients (552 continued, 1 044 discontinued follow up) were included with a median (interquartile range) follow up of 89.1 months (52.6). Cumulative aneurysm related, overall, and intervention free survival was 99.4/94.8/96.1%, 98.5/72.9/85.9%, and 96.3/45.4/71.1% at 1, 5, and 10 years, respectively. American Society of Anesthesiologists (ASA) classification (ASA IV hazard ratio [HR] 3.810, 95% confidence interval [CI] 1.296 - 11.198), increase in AAA diameter (HR 3.299, 95% CI 1.408 - 7.729), and continued follow up (HR 3.611, 95% CI 1.780 - 7.323) were independently associated with aneurysm related mortality. The same variables and age (HR 1.063 per year, 95% CI 1.052 - 1.074) were significantly associated with all cause mortality. No difference in secondary interventions was observed between patients with continued vs. discontinued follow up (89/552; 16% vs. 136/1044; 13%; p = .091). Sensitivity analyses showed worse aneurysm related and overall survival in patients with continued follow up. CONCLUSION: Discontinued follow up is not associated with poor outcomes. Future prospective studies are indicated to determine in which patients imaging follow up can be safely reduced.

Results from a nationwide prospective registry on open surgical or endovascular repair of juxtarenal abdominal aortic aneurysms.

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.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence.

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.

Real World Practice Deviation from Nationwide Guidelines in Patients with Intermittent Claudication.

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.

Successful Implementation of the Exercise First Approach for Intermittent Claudication in the Netherlands is Associated with Few Lower Limb Revascularisations.

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 < .001 and HR 1.45; 95% CI 1.34-1.57; p < .001, respectively) and a higher mortality risk compared with SET as a primary treatment (HR 1.38; 95% CI 1.29-1.48; p < .001 and HR 1.49; 95% CI 1.34-1.65; p < .001, respectively). 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.

A Composite Measure for Quality of Care in Patients with Symptomatic Carotid Stenosis Using Textbook Outcome.

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.

Outcomes of open repair of postdissection abdominal aortic aneurysms.

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.

Editor's Choice - Sex Related Differences in Peri-operative Mortality after Elective Repair of an Asymptomatic Abdominal Aortic Aneurysm in the Netherlands: a Retrospective Analysis of 2013 to 2018.

OBJECTIVE: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Factors Associated with Hospital Dependent Delay to Carotid Endarterectomy in the Dutch Audit for Carotid Interventions.

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.

A Comparative Cost-Effectiveness Analysis of Percutaneous Transluminal Angioplasty With Optional Stenting and Femoropopliteal Bypass Surgery for Medium-Length TASC II B and C Femoropopliteal Lesions.

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.

The Value of Sigmoidoscopy to Detect Colonic Ischaemia After Ruptured Abdominal Aortic Aneurysm Repair.

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.

Long-Term Clinical Outcomes of Percutaneous Transluminal Angioplasty with Optional Stenting in Patients with Superficial Femoral Artery Disease: A Retrospective, Observational Analysis.

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.

Anticoagulation and antiplatelet therapy in patients with peripheral arterial disease of the femoropopliteal arteries.

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.

Long-term survival after acute kidney injury following ruptured abdominal aortic aneurysm repair.

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.

Textbook Outcome: A Composite Measure for Quality of Elective Aneurysm Surgery.

OBJECTIVE: To investigate a new composite quality measurement, which comprises a desirable outcome for elective aneurysm surgery, called "Textbook Outcome" (TO). BACKGROUND: Single-quality indicators in vascular surgery are often not distinctive and insufficiently reflect the quality of care. METHODS: All patients undergoing elective abdominal aortic aneurysm repair, registered in the Dutch Surgical Aneurysm Audit between 2014 and 2015 were included. TO was defined as the percentage of patients who had abdominal aortic aneurysm-repair without intraoperative complications, postoperative surgical complications, reinterventions, prolonged hospital stay [endovascular aneurysm repair (EVAR) ≤4 d, open surgical repair (OSR) ≤10 d], readmissions, and postoperative mortality (≤30 d after surgery/at discharge). Case-mix adjusted TO rates were used to compare hospitals and to compare individual hospital results for different procedures. RESULTS: Five thousand one hundred seventy patients were included, of whom 4039 were treated with EVAR and 1131 with OSR. TO was achieved in 71% of EVAR and 53% of OSR. Important obstacles for achieving TO were a prolonged hospital stay, postoperative complications, and readmissions. Adjusted TO rates varied from 38% to 89% (EVAR) and from 0% to 97% (OSR) between individual hospitals. Hospitals with a high TO for OSR also had a high TO for EVAR; however, a high TO for EVAR did not implicate a high TO for OSR. CONCLUSIONS: TO generates additional information to evaluate the overall quality of the care of elective aneurysm surgery, which subsequently can be used by hospitals to improve the quality of their care.

Validation of pre-procedural aortic aneurysm volume calculations to estimate procedural fill volume of endobags in endovascular aortic sealing.

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.