Clinical outcomes following invasive treatment of femoropopliteal artery disease: a retrospective single-center cohort study.

PURPOSE: To identify predictors of clinical success in invasive treatment for femoropopliteal disease aiding clinical decision-making. MATERIALS AND METHODS: A retrospective analysis was performed on 676 consecutive patients who underwent a first episode of invasive treatment for femoropopliteal disease, either endovasular therapy (EVT) or femoropopliteal bypass (FPB), between 2004 and 2015. Primary endpoints were primary and secondary clinical patency and amputation rate. Kaplan-Meier curves were used to evaluate clinical patency. A Cox proportional hazard model explored predictors of primary endpoints. RESULTS: Most patients (58%) underwent EVT as primary intervention, while 42% underwent FPB. Median follow-up was 43 months. The only independent predictor for loss of primary clinical patency was critical limb-threatening ischemia (CLTI) (P=0.008, HR 1.25; 95% CI 1.07 to 1.47). Secondary clinical patency was positively associated with FPB surgery (P=0.037, HR 0.66; 95% CI 0.44 to 0.97), a higher pre-interventional ankle-brachial index (ABI) (P=0.029, HR 0.43; 95% CI 0.20 to 0.92), more distal runoff vessels (P=0.036, HR 0.77; 95% CI 0.60 to 0.98) and the absence of ischemic heart disease (P=0.006, HR 1.69; 95% CI 1.16 to 2.47). In CLTI patients, chronic renal failure predicted loss of primary and secondary clinical patency and increased amputation risk. CONCLUSION: In this cohort, CLTI was independently associated with decreased primary clinical patency in invasive treatment for femoropopliteal disease. Secondary clinical patency was positively associated with FPB, higher ABI, more runoff vessels and the absence of ischemic heart disease.

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.

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.

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.

Secondary Interventions and Long-term Follow-up after Endovascular Abdominal Aortic Aneurysm Repair.

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.

Variation in Surgical Treatment of Abdominal Aortic Aneurysms With Small Aortic Diameters in the Netherlands.

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 <55 mm for men and <50 mm for women were considered guideline deviations. National deviation and hospital variation in deviation were evaluated over time. Questionnaires were distributed among all Dutch VSUs, inquiring for acceptable reasons for guideline deviation. VSUs were asked to estimate the guideline deviation percentage in their hospital which was then compared with their DSAA percentage. RESULTS: In all, 9039 patients were included. In 15%, we found guideline deviation, varying from 2% to 40% between VSUs. Over time, 21 VSUs were identified with a lower percentage of deviation than the national mean each year and 8 VSUs with a higher percentage. 44/60 VSUs completed the questionnaire. Most commonly reported reasons to deviate were concomitant large iliac diameter (91%) and saccular aneurysm (82%). The majority of the VSUs (77%) estimated their guideline deviation to be <5%. Eleven VSUs (25%) estimated their deviation concordant with their DSAA percentage, but 75% of VSUs underestimated their deviation. CONCLUSIONS: Dutch VSUs regularly deviate from the guidelines regarding aneurysm diameter, with variation between VSUs. Consensus exists amongst VSUs on acceptable reasons for guideline deviations; however, the majority underestimates their actual deviation percentage.

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.

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.

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.

National Numbers of Secondary Aortic Reinterventions after Primary Abdominal Aortic Aneurysm Surgery from the Dutch Surgical Aneurysm Audit.

BACKGROUND: Long-term secondary aortic reinterventions (SARs) can be a sign of (lack of) effectiveness of abdominal aortic aneurysm (AAA) surgery. This study provides insight into the national number of SARs after primary AAA repair by endovascular aneurysm repair (EVAR) or by open surgical repair in the Netherlands. METHODS: Observational study included all patients undergoing SAR between 2016 and 2017, registered in the compulsory Dutch Surgical Aneurysm Audit (DSAA). The DSAA started in 2013, SARs are registered from 2016. Characteristics of SAR and postoperative outcomes (mortality/complications) were analyzed, stratified by urgency of SAR. Data of SARs were merged with data of their preceded primary AAA repair, registered in the DSAA after January 2013. In these patients undergoing SAR, treatment characteristics of the preceded primary AAA repair were additionally described, with focus on differences between stent grafts. RESULTS: Between 2016 and 2017, 691 patients underwent SAR, this concerned 9.3% of all AAA procedures (infrarenal/juxtarenal/suprarenal) in the Netherlands (77% elective/11% acute symptomatic/12% ruptured). Endoleak (60%) was the most frequent indication for SAR. SARs were performed with EVAR in 66%. Postoperative mortalities after SAR were 3.4%, 11%, and 29% in elective, acute symptomatic, and ruptured patients, respectively. In 26% (n = 181) of the patients undergoing SAR their primary AAA repair was performed after January 2013 and data of primary and SAR procedures could be merged. In 93% (n = 136), primary AAA repair was EVAR. Endografts primarily used were nitinol/polyester (62%), nitinol/polytetrafluoroethylene (8%), endovascular sealing (21%), and others (9%), compared with their national market share of 76% (odds ratio [OR], 0.52; 95% confidence interval [CI], 0.38-0.71), 15% (OR, 0.50; CI, 0.29-0.89), 4.9% (OR, 5.04; CI, 3.44-7.38), and 4.1% (OR, 2.81; CI, 1.66-4.74), respectively. CONCLUSIONS: In the Netherlands, about one-tenth of the annual AAA procedures concerns an SAR. A quarter of this cohort had an SAR within 1-5 years after their primary AAA repair. Most SARs followed after primary EVAR procedures, in which an overrepresentation of endovascular sealing grafts was seen. Postoperative mortality after SAR is comparable with primary AAA repair.

Patients with a Ruptured Abdominal Aortic Aneurysm Are Better Informed in Hospitals with an "EVAR-preferred" Strategy: An Instrumental Variable Analysis of the Dutch Surgical Aneurysm Audit.

BACKGROUND: While several observational studies suggested a lower postoperative mortality after minimal invasive endovascular aneurysm repair (EVAR) in patients with a ruptured abdominal aortic aneurysm (RAAA) compared to conventional open surgical repair (OSR), landmark randomized controlled trials have not been able to prove the superiority of EVAR over OSR. Randomized controlled trials contain a selected, homogeneous population, influencing external validity. Observational studies are biased and adjustment of confounders can be incomplete. Instrumental variable (IV) analysis (pseudorandomization) may help to answer the question if patients with an RAAA have lower postoperative mortality when undergoing EVAR compared to OSR. METHODS: This is an observational study including all patients with an RAAA, registered in the Dutch Surgical Aneurysm Audit between 2013 and 2017. The risk difference (RD) in postoperative mortality (30 days/in-hospital) between patients undergoing EVAR and OSR was estimated, in which adjustment for confounding was performed in 3 ways: linear model adjusted for observed confounders, propensity score model (multivariable logistic regression analysis), and IV analysis (two-stage least square regression), adjusting for observed and unobserved confounders, with the variation in percentage of EVAR per hospital as the IV instrument. RESULTS: 2419 patients with an RAAA (1489 OSR and 930 EVAR) were included. Unadjusted postoperative mortality was 34.9% after OSR and 22.6% after EVAR (RD 12.3%, 95% CI 8.5-16%). The RD adjusted for observed confounders using linear regression analysis and propensity score analysis was, respectively, 12.3% (95% CI 9.6-16.7%) and 13.2% (95%CI 9.3-17.1%) in favor of EVAR. Using IV analysis, adjusting for observed and unobserved confounders, RD was 8.9% (95% CI -1.1-18.9%) in favor of EVAR. CONCLUSIONS: Adjusting for observed confounders, patients with an RAAA undergoing EVAR had a significant better survival than OSR in a consecutive large cohort. Adjustment for unobserved confounders resulted in a clinical relevant RD. An "EVAR preference strategy" in patients with an RAAA could result in lower postoperative mortality.

Saccular Abdominal Aortic Aneurysms: Patient Characteristics, Clinical Presentation, Treatment, and Outcomes in the Netherlands.

OBJECTIVE: The aim of this was to analyze differences between saccular-shaped abdominal aortic aneurysms (SaAAAs) and fusiform abdominal aortic aneurysms (FuAAAs) regarding patient characteristics, treatment, and outcome, to advise a threshold for intervention for SaAAAs. BACKGROUND: Based on the assumption that SaAAAs are more prone to rupture, guidelines suggest early elective treatment. However, little is known about the natural history of SaAAAs and the threshold for intervention is not substantiated. METHODS: Observational study including primary repairs of degenerative AAAs in the Netherlands between 2016 and 2018 in which the shape was registered, registered in the Dutch Surgical Aneurysm Audit (DSAA). Patients were stratified by urgency of surgery; elective versus acute (symptomatic/ruptured). Patient characteristics, treatment, and outcome were compared between SaAAAs and FuAAAs. RESULTS: A total of 7659 primary AAA-patients were included, 6.1% (n = 471) SaAAAs and 93.9% (n = 7188) FuAAAs. There were 5945 elective patients (6.5% SaAAA) and 1714 acute (4.8% SaAAA). Acute SaAAA-patients were more often female (28.9% vs 17.2%, P = 0.007) compared with acute FuAAA-patients. SaAAAs had smaller diameters than FuAAAs, in elective (53.0 mm vs 61 mm, P = 0.000) and acute (68 mm vs 75 mm, P = 0.002) patients, even after adjusting for sex. In addition, 25.2% of acute SaAAA-patients presented with diameters <55 mm and 8.4% <45 mm, versus 8.1% and 0.6% of acute FuAAA-patients (P = 0.000). Postoperative outcomes did not significantly differ between shapes in both elective and acute patients. CONCLUSIONS: SaAAAs become acute at smaller diameters than FuAAAs in DSAA patients. This study therefore supports the current idea that SaAAAs should be electively treated at smaller diameters than FuAAAs. The exact diameter threshold for elective treatment of SaAAAs is difficult to determine, but a diameter of 45 mm seems to be an acceptable threshold.

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.

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.

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.

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.

Toward Optimizing Risk Adjustment in the Dutch Surgical Aneurysm Audit.

BACKGROUND: To compare hospital outcomes of aortic aneurysm surgery, casemix correction for preoperative variables is essential. Most of these variables can be deduced from mortality risk prediction models. Our aim was to identify the optimal set of preoperative variables associated with mortality to establish a relevant and efficient casemix model. METHODS: All patients prospectively registered between 2013 and 2016 in the Dutch Surgical Aneurysm Audit (DSAA) were included for the analysis. After multiple imputation for missing variables, predictors for mortality following univariable logistic regression were analyzed in a manual backward multivariable logistic regression model and compared with three standard mortality risk prediction models: Glasgow Aneurysm Score (GAS, mainly clinical parameters), Vascular Biochemical and Haematological Outcome Model (VBHOM, mainly laboratory parameters), and Dutch Aneurysm Score (DAS, both clinical and laboratory parameters). Discrimination and calibration were tested and considered good with a C-statistic > 0.8 and Hosmer-Lemeshow (H-L) P > 0.05. RESULTS: There were 12,401 patients: 9,537 (76.9%) elective patients (EAAA), 913 (7.4%) acute symptomatic patients (SAAA), and 1,951 (15.7%) patients with acute rupture (RAAA). Overall postoperative mortality was 6.5%; 1.8% after EAAA surgery, 6.6% after SAAA, and 29.6% after RAAA surgery. The optimal set of independent variables associated with mortality was a mix of clinical and laboratory parameters: gender, age, pulmonary comorbidity, operative setting, creatinine, aneurysm size, hemoglobin, Glasgow coma scale, electrocardiography, and systolic blood pressure (C-statistic 0.871). External validation overall of VBHOM, DAS, and GAS revealed C-statistics of 0.836, 0.782, and 0.761, with an H-L of 0.028, 0.00, and 0.128, respectively. CONCLUSIONS: The optimal set of variables for casemix correction in the DSAA comprises both clinical and laboratory parameters, which can be collected easily from electronic patient files and will lead to an efficient casemix model.

A registry-based rationale for discrete intervention thresholds for open and endovascular elective abdominal aortic aneurysm repair in female patients.

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 < .01). 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.

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.