Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

Predicting 30-day Mortality after Ruptured Abdominal Aortic Aneurysms: Validation of the Harborview Risk Score in a Single-Center Dutch Study Population.

BACKGROUND: The Harborview Risk Score (HRS) was recently proposed as scoring tool to predict 30-day mortality in patients with ruptured abdominal aortic aneurysms (rAAAs). The HRS assigns 1 point for each of the following preoperative characteristics: age > 76 years, pH < 7.2, creatinine level > 2 mg/dL (> 176.8 µmol/L), and systolic blood pressure < 70 mm Hg, resulting in scores from 0 to 4. The 30-day mortality risk increases with every point. Primarily, we aimed to validate the HRS for the first time in a Dutch study population. A second objective was to identify other clinically relevant predictors for 30-day mortality after repair of rAAA. METHODS: Retrospective data from patients who underwent open repair or endovascular aortic repair for a rAAA between January 2009 and February 2022 were reviewed. Patients were grouped by HRS category (score 0-4). The 30-day mortality rate was calculated for each HRS category. Determinants for 30-day mortality were tested for significance and validated for HRS. RESULTS: In total, data from 135 patients were included. Open repair was performed in 95 patients and 40 patients underwent endovascular aortic repair. Univariate logistic regression identified pH < 7.2, systolic blood pressure < 70 mm Hg, female sex, performance status, and increase per HRS unit as significant determinants for 30-day mortality. After adjusting for sex and performance status in the multivariate analysis, the association between the HRS per-unit increase and 30-day mortality remained significant (odds ratio 2.532 (95% confidence interval: 1.437-4.461)). The 30-day mortality rate for HRS score 0 was 15.2%, while for HRS score 3 and 4 the mortality was 80% and 100% respectively. CONCLUSIONS: The Harborview Risk Score was validated in this single-center Dutch population. Results were concordant with data presented in earlier studies. Therefore, the HRS seems accurate and accessible as preoperative tool. For now, the HRS should guide as an insightful tool to indicate the chances of postoperative mortality during the preoperative conversations in the emergency room, rather than as a decision-making tool whether to operate or not. Our results suggest that female sex and performance status are also relevant predictors that should be assessed in other populations to improve preoperative scoring systems.

Pilot Study on Feasibility and Outcome of a Nerve-Preserving Aortoiliac Exposure Technique.

BACKGROUND: Dysfunctional ejaculation is a common complication following open aortoiliac aneurysm surgery. It may occur in 49-63% of patients and is caused by iatrogenic damage to the sympathetic lumbar splanchnic nerves and superior hypogastric plexus. A nerve-preserving operative technique based on a unilateral right-sided approach to the abdominal aorta, was implemented in clinical practice. The aim of this pilot study was to establish the safety and feasibility of the technique, and whether a sympathetic pathway and ejaculatory function was preserved. METHODS: Patients were asked to fill out questionnaires preoperatively, and 6 weeks, 6 months, and 9 months postoperatively. The International Index of Erectile Function, Cleveland Clinic Incontinence Score (CCIS), Patient assessment of constipation symptoms (Pac-Sym), and International Consultation on Incontinence Questionnaire on male lower urinary tract symptoms were used. Surgeons were asked to complete a technical feasibility questionnaire. RESULTS: Twenty-four patients undergoing aortoiliac aneurysm surgery were included. The nerve-sparing phase of the procedure added an average of 5-10 min of operating time and was technically feasible in twenty-two patients. No major complications occurred during nerve-sparing exposure. Fifteen of twenty-four patients were sexually active at some point throughout the study. No postoperative loss of ejaculation was seen in sexually active patients. CCIS, Pac-sym, International Index of Erectile Function, and Incontinence Questionnaire on male lower urinary tract symptoms scores remained similar throughout the study. CONCLUSIONS: Nerve-preserving aortoiliac reconstruction surgery is safe and feasible. Ejaculatory function is preserved. Given the low number of patients in the study, further research is needed to provide robust data.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study.

OBJECTIVE: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. METHODS: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. RESULTS: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 - 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 - 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 - 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 - 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 - 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 - 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. CONCLUSION: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged.

One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. METHODS: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. RESULTS: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. CONCLUSIONS: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.

Percutaneous EVAR for Ruptured Abdominal Aortic Aneurysms Using the Cordis INCRAFT Endograft.

OBJECTIVES: Low profile endovascular aneurysm repair (EVAR) devices such as the Cordis INCRAFT AAA Stent Graft System may expand the category of patients suitable for endovascular repair. We report our experience with the INCRAFT system in treating ruptured abdominal aortic aneurysms (rAAA). METHODS: We included all patients presenting with rAAA from 2015 to 2019 in our hospital who were treated by percutaneous EVAR with the INCRAFT system. The primary outcome was technical success, referring to adequate stent graft placement. Secondary outcomes included completion of the procedure under local anesthesia and mortality at 30-days, one year and long-term follow-up. RESULTS: Fifteen male patients (mean age: 74 years, SD 6.7) were treated for rAAA with a median aneurysm diameter of 8.25 cm (SD 1.66). The device was successfully delivered and deployed in all subjects. Per-procedurally one type I endoleak required additional stent placement and one patient developed an acute thrombosis of the device main body and iliac limbs requiring thrombectomy. 80.0% of patients were successfully treated under local anesthesia only. The 30 day and one year mortality were 26.6% and 33.3% respectively. Long-term survival was 60.0% at a median follow-up period of 57 months, with two patients requiring late reintervention for an endoleak. CONCLUSIONS: The INCRAFT system can be used to percutaneously treat rAAA with a high technical success rate and mortality similar to reported in the literature for other devices. The large majority of procedures can be completed with only local anesthesia.

Clinical Relevance of Closed-Incision Negative Pressure Therapy (ciNPT) for SSI-Risk Reduction in Vascular Surgery Through a Groin Incision.

BACKGROUND: Vascular surgery, especially lower limb revascularization surgery, has one of the highest rates of surgical complications, predominantly surgical site infections (SSI). Resulting in a significant burden of additional costs due to longer hospital stays, re-admissions and re-interventions, mainly attributable to deep incisional SSIs. Closed incisional negative pressure therapy (ciNPT) is a relatively new strategy in the postoperative management surgical wounds, aiming to reduce surgical wound complications. When discussing the clinical relevance of ciNPT, it is crucial to take into account the outcome of therapy as well as the additional costs related to ciNPT. Since, the additional costs must be justified by an associated decrease in the morbidity and costs associated with groin wound complications, which are particularly attributable to deep incisional SSIs. The current literature evaluating the beneficial effect of ciNPT in groin incisional vascular surgery, predominantly focusses on the decrease in superficial SSIs. Whereas this study aims to address and discuss the clinical relevance of ciNPT over conventional wound dressings, by separately evaluating and comparing the incidence of superficial and deep SSIs and their related re-admissions and re-interventions. METHODS: In this single center prospective cohort study performed in a non-academic hospital in The Netherlands, 59 consecutive patients (67 incisions) were included between January and October 2019. All underwent elective vascular surgery with groin (access) incisions for either lower limb revascularization surgery or abdominal aortic aneurysm surgery. The study group was treated with six days ciNPT (PREVENA Incision Management System; KCI/3M, San Antonio, TX, USA) and matched for equal comparison to a historical retrospectively analysed cohort of 54 consecutive patients (60 incisions), all of whom have undergone elective vascular surgery for equal indications with groin (access) incisions in our center between January and October 2018. The standard-care group was treated following standard surgical wound care protocol with conventional surgical self-adhesive plaster (10 × 15cm, Mepore, Mölnlycke Health Care AB, Gothenburg, Sweden). RESULTS: Study groups were comparable at baseline, except for Body Mass Index (BMI), which was significantly higher in the ciNPT-group (P =.021). No significant differences for formation of seroma, hematoma, as well as wound dehiscence and SSIs were found between both groups. Groin SSIs were seen in 12.1% of the patients in the ciNPT-group and in 13.0% in the Standard-care group (OR 0.80, CI ((0.26, 2.48)), deep SSI contributed for 4 out of 7 patients of total SSIs in the ciNPT-group and for 2 out of 7 patients in the standard of care group (P-value >0.05). Analysis for incidence of hospital re-admission and re-intervention in both study groups showed no significant difference. Subset analysis in both study groups for SSIs differentiated in superficial and deep SSIs showed that only deep SSIs resulted in re-interventions. CONCLUSIONS: Based on the findings in the population of our single center study, we conclude that routine use of ciNPT was not effective in reducing groin wound complications, and therefore could not replicate the promising findings from some previous studies. Furthermore, we did not find a reduction in the incidence of deep SSIs, which comprise the highest morbidity and costs. Considering our findings as well as the associated additional expenses related to ciNPT, it might be superfluous at this stage to use ciNPT as the new standard of post-operative groin incision care for all lower limb revascularization and abdominal aortic aneurysm surgeries. In our opinion further research is warranted for establishing a risk-factor based model for determination of the indication of ciNPT. To be able to achieve a more substantiated decision for utilizing ciNPT compared to standard surgical wound care in groin incisional vascular surgical interventions.

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients.

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR). METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion. RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1). CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

OBJECTIVE: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. BACKGROUND: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up. METHODS: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle. RESULTS: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149). CONCLUSIONS: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study.

OBJECTIVE: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. SUMMARY OF BACKGROUND DATA: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR). METHODS: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. RESULTS: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9. CONCLUSIONS: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates.

Wall Shear Stress Assessment of the False Lumen in Acute Type B Aortic Dissection Visualized by 4-Dimensional Flow Magnetic Resonance Imaging: An Ex-Vivo Study.

BACKGROUND: Four-dimensional flow magnetic resonance imaging (4D flow MRI) can accurately visualize and quantify flow and provide hemodynamic information such as wall shear stress (WSS). This imaging technique can be used to obtain more insight in the hemodynamic changes during cardiac cycle in the true and false lumen of uncomplicated acute Type B Aortic Dissection (TBAD). Gaining more insight of these forces in the false lumen in uncomplicated TBAD during optimal medical treatment, might result in prediction of adverse outcomes. METHODS: A porcine aorta dissection model with an artificial dissection was positioned in a validated ex-vivo circulatory system with physiological pulsatile flow. 4D flow MR images with 3 set heartrates (HR; 60 bpm, 80 bpm and 100 bpm) were acquired. False lumen volume per cycle (FLV), mean and peak systolic WSS were determined from 4D flow MRI data. For validation, the experiment was repeated with a second porcine aorta dissection model. RESULTS: During both experiments an increase in FLV (initial experiment: ΔFLV = 2.05 ml, p < 0.001, repeated experiment: ΔFLV = 1.08 ml, p = 0.005) and peak WSS (initial experiment: ΔWSS = 1.2 Pa, p = 0.004, repeated experiment: ΔWSS = 1.79 Pa, p = 0.016) was observed when HR increased from 60 to 80 bpm. Raising the HR from 80 to 100 bpm, no significant increase in FLV (p = 0.073, p = 0.139) was seen during both experiments. The false lumen mean WSS increased significant during initial (2.71 to 3.85 Pa; p = 0.013) and non-significant during repeated experiment (3.22 to 4.00 Pa; p = 0.320). CONCLUSION: 4D flow MRI provides insight into hemodynamic dimensions including WSS. Our ex-vivo experiments showed that an increase in HR from 60 to 80 bpm resulted in a significant increase of FLV and WSS of the false lumen. We suggest that strict heart rate control is of major importance to reduce the mean and peak WSS in uncomplicated acute TBAD. Because of the limitations of an ex-vivo study, 4D flow MRI will have to be performed in clinical setting to determine whether this imaging model would be of value to predict the course of uncomplicated TBAD.

Outcomes in Octogenarians and the Effect of Comorbidities After Intact Abdominal Aortic Aneurysm Repair in the Netherlands: A Nationwide Cohort Study.

OBJECTIVE: Age is an independent risk factor for mortality after both elective open surgical repair (OSR) and endovascular aneurysm repair (EVAR). As a result of an ageing population, and the less invasive nature of EVAR, the number of patients over 80 years (octogenarians) being treated is increasing. The mortality and morbidity following aneurysm surgery are increased for octogenarians. However, the mortality for octogenarians who have either low or high peri-operative risks remains unclear. The aim of this study was to provide peri-operative outcomes of octogenarians vs. non-octogenarians after OSR and EVAR for intact aneurysms, including separate subanalyses for elective and urgent intact repair, based on a nationwide cohort. Furthermore, the influence of comorbidities on peri-operative mortality was examined. METHODS: All patients registered in the Dutch Surgical Aneurysm Audit (DSAA) undergoing intact AAA repair between 2013 and 2018, were included. Patient characteristics and peri-operative outcomes (peri-operative mortality, and major complications) of octogenarians vs. non-octogenarians for both OSR and EVAR were compared using descriptive statistics. Multivariable logistic regression analyses were used to examine whether age and the presence of cardiac, pulmonary, or renal comorbidities were associated with mortality. RESULTS: This study included 12 054 EVAR patients (3 015 octogenarians), and 3 815 OSR patients (425 octogenarians). Octogenarians in both the EVAR and OSR treatment groups were more often female and had more comorbidities. In both treatment groups, octogenarians had significantly higher mortality rates following intact repair as well as higher major complication rates. Mortality rates of octogenarians were 1.9% after EVAR and 11.8% after OSR. Age ≥ 80 and presence of cardiac, pulmonary, and renal comorbidities were associated with mortality after EVAR and OSR. CONCLUSION: Because of the high peri-operative mortality rates of octogenarians, awareness of the presence of comorbidities is essential in the decision making process before offering aneurysm repair to this cohort, especially when OSR is considered.

Nationwide Study to Predict Colonic Ischemia after Abdominal Aortic Aneurysm Repair in The Netherlands.

BACKGROUND: Colonic ischemia remains a severe complication after abdominal aortic aneurysm (AAA) repair and is associated with a high mortality. With open repair being one of the main risk factors of colonic ischemia, deciding between endovascular or open aneurysm repair should be based on tailor-made medicine. This study aims to identify high-risk patients of colonic ischemia, a risk that can be taken into account while deciding on AAA treatment strategy. METHODS: A nationwide population-based cohort study of 9,433 patients who underwent an AAA operation between 2014 and 2016 was conducted. Potential risk factors were determined by reviewing prior studies and univariate analysis. With logistic regression analysis, independent predictors of intestinal ischemia were established. These variables were used to form a prediction model. RESULTS: Intestinal ischemia occurred in 267 patients (2.8%). Occurrence of intestinal ischemia was seen significantly more in open repair versus endovascular aneurysm repair (7.6% vs. 0.9%; P < 0.001). This difference remained significant after stratification by urgency of the procedure, in both intact open (4.2% vs. 0.4%; P < 0.001) and ruptured open repair (15.0% vs. 6.2%); P < 0.001). Rupture of the AAA was the most important predictor of developing intestinal ischemia (odds ratio [OR], 5.9, 95% confidence interval [CI] 4.4-8.0), followed by having a suprarenal AAA (OR 3.4; CI 1.1-10.6). Associated procedural factors were open repair (OR 2.8; 95% CI 1.9-4.2), blood loss >1L (OR 3.6; 95% CI 1.7-7.5), and prolonged operating time (OR 2.0; 95% CI 1.4-2.8). Patient characteristics included having peripheral arterial disease (OR 2.4; 95% CI 1.3-4.4), female gender (OR 1.7; 95% CI 1.2-2.4), renal insufficiency (OR 1.7; 1.3-2.2), and pulmonary history (OR 1.6; 95% CI 1.2-2.2). Age <68 years proved to be a protective factor (OR 0.5; 95% CI 0.4-0.8). Associated mortality was higher in patients with intestinal ischemia versus patients without (50.6% vs. 5.1%, P < 0.001). Each predictor was given a score between 1 and 4. Patients with a score of ≥10 proved to be at high risk. A prediction model with an excellent AUC = 0.873 (95% CI 0.855-0.892) could be formed. CONCLUSIONS: One of the main risk factors is open repair. Several other risk factors can contribute to developing colonic ischemia after AAA repair. The proposed prediction model can be used to identify patients at high risk for developing colonic ischemia. With the current trend in AAA repair leaning toward open repair for better long-term results, our prediction model allows a better informed decision can be made in AAA treatment strategy.

The Influence of Aortic Wall Elasticity on the False Lumen in Aortic Dissection: An In Vitro Study.

BACKGROUND: Hemodynamics, dissection morphology, and aortic wall elasticity have a major influence on the pressure in the false lumen. In contrast to aortic wall elasticity, the influence of hemodynamics and dissection morphology have been investigated often in multiple in vitro and ex vivo studies. The purpose of this study was to evaluate the influence of aortic wall elasticity on the diameter and pressure of the false lumen in aortic dissection. METHODS: An artificial dissection was created in 3 ex vivo porcine aortas. The aorta models were consecutively positioned in a validated in vitro circulatory system with physiological pulsatile flow. Each model was imaged with ultrasound on 4 positions along the aorta and the dissection. At these 4 locations, pressure measurement was also performed in the true and false lumen with an arterial catheter. After baseline experiments, the aortic wall elasticity was adjusted with silicon and the experiments were repeated. RESULTS: The aortic wall elasticity was decreased in all 3 models after siliconizing. In all 3 siliconized models, the diameters of the true and false lumen increased at proximal, mid, and distal location, while the mean arterial pressure did not significantly change. CONCLUSIONS: In this in vitro study, we showed that aortic wall elasticity is an important parameter altering the false lumen. An aortic wall with reduced elasticity results in an increased false lumen diameter in the mid and distal part of the false lumen. These results can only be transferred to corresponding clinical situations to a limited extent.

Chimney Technique to Preserve Visceral Flow in a Coral Reef Aorta.

The coral reef aorta (CRA) is a rare phenomenon of extreme calcification in the juxtarenal and suprarenal aorta. Open revascularization has an overall in-hospital mortality rate of 13%. We present a patient with a suprarenal CRA with colon ischemia. She has an extensive past medical history of percutaneous transluminal angioplasty and stenting of the celiac trunk (CT) and superior mesenteric artery (SMA). The computed tomography angiography showed a CRA of the suprarenal aorta with occlusion of the CT stent and near occlusion of the SMA stent. Our case illustrates that the CRA in the suprarenal part of the aorta can be treated well by chimney graft procedure, although owing to lack of long-term follow-up, it might be reserved for high-risk candidates for (thoraco)abdominal aortic surgery.

Nationwide study of the treatment of mycotic abdominal aortic aneurysms comparing open and endovascular repair in The Netherlands.

OBJECTIVE: Mycotic aneurysms of the abdominal aorta (MAAA) can be treated by open repair (OR) or endovascular aneurysm repair (EVAR). This nationwide study provides an overview of the situation of MAAA treatment in The Netherlands in 2016. METHODS: A retrospective cohort study was conducted with all centers that registered aortic abdominal aneurysms in the Dutch Surgical Aneurysm Audit in 2016. Questionnaires on 1-year outcomes were sent to all centers that treated patients with MAAA. The primary aim was to determine 30-day and 1-year mortality and morbidity of OR- and EVAR-treated patients. Morbidity was determined by the need for reoperations and the number of readmissions to the hospital. RESULTS: Twenty-six MAAA were detected in the Dutch Surgical Aneurysm Audit database of 2016, resulting in an incidence of 0.7% of all registered abdominal aortic aneurysms. The 30-day mortality for OR and EVAR treated patients was 1 in 13 and 0 in 13, respectively. Major and minor reinterventions within 30 days were needed for two (one OR and one EVAR) and two (one OR and one EVAR) patients, respectively. Two patients (15.4%) in the OR group and one patient (7.7%) in the EVAR group were readmitted to hospital within 30 days. In total, 1-year outcomes of 23 patients were available. In the OR group, one patient (9.1%) died in the first postoperative year. There was one major reintervention (removal of endoprosthesis and spiralvein reconstruction) in the EVAR group. Two patients (18.2%) treated with OR and two (16.7%) treated with EVAR required a minor reintervention. In both groups, four patients (OR, 36.4%; EVAR, 33.3%) were readmitted to hospital within 1 year postoperatively. CONCLUSIONS: Both OR- and EVAR-treated patients show acceptable clinical outcomes after 30 days and at the 1-year follow-up. Depending on the clinical course of the patient, EVAR may be considered in the management of this disease.

Clinical outcomes of postcarotid endarterectomy hypertension.

OBJECTIVE: The objective of this study was to determine the clinical relevance of postcarotid endarterectomy hypertension (PEH) by investigating the effect of PEH on hospital length of stay (LOS) and by investigating short-term and long-term complications of PEH. In addition, risk factors for PEH were determined. METHODS: A single-center retrospective cohort study was performed. Demographic, preoperative, intraoperative, and postoperative outcomes of 192 patients undergoing carotid endarterectomy were evaluated. Outcomes were compared between patients with PEH and patients without PEH. PEH was defined as an acute systolic blood pressure (SBP) rise >170 mm Hg or persistent SBP >150 mm Hg on the ward and leading to the consultation of an internist. The overall survival and event-free survival were compared using a Kaplan-Meier analysis and a Cox regression analysis. A multivariate logistic regression analysis was performed to determine risk factors for PEH. RESULTS: PEH developed in 44 of 192 patients (25%). Preoperative hypertension (SBP >150 mm Hg) was determined to be a risk factor for PEH (odds ratio, 3.3; 95% confidence interval [CI], 1.6-6.9). Hospital LOS was prolonged in patients with PEH compared with patients without PEH (median LOS of 5 days vs 3 days, respectively; P < .001). No difference in the occurrence of ischemic neurologic events or rebleeding during hospitalization was observed (P = .58 and P = .72, respectively). Cardiovascular and ischemic neurologic events during follow-up did not occur more often in patients with PEH than in patients without PEH (P = .46). There was no difference in mortality between the PEH and non-PEH groups (hazard ratio, 1.6; 95% CI, 0.6-4.3). The same applies to the event-free survival (hazard ratio, 0.77; 95% CI, 0.4-1.7). Combined event-free survival for stroke and myocardial infarction was 92% (95% CI, 87%-97%) at 2 years for patients without PEH and 86% (95% CI, 74%-98%) at 2 years for patients with PEH (P = .25). Event-free survival for mortality was 90% (95% CI, 85%-96%) at 2 years for patients without PEH and 94% (95% CI, 86%-100%) at 2 years for patients with PEH (P = .36). CONCLUSIONS: Patients with PEH had a significant increase in hospital LOS. However, adverse short-term and long-term events did not occur more often in patients with PEH. High preoperative SBP was identified as a risk factor for PEH; no other demographic and clinical variables were associated with PEH.

Endovascular Revascularization of a Chronic Occluded Aortobifemoral Bypass.

Bilateral limb occlusion after aortobifemoral (ABF) prosthesis occurs in 1-3% patients. Multiple remedial choices are known in literature to manage a bilateral occluded ABF such as "redo" ABF bypass, axillobifemoral bypass, endovascular recanalization of the native aortoiliac system, and thrombectomy. We present a patient with an occluded ABF bypass since 2001. A new minimal invasive treatment strategy was performed by traversing the occluded limbs with aortic re-entry using stiff Terumo wires. To make way for safe passing of the stents, kissing balloon angioplasty was performed of the entire ABF bypass. Kissing Viabahn (W. L. Gore & Associates, Flagstaff, AZ) balloon-expandable stents were placed in the proximal part of the ABF bypass and extended with a Viabahn self-expandable stent (standard Viabahn). This option should be added to the known multiple remedial choices in case of bilateral limb occlusion of an ABF.

Severe Infrarenal Atheroma Load in Open Aortic Aneurysm Repair Is Not a Risk Factor for Postoperative Acute Kidney Injury.

BACKGROUND: Acute kidney injury (AKI) after open aortic repair is subject to multiple patient- and operation-related variables. Hostile neck morphology in open aneurysm repair is thought to contribute to this AKI risk postoperatively. The aim of this study was to evaluate if large neck atheroma is a possible risk factor in the postoperative development of AKI. METHODS: Retrospectively 137 patients were evaluated for neck atheroma and AKI incidence. Atheroma load measurements were performed by 2 different techniques. Results were compared, and secondly a univariate analysis was performed for multiple additional risk factors regarding AKI occurrence. RESULTS: Significant (>30%) neck atheroma was not associated with a higher risk for developing AKI (odds ratio [OR]: 1.81; 95% confidence intervals: 0.74-4.44). Overall incidence of AKI based upon Acute Kidney Injury Network criteria was 19.7%. In univariate analysis coronary artery disease and the presence of a renal artery stenosis were both significantly associated with AKI (OR: 2.38, 3.31, respectively) as well as the use of B-blockers and angiotensin converting enzyme inhibitors (OR 3.05, 2.48, respectively). CONCLUSIONS: Cross-clamping in case of significant neck atheroma during open aortic aneurysm repair is not associated with increased risk of AKI. Defining high-risk patients based on additional risk factors must be a part of preoperative patient selection.