A Comparison of Two Transport Monitor Systems With Regard to Efficiency and Staff Satisfaction in the Perioperative Setting.

BACKGROUND: Medical research aims to improve patient safety and efficiency in the perioperative setting. One critical aspect of patient safety is the intrahospital transfer of patients. Also, reliable monitoring of vital signs is crucial to support the medical staff. This study was conducted to assess two monitoring systems in terms of the handover time and staff satisfaction. METHODS: To assess several aspects, two monitoring systems were compared: an organizational unit-related monitoring system that needs to be changed and brought back to the initial organizational unit after the patient transfer and a patient-specific monitoring system that accompanies the patient during the whole perioperative process. RESULTS: In total, 243 patients were included, and 375 transfers were examined to analyze economic factors, including differences in handover times and user-friendliness. To this end, 30 employees of the Heidelberg University Hospital were asked about their satisfaction with the two monitoring systems based on a systematic questionnaire. It could be shown that, especially during transfers from the operating theater to the intensive care unit or the recovery room, the time from arrival to fully centralized monitoring and the total handover time were significantly shorter with the patient-specific monitoring system (p < 0.001). Furthermore, the staff was more satisfied with the patient-specific monitor system in terms of flexibility, cleanability and usability. CONCLUSION: The increased employee satisfaction and significant time benefits during intrahospital transports may increase patient safety and efficiency of patient care, reduce employee workload, and reduce costs in the overall context of patient care.

Image-based assessment of aortoiliac aneurysm anatomical characteristics in patients from the global iliac branch study.

OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.

[Cost-revenue aspects of endovascular treatment of distal aortic arch pathologies with respect to the introduction of a new thoracic side-branch prosthesis]. / Kosten-Erlös-Aspekte der endovaskulären Versorgung distaler Aortenbogenpathologien im Hinblick auf die Einführung einer neuen thorakalen Seitenarmprothese.

BACKGROUND: The standard vascular surgical procedure (SV) for the treatment of distal aortic arch pathologies involves a hybrid approach using a left carotid-subclavian bypass and thoracic endovascular aortic repair. Considering the introduction of a thoracic side branch prosthesis (TBE), the aim of this study was to analyze the cost-revenue aspects of both procedures. MATERIAL AND METHODS: A retrospective analysis was conducted on cases treated by SV from 2017 to 2022. To draw conclusions regarding the use of TBE, the main diagnoses and procedures of SV were recoded based on current classifications (ICD/OPS 2023) for revenue calculations and regrouped according to aG-DRG 2023. An OPS modification and regrouping were performed for modeling TBE revenues. RESULTS: A total of 13 cases were identified (mean age 62.5 ± 13.8 years; 10 males). After regrouping, the following DRGs were obtained: F42Z in N = 5, F51A in N = 4, F08B in N = 2, and F07A and F36B each in N = 1. The total revenue after regrouping was €â€¯666,514.13, including an additional payment (ZE) of €â€¯132,729.14. With the modeled application of TBE, a total revenue of €â€¯659,212.19 was achieved. Compared to SV, this represents a revenue decrease of €â€¯16,886.71 (changed DRG), but with an increase in ZE revenue by €â€¯65,559.78 (different ZE). The use of TBE resulted in a saving of 74 occupancy days, including 13.5 days in intensive care. CONCLUSION: A cost coverage seems probable with a change in the procedure, despite the yet to be determined pricing of TBE. This is highly dependent on the coding quality and the future development of ZE, given the annually changing DRG relative weights. Precise and transparent performance and cost documentation are essential for determining the pricing.

[Diagnosis and Management of Perioperative Myocardial Ischemia after Elective Aortic Aneurysm Surgery]. / Diagnostik und Management der perioperativen Myokardischämie im Rahmen elektiver Eingriffe bei Aortenaneurysmen.

INTRODUCTION: Perioperative myocardial ischemia (PMI) is a serious postoperative complication. Aortic operations represent an especially high-risk surgery concerning cardiac complications. This aim of this study was to analyse the clinical features of PMI after elective aortic aneurysm surgery. PATIENTS AND METHODS: This study is a retrospective analysis of 863 patients who underwent elective aortic aneurysm surgery between 2005 and 2012 in the Department of Vascular and Endovascular Surgery of Heidelberg University Hospital with regard to PMI. The PMI diagnosis was based on a positive serum troponin diagnostic test. We evaluated the clinical course, time point of the diagnosis and features of diagnostics to characterise PMI. Moreover, we analysed the treatment options and management of the patients' discharge. RESULTS: Thirty-one patients (3.6% of 863) with PMI after elective aortic aneurysm surgery were identified. Of these, 21 patients (67.7%) underwent open surgery and 10 patients (32.3%) received endovascular treatment. PMI was diagnosed in 24 patients (77%) during the first 3 days. More than half of these patients (16/31) were clinically asymptomatic. Electrocardiogram did not show pathological findings in 24 cases (77.4%). The first troponin measurement was not elevated in eight patients (25.8%). Drug therapy alone was used in 17 cases (54.8%) of PMI, coronary catheterisation was performed in 12 patients (38.7%) and two patients (6.5%) received aortocoronary bypass. Fourteen patients (45.1%) were discharged home and another 14 patients (44.1%) were transferred to another hospital or to a rehabilitation institution. Two patients died because of multi-organ failure. CONCLUSION: PMI is not a rare complication after elective aortic surgery. The diagnosis of PMI can be challenging because of occult symptoms especially in a perioperative setting. Due to the potentially serious consequences, cardiac enzyme diagnostics should be initiated immediately if there is suspicion of PMI or routinely in defined at-risk patients after aortic surgery.

Thoracic Endovascular Aortic Repair (TEVAR) First in Patients with Lower Limb Ischemia in Complicated Type B Aortic Dissection: Clinical Outcome and Morphology.

Acute Type B aortic dissection (TBAD) can cause organ malperfusion, e.g., lower limb ischemia (LLI). Thoracic endovascular aortic repair (TEVAR) represents the standard treatment for complicated TBAD; however, with respect to LLI, data is scant. The aim of this study was to investigate clinical and morphological outcomes in patients with complicated TBAD and LLI managed with a "TEVAR-first" policy. Between March 1997 and December 2021, 731 TEVAR-procedures were performed, including 106 TBAD-cases. Cases with TBAD + LLI were included in this retrospective analysis. Study endpoints were morphological/clinical success of TEVAR, regarding aortic and extremity-related outcome, including extremity-related adjunct procedures (erAP) during a median FU of 28.68 months. A total of 20/106 TBAD-cases (18.8%, 32-82 years, 7 women) presented with acute LLI (12/20 Rutherford class IIb/III). In 15/20 cases, true lumen-collapse (TLC) was present below the aortic bifurcation. In 16/20 cases, TEVAR alone resolved LLI. In the remaining four cases, erAP was necessary. A morphological analysis showed a relation between lower starting point and lesser extent of TLC and TEVAR success. No extremity-related reinterventions and only one major amputation was needed. The data strongly suggest that aTEVAR-first-strategy for treating TBAD with LLI is reasonable. Morphological parameters might be of importance to anticipate the failure of TEVAR alone.

Late Endograft Migration After Thoracic Endovascular Aortic Repair: A Systematic Review and Meta-analysis.

PURPOSE: The objective of this systematic review was to report the cumulative incidence of endograft migration (EM), as well as the morbidity, reintervention rates, and mortality related to EM. This study aimed to provide evidence-based data on patient-relevant sequelae of EM after thoracic endovascular aortic repair (TEVAR) performed using contemporary aortic endografts. MATERIALS AND METHODS: A systematic electronic search of literature in MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials was performed. The pooled synthesis of outcomes was performed using the inverse variance method. RESULTS: Seven prospective non-randomized and 4 retrospective studies, including a total of 1783 patients presenting 70 EMs, were considered for the quantitative analysis. The pooled rate of EM was 4% (95% CI, 2%-7%; range, 0.2%-11%; I2=82%); pooled morbidity rate was 31% (95% CI, 12%-59%; range, 0%-100%; I2=64%) and pooled reintervention rate was 32% (95% CI, 15%-56%; range, 0%-100%; I2=55%). The pooled mortality rate due to EM was 5% (95% CI, 1%-21%; range, 0%-40%; I2=24%). CONCLUSION: For the first time, this meta-analysis provides pooled reference estimates of EM after TEVAR. Thus, the results hold the potential to further characterize EM after TEVAR. The clinical relevance of EM is underlined by its association with high rates of endoleak-related morbidity, reintervention, and mortality. Close standardized surveillance after TEVAR for early detection of EM and prophylaxis of its sequelae is essential.

Distribution of Mobile Health Applications amongst Patients with Symptomatic Peripheral Arterial Disease in Germany: A Cross-Sectional Survey Study.

BACKGROUND: Broadly available digital and mobile health applications (also known as mHealth) have recently gained increasing attention by the vascular community, but very little is known about the dissemination and acceptance of such technologies in certain target populations. The current study aimed to determine the user behaviour and acceptance of such digital technologies amongst patients with peripheral arterial disease (PAD). METHODS: A cross-sectional survey of consecutively treated inpatients at 12 university institutions, as well as one non-university institution, was conducted. All admitted patients with symptomatic PAD were surveyed for 30 consecutive days within a flexible timeframe between 1 July and 30 September 2021. The factors associated with smartphone use were estimated via backward selection within a logistic regression model with clustered standard errors. RESULTS: A total of 326 patients participated (response rate 96.3%), thereof 102 (34.0%) were treated for intermittent claudication (IC, 29.2% women, 70 years in median) and 198 were treated for chronic limb-threatening ischaemia (CLTI, 29.5% women, 70 years in median). Amongst all of the patients, 46.6% stated that they had not changed their lifestyle and health behaviour since the index diagnosis (four years in median), and 33.1% responded that they were not aware of the reasons for all of their medication orders. Amongst all those surveyed, 66.8% owned a smartphone (IC: 70.6%, CLTI: 64.1%), thereof 27.9% needed regular user support. While 42.5% used smartphone apps, only 15.0% used mobile health applications, and 19.0% owned wearables. One out of five patients agreed that such technologies could help to improve their healthy lifestyle. Only higher age was inversely associated with smartphone possession. CONCLUSIONS: The current survey showed that smartphones are prevalent amongst patients with peripheral arterial disease, but only a small proportion used mobile health applications and a considerable number of patients needed regular user support. Almost half of the patients did not change their lifestyle and one third were not aware of the reasons for their medication orders, emphasising room for improvement. These findings can further help to guide future projects using such applications to identify those target populations that are reachable with digital interventions.

Genetic Variation in LRP1 Associates with Stanford Type B Aortic Dissection Risk and Clinical Outcome.

Genetic variation in LRP1 (low-density lipoprotein receptor-related protein 1) was reported to be associated with thoracic aortic dissections and aneurysms. The aims of this study were to confirm this association in a prospective single-center patient cohort of patients with acute Stanford type B aortic dissections (STBAD) and to assess the impact of LRP1 variation on clinical outcome. The single nucleotide variation (SNV) rs11172113 within the LRP1 gene was genotyped in 113 STBAD patients and 768 healthy control subjects from the same population. The T-allele of rs11172113 was more common in STBAD patients as compared to the reference group (72.6% vs. 59.6%) and confirmed to be an independent risk factor for STBAD (p = 0.002) after sex and age adjustment in a logistic regression model analyzing diabetes, smoking and hypertension as additional risk factors. Analysis of clinical follow-up (median follow-up 2.0 years) revealed that patients with the T-allele were more likely to suffer aorta-related complications (T-allele 75.6% vs. 63.8%; p = 0.022). In this study sample of STBAD patients, variation in LRP1 was an independent risk factor for STBAD and affected clinical outcome.

[Discuss Many to Benefit More - Five-Year Analysis of a Multidisciplinary Aortic Board]. / Discuss Many to Benefit More ­ Fünf-Jahres-Analyse eines interdisziplinären Aortenkolloquium.

BACKGROUND: Multidisciplinary aortic boards (mAB) are a valuable tool for decision making in patients with aortic pathologies. The aim of this study was to evaluate the mAB of a maximum care hospital with regards to total patient volume and discipline-specific presentations. Furthermore, the indications for conservative/surgical treatment and the patients' allocation were reviewed. METHODS: A retrospective analysis was performed of all patients discussed in the mAB of Heidelberg University Hospital (Department of Vascular and Endovascular Surgery [VS]/Department of Cardiac Surgery [CS]/Department of Radiology), between 01/2014 and 12/2018. RESULTS: Within a five-year period, 344 patients (median of 71 patients/year) were discussed. Of those, 262 (76%) were presented by VS, mostly recruited from the outpatient sector. Another 63 cases (18%), originated from CS and 19 patients (6%) from other disciplines. An indication for surgical treatment was defined in 153 of 344 patients (45%), whereas 191 of 344 cases (55%) were treated in a conservative fashion. Procedures performed by VS were indicated in 85/153 (55%) cases, including 25% (22/85) of non-VS-patients. Procedures performed by CS were indicated in 68/153 (45%) cases containing 84% (57/68) of non-CS-patients. Despite a dedicated indication for surgery, 59/153 patients (39%) did not receive the recommended therapy. CONCLUSION: mAB maintenance is highly dependent on the outpatient sector. With respect to patient selection, the mAB has an important filter function towards conservative treatment. The nearly balanced distribution between VS and CS underlines the importance of a multidisciplinary approach to aortic surgery. Given the relevant number of untreated patients, a central management office with an in-hospital registry seems crucial in order to improve mAB performance.

A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease.

OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHODS: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6-67.0) and was completed in 91.2% (177/194) of patients. RESULTS: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76-0.70]) and 56.6% (95% CI = [0.57-0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07-0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21-0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004-0.05]) and 3.9% (95% CI = [0.007-0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. CONCLUSIONS: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.

Outcome Analysis and Risk Factors for Perioperative Myocardial Ischemia After Elective Aortic Surgery.

BACKGROUND: Perioperative myocardial ischemia (PMI) after non-cardiac surgery remains a serious postoperative complication. This study analyzed the risk factors and outcomes of patients who suffered from PMI after elective aortic surgery. PATIENTS AND METHODS: Data from 863 patients who underwent elective aortic surgery for aneurysms or Leriche syndrome were retrospectively analysed with regard to PMI. The diagnosis of PMI was based on a positive serum troponin diagnostic test. According to the clinical signs and symptoms, the patients with PMI were divided into two groups: symptomatic and asymptomatic patients. Comorbidities, preoperative medication, intraoperative parameters, postoperative complications, mortality, length of intensive care stay and hospitalisation, as well as the long-term follow-up, were compared in a matched-pair analysis (1:3) with patients without PMI. Logistic regression analyses were performed to identify independent risk factors for PMI. RESULTS: Thirty-two patients with PMI were identified. Cardiac comorbidities (previous myocardial ischemia, P = 0.0099; left ventricular systolic dysfunction, P = 0.0429), ASA score ≥III (P = 0.0114) and preoperative elevated creatinine (P = 0.0194) were more common in patients who suffered PMI. The regression analysis confirmed that peripheral artery disease and prolonged operative duration >180 min are significant predictors of PMI. Surgical complications (wound healing deficit, P = 0.0027; rate of secondary interventions during primary admission, P = 0.0057) and medical complications (pneumonia, P = 0.0002; renal dysfunction, P = 0.0041) were more common in patients with PMI compared to the control group. Patients who suffered PMI remained in intensive care for a significantly longer period (P = 0.0001) and were also hospitalized for longer (P = 0.0001) than the control group. The long-term survival of patients who suffered PMI after aortic surgery was significantly worse than the control group (P < 0.0001, median 53 vs. 84 months), independent of clinical ischemia-associated symptoms. CONCLUSIONS: PMI after aortic surgery not only affects long-term survival, but also correlates with worsening of surgical outcome. Thus, meticulous preoperative risk stratification is required for high-risk patients, together with routine postoperative monitoring of troponin levels after aortic surgery.

Dynamic Morphology of the Ascending Aorta and Its Implications for Proximal Landing in Thoracic Endovascular Aortic Repair.

In this study, we assessed the dynamic segmental anatomy of the entire ascending aorta (AA), enabling the determination of a favorable proximal landing zone and appropriate aortic sizing for the most proximal thoracic endovascular aortic repair (TEVAR). Methods: Patients with a non-operated AA (diameter < 40 mm) underwent electrocardiogram-gated computed tomography angiography (ECG-CTA) of the entire AA in the systolic and diastolic phases. For each plane of each segment, the maximum and minimum diameters in the systole and diastole phases were recorded. The Wilcoxon signed-rank test was used to compare aortic size values. Results: A total of 100 patients were enrolled (53% male; median age 82.1 years; age range 76.8−85.1). Analysis of the dynamic plane dimensions of the AA during the cardiac cycle showed significantly higher systolic values than diastolic values (p < 0.001). Analysis of the proximal AA segment showed greater distal plane values than proximal plane values (p < 0.001), showing a reversed funnel form. At the mid-ascending segment, the dynamic values did not notably differ between the distal plane and the proximal segmental plane, demonstrating a cylindrical form. At the distal segment of the AA, the proximal plane values were larger than the distal segmental plane values (p < 0.001), thus generating a funnel form. Conclusions: The entire AA showed greater systolic than diastolic aortic dimensions throughout the cardiac cycle. The mid-ascending and distal-ascending segments showed favorable forms for TEVAR using a regular cylindrical endograft design. The most proximal segment of the AA showed a pronounced conical form; therefore, a specific endograft design should be considered.

Outcome analysis of the Gore Conformable Thoracic Stent Graft with active control system for the treatment of arch and descending thoracic aortic disease.

OBJECTIVES: The aim of this study was to evaluate technical/clinical outcomes of the Gore TAG Conformable Thoracic Stent Graft with Active Control System (CTAG with ACS) in thoracic aortic disease since its introduction in Europe in 2017. METHODS: Patients undergoing thoracic endovascular aortic repair (TEVAR) with the device between 2017 and 2020 were identified from a prospectively maintained single-centre database and retrospectively analysed. Predominant indications were aortic dissection (n = 46), thoracic/thoraco-abdominal aneurysm (n = 20/n = 7), penetrating ulcer (n = 14) and intramural haematoma (n = 12). Emergency procedures were performed in 47% (54/115). The primary outcome was technical success. Secondary outcomes were clinical success, serious adverse events and procedure-related reintervention. ACS was assessed regarding angulation, accuracy and apposition. The median follow-up was 8.46 months (interquartile range: 3.18-16.89 months). RESULTS: A total of 115 consecutive patients (82 males, median age 63; interquartile range: 53-74 years) have been included. Technical success was achieved in 95.7% (110/115). Clinical success rate was 80.9% (93/115); mostly due to procedure-related death (n = 14). Overall mortality was 19.1% (22/115), with significant differences between elective/emergency procedures (log-rank: P < 0.001). Procedure-related serious adverse event rate was 44.3% (51/115). Procedure-related reintervention was performed in 20.9% (24/115). The cumulative incidence for reintervention differed significantly between elective/emergency cases (Gray's test: P = 0.0033). Angulation was used in 40.9% of patients (47/115), mostly in type II arches (52.7%). Deployment accuracy was 87.8% (101/115). Sufficient apposition was present in 93.0% (107/115). CONCLUSIONS: This single-centre study shows encouraging performance of the CTAG with ACS in an array of aortic pathologies. Although longer-term data must be awaited, ACS leads to overall favourable device placement. Despite ongoing advances in device technology, TEVAR remains challenging and is associated with significant burden inherent to the underlying disease.

Extended intensive care correlates with worsening of surgical outcome after elective abdominal aortic reconstruction.

BACKGROUND: The aim of this study was to evaluate the impact of extended postoperative intensive care on short- and long-term patient outcome after elective abdominal aortic surgery and to assess the risk factors for patient survival after extended intensive care unit (ICU) treatment. METHODS: The data of 231 patients that underwent open or endovascular abdominal aortic surgery were retrospectively analysed with regard to extended postoperative intensive care, defined as ICU treatment for more than 24 consecutive hours. Pre- and intraoperative factors were evaluated. The endpoints of the study were postoperative complications, mortality, and long-term follow-up. Univariate and multivariate Cox proportional regression analyses were performed to identify risk factors of worse overall survival. RESULTS: Extended postoperative intensive care was needed in 84 patients (63 after open and 21 after endovascular surgery). The period of ICU treatment was similar in both groups. Only the wound complications (31.8% vs. 9.5%, P=0.0498; OR 4.42 [0.94-20.84]) and the rate of acute kidney injury (82.5% vs. 57.1%, P=0.0352; OR 3.55 [1.20-0.46]) were more frequent after open surgery, whereas brief reactive psychosis (38.1% vs. 14.3%, P=0.0281; OR 0.27 [0.09-0.84]) was more frequent after endovascular surgery. ICU stay of ≥8 days correlated with significantly lower survival rates compared to a shorter ICU stay (P=0.0034), independent of open or endovascular techniques. Other multivariate risk factors for worse survival were the absence of preoperative aspirin medication, a Body Mass Index (BMI) of <25, chronic renal insufficiency, and coronary artery disease. Endovascular therapy was a positive predictive factor of short ICU stay of ≤3 days. CONCLUSIONS: The outcome after extended intensive care following elective aortic surgery is strongly dependent on the length of ICU stay.

Midterm single-center results after endovascular aneurysm sealing reveal a high rate of stent graft migration, secondary aneurysm ruptures, and device-related reinterventions.

OBJECTIVE: To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic disease. METHODS: In this retrospective observational study, all patients treated with EVAS between March 2013 and January 2018 for abdominal aortic aneurysm (AAA) or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, and procedural and clinical surveillance outcomes. Furthermore, patients treated within the original instructions for use (IFU-group) were compared with patients treated outside the IFU (non-IFU-group) with regard to survival, reintervention-free survival, freedom from type I endoleak, and freedom from stent graft migration. RESULTS: Seventy patients were included (67 male; median age, 72.5 years). Sixty-five patients were treated for AAA and 5 patients for abdominal penetrating aortic ulcer. Sixty-nine cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow-up was 50.5 months (interquartile range, 29.3-62.7 months) with a median computed tomography angiographic follow-up of 38.5 months (interquartile range, 17.1-60.2 months). There were five deaths during the study period (7.1%), four of which were aneurysm related (5.7%). Five secondary AAA ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly owing to thrombotic complications (18.6%), stent graft migration (17.1%), and type I endoleak (12.9%). Fifteen patients were treated outside of the IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days and 1, 3, and 5 years was 94.3%, 88.5%, 72%, and 56.9%, respectively. Freedom from stent graft migration at 1, 3, and 5 years was 98.6%, 82.0%, and 47.3%, respectively. The estimated freedom from type I endoleak at 30 days and 1, 3, and 5 years in the IFU-group was 100%, 100%, 94.9% and, 91.1% and significantly different when compared with the non-IFU-group with 79.5%, 72.2%, 72.2%, and 72.2% (P = .012). CONCLUSIONS: Although the technical and initial results were satisfying, the mid-term results were disappointing. The enforcement of a close follow-up protocol for all patients treated with EVAS, especially vigilant for stent graft migration to prevent secondary type I endoleak and rupture, is strongly recommended.