One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair.

OBJECTIVE: This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year. METHODS: A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days. RESULTS: Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients. CONCLUSIONS: In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.

[Long-term Results after Endovascular and Open Repair of Ruptured Abdominal Aortic Aneurysm - a Propensity Score Matched Analysis]. / Langzeitergebnisse nach endovaskulärer und offener Versorgung des rupturierten Bauchaortenaneurysmas ­ eine Propensity-Score-Analyse.

BACKGROUND: This retrospective propensity score matched study presents the perioperative mortality and long-term survival up to 9 years after endovascular (EVAR) and open (OAR) repair of patients with ruptured abdominal aortic aneurysm (rAAA) in Germany using health insurance data. MATERIALS AND METHODS: 2170 patients treated between January 1st, 2010 and December 31st, 2016, for rAAA within 24 hours of hospital admission and receiving blood transfusions were enrolled in the study and tracked until December 31st, 2018. For better comparability of EVAR and OAR, a 1:1 propensity score matching with 624 pairs according to patient age, sex and comorbidities was carried out using the R program (Foundation for Statistical Computing, Vienna, Austria). RESULTS: In the unadjusted groups, 29.1% (631/2170) of the patients were treated with EVAR and 70.9% (1539/2170) with OAR. EVAR patients had a significantly higher overall rate of comorbidities. After adjustment, EVAR patients showed significantly better perioperative survival (EVAR 35.7%, OAR 51.0%, p = 0.000). Perioperative complications occurred in 80.4% of EVAR patients and 80.3% of OAR patients (p = 1.000). At the end of follow-up, Kaplan-Meier estimated that 15.2% of patients survived after EVAR vs. 19.5% after OAR (p = 0.027). In the multivariate Cox regression analysis, OAR, age ≥ 80 years, diabetes mellitus type 2 and renal failure stages 3 to 5 had a negative impact on overall survival. Patients treated on weekdays had a significantly lower perioperative mortality than patients treated during the weekend (perioperative mortality on weekdays 40.6% vs. 53.4% during the weekend; p = 0.000) and a better overall survival as estimated by Kaplan-Meier. CONCLUSION: Significantly better perioperative and overall survival was observed with EVAR than with OAR in patients with rAAA. The perioperative survival benefit of EVAR was also found in patients older than 80 years. Female gender had no significant influence on perioperative mortality and overall survival. Patients treated on weekends had a significantly poorer perioperative survival than patients treated on weekdays, and this lasted through the end of follow-up. The extent to which this was dependent on hospital structure was unclear.

[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.

[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.

Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy.

OBJECTIVE: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. METHODS: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. RESULTS: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099). CONCLUSIONS: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes.

Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair.

OBJECTIVE: The objective of this study was to review the current anatomic indications for and early results of aortouni-iliac (AUI) devices for endovascular aneurysm repair. METHODS: A total of 128 patients receiving an Endurant (Medtronic Inc, Minneapolis, Minn) AUI device in the U.S. Investigational Device Exemption trial (44 patients) or the Endurant Stent Graft Natural Selection Global Postmarket Registry (84 patients) were reviewed. Preoperative computed tomography imaging of patients in the Investigational Device Exemption trial and case report forms of Registry patients were used to determine anatomic indications. Baseline characteristics and early results were compared with those of 1305 patients receiving a bifurcated (BIF) device in sister studies. RESULTS: The indication for the AUI device was unclear from case report forms in two Registry cases. The remaining 126 patients had a unilateral iliac occlusion in 30 (23%), a severely narrowed aortic segment in 58 (45%), severe iliac occlusive disease in 28 (22%), severe iliac tortuosity in 29 (23%), or complex iliac aneurysms in 19 (15%). Two patients had a previous aortobifemoral graft; 38 patients (30%) had multiple indications. The AUI cohort included more women than the BIF group did (19% vs 10%; P < .01) and had more severe comorbidities. Successful deployment was achieved in all AUI cases. The 30-day mortality was 2% (BIF cohort, 1%; P = .21). More AUI patients underwent repair under general anesthesia (81% vs 64%; P < .01), and procedures were longer (110.9 ± 54.9 minutes vs 99.2 ± 44.3 minutes; P = .02). Except for longer intensive care unit stays (19.6 ± 80.0 hours vs 9.0 ± 34.8 hours; P = .01) and higher myocardial infarction rates (4% vs 1%; P < .01), outcomes of the AUI cohort were similar to those of the BIF cohort. There were no migrations, ruptures, fractures, or open conversions at up to 1-year follow-up. CONCLUSIONS: The AUI configuration extends endovascular aneurysm repair feasibility to several hostile anatomic conditions. Despite increased comorbidities in the recipient patient population and associated higher rates of postoperative myocardial infarction and respiratory complications, early outcomes with the new generation of AUI devices are acceptable and comparable to those after treatment with BIF configurations.

Development, implementation, and evaluation of a structured reporting web tool for abdominal aortic aneurysms.

BACKGROUND: The majority of radiological reports are lacking a standard structure. Even within a specialized area of radiology, each report has its individual structure with regards to details and order, often containing too much of non-relevant information the referring physician is not interested in. For gathering relevant clinical key parameters in an efficient way or to support long-term therapy monitoring, structured reporting might be advantageous. OBJECTIVE: Despite of new technologies in medical information systems, medical reporting is still not dynamic. To improve the quality of communication in radiology reports, a new structured reporting system was developed for abdominal aortic aneurysms (AAA), intended to enhance professional communication by providing the pertinent clinical information in a predefined standard. METHODS: Actual state analysis was performed within the departments of radiology and vascular surgery by developing a Technology Acceptance Model. The SWOT (strengths, weaknesses, opportunities, and threats) analysis focused on optimization of the radiology reporting of patients with AAA. Definition of clinical parameters was achieved by interviewing experienced clinicians in radiology and vascular surgery. For evaluation, a focus group (4 radiologists) looked at the reports of 16 patients. The usability and reliability of the method was validated in a real-world test environment in the field of radiology. RESULTS: A Web-based application for radiological "structured reporting" (SR) was successfully standardized for AAA. Its organization comprises three main categories: characteristics of pathology and adjacent anatomy, measurements, and additional findings. Using different graphical widgets (eg, drop-down menus) in each category facilitate predefined data entries. Measurement parameters shown in a diagram can be defined for clinical monitoring and be adducted for quick adjudications. Figures for optional use to guide and standardize the reporting are embedded. Analysis of variance shows decreased average time required with SR to obtain a radiological report compared to free-text reporting (P=.0001). Questionnaire responses confirm a high acceptance rate by the user. CONCLUSIONS: The new SR system may support efficient radiological reporting for initial diagnosis and follow-up for AAA. Perceived advantages of our SR platform are ease of use, which may lead to more accurate decision support. The new system is open to communicate not only with clinical partners but also with Radiology Information and Hospital Information Systems.