Purpose: The navigation of endovascular guidewires is a dexterous task where physicians and patients can benefit from automation. Machine learning-based controllers are promising to help master this task. However, human-generated training data are scarce and resource-intensive to generate. We investigate if a neural network-based controller trained without human-generated data can learn human-like behaviors. Methods: We trained and evaluated a neural network-based controller via deep reinforcement learning in a finite element simulation to navigate the venous system of a porcine liver without human-generated data. The behavior is compared to manual expert navigation, and real-world transferability is evaluated. Results: The controller achieves a success rate of 100% in simulation. The controller applies a wiggling behavior, where the guidewire tip is continuously rotated alternately clockwise and counterclockwise like the human expert applies. In the ex vivo porcine liver, the success rate drops to 30%, because either the wrong branch is probed, or the guidewire becomes entangled. Conclusion: In this work, we prove that a learning-based controller is capable of learning human-like guidewire navigation behavior without human-generated data, therefore, mitigating the requirement to produce resource-intensive human-generated training data. Limitations are the restriction to one vessel geometry, the neglected safeness of navigation, and the reduced transferability to the real world.

Purpose: Endovascular intervention is the state-of-the-art treatment for common cardiovascular diseases, such as heart attack and stroke. Automation of the procedure may improve the working conditions of physicians and provide high-quality care to patients in remote areas, posing a major impact on overall treatment quality. However, this requires the adaption to individual patient anatomies, which currently poses an unsolved challenge. Methods: This work investigates an endovascular guidewire controller architecture based on recurrent neural networks. The controller is evaluated in-silico on its ability to adapt to new vessel geometries when navigating through the aortic arch. The controller’s generalization capabilities are examined by reducing the number of variations seen during training. For this purpose, an endovascular simulation environment is introduced, which allows guidewire navigation in a parametrizable aortic arch. Results: The recurrent controller achieves a higher navigation success rate of 75.0% after 29,200 interventions compared to 71.6% after 156,800 interventions for a feedforward controller. Furthermore, the recurrent controller generalizes to previously unseen aortic arches and is robust towards size changes of the aortic arch. Being trained on 2048 aortic arch geometries gives the same results as being trained with full variation when evaluated on 1000 different geometries. For interpolation a gap of 30% of the scaling range and for extrapolation additional 10% of the scaling range can be navigated successfully. Conclusion: Adaption to new vessel geometries is essential in the navigation of endovascular instruments. Therefore, the intrinsic generalization to new vessel geometries poses an essential step towards autonomous endovascular robotics.

Percutaneous femoral arterial access is daily practice in a variety of medical specialties and enables physicians worldwide to perform endovascular interventions. The reported incidence of percutaneous femoral arterial access complications is 3–18% and often results from suboptimal puncture location due to insufficient visualization of the target vessel. The purpose of this proof-of-concept study was to evaluate the feasibility and the positional error of a mixed-reality (MR)-assisted puncture of the common femoral artery in a phantom model using a commercially available navigation system. In total, 15 MR-assisted punctures were performed. Cone-beam computed tomography angiography (CTA) was used following each puncture to allow quantification of positional error of needle placements in the axial and sagittal planes. Technical success was achieved in 14/15 cases (93.3%) with a median axial positional error of 1.0 mm (IQR 1.3) and a median sagittal positional error of 1.1 mm (IQR 1.6). The median duration of the registration process and needle insertion was 2 min (IQR 1.0). MR-assisted puncture of the common femoral artery is feasible with acceptable positional errors in a phantom model. Future studies should aim to measure and reduce the positional error resulting from MR registration.

Summary:Background: To investigate the usability of Mixed-Reality (MR) during patient education in patients scheduled for abdominal aortic aneurysm (AAA) repair. Patients and methods: Consecutive patients scheduled for elective AAA repair were block-randomized in either the Mixed-Reality group (MR group) or the conventional group (control group). Patients of both groups were educated about open and endovascular repair of their respective AAA. The MR group was educated using a head-mounted display (HMD) demonstrating a three-dimensional virtual reconstruction of the respective patient’s vascular anatomy. The control group was educated using a conventional two-dimensional monitor to display the patient’s vasculature. Outcomes were informational gain as well as patient satisfaction with the educational process. (DRKS-ID: DRKS00025174). Results: 50 patients were included with 25 patients in either group. Both groups demonstrated improvements in scores in the Informational Gain Questionnaire (IGQ) when comparing pre- and post-education scores. (MR group: 6.5 points (±1.8) versus 7.9 points (±1.5); Control group: 6.2 points (±1.8) versus 7.6 points (±1.6); p<0.01) There was no significant difference between the MR group and the control group either in informational gain (MR group: 1.4±1.8; Control group: 1.4±1.8; p=0.5) nor in patient satisfaction scores (MR group: mean 18.3 of maximum 21 points (±3.7); Control group: mean 17 of 21 points (±3.6); p=0.1) Multiple regression revealed no correlation between the use of MR and informational gain or patient satisfaction. Usability of the system was rated high, and patients’ subjective assessment of MR was positive. Conclusions: The use of MR in patient education of AAA patients scheduled for elective repair is feasible. While patients reported positively on the use of MR in education, similar levels of informational gain and patient satisfaction can be achieved with MR and conventional methods.

Purpose: To determine the evolution of abdominal aortic aneurysm (AAA) diameter in the presence of persisting type 2 endoleaks (pEL2) following endovascular abdominal aortic aneurysm repair (EVAR). Materials and Methods: This is a retrospective, single-center, case-control study. All patients with pEL2 (pEL2 group, persisting for > 12 months) between 2004 and 2018 were identified and compared with a 1:1 age- and gender-matched control with no endoleak (control group). Primary outcome measures were freedom from AAA expansion and freedom from AAA shrinkage over time. AAA diameter measurements were performed on computed tomography angiography (CTA). Secondary outcome measures were survival, AAA-related mortality, reinterventions for pEL2, incidence of secondary type 1 endoleaks (EL1), and infrarenal aortic branch vessel anatomy. Results: A total of 773 patients were treated with EVAR for AAA between 2004 and 2018. Of them, 286 patients demonstrated type 2 endoleaks (EL2) in postoperative CTA or intraoperative angiography (37%). Forty-five of 286 EL2 (15.7%) were pEL2 (pEL2 group). Freedom from AAA expansion in the pEL2 group was 100%, 96.7%, 85.2%, and 54.3% after 1, 2, 3, and 4 years, respectively, compared with 100% after 1, 2, 3, and 4 years in the control group (p<0.01). Freedom from AAA shrinkage in the pEL2 group after 1, 2, 3, and 4 years was 95.5%, 90.4%, 90.4%, and 79.1%, respectively, compared with 86.7%, 34.8%, 19.3%, and 19.3% in the control group (p<0.01). Overall survival at 1, 2, 3, and 4 years was 100%, 97.6%, 95.0% and 95.0% in the pEL2 group and 100% at 1, 2, 3, and 4 years in the control group (p=0.17). There were no AAA-related deaths in either group. Patients with pEL2 had a significantly increased number of infrarenal aortic branches (p<0.05, respectively). Eighteen patients (40.0%) in the pEL2 group underwent 34 reinterventions for pEL2, with a median follow-up (FU) of 925 days (0–4173). Clinical success was achieved in 9 patients (50.0%). Four patients (8.9%) with pEL2 developed secondary EL1 after a median FU of 1278 days (662–2121). Conclusion: pEL2 are associated with AAA expansion during midterm FU. Further studies are warranted to evaluate the association of AAA expansion due to pEL2 with clinical outcomes to allow recommendations with regard to treatment indications.

The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with 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 were included in 14 sites across Germany, Belgium, and the Netherlands. 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. A total of 347 patients were included in the ZEPHYR registry. 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 year, 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 cause for secondary interventions was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1 year, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariate and multivariate Cox regression analyses could not identify any independent predictor for limb complications. While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is concerning. The manufacturer's instructions for use should be closely followed. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.