The use of video motion analysis to determine the impact of anatomic complexity on endovascular performance in carotid artery stenting.

OBJECTIVE: Video motion analysis (VMA) uses fluoroscopic sequences to derive information on catheter and guidewire movement and is able to calculate two-dimensional catheter tip path length (PL) on the basis of frame-by-frame pixel coordinates. The objective of this study was to evaluate the effect of anatomic complexity on the efficiency of completion of defined stages of simulated carotid artery stenting as measured by VMA. METHODS: Twenty interventionists each performed a standardized easy, medium, and difficult carotid artery stenting case in random order on an ANGIO Mentor (Simbionix, Airport City, Israel) simulator. Videos of all procedures were analyzed using VMA software, and performance was expressed in terms of two-dimensional guidewire tip trajectory distance (PL). Comparisons of PL were used to identify differences in cannulation performance of the participants between the three cases of varying difficulty. The procedure was subdivided into four procedural phases: arch navigation, common carotid artery (CCA) cannulation, external carotid manipulation, and carotid lesion crossing. Comparisons of PL were used to identify differences in performance between the three cases of varying difficulty for each of the procedural phases. RESULTS: There were significant differences in PL in relation to anatomic complexity, with a stepwise increase in PL from easy to difficult cases: easy, median of 5000 pixels (interquartile range, 4075-5403 pixels); intermediate, 9059 (5974-14,553) pixels; difficult, 17,373 (11,495-26,594) pixels (P < .001). Similarly, during CCA cannulation, there was a stepwise increase in PL from easy to difficult cases: easy, 749 (603-1403) pixels; intermediate, 3274 (1544-8142) pixels; difficult, 8845 (5954-15,768) pixels (P < .001). There were no observed differences across the groups of anatomic difficulty for the phases of arch navigation, external carotid manipulation, and carotid lesion crossing. CONCLUSIONS: Increasing anatomic complexity leads to significant increases in PL of endovascular tools, in particular during CCA cannulation. This increase in tool movement may have a bearing on clinical outcome.

Reducing contact forces in the arch and supra-aortic vessels using the Magellan robot.

OBJECTIVE: Conventional catheter manipulation in the arch and supra-aortic trunks carries a risk of cerebral embolization. This study proposes a platform for detailed quantitative analysis of contact forces (CF) exerted on the vasculature, in order to investigate the potential advantages of robotic navigation. METHODS: An anthropomorphic phantom representing a type I bovine arch was mounted and coupled onto a force/torque sensor. Three-axis force readings provided an average root-mean-square modulus, indicating the total forces exerted on the phantom. Each of the left subclavian, left common carotid, and right common carotid arteries was cannulated within a simulated endovascular suite with conventional (n = 42) vs robotic techniques (n = 30) by two operator groups: experts and novices. The procedure path was divided into three phases, and performance metrics corresponding to mean and maximum forces, force impact over time, standard deviation of forces, and number of significant catheter contacts with the arterial wall were extracted. RESULTS: Overall, median CF were reduced from 1.20 N (interquartile range [IQR], 0.98-1.56 N) to 0.31 N (IQR, 0.26-0.40 N; P < .001) for the right common carotid artery; 1.59 N (IQR, 1.11-1.85 N) to 0.33 N (IQR, 0.29-0.43 N; P < .001) for the left common carotid artery; and 0.84 N (IQR, 0.47-1.08 N) to 0.10 N (IQR, 0.07-0.17 N; P < .001) for the left subclavian artery. Robotic navigation resulted in significant reductions for the mean and maximum forces for each procedural phase. Significant improvements were also seen in other metrics, particularly at the target vessel ostium and for the more anatomically challenging procedural phases. Force reductions using robotic technology were evident for both novice and expert groups. CONCLUSIONS: Robotic navigation can potentially reduce CF and catheter-tissue contact points in an in vitro model, by enhancing catheter stability and control during endovascular manipulation.

Robot-assisted uterine artery embolization: a first-in-woman safety evaluation of the Magellan System.

PURPOSE: To provide a technical description of robot-assisted uterine artery embolization and to investigate the safety and feasibility of the Magellan (Hansen Medical, Mountain View, California, USA) robotic catheter in this complex arterial bed. MATERIALS AND METHODS: Five women (mean age, 48.8 y) underwent robot-assisted bilateral uterine artery embolization over a 10-month period using the Magellan robotic catheter. Demographic, clinicopathologic, and endovascular performance metric data (fluoroscopy and cannulation times) were recorded as well as short-term outcomes. RESULTS: Robotic cannulation of bilateral internal iliac and uterine arteries was successful in all cases. Median right and left internal iliac artery cannulation and total fluoroscopy times were 3 minutes (interquartile range [IQR], 1.5-4 min), 2 minutes (IQR, 1.5-4 min), and 11 minutes (IQR, 9.5-14 min). Median right and left uterine artery cannulation times were both 11 minutes (IQR, 6.5-15 min and 8-12 min, respectively). Technical success was 100%. All patients were discharged on postoperative day 1, and there were no major or access site complications. At 6 months after the procedure, all patients reported significant improvement of symptoms, with a median increase in health-related quality-of-life score of 58% (48.5%-61.75%). CONCLUSIONS: The use of the new-generation Magellan system in uterine artery embolization is feasible and appears to be safe. The additional navigational capability and added maneuverability of the NorthStar catheter (Hansen Medical, Mountain View, California) may facilitate selective catheterization of small iliac artery divisions and may be useful in any procedure where complex arterial selection is needed.

Renal artery aneurysm formation secondary to pseudoxanthoma elasticum.

This report describes a patient with pseudoxanthoma elasticum (PXE) who presented with an incidental finding of a renal artery aneurysm. PXE is a rare genetic condition. It is associated with calcification of elastin fibers and is characterized by skin, eye, and cardiovascular complications. Our patient was previously treated for retinal and gastrointestinal hemorrhage and coronary artery disease, and is under surveillance for cerebral aneurysms. Five reports in the published literature have described aneurysms in patients with PXE, but, to our knowledge, this is the first report of a patient with PXE and renal artery aneurysm. The literature on PXE and aneurysms is reviewed.

Robot-assisted fenestrated endovascular aneurysm repair (FEVAR) using the Magellan system.

A 67-year-old man underwent robot-assisted three-vessel fenestrated endovascular aneurysm repair (FEVAR) for a 7.3-cm juxtarenal aneurysm. The 6-F robotic catheter was manipulated from a remote workstation, away from the radiation source. Robotic cannulation of the left renal artery was achieved within 3 minutes. System setup time was 5 minutes. There were no postoperative complications. Computed tomography angiography performed at discharge and at 4-month follow-up confirmed target vessel patency with no evidence of an endoleak. Selective cannulation of target vessels during FEVAR using this novel technology is feasible. Endovascular robotics may have a role in simplifying complex endovascular tasks and potentially reducing radiation exposure to the operator.

Current State of Robotics in Interventional Radiology.

As a relatively new specialty with a minimally invasive nature, the field of interventional radiology is rapidly growing. Although the application of robotic systems in this field shows great promise, such as with increased precision, accuracy, and safety, as well as reduced radiation dose and potential for teleoperated procedures, the progression of these technologies has been slow. This is partly due to the complex equipment with complicated setup procedures, the disruption to theatre flow, the high costs, as well as some device limitations, such as lack of haptic feedback. To further assess these robotic technologies, more evidence of their performance and cost-effectiveness is needed before their widespread adoption within the field. In this review, we summarise the current progress of robotic systems that have been investigated for use in vascular and non-vascular interventions.

Reducing error and improving efficiency during vascular interventional radiology: implementation of a preprocedural team rehearsal.

PURPOSE: To determine the type and frequency of errors during vascular interventional radiology (VIR) and design and implement an intervention to reduce error and improve efficiency in this setting. MATERIALS AND METHODS: Ethical guidance was sought from the Research Services Department at Imperial College London. Informed consent was not obtained. Field notes were recorded during 55 VIR procedures by a single observer. Two blinded assessors identified failures from field notes and categorized them into one or more errors by using a 22-part classification system. The potential to cause harm, disruption to procedural flow, and preventability of each failure was determined. A preprocedural team rehearsal (PPTR) was then designed and implemented to target frequent preventable potential failures. Thirty-three procedures were observed subsequently to determine the efficacy of the PPTR. Nonparametric statistical analysis was used to determine the effect of intervention on potential failure rates, potential to cause harm and procedural flow disruption scores (Mann-Whitney U test), and number of preventable failures (Fisher exact test). RESULTS: Before intervention, 1197 potential failures were recorded, of which 54.6% were preventable. A total of 2040 errors were deemed to have occurred to produce these failures. Planning error (19.7%), staff absence (16.2%), equipment unavailability (12.2%), communication error (11.2%), and lack of safety consciousness (6.1%) were the most frequent errors, accounting for 65.4% of the total. After intervention, 352 potential failures were recorded. Classification resulted in 477 errors. Preventable failures decreased from 54.6% to 27.3% (P < .001) with implementation of PPTR. Potential failure rates per hour decreased from 18.8 to 9.2 (P < .001), with no increase in potential to cause harm or procedural flow disruption per failure. CONCLUSION: Failures during VIR procedures are largely because of ineffective planning, communication error, and equipment difficulties, rather than a result of technical or patient-related issues. Many of these potential failures are preventable. A PPTR is an effective means of targeting frequent preventable failures, reducing procedural delays and improving patient safety.

Evaluation of robotic endovascular catheters for arch vessel cannulation.

OBJECTIVE: Conventional catheter instability and embolization risk limits the adoption of endovascular therapy in patients with challenging arch anatomy. This study investigated whether arch vessel cannulation can be enhanced by a remotely steerable robotic catheter system. METHODS: Seventeen clinicians with varying endovascular experience cannulated all arch vessels within two computed tomography-reconstructed pulsatile flow phantoms (bovine type I and type III aortic arches), under fluoroscopic guidance, using conventional and robotic techniques. Quantitative (catheterization times, catheter tip movements, vessel wall hits, catheter deflection) and qualitative metrics (Imperial College Complex Endovascular Cannulation Scoring Tool [IC3ST]) performance scores were compared. RESULTS: Robotic catheterization techniques resulted in a significant reduction in median carotid artery cannulation times and the median number of catheter tip movements for all vessels. Vessel wall contact with the aortic arch wall was reduced to a median of zero with robotic catheters. During stiff guidewire exchanges, robotic catheters maintained stability with zero deflection, independent of the distance the catheter was introduced into the carotid vessels. Overall IC3ST performance scores (interquartile range) were significantly improved using the robotic system: Type I arch score was 26/35 (20-30.8) vs 33/35 (31-34; P = .001), and type III arch score was 20.5/35 (16.5-28.5) vs 26.5/35 (23.5-28.8; P = .001). Low- and medium-volume interventionalists demonstrated an improvement in performance with robotic cannulation techniques. The high-volume intervention group did not show statistically significant improvement, but cannulation times, movements, and vessel wall hits were significantly reduced. CONCLUSION: Robotic technology has the potential to reduce the time, risk of embolization and catheter dislodgement, radiation exposure, and the manual skill required for carotid and arch vessel cannulation, while improving overall performance scores.

Vascular and Interventional Radiology Training; International Perspectives and Challenges.

PURPOSE: Assess international interventional radiology (IR) training standards and trainee satisfaction to identify challenges and drive positive change. MATERIALS AND METHODS: An anonymous survey was created using Survey Monkey and distributed as a single-use web link via eight IR national and international societies around the world. It consisted of two parts: the first assessed the general exposure of radiology trainees to IR and whether this influenced their decision to pursue a career in IR; the second focussed on satisfaction and quality of training by those who are in training or have recently completed an IR training program. RESULTS: There were 496 participants of which 274 were eligible to complete part one of the survey and 222 were eligible to complete the whole survey. UK and Europe contributed 52% of the responses. The USA and Middle East contributed 23%, and the rest of the world 9%. Over half of responders expressed that exposure early in their career was the main inspiration to pursue a career in IR. Overall satisfaction with training was high across all regions; however, satisfaction regarding vascular training varied. The negative impact of competition from other specialities ranged from 9% (USA) to 61% (UK). Great variability was reported regarding the amount of time spent dedicated to IR and IR on call. CONCLUSION: Despite significant progress in creating structured and comprehensive IR training, there is still room for improvement. Early promotion of IR is essential for on-going high-quality recruitment. Monitoring and standardization of the training environment at a national and international level are necessary to equip IR trainees and to consolidate IR's speciality status in the medical field.

Clinical experience with a shape memory polymer peripheral vascular embolisation plug: a case series.

BACKGROUND: Shape memory polymers are materials that are manufactured in a certain shape, can be stored in a temporary deformed shape, and then return to - or remember - their original shape upon exposure to external stimuli such as temperature and moisture. This property lends itself to application in endovascular medical devices. Peripheral vasculature embolisation devices incorporating this novel technology have become commercially available and this case series, where the data were collected as part of a post market registry, outlines initial clinical experience with these novel devices. RESULTS: Eight cases are described in this series. The disease state/conditions for which embolisation was indicated were right common iliac artery aneurysms (n = 3), a type II endoleak into the thoracic aorta following thoracic endovascular aneurysm repair (n = 1), a left inferior gluteal artery aneurysm (n = 1), left internal iliac artery aneurysms (n = 2), and a case of splenomegaly, where splenectomy was planned after the embolisation procedure (n = 1). Target arteries were 5-10 mm in diameter. In each case, at least one IMPEDE Embolization Plug (IMP-Device) of an appropriate diameter was used. All procedures were technically successful and target vessel thrombosis was achieved in all cases. Follow-up imaging available during the 45-90-day data collection timeframe showed sustained vessel occlusion. This case series includes examples of situations commonly encountered when embolising the peripheral vasculature, namely, the use of one or multiple devices in a single vessel and in combination with the use of other embolic devices (e.g., microcoils, gelatin sponge, and PVA particles) in the same case. There were no adverse events related to the specific use of the device. CONCLUSIONS: This small series illustrates the safety and efficacy of this novel sponge-based embolic device for the embolisation of small and medium sized arteries and further experience will demonstrate the utility of the shape memory polymer devices.

The role of robotic endovascular catheters in fenestrated stent grafting.

OBJECTIVE: Fenestrated stent grafting has allowed the treatment of complex thoraco-abdominal aneurysm disease via a totally endovascular approach, but the procedure can be technically challenging and time consuming. We investigated whether this procedure may be enhanced by remotely steerable robotic endovascular catheters. METHODS: A four-vessel fenestrated stent graft partially deployed within a computed tomography (CT)-reconstructed pulsatile thoraco-abdominal aneurysm silicon model was used. Fifteen operators were recruited to participate in the study and divided into three groups, based on their endovascular experience: group A (n = 4, 100-200 endovascular procedures, group B (n = 5, 200-300), and group C (n = 6, >300). All operators were asked to cannulate the renal and visceral vessels under fluoroscopic guidance, using conventional and robotic techniques. Quantitative (catheterization times and wire/catheter tip movements) and qualitative metrics (procedure-specific-rating scale [IC3ST]), which grades operators on catheter use, instrumentation, successful cannulation/catheterization, and overall performance were compared. RESULTS: Median procedure time for cannulation of all four vessels was reduced using the robotic system (2.87 min, interquartile range [IQR; 2.20-3.90] versus 17.24 min [11.90-19.80]; P < .001) for each individual operator, regardless of the level of endovascular experience. The total number of wire/catheter movements taken to complete the task was also significantly reduced (38, IQR [29-57] versus 454 [283-687]; P < .001). There were significant differences in time and movement for cannulation of each individual vessel in the phantom. Robotic catheter operator radiation exposure was negligible as the robotic workstation is remote and away from the radiation source. Overall performance scores significantly improved using the robotic system, despite minimal operator exposure to this technology (IC3ST score 29/35, IQR [22.8-30.7] versus 19/35 [13-24.3]; P = .002). Each group of operators demonstrated an improvement in performance with robotic cannulation. For group A, median IC3ST score was 28/35, IQR (22-33) versus 15/35 (11-20); P = .04; for group B, 30/35 (27-31) versus 19/35 (18-24); P = .07; and for group C, 28.8/35 (28.5-29) versus 22/35 (16-24); P = .06. For groups B and C, these differences did not reach statistical significance. CONCLUSION: Robotic catheterization of target vessels during this procedure is feasible and minimizes radiation exposure for the operator. Steerable robotic catheters with intuitive control may overcome some of the limitations of standard catheter technology, enhance target vessel cannulation, reduce instrumentation, and improve overall performance scores.

How to manage the left subclavian artery during endovascular stenting for thoracic aortic dissection? An assessment of the evidence.

BACKGROUND: Despite the publication of recent guidelines for management of the left subclavian artery (LSA) during endovascular stenting procedures of the thoracic aorta, specific management for those presenting with dissection remains unclear. This systematic review attempts to address this issue. METHODS: Systematic assessment of the published data on thoracic aorta dissection was performed identifying 46 studies, which incorporated 1,275 patients. Primary outcomes included the prevalence of left arm ischemia, stroke, spinal cord ischemia, endoleak, stent migration, and mortality. Outcomes were compared between patients with and without LSA coverage and revascularization incorporating factors such as the number of stents used, length of aorta covered, urgency of intervention, and type of dissection (acute or chronic). Statistical pooling techniques, χ(2) tests, and Fisher's exact testing were used for group comparisons. RESULTS: As compared with other outcomes, LSA coverage without revascularization in the presence of aortic dissection is much more likely to be complicated by left arm ischemia (prevalence increased from 0.0% to 4.0% [p = 0.021]), stroke (prevalence increased from 1.4% to 9.0% [p = 0.009]), and endoleak (prevalence increased from 4.0% to 29.3% [p = 0.001]). However, revascularization was not shown to reverse these effects. Longer aortic coverage (≥ 150 mm) was associated with an increased prevalence of spinal cord ischemia (from 1.3% to 12.5% [p = 0.011]) and mortality (from 1.3% to 15.6% [p = 0.003]). CONCLUSION: In patients undergoing endovascular stenting for thoracic aortic dissection, in cases where LSA coverage is necessary, revascularization should be considered before the procedure to avoid complications such as left arm ischemia, stroke, and endoleak, and where feasible, an appropriate preoperative assessment should be carried out.

Flexible robotics in pelvic disease: does the catheter increase applicability of embolic therapy?

Interventional radiology procedures, equipment, and techniques as well as image guidance have developed dramatically over the last few decades. The evidence for minimally invasive interventions in vascular and oncology fields is rapidly growing and several procedures are considered the first line management. However, radiation exposure, image guidance and innovative solutions to known anatomical challenges are still lagging behind. Robotic technology and its role in surgery have been developing at a steady speed. Endovascular robotics are following suit with a different set of problems and targets. This article discusses the advances and limitations in one aspects of endovascular robotic, namely pelvic pathology that includes aneurysms, fibroids, benign prostatic hypertrophy and vascular malformation.

Flexible robotic catheters in the visceral segment of the aorta: advantages and limitations.

Flexible robotic catheters are an emerging technology which provide an elegant solution to the challenges of conventional endovascular intervention. Originally developed for interventional cardiology and electrophysiology procedures, remotely steerable robotic catheters such as the Magellan system enable greater precision and enhanced stability during target vessel navigation. These technical advantages facilitate improved treatment of disease in the arterial tree, as well as allowing execution of otherwise unfeasible procedures. Occupational radiation exposure is an emerging concern with the use of increasingly complex endovascular interventions. The robotic systems offer an added benefit of radiation reduction, as the operator is seated away from the radiation source during manipulation of the catheter. Pre-clinical studies have demonstrated reduction in force and frequency of vessel wall contact, resulting in reduced tissue trauma, as well as improved procedural times. Both safety and feasibility have been demonstrated in early clinical reports, with the first robot-assisted fenestrated endovascular aortic repair in 2013. Following from this, the Magellan system has been used to successfully undertake a variety of complex aortic procedures, including fenestrated/branched endovascular aortic repair, embolization, and angioplasty.

Two-Vessel Branched Stent Graft for Severely Angulated Aortic Arch Aneurysm in a Jehovah's Witness.

Aneurysmal disease involving the origins of supra aortic vessels often requires complex open and/or endovascular repair that is not only associated with significant risk of mortality and morbidity but also often with perioperative blood loss requiring transfusion. We report a successful repair of a large thoracic aortic aneurysm (TAA) involving the aortic arch with a custom-made Bolton Relay 2-vessel branched thoracic aortic endograft in a 42-year-old Jehovah's Witness who would otherwise be very unlikely to survive an open repair. Branched thoracic aortic endografting offers a potentially safe, minimally invasive, and effective alternative for TAA disease involving the supra-aortic arteries, especially in patients who are at high risk of open surgery.

Endovascular repair of ruptured abdominal aortic aneurysm: technical and team training in an immersive virtual reality environment.

PURPOSE: This study evaluates a fully immersive simulated angiosuite for training and assessment of technical endovascular and human factor skills during a crisis scenario. MATERIALS AND METHODS: Virtual reality (VIST-C, Mentice) simulators were integrated into a simulated angiosuite (ORCAMP, Orzone). Teams, lead by experienced (N = 5) or trainee (N = 5) endovascular specialists, performed simulated endovascular ruptured aortic aneurysm repair (rEVAR). Timed performance metrics were recorded as surrogate measures of performance. Participants (N = 22) completed postprocedure questionnaires evaluating face validity, as well as technical and human factor aspects, of the simulation on a Likert scale from 1 (not at all) to 5 (very much). RESULTS: Experienced team leaders were significantly faster than trainees in obtaining proximal control with an intra-aortic occlusion balloon (352 vs. 501 s, p = 0.047) and all completed the procedure within the allotted time, whilst no trainee was able to do so. Total fluoroscopy times were significantly lower in the experienced group (782 vs. 1,086 s, p = 0.016). Realism of the simulated angiosuite was scored highly by experienced team leaders (median 4/5, IQR 4-5). Participants found the simulation useful for acquiring technical (4/5, IQR 4-5) and communication skills (4/5, IQR 4-5) and particularly valuable for enhancing teamwork (5/5, IQR 4-5) and patient safety (5/5, IQR 4-5). CONCLUSION: This study shows feasibility of creation of a crisis scenario in a fully immersive angiosuite simulation and team performance of a simulated rEVAR. Performance metrics differentiated between experienced specialists and trainees, and the realism of the simulation exercise and environment were rated highly by experienced endovascular specialists. This simulation has potential as a powerful training and assessment tool with opportunities to improve team performance in rEVAR through both technical and human factor skills training.

Analysis of the quality of information obtained about uterine artery embolization from the internet.

PURPOSE: The Internet is widely used by patients to source health care-related information. We sought to analyse the quality of information available on the Internet about uterine artery embolization (UAE). MATERIALS AND METHODS: We searched three major search engines for the phrase "uterine artery embolization" and compiled the top 50 results from each engine. After excluding repeated sites, scientific articles, and links to documents, the remaining 50 sites were assessed using the LIDA instrument, which scores sites across the domains of accessibility, usability, and reliability. The Fleisch reading ease score (FRES) was calculated for each of the sites. Finally, we checked the country of origin and the presence of certification by the Health On the Net Foundation (HONcode) as well as their effect on LIDA and FRES scores. RESULTS: The following mean scores were obtained: accessibility 48/60 (80%), usability 42/54 (77%), reliability 20/51 (39%), total LIDA 110/165 (67%), and FRES 42/100 (42%). Nine sites had HONcode certification, and this was associated with significantly greater (p < 0.05) reliability and total LIDA and FRES scores. When comparing sites between United Kingdom and United States, there was marked variation in the quality of results obtained when searching for information on UAE (p < 0.05). CONCLUSION: In general, sites were well designed and easy to use. However, many scored poorly on the reliability of their information either because they were produced in a non-evidence-based way or because they lacking currency. It is important that patients are guided to reputable, location-specific sources of information online, especially because prominent search engine rank does not guarantee reliability of information.