Patient Views on Surgeon-specific Outcome Reporting in Vascular Surgery: Novel Validated Patient Questionnaire Study.

BACKGROUND: SSMD are used to enhance transparency, improve quality and facilitate patient choice. The use of SSMD is controversial, but patients' views on such data are largely unknown. OBJECTIVES: The aim of this study was therefore to explore the views of patients and to identify their priorities for outcome reporting in vascular surgery. METHODS: A prospective questionnaire study of 165 patients receiving care in a single academic vascular unit was performed. Data on patients' current understanding and use of SSMD, together with future priorities were collected. RESULTS: Of the 165 patients 80% were unaware of SSMD. 72% thought they should be made aware of the data, although 63% thought they were likely to misinterpret the results. The majority recognized the utility of SSMD to inform treatment (60%) and surgeon (53%) choice. The majority prioritize the patient-surgeon relationship (90%) and past experiences of care (71%) when making treatment decisions. A significant majority (66% vs 49%; P < 0.005) would favour hospital-level to surgeon-level data. The main patient priorities for future outcome reporting were waiting list length (56%), the quality of hospital facilities (55%), and patient satisfaction (54%). CONCLUSIONS: The aims of SSMD reporting are not currently being met, and both patients and healthcare professionals have shared concerns over the nature and usefulness of the data. Patients express a preference for hospital-level outcomes and prioritize the experience of receiving care over outcomes when making treatment decisions. Future outcome reporting should include patient-directed hospital-level metrics that are readily accessible and understood by all.

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.

Experience with a novel custom-made fenestrated stent graft in the repair of juxtarenal and type IV thoracoabdominal aneurysms.

OBJECTIVE: Fenestrated stent grafting has become increasingly popular as a means to manage complex aortic pathology, including juxta- and pararenal aneurysms. The design of a recently developed custom-made fenestrated stent graft, in theory, confers advantages when managing anatomically challenging aortic morphology. This study evaluated its feasibility in anatomically challenging scenarios. METHODS: Over a 12-month period, 20 patients received fenestrated stent grafts. Among those, 13 patients with juxtarenal or type IV thoracoabdominal aortic aneurysms underwent endovascular repair with the novel fenestrated stent graft at a single UK institution. Data on aneurysm morphology and immediate and short-term results were collected prospectively. RESULTS: The mean aneurysmal sac size was 7.3 cm (range, 5.5-10.0 cm). The mean infrarenal neck length was 4.4 mm (range, 0-9 mm), and in three cases was lined by a pre-existing infrarenal stent graft. Nine cases had an infrarenal neck angulation of 60(°) or more in either the anteroposterior or coronal planes. Five cases had ≥50% thrombus at the proximal landing zone. A total of 35 target vessels were cannulated, of which six right renal and four left renal arteries were angulated ≥120(°). Two-thirds of cannulated celiac trunks were angulated ≥120(°), and one cannulated superior mesenteric artery was angulated ≥ 140(°). Seven of the cannulated targets were stenosed more than 60%. One patient had two right renal arteries arising 3 mm from each other. Four right and four left common iliac arteries were angulated ≥90(°) in relation to the infrarenal aorta. Technical success was 100%. Median time from date of procedure to most recent follow-up with computed tomography scanning was 33 weeks. There was no type I or III endoleak. One type II endoleak was observed at the time of most recent computed tomography scanning and treated expectantly. There was a single incident of left renal artery occlusion. One patient required repair of a brachial artery, fasciotomies, and temporary haemofiltration. One patient died from ischemic heart disease 77 weeks after the procedure. CONCLUSIONS: The use of the novel fenestrated stent graft system in patients with hostile aortic aneurysmal morphology is feasible with acceptable short-term outcomes.

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.

In vitro fenestration of aortic stent-grafts: implications of puncture methods for in situ fenestration durability.

PURPOSE: To investigate the quality of stent-graft fenestrations created in vitro using different needle puncture and balloon dilation angles in different commercial endografts. METHODS: Fenestrations were made in a standardized fashion in 3 different endograft types: Talent monofilament twill woven polyester, Zenith multifilament tubular woven polyester, and Endofit thin-walled expanded polytetrafluoroethylene (PTFE). Punctures were made at 30°, 60°, and 90° angles using a 20-G needle and dilated using 6-mm standard and 7-mm cutting balloons; at least 6 fenestrations were made at each angle with standard balloons and at least 6 with cutting balloons. The 137 fenestrations were examined under light microscopy; quantitative and qualitative digital image analysis was performed to determine size, shape, and fenestration quality. RESULTS: PTFE grafts were easier to puncture/dilate, resulting in larger, elliptical fenestrations with overall better quality than the Dacron grafts; however, the puncture/dilation angle made an impact on the shape and quality of fenestrations. A significant number of fabric tears were observed in PTFE fabric at <90° puncture/dilation angles compared to Dacron grafts. In Dacron grafts, fenestration quality was significantly higher with 90° puncture/dilation angles (higher in Talent grafts). Cutting balloon use resulted in significantly more fabric tears and poor quality fenestrations in all graft types. CONCLUSION: Different endografts behave significantly differently when fenestrations are fashioned. Optimum puncture/dilation is important when considering in vivo fenestration techniques. Improvements in instrumentation, materials, and techniques are required to make this a reliable and reproducible endovascular option.

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.

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.

Reducing errors in combined open/endovascular arterial procedures: influence of a structured mental rehearsal before the endovascular phase.

PURPOSE: To assess the incidence of errors before and after implementation of a structured mental rehearsal prior to the endovascular phase of combined open/endovascular arterial procedures. METHODS: Over 6 weeks, 15 combined open/endovascular procedures (7 abdominal aorta and 8 thoracic aorta) lasting 58 hours were evaluated by a trained observer. In a blinded fashion, 2 individuals scrutinized event logs for errors, which were categorized by type, by potential to cause patient harm (danger), and by potential to disrupt the procedure (delay). After 9 procedures, a focus group-devised structured mental rehearsal was implemented prior to the endovascular phase for 6 combined procedures. Error patterns were compared before and after implementation. Data are expressed as median (range). RESULTS: The error rate during the endovascular phase of the combined procedures was higher than the non-endovascular phase [7.64/hour (1.71-9.6) vs. 3.75/hour (1.71-5.54), respectively; p = 0.05]. Error rates during the endovascular phase were lower after the intervention compared to before [2.5/hour (1.4-6.0) vs. 7.6/hour (1.7-9.6), respectively; p = 0.05]. During the endovascular phase, danger and delay scores were also lower after the intervention [1.2/error (1.0-2.0) and 1.3/error (1.0-2.3), respectively] compared to before [1.75/error (1.4-2.5) and 2.0/error (1.3-2.5), respectively] (p = 0.036 and p = 0.036 for danger and delay, respectively). CONCLUSION: A structured mental rehearsal before critical stages of procedures may reduce the rate and severity of intraoperative error.

Tortuous iliac systems--a significant burden to conventional cannulation in the visceral segment: is there a role for robotic catheter technology?

PURPOSE: To attempt to quantify the effect of varying degrees of iliac tortuosity on maneuverability and "torquability" of endovascular catheters in the visceral segment, comparing conventional and robotic cannulation techniques. MATERIALS AND METHODS: In a fenestrated endograft within a pulsatile phantom, 10 experienced operators cannulated the renal arteries via three different access vessels of varying iliac tortuosity with the use of conventional and robotic techniques. All procedures were performed in the angiography suite and recorded for blinded video assessment for quantitative (time, catheter-tip movements) and qualitative metrics (operator performance scores). RESULTS: In total, 120 cannulations were observed. With increasing iliac tortuosity, median time and number of catheter movements required for renal cannulation with conventional techniques increased in stepwise fashion for mild, moderate, and severe iliac tortuosity (times, 7.6 min [interquartile range (IQR), 4.6-9.3 min] vs 6.9 min [4.2-11.4 min] vs 17.7 min [13.3-22.6 min], respectively; movements, 184 [IQR, 110-351] vs 251 [207-395] vs 569 [409-616], respectively). Median renal cannulation times were significantly reduced with the use of the robotic system irrespective of mild, moderate, or severe tortuosity (times, 1.4 min [IQR, 1.1-1.9 min] vs 3 min [2.3-3.3 min] vs 2.8 min [1.5-3.9 min], respectively; movements, 19 [IQR, 14-27] vs 46 [43-58] vs 45 [40-66], respectively; P < .005). Overall operator performance scores improved significantly with the use of the robotic system irrespective of iliac tortuosity severity. CONCLUSIONS: In cases of moderate to severe iliac tortuosity, conventional catheter manipulation and control becomes an issue. The improvement in positional control and predictability seen with advanced catheter designs may be amplified in cases of severe iliac tortuosity.

Strategies to tackle unrecognized bilateral renal artery occlusion after endovascular aneurysm repair.

BACKGROUND: Unintentional renal artery occlusion after endovascular aortic aneurysm repair (EVAR) is an uncommon phenomenon. The sequelae from this specific complication are severe; consequently, the topic of renal artery coverage is a pertinent issue. We present a case series of patients undergoing EVAR with unintentional renal artery coverage, review the treatment options available, and suggest a treatment algorithm for this scenario based on the evidence. METHODS AND RESULTS: We report four patients who were found to have renal artery occlusion after EVAR detected up to 5 weeks postoperatively. Renal revascularization was achieved using endovascular renal artery stenting in two patients, and open hepato-spleno-renal bypass in the remaining two cases. Treatment strategies used led to symptom resolution and recovery of renal function in all cases. CONCLUSIONS: Both open and endovascular techniques may be used as procedures to treat this condition-the choice of procedure is primarily determined by accessibility of the renal orifice.

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.

Clinical applications of robotic technology in vascular and endovascular surgery.

BACKGROUND: Emerging robotic technologies are increasingly being used by surgical disciplines to facilitate and improve performance of minimally invasive surgery. Robot-assisted intervention has recently been introduced into the field of vascular surgery to potentially enhance laparoscopic vascular and endovascular capabilities. The objective of this study was to review the current status of clinical robotic applications in vascular surgery. METHODS: A systematic literature search was performed in order to identify all published clinical studies related to robotic implementation in vascular intervention. Web-based search engines were searched using the keywords "surgical robotics," "robotic surgery," "robotics," "computer assisted surgery," and "vascular surgery" or "endovascular" for articles published between January 1990 and November 2009. An evaluation and critical overview of these studies is reported. In addition, an analysis and discussion of supporting evidence for robotic computer-enhanced telemanipulation systems in relation to their applications in laparoscopic vascular and endovascular surgery was undertaken. RESULTS: Seventeen articles reporting on clinical applications of robotics in laparoscopic vascular and endovascular surgery were detected. They were either case reports or retrospective patient series and prospective studies reporting laparoscopic vascular and endovascular treatments for patients using robotic technology. Minimal comparative clinical evidence to evaluate the advantages of robot-assisted vascular procedures was identified. Robot-assisted laparoscopic aortic procedures have been reported by several studies with satisfactory results. Furthermore, the use of robotic technology as a sole modality for abdominal aortic aneurysm repair and expansion of its applications to splenic and renal artery aneurysm reconstruction have been described. Robotically steerable endovascular catheter systems have potential advantages over conventional catheterization systems. Promising results from applications in cardiac interventions and preclinical studies have urged their use in vascular surgery. Although successful applications in endovascular repair of abdominal aortic aneurysm and lower extremity arterial disease have been reported, published clinical experience with the endovascular robot is limited. CONCLUSIONS: Robotic technology may enhance vascular surgical techniques given preclinical evidence and early clinical reports. Further clinical studies are required to quantify its advantages over conventional treatments and define its role in vascular and endovascular surgery.

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.

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.

Video motion analysis in live coronary angiography differentiates levels of experience and provides a novel method of skill assessment.

AIMS: Video motion analysis (VMA) uses fluoroscopic sequences to derive catheter and guidewire movement, and is able to calculate 2D catheter-tip path length (PL) on the basis of frame-by-frame pixel coordinates. The objective of this study was to validate VMA in coronary angiography as a method of skill assessment. METHODS AND RESULTS: Forty-seven coronary interventions performed by 10 low- (<1,000 cases; group A), five medium- (1,000-4,000; group B) and six high- (>4,000; group C) experience-volume cardiologists were prospectively recorded and analysed using VMA software. Total PL was calculated and procedure, fluoroscopy times, and radiation dose were recorded. Comparisons of PL were made between groups of experience. Groups A, B and C performed 24, 14 and 6 paired (right and left coronary) cannulations, respectively. Calculation of PL was possible in all recorded cases and significantly correlated with procedure (p=<0.001, rho=0.827) and fluoroscopy times (p=<0.001, rho=0.888). Median total path length (combined right and left coronaries) was significantly shorter in group C which used 3,836 pixels of movement (IQR: 3,003-4,484) vs. 10,556 (7,242-31,408) in group A (p=<0.001) and 8,725 (5,187-15,150) in group B (p=0.013). CONCLUSIONS: VMA in coronary angiography is feasible and PL is able to differentiate levels of experience.

Catheter manipulation analysis for objective performance and technical skills assessment in transcatheter aortic valve implantation.

PURPOSE: Transcatheter aortic valve implantation (TAVI) demands precise and efficient handling of surgical instruments within the confines of the aortic anatomy. Operational performance and dexterous skills are critical for patient safety, and objective methods are assessed with a number of manipulation features, derived from the kinematic analysis of the catheter/guidewire in fluoroscopy video sequences. METHODS: A silicon phantom model of a type I aortic arch was used for this study. Twelve endovascular surgeons, divided into two experience groups, experts ([Formula: see text]) and novices ([Formula: see text]), performed cannulation of the aorta, representative of valve placement in TAVI. Each participant completed two TAVI experiments, one with conventional catheters and one with the Magellan robotic platform. Video sequences of the fluoroscopic monitor were recorded for procedural processing. A semi-automated tracking software provided the 2D coordinates of the catheter/guidewire tip. In addition, the aorta phantom was segmented in the videos and the shape of the entire catheter was manually annotated in a subset of the available video frames using crowdsourcing. The TAVI procedure was divided into two stages, and various metrics, representative of the catheter's overall navigation as well as its relative movement to the vessel wall, were developed. RESULTS: Experts consistently exhibited lower values of procedure time and dimensionless jerk, and higher average speed and acceleration than novices. Robotic navigation resulted in increased average distance to the vessel wall in both groups, a surrogate measure of safety and reduced risk of embolisation. Discrimination of experience level and types of equipment was achieved with the generated motion features and established clustering algorithms. CONCLUSIONS: Evaluation of surgical skills is possible through the analysis of the catheter/guidewire motion pattern. The use of robotic endovascular platforms seems to enable more precise and controlled catheter navigation.

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.

The use of robotic endovascular catheters in the facilitation of transcatheter aortic valve implantation.

OBJECTIVES: The use of transcatheter aortic valve implantation (TAVI) is rapidly increasing with advances in technology and improved clinical outcomes. Adoption of robotic catheter technologies could have a role in TAVI, in different stages of the procedure, to improve endovascular tool manipulation and potentially reduce the risk of cerebral embolization. The aim was to determine whether there are advantages in using a robotic catheter for TAVI in the initial stages of the procedure; aortic arch navigation and valve crossing. METHODS: A silicone in vitro model of the aorta and stenotic aortic valve was developed. Fifteen operators performed the fluoroscopy-guided simulation using manual and robotic techniques. Performance metrics-time and vessel wall contact (wall-hits) were compared (Wilcoxon's signed-rank test). RESULTS: Overall, the time taken for robotic arch navigation was increased (3.09 min interquartile range (1.24-6.29) vs 1.21 min (0.15-4.42); P = 0.03). Contact with the aortic arch wall, however, significantly decreased using the robotic catheter: wall-hits 1 (0-5) vs 6 (2-22), P < 0.01. For valve crossing, there was no significant increase in time and wall-hits when using the robotic technology. CONCLUSIONS: Use of robotic catheter technology is feasible in the initial stages of TAVI. Although it takes longer, robotic navigation reduces contact with the aortic arch wall, potentially reducing the embolic risk during endovascular manipulation. Using a robotic catheter is possible without increasing the number of wall-hits during valve crossing. This may provide a stable platform for wire positioning in the ventricle. With improvements in technology, perhaps allowing valve deployment, the stability and accuracy of the robotic arm may further improve performance.