Robotic Arch Catheter Placement Reduces Cerebral Embolization During Thoracic Endovascular Aortic Repair (TEVAR).

OBJECTIVE: Stroke caused by cerebral embolization constitutes a principal risk during arch manipulation and thoracic endovascular aortic repair (TEVAR). This study investigates the incidence of cerebral embolization during catheter placement in the aortic arch, and compares robotic and manual techniques. METHODS: Intra-operative transcranial Doppler (TCD) was performed in 11 patients undergoing TEVAR. Wire and catheter placement in the arch was performed by two experienced operators. Manual and robotic catheter placement and removal were compared for each patient; 44 manoeuvres were studied in total. A conventional 5Fr pigtail catheter was used for manual cannulation via a 5Fr access sheath. The 6Fr/9Fr co-axial Magellan endovascular robotic system was used for robotic navigation operated from a remote workstation. The number of high intensity transient signals (HITS) detected by TCD during different stages of TEVAR was recorded. RESULTS: The median procedural embolization rate was 173 (interquartile range 97-240). There were significantly fewer HITS detected during robotic catheter placement with six in total (median 0, IQR 0-1), compared with 38 HITS (median 2, IQR 1-5) during manual catheter placement (p = .018). There were no HITS detected during robotic catheter removal by auto-retraction as per manufacturer instructions. On two occasions, however, when the robotic catheter system was removed manually without correcting for articulation, it resulted in one HIT in one case and 11 HITS in the second case. CONCLUSIONS: Robotic catheter placement is feasible during TEVAR, and results in significantly less cerebral embolization compared with manual techniques. The active manoeuvrability, control, and stability of the robotic system is likely to reduce contact with an atheromatous aortic arch wall, and thereby reduce dislodgement of particulate matter and result in less embolization. The importance of adhering to manufacturer instructions during use and removal of the robotic catheter is also highlighted.

A pilot study of video-motion analysis in endovascular surgery: development of real-time discriminatory skill metrics.

OBJECTIVES: Accurate assessment and credentialing of physicians is essential. Objective motion analysis of guide-wire/catheter manipulation to assess proficiency during endovascular interventions remains unexplored. This study aims to assess its feasibility and its role in evaluation of technical ability. MATERIALS AND METHODS: A semi-automated catheter-tracking software was developed which allows for frame-by-frame motion analysis of fluoroscopic videos and calculation 2D catheter tip path-length. 21 interventionalists (6 cardiologists, 8 interventional radiologists, 7 vascular surgeons; 14/21 had performed >500 endovascular procedures) performed an identical carotid artery stenting procedure (CAS) on a VIST simulator (Mentice, Gothenburg, Sweden). Operators were sub-divided into four categories according to CAS experience: 6 inexperienced (0 CAS-group A), 3 low-volume (1-20 CAS-group B), 5 moderate-volume (21-50 CAS-group C) and 7 high-volume (>50 CAS-group D) CAS experience. Total PL was calculated for each case and comparisons made between groups. PL was correlated with: quantitative, simulator-derived metrics and qualitative performance scores (generic and procedure-specific) derived from post-hoc video analysis by three blinded observers. RESULTS: Group D used 5160.3 (inter-quartile range- IQR 4046.4-7142.9) pixels of movement, compared to 6856.7 (5914.4-8106.9) for group A (p = 0.046); 10,905.1 (7851.1-14,381.5) for group B (p = 0.017); and 9482.6 (8663.5-13,847.6) for group C (p = 0.003). Statistically significant inverse correlations were seen between total PL and qualitative performance scores (rho = -0.519 for generic (p = 0.027) rho = -0.567 for procedure-specific (p = 0.014) scores). PL did not correlate with any of the simulator-derived metrics (errors, contrast volume, total procedure and fluoroscopy times, cine-loops used). CONCLUSION: Endovascular instrument video motion analysis is feasible and may represent a valuable tool for the objective assessment of endovascular skill.

Design and validation of an error capture tool for quality evaluation in the vascular and endovascular surgical theatre.

BACKGROUND: The unique and complex vascular and endovascular theatre environment is associated with significant risks of patient harm and procedural inefficiency. Accurate evaluation is crucial to improve quality. This pilot study attempted to design a valid, reproducible tool for observers and teams to identify and categorise errors. METHODS: Relevant published literature and previously collected ethnographic field notes from over 250 h of arterial surgery were analysed. A comprehensive log of vascular procedural errors was compiled and twelve vascular experts graded each error for the potential to disrupt procedural flow and cause harm. Using this multimodal approach, the Imperial College Error CAPture (ICECAP) tool was developed. The tool was validated during 21 consecutive arterial cases (52 h operating-time) as an observer-led error capture record and as a prompt for surgical teams to determine the feasibility of error self-reporting. RESULTS: Six primary categories (communication, equipment, procedure independent pressures, technical, safety awareness and patient related) and 20 error sub-categories were determined as the most frequent and important vascular procedural errors. Using the ICECAP, the number of errors detected correlated well between two observers (Spearman rho = 0.984, p < 0.001). Both observers identified all moderate or severe errors similarly and categorised all but 4/139 (2.9%) of the total errors in an identical fashion. Self-reporting of errors without prompting identified a mean of 24.4% (range 0-50%) of all recorded errors, whereas surgical teams reported a mean of 69.7% (range 50-100%) of errors when ICECAP error-category prompts were used. CONCLUSION: The ICECAP tool may be useful for capturing and categorising errors that occur during vascular/endovascular procedures. ICECAP may also have a role as an error recall prompt for self-reporting purposes by vascular surgical teams.

Identification of patient safety improvement targets in successful vascular and endovascular procedures: analysis of 251 hours of complex arterial surgery.

OBJECTIVES: To investigate failures in patient safety for patients undergoing vascular and endovascular procedures to guide future quality and safety interventions. DESIGN: Single centre prospective observational study. METHODS: 66 procedures (17 thoracoabdominal and 23 abdominal aortic aneurysms, 4 carotid and 22 limb procedures) were observed prospectively over a 9-month period (251 h operating time) by two trained observers. Event logs were recorded for each procedure. Two blinded experts identified and independently categorised failures into 22 types (using a validated category tool) and severity (5-point scale). Data are expressed as median (range). Statistical analysis was performed using Mann-Whitney U, Kruskal-Wallis and Spearman's Rank tests. RESULTS: 1145 failures were identified with good inter-assessor reliability (Cronbach's alpha 0.844). The commonest failure types related to equipment (including unavailability, configuration and other failures) (269/1145 [23.5%]) and communication (240/1145 [21.0%]). A comparatively lower number of technical and psychomotor failures were identified (103 [9.0%]). The number of failures correlated with procedure duration (rho = 0.695, p < 0.001) but not anatomical site of the procedure or pathology of the disease process. Failure rate was higher in patients undergoing combined surgical/endovascular procedures compared to open surgery (median 5.7/h [IQR 4.2-8.1] vs 3.0/h [2.5-3.5]; p < 0.001). The severity of failures was similar (1.5/5 [1-2] vs 1/5 [1-2] respectively; p = 0.095). For combined procedures, failure rates were significantly higher during the endovascular phase (9.6/h [7.5-13.7]) compared to the non-endovascular phase (3.0/h [1.0-5.0]; p < 0.001). CONCLUSIONS: Failures in patient safety are common during complex arterial procedures. Few failures were severe, although minor failures during critical stages and accumulation of multiple minor failures may potentially be important. Failures occurred especially during the endovascular phase and were often related to equipment or communication aspects. Interventions to improve procedural safety and quality of care should primarily target these specific areas.

Advanced catheter technology: is this the answer to overcoming the long learning curve in complex endovascular procedures.

INTRODUCTION: Advanced endovascular procedures require a high degree of skill with a long learning curve. We aimed to identify differential increases in endovascular skill acquisition in novices using conventional (CC), manually steerable (MSC) and robotic endovascular catheters (RC). MATERIALS/METHODS: 10 novices cannulated all vessels within a CT-reconstructed pulsatile-flow arch phantom in the Simulated Endovascular Suite. Subjects were randomly assigned to conventional/manually-steerable/robotic techniques as the first procedure undertaken. The operators repeated the task weekly for 5 weeks. Quantitative (cannulation times, wire/catheter-tip movements, vessel wall hits) and qualitative metrics (validated rating scale (IC3ST)) were compared. RESULTS: Subjects exhibited statistically significant differences when comparing initial to final performance for total procedure times and catheter-tip movements with all catheter types. Sequential non-parametric comparisons identified learning curve plateau levels at weeks 2 or 3(RCs, MSCs), and at week 4(CCs) for the majority of metrics. There were significantly fewer catheter-tip movements using advanced catheter technology after training (Week 5: CC 74 IQR(59-89) versus MSC 62(44-81); p = 0.028, and RC 33 (28-44); p = 0.012). RCs virtually eliminated wall hits at the arch (CC 29(28-76) versus RC 8(6-9); p = 0.005) and produced significantly higher overall performance scores (p < 0.02). CONCLUSION: Advanced endovascular catheters, although more intricate, do not seem to take longer to master and in some areas offer clear advantages with regards to positional control, at a faster rate. RCs seem to be the most intuitive and advanced skill acquisition occurs with minimal training. Robotic endovascular technology may have a significantly shorter path to proficiency allowing an increased number of trainees to attempt more complex endovascular procedures earlier and with a greater degree of safety.

Contemporary management of splanchnic and renal artery aneurysms: results of endovascular compared with open surgery from two European vascular centers.

INTRODUCTION: Splanchnic and renal artery aneurysms (SRAAs) are uncommon but potentially life-threatening in case of rupture. Whether these aneurysms are best treated by open repair or endovascular intervention is unknown. The aim of this retrospective study is to report the results of open and endovascular repairs in two European institutions over a fifteen-year period. We have reviewed the available literature published over the 10 last years. METHODS: All patients with SRAAs diagnosed from 1995 to 2010 in St Marys Hospital (London, UK) and Henri Mondor Hospital (Créteil, France) were reviewed. Preoperative clinical and anatomical data, operative management and outcomes were recorded from the charts and analyzed. RESULTS: 40 patients with 51 SRAAs were identified. There were 21 males and 19 females with a mean age of 57 ± 14.9 years. The aneurysms locations were: 14 (27%) renal, 11 (22%) splenic, 7 (14%) celiac trunk, 7 (14%) superior mesenteric artery, 4 (8%) hepatic, 4 (8%) pancreaticoduodenal arcades, 3 (6%) left gastric and 1 (2%) gastroduodenal. 4 patients presented with a ruptured SRAA. 17 SRAAs in 16 patients were treated by open repair, 15 in 15 patients were treated endoluminally and 17 (mean diameter: 18 mm, range: 8-75 mm) were managed conservatively. One patient with metastatic pulmonary cancer with two mycotic aneurysms of the superior mesenteric artery (75 mm) and celiac trunk (15 mm) was palliated. After endovascular treatment, the immediate technical success rate was 100%. There was no significant difference between open repair and endovascular patients in terms of 30-day post-operative mortality rate and peri-operative complications. No in-hospital death occurred in patients treated electively. Postoperatively, four patients (1 ruptured and 3 elective) suffered non-lethal mild to severe complication in the open repair group, as compared with one in the endovascular group (p = .34). The mean length of stay was significantly higher after open repair as compared with endovascular repair (17 days, range: 8-56 days vs. 4 days, range: 2-6; p < .001). The mean follow-up time was 17.8 months (range: 0-143 months) after open repair, 15.8 months (range: 0-121 months) after endovascular treatment, and 24.8 (range: 3-64 months) for patient being managed conservatively. No late death related to the VAA occurred. In each group, 2 successful reoperations were deemed necessary. In the endovascular group, two patients presented a reperfusion of the aneurysmal sac at 6 and 24 months respectively. CONCLUSION: No significant difference in term of 30-day mortality and post-operative complication rates could be identified between open repair and endovascular treatment in the present series. Endovascular treatment is a safe alternative to open repair but patients are exposed to the risk of aneurysmal reperfusion. This mandates careful long-term imaging follow up in patients treated endoluminally.

Analysis of flow patterns in a patient-specific aortic dissection model.

Aortic dissection is the most common acute catastrophic event affecting the thoracic aorta. The majority of patients presenting with an uncomplicated type B dissection are treated medically, but 25% of these patients develop subsequent aneurysmal dilatation of the thoracic aorta. This study aimed at gaining more detailed knowledge of the flow phenomena associated with this condition. Morphological features and flow patterns in a dissected aortic segment of a presurgery type B dissection patient were analyzed based on computed tomography images acquired from the patient. Computational simulations of blood flow in the patient-specific model were performed by employing a correlation-based transitional version of Menter's hybrid k-epsilon/k-omega shear stress transport turbulence model implemented in ANSYS CFX 11. Our results show that the dissected aorta is dominated by locally highly disturbed, and possibly turbulent, flow with strong recirculation. A significant proportion (about 80%) of the aortic flow enters the false lumen, which may further increase the dilatation of the aorta. High values of wall shear stress have been found around the tear on the true lumen wall, perhaps increasing the likelihood of expanding the tear. Turbulence intensity in the tear region reaches a maximum of 70% at midsystolic deceleration phase. Incorporating the non-Newtonian behavior of blood into the same transitional flow model has yielded a slightly lower peak wall shear stress and higher maximum turbulence intensity without causing discernible changes to the distribution patterns. Comparisons between the laminar and turbulent flow simulations show a qualitatively similar distribution of wall shear stress but a significantly higher magnitude with the transitional turbulence model.

Prevention of paraplegia during thoracoabdominal aortic aneurysm repair.

Paraplegia affects up to 22% of patients undergoing thoarcoabdominal aneurysm surgery, producing long-term morbidity and a significant burden to healthcare. This article discusses the mechanisms that may lead to paraplegia during open and endovascular repair from an anatomical and physiological perspective. There are many adjuncts that must be considered to reduce the risk of spinal cord injury, such as revascularisation of intercostal arteries, maintenance of high mean blood pressure, spinal cord drainage and cooling. These adjuncts are discussed, highlighting the evidence available for each method and the practical ways in which they may be used.

Treatment of complex aneurysmal disease with fenestrated and branched stent grafts.

OBJECTIVES: To describe our experience of treating juxtarenal (JRAAA's <4mm neck) and thoracoabdominal aortic aneurysms (TAAA's) using fenestrated and branched stent graft technology. DESIGN: Prospective single centre experience. METHODS: Since 2005, 29 fenestrated/branched procedures have been performed. 15 patients are studied with JRAAAs (n=7; median neck length 0mm (IQR 0-3.8)) or TAAAs (type I (n=2), III (n=2), IV (n=4)). ASA grade III in 12/15. Maximum diameter of aneurysm 64 mm (56-74 mm). Aneurysms were excluded using covered stents or branches from the main body to patent visceral vessels (40 target vessels total). Pre-operative and follow-up CT scans (1, 3, and 12 months) were analysed by a single Vascular Interventional Radiologist. RESULTS: Technical success for cannulation and stenting of target vessels was 98%. In-hospital mortality was 0%. One patient underwent conversion to open repair. Five had major complications including one paraplegia (type III TAAA) with subsequent recovery. Median length of stay was 9 days (IQR 7-18.75). At a median follow-up of 12 months (9-14), CT confirmed 36/37 (97%) target vessels remain patent. Sac size increased >5 mm in one patient only. There were no type I endoleaks, three type II endoleaks (one embolised, two under surveillance) and three type III endoleaks (two successfully treated percutaneously, one aneurysm ruptured 18 months after endografting and died). CONCLUSION: In selected patients, fenestrated and branched stents appear to be a safe and effective alternative to surgery for juxtarenal and thoracoabdominal aneurysms. The complication and mortality rates are low. The long-term durability of this procedure, however, needs to be proven.

Planning for EVAR: the role of modern software.

Endovascular intervention has revolutionized the treatment of aortic disease, extending the cohort of patients eligible for repair. Accurate planning for endovascular aortic repair is essential. Recent advances in modern software have demonstrated potential for improving outcomes and enhancing the decision making process beyond 3D measurements and intraoperative navigation techniques. With increasing uptake and complexity of endovascular therapies requiring multidisciplinary collaborations, it has become apparent that planning must extend to the preparation of entire interventional teams and support the early identification and prevention of potentially harmful events. This paper will examine recent advances not only in morphological planning and computational modelling, but also the role of software in the preparation of teams and prevention of error.

Advantages and limitations of robotic endovacular catheters for carotid artery stenting.

Carotid artery stenting (CAS) is an important development in the treatment of carotid artery stenosis and prevention of stroke. However, despite advances in technology, including embolic protection devices (EDPs), there are concerns that the embolic stroke risk is still too high in many reports, including a number of randomized controlled trials. Robotic technology has the potential to reduce the embolic risk by facilitating accurate and safe navigation to place sheaths in the common carotid artery, reducing the embolic load during this phase of the procedure prior to EDP placement. This paper identifies the embolic risk associated with different phases of the CAS procedure and predisposing factors that are primarily implicated in increased embolic load from a literature review. The potential for robotic technology to reduce risk in CAS is discussed using preclinical and experimental studies.