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1.
Vascular ; 25(3): 266-271, 2017 Jun.
Article in English | MEDLINE | ID: mdl-27688294

ABSTRACT

Purpose The aim of this paper is to report our experience of type II endoleak treatment after endovascular aneurysm repair with intra-arterial injection of the embolizing liquid material, Onyx liquid embolic system. Methods From 2005 to 2012, we performed a retrospective review of 600 patients, who underwent endovascular repair of an abdominal aortic aneurysm. During this period, 18 patients were treated with Onyx for type II endoleaks. Principal findings The source of the endoleak was the internal iliac artery in seven cases, inferior mesenteric artery in seven cases and lumbar arteries in four cases. Immediate technical success was achieved in all patients and no endoleak from the treated vessel recurred. During a mean follow-up of 19 months, no major morbidity or mortality occurred, and one-year survival was 100%. Conclusions Treatment of type II endoleaks with Onyx is safe and effective over a significant time period.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Dimethyl Sulfoxide/administration & dosage , Embolization, Therapeutic/methods , Endoleak/therapy , Endovascular Procedures/adverse effects , Iliac Artery , Lumbar Vertebrae/blood supply , Mesenteric Artery, Inferior , Polyvinyls/administration & dosage , Tantalum/administration & dosage , Aged , Aged, 80 and over , Angiography, Digital Subtraction , Computed Tomography Angiography , Dimethyl Sulfoxide/adverse effects , Drug Combinations , Embolization, Therapeutic/adverse effects , Endoleak/diagnostic imaging , Endoleak/etiology , Female , Humans , Iliac Artery/diagnostic imaging , Injections, Intra-Arterial , Male , Mesenteric Artery, Inferior/diagnostic imaging , Polyvinyls/adverse effects , Retrospective Studies , Tantalum/adverse effects , Time Factors , Treatment Outcome
2.
Br J Surg ; 103(11): 1467-75, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27557606

ABSTRACT

BACKGROUND: Vascular surgical care has changed dramatically in recent years with little knowledge of the impact of system failures on patient safety. The primary aim of this multicentre observational study was to define the landscape of surgical system failures, errors and inefficiency (collectively termed failures) in aortic surgery. Secondary aims were to investigate determinants of these failures and their relationship with patient outcomes. METHODS: Twenty vascular teams at ten English hospitals trained in structured self-reporting of intraoperative failures (phase I). Failures occurring in open and endovascular aortic procedures were reported in phase II. Failure details (category, delay, consequence), demographic information (patient, procedure, team experience) and outcomes were reported. RESULTS: There were strong correlations between the trainer and teams for the number and type of failures recorded during 88 procedures in phase I. In 185 aortic procedures, teams reported a median of 3 (i.q.r. 2-6) failures per procedure. Most frequent failures related to equipment (unavailability, failure, configuration, desterilization). Most major failures related to communication. Fourteen failures directly harmed 12 patients. Significant predictors of an increased failure rate were: endovascular compared with open repair (incidence rate ratio (IRR) for open repair 0·71, 95 per cent c.i. 0·57 to 0·88; P = 0·002), thoracic aneurysms compared with other aortic pathologies (IRR 2·07, 1·39 to 3·08; P < 0·001) and unfamiliarity with equipment (IRR 1·52, 1·20 to 1·91; P < 0·001). The major failure total was associated with reoperation (P = 0·011), major complications (P = 0·029) and death (P = 0·027). CONCLUSION: Failure in aortic procedures is frequently caused by issues with team-working and equipment, and is associated with patient harm. Multidisciplinary team training, effective use of technology and new-device accreditation may improve patient outcomes.


Subject(s)
Aortic Diseases/surgery , Vascular Surgical Procedures/standards , Adult , Aged , Aged, 80 and over , Clinical Competence/standards , England , Equipment Failure/statistics & numerical data , Female , Humans , Intraoperative Complications/etiology , Male , Medical Errors/statistics & numerical data , Middle Aged , Operative Time , Patient Reported Outcome Measures , Surgical Instruments/supply & distribution , Treatment Failure
3.
Eur J Vasc Endovasc Surg ; 48(1): 13-22, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24785650

ABSTRACT

OBJECTIVE: To investigate and rank factors that influence endovascular treatment decisions by specialists for patients with descending thoracic aortic aneurysm (dTAA). METHODS: Specialists completed a diagrammatic survey describing uncertainty about the benefit of thoracic endovascular aneurysm repair (TEVAR) for dTAA with respect to age, sex, and aneurysm diameter. Subsequently, a detailed discrete choice experiment was designed. Specialists were recruited and asked to indicate treatment their preference (TEVAR or surveillance) in 25 hypothetical cases of dTAA, with variable patient attributes: age, sex, American Society of Anesthesiologists (ASA) grade, aneurysm diameter, adequate landing zone distal to left subclavian artery (LSA), and length of aortic coverage. Data were analysed using multiple logistic regression. RESULTS: The diagrammatic survey, based on 50 respondents, showed that uncertainty about the benefits of TEVAR was greatest for patients aged 80-85 years (up to 47% of respondents were "unsure") and that uncertainty increased with increasing aneurysm diameter (for an 80-year-old man, 7% were unsure at 5.5 cm and 33% were unsure at 7.0 cm). Seventy-one specialists (mainly from Europe and North America, 86% vascular surgeons and 98% working in units offering TEVAR) completed the discrete choice experiment. Preference for TEVAR increased greatly with enlarging diameter: adjusted odds ratios (OR) >5.5-6.0 cm = 15.8 (95% confidence interval [CI] 9.83-25.40); >6.0-6.5 cm = 393.0 (95% CI 202.00-766.00); >6.5-7.0 cm = 1829.0 (95% CI 400.00-4,181.00). TEVAR was less likely to be preferred in patients older than 75 years (>75-80 years OR 0.32, 95% CI 0.21-0.49; >80-85 years = 0.18, 95% CI 0.11-0.28); in women (OR 0.52, 95% CI 0.37-0.74); in patients classified as ASA grade 4 (OR 0.44, 95% CI 0.36-0.57); and in patients with aorta coverage >25 cm (OR 0.48, 95% CI 0.32-0.74). The proximal landing zone did not influence preference. CONCLUSION: Specialists' preferences for endovascular repair of degenerative dTAA vary widely, and demonstrate clinical uncertainty, especially in octogenarians, and a reluctance to offer TEVAR to women. Aneurysm diameter dominates treatment preferences, but patient fitness and length of aortic coverage (>25 cm) also were influential, although the landing zone distal to LSA was not.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Patient Selection , Practice Patterns, Physicians' , Watchful Waiting , Age Factors , Aged , Aged, 80 and over , Aortic Aneurysm, Thoracic/diagnosis , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Female , Health Care Surveys , Healthcare Disparities , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Risk Assessment , Risk Factors , Sex Factors , Surveys and Questionnaires , Time Factors , Treatment Outcome , Uncertainty
4.
Eur J Vasc Endovasc Surg ; 47(1): 19-26, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24183250

ABSTRACT

OBJECTIVE: Evaluation of variation in descending thoracic aortic aneurysm (dTAA) diameters measured on CT scans in different planes and by different observers and the potential impact on treatment decisions. METHODS: CT angiography of dTAA (N = 20) were assessed by three specialists, with measurements repeated after 1 month. Calliper measurements of maximum external diameters were made on unformatted images and perpendicular to the aneurysm centerline after image processing (corrected). Repeatability was assessed using Bland-Altman plots. RESULTS: Maximum corrected diameter measurements were smaller than axial measurements (66.3 ± 7.9 mm vs. 74.9 ± 20.9 mm, p < .001). Both intraobserver and interobserver variation were less for corrected than for axial measurements (mean intraobserver differences 5.0 ± 3.8 mm vs. 11.8 ± 9.3 mm, p < .001; mean interobserver differences 2.8 ± 2.5 mm versus 10.4 ± 14.0 mm, p < .001) and interobserver variation increased with aneurysm diameter for maximum axial but not corrected measurements. Using corrected rather than axial measurements could have changed treatment decisions in two patients (10%) using a treatment threshold diameter of 55 mm and 10 patients (50%) using a threshold of 65 mm. CONCLUSION: Corrected diameters were smaller than axial diameters, could be measured with higher repeatability, and were subject to less interobserver variability. Using corrected versus axial measurements would have changed management decisions in up to half of the cases in this study.


Subject(s)
Aorta, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortography/methods , Multidetector Computed Tomography , Radiographic Image Interpretation, Computer-Assisted , Analysis of Variance , Aortic Aneurysm, Thoracic/therapy , Humans , Observer Variation , Predictive Value of Tests , Prognosis , Reproducibility of Results
5.
J Cardiovasc Surg (Torino) ; 55(1): 1-7, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24356041

ABSTRACT

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.


Subject(s)
Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Robotics , Software , Surgery, Computer-Assisted , Aortic Diseases/diagnostic imaging , Aortic Diseases/physiopathology , Aortography , Computer Simulation , Hemodynamics , Humans , Imaging, Three-Dimensional , Models, Cardiovascular , Predictive Value of Tests , Radiographic Image Interpretation, Computer-Assisted , Tomography, X-Ray Computed
6.
Eur J Vasc Endovasc Surg ; 45(5): 509-15, 2013 May.
Article in English | MEDLINE | ID: mdl-23465454

ABSTRACT

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.


Subject(s)
Clinical Competence , Endovascular Procedures/education , Videotape Recording , Feasibility Studies , Humans , Pilot Projects
7.
Eur J Vasc Endovasc Surg ; 45(3): 248-54, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23305790

ABSTRACT

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.


Subject(s)
Endovascular Procedures/instrumentation , Medical Errors/prevention & control , Technology Assessment, Biomedical/methods , Vascular Diseases/surgery , Vascular Surgical Procedures/instrumentation , Endovascular Procedures/methods , Humans , Pilot Projects , Treatment Outcome , Vascular Surgical Procedures/methods
8.
J Cardiovasc Surg (Torino) ; 53(6): 747-53, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23207557

ABSTRACT

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.


Subject(s)
Carotid Stenosis/surgery , Endovascular Procedures/instrumentation , Robotics , Stents , Vascular Access Devices , Embolic Protection Devices , Embolism/etiology , Embolism/prevention & control , Endovascular Procedures/adverse effects , Humans , Risk Assessment , Stroke/etiology , Stroke/prevention & control , Vascular Access Devices/adverse effects
9.
Br J Surg ; 99(9): 1304-13, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22864891

ABSTRACT

BACKGROUND: Recent advances in simulation science permit patient-specific rehearsal of endovascular stenting procedures. This study aimed to evaluate how effectively real interventions are replicated by patient-specific rehearsal technology, and to assess its value as a preparatory tool for the interventionalist and the operating team. METHODS: All patients deemed candidates for carotid artery stenting procedures with suitable computed tomography images were enrolled. Each team member rehearsed the virtual procedure in the laboratory, simulated operating theatre or angiography suite environment immediately before treating the real patient. Dexterity and qualitative metrics were recorded. Subjective questionnaires used a Likert scale from 1 (poor) to 5 (excellent). RESULTS: Of 18 patients, three were excluded. In 11 of 15 and 13 of 15 patients respectively endovascular tool use and fluoroscopy angles were identical during rehearsal and the real procedure. In a third of patients, the simulator did not adequately predict difficulties in cannulating the stenotic internal or common carotid arteries. The procedure realism, value in evaluating the case, increase in efficiency in tool use, and potential to increase communication, confidence and team performance were all rated highly (4 of 5). CONCLUSION: Patient-specific rehearsal was rated highly for both face and content validity. Access strategy, endovascular material use and angiographic imaging were all replicated effectively, although certain biomechanical vessel properties seemed to be replicated to a lesser degree. Patient-specific rehearsal constitutes a unique tool that may help tailor endovascular material choice, and optimize the preoperative preparation of the interventionalist and team.


Subject(s)
Carotid Artery, Common/surgery , Carotid Stenosis/surgery , Computer Simulation , Patient Participation , Stents , User-Computer Interface , Aged , Aged, 80 and over , Clinical Competence/standards , Endovascular Procedures , Female , Humans , Interprofessional Relations , Male , Middle Aged , Patient Care Planning , Patient Care Team/standards , Practice, Psychological , Psychomotor Performance , Surveys and Questionnaires
10.
J Cardiovasc Surg (Torino) ; 52(6): 829-39, 2011 Dec.
Article in English | MEDLINE | ID: mdl-22051991

ABSTRACT

Despite many randomised controlled trials there are none that recommend carotid artery stenting (CAS) replaces carotid endarterectomy (CEA) for preventing stroke in patients with atherosclerotic carotid artery stenosis. CAS continues to be attractive due to its minimally-invasive nature and potential benefit in those patients at 'high risk' during open surgery. The belief that CAS will replace CEA is likely misplaced; a complimentary role for each mode of treatment is a more realistic vision for the future. Assessment of the existing data may provide useful information as to the subgroups that have most to benefit from each treatment type, therefore allowing a patient-specific approach to the management of individual lesions. This knowledge, coupled with further advances in the techniques of open and endovascular surgery, will progress the application of CAS and better its results.


Subject(s)
Angioplasty/instrumentation , Carotid Artery Diseases/therapy , Endarterectomy, Carotid , Stents , Angioplasty/adverse effects , Carotid Artery Diseases/surgery , Endarterectomy, Carotid/adverse effects , Evidence-Based Medicine , Humans , Patient Selection , Prosthesis Design , Randomized Controlled Trials as Topic , Registries , Risk Assessment , Risk Factors , Treatment Outcome
11.
Eur J Vasc Endovasc Surg ; 42(3): 340-6, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21628100

ABSTRACT

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.


Subject(s)
Aneurysm/surgery , Renal Artery , Splanchnic Circulation , Adult , Aged , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Female , France , Humans , Male , Middle Aged , Retrospective Studies , United Kingdom
12.
Eur J Vasc Endovasc Surg ; 42(2): 158-66, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21612950

ABSTRACT

OBJECTIVE(S): Patient-specific simulated rehearsal (PsR) is a technological advance within the domain of endovascular virtual reality (VR) simulation. It allows incorporation of patient-specific computed tomography Digital Imaging and Communications in Medicine (CT DICOM) data into the simulation and subsequent rehearsal of real patient cases. This study aimed to evaluate whether a part-task rehearsal (PTr) of a carotid artery stenting procedure (CAS) on a VR simulator is as effective as a full-task (FTr) preoperative run through. METHODS: Medical trainees were trained in the CAS procedure and randomised to a PTr or FTr of a challenging CAS case (Type-II arch). PTr consisted of 30 min of repeated catheterisations of the common carotid artery (CCA). Thereafter, both groups performed the CAS procedure in a fully functional simulated operating suite (SOS) with an interventional team. Technical performances were assessed using simulator-based metrics and expert ratings. Other aspects of performance were assessed using the Non-Technical Skills for Surgeons (NOTSS) scoring. RESULTS: Twenty trainees were evenly randomised to either PTr or FTr. No differences in performance were seen except for the total time the embolic protection device (EPD) was deployed (9.4 min for the PT vs. 8.1 min for the FT, p = 0.02). Total time (26.3 vs. 25.5 min, p = 0.94), fluoroscopy time (15.8 vs. 14.4 min, p = 0.68), number of roadmaps (10.5 vs. 11.0, p = 0.54), amount of contrast (53.5 vs. 58.0 ml, p = 0.33), time to deploy the EPD (0.9 vs. 0.8 min, p = 0.31) and time to catheterise the CCA (9.2 vs. 8.9 min, p = 0.94) were similar. Qualitative performances as measured by expert ratings (score 24 vs. 24, p = 0.49) and NOTSS (p > 0.05 for all categories) were also comparable. CONCLUSIONS: Part- and full-task rehearsals are equally effective with respect to the operative performance of a simulated CAS intervention. This finding makes a patient-specific rehearsal more efficient and may increase the feasibility of implementation of this technology into medical practice.


Subject(s)
Angioplasty/education , Angioplasty/instrumentation , Carotid Stenosis/therapy , Computer Simulation , Computer-Assisted Instruction , Education, Medical, Graduate/methods , Models, Cardiovascular , Stents , Adult , Aged , Carotid Stenosis/diagnostic imaging , Clinical Competence , Embolic Protection Devices , Europe , Female , Humans , Imaging, Three-Dimensional , Learning Curve , Male , Motor Skills , Program Evaluation , Self-Assessment , Severity of Illness Index , Task Performance and Analysis , Time Factors , Tomography, X-Ray Computed , Video Recording
13.
J Cardiovasc Surg (Torino) ; 52(3): 353-62, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21577190

ABSTRACT

In recent years, steerable catheter systems have been introduced into clinical practice for cardiac mapping and ablation procedures. As endovascular therapy is becoming more complex, more advanced and versatile catheter designs utilizing robotic technology may have a role in aortic and peripheral arterial interventions. This article discusses alternative steerable catheter designs focusing on robotic endovascular catheter technology. A comprehensive comparison, review and analysis of robotic versus manual techniques in the visceral segment are presented to reveal both their advantages and limitations. Preclinical studies and early experience suggest that robotically steerable endovascular catheters offer improved manoeuvrability at the catheter tip, enhanced positional control and "off-the-wall" centreline navigation in a remote-control fashion. These advanced systems have the potential to overcome some of the technical difficulties with manual catheter control, improve stability at key target areas, reduce the risk of vessel trauma, distal embolization and radiation exposure, whilst improving overall operator performance with short learning curves. Robotic catheter technology may be more suitable to complex and often unpredictable anatomy in the visceral segment and may offer a reliable platform for future applications involving device delivery or target intervention. This intuitive technology is rapidly evolving and still requires technological refinements to extend current capabilities. Clinical studies involving head-to-head comparisons with conventional techniques are essential for evaluating its long-term safety and efficacy.


Subject(s)
Aorta , Catheterization, Peripheral/instrumentation , Catheters , Endovascular Procedures/instrumentation , Robotics , Therapy, Computer-Assisted/instrumentation , Viscera/blood supply , Arteries , Catheterization, Peripheral/adverse effects , Catheters/adverse effects , Endovascular Procedures/adverse effects , Equipment Design , Humans , Radiography, Interventional/instrumentation , Risk Assessment , Risk Factors
14.
Eur J Vasc Endovasc Surg ; 42(4): 531-8, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21388839

ABSTRACT

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.


Subject(s)
Catheterization , Endovascular Procedures/education , Learning Curve , Robotics , Catheters , Computer Simulation , Equipment Design , Humans
15.
Eur J Vasc Endovasc Surg ; 41(4): 492-500, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21276738

ABSTRACT

OBJECTIVE: The ability to perform patient-specific simulated rehearsal of complex endovascular interventions is a technological advance with potential benefits to patient outcomes. This study aimed to evaluate whether patient-specific rehearsal of a carotid artery stenting (CAS) procedure has an influence on tool selection and the use of fluoroscopy. METHODS: Following case note and computed tomography (CT) angiographic review of a real patient case, subjects performed the CAS procedure on a virtual reality simulator. Endovascular tool requirements and fluoroscopic angles were evaluated with a pre- and post-case questionnaire. Participants also rated the simulation from 1 (poor) to 5 (excellent). RESULTS: Thirty-three endovascular physicians with varying degrees of CAS experience were recruited: inexperienced (5-20 CAS procedures) n = 11, moderately (21-50 CAS procedures) n = 7 or highly experienced (>50 CAS procedures) n = 15. For all participants, 96 of a possible 363 changes (26%) were observed from pre- to post-case questionnaires. This was most notable for optimal fluoroscopy C-arm position 15/33 (46%), choice of selective catheter 13/33 (39%), choice of sheath or guiding catheter 11/33 (33%) and balloon dilatation strategy 10/33 (30%). Experience with the CAS procedure did not influence the degree of change significantly (p > 0.05), and all groups exhibited a considerable modification in tool and fluoroscopy preference. The model was considered realistic and useful as a tool to practice a real case (median score 4/5). CONCLUSION: Patient-specific simulated rehearsal of a complex endovascular procedure strongly influences tool selection and fluoroscopy preferences for the real case. Further research has to evaluate how this technology may transfer from in vitro to in vivo and if it can reduce the radiation dose and the number of endovascular tools used and improve outcomes for patients in the clinical setting.


Subject(s)
Angioplasty, Balloon/instrumentation , Carotid Stenosis/therapy , Clinical Competence , Computer Simulation , Models, Cardiovascular , Radiography, Interventional , Stents , Therapy, Computer-Assisted , Adult , Aged , Carotid Stenosis/diagnostic imaging , Catheters , Equipment Design , Fluoroscopy , Humans , Imaging, Three-Dimensional , Male , Medical Records , Middle Aged , Radiographic Image Interpretation, Computer-Assisted , Radiography, Interventional/instrumentation , Severity of Illness Index , Surveys and Questionnaires , Task Performance and Analysis , Tomography, X-Ray Computed , User-Computer Interface
16.
Eur J Vasc Endovasc Surg ; 41(6): 795-802, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21320788

ABSTRACT

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.


Subject(s)
Aortic Aneurysm/surgery , Carotid Artery Diseases/surgery , Medical Errors/statistics & numerical data , Peripheral Arterial Disease/surgery , Quality Improvement , Vascular Surgical Procedures/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Equipment Failure/statistics & numerical data , Humans , Medical Errors/prevention & control , Middle Aged , Prospective Studies , Treatment Failure , Young Adult
17.
Eur J Vasc Endovasc Surg ; 41(4): 488-91, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21232994

ABSTRACT

This report describes endovascular stenting of an acute mycotic ascending aortic aneurysm. An eighty-three year old lady presented nine weeks after aortic valve surgery and subsequent thyroidectomy with sternal pain secondary to a mycotic ascending aortic pseudoaneurysm. The pseudoaneurysm was visible through the unhealed sternum. Open repair was considered too high a mortality risk. Endovascular stenting was performed using two covered infrarenal proximal extension devices (GORE Excluder Aortic Extender(®), W. L. Gore & Associates, Flagstaff, Arizona, USA) deployed from a right axillary approach utilising overdrive cardiac pacing. Post procedure imaging revealed shrinkage of the pseudoaneurysm sac.


Subject(s)
Aneurysm, False/surgery , Aneurysm, Infected/surgery , Aortic Aneurysm/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Acute Disease , Aged, 80 and over , Aneurysm, False/diagnostic imaging , Aneurysm, False/microbiology , Aneurysm, Infected/diagnostic imaging , Aneurysm, Infected/microbiology , Angiography, Digital Subtraction , Anti-Bacterial Agents/therapeutic use , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/microbiology , Aortic Valve/surgery , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Cardiac Pacing, Artificial , Endovascular Procedures/instrumentation , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Prosthesis Design , Staphylococcus aureus/isolation & purification , Stents , Tomography, X-Ray Computed , Treatment Outcome
18.
J Cardiovasc Surg (Torino) ; 52(1): 17-37, 2011 Feb.
Article in English | MEDLINE | ID: mdl-21224807

ABSTRACT

Reduced training times, increasing complexity of endovascular and open vascular interventions and concerns for patient's safety have necessitated a modernisation in surgical training. A more strategic approach is required to facilitate the acquisition of surgical skills outside the operating room and to minimize the risks to patients as surgeons develop their technical expertise. Virtual reality simulation has been proposed as a means to train and objectively assess technical endovascular performance without risks to patient safety. This article reviews the evidence and the limitations for this adjunctive tool, the implementation in current training programmes and future applications to maintain the highest standards of care for treatment of vascular disease.


Subject(s)
Computer Simulation , Computer-Assisted Instruction , Education, Medical, Graduate/methods , Endovascular Procedures/education , Internship and Residency , Operating Rooms , Vascular Surgical Procedures/education , Clinical Competence , Computer Graphics , Curriculum , Humans , Models, Cardiovascular , Models, Educational
20.
Eur J Vasc Endovasc Surg ; 41(2): 175-85, 2011 Feb.
Article in English | MEDLINE | ID: mdl-21130007

ABSTRACT

OBJECTIVE: To determine the proportion of TAAAs which might be suitable for pure endovascular repair based on aneurysm morphology and to develop an MDCTA based scoring system to grade case complexity. DESIGN: 70 consecutive MDCTA of patients with TAAAs were analysed in relation to specific morphological characteristics. METHODS: The characteristics included potential stent landing zone lengths, arch angulation, thoraco-abdominal aorta angulation, branch vessel origin stenosis, access tortuosity/diameter and aortic dissection. RESULTS: 60% of TAAAs would be suitable for branched/fenestrated stent grafting but 40% are unsuitable due to adverse anatomy. 27% had an aortic arch angulation of ≤ 110° and 24% had descending thoracic aorta angulation of ≤ 90°. Significant ostial stenosis was identified in 31% of celiac arteries, 7% superior mesenteric arteries, 24% left renal artery and 19% right renal arteries. 11% of left common iliac and 7% right common iliac arteries had angulation of ≤ 70°. There were 26 cases with aortic dissection and 54% of these had a true lumen of ≤ 26 mm. CONCLUSION: Successful fenestrated/branched stent graft repair of TAAAs requires adequate landing zones, cannulation of visceral arteries and suitable diameter access vessels. 60% of TAAAs studied were suitable for branched/fenestrated stent graft repair but 40% of TAAAs were unsuitable; aortic angulation, visceral vessel ostial stenosis and dissection true lumen diameter were the principle issues. Development in stent technology may address these anatomical challenges.


Subject(s)
Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortography/methods , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Decision Support Techniques , Endovascular Procedures/instrumentation , Stents , Tomography, X-Ray Computed , Adult , Aged , Aged, 80 and over , Female , Humans , Iliac Artery/diagnostic imaging , London , Male , Middle Aged , Patient Selection , Predictive Value of Tests , Prosthesis Design , Retrospective Studies
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