Multicentre observational study of surgical system failures in aortic procedures and their effect on patient outcomes.

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.

Treatment decisions for descending thoracic aneurysm: preferences for thoracic endovascular aneurysm repair or surveillance in a discrete choice experiment.

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.

Variation in maximum diameter measurements of descending thoracic aortic aneurysms using unformatted planes versus images corrected to aortic centerline.

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.

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.

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.

The suitability of thoraco-abdominal aortic aneurysms for branched or fenestrated stent grafts--and the development of a new scoring method to aid case assessment.

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.

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.

Endovascular repair of an acute, mycotic, ascending aortic pseudoaneurysm.

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.

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.

Patient-specific endovascular simulation influences interventionalists performing carotid artery stenting procedures.

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.

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.

Robotically-steerable catheters and their role in the visceral aortic segment.

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.

Training with simulation versus operative room attendance.

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.

Hybrid repair of the aortic arch in patients with extensive aortic disease.

OBJECTIVE: To evaluate the outcome of hybrid treatment of the aortic arch with supra-aortic debranching and endovascular stent-graft repair in a selected group of patients with complex disease. DESIGN: Case series study with retrospective analysis of prospectively collected non-randomised data. METHODS: Patients with hybrid repair of complex arch disease at a single centre over a 6-year period were enrolled in the study. Only patients with extensive arch pathologies requiring debranching of at least the left carotid artery were considered. Patients were divided into those who underwent complete and partial supra-aortic revascularisation. The χ2 test was used to evaluate differences in outcomes. Logistic regression analyses were applied to identify predictors of poor outcome. RESULTS: A total of 33 patients were included in the study. Complete and partial arch repair was performed in nine and 24 patients, respectively. The aortic disease extended to the thoracic and abdominal aorta in 39% and 52% of the patients, respectively. One-third of the patients (30%) were treated on an urgent/emergency basis. Elective 30-day mortality and morbidity rates were 13% and 35%, respectively. Early mortality was significantly higher in the complete arch repair group (p=0.046). Pre-existing renal impairment was identified as a poor prognostic factor. All extra-anatomic bypasses remained patent and no aortic disease-related deaths occurred during a mean follow-up period of 23 months (range, 1.5-58 months). Complete arch repair was associated with an increased incidence of late endoleak (p=0.018). CONCLUSIONS: Hybrid treatment of the aortic arch provides a feasible alternative treatment in patients who are high risk for conventional open surgical repair. Careful selection of patients is required to achieve satisfactory results.

Recent advances in thoraco-abdominal aortic aneurysm repair.

Thoraco-abdominal aortic aneurysm repair remains a formidable challenge to vascular surgeons. The traditional repair of thoraco-laparotomy with aortic cross-clamping is associated with a high morbidity and mortality despite significant advances in perioperative critical care, anaesthetic and surgical techniques. The advent of the endovascular revolution has shown a marked paradigm in the approach to all aneurysm repairs. As a logical progression from the open repair, the St Mary's visceral hybrid repair combines traditional open techniques (retrograde visceral and renal revascularisation via mid-line laparotomy) with endovascular stent grafting, thereby avoiding the need for thoracotomy and aortic cross-clamping. In specialist centres, the results have been encouraging and easily comparable to the open repair. The technique has been used in several centres around the world and represents a robust, transferrable method of repairing thoraco-abdominal aortic aneurysms. Stent-grafting technologies have reached a point of sophistication that wholly endovascular methods of repairing thoraco-abdominal aortic aneurysms are being performed in several centres around the world. Although these stent grafts have to be customised to the individual patient and are only suitable for certain types of aneurysmal anatomies, they represent the future of thoraco-abdominal aortic aneurysm repair. We review the history of thoraco-abdominal aortic aneurysm repair, the exciting advances in their treatment and discuss our approach to the management of thoraco-abdominal aortic aneurysms in the 21st century.

Concurrent colorectal malignancy and abdominal aortic aneurysm: a multicentre experience and review of the literature.

OBJECTIVES: There is lack of consensus regarding concurrent vs. staged approaches, and the prioritisation of staged procedures in cases presenting with colorectal carcinoma (CRC) and abdominal aortic aneurysm (AAA) synchronously. We aim to present our experience, review the literature on this therapeutic dilemma and examine the role of endovascular aortic repair (EVAR). DESIGN, MATERIALS AND METHODS: An observational study of the experience of two centres and a systematic review of the published literature. RESULTS: Twenty-four patients were identified from the prospective databases of two tertiary referral centres between 2001 and 2006. Intervention for both malignancy and aneurysm was performed in 13 patients. In 10 patients, cancer resection was performed initially and was followed by open aneurysm repair (n=3) or EVAR (n=7). Two patients (AAA diameters: 7.0 and 8.0cm) underwent EVAR prior to colonic resection. One patient was selected for synchronous surgery. There were no interval AAA ruptures, graft infection or postoperative mortalities. Literature review identified 269 such cases; of these 101 were treated by combined surgery. In staged surgery, there were nine interval aneurysmal ruptures and one aortic graft infection. CONCLUSIONS: In our experience, staged management can be undertaken, without interval aneurysmal rupture. EVAR has an evolving role in preventing delay in CRC management, in high-risk patients, and during combined intervention.

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.

The visceral hybrid repair of thoraco-abdominal aortic aneurysms--a collaborative approach.

OBJECTIVE: To report the collaborative data of 3 major European Vascular Units using the 'visceral hybrid' procedure for thoraco-abdominal aortic aneurysms and dissections. METHODS: A consecutive series of 107 urgent and elective high-risk patients were included in a prospectively collected database. RESULTS: All stents involved the entire thoracic and abdominal aorta with left subclavian coverage in 19 and revascularisation in 12. The distal landing zone was in the infra-renal aorta in 75% and in the iliac artery in 25%. The 30-day mortality rate was 16/107 (14.95%). 13/107 (12.1%) of the patients suffered spinal cord ischaemia which was complete and permanent in 9/12 (8.4%). 4 patients (3.7%) required long term dialysis and a segment of gut infarction requiring resection occurred in 3 (2.8%). Most patients had visceral bypass grafting and aortic stent-grafting performed in one stage. In 18 patients the stenting was performed later. Three of these patients ruptured before the stenting procedure was undertaken. CONCLUSION: These early results of visceral hybrid repair for high-risk patients with complex thoraco-abdominal aortic aneurysms are encouraging, in a group of patients in whom fenestrated/branched stent-grafting is not an option and open surgery hazardous.

The Immediate Management of the Patient with Rupture: Open Versus Endovascular repair (IMPROVE) aneurysm trial--ISRCTN 48334791 IMPROVE trialists.

BACKGROUND: Systematic reviews have suggested a survival advantage for patients with ruptured abdominal aortic aneurysm (AAA), who are managed by endovascular repair. These reviews are based on single centre experiences of selected patients. OBJECTIVE: To determine whether a policy of endovascular repair improves the survival of all patients with ruptured AAA. METHODS: A randomized controlled trial, IMPROVE (ISRCTN 48334791) will randomize patients with a clinical diagnosis of rAAA, made in hospital, either to immediate CT scan and endovascular repair whenever anatomically suitable (endovascular first), or to open repair, with CT scan being optional (normal care), The trial is set on a background of guidelines for emergency care, CT scanning and anaesthesia, which incorporate the protocol of permissive hypotension. Recruitment started in October 2009 and 600 patients are required to show a 14% survival benefit at 30 days (primary outcome) for the endovascular first policy. Recruitment will be from the UK and Europe. Secondary outcomes include 24h, in-hospital and 1 year survival, complications, major morbidities, costs and quality of life. DISCUSSION: This is a "real life" trial that will answer the fundamental relevant clinical dilemma, namely, do patients who present with ruptured AAA derive benefit from treatment in a system, which offers a preferential strategy of endovascular repair? The trial addresses whether the anticipated reduced mortality and morbidity associated with endovascular repair is offset by the relatively greater ease of access and speed to conventional surgery. This issue is pivotal to future patient care and provision of services.

Recombinant activated factor VII: a solution to refractory haemorrhage in vascular surgery?

OBJECTIVES: Post-operative haemorrhage is a recognised complication and independent predictor of outcome in complex vascular surgery. The off-license administration of activated Recombinant Factor VII (rFVIIa) to treat haemorrhage in other surgical settings has been investigated, but concerns over potential adverse events have limited its use in vascular surgery. This article reports rFVIIa's method of action and systematically reviews rFVIIa's role in complex vascular surgery. METHODS: A systematic literature search identified articles reporting on rFVIIa administration within vascular surgery patients. Patient-specific data regarding transfusion requirements was extracted and pooled statistical analysis performed. RESULTS: 15 articles reporting 43 patients were identified. RFVIIa has been administered in open and endovascular procedures and in both elective and emergency settings. Major aortic surgery accounted for 75% of cases. The range of rFVIIa administered as a cumulative dose was large, as was the variation in initial dose. Transfusion data from 9 patients was pooled and analysed. Significant differences were found between pre- and post- rFVIIa for packed red cell transfusions (mean 29.2 vs. 8.2, p=0.015). Intra-arterial thrombosis was reported in 3 cases. CONCLUSIONS: RFVIIa may reduce haemorrhage in selected vascular surgical patients. Randomized controlled trials are justified to definitively investigate its role within this setting.