Immediate and 1-year success rate of type 2 endoleak treatment using three-dimensional image fusion guidance.

PURPOSE: To retrospectively assess immediate and 1-year success rate of type 2 endoleak (T2E) treatment with ethylene-vinyl-alcohol-polymer using three-dimensional (3D) image fusion guidance with cone beam computed tomography via trans-arterial embolization (TAE) or direct percutaneous sac injection (DPSI). MATERIALS AND METHODS: A total of 37 patients with T2E who were treated either using TAE (34/37; 92%) or DPSI (9/37; 8%) were included. There were 34 men and 3 women with a mean age of 86±9 (SD) years (range: 67-104years). Mean aneurysm diameter was 67±14 (SD) mm (range: 42-101mm) at pre-procedure evaluation. Immediate success was complete embolization of the sac and feeding artery. 1-year success was reduction or stability of the aneurysmal sac diameter based on pre-procedure and 12-month follow-up examinations. Safety (treatment-related complications), patient demographics, duration of procedure and contrast volume were reported. RESULTS: Immediate and 1-year successful outcomes were reported in 94% (n=32) and 88% (n=28) of patients after TAE and 100% (n=9) and 89% (n=8) after DPSI. T2E treatments were immediately successful for 95% of the procedures (41/43) and for 88% (36/41) at 1year. Overall, T2E treatment was effective in 33 patients (89%). No major complications occurred. Mean procedure time and contrast volume were significantly different between the 2 techniques with respectively 87±16 (SD) min (range: 65-120min) and 75±26 (SD) mL (range: 40-130mL) for TAE and 32±10 (SD) min (range: 20-50min) (P<0.01) and 6±6 (SD) mL (range: 2-22mL) (P<0.01) for DPSI. Mean aneurysm diameter at 1-year was 68±17 (SD) mm (range: 43-101mm). No significant differences in the pre-procedure sac diameter were found at long-term follow-up between patients without T2E and those with persistent T2E (P=0.1) in the successful embolization group (n=33). CONCLUSION: TAE or DPSI treatments of T2E with ethylene-vinyl-alcohol-polymer using 3D-image fusion guidance were immediately successful for 95% of the procedures and remained effective for 88%. Longer follow-up is necessary to assess sac stability in the case of persistent endoleak.

Predictive Numerical Simulations of Double Branch Stent-Graft Deployment in an Aortic Arch Aneurysm.

Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, our aim is to develop a computational tool able to predict SG deployment in such highly complex situations. A patient-specific case is performed with complete deployment of the DB and its bridging stents in an aneurysmal aortic arch. Deviations of our simulation predictions from actual stent positions are estimated based on post-operative scan and a sensitivity analysis is performed to assess the effects of material parameters. Results show a very good agreement between simulations and post-operative scan, with especially a torsion effect, which is successfully reproduced by our simulation. Relative diameter, transverse and longitudinal deviations are of 3.2 ± 4.0%, 2.6 ± 2.9 mm and 5.2 ± 3.5 mm respectively. Our numerical simulations show their ability to successfully predict the DB deployment in complex anatomy. The results emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

Early Results of Physician Modified Fenestrated Stent Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms.

OBJECTIVES: The aim was to determine whether physician modified stent grafts (PMSGs) are safe and effective for the treatment of high risk patients with thoraco-abdominal aortic aneurysms (TAAAs). DESIGN: This was a retrospective single institution study. MATERIAL: Consecutive patients with TAAA undergoing endovascular repair using a PMSG between January 2012 and June 2014 were evaluated. METHODS: Fenestrations to preserve branch vessels were created in TX2 thoracic (Cook Medical) stent grafts. Pre- intra- and post-operative data were recorded by means of a prospectively maintained database. RESULTS: Eleven high risk patients with TAAA (type I, n = 4; type III, n = 3; type IV, n = 3; type V, n = 1) underwent fenestrated endovascular repair using PMSGs. Indications were painful aneurysm (n = 5), >70 mm rapidly enlarging aneurysm (n = 4), saccular aneurysm (n = 1), and visceral patch false aneurysm after open repair of a type IV TAAA (n = 1). In four asymptomatic patients, an additional fenestration was created for temporary selective sac perfusion and occluded 2-4 weeks later. Median duration for stent graft modifications was 2 hours (range 1-3 hours). The median number of fenestrations was three (range 2-4). One patient died during the post-operative period from colonic ischemia, giving a 9% in hospital mortality rate. Four (36%) patients presented with moderate to severe complications. One (9%) patient presented with a paraparesis that resolved completely after spinal fluid drainage. Among surviving patients, four required early endovascular re-intervention for type III endoleak (n = 2), type Ia endoleak (n = 1), or target vessel cannulation failure (n = 1). The median follow up time was 6 months (range 3-20 months). During follow up, no other complications occurred and all target vessels remained patent. One patient presented with a persistent type II endoleak. CONCLUSION: PMSGs provided acceptable short-term results and may be a management option for the treatment of TAAA in selected high risk patients. Durability concerns need to be assessed in additional studies with long-term follow up.

Inferior Mesenteric Artery Stenting as a Novel Treatment for Chronic Mesenteric Ischemia in Patients with an Occluded Superior Mesenteric Artery and Celiac Trunk.

INTRODUCTION: Chronic mesenteric ischemia (CMI) is a challenging problem, with revascularization the mainstay of treatment. Management of CMI is especially challenging in the patient with superior mesenteric artery (SMA) and celiac artery (CA) occlusions. REPORT: We report a case series of four patients with chronic mesenteric ischemia who were not candidates for CA or SMA revascularization who were successfully treated with inferior mesenteric artery (IMA) angioplasty and stent placement to improve collateral circulation and palliate symptoms. DISCUSSION: To our knowledge, this is the largest case series to date reporting the use of an IMA stent to improve collateral circulation in patients with CMI.

In situ reconstruction in native and prosthetic aortic infections using cryopreserved arterial allografts.

OBJECTIVES: To evaluate overall survival and complications of cryopreserved arterial allografts in aortic graft infections and infected aortic aneurysms. METHODS: A retrospective review of consecutive patients was conducted with native or prosthetic aortic infections, who underwent local debridement and in situ implantation of a cryopreserved aortic allograft from September 2004 to June 2012 at the Henri Mondor University Hospital. Patient characteristics, indications for allograft implantation, perioperative events, bacteriological data, and events related to follow-up were identified. The primary outcome was overall survival. Overall survival was estimated using the Kaplan-Meier method. Predictors of postoperative mortality were identified using uni- and multivariate analysis with a Cox proportional hazard regression. RESULTS: During the study period, 54 patients (45 [83%] men, mean age 66.2 ± 10.2 years) underwent aortic reconstruction using cryopreserved allografts. Indications were native aortic infection in 17 patients and prosthetic graft infection in 37 patients, including seven aortoenteric fistulae. Twelve aortic reconstructions (22%) were performed as emergency procedures. The median duration of follow-up was 12.1 months (range 0.4-83.6). The 30-day mortality rate was 28%. The overall mortality rate was 39% at a median follow-up of 12.1 months. Early significant postoperative complications occurred in 52% of patients. The graft-related mortality rate was 7%. The graft-related complication rate was 19%. During follow-up, there were two recurrences of aortic infection and two recurrences of allograft limb occlusion. Multivariate survival analysis identified age, chronic renal disease, prosthetic infection, emergent procedure, and coronary disease as independent predictors for postoperative mortality. CONCLUSION: This experience with cryopreserved aortic allografts in aortic reconstructions shows an unsatisfactory 30-day survival rate, as well as a substantial early graft-related complication rate. Longer follow-up is needed in order to support the preferential use of cryopreserved allografts based on their long-term behavior.

Evaluation of an electromagnetic 3D navigation system to facilitate endovascular tasks: a feasibility study.

INTRODUCTION: We describe a novel approach to arterial cannulation using the StealthStation(®) Guidance System (Medtronic, USA). This uses electromagnetic technology to track the guidewire, displaying a 3D image of the vessel and guidewire. METHODS: The study was performed on a 'bench top' simulation model called the Cannulation Suite comprising of a silicone aortic arch model and simulated fluoroscopy. The accuracy of the StealthStation(®) was assessed. 16 participants of varying experience in performing endovascular procedures (novices: 6 participants, ≤5 procedures performed; intermediate: 5 participants, 6-50 procedures performed; experts: 5 participants, >50 procedures performed) underwent a standardised training session in cannulating the left subclavian artery on the model with the conventional method (i.e. with fluoroscopy) and with the StealthStation(®). Each participant was then assessed on cannulating the left subclavian artery using the conventional method and with the StealthStation(®). Performance was video-recorded. The subjects then completed a structured questionnaire assessing the StealthStation(®). RESULTS: The StealthStation(®) was accurate to less than 1 mm [mean (SD) target registration error 0.56 mm (0.91)]. Every participant was able to complete the cannulation task with a significantly lower use of fluoroscopy with the navigation system compared with the conventional method [median 0 s (IQR 0-2) vs median 14 s (IQR 10-19), respectively; p = <0.001]. There was no significant difference between the StealthStation(®) and conventional method for: total procedure time [median 17 s (IQR 9-53) vs median 21 s (IQR 11-32), respectively; p=0.53]; total guidewire hits to the vessel wall [median 0 (IQR 0-1) vs median 0 (IQR 0-1), respectively; p=0.86]; catheter hits to the vessel wall [median 0.5 (IQR 0-2) vs median 0.5 (IQR 0-1), respectively; p=0.13]; and cannulation performance on the global rating scale [median score, 39/40 (IQR 28-39) vs 38/40 (IQR 33-40), respectively; p=0.40]. The intra-class correlation coefficient for agreement between video-assessors for all scores was 0.99. 88% strongly agreed that the StealthStation(®) can potentially decrease exposure of the patient to contrast and radiation. CONCLUSION: Arterial cannulation is feasible with the StealthStation(®).

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.

Efficient implementation of patient-specific simulated rehearsal for the carotid artery stenting procedure: part-task rehearsal.

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.

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.

Fenestrated endovascular grafting: the French multicentre experience.

PURPOSE: This study aims to evaluate the medium-term outcomes following aortic aneurysm repair using fenestrated endografts performed in 16 French academic centres. MATERIALS AND METHODS: A retrospective analysis of prospectively collected data was carried out. This study included all patients treated with fenestrated endografts in France between May 2004 and January 2009. Patients were judged to be at high risk for open surgical repair. Fenestrated endografts were designed using computed tomography (CT) reconstructions performed on three-dimensional (3D) workstations. All patients were evaluated with CT, duplex ultrasound and plain film radiograph at discharge, 6, 12, 18 and 24 months, and annually thereafter. RESULTS: A total of 134 patients (129 males) were treated over the study period. Median age and aneurysm size were 73 years (range 48-91 years) and 56 mm (range 45-91 mm), respectively. A total of 403 visceral vessels were perfused through a fabric fenestration, including 265 renal arteries. One early conversion to open surgery was required. Completion angiography and discharge CT scan showed that 398/403 (99%) and 389/394 (99%) respective target vessels were patent. The 30-day mortality rate was 2% (3/134). Pre-discharge imaging identified 16 (12%) endoleaks: three type I, 12 type II and one type III. After the procedure, transient or permanent dialysis was required in four (3%) and two (1%) patients, respectively. The median duration of follow-up was 15 months (range 2-53 months). No aneurysms ruptured or required open conversion during the follow-up period. Twelve of 131 patients (9%) died during follow-up (actuarial survival at 12 and 24 months: 93% and 86%, respectively). Median time from procedure to death was 15 months. None of these deaths were aneurysm related. Aneurysm sac size decreased by more than 5 mm in 52%, 65.6% and 75% of patients at 1, 2 and 3 years, respectively. Three (4%) patients had sac enlargement within the first year, associated with a persistent endoleak. During follow-up, four renal artery occlusions were detected. A total of 12 procedure-related re-interventions were performed in 12 patients during follow-up, including six to correct endoleaks, and five to correct threatened visceral vessels. CONCLUSIONS: The use of endovascular prostheses with graft material incorporating the visceral arteries is safe and effective in preventing rupture in the medium term. A predictable high mortality rate was depicted during follow-up in this high-risk cohort. Meticulous follow-up to assess sac behaviour and visceral ostia is critical to ensure optimal results.

New insight in aetiopathogenesis of aortic diseases.

BACKGROUND: Knowledge in the aetiopathogeny of aortic disease helps to characterise aortic lesions better and determine the risk of evolution and therapeutic strategies as well. This article focusses on aneurysms and dissections, and excludes causes related to infection, systemic inflammatory diseases and trauma. METHODS AND RESULTS: The biomedical literature of the past 10 years has been reviewed here. Aortic diseases are heterogeneous along the aorta as far as their genetic determinants, contribution of smooth muscle cells, inflammation and thrombus formation are concerned. Degradation of extracellular matrix by proteases causing aortic disease is a 'terminal' event, modulated by genetic background, haemodynamic strain, cellular events and thrombus formation. New genetic determinants of aortic disease have been identified. Proteases degrading the aortic wall are derived from a variety of cell types in addition to macrophages, including neutrophils on the luminal thrombus, mesenchymal and endothelial cells in the wall. Smooth muscle cells contribute to aortic wall homeostasis against inflammation and proteolysis. The degradation of the wall is followed by, or paralleled with, a failure of aortic reconstruction. CONCLUSIONS: Aortic diseases are diverse, and involve a multiplicity of biological systems in the vascular wall and at the interface with blood. Future research needs to unravel distinct cellular and molecular mechanisms causing the clinical events, in particular, dissection, expansion of already formed aneurysms and rupture.

Limb graft occlusion following EVAR: clinical pattern, outcomes and predictive factors of occurrence.

INTRODUCTION: We reviewed our experience with limb occlusion after EVAR in order (1) to assess the clinical pattern and treatment options (2) to assess outcomes and (3) to identify predictive factors of occurrence. MATERIALS AND METHOD: Between 1995 and 2005, 460 AAA patients were electively treated with a variety of commercially available stent grafts. There were 369 bifurcated and 91 aortouniiliac grafts (829 limbs). Follow-up included physical examination, plain X-ray, Duplex ultrasonography, and spiral computed tomographic scans at 1, 6, 12 months and annually thereafter. All pertinent data were collected prospectively and analysed retrospectively. The follow-up period ranged from Day 0 to 104 months, with a median follow-up of 23.4 months. RESULTS: 36 limbs in 33 patients (7.2%) occluded between Day 0 and 71 months (average: 9.5 months) after EVAR. Presentation was acute ischemia in 11 cases, rest pain in 9, claudication in ten. Four occlusions remained asymptomatic and two occurred intraoperatively. Treatment was femoro-femoral cross-over graft in 19 cases, axillo-femoral bypass in three, thrombectomy and stent in three, thrombolysis and stent in nine, and conservative in two. One patient (3%) died of multiple organ failure after thrombolysis. There was no amputation. Reocclusions occurred in two patients (6.1%). Multivariate logistic regression showed that kinking (odds ratio [OR] 11.9; confidence interval [CI] 3.39-42.1; p=0.0001), first graft generation (OR 2.87; CI 1.25-6.62; p=0.017) and younger age (OR 1.05; CI 1.00-1.09; p=0.034) were independently related to the occurrence of graft limb occlusion. CONCLUSION: Acute graft limb occlusion is not rare after EVAR. The frequency of limb occlusion has declined with current stent grafts generation. Although surgery and endovascular treatments are efficient and safe, development of a graft limb kink should lead to aggressive pre-emptive treatment to prevent occlusion.