Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation.

OBJECTIVE: The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019. METHODS: Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery. RESULTS: Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan-Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001). CONCLUSION: For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240).

Erectile Dysfunction Resistant to Medical Treatment Caused by Cavernovenous Leakage: An Innovative Surgical Approach Combining Pre-operative Work Up, Embolisation, and Open Surgery.

OBJECTIVE: Thirty per cent of cases of erectile dysfunction (ED)/male impotence are resistant to oral treatment. Half of these cases are due to blood drainage from the corpora cavernosa occurring too soon, due to cavernovenous leakage (CVL). The aim of this study was to report on an innovative treatment scheme combining pre- and post-operative haemodynamic assessment, venous embolisation, and open surgery for drug resistant ED caused by CVL. METHODS: An analysis of prospectively collected data, with clinical and haemodynamic pre- and post-operative assessment, was carried out. Forty-five consecutive patients operated on for drug resistant ED caused by CVL were evaluated pre-operatively and three months post-operatively by pharmacologically challenged penile duplex sonography (PC-PDS), pharmacologically challenged Erection Hardness Score (PC-EHS), and pharmacologically challenged computed caverno tomography (PC-CCT). Follow up consisted of patient interview, PC-PDS, PC-EHS and if needed PC-CCT. RESULTS: Mean patient age was 43.9 ± 12.0 years (range 20-67). Forty-nine per cent of patients had primary ED. Patients with diabetes, a smoking habit, hypercholesterolaemia, and hypertension were 18%, 11%, 9%, and 4%, respectively. Three months post-operatively, PC-EHS increased from 2.0 ± 0.7 to 3.1 ± 0.74 (p < .001), with an EHS of 3 being the threshold allowing for penetration. Deep dorsal vein velocity, a haemodynamic marker of CVL, decreased from 14.2 ± 13.0 to 0.9 ± 3.5 cm/s (p < .001). After a 14.0 ± 10.7 month follow up, the primary success rate (clinical EHS ≥ 3, possible sexual intercourse with penetration, no vascular re-operation, no penile prosthesis implant) was 73.3%. Four patients (9%) underwent successful re-operation for persistent ED and CVL. Accordingly, compared with a possible penetration rate of 8.9% before surgery, 37 patients (secondary success rate: 82.2%) were able to achieve sexual intercourse with penetration. Type of ED (primary vs. secondary) and diabetes had no influence on the results. Thirty-two per cent of patients with secondary success achieved penetration with no medication. CONCLUSIONS: After a 14 month follow up, pre-operative work up, embolisation, and open surgery during the same procedure allowed patients with ED resistant to oral medical to achieve intercourse with penetration.

The Common Femoral Artery Bifurcation Lesions: Clinical Outcome of Simple Versus Complex Stenting Techniques - An Analysis Based on the TECCO Trial.

BACKGROUND: Common femoral artery (CFA) stenting appears as a promising alternative treatment to the open surgery for de novo CFA stenosis. The stenting of lesions just located at the CFA is simple, whereas stenting of CFA bifurcation lesions is more complex, and outcomes are still matter of debate. The aim of this study was to describe and to compare clinical outcomes of techniques used to treat simple over complex lesions for the stenting of CFA lesions. MATERIALS/METHODS: From the French randomized controlled trial, TECCO, a total of 54 patients underwent stenting intervention and were enrolled in this study. Patients were excluded if they had CFA thrombosis, restenosis, and nonatheromatous lesions. Patients were classified by simple and complex lesions based on the type of lesion. The primary end point was the primary sustained clinical improvement. RESULTS: Eighteen patients were included in the simple lesion group, and 36 patients, in the complex lesion group. Baseline characteristics of patients were comparable between the 2 groups. The technical success was 100% in the simple lesion group and 91.7% in the complex lesion group. There was no significant difference between the 2 groups, regarding the primary sustained clinical improvement. The primary patency rates at 24 months for simple and complex lesion groups were 86.3% and 79%, respectively (P = 0.66). Freedom from target lesion revascularization was of 93.3% and 82% in the simple and complex lesion group, respectively (P = 0.34). CONCLUSIONS: The stenting technique for CFA bifurcation lesions is a safe and effective technique. More trials with a large number of patients are needed to define the optimal stenting technique.

From bedside to bench: an evaluation of expectations and challenges encountered by young surgeons facing basic science.

Background: The evolution of surgical practice may lead to increasing difficulties for surgeons to perform fundamental research. The aim of this study was to evaluate the expectations and the challenges encountered by young surgeons when starting basic science.Methods: A qualitative study was conducted in France. A written questionnaire was anonymously filled by the participants attending to the Master Degree in surgical science.Results: The study included 47 participants (median age: 28 years, 59.6% of men); 37 (78.7%) participants had applied for a grant for their salary and 32 (68.1%) had obtained it. Nine (19.1%) participants had planned to keep their usual clinical activity. The main motivations were the perspective to embark on an academic career (55.3%) and improvement of knowledge in science (38.3%). The main barriers encountered were the lack of time (70.2%), the lack of interest (27.7%), the lack of financial support (23.4%) and administrative difficulties (12.8%).Conclusion: This study identified main barriers that young surgeons have to face when getting involved in basic science underlining the need to improve institutional and financial support to ensure involvement of new generations of surgeons in surgical research.

Positron Emission Tomography/Computed Tomography Predicts and Detects Complications After Endovascular Repair of Abdominal Aortic Aneurysms.

Purpose: To assess if aortic 18F-fluorodeoxyglucose (FDG) uptake on positron emission tomography/computed tomography (PET/CT) could play a role in predicting complications after endovascular aneurysm repair (EVAR). Materials and Methods: This study involved 2 cohorts of men with abdominal aortic aneurysm treated by EVAR: those who underwent a PET/CT scan before EVAR (n=17) and those who had a PET/CT during follow-up (n=34). Uptake of FDG was measured as the standardized uptake value (SUV). D-dimer, a marker of fibrinolysis, was measured in blood drawn concomitantly with the PET/CT. Results: A significant uptake of FDG in the aneurysm wall was detected by PET/CT before EVAR in 6 of 17 patients. During the first year after EVAR, type II endoleaks developed in 5 of these FDG+ patients vs 3 of 11 FDG- patients (p=0.04). Two of the FDG+ patients had continued sac growth and required conversion to open repair. A significant association between sac growth rate, SUV, and the presence of endoleak was found in the 34 patients who underwent PET/CT after EVAR. Finally, D-dimer was significantly increased in patients with both endoleak and positive PET/CT in the post-EVAR group. Conclusion: This study suggests that the presence of FDG uptake in the aortic wall might be a useful tool to predict patients at high risk of developing post-EVAR complications.

Loss of anisotropic properties in abdominal aorta aneurysm obtained from the xenograft rat model.

BACKGROUND: Cellular treatments using mesenchymal stem cells (MSCs) cultured in 3D conditions constitute a solution to the classical surgery in treating abdominal aortic aneurysm (AAA). The recurrent question is: how this type of biotherapy changes the mechanical behavior of artery? METHODS: Experiments measurements based on xenograft rat model showed that the proposed cellular treatment leads to a decreasing radius and length of the AAA during its growth. An inverse finite element method was used to investigate the mechanical hyperelastic behavior of the AAA in the untreated case compared to the treated one. RESULTS: Although AAA leads a loss anisotropy while the cellular treatment does not restore it, it was shown that the stiffness of the arterial wall was improved. The numerical analysis of the stress distributions permitted to localize the stress concentration through the arterial wall and the probable zone of the rupture of the aneurysm developed from the xenograft rat model. CONCLUSIONS: The treatment of AAA with MSCs cultured in a 3D conditions constitutes a new challenge. Based on xenograft rat model, this study shows the potential of this cellular treatment to reduce the variation of the growth, the stiffness and the stress distributions.

Impact of Stent-Graft Oversizing on Gutter Areas after Chimney Graft Repair for Complex Abdominal Aortic Aneurysms.

BACKGROUND: The aim of this retrospective study was to examine the impact of graft oversizing on gutter area and stent compression in chimney graft (CG) for complex abdominal aortic aneurysm (CAAA) repair. The influence of stent-graft oversizing on type Ia endoleaks and bridging stent occlusion rates was also examined. METHODS: Preoperative and postoperative computed tomographic angiography scans of patients requiring CGs for CAAA between June 2009 and April 2013 in our institution were analyzed. Two groups were identified: proximal oversizing of the stent-graft component < 25% (group 1) and >25% (group 2). Relative gutter areas were calculated and compared between both groups. Incidence of target vessel stent compression, target vessel occlusions, and type Ia endoleaks was also analyzed. RESULTS: Of 39 patients treated with CG during the study period, 23 fulfilled the selection criteria for analysis. Group 1 included 10 patients and group 2 included 13 patients (mean oversizing: 18.4 ± 4.9% and 34.5 ± 6% respectively). Relative gutter areas were significantly higher in group 1 when compared with group 2 (6.1 ± 2.1% vs. 4.2 ± 3.2%, P = 0.03). No stent compression and no target vessel occlusion occurred in either groups. There was no statistical difference in type Ia endoleak in both groups (group 1 n = 0, group 2 n = 2; P = 0.48). CONCLUSIONS: In our study, a >25% stent-graft oversizing reduced the gutter area without modifying the bridging stent patency. However, no benefit in terms of type Ia endoleak was observed.

[EVAR for aortic abdominal aneurysms: A 20-year's experience of 1900 patients]. / Endoprothèses aortiques pour anévrisme : 20 ans après, l'expérience de 1900 patients.

Abdominal aortic aneurysms (AAA), also called "silent killer" as they grow without symptoms until the final rupture, are the 3rd cause of cardiovascular deaths, after myocardial infarction and stroke. Surgery is the only efficient way of preventing aortic rupture. The initial technique, described by Charles Dubost in 1952 has evolved and results and provides fair long-term results: open repair (OR) is performed under general anesthesia, via a transperitoneal or a retroperitoneal approach. Laparoscopic repair aims to reduce the consequences of surgery, but its role is still debated due to limited experience and to variable results. Since initial reports by Volodos, and Parodi of endovascular aortic repair (EVAR) in 1993, there have been continuous technological improvements, initiated by Claude Mialhe's "modular" and "bifurcated" concepts. More recently, novel techniques and new devices have contributed to the widening of EVAR indications. In this article, we describe 20 years of our EVAR experience.

Catheter Injected Bone Marrow Mesenchymal Stem Cells Induce Efficacious Occlusion of Arteriovenous Nidus in a Swine Model.

OBJECTIVES: Arteriovenous malformations (AVMs) are complex vascular lesions. Surgical excision is the treatment of choice, but is often not achievable. Embolo-sclerotherapy alone is associated with high recurrence rates. This study tested the hypothesis that seeding hydrogel conditioned bone marrow derived mesenchymatous stem cells (BM-MSCs) in an AVM nidus model induces solid microvascular occlusion through endoluminal tissue growth. METHODS: AVMs were modelled as arteriovenous microvascular nidus, using swine rete mirabile, a plexiform intracranial structure composed of arterial microvessels that extensively anastomose. A right carotid-jugular fistula was created to generate high flow in the rete, and bone marrow was aspirated. At day 14, cultured BM-MSCs marked with a red fluorochrome were incorporated into a hyaluronic acid hydrogel, and injected through a catheter into the rete mirabile, using femoral access. In specific groups microsphere embolisation immediately preceded gel injection. At day 28, the swine were euthanased and the rete mirabile harvested for qualitative and quantitative analysis of microvessel lumen occlusion. RESULTS: Actual transfer of PKH26 labelled cells in rete was confirmed. In a first phase of the study, five swine died as a result of neurological events, prompting reductions of the injected volumes. Twenty-three animals survived until day 28. Injection of BM-MSC loaded hydrogel (n=6) significantly increased the occlusion rate compared with injection of acellular hydrogel (n=7) (10% [range, 10-12%] vs. 26% [range, 20-41%], p=.016). Injection of BM-MSC loaded hydrogel immediately after microspheres (n=6) enhanced the occlusion rate compared with embolic microspheres alone (n=6) (50% [range 46-56%] vs. 22% [range, 15-27%] p=.045). Microsphere injection resulted in vascular luminal thrombus formation. Injection of BM-MSCs induced endoluminal growth of vascular smooth muscle cells with cell proliferation and a dense collagen rich extracellular matrix. CONCLUSION: The luminal occlusion pattern of a microvascular AVM like structure can be changed from thrombus to solid cellular accumulation. The possibility of injecting living cells in a microvascular network, in a chronic survival model, provides new tools for research and treatment of AVMs and other microvascular diseases.

Stenting or Surgery for De Novo Common Femoral Artery Stenosis.

OBJECTIVES: The TECCO (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery]) trial is a randomized comparison of safety and efficacy of stenting versus open surgery for de novo common femoral artery (CFA) stenosis. BACKGROUND: Surgery for CFA lesions is considered effective and durable. Despite the widespread use of endovascular repair for infrainguinal disease, the value of this procedure for such lesions is uncertain. METHODS: From February 23, 2011, to September 5, 2013, a total of 117 patients with de novo atherosclerotic lesions of the CFA were randomly assigned to undergo surgery (n = 61) or stenting (n = 56). The main exclusion criteria were asymptomatic disease, restenosis, and thrombosis of the CFA. The primary outcome was the morbidity and mortality rate within 30 days. This includes any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3 days, and post-operative paresthesia that required drugs. The median duration of follow-up was 2 years (interquartile range [IQR]: 19.8 to 24.9 years). RESULTS: Primary outcome events occurred in 16 of 61 patients (26%) in the surgery group and 7 of 56 patients (12.5%) in the stenting group (odds ratio: 2.5; 95% confidence interval: 0.9 to 6.6; p = 0.05). The mean duration of hospitalization was significantly lower in the stenting group (3.2 ± 2.9 days vs. 6.3 ± 3 days; p < 0.0001). At 24 months, the sustained clinical improvement, the primary patency rate, and the target lesion and extremity revascularization rates were not different in the 2 groups. CONCLUSIONS: In patients with de novo atherosclerotic lesions of the CFA, the perioperative morbidity and mortality rate was significantly lower among patients who underwent endovascular therapy by stenting compared with surgery, whereas clinical, morphological, and hemodynamic outcomes were comparable at mid-term. (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery] [TECCO]; NCT01353651).

Diameter and thickness-related variations in mechanical properties of degraded arterial wall in the rat xenograft model.

The purpose of this study was to evaluate the diameter and thickness-related variations in mechanical properties of degraded arterial wall. To this end, ring tests were performed on 31 samples from the rat xenograft model of abdominal aortic aneurysm (AAA) and failure properties were determined. An inverse finite element method was then employed to identify the material parameters of a hyperelastic and incompressible strain energy function. Correlations with outer diameter and wall thickness of the rings were examined. Furthermore, we investigated the changes in mechanical properties between the grafts, which consist in guinea pig decellularized aortas, native murine aortas and degraded aortas (AAAs). Decellularized aortas presented a significantly lower ultimate strain associated with a higher stiffening rate compared to native aortas. AAAs exhibited a significantly lower ultimate stress than other groups and an extensible-but-stiff behavior. The proposed approach revealed correlations of ultimate stress and material parameters of aneurysmal aortas with outer diameter and thickness. In particular, the negative correlations of the material parameter accounting for the response of the non-collagenous matrix with diameter and thickness (r=-0.67 and r=-0.73, p<0.001) captured the gradual loss of elastin with dilatation observed in histology (r=-0.97, p<0.001). Moreover, it exposed the progressive weakening of the wall with enlargement and thickening (r=-0.64 and r=-0.69, p<0.001), suggesting that wall thickness and diameter may be indicators of rupture risk in the rat xenograft model.

Treatment of an Abdominal Aortic Aneurysm Infected by Coxiella Burnetii Using a Cryopreserved Allograft.

Q fever is a worldwide zoonosis caused by an intracellular bacillus named Coxiella burnetii (CB) and is a rare cause of vascular infections. We report a case of abdominal aortic aneurysm infected by CB with bilateral paravertebral abscesses and contiguous spondylodiscitis treated by open repair using a cryopreserved allograft and long-term antibiotic therapy by oral doxycycline and oral hydroxychloroquine for a duration of 18 months. Twenty months after the operation, the patient had no infections signs and vascular complication.

Small bowel in vivo bioengineering using an aortic matrix in a porcine model.

OBJECTIVE: To evaluate the feasibility of an in vivo small bowel bioengineering model using allogeneic aortic grafts in pigs. BACKGROUND: The best treatment for short bowel syndrome is still unclear. Intestinal transplantation, as well as lifelong parenteral nutrition is associated with a 5-year survival rate of less than 50 %. We have already used allogeneic arterial segments to replace the upper airway in sheep. The results were encouraging with an induced transformation of the aortic wall into tracheo-bronchial bronchial-type tissue. METHODS: Seven young mini-pigs were used. A 10-cm-diameter, allogeneic, aortic graft was interposed in an excluded small bowel segment and wrapped by the neighboring omentum. Animals were autopsied at 1 (n = 2), 3 (n = 3), and 6 months (n = 2), respectively. Specimens were examined macroscopically and microscopically. RESULTS: The overall survival rate of the animals was 71.4 %. No anastomotic leak occurred. Histologic analysis revealed intestinal-like wall transformation of the aortic graft in the surviving animals. CONCLUSION: Aortic-enteric anastomosis is feasible in a porcine model. Moreover, in vivo, bioengineered, intestinal-like transformation of the vascular wall was identified.

Initial Experience with Percutaneous Angioplasty of the Common Femoral Artery in De Novo Stenotic Lesions.

BACKGROUND: The aim of this study was to report an initial experience with percutaneous transluminal angioplasty (PTA) in de novo stenotic lesions of the common femoral artery (CFA). METHODS: A retrospective analysis for 34 consecutive patients was conducted. The follow-up consisted of clinical evaluation and color duplex ultrasound scan (CDU) 1, 6, and 12 months after the procedure. RESULTS: The symptoms were claudication in 16 patients (47%), critical limb ischemia in 17 (50%), and preservation of an infrainguinal bypass in 1 (3%). PTA was performed in CFA alone in 45.7%, associated to iliac and/or profunda/superficial femoral artery PTA in 54.3%. Stenting was performed in 23 patients (65.7%). All procedures were successful. Two patients required surgery for a local complication. Median hospital stay was 2 days. Mean follow-up was 11 months (range 1-56). Primary and secondary sustained clinical improvement rates were 77% and 85%, and primary, CDU-controlled patency rate was 88%. Four reinterventions were required for symptomatic CFA restenosis. At the end of follow-up, no major amputation had been performed, all patients with claudication remained improved with no restenosis, and the secondary sustained improvement rate was 85%. CONCLUSIONS: PTA for primary CFA lesions is feasible and safe, with acceptable short-term results in claudicants. In patients with tissue loss, frequent reinterventions raise questions about PTA benefit. This approach needs to be compared with open surgery in a randomized trial.

Feasibility and safety of renal and visceral target vessel cannulation using robotically steerable catheters during complex endovascular aortic procedures.

PURPOSE: To evaluate the safety and success of target vessel cannulation in the visceral aortic segment using the Magellan robotic catheter system (RCS) during complex endovascular aortic procedures. METHODS: Robotic navigation was attempted for access to 37 target vessels in 15 patients (14 men; mean age 75±10 years) during 16 fenestrated and/or branched stent-grafting procedures and 1 endovascular repair requiring the chimney technique. For each target vessel, robotic navigation was attempted for a maximum of 15 minutes; if cannulation was unsuccessful in that time, manual catheters were employed. Safety was evaluated by recording intraoperative adverse events, intraoperative complications related to robotic navigation, and postoperative complications. Technical success of robotic cannulation, wire cannulation times, and times for inserting the leader over the wire in the target vessels were recorded to assess RCS performance. RESULTS: Successful robotic cannulation was achieved for 30 (81%) of the 37 target vessels, with a median wire cannulation time of 263 seconds (range 40-780) and a median 15 seconds (range 5-450) for inserting the leader over the wire. No intraoperative complications related to robotic navigation were observed. Seven of 27 arteries accessed via 7 fenestrations could not be cannulated within 15 minutes; all were cannulated successfully using conventional catheters (mean cannulation time 31±7 minutes). All 10 target vessels accessed via branches and chimney stents were successfully cannulated with the RCS. CONCLUSION: Cannulation of target vessels with the RCS during complex endovascular aortic procedures is feasible and safe. The robotic system was particularly effective for branched and chimney stents.

Endovascular balloon occlusion is associated with reduced intraoperative mortality of unstable patients with ruptured abdominal aortic aneurysm but fails to improve other outcomes.

BACKGROUND: Proximal aortic control by endovascular balloon occlusion (EBO) is an alternative to conventional aortic cross-clamping (CAC) in hemodynamically unstable patients presenting with a ruptured abdominal aortic aneurysm (rAAA). The aim of this study was to evaluate the potential clinical benefit of EBO over CAC. METHODS: Data from 72 patients with rAAA treated at our institution from 2001 to 2013 were retrospectively analyzed. All patients were hemodynamically unstable (mean arterial blood pressure at admission <65 mm Hg or associated unconsciousness, cardiac arrest, or emergency endotracheal intubation). Clinical end points of hemodynamic restoration, mortality rate, and major postoperative complications were assessed for CAC (group 1) and EBO (group 2). RESULTS: At admission, 72 patients were unstable. CAC was performed in 40 and EBO in 32. Intraoperative mortality was 43% in group 1 vs 19% in group 2 (P = .031). In group 1, the approach for CAC (thoracotomy [n = 23] vs laparotomy [n = 17]) did not influence intraoperative mortality (43% vs 41%). There was no significant difference in 30-day (75% vs 62%) and in-hospital (77% vs 69%) mortality rates between groups. After EBO, the treatment-open vs endovascular repair-did not influence the intraoperative mortality rate (31% vs 43%; P = .5). Eight surgical complications were secondary to CAC (1 vena cava injury, 3 left renal vein injuries, 1 left renal artery injury, 1 pancreaticoduodenal vein injury, and 2 splenectomies), but no EBO-related complication was noted (P = .04). Differences in colon ischemia (15% vs 28%) and renal failure (12% vs 9%) were not statistically significant. Abdominal compartment syndrome occurred in four patients in group 2 and in no patients in group 1. CONCLUSIONS: Compared with CAC, EBO is a feasible and valuable strategy and is associated with reduced intraoperative mortality of unstable rAAA patients, but not in-hospital mortality, in this retrospective study.