Ultrasound Coded-Excitation Imaging for Endoleak Detection After Complex Endovascular Aortic Repair.

OBJECTIVES: Several imaging modalities have been suggested for surveillance after fenestrated endovascular aortic repair in general and endoleak detection in specific. In the present project a coded excitation-based ultrasound (B-Flow) was investigated for endoleak detection after complex endovascular aortic repair. METHODS: Patients post complex endovascular aortic repair (FEVAR or T/FEVAR) undergoing follow-up appointments including ultrasonography of the aorta at a vascular and endovascular surgery outpatient center were included in the study. B-Flow was compared with computed tomography angiography (CTA), Duplex ultrasound (DUS), and contrast-enhanced ultrasound (CEUS) regarding agreement and reliability for endoleak detection and characterization. RESULTS: In total, 47 follow-ups were included. They accumulated in a total of 149 imaging investigations. Endoleaks were discovered in 44.7% of B-Flow studies and a majority of these endoleaks were classified as type II. Agreement between B-Flow and other imaging modalities was good (>80.0%) in general. However, with B-Flow 6 and 2 endoleaks would have been missed compared with CEUS and CTA, respectively. Regarding endoleak classification, B-Flow had a strong agreement (94.5%) with CEUS in detected cases. Furthermore, in a limited subset analysis, imaging findings were externally validated using findings from angiography. CONCLUSIONS: Ultrasonography allows for endoleak detection and characterization without an invasive procedure or the use of potentially nephrotoxic contrast medium and can reduce radiation exposure. While CEUS mitigates issues of radiation and nephrotoxicity it still requires the intravenous application of contrast enhancers. Ultrasound coded-excitation imaging such as B-Flow could therefore further simplify endoleak surveillance after fenestrated endovascular aortic repair.

The Effect of Age on Peri-Operative Outcomes after FEVAR.

INTRODUCTION: Fenestrated endovascular aortic repair (FEVAR) has become a popular custom-made treatment option for juxtarenal and pararenal aneurysms. It has been previously investigated whether octogenarians as a distinct subgroup are at increased risk for adverse outcomes after FEVAR. With diverging results and an inconclusive understanding of age as a risk factor in general, an analysis of the historical data of a single center was conducted to add to the available body of evidence and further investigate the effect of age as a continuous risk factor. METHODS: A retrospective data analysis of a prospectively maintained single-center database of all patients who underwent FEVAR at a single department of vascular surgery was performed. The main endpoint was post-operative survival. In addition to association analyses, potential confounders such as co-morbidities, complication rates, or aneurysm diameter were examined. In terms of sensitivity analyses, logistic regression models were created for the dependent variables of interest. RESULTS: During the observation period from April 2013 to November 2020, 40 patients over the age of 80 and 191 patients under the age of 80 were treated by FEVAR. The 30-day survival showed no significant difference between the groups (95.1% in octogenarians and 94.3% in patients under 80 years of age). The sensitivity analyses conducted also showed no difference between the two groups, and complication and technical success rates were comparable. The aneurysm diameter was 67 ± 13 mm in the study group and 61 ± 15 mm in those under 80 years of age. Additionally, the sensitivity analyses showed that age as a continuous variable exhibits no effect on the outcomes of interest. DISCUSSION: In the present study, age was not associated with adverse peri-operative outcomes after FEVAR, including mortality, lower technical success rates, complications, or length of hospital stay. Essentially, the most highly associated factor with hospital and ICU length of stay was time spent in surgery. However, octogenarians had a significantly larger aortic diameter at the time of treatment, which might indicate the potential introduction of bias by pre-interventional patient selection. Nevertheless, the usefulness of research on octogenarians as a distinct subgroup might be questionable regarding the scalability of results, and future studies might focus on age as a continuous risk factor instead.

Fenestrated Endovascular Aortic Repair After Failed Endovascular Aortic Repair.

PURPOSE: Fenestrated endovascular aortic repair (FEVAR) is technically more challenging when performed after a failing EVAR procedure (FEVAR after EVAR). This study aims to assess the technical outcome of FEVAR after EVAR and to identify factors that may influence complication rates. METHODS: A retrospective observational study was conducted at a single department of vascular and endovascular surgery. The rate of FEVAR after EVAR compared to primary FEVAR is reported. Complication and primary unconnected fenestration (PUF) rates as well as survival were assessed for the FEVAR after EVAR cohort. PUF rates and operating time were also compared to all primary FEVAR patients. Patient characteristics and technical factors such as number of fenestrations or use of a steerable sheath were assessed as possible influencers on technical success when performing FEVAR after EVAR. RESULTS: Two hundred and nine fenestrated devices were implanted during the study period (2013 to April 2020). Thirty-five patients (16.7% of all FEVAR patients) had undergone FEVAR after EVAR and were included in the study. Overall survival at last follow-up (20.2±19.1 months) was 82.9% in FEVAR after EVAR patients. Rates of technical failure dropped significantly after 14 procedures (42.9% vs. 9.5%; p=0.03). Primary unconnected fenestrations were seen in 3 cases of FEVAR after EVAR (8.6%) and 14 of 174 primary FEVAR cases (8.0%; p>0.99). Operating time for FEVAR after EVAR was significantly higher than for primary FEVAR (301.1±110.5 minutes vs. 253.9±103.4 minutes; p=0.02). The availability of a steerable sheath was a significant predictor of reduced risk of PUFs, whereas age and gender, number of fenestrations or suprarenal fixation of the failed EVAR did not significantly influence PUF rates. CONCLUSION: Fewer technical complications were seen over the study period in FEVAR after EVAR patients. While rates of PUFs were not different from primary FEVAR, operating time was significantly longer in patients undergoing FEVAR for failed EVAR. Fenestrated EVAR can be a valuable and safe tool to treat patients with progression of aortic disease or type Ia endoleak after EVAR but may be more complex to achieve than primary FEVAR. CLINICAL IMPACT: This retrospective study assesses the technical outcome of fenestrated endovascular aortic repair (fenestrated EVAR; FEVAR) after prior EVAR. While rates of primary unconnected fenestrations were not different from primary FEVAR, operating time was significantly longer in patients undergoing FEVAR for failed EVAR. Fenestrated EVAR after prior EVAR may be technically more challenging than primary FEVAR procedures, but could be performed with equally good results in this patient cohort. FEVAR offers a feasible treatment option for patients with progression of aortic disease or type Ia endoleak after EVAR.

Remote training and evaluation of a simulator-based training course for complex endovascular procedures.

Background: Intimate knowledge of the materials used in endovascular aortic interventions is essential for trainees and supporting staff taking part in an endovascular intervention. Training courses can help to familiarize trainees with the equipment. However, the pandemic has changed the landscape of hands-on training courses significantly. Therefore, we developed a training course including an educational recording of the procedure to transfer knowledge about the materials used during endovascular interventions and radiation exposure reduction. Methods: We produced a video depicting cannulation of the left renal artery in a silicon cast of an aorta and its major side branches under C­arm fluoroscopy. A presentation using the video was given to the trainees. The trainees were randomized into a control and an intervention group. Their performance was filmed and rated on a standardized five-point scale in the style of the OSATS global rating scale. The intervention group was remeasured after additional training time. Results: In total, 23 trainees participated in the training and agreed to have their performance recorded. The control and intervention groups showed no difference in the assessed performance metrics during their initial attempt. However, after receiving additional training, the intervention group significantly improved in all evaluated metrics. Conclusion: Our data add to the growing evidence that simulator-based training can help to increase trainees' understanding and performance of relevant skills. A standardized and evidence-based validation process for simulators could improve their acceptance in the medical field.

Precision Medicine in Vascular and Endovascular Surgery.

Personalized medicine and precision medicine are terms often used to refer to treatment strategies tailored specifically to individual characteristics of patients, as opposed to a one-size fits all approach [...].

Multicentre experience with an iliac fenestrated device.

OBJECTIVES: The aim of this study was to present a multicentre experience of technical results and mid-term follow-up using a custom-made iliac fenestrated device (Terumo Aortic, Inchinnan, Renfrewshire, UK) for the treatment of iliac aneurysms and endoleaks. METHODS: A multicentre retrospective evaluation of 22 patients (3-12 per institution) with either an iliac artery aneurysm or endoleak treated with an iliac fenestrated device was performed. Data were gathered from 3 departments of vascular and endovascular surgery at 3 European institutions. RESULTS: Ten of the included patients (45.5%) were treated for an endoleak and 12 had aorto-iliac aneurysms (54.5%). Two patients underwent bilateral fenestrated device implantation for a total of 24 devices included in this analysis. Primary technical success was 91.7% (22 of 24 implanted devices). One of the 24 internal iliac arteries could not be cannulated and was covered (primary assisted technical success rate 95.8%) and 1 patient required a relining of the stent graft due to a mid-grade stenosis opposite the internal iliac artery fenestration. Survival at the last available follow-up (mean 15.2 ± 12.0 months, range 0.5-36.6 months) was 90.9%. CONCLUSIONS: The present investigation adds to a growing body of literature on custom-made endografts and their usefulness in achieving endovascular repair without compromising blood flow via important arterial branch vessels, such as the internal iliac artery. It presents encouraging technical and mid-term follow-up data from consecutive patients treated for iliac aneurysms or endoleaks using this custom-made device. The technique may help avoid adverse sequelae associated to a coil-and-cover approach when iliac branch devices are not feasible.

Exclusion of complex aortic aneurysm with chimney endovascular aortic repair is applicable in a minority of patients treated with fenestrated endografts.

OBJECTIVES: The Medtronic Endurant II stent graft has recently received Conformité Européenne (CE) approval for the use in chimney endovascular aortic repair (ChEVAR) for the treatment for juxtarenal aortic aneurysms. The aim of this study was to assess the percentage of patients treated by fenestrated endovascular repair who would have been alternatively suitable for the treatment by the CE approved Medtronic ChEVAR. METHODS: Preoperative computed tomography scans of 100 patients who underwent fenestrated endovascular aortic repair (FEVAR) between April 2013 and February 2017 were retrospectively assessed for the applicability of the ChEVAR technique according to the Medtronic instructions for use. Eligibility criteria included an aortic neck diameter of 19-30 mm, a minimum infrarenal neck length of 2 mm, a total proximal sealing zone of at least 15 mm, thrombus in the aortic neck in ˂25% of the circumference, and maximum aortic angulations of 60° in the infrarenal, 45° in the suprarenal segment and ˂45° above the superior mesenteric artery. RESULTS: According to CE-approved inclusion criteria, 19 individuals (19%) would have been eligible for ChEVAR. In 81 patients, at least 1 measure was found outside instructions for use: (i) excluding factor was detected in 26 patients, (ii) incongruous measures in 28 patients and in 27 patients, 3-5 measures were outside the instructions for use. The most frequently identified excluding factor was an insufficient infrarenal neck at ˂2 mm length (n = 63; 63%). CONCLUSIONS: Patients with juxta- or pararenal aneurysm treated by FEVAR are in 19% of the cases alternatively suitable for the treatment by ChEVAR within CE-approved instructions for use. While ChEVAR is suitable in many emergency cases, FEVAR offers a broader applicability in an elective setting.

Decrease of peripheral resistance after intraoperative administration of iloprost in patients with and without type 2 diabetes mellitus and with peripheral arterial occlusive disease.

BACKGROUND: In many cases, Ilomedin® infusions are applied as part of a perioperative measure in patients with peripheral arterial occlusive disease because it makes a relevant vasodilatatory effect in patients with type 2 diabetes mellitus and with/without peripheral neuropathy. AIMS: A prospective case-control study was performed to investigate the effect of prostanoids on peripheral resistance in patients with type 2 diabetes mellitus and patients without type 2 diabetes mellitus, as well as the role of peripheral neuropathy in patients undergoing arterial reconstruction. METHODS: Sixty patients undergoing arterial reconstruction were enrolled. Sufficient data were collected on 38 patients. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow volume at the common femoral artery was assessed intraoperatively using a Doppler flowmeter at four time points: at baseline before arterial reconstruction (T0), after reconstruction (T1), after 5 (T2) and 10 min (T3) after intra-arterial application of 3000 ng of Ilomedin. Peripheral resistance units were calculated as a function of mean arterial pressure and flow volume using the following formula: peripheral resistance unit = mean arterial pressure (mm Hg) / flow volume (mL/min). RESULTS: Ilomedin produced an immediate and significant drop of peripheral resistance in patients without type 2 diabetes mellitus as well as in patients with type 2 diabetes mellitus. Patients with peripheral neuropathy showed a less pronounced effect to Ilomedin compared to individuals with normal nerve conduction velocity.

Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training in a Pulsatile Model.

OBJECTIVE: The current study assesses the feasibility of in vitro practice of percutaneous puncture techniques in a pulsatile flow-model. DESIGN: Prospective, controlled, randomized study. SETTING: The percutaneous access to endovascular aortic repair is considered safe, but success rates may be dependent on surgeon experience with the technique. PARTICIPANTS: Fourteen vascular surgery trainees and consultants were enrolled and randomized to a study or control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device. The study group received additional hands-on training on a pulsatile flowmodel of the groin and the performance of both groups was then graded. Study group participants were timed during and after their training on the model. RESULTS: The study group achieved higher overall grading than the control group on a 5-point scale with higher scores indicating a better performance (mean overall scores 4.0 ± 0.7 versus 2.8 ± 1.0, respectively; p = 0.03). Experienced participants (more than 20 punctures performed before the study) achieved higher overall scores than trainees (3.8 ± 0.4 versus 2.5 ± 0.8, respectively; p = 0.01). Five participants in the study group could deploy and close the ProGlide closure device correctly without the help of a tutor while being graded (71% in the study versus 0% in the control group; p = 0.02). Study group participants improved their overall score from 3.2 ± 0.9 to 4.0 ± 0.7 during training (p = 0.02). Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001). CONCLUSIONS: Study group participants could improve their overall score while working on the simulator. More experienced participants performed better during the simulation, which may indicate the model to be life-like and a potential skills assessment tool. Simulation training may be a valuable adjunct to traditional forms of training when teaching an endovascular technique but is limited by its reliance on simulators and demo devices.

Assessment of Pull-out Forces in TEVAR and ANACONDA FEVAR Combination and Early Clinical Results: Creation of a Proximal Landing Zone for FEVAR in Patients with Extent I and Extent IV TAAAs.

BACKGROUND: Although recent data on the treatment of thoracoabdominal aortic aneurysms (TAAAs) are promising, in some cases, the paravisceral segment of the aorta may not be suitable for a branched endograft due to space restrictions. A combination of a fenestrated aneurysm repair (FEVAR) with a thoracic aneurysm repair (TEVAR) may represent a feasible treatment option. The current investigation was performed to assess the stability of a fenestrated Anaconda device implanted into a set of thoracic endografts from different manufacturers. We then assessed our clinical results with the FEVAR/TEVAR combination. METHODS: Pull-out forces were measured in vitro after docking a fenestrated Anaconda graft within the distal end of different TEVAR devices. Anaconda devices were implanted in 28- or 30-mm thoracic tube grafts (oversizing of at least 2 mm: 13.3-21.4; minimum overlap of 15 mm). Continuously increasing longitudinal pull forces of up to 100 N were applied on an Instron Tensile Tester. Initial break point and damage to the endografts were documented. Clinical results of patients treated with such an FEVAR/TEVAR combination at our institution are presented as a second part of this study. RESULTS: Median pull-out forces ranged from 2.38 N to 55.0 N. The highest stability was achieved with 34-mm Anaconda devices in 28-mm thoracic tube grafts. Grafts with either thinner Dacron material or those featuring a polytetrafluorethylene membrane seemed especially vulnerable to punctures and tears caused by the downward-looking hooks of the Anaconda device. Between April 1, 2013 and December 31, 2018, in 28 of 172 patients treated with a fenestrated Anaconda device, prior implantation of a thoracic tube graft was necessary to create a sufficient proximal landing zone. In 25 cases (89.3%), the aneurysm was successfully treated. Although the 30-day reintervention rate in this subgroup was relatively high at 28.6%, none of these was due to a failure of the FEVAR/TEVAR combination. Upon an average follow-up of 15 months, no failure of the graft connection and no type III endoleak due to membrane damage were observed. CONCLUSIONS: The combination of a thoracic tube graft and a fenestrated Anaconda device is a viable option for the treatment of patients with Extent I or IV TAAAs with no adequate landing zone above the celiac trunk. Although pull-out testing has shown good stability with most assessed grafts, the thoracic devices with thicker Dacron membranes seemed to be especially suitable.

Endovascular treatment of hypogastric artery aneurysms.

OBJECTIVE: Internal iliac artery aneurysm (IIAA) is a rare entity. Its treatment can be technically challenging. The aim of this study was to evaluate the treatment possibilities in an era of advanced endovascular techniques and their potential to preserve iliac blood flow while reliably excluding the aneurysm. METHODS: A retrospective analysis of 46 consecutive patients with endovascularly treated IIAA was performed. Data were collected from a single-institution aortoiliac database. The following end points were recorded: technique of aneurysm exclusion, technical success rates, perioperative morbidity and mortality, primary patency, and midterm follow-up. RESULTS: Between September 2009 and May 2016, a total of 46 patients with 55 IIAAs were identified. The majority of patients (n = 39 [84.8%]) had aortoiliac aneurysms and seven had isolated IIAAs (15.2%). The following surgical techniques were used: implantation of iliac branch devices (IBDs; n = 29), occlusion of the internal iliac artery (IIA) by ostium coverage with or without prior coil embolization (n = 23), and other endovascular techniques (n = 3). Primary assisted technical success was achieved in 93.1% of IBD implantations and in 100% of occlusions by ostium coverage and other techniques. Overall 30-day mortality was 4.3% (n = 2) and 0% in electively treated patients. Assisted midterm patency after IBD implantation was 93.1%. Gluteal claudication occurred in seven patients (15.2%) who had undergone intentional or accidental occlusion of the IIA or the superior gluteal artery. Reintervention rates within the midterm follow-up were 13.8% (n = 4) after IBD implantation and 4.3% (n = 1) after coverage of the IIA ostium. No ruptures were observed during follow-up, and no complications occurred during reinterventions. CONCLUSIONS: Implantation of IBD devices for the treatment of hypogastric artery aneurysms shows good technical results with a high primary patency and a low rate of perioperative complications. Although successful aneurysm exclusion while preserving pelvic blood flow is associated with a higher rate of reinterventions during midterm follow-up, it should be taken into consideration, especially in complex endovascular aortoiliac aneurysm repair.

Custom-Made Iliac Fenestrated Device.

Iliac branch devices (IBDs) are undergoing rapid popularization. They allow for treatment of an iliac aneurysm while preserving blood flow to the hypogastric artery. Certain anatomic criteria are necessary for the use of an iliac side branch device to be technically feasible. Custom-made fenestrated iliac stent grafts may provide an alternative when anatomic criteria for an IBD are not met.

Assessing the institutional learning curve for pararenal aortic repair using the fenestrated Anaconda endograft.

OBJECTIVE: Custom-made fenestrated aortic endografts allow exclusion of pararenal aortic aneurysms while maintaining blood flow to aortic branches. Meticulous device planning and precise deployment of the main body are essential to allow successful cannulation of the fenestrations. This study investigates whether a learning curve can be observed with more reliable cannulation and connection of fenestrations over time at a single department of vascular and endovascular surgery with multiple surgeons trained to use the device. METHODS: A retrospective analysis of data from all patients undergoing primary fenestrated endovascular aneurysm repair during the study period was performed. Outcome measures included case volume and average number of fenestrations over time, average fluoroscopy dose area product per calendar year and primary unconnected fenestration and 30-day mortality rates. RESULTS: Between 1 January 2013 and 31 December 2016, 89 patients with no history of endovascular aneurysm repair underwent fenestrated endovascular aneurysm repair at our institution. The number of fenestrations per case increased over time, averaging 2.6 in 2013 and 3.3 in 2016. Primary unconnected fenestration and 30-day mortality rates were 5.6%. Primary-assisted technical success was 93.3%, secondary-assisted technical success was 94.4%. Fluoroscopy dose area product declined over the study period. Thirty-day mortality and primary unconnected fenestration rates did not significantly change over the study period. CONCLUSION: Albeit the reduction in lethal complications and primary technical success rates were not statistically significant, a lower percentage of unconnected fenestrations and 30-day mortality per calendar year were observed over time. At the same time, an increasing complexity of performed cases, as reflected by an increasing number of fenestrations per case, was observed. Complications associated with this complex endovascular procedure are potentially lethal and remain an unfortunate reality and may not be entirely dependent on overcoming a learning curve. A higher volume of cases performed over the study period and a reduction in fluoroscopy use can be considered a representation of the institutional development and learning curve for the Anaconda fenestrated endograft at a department with prior complex endovascular aortic repair experience, but due to limitations of the current retrospective observation, deserve further consideration in future trials, ideally designed in a prospective fashion.

Endograft Infection Due to Secondary Aortoenteric Fistula Treated With Custom-Made Bovine In Situ Aortic Bifurcation Graft.

PURPOSE:: To increase awareness of the clinical presentation, diagnostic workup, and treatment options for endograft infections. CASE REPORT:: A 75-year-old male patient was admitted with suspected endograft infection 4 years after endovascular aortic aneurysm repair (EVAR). Although preoperative diagnostics showed no definitive signs of endograft infection, eventual surgical exposure of the endograft revealed signs of advanced inflammation, including the unexpected finding of an aortoduodenal fistula. CONCLUSION:: A detailed evaluation of patient history and clinical examination, performed as a part of routine follow-ups, may be beneficial in identifying possible severe complications after EVAR early on. Regarding options for aortic reconstruction in case of endograft infection, bovine pericardium deserves consideration as a promising, feasible, and easily available graft material.

Successful percutaneous access for endovascular aneurysm repair is significantly cheaper than femoral cutdown in a prospective randomized trial.

OBJECTIVE: Because of its minimally invasive nature, percutaneous femoral access for endovascular aneurysm repair (pEVAR) is currently undergoing rapid popularization. Compared with surgical cutdown for femoral access (cEVAR), it offers the advantage of faster recovery after surgery as well as a reduction in wound complications. Despite proposed advantages, the method is largely considered uneconomical because of its reliance on costly closure devices. METHODS: There were 50 patients undergoing EVAR who were enrolled in this randomized prospective single-center trial. Each patient randomly received percutaneous access in one groin and surgical access in the other. The primary end points were access duration and cost. Secondary end points were wound complications and the postoperative pain levels. RESULTS: Surgery was performed per protocol in 44 patients. Mean access times for pEVAR and cEVAR were 11.5 ± 3.4 minutes and 24.8 ± 12.1 minutes (P < .001), respectively. Total access costs were €559.65 ± €112.69 for pEVAR and €674.85 ± €289.55 for cEVAR (P = .016). Eight complications in six patients were attributed to cutdown, none to pEVAR (P = .02). The percutaneously accessed groin was significantly less painful at day 1 and day 5 after surgery (P < .001). An intention-to-treat analysis (N = 50 patients) included six cases of pEVAR conversion due to technical failure in three patients (6%) and change of the operative strategy in another three patients (eg, aortouni-iliac stent graft followed by crossover bypass). The intention-to-treat analysis showed shorter mean overall access time for pEVAR (pEVAR, 14.65 ± 10.20 minutes; cEVAR, 25.12 ± 11.77 minutes; P < .001) and no cost difference between the two methods (pEVAR, €651.29 ± €313.49; cEVAR, €625.53 ± €238.29; P = .65). CONCLUSIONS: Our data confirm proposed potential benefits attributable to the minimally invasive nature of pEVAR while demonstrating cost-effectiveness despite the additional cost of closure devices. Taking into account pEVAR failures still does not increase pEVAR costs over cEVAR. Further considering reduced postoperative pain and wound complications, the technique deserves consideration in suitable patients.

Rescue of failed endovascular aortic aneurysm repair using the fenestrated Anaconda device.

OBJECTIVE: Endovascular aortic aneurysm repair (EVAR) with a fenestrated device (FEVAR) allows an extension of the proximal sealing zone above the renal arteries to an adequate, healthier segment of the aorta. This feature makes FEVAR an option to treat patients with a diseased aortic neck or type Ia endoleak after EVAR. The aim of this investigation was to present a single-center experience with FEVAR for patients with an abdominal aortic endograft in situ compared with primary FEVAR. METHODS: A prospectively held database on FEVAR patients treated with the fenestrated Anaconda device (Vascutek/Terumo, Inchinnan, Scotland, United Kingdom) at our institution was screened for individuals who had previously undergone EVAR. RESULTS: Between April 1, 2013, and July 31, 2016, 94 fenestrated Anaconda devices were implanted at our institution. Twelve patients with prior EVAR were treated for pathology of the proximal neck: type I endoleak (n = 7), for stent migration with aneurysm progression but no visible endoleak (n = 2), and progressive aortic disease at the level of the visceral segment (n = 3). When redo cases and primary FEVARs were compared, primary technical success rates were 58.3% and 87.8% (P = .02) and primary functional success rates were 91.7% and 95.1%, respectively (P = .62). Perioperative rate of major deployment-related (14.6% and 16.7%) and systemic complications (8.5% and 8.3%) as well as 30-day mortality (6.1% and 0%; P = .5) were comparable between groups. After an average follow-up interval of 10 months (range, 0-43 months), no late occlusions of connecting stents were observed. The late reintervention rates were 11.0% and 16.7%, respectively (P = .57). CONCLUSIONS: The risk of a failure to cannulate one or more visceral arteries through the respective fenestrations was increased in patients who had previously undergone EVAR. This is most likely caused by increased friction between the fenestrated endograft and the failing graft in situ, which may impair the adaption of the unsupported Anaconda device to the aortic wall. As a consequence, fenestrations may not line up perfectly at the respective openings of the visceral or renal arteries, and folding of the fabric may be increased, making cannulation of the fenestrations more difficult.

The influence of prototype testing in three-dimensional aortic models on fenestrated endograft design.

OBJECTIVE: The fenestrated Anaconda endograft (Vascutek/Terumo, Inchinnan, UK) is intended for the treatment of abdominal aortic aneurysms with an insufficient infrarenal landing zone. The endografts are custom-made with use of high-resolution, 1-mm-slice computed tomography angiography images. For every case, a nonsterile prototype and a three-dimensional (3D) model of the patient's aorta are constructed to allow the engineers as well as the physician to test-implant the device and to review the fit of the graft. The aim of this investigation was to assess the impact of 3D model construction and prototype testing on the design of the final sterile endograft. METHODS: A prospectively held database on fenestrated endovascular aortic repair patients treated at a single institution was completed with data from the Vascutek engineers' prototype test results as well as the product request forms. Changes to endograft design based on prototype testing were assessed and are reported for all procedures. RESULTS: Between April 1, 2013, and August 18, 2015, 60 fenestrated Anaconda devices were implanted. Through prototype testing, engineers were able to identify and report potential risks to technical success related to use of the custom device for the respective patient. Theoretical concerns about endograft fit in the rigid model were expressed in 51 cases (85.0%), and the engineers suggested potential changes to the design of 21 grafts (35.0%). Thirteen cases (21.7%) were eventually modified after the surgeon's testing of the prototype. A second prototype was ordered in three cases (5.0%) because of extensive changes to endograft design, such as inclusion of an additional fenestration. Technical success rates were comparable for grafts that showed a perfect fit from the beginning and cases in which prototype testing resulted in a modification of graft design. CONCLUSIONS: Planning and construction of fenestrated endografts for complex aortic anatomies where exact fit and positioning of the graft are paramount to allow cannulation of the aortic branches are challenging. In the current series, approximately one in five endografts was modified after prototype testing in an aortic model. Eventually, success rates were comparable between the groups of patients with a good primary prototype fit and those in which the endograft design was altered. Prototype testing in 3D aortic models is a valuable tool to test the fit of a custom-made endograft before implantation. This may help avoid potentially debilitating adverse events associated with misaligned fenestrations and unconnected aortic branches.

Covered endovascular repair of the paravisceral aorta.

Open aortic repair is considered the "gold standard" treatment for aortic occlusive disease. We present the case of an 83-year-old patient with refractory hypertension caused by paravisceral aortic stenosis including both renal arteries and the superior mesenteric artery. We planned an endovascular approach and treated the patient with parallel stent grafts in the paravisceral aorta. At 1.5 years after the operation, the patient was free of hypertensive episodes. Covered endovascular repair of the paravisceral aorta may be a valuable alternative to open aortic repair in patients unfit for open surgery. More research is needed to evaluate the long-term effects of this technique.

B-Vitamin Serum Concentrations Predicting Long-Term Overall and Stroke-Free Survival after Carotid Endarterectomy.

BACKGROUND: Both deficiency and, according to recent reports, excess of vitamin B12 (B12) are associated with increased mortality. Thus, it is difficult to estimate the effect of B12 on overall survival, which also depends on folate (FA) in homocysteine lowering. This study aimed to assess FA and B12 serum concentrations associated with long-term survival of vascular surgery patients by means of a prognostic index (PI). METHODS: This single-center, prospective cohort study comprised 485 consecutive carotid surgery patients. B-vitamin baseline concentrations of B12 and FA were used to compute a PI for postoperative overall survival from January 2003 to January 2012 (mean observation period 102.3 months). RESULTS: Increasing B12 serum concentrations showed a nonlinear association with overall survival (P = .033). A B vitamin-based PI significantly predicted overall (hazard ratio [HR] per standard deviation = 1.97, confidence interval [CI] 1.37-2.82; P < .001), cardiovascular (HR = 3.03, CI 1.78-5.14; P < .001), and stroke-free survival (HR = 2.20, CI 1.22-3.98; P = .009), and revealed that the highest adverse event-free survival was predicted by high FA (16.3 ± 12.9 ng/mL) but only moderate B12 (360.3 ± 156.0 pmol/L) baseline concentrations. CONCLUSIONS: Prediction of increased long-term overall, cardiovascular, and stroke-free survival is based on high FA but only moderate B12 serum concentrations. Excessive B12 concentrations might harbor a potential harm and are no requisite for low homocysteine concentrations. The association between B vitamins and survival might serve either as a tool for risk stratification or, if causative, as effective therapy, if optimal dosing of B vitamins is provided and on-treatment concentrations, including homocysteine and renal functions, are closely monitored.

Long-term sequelae of patients with retained drains in spine surgery.

STUDY DESIGN: Case series. OBJECTIVE: To assess sequelae of retained surgical drains in patients undergoing spine surgery. SUMMARY OF BACKGROUND DATA: Although a rare event, surgical drains may break either before or during removal attempts. In cases of retained surgical drains, the patient and surgeon are left with a decision of either surgically removing the drain fragment, or leaving it in situ. There is a paucity of literature that pertains to this unusual complication of spine surgery and its effect on long-term outcome. METHODS: Cases of retained drain fragments that occurred at the spine service of a single institution between January 1, 1990 and December 31, 2008 were identified using the institutional electronic billing system, International Classification of Diseases and Related Health Problems-9 codes, and surgeons' records. RESULTS: Seven cases of retained drains were identified to have occurred during the study period. Five of the patients underwent a subsequent operation for drain removal without complications, whereas 2 patients elected to leave the drain in situ. At a minimum of 2-year follow-up, neither of the patients in which the drain fragment had been left in situ reported complications or sequelae related to the drain fragment, and radiographic imaging showed no distinct migration of the fragment within the soft tissue. CONCLUSIONS: The 2 reported cases with a retained drain fragment left in situ support published and anecdotal opinions on retained soft-tissue drains not adversely affecting long-term patient outcome. In cases of asymptomatic patients with retained drains within soft tissue, leaving the fragment in situ is a treatment option that deserves consideration.