Rescue of Failed Aortic Repair with Fenestrated Endovascular Device.

INTRODUCTION: The incidence of failed endovascular (EVAR) and open repair (OR) is increasing. Redo aortic repair is required in 10% of patients. Extension of the proximal sealing zone above the visceral arteries to adequate, healthier thoracic aorta using a fenestrated graft (FEVAR) can rescue a failing repair. A custom-made device can treat proximal type 1a endoleaks or proximal dilatation post endovascular or open repair, respectively. The aim of this investigation was to present a single-centre experience with FEVAR for patients with a failing aortic repair. METHODS: A prospectively maintained database of FEVAR patients treated with a ZenithⓇ Fenestrated endovascular (ZFEN) device (Cook Medical LLC, Bloomington, Indiana, USA) was interrogated for individuals who had the device implanted as a rescue therapy after prior endovascular (EVAR) or open repair (OR). Statistical analysis was performed with SPSS v 25 software. RESULTS: Between January 1, 2011 and March 31, 2019, 17 ZFEN devices were implanted. 10 patients had a type 1a endoleak from a prior EVAR and 7 patients had proximal disease progression after prior OR. There were 12 males and 5 females, median age of 75 (interquartile range, IQR 7). 76.4% (n = 13) of patients had an American Society of Anaesthesiologists (ASA) grade of 3. Primary technical success was 70.5% (n = 12). Of the remainder, 4 cases (24%) had a type III endoleak at completion angiogram; of which, 2 patients (12%) required re-intervention within 30 days. One further case (6%) had primary assisted technical success as stenting of a flow limiting dissection flap in an iliac vessel was required. Peri-operative rate of deployment related complications and systemic complications were 5.8% (n = 1) and 35% (n = 6), respectively. Median length of hospital stay was 11 days (IQR 11). There was no mortality within the study follow up. Overall 30-day re-intervention rate was 23.5%. Overall survival was 92% at one year. CONCLUSION: FEVAR is a safe but technically challenging option for rescue of failing aortic repairs. These are a high-risk group of patients and this is reflected in the high post-operative morbidity rate. Technical success was high and 30-day mortality was low.

Staged treatment for pancreaticoduodenal artery aneurysm with coeliac artery revascularisation: Case report and systematic review.

BACKGROUND: Despite being rare, pancreaticoduodenal artery aneurysms (PDAAs) carry a risk of rupture of up to 50% and are frequently associated with coeliac artery occlusion. METHODS: PubMed and Embase databases were searched using appropriate terms. The systematic review was conducted according to PRISMA guidelines. RESULTS: We present the case of a 2 cm pancreaticoduodenal artery aneurysm pre-operative angiography demonstrated that the coeliac artery was occluded and the pancreaticoduodenal artery was providing collateral blood supply to the liver. Treatment was a staged hybrid intervention inclusive of an aorto-hepatic bypass using a 6 mm graft, followed by coil embolisation of the aneurysm. We also present a systematic review of the management of PDAAs. Two hundred and ninety-two publications were identified initially with 81 publications included in the final review. Of the 258 peripancreatic aneurysms included, 175 (61%) were associated with coeliac artery disease either occlusion or stenosis. Abdominal pain was the main presentation in 158 cases. Rupture occurred in 111 (40%) of patients with only ten (3.8%) cases being unstable on presentation. Fifty (18%) cases were detected incidentally while investigating another pathology. Over half the cases (n=141/54.6%) were treated by trans arterial embolisation (TAE) alone, while 37 cases had open surgery only. Twenty-one cases needed TAE and a coeliac stent. Seventeen cases underwent hybrid treatment (open and endovascular). Sixteen cases were treated conservatively and in 26 cases, treatment was not specified. CONCLUSION: PDAAs are commonly associated with coeliac artery disease. The most common presentation is pain followed by rupture. The scarcity of literature about true peripancreatic artery aneurysms associated with CA occlusive disease makes it difficult to assess the natural history or the appropriate treatment. Revascularisation of hepatic artery is better done with bypass in setting of median arcuate ligament compression and occluded celiac trunk.

A systematic review of simulation in open abdominal aortic aneurysm repair.

OBJECTIVE: Concerns about the long-term durability of endovascular aortic aneurysm repair and the requirement for explantation of stents in the case of infection demonstrate the continued need for open abdominal aortic aneurysm (AAA) repair. However, with the increased complexity and decreasing volume of open cases performed, maintenance of skills and training of younger surgeons are challenging. The aim of this review was to identify and to examine studies pertaining to open AAA simulation, with focus on methods and outcomes. METHODS: We performed a systematic review of the literature to identify primary research pertaining to open AAA repair through the use of simulators. The primary outcome was to identify predominant modes of simulator design and validated assessment tools that could demonstrate improvement in trainee skills. Secondary outcomes included identifying participant numbers needed to power studies and whether tools not validated externally contributed to the studies. RESULTS: There were 309 unique papers identified, from which five papers met the inclusion criteria. The selected papers used a combination of synthetic (commercial and homemade) and cadaveric simulators. A variety of validated and nonvalidated assessment metrics were used, including Objective Structured Assessment of Technical Skills, global rating scales, and realism surveys. Three of the five papers used blinding as part of their assessments. Mean participant numbers were 30.8 ± 25.7 and with the exception of one paper consisted entirely of surgical trainees in dedicated general or vascular surgery training programs. CONCLUSIONS: Several options are currently available for open AAA simulation, all of which demonstrate improved scoring metrics after simulator use. Validated scoring systems, the Objective Structured Assessment of Technical Skills in particular, were most frequently used to deliver objective results. Whereas junior trainees derive the most benefit, senior trainees also showed significant improvements, demonstrating that simulation benefits all levels of surgical trainees. Low numbers of participants were sufficient to achieve statistical benefit within individual studies.

Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia.

OBJECTIVE: Neurologic dysfunction remains a persistent complication of extensive aortic repair owing to disruption of the spinal collateral network. We hypothesized that staged repair might mitigate the incidence and severity of this spinal cord ischemia (SCI). METHODS: We conducted a retrospective cohort study of patients undergoing a Crawford type II repair of a thoracoabdominal aortic aneurysm between January 2008 and July 2013. Baseline demographics, incidence of prior aortic surgery, comorbidities, and outcomes were prospectively recorded. Staged repair was defined as intentional completion of the endovascular repair as two temporally separate procedures, referred to as a two-stage repair. Extent of aortic cover was calculated by three-dimensional imaging and reported as the proportion of the aorta covered between the left subclavian artery and the aortic bifurcation. Primary outcome measures were incidence and severity of SCI and mortality. RESULTS: The study included 87 patients, divided into the following subgroups: single-stage repair (n = 32; repair in a single procedure, without prior aortic surgery), two-stage repair (n = 27; repair in two separate procedures, without prior aortic surgery), and unintentionally staged repair (n = 28; those with prior aortic surgery, without an intention to stage). Median time between stages was 5 months (range, 1-60 months). All groups were equivalent in terms of demographics and risk factors; however, the staged group had significantly greater proximal aortic cover (P = .001). The overall rates of SCI in the nonstaged and staged groups were 37.5% (12 of 32) and 11.1% (3 of 27), respectively (P = .03). Furthermore, all neurologic injuries in the staged group were temporary. The 30-day survival in the single-stage, two-stage, and unintentionally staged repairs was 18.8%, 0%, and 10.7%, respectively (P = .52). CONCLUSIONS: Staged repair appears both to protect against SCI and to enhance overall survival in extensive aortic repair.

Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality.

OBJECTIVES: Fenestrated and branched endografts allow for proximal sealing zone extension into or above the visceral aorta to optimize landing in healthy aorta. We describe the incidence, causes, and implications of proximal endoleak development in patients undergoing complex endovascular aortic aneurysm repair. METHODS: All patients undergoing a fenestrated/branched repair were entered onto a prospective database, and this analysis included all those with at least one postoperative contrast computed tomography scan. Preoperative and postoperative three-dimensional imaging was reanalyzed to characterize morphology and identify endoleak. A blinded assessor used the preoperative imaging to resize the repairs in the endoleak group and a matched cohort of patients without endoleak. The outcome measures were proximal endoleak development, mortality, and component stability, and a comparison was made with all patients undergoing complex aortic repair. RESULTS: From 2001 to July 2013, 969 patients underwent repair in a physician-sponsored investigational device exemption trial. Excluded were 24 emergency patients and 21 patients without requisite imaging, leaving 924 available for analysis. A proximal type Ia endoleak developed in 26 patients (2.8%). Poor choice of landing zone was implicated in most cases, with an area of sealing in the visceral aorta, compared with the thoracic aorta, being significantly associated with endoleak development (P < .01). Aortic-related mortality was significantly higher in the endoleak group (26.9%) than in the group without endoleak (6.2%; P = .001). These patients also experienced a higher incidence of component instability of 30.8% compared with 9.6% in patients without type Ia endoleak (P < .01). CONCLUSIONS: Fenestrated/branched endovascular repair has a low incidence of sealing zone failure despite the increased complexity. However, development of a proximal endoleak destabilizes the repair and leads to increased mortality. Increasing complexity of design seems to improve the long-term outcome for patients requiring complex aortic repair.

Late rescue of proximal endograft failure using fenestrated and branched devices.

OBJECTIVE: Endovascular aneurysm repair (EVAR) will fail over time in a percentage of patients. Mechanical failure of the device, progression of aortic disease, or interface complications between the device and the native vasculature may contribute. Our aim was to evaluate the role of fenestrated and branched endografts as treatment options for failed devices. METHODS: Between January 2001 and June 2013, 970 patients were enrolled into a physician-sponsored investigational device exemption (PSIDE) study and treated with a fenestrated/branched endograft. All patients treated for nonurgent proximal neck failure of an infrarenal endoprosthesis previously implanted during EVAR comprised the study group. Patients treated for a primary aneurysm within the PSIDE were evaluated as a comparison group to identify preoperative risk factors for failure. A retrospective review was undertaken to determine the details of the initial EVAR, whereas the prospective PSIDE database was used to assess outcomes of secondary treatment. Three-dimensional imaging techniques were used to define all morphologic measurements. Statistical analysis included comparisons between categoric variables with the χ(2) test and between continuous variables with the Wilcoxon rank sum test between patients with late failures and those with native aortic repair. Kaplan-Meier curves were used to analyze overall survival. RESULTS: Of 970 patients enrolled in the PSIDE, 54 (5.6%) had late failure of a prior endograft. Fenestrated/branched devices were used to address the failure in each patient. The etiology of failure was related to a proximal neck issue in all patients: type Ia endoleak in 38, stent migration in 18, neck degeneration in 28, or some combination of these factors. The endovascular rescue procedure took place a mean of 61 months after the primary procedure. The mean aneurysm diameter at reintervention was 67 mm. Patients requiring a secondary fenestrated procedure were younger at the time of their primary intervention (P = .039) and were more likely to have a history of chronic renal insufficiency (P = .05) compared with other patients in the PSIDE. Technical success rate in the study group was 85% (44 of 52). Successful stenting was achieved in 71 of 77 (92%) target vessels. Thirty-day mortality was 3.8% (two of 52). Fluoroscopy dose and operating time were longer in the rescue group (P = .07) than in the control group (P = .008). Secondary interventions were required in 36.5% (19 of 52) of patients. CONCLUSIONS: Our series demonstrates the risk for late failure after EVAR is greater in patients who are younger and have chronic renal impairment at the time of implantation. Branched and fenestrated repair after failed EVAR is more complex than repair in the native aorta. More research is needed to identify patients at higher risk of failure after EVAR to prevent the need for rescue in the future.

Outcomes for supra-aortic branch vessel stenting in the treatment of thoracic aortic disease.

OBJECTIVE: Endovascular options for the treatment of proximal thoracic and arch disease have evolved over the years. In this manuscript, we review the midterm results of fenestrated compared with chimney configurations for proximal aortic aneurysm disease. METHODS: We performed an analysis of all patients with chimney grafts or custom fenestrated endografts used for treatment of proximal thoracic aneurysm disease (involving the supra-aortic trunk vessels) presenting to our institution between 2004 and 2013. Patients were identified by retrospective chart review and through the prospective database (National Institutes of Health study number NCT00583050). Details of devices placed, intraoperative details, and measurements from postoperative imaging were included in the analysis. The primary outcomes of interest were long-term freedom from branch stent complications and freedom from proximal endoleak, but we also included perioperative events, in-hospital mortality, and requirement for secondary interventions in our review. The log-rank test (Mantel-Cox) was used to compare survival data. Student t-test (two tailed) and Fisher exact test (two tailed) were used for continuous and categorical data, respectively. RESULTS: Of 767 patients who underwent thoracic endovascular repair from January 2004 to February 2013, 33 satisfied the inclusion criteria (4%): 18 of 33 noncustom and 15 of 33 custom graft designs. Overall, the rate of technical success was 97%. There were four branch stent-related problems in the follow-up period, one of 15 (7%) in the custom group and three of 18 (17%) in the noncustom group. There were three proximal sealing failures in the immediate postoperative and follow-up period, one of 15 (7%) in the custom group and two of 18 (11%) in the noncustom group. Overall, 10 patients underwent secondary procedures, four of 15 (27%) in the custom group and six of 18 (33%) in the noncustom group. CONCLUSIONS: Although they are technically feasible, both custom fenestrated endografts and chimney repairs for proximal thoracic disease involving the supra-aortic trunk vessels suffer from failures in intermediate follow-up, with a trend toward better long-term outcomes for custom devices. More work is needed to develop durable devices for this anatomic territory in the future.

Remote feedback in endovascular simulation training: a mixed-methods study.

BACKGROUND: There is an increasing need to increase simulation-based learning opportunities for vascular surgery residents in endovascular skills training. This study aims to explore the effectiveness of remote expert instructional feedback of endovascular simulation-based education, as a means of increasing training opportunities in this area for vascular surgery residents. METHODS: A mixed-methods study design was adopted. Twelve vascular surgery residents from Ireland were tasked with completing two endovascular renal artery procedures: one with in-person expert feedback and the other with remote instruction. Participants ranged in experience levels from second year to final year of residency. Following the training activities, interviews and a questionnaire were employed to gather information on the usefulness of remote feedback. RESULTS: There was no significant difference reported by participants using a post-event validated questionnaire between remote and in-person feedback. During the interviews, participants expressed mixed feelings about the presence of the educator while practicing, but they eventually saw no limiting factors to their practice when the trainer provided remote feedback. When receiving performance feedback remotely, clear communication and a shared knowledge of the task development are critical to success. CONCLUSIONS: We believe these findings can inform the design and development of remote learning and assessment of endovascular skills training and ultimately provide increased opportunities for more skills practice for vascular surgical residents.

Role of laparoscopy in penetrating abdominal trauma: a systematic review.

BACKGROUND: Debate remains regarding the optimum role of laparoscopy in the setting of trauma although it can offer advantages over traditional exploratory laparotomy. Laparoscopy can be a screening, diagnostic or therapeutic tool in trauma. The purpose of this review is to evaluate the role of laparoscopy in penetrating abdominal trauma METHODS: The PUBMED database was searched with the keywords "Laparoscopy AND Trauma". Additional citation searching and searching of the grey literature was conducted. Relevant studies were chosen on the basis of the defined inclusion and exclusion criteria and quality was assessed where appropriate using the Downs and Black checklist RESULTS: In total, 51 studies were included in the analysis of which only 13 were prospective. In most studies, laparoscopy was used as a screening, diagnostic or therapeutic tool. In total, 2569 patients underwent diagnostic laparoscopy (DL) for penetrating abdominal trauma (PAT), 1129 (43.95 %) were positive for injury. 13.8 % of those with injury had a therapeutic laparoscopy. In total 33.8 % were converted to laparotomy, 16 % of which were non-therapeutic and 11.5 % of them were negative. 1497 patients were spared a non-therapeutic laparotomy. Overall, 72 patients suffered complications, there were 3 mortalities and 83 missed injuries. Sensitivity ranged from 66.7-100 %, specificity from 33.3-100 % and accuracy from 50-100 %. 23 of the 50 studies reported sensitivity, specificity and accuracy of 100 %, including the four most recent studies. In general the quality of the reported studies was poor. When used for cohort studies, the mean Downs and Black checklist score was 13.25 out of a possible total of 28. CONCLUSIONS: In summary, laparoscopy in PAT may have an important role in a selected subgroup of patients, with surgeon expertise also an important factor. Laparoscopy has screening, diagnostic and therapeutic roles, particularly where diaphragm injury is suspected. It is extremely sensitive in determining need for laparotomy but detects hollow visceral injuries less reliably. It has potential as a therapeutic tool in centres with appropriate expertise. The development of specific guidelines or protocols may increase the value of laparoscopy in trauma but this would require more evidence of a higher quality.

A National Needs Assessment in Simulation Based Training in Vascular Surgery.

OBJECTIVES: The aim of this research was to ascertain the highest need areas for vascular simulation, in order to tailor training for the highest impact. DESIGN, PARTICIPANTS AND SETTING: A needs assessment was conducted according to best practices using the Delphi method. All consultant vascular surgeons/trainers in the training jurisdiction (n=33) were approached through an independent intermediary to contribute and generate a prioritized list of procedures for training. The research team were blinded to participant identities. Three rounds were conducted according to the Delphi process and scored according to the Copenhagen Needs Assessment Formula (CAMES-NAF). RESULTS: A final list of 34 vascular procedures was selected and prioritized by surgical trainers. Principles of arterial repair and endarterectomy/patching were considered the highest priority. Complex major interventions such as open abdominal aortic aneurysm (AAA) repair, carotid endarterectomy, and endovascular aortic repair (EVAR) consistently ranked higher than rarer, such as first rib resection and more basic procedures, such as foam injection for varicose veins. Major lower limb amputations typically ranked lower overall compared to arterial interventions. Surgical trainers generally agreed with the ranking according to the CAMES-NAF. There was some disagreement for a select few procedures such as iliac stenting (which rose 13 places) and open radial artery exposure (which fell 6 places) on subsequent iterations. CONCLUSIONS: Core operative principles and common major operative cases should remain the priority for vascular technical skills training. Other procedures which may be less invasive, but have the potential for major complications should also not be overlooked. In designing simulators the main focus should center on specific skill acquisition for commonly performed major procedures and management of the recognized potential complications. Lower limb amputations are considered adequately taught in clinical practice, or are too challenging to simulate in simulator models apart from cadaveric models.

Ambulatory outpatient venous surgery service: An examination of patient satisfaction and experiences.

BACKGROUND: This study aimed to ascertain patients' experience of the out-patient venous service being provided,; identify the level of patient satisfaction with the service and identify areas for further improvement and development. METHOD: A prospective descriptive quantitative study. A questionnaire was distributed to all patients who used the service between June 2017 and March 2018. A total of 195 questionnaires was distributed with 162 valid questionnaires returned; response rate of 83%. RESULTS: This study found high satisfaction levels with endovenous ablation procedures, with concomitant phlebectomy, in the ambulatory outpatient setting and patient experiences of the service are overwhelmingly positive. CONCLUSION: Study findings support the management of ambulatory outpatient varicose vein endovenous ablation procedures as a feasible alternative to day surgery theatre settings and is the blueprint for future management of varicose vein surgery in Ireland.

Tolerization with BLP down-regulates HMGB1 a critical mediator of sepsis-related lethality.

Tolerization with bacterial lipoprotein (BLP) affords a significant survival benefit in sepsis. Given that high mobility group box protein-1 (HMGB1) is a recognized mediator of sepsis-related lethality, we determined if tolerization with BLP leads to alterations in HMGB1. In vitro, BLP tolerization led to a reduction in HMGB1 gene transcription. This was mirrored at the protein level, as HMGB1 protein expression and release were reduced significantly in BLP-tolerized human THP-1 monocytic cells. BLP tolerance in vivo led to a highly significant, long-term survival benefit following challenge with lethal dose BLP in C57BL/6 mice. This was associated with an attenuation of HMGB1 release into the circulation, as evidenced by negligible serum HMGB1 levels in BLP-tolerized mice. Moreover, HMGB1 levels in peritoneal macrophages from BLP-tolerized mice were reduced significantly. Hence, tolerization with BLP leads to a down-regulation of HMGB1 protein synthesis and release. The improved survival associated with BLP tolerance could thus be explained by a reduction in HMGB1, were the latter associated with lethality in BLP-related sepsis. In testing this hypothesis, it was noted that neutralization of HMGB1, using anti-HMGB1 antibodies, abrogated BLP-associated lethality almost completely. To conclude, tolerization with BLP leads to a down-regulation of HMGB1, thus offering a novel means of targeting the latter. HMGB1 is also a mediator of lethality in BLP-related sepsis.

Endovascular brachytherapy and restenosis following lower limb angioplasty: Systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Restenosis is a fundamental weakness of percutaneous femoropopliteal angioplasty (PTA). The potential of endovascular brachytherapy (EVBT) to reduce restenosis has been evaluated in randomized clinical trials, but no pooled analysis has been undertaken. METHODS: A systematic review was undertaken to identify randomized controlled trials in which PTA alone was compared to PTA plus EVBT. The Pubmed and Medline databases, American Heart Association OASIS database and conference proceedings from the Peripheral Vascular Surgery Society and Vascular Society of Great Britain and Ireland were searched. Eligible studies were randomised controlled trials comparing PTA to PTA plus EVBT in human subjects with at least one clinical outcome reported (restenosis, complications, patency). Study quality was assessed by the Jadad score. Random-effects modeling was used to generate pooled effect size estimates. RESULTS: Six trials (687 patients) were identified. EVBT reduced 12-month restenosis rates (pooled odds ratio 0.50; 95% CI 0.301-0.836; p=0.008). The benefit disappeared by 24 months. The short-term risk of new lesions elsewhere in the treated artery was significantly increased by EVBT (pooled odds ratio 8.65; 95% CI 2.176-34.391; p=0.002). CONCLUSIONS: While limited by the small sample sizes in the included trials, this analysis suggests that the early benefit of EVBT is counter-balanced by the increased risk of new lesions and the lack of medium- to long-term reductions in restenosis risk. Based upon the best available evidence, EVBT cannot be recommended for routine clinical use.