Arterio-Ureteral Fistula: Systematic Review of 445 Patients.

PURPOSE: Arterio-ureteral fistula (AUF) is an uncommon diagnosis, but increasingly reported and potentially lethal. This systematic review comprehensively presents risk factors, pathophysiology, location and clinical presentation of AUF aiming to increase clinical awareness of this rare but life-threatening condition, and to put this entity into a contemporary perspective with modern diagnostic tools and treatment strategies. MATERIALS AND METHODS: This review was performed according to the PRISMA (Preferred Reporting Items for a Systematic Review and Meta-Analysis of Individual Participant Data) guidelines. A literature search in PubMed® and EMBASE™ was conducted. In addition, retrieved articles were cross-referenced. Data parameters included oncologic, vascular and urological history, diagnostics, treatment, and followup, and were collected using a standard template by 2 independent reviewers. RESULTS: A total of 245 articles with 445 patients and 470 AUFs were included. Most patients had chronic indwelling ureteral stents (80%) and history of pelvic oncology (70%). Hematuria was observed in 99% of the patients, of whom 76% presented with massive hematuria with or without previous episodes of (micro)hematuria. For diagnosis, angiography had a sensitivity of 62%. The most predominant location of AUF was at the common iliac artery ureteral crossing. AUF-specific mortality before 2000 vs after 2000 is 19% vs 7%, coinciding with increasing use of endovascular stents. CONCLUSIONS: AUF should be considered in patients with a medical history of vascular surgery, pelvic oncologic surgery, irradiation and/or chronic indwelling ureteral stents presenting with intermittent (micro)hematuria. A multidisciplinary consultation is necessary for diagnosis and treatment. The most sensitive test is angiography and the preferred initial treatment is endovascular.

Arterio-ureteral fistula: a nationwide cross-sectional questionnaire analysis.

PURPOSE: Arterio-ureteral fistula (AUF) is an uncommon diagnosis, but potentially lethal. Although the number of reports has increased over the past two decades, the true incidence and contemporary urologists' experience and approach in clinical practice remains unknown. This research is conducted to provide insight in the incidence of AUF in The Netherlands, and the applied diagnostic tests and therapeutic approaches in modern practice. METHODS: A nationwide cross-sectional questionnaire analysis was performed by sending a survey to all registered Dutch urologists. Data collection included information on experience with patients with AUF; and their medical history, diagnostics, treatment, and follow-up, and were captured in a standardized template by two independent reviewers. Descriptive statistics were used. RESULTS: Response rate was 62% and 56 AUFs in 53 patients were reported between 2003 and 2018. The estimated incidence of AUF in The Netherlands in this time period is 3.5 AUFs per year. Hematuria was observed in all patients; 9% intermittent microhematuria, and 91% presenting with, or building up to massive hematuria. For the final diagnosis, angiography was the most efficient modality, confirming diagnosis in 58%. Treatment comprised predominantly endovascular intervention. CONCLUSION: The diagnosis AUF should be considered in patients with persistent intermittent or massive hematuria.

Early and Late Outcomes of Endovascular Aneurysm Repair for Infected Abdominal Aortic and/or Iliac Aneurysms.

BACKGROUND: Infected abdominal aortic and/or iliac aneurysm (AAIA) is a rare condition with a high mortality rate when treated with open surgery. In the past decade, the condition has increasingly been treated with endovascular aneurysm repair (EVAR). However, early and late outcomes, including the continued need for antibiotic treatments and predictors of persistent infection, are poorly understood. METHODS: We evaluated the outcomes of patients who underwent EVAR for infected AAIA from January 2010 to October 2017. We collected data including patient age, gender, clinical presentation, aneurysm location, culture results, intraoperative details, postoperative complications, 30-day mortality, in-hospital mortality, persistent infection, reintervention, and survival. RESULTS: Among 792 patients diagnosed with AAIA, 64 were diagnosed with primary infected aneurysm, underwent EVAR, and were included in this study (81.3% male; median age, 72 years; range, 18-94 years). The most commonly isolated organisms were Salmonella species (34%), followed by Streptococcus (21%), and Staphylococcus species (21%). Aneurysms were intact in 48 patients (75%) and were ruptured in 16 (25%). The perioperative mortality was 4.7% (3 patients) of whom one was diagnosed with ruptured infected AAIA. Six (9.4%) patients died during hospitalization, 5 of severe sepsis with multiorgan failure and one of myocardial infarction. Among the 58 surviving patients, 34 (58.6%) had persistent infection, of whom 13 (22.4%) required early and late reintervention, including 2 with endograft infection, 8 with primary and secondary aortoenteric fistula, 2 with recurrent new aortic infection, and one with graft limb occlusion. The remaining 24 patients were able to discontinue antibiotics and had no recurrence or need for reintervention. Overall survival rates at 1, 3, and 5 years in the antibiotic-discontinuation group were 91.7%, 87.5%, and 68.0%, respectively, and 82.4%, 52.6%, and 32.9%, respectively, in the persistent-infection group (P = 0.009). In multivariable analysis, primary aortoenteric fistula (Adjusted OR [aOR], 20.469; 95% confidence interval (CI), 1.265-331.320; P = 0.034) and preoperative serum albumin level <3 g/dL (aOR, 7.399; 95% CI, 1.176-46.558; P = 0.033) were preoperative parameter that predicted persistent infection. A C-reactive protein level more than 5 mg/L (aOR, 34.378; 95% CI, 4.888-241.788; P < 0.001) was observed in patients with persistent infection. CONCLUSIONS: EVAR is a feasible treatment with acceptable perioperative mortality for infected AAIA. Patients able to discontinue antibiotics have better survival and lower reintervention rates than those with persistent infection. A preoperative albumin level below 3 g/dL and primary aortoenteric fistula predicted persistent infection in this population.

Mid-Term Outcomes of Chimney Endovascular Aortic Aneurysm Repair: A Systematic Review and Meta-analysis.

BACKGROUND: To provide an overview of the literature on the mid-term outcomes of chimney EVAR (ChEVAR) for the treatment of juxtarenal abdominal aortic aneurysms (JAAA). METHODS: Different electronic databases were searched for published articles up to January 2020. The eligibility criteria were studies describing mid- or long-term outcomes of chimney EVAR (mean follow-up at least 1 year) for treatment of JAAA, including more than 10 cases, published in English, and with full text available. The outcomes measure were overall survival rate, target vessel patency, and freedom from reintervention at 3 years. Quality of the included studies was analyzed using the MINORS criteria. Pooled effect estimates were analyzed using random-effect models and heterogeneity was tested using I2 statistics. RESULTS: Thirteen articles met the inclusion criteria. The included studies described 1,019 patients. According to the quality assessment, methodological quality was moderate to poor. The pooled overall survival, freedom from reintervention, and target vessel patency at 3 year was 81.4 % (95%CI 73.8-87.9), 85.7% (95%CI 75.6-93.5), and 95.1% (95%CI 89.3-98.7) respectively. CONCLUSIONS: The results of this review show good to acceptable short and mid-term survival and good mid-term durability, which supports that ChEVAR as a suitable alternative in high-risk JAAA. However, proper patient selection for ChEVAR seems essential to attain good mid-term outcomes, and further large prospective and good quality studies are required to demonstrate its long-term results and enable conclusions on specific determinants for outcome.

Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice.

INTRODUCTION: While the operator radiation dose rates are correlated to patient radiation dose rates, discrepancies may exist in the effect size of each individual radiation dose predictors. An operator dose rate prediction model was developed, compared with the patient dose rate prediction model, and converted to an instant operator risk chart. MATERIALS AND METHODS: The radiation dose rates (DRoperator for the operator and DRpatient for the patient) from 12,865 abdomen X-ray acquisitions were selected from 50 unique patients undergoing standard or complex endovascular aortic repair (EVAR) in the hybrid operating room with a fixed C-arm. The radiation dose rates were analyzed using a log-linear multivariable mixed model (with the patient as the random effect) and incorporated varying (patient and C-arm) radiation dose predictors combined with the vascular access site. The operator dose rate models were used to predict the expected radiation exposure duration until an operator may be at risk to reach the 20 mSv year dose limit. The dose rate prediction models were translated into an instant operator radiation risk chart. RESULTS: In the multivariate patient and operator fluoroscopy dose rate models, lower DRoperator than DRpatient effect size was found for radiation protocol (2.06 for patient vs 1.4 for operator changing from low to medium protocol) and C-arm angulation. Comparable effect sizes for both DRoperator and DRpatient were found for body mass index (1.25 for patient and 1.27 for the operator) and irradiated field. A higher effect size for the DRoperator than DRpatient was found for C-arm rotation (1.24 for the patient vs 1.69 for the operator) and exchanging from femoral access site to brachial access (1.05 for patient vs 2.5 for the operator). Operators may reach their yearly 20 mSv year dose limit after 941 minutes from the femoral access vs 358 minutes of digital subtraction angiography radiation from the brachial access. CONCLUSION: The operator dose rates were correlated to patient dose rate; however, C-arm angulation and changing from femoral to brachial vascular access site may disproportionally increase the operator radiation risk compared with the patient radiation risk. An instant risk chart may improve operator dose awareness during EVAR.

Endovascular ascending aortic repair in type A dissection: A systematic review.

PURPOSE: Up to 10% of acute type A aortic dissection (TAAD) patients are deemed unfit for open surgical repair, exposing these patients to high mortality rates. In recent years, thoracic endovascular aortic repair has proven to be a promising alternative treatment modality in specific cases. This study presents a comprehensive overview of the current state of catheter-based interventions in the setting of primary TAAD. METHODS: A literature search was conducted, using MEDLINE and PubMed databases according to PRISMA guidelines, updated until January 2020. Articles were selected if they reported on the endovascular repair of DeBakey Type I and II aortic dissections. The exclusion criteria were retrograde type A dissection, hybrid procedures, and combined outcome reporting of mixed aortic pathologies (e.g., pseudoaneurysm and intramural hematoma). RESULTS: A total of 31 articles, out of which 19 were case reports and 12 case series, describing a total of 92 patients, were included. The median follow-up was 6 months for case reports and the average follow-up was 14 months for case series. Overall technical success was 95.6% and 30-day mortality of 9%. Stroke and early endoleak rates were 6% and 18%, respectively. Reintervention was required in 14 patients (15%). CONCLUSION: This review not only demonstrates that endovascular repair in the setting of isolated TAAD is feasible with acceptable outcomes at short-term follow-up, but also underlines a lack of mid-late outcomes and reporting consistency. Studies with longer follow-up and careful consideration of patient selection are required before endovascular interventions can be widely introduced.

Telehealth and telemedicine applications for the diabetic foot: A systematic review.

The aim of this systematic review is to assess the peer-reviewed literature on the psychometric properties, feasibility, effectiveness, costs, and current limitations of using telehealth and telemedicine approaches for prevention and management of diabetic foot disease. MEDLINE/PubMed was searched for peer-reviewed studies on telehealth and telemedicine approaches for assessing, monitoring, preventing, or treating diabetic foot disease. Four modalities were formulated: dermal thermography, hyperspectral imaging, digital photographic imaging, and audio/video/online communication. Outcome measures were: validity, reliability, feasibility, effectiveness, and costs. Sixty-one studies were eligible for analysis. Three randomized controlled trials showed that handheld infrared dermal thermography as home-monitoring tool is effective in reducing ulcer recurrence risk, while one small trial showed no effect. Hyperspectral imaging has been tested in clinical settings to assess and monitor foot disease and conflicting results on its diagnostic use show that this method is still in an experimental stage. Digital photography is used to assess and monitor foot ulcers and pre-ulcerative lesions and was found to be a valid, reliable, and feasible method for telehealth purposes. Audio/video/online communication is mainly used for foot ulcer monitoring. Two randomized controlled trials show similar healing efficacy compared with regular outpatient clinic visits, but no benefit in costs. In conclusion, several technologies with good psychometric properties are available that may be of benefit in helping to assess, monitor, prevent, or treat diabetic foot disease, but in most cases, feasibility, effectiveness, and cost savings still need to be demonstrated to become accepted and used modalities in diabetic foot care.

Impact of Aortic Tortuosity on Displacement Forces in Descending Thoracic Aortic Aneurysms.

OBJECTIVE: As elastin fibres in the aorta deteriorate with age, the descending thoracic aorta (DTA) becomes longer and more tortuous. In patients with DTA aneurysms, this increased tortuosity may result in a hostile haemodynamic environment for thoracic endovascular aortic repair (TEVAR). The objective of this study was to analyse how increased tortuosity affects haemodynamic displacement forces (DFs) in different segments of the DTA in patients with DTA aneurysms (DTAAs). METHODS: Thirty patients with DTAAs were selected to form three equal groups based on the maximum tortuosity of their DTA: low < 30°, moderate 30°-60°, and high > 60°. Computational fluid dynamics simulations were performed to calculate DFs in all patients. Image based segmentations were carried out to create patient specific models of the aortic geometry. When physiological simulation results were obtained, the haemodynamic DFs on the aortic wall were calculated in four segments of the DTA (zones 4A - D). To enable comparison of DFs in different segments, the DF was normalised by the aortic wall surface area, the equivalent surface traction (EST). RESULTS: The mean age was 73 years, with 67% male. In zone 4C, where most tortuosity occurs, the EST in patients with high tortuosity was more than three times higher, than those with low tortuosity (low, 743 N/m2; moderate, 956 N/m2; high, 2294 N/m2; p = .004). These differences could be attributed to the higher sideways components of the DF vectors, which were more than two times greater in patients with high tortuosity than in patients with low or moderate tortuosity (low, 5.01 N; moderate, 5.50 N; high, 13.21 N; p = .009). CONCLUSION: High tortuosity results in increased displacement forces in the distal segments of the DTA. These forces should be taken into account when planning for TEVAR, as potentially they increase the risk of stent graft related complications, such as migration and endoleak.

Reticulated Platelets as Predictor of Myocardial Injury and 30 Day Mortality After Non-cardiac Surgery.

OBJECTIVE: A pre-operative marker for identification of patients at risk of peri-operative adverse events and 30 day mortality might be the percentage of young, reticulated platelets (pRP). This study aimed to determine the predictive value of pre-operative pRP on post-operative myocardial injury (PMI) and 30 day mortality, in patients aged ≥ 60 years undergoing moderate to high risk non-cardiac surgery. METHODS: The incidence of PMI (troponin I > 0.06 µg/L) and 30 day mortality was compared for patients with normal and high pRP (≥2.82%) obtained from The Utrecht Patient Orientated Database. The predictive pRP value was assessed using logistic regression. A prediction model for PMI or 30 day mortality with known risk factors was compared with a model including increased pRP using the area under the receiving operator characteristics curve (AUROC). RESULTS: In total, 26.5% (607/2289) patients showed pre-operative increased pRP. Increased pRP was associated with more PMI and 30 day mortality compared with normal pRP (36.1% vs. 28.3%, p < .001 and 8.6% vs. 3.6%, p < .001). The median pRP was higher in patients suffering PMI and 30 day mortality compared with not (2.21 [IQR: 1.57-3.11] vs. 2.07 [IQR: 1.52-1.78], p = .002, and 2.63 [IQR: 1.76-4.15] vs. 2.09 [IQR: 1.52-3.98], p < .001). pRP was independently related to PMI (OR: 1.28 [95% CI: 1.04-1.59], p = .02) and 30 day mortality (OR: 2.35 [95% CI: 1.56-3.55], p < .001). Adding increased pRP to the predictive model of PMI or 30 day mortality did not increase the AUROC 0.71 vs. 0.72, and 0.80 vs. 0.81. CONCLUSION: In patients undergoing major non-cardiac surgery, increased pre-operative pRP is related to 30 day mortality and PMI.

Tortuosity of the Descending Thoracic Aorta in Patients with Aneurysm and Type B Dissection.

OBJECTIVE: Tortuosity in the descending thoracic aorta (DTA) comes with aging and increases the risk of endoleaks after TEVAR. With this report, we would like to define and classify tortuosity in the DTA of patients with thoracic aortic disease. METHODS: Retrospective case-control study of two hundred seven patients, comparing sixty-nine controls without aortic disease (CG), to sixty-nine patients with descending thoracic aortic aneurysm (AG) and sixty-nine patients with type B aortic dissection (DG). 3Mensio Vascular software was used to analyze CTA scans and collect the following measurements; tortuosity index, curvature ratio and the maximum tortuosity of the DTA. The DTA was divided into four equal zones. The maximum tortuosity was divided into three groups: low (<30°), moderate (30°-60°) and high tortuosity (>60°). RESULTS: Compared to the CG, tortuosity was more pronounced in the DG, and even more in the AG, evidenced by the tortuosity index (1.11 vs. 1.20 vs. 1.31; p < 0.001), curvature ratio (1.00 vs. 1.01 vs. 1.03; p < 0.001), maximum tortuosity in degrees (28.17 vs. 33.29 vs. 43.83; p < 0.001) and group of tortuosity (p < 0.001). The maximum tortuosity was further distal for the DG and AG, evidenced by the zone of maximum tortuosity (4A vs. 4B vs. 4B; p < 0.001). CONCLUSION: This study shows that tortuosity in the DTA is more prominent in diseased aortas, especially in aneurysmal disease. This phenomenon needs to be taken into account during planning of TEVAR to prevent stent graft-related complications and to obtain positive long-term outcome.

Type 1b Endoleaks After Thoracic Endovascular Aortic Repair are Inadequately Reported: A Systematic Review.

BACKGROUND: Complications after thoracic endovascular aortic repair (TEVAR) are common. Even after a successful TEVAR, a late endoleak (>30 days) can occur. The objective of this study is to summarize the current evidence and, if lacking, the need of evidence regarding the incidence and predictive factors for type 1b endoleak in patients with aortic aneurysm treated with TEVAR. METHODS: A systematic review of the literature was performed on endoleak type 1b, in patients with aortic aneurysm, after TEVAR. The PubMed and Embase databases were systematically searched for articles regarding endoleak type 1b up to January 2019. The main subjects discussed are the incidence, risk factors, treatment, and prognosis. RESULTS: About 722 articles were screened, and 16 articles were included in this review. The reported incidence of endoleak is between 1.0% and 15.0%, with a mean follow-up duration of at least 1 year. Type 1b endoleak is associated with an increased aortic tortuosity index (>0.15 cm-1). No significant difference is found in relation to age and gender. Treatment is required in most cases (22/27) and is usually performed with distal extension of the stent graft (21/27). There are no data regarding stent graft oversizing, length of distal landing zone, and differences between devices or the prognosis for patients with type 1b endoleak. CONCLUSIONS: Limited literature is available on the occurrence of type 1b endoleak after TEVAR. A tortuous aorta can be associated as a predictive factor for the occurrence of type 1b endoleak. Data clearly delineating the anatomic variables predicting type 1b endoleak should be examined and listed. Likewise, the impact of more recent conformable devices to prevent complications like type 1b endoleaks from occurring should be elucidated.

Early and late outcomes of endovascular aneurysm repair to treat abdominal aortic aneurysm compared between severe and non-severe infrarenal neck angulation.

BACKGROUND: Abdominal aortic aneurysm with severe infrarenal neck angle (>60°) has long been thought to be an obstacle to endovascular aneurysm repair. However, some previous studies reported endovascular aneurysm repair to be safe and efficacious for treating abdominal aortic aneurysm in patients with severe neck angulation. The aim of this study was to investigate the early and late outcomes of endovascular aneurysm repair to treat abdominal aortic aneurysm compared between patients with severe and non-severe infrarenal neck angulation. METHODS: Fifty-four severe and 144 non-severe neck angulation patients who were treated at Siriraj Hospital (Bangkok, Thailand) during January 2010-October 2013 were recruited. The primary endpoints were intraoperative neck complications (e.g., type 1A endoleak or proximal graft migration) and immediate adjunct aortic neck procedures. The secondary endpoints included perioperative mortality, overall survival, and the proportion of patients that were reintervention-free at five years compared between the severe and non-severe groups. RESULTS: Severe angulation patients were significantly older than non-severe angulation patients (77 ± 6.3 vs. 74 ± 7.9 years; p = 0.021). The median proximal angle was significantly greater in the severe group (82° vs. 13.5°; p < 0.001). Intraoperative proximal neck complications developed in 29.6% of patients in the severe angulation group compared with 9.0% in the non-severe group (p < 0.001). Significantly more patients in the severe group required intraoperative adjunct procedures (29.6% vs. 7.6%; p < 0.001). There was no significant difference in perioperative mortality between groups. At the five-year follow-up, there was no significant difference between groups for overall survival or the proportion of patients that remained reintervention-free. CONCLUSIONS: Endovascular aneurysm repair to treat abdominal aortic aneurysm in patients with severe proximal neck angulation is technically feasible and safe Although the severe angulation group had a higher rate of intraoperative neck complications and immediate adjunct neck procedures than the non-severe group, there was no significant difference between groups for 30-day mortality, overall survival or the proportion of patients who remained reintervention-free at five years.

Critical appraisal of multidimensional CT measurements following acute open repair of type A aortic dissection.

INTRODUCTION: To identify patients with aneurysmal degeneration of the native aorta following type A aortic dissection (TAAD), reproducible serial measurements of aortic dimensions are critical. We used a systematic workflow for measuring aortic geometry following TAAD, using computed tomography angiography data, and test its reproducibility. METHODS: The workflow for aortic measurements included centerline generation, luminal diameter, and area measurement at six anatomically defined locations along the aorta and luminal volumetric measurements in the descending aorta. Two independent observers measured the aortic geometry in 20 surgically repaired TAAD patients, preoperatively and at 3 months follow-up. To test reproducibility, intraobserver and interobserver agreement scores were analyzed using a concordance correlation coefficient (CCC). RESULTS: The interobserver agreement scores of the diameter, area, and volumetric measurements in the descending aorta were acceptable. The agreement scores of the area measurements were highest, with CCCs ranging from 0.909 to 0.984. Luminal diameter measurements scored lower than luminal area measurements and were least reproducible at the mid aortic arch (CCC < 0.886). Overall, intraobserver agreement scores were better than interobserver agreement scores (SD of mean difference was 1.89 vs 1.94 for intraobserver vs interobserver diameter measurements, and 0.61 vs 0.66 for area measurements). CONCLUSION: Although overall reproducibility was acceptable in descending aortic measurements, our results show that it remains challenging to reliably measure luminal diameters, compared with areas. To aid identification of early adverse remodeling following acute TAAD, novel two- and three-dimensional measurement techniques are needed that capture locoregional changes in the false lumen and true lumen morphology more accurately.

Outcomes of Open Repair, Fenestrated Stent Grafting, and Chimney Grafting in Juxtarenal Abdominal Aortic Aneurysm: Is It Time for a Randomized Trial?

BACKGROUND: The well-established, gold standard treatment for juxtarenal abdominal aortic aneurysms (JAAAs) is open repair (OR). However, endovascular treatment with fenestrated or chimney grafts has been increasingly performed in the past decade. This study compared the outcomes of OR with 2 endovascular methods in JAAA. METHODS: We retrospectively reviewed consecutive patients with JAAA who underwent OR (n = 32), repair with fenestrated stent grafts (fenestrated endovascular aortic aneurysm repair [FEVAR], n = 20), or chimney grafts (Ch-EVAR, n = 23) during the period from January 2011 to December 2016 at a single center. Our primary end point was perioperative mortality. Secondary end points included renal function impairment, new-onset dialysis, procedural details, and postoperative complications. Kaplan-Meier analysis was used to estimate freedom from late reintervention, primary patency of target vessel stent grafts, and overall survival. RESULTS: There were no significant differences between groups in baseline characteristics. Perioperative mortality was similar in all the 3 groups (3.1% (1/32) in the OR group, 0% in the FEVAR group, and 4.3% (1/23) in the Ch-EVAR group. Mean follow-up duration was 36.7 months (range 1-75 months). There were no significant differences between groups regarding any of the secondary end points, except for blood loss (which was significantly greatest in the OR group), and there was no significant difference in overall survival. Estimated target vessel stent patency at 1 and 4 years was 93.8% and 93.8% in the FEVAR group, and 89.5% and 89.5% in the Ch-EVAR group. There was no significant difference between groups in estimated freedom from late reintervention (96.4% in the OR group, 77.2% in the FEVAR group, and 82.3% in the Ch-EVAR group). CONCLUSIONS: Open surgery is an acceptable and effective treatment for JAAA. However, FEVAR and Ch-EVAR also showed high technical success rates and low perioperative mortality, with acceptable reintervention rates during follow-up.

Effect of Phenylephrine and Ephedrine on Cerebral (Tissue) Oxygen Saturation During Carotid Endarterectomy (PEPPER): A Randomized Controlled Trial.

BACKGROUND: Short-acting vasopressor agents like phenylephrine or ephedrine can be used during carotid endarterectomy (CEA) to achieve adequate blood pressure (BP) to prevent periprocedural stroke by preserving the cerebral perfusion. Previous studies in healthy subjects showed that these vasopressors also affected the frontal lobe cerebral tissue oxygenation (rSO2) with a decrease after administration of phenylephrine. This decrease is unwarranted in patients with jeopardized cerebral perfusion, like CEA patients. The study aimed to evaluate the impact of both phenylephrine and ephedrine on the rSO2 during CEA. METHODS: In this double-blinded randomized controlled trial, 29 patients with symptomatic carotid artery stenosis underwent CEA under volatile general anesthesia in a tertiary referral medical center. Patients were preoperative allocated randomly (1:1) for receiving either phenylephrine (50 µg; n = 14) or ephedrine (5 mg; n = 15) in case intraoperative hypotension occurred, defined as a decreased mean arterial pressure (MAP) ≥ 20% compared to (awake) baseline. Intraoperative MAP was measured by an intra-arterial cannula placed in the radial artery. After administration, the MAP, cardiac output (CO), heart rate (HR), stroke volume, and rSO2 both ipsilateral and contralateral were measured. The timeframe for data analysis was 120 s before, until 600 s after administration. RESULTS: Both phenylephrine (70 ± 9 to 101 ± 22 mmHg; p < 0.001; mean ± SD) and ephedrine (75 ± 11 mmHg to 122 ± 22 mmHg; p < 0.001) adequately restored MAP. After administration, HR did not change significantly over time, and CO increased 19% for both phenylephrine and ephedrine. rSO2 ipsilateral and contralateral did not change significantly after administration at 300 and 600 s for either phenylephrine or ephedrine (phenylephrine 73%, 73%, 73% and 73%, 73%, 74%; ephedrine 72%, 73%, 73% and 75%, 74%, 74%). CONCLUSIONS: Within this randomized prospective study, MAP correction by either phenylephrine or ephedrine showed to be equally effective in maintaining rSO2 in patients who underwent CEA. Clinical Trial Registration ClincalTrials.gov, NCT01451294.

Prognostic value of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification in patients with no-option chronic limb-threatening ischemia.

OBJECTIVE: The Wound, Ischemia, and foot Infection (WIfI) classification was developed to assess amputation risk and hence to aid in clinical decision-making in patients with chronic limb-threatening ischemia (CLTI). WIfI has been validated in multiple CLTI cohorts worldwide. In this study, we examined the relationship between WIfI stage and clinical outcomes in a well-defined subpopulation of CLTI patients considered not eligible for conventional revascularization. The aim of this study was to assess the prognostic value of the WIfI classification for clinical outcomes in a "no-option" CLTI population. METHODS: The Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation (JUVENTAS) trial was a single-center, double-blinded, randomized placebo-controlled trial studying the effects of autologous bone marrow mononuclear cells in no-option CLTI patients (N = 160). We conducted a retrospective analysis incorporating baseline and follow-up data from the JUVENTAS trial. All wounds were photographed and described at the start and end of the trial to allow WIfI staging. Two independent researchers retrospectively classified all limbs according to the WIfI scheme, which was then related to prospectively collected trial data. Outcomes including wound healing, clinical improvement, minor and major amputation rate, amputation-free survival, and mortality were assessed using Kaplan-Meier analyses. RESULTS: Of the 160 patients, 150 could be included in this study. Most patients had been classified as Rutherford stage 4 (34%) and stage 5 (61%), with corresponding WIfI stage 2 (33%), stage 3 (21%), or stage 4 (35%). Diabetes, impaired renal function, and ankle-brachial index were independently associated with WIfI stage. On univariate analysis, WIfI stage was strongly associated with wound healing (P = .001), improvement of Rutherford stage (P = .009), amputation rate (P < .001), and long-term mortality (median follow-up, 21.1 months; P = .025). Of note, WIfI stage 2 patients had a worse 6-month major amputation rate compared with stage 3. Of the seven amputated stage 2 patients, six were in WIfI category W0-I3-fI0 and scored a maximum grade 3 on ischemia. Reclassification of ischemic rest pain (W0-I3-fI0) to stage 3 improved and reordered the discrimination of outcomes by WIfI stage in this cohort. CONCLUSIONS: This is the first study to demonstrate that WIfI classification is associated with important clinical outcomes in a no-option CLTI population. Our data suggest that limb prognosis is poor in patients with classic ischemic rest pain, without wounds or infection (W0-I3-fI0), when they lack revascularization options. Further studies are needed to determine whether reassignment of this population from WIfI stage 2 to WIfI stage 3 may be appropriate to reflect amputation risk in the absence of successful revascularization for patients suffering from ischemic rest pain in general.

Procedure and step-based analysis of the occupational radiation dose during endovascular aneurysm repair in the hybrid operating room.

OBJECTIVE: This study measured the cumulative occupational X-ray radiation dose received by support staff during endovascular aortic procedures and during additional intraoperative steps in the hybrid operating room. METHODS: Radiation dose measurements were performed during interventions on 65 patients receiving 90 stent grafts during endovascular aneurysm repair (EVAR), bifurcated EVAR, thoracic EVAR, iliac branched device deployment, aortouni-iliac stenting, and fenestrated/branched EVAR (F/BrEVAR). X-ray imaging was acquired using the Philips Allura FD20 Clarity System (Philips Medical Systems, Best, The Netherlands). The occupational radiation dose (also referred to as the estimated effective dose, E, measured in millisieverts) was measured with the DoseAware Xtend system (Philips Medical Systems) personal dosimeters. E was reported per staff member (ESTAFF), where "staff" was a generic term for each staff member included in the study: the first operator (FO), the second operator (ESO), a virtual maximum operator (MO), and all additional supporting staff, including the sterile nurse, nonsterile nurse, anaesthesiologist, and radiation technician. The primary outcome was the median cumulative ESTAFF (or EFO, EMO, and so on), which was presented as the median cumulative dose per intervention and stratified for several within-interventional EVAR and F/BrEVAR steps or stents. The second outcome was the percentage of the absorbed E by a supporting staff member in relation to the E measured by the reference badge attached on the C-arm (ESTAFF% or EFO%, EMO%, and so on). All outcomes are presented as median with interquartile range, unless stated differently. RESULTS: The occupational effective dose in millisieverts of the MO (EMO) was 0.055 (0.029-0.082) for aortouni-iliac stenting (n = 6), 0.084 (0.054-0.141) during thoracic EVAR (n = 14), 0.036 (0.026-0.068) during bifurcated EVAR (n = 38), 0.054 (0.035-0.126) during iliac branched device deployment (n = 8), and 0.345 (0.235-0.757) during F/BrEVAR (n = 24). The median EMO in millisieverts was 0.025 (0.012-0.062) per renal target vessel (TV) and 0.146 (0.07-0.315) for a nonrenal visceral TV. During all noncomplex interventions, the EMO% was 4.4% (2.7%-7.3%), with the lowest median rate at 3.5% (2.5%-5%) for EVAR. The highest median rate EMO% was found for F/BrEVAR procedures: 8.2% (5.0%-14.4%). CONCLUSIONS: With maximum operator shielding during femoral access, relative occupational radiation risk can be minimized. However, digital subtraction angiography image acquisition, recanalization of TVs, recanalization of superior mesenteric artery or celiac artery, and recanalization of branched TVs are predictors for increased occupational radiation dose risks caused by increased radiation doses to the patient and reduced options for shielding of the operator.

Long-term mortality benefit of renin-angiotensin system inhibitors in patients with chronic limb-threatening ischemia undergoing vascular intervention.

OBJECTIVE: The beneficial effect of renin-angiotensin system (RAS) inhibitors has been well-established in patients with cardiovascular disease; however, their effectiveness in patients with chronic limb-threatening ischemia (CLTI), a selected disease-burdened population, is largely unknown. The purpose of this study was to evaluate long-term outcomes of RAS inhibitor use in patients with CLTI undergoing a vascular intervention. METHODS: For this study, all patients with CLTI undergoing a first-time revascularization (bypass or endovascular) were analyzed at our institution between 2005 and 2014. Patients discharged on an RAS inhibitor (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) were compared with those not on an RAS inhibitor. The inverse probability of treatment weighting with additional regression analyses were used to determine the long-term risk of mortality and major adverse events. A sensitivity analysis was performed to assess the dose-related therapeutic response of RAS inhibitors (low-dose vs high-dose therapy). RESULTS: Between 2005 and 2014, 1303 limbs from 1161 patients were identified. Of these patients, 52% were discharged on an RAS inhibitor, with 67% discharged on a high-dose therapy and 33% on a low-dose therapy. Patients discharged on an RAS inhibitor suffered more frequently from diabetes, hypertension, and myocardial infarction, whereas those not on an RAS inhibitor had more chronic kidney disease (all P < .05). There was no difference in the proportion of patients presenting with tissue loss. After adjustment for these and other baseline covariates, RAS inhibitor use was associated with less late mortality (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.65-0.94). Discharge on a high-dose RAS inhibitor was associated with lower mortality (HR, 0.70; 95% CI, 0.57-0.86), whereas a low-dose RAS inhibitor was not associated with less mortality (HR, 0.95; 95% CI, 0.73-1.24) compared with patients not prescribed an RAS inhibitor. This association remained significant when comparing high-dose with low-dose therapy (HR, 0.74; 95% CI, 0.55-0.98). No associations were found between RAS inhibitor use and major adverse limb event (HR, 0.95; 95% CI, 0.73-1.22), major amputation (HR, 0.82; 95% CI, 0.57-1.18), or reintervention (HR, 1.05; 95% CI, 0.85-1.31). These point estimates were not different for those on angiotensin-converting enzyme inhibitors vs angiotensin receptor blockers, nor were they affected by the type of revascularization. CONCLUSIONS: Patients with CLTI prescribed an RAS inhibitor at discharge demonstrated significantly less long-term mortality, whereas limb events were unaffected. These data indicate that, in these heavily burdened patients, the benefit is restricted to those on a high dose, which underscores the importance of attaining these doses.

Patient selection and perioperative outcomes of bypass and endovascular intervention as first revascularization strategy for infrainguinal arterial disease.

OBJECTIVE: The optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization. METHODS: Patients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes. RESULTS: Of 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ≥80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ≥80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4). CONCLUSIONS: An endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease.

Midterm outcomes and evolution of gutter area after endovascular aneurysm repair with the chimney graft procedure.

OBJECTIVE: The objective of this study was to describe our experience with endovascular aneurysm repair (EVAR) with the use of chimney grafts for branch vessel preservation. METHODS: Patients treated with a chimney graft procedure between October 2009 and May 2015 were included for analysis. Patients who were not considered eligible for open surgical repair or for conventional, branched, or fenestrated endovascular repair were selected. A standardized operating procedure with left brachial or axillary artery cutdown access for the chimney grafts and bilateral femoral artery cutdown access for the aortic main device was used. Outcomes were noted according to the Society for Vascular Surgery reporting standards. In addition, evolution of gutter area over time was determined. Estimated rates of survival, freedom from aneurysm growth, and clinical success at 24 months of follow-up were calculated. RESULTS: Thirty-three patients (mean age, 77.6 ± 6.8 years; 87.9% male) with a mean preoperative maximum aneurysm diameter of 71.7 ± 13.5 mm were included. A total of 54 of an intended 54 chimney grafts were deployed. Primary technical success and 30-day secondary clinical success rates were 87.9% and 84.8%, respectively. The early mortality rate was 6.1% (n = 2). The early type IA endoleak rate was 6.1% (n = 2), and the chimney graft occlusion rate was 6.1% (n = 2). Median follow-up duration was 26 months (interquartile range, 14.8-37.3 months). The estimated 2-year actuarial survival rate was 78.1% (standard error, ±7.4%). Late complications included type IA endoleak (n = 1), chimney graft occlusion (n = 2), type II endoleak with aneurysm growth (n = 4), and distal stent graft limb kinking and occlusion (n = 1). Late reinterventions included coil or glue embolization (n = 3), distal limb extension (n = 2), open endoleak ligation (n = 2), Palmaz stent placement (n = 1), repeated EVAR (n = 1), and femorofemoral bypass graft (n = 1). At 2 years, the estimated secondary clinical success and freedom from aneurysm growth rates were 80.5% (±7.2%) and 84.4% (±7.2%). Gutter size showed a small but significant decrease over time at the level of the proximal markers and at 10 mm distal from the markers. CONCLUSIONS: Midterm results show that a standardized procedure for EVAR using chimney grafts for branch vessel preservation is an acceptable option for high-risk patients with large, complex aneurysms who are unfit for open repair and who have been excluded from fenestrated EVAR. Gutter size decreases over time, but the rate of branch vessel loss and reinterventions demonstrate that this approach should remain reserved for those who are at truly prohibitive risk for open or fenestrated stent graft repair.