Faculty Bibliography

OBJECTIVE:Randomized controlled trials (RCTs) constitute level I evidence and are used as the backbone of guidelines and recommendations for treatment. Although RCTs are theoretically the studies of choice for the assessment of the effectiveness of health care interventions, these trials (and their interpretation) may sometimes result in erroneous conclusions, erroneous therapeutic decisions, and incorrect recommendations. We aimed to check the applicability of the results of RCTs to everyday practice. METHODS:We reviewed the literature for studies comparing the results of RCTs with observational or population-based studies in the field of vascular surgery, focusing on two specific topics: the results of carotid artery stenting vs carotid endarterectomy for the management of carotid artery stenosis; and the results of open surgical repair vs endovascular aneurysm repair for the management of ruptured abdominal aortic aneurysms. RESULTS:We found considerable discrepancy in the results of RCTs with real-life registries and observational studies in both topics. In the management of carotid artery stenosis, observational studies reported worse outcomes after carotid artery stenting compared with carotid endarterectomy. Regarding ruptured abdominal aortic aneurysms, population-based studies reported better results for endovascular aneurysm repair compared with open repair. In contrast, RCTs in both topics reported similar results for the two procedures. CONCLUSIONS:There is evidence that RCTs sometimes do not reflect clinical reality and are therefore potentially misleading to the reader. Every RCT has to be interpreted and applied carefully using complete available evidence and good clinical judgment.

OBJECTIVE:Hypogastric aneurysms (HAs) frequently coexist with aortoiliac aneurysms (AIAs). However, the presence of an HA is a contraindication to endovascular aneurysm treatment by iliac branch devices (IBDs) because of the risk of distal sealing-related endoleaks. No robust evidence exists in the published literature, and therefore we sought to evaluate the performance of IBDs in the presence of HAs within a multicenter registry of nine vascular centers. METHODS:Clinical and radiographic information of 804 patients with AIAs treated by IBDs was retrospectively reviewed and analyzed using prearranged, defined, and documented protocols. The treatment period was between January 2005 and April 2017. RESULTS:HA was present in 315 (32.6%) of the overall 910 deployed IBDs. Mean radiologic follow-up was 32 months. The incidence of incomplete aneurysm exclusion and type I endoleak was 3% in the HA group vs 0.7% in the non-HA group (P = .019). The 5-year freedom from IBD-related type I endoleak was 93% vs 98% in the HA group vs the non-HA group, respectively (P = .006). Subgroup analysis of the HA group revealed that use of a single distal bridging stent graft vs multiple bridging devices led to higher rate of type I endoleak (9.6% vs 2.8%; P = .031), branch occlusions (8.3% vs 0.9%; P = .009), and buttock claudication (7.6% vs 1.9%; P = .038). CONCLUSIONS:This series of AIAs with HAs is the largest reported. It shows that HAs coexisting with AIAs, when treated with IBDs, have significantly worse outcomes. Lengthening the distal landing zone with more than one bridging stent graft into the distal healthy hypogastric artery or one of its main branches improves outcomes.

OBJECTIVE:Chimney endovascular aortic aneurysm repair is gaining ever greater acceptance. However, persistent gutters leading to type IA endoleaks represent an unsolved issue. The aim of the current study was to analyze the impact of abdominal endograft oversizing to the occurrence of this phenomenon. METHODS:The PERformance of the snorkel/chImney endovascular teChnique in the treatment of compLex aortic PathologiesES registry includes the largest experience with chimney endovascular aortic aneurysm repair from 13 vascular centers in Europe and the U.S. Prospectively collected data from centers with standard use of the Endurant stent-graft and balloon-expandable covered stents as chimney grafts only were included in the present analysis. The parameter which varied was the degree of oversizing of the aortic stent-graft classifying the cohort in two groups, group A (20% and less oversizing) and group B (>20% of oversizing). The primary endpoint was the incidence of persistent type IA endoleak needed reintervention. Secondary endpoints were all-cause mortality and freedom from reintervention. RESULTS:Group A included 21 patients while group B 144. The mean preoperative pathology's neck length and diameter was 5.8 mm (±4.4) versus 4.9 mm (±3.8) and 27.6 mm (±4.7) versus 24.9 mm (±3.7) for group A and group B, respectively. The mean length of the new sealing zone after chimney graft placement was similar for both groups (group A versus group B; 17.9 mm versus 18.3 mm, respectively, P = .21). The percentage of oversizing of the aortic stent-graft ranged between 13.8 and 20% versus 22.2 and 30%, for group A and group B, respectively. Patients of group A had more type 1A endoleaks, (14.3%) versus patients of group B (2.1%) based on the first follow-up imaging, P = .02. The incidence of persistent type IA endoleaks needing a reintervention was 14.3 and 1.4% for the group A and group B, respectively, P = .01. The mean volume of contrast medium used was greater in group A versus group B with 239 ml versus150 ml, P = .05. Additionally, 14.3% of patients of group A experienced acute renal failure compared to those in group B which was 1.0%, P = .01. CONCLUSIONS:Oversizing of ideally 30% of the Endurant stent-graft is associated with significant lower incidence of type IA endoleaks requiring reintervention for patients treated by chimney endovascular aortic aneurysm repair.

Objective: Vascular graft infections (VGIs) lead to increased morbidity and mortality, and elderly and comorbid patients are often affected. Negative pressure wound therapy (NPWT) is increasingly used for VGI, and some authors even advocate that a better surgical treatment option is NPWT, debridement, and graft preservation compared with more aggressive approaches in case of VGI with intact anastomosis (Samson III infection). We aimed to assess the effect of NWPT in a large cohort of patients with VGI. Methods: Participants of the prospective Vascular Graft Infection Cohort Study (VASGRA) with vascular surgery between March 2013 and March 2017 were included. Observation time was calculated from the end of surgical treatment after diagnosis of VGI to the end of antimicrobial therapy (cure of infection) or last follow-up, whichever occurred first. Patient-and procedure-related variables were assessed by NPWT status (yes/no), location of VGI (aortoiliac, thoracic, or infrainguinal), or surgical procedure (debridement and retention of graft; partial or total explantation of graft) using nonparametric tests. We performed Kaplan-Meier curves and univariable and multivariable Cox proportional hazards regression models. Results: A total of 175, predominantly male (77%) patients with a median age of 67 years contributed to the analysis. Thereof, only 15 patients (8.3%) died of VGI after a follow-up time of 2.2 years. A surgical procedure was performed in 145 of 175 (83%) patients. The graft could be retained and debrided in 78 of 145 (54%) patients, whereas 67 (46%) patients had a partial (n = 12) or complete graft excision (n = 55). NPTW therapy showed an association with cure of infection (Fig) in patients with infrainguinal NPWT treatment (adjusted hazard ratio [aHR], 3.42; 95% confidence interval [CI], 1.37-8.60]; P = .009) and female sex (aHR, 1.74; 95% CI, 1.02-2.97; P = .042). There was no association of cure with NPWT for thoracic (aHR, 0.49; 95% CI, 0.13-1.85; P = .296) or abdominal VGI (aHR, 1.38; 95% CI, 0.57-3.34; P = .471). Conclusions: Multistaged NPWT treatment for downgrading of the infections was associated with a much lower VGI mortality than before. Among patients with VGI, patients with infrainguinal infections seem to benefit most of all from NPWT treatment, thus substantiating the algorithm for management of Samson III extracavitary graft infections as suggested by the recommendations from the American Heart Association for VGI.

Offering routine carotid endarterectomy (CEA) or carotid artery stenting (CAS) to patients with asymptomatic carotid artery stenosis (ACS) is no longer considered as the optimal management of these patients. Equally suboptimal, however, is the policy of offering only best medical treatment (BMT) to all patients with ACS and not considering any of them for prophylactic CEA. In the last few years, there have been many studies aiming to identify reliable predictors of future cerebrovascular events that would allow the identification of patients with high-risk ACS and offer a prophylactic carotid intervention only to these patients to prevent them from becoming symptomatic. All patients with ACS should receive BMT. The present article will summarise the evidence suggesting ways to identify these high-risk asymptomatic individuals, namely: (1) microemboli detection on transcranial Doppler, (2) plaque echolucency on Duplex ultrasound, (3) progression in the severity of ACS, (4) silent embolic infarcts on brain CT/MRI, (5) reduced cerebrovascular reserve, (6) increased size of juxtaluminal hypoechoic area, (7) identification of intraplaque haemorrhage using MRI and (8) carotid ulceration. The evidence suggests that approximately 10%-15% of patents with asymptomatic stenosis might benefit from intervention; this will become more clear after publication of ongoing studies comparing stenting or endarterectomy with best medical therapy. In the meantime, no patient should be offered intervention unless there is evidence of high risk of ipsilateral stroke, from modalities such as those discussed here.

PURPOSE/OBJECTIVE:The aim of this retrospective analysis was to evaluate the performance of the chimney (ch) technique in the treatment of type Ia endoleaks after standard endovascular aneurysm repair (EVAR). METHODS:Between January 2008 and December 2014, 517 chEVAR procedures were performed in 13 US and European vascular centers (PERICLES registry). Thirty-nine patients (mean age 76.9±7.1 years; 33 men) were treated for persistent type Ia endoleak and had computed tomography angiography or magnetic resonance angiography follow-up at >1 month. Endurant abdominal stent-grafts were used in the 20 cases. Single chimney graft placement was performed in 18 (46%) patients and multiple in 21 (54%). Overall, 70 visceral vessels were targeted for revascularization. RESULTS:Technical success was achieved in 35 (89.7%) cases; 3 persistent type Ia endoleaks and 1 chimney graft occlusion were detected within the first 30 days. Thirty-day mortality was 2.6%. Two other deaths (not aneurysm related) occurred during a mean follow-up of 21.9 months (0.23-71.3). Primary patency of the chimney grafts was 94.3% at 36 months. In a subgroup analysis comparing Endurant to other stent-grafts, no significant differences were observed regarding persistent endoleak [1/20 (5%) vs 2/19 (11%), p=0.6] or reintervention [1/20 (5%) vs 0/19 (0%)]. CONCLUSION/CONCLUSIONS:The present series demonstrates that chEVAR in the treatment of post-EVAR type Ia endoleaks has satisfactory results independent of the abdominal and chimney graft combinations. Midterm results show that chEVAR is an effective method for treating type Ia endoleaks.

CONTEXT/BACKGROUND:Over the past decade, a number of endovascular approaches have evolved to treat aortic aneurysms with anatomy that is not amenable to traditional endovascular repair, although the optimal practice and referral patterns remain in question. The Zenith fenestrated (Z-Fen) endograft (Cook Medical) represents the first commercially available fenestrated graft product in the United States. OBJECTIVE:We aim to quantify practice patterns in Z-Fen use during the first 5 years of commercial availability, and we identify predictors of high and low uptake. DESIGN, SETTING, AND PATIENTS/METHODS:This is a retrospective review of complete order records for Z-Fen endografts since June 2012. We performed univariate and multivariate regressions of predictors that surgeons and centers would be in the top and bottom quartiles of annual Z-Fen use. RESULTS:Since June 15, 2012, 744 surgeons have been trained to use Z-Fen, and 4133 cases have been performed at 409 trained centers. The average annual number of cases per trained surgeon was 4.46 [95% confidence interval (CI), 3.58-5.70]; however, many surgeons performed few or no cases following training, and there was a skew toward users with low average annual volumes (25th percentile 1.23, 50th percentile 2.35, 75th percentile 4.93, and 99th percentile 33.29). Predictors of high annual use in the years following training included academic center (aOR 5.87, P = .001) and training within the first 2 years of availability (aOR 46.23, P < .001). CONCLUSION/CONCLUSIONS:While there is literature supporting the safety and efficacy of Z-Fen, adoption has been relatively slow in an era when the vast majority of vascular surgeons have advanced endovascular skills. Given the training and resources required to use fenestrated or branched aortic endovascular devices, referral patterns should be determined and training should be focused on centers with high expected volumes.