Faculty Bibliography

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.

OBJECTIVE:The majority of previous studies, including randomized controlled trials, have failed to provide sufficient evidence of superiority of endovascular aneurysm repair (EVAR) over open aortic repair (OAR) of ruptured abdominal aortic aneurysm (rAAA) while comparing mortality and complications. This is in part due to small study size, patient selection bias, scarce adjustment for essential variables, single insurance type, or selection of only older patients. This study aimed to provide real-world, contemporary, comprehensive, and robust evidence on mortality of EVAR vs OAR of rAAA. METHODS:A retrospective observational cohort study was performed of rAAA patients registered in the Premier Healthcare Database between July 2009 and March 2015. A multivariate logistic regression model was operated to estimate the association between procedure types (OAR vs EVAR) and in-hospital mortality. The final model was adjusted for demographics (age, sex, race, marital status, and geographic region), hospital characteristics (urban or rural, teaching or not), and potential confounders (hypertension, diabetes, hypercholesterolemia, obesity, ischemic heart disease, chronic kidney disease, symptoms of critical limb ischemia, chronic obstructive pulmonary disease, smoking, and alcoholism). Furthermore, coarsened exact matching was applied to substantiate the result in the matched cohort. RESULTS:There were a total of 3164 patients with rAAA (1550 [49.0%] OAR and 1614 [51.0%] EVAR). Mortality was 23.79% in the EVAR group compared with 36.26% in the OAR group (P < .001). The adjusted odds ratios of mortality (1.91; 95% confidence interval [CI], 1.62-2.25; P < .001), cardiac complication (1.54; 95% CI, 1.22-1.96; P < .001), pulmonary failure (1.90; 95% CI, 1.60-2.24; P < .001), renal failure (1.90; 95% CI, 1.61-2.23; P < .001), and bowel ischemia (2.40; 95% CI, 1.70-3.35; P < .001) were significantly higher after OAR compared with EVAR. We further applied coarsened exact matching, which followed the same pattern of mortality (odds ratio, 1.68; 95% CI 1.41-1.99; P < .001) and all major complications. CONCLUSIONS:Although the choice of repair of rAAA is highly dependent on the experience of the operating team and the anatomic suitability of the patient, this contemporary analysis of a large cohort of rAAA showed significantly higher adjusted risk of mortality in OAR compared with EVAR and substantially higher complications.

OBJECTIVE:The Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. METHODS:A retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. RESULTS:There were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7%) were symptomatic and 12 (25.5%) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9%). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1%; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30%) and no type I or type III endoleaks were detected. Two of 80 (2.5%) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. CONCLUSIONS:Preservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.

OBJECTIVE:The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. METHODS:Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. RESULTS:In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. CONCLUSIONS:The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.

OBJECTIVE:The ideal stent combination for chimney endovascular aneurysm repair remains undetermined. Therefore, we sought to identify optimal aortic and chimney stent combinations that are associated with the best outcomes by analyzing the worldwide collected experience in the PERformance of chImney technique for the treatment of Complex aortic pathoLogiES (PERICLES) registry. METHODS:The PERICLES registry was reviewed for patients with pararenal aortic disease electively treated from 2008 to 2014. Eleven different aortic devices were identified with three distinct subgroups: group A (n = 224), nitinol/polyester; group B (n = 105), stainless steel/polyester; and group C (n = 69), nitinol/expanded polytetrafluoroethylene. The various chimney stent subtypes included the balloon-expandable covered stent (BECS), self-expanding covered stent, and bare-metal stent. Deidentified aortic and chimney device combinations were compared for risk of chimney occlusion, type Ia endoleak, and survival. Effects of high-volume centers (>100 cases), use of an internal lining chimney stent, number of chimney stents, and number of chimney stent subtypes deployed were also considered. We considered demographics, comorbidities, and aortic anatomic features as potential confounders in all models. RESULTS:The 1- and 3-year freedom from BECS chimney occlusion was not different between groups (group A, 96% ± 2% and 87% ± 5%; groups B and C, 93% ± 3% and 76% ± 10%; Cox model, P = .33). Similarly, when non-BECS chimney stents were used, no difference in occlusion risk was noted for the three aortic device groupings; however, group C patients receiving BECS did have a trend toward higher occlusion risk relative to group C patients not receiving a BECS chimney stent (hazard ratio [HR], 4.0; 95% confidence interval [CI], 0.85-18.84; P = .08). Patients receiving multiple chimney stents, irrespective of stent subtype, had a 1.8-fold increased risk of occlusion for each additional stent (HR, 1.8; 95% CI, 1.2-2.9; P = .01). Use of a bare-metal endolining stent doubled the occlusion hazard (HR, 2.1; 95% CI, 1.0-4.5; P = .05). Risk of type Ia endoleak (intraoperatively and postoperatively) did not significantly differ for the aortic devices with BECS use; however, group C patients had higher risk relative to groups A/B without BECS (C vs B: odds ratio [OR], 3.2 [95% CI, 1-11; P = .05]; C vs A/B: OR, 2.4 [95% CI, 0.9-6.4; P = .08]). Patients treated at high-volume centers had significantly lower odds for development of type Ia endoleak (OR, 0.2; 95% CI, 0.1-0.7; P = .01) irrespective of aortic or chimney device combination. Mortality risk was significantly higher in group C + BECS vs group A + BECS (HR, 5.3; 95% CI, 1.6-17.5; P = .006). The 1- and 3-year survival for groups A, B, and C (+BECS) was as follows: group A, 97% ± 1% and 92% ± 3%; group B, 93% ± 3% and 83% ± 7%; and group C, 84% ± 7% and 63% ± 14%. Use of more than one chimney subtype was associated with increased mortality (HR, 3.2; 95% CI, 1.4-7.5; P = .006). CONCLUSIONS:Within the PERICLES registry, use of nitinol/polyester stent graft devices with BECS during chimney endovascular aneurysm repair is associated with improved survival compared with other aortic endografts. However, this advantage was not observed for non-BECS repairs. Repairs incorporating multiple chimney subtypes were also associated with increased mortality risk. Importantly, increasing chimney stent number and bare-metal endolining stents increase chimney occlusion risk, whereas patients treated at low-volume centers have higher risk of type Ia endoleak.

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.