Traumatic spondylolisthesis of axis: clinical and imaging experience at a level one trauma center.

PURPOSE: Traumatic spondylolisthesis of the axis (TSA) with bilateral pars interarticularis fracture (a pattern also known as Hangman's fractures) accounts for 4-5% of all cervical fractures. Various classification systems have been described to assist therapeutic decision-making. The goal is to reassess the utility of these classifications for treatment strategy and evaluate additional imaging associations. METHODS: This is an IRB approved, retrospective analysis of patients with imaging diagnosis of TSA from 2016 to 2019. Consensus reads were performed classifying TSA into various Levine and Edwards subtypes and typical vs. atypical fractures. Other imaging findings such as additional cervical fractures, traumatic brain injury, spinal cord injury, and vertebral artery injury were recorded. Treatment strategy and outcome were reviewed from clinical charts. Fisher exact test was used for statistical analysis. RESULTS: A total of 58 patients were included, with a mean age of 62.7 ± 25 years, and male to female ratio of 1:1.2. Motor vehicle collision was the most common cause of TSA. Type I and III injuries were the most and the least common injuries, respectively. Patients with type I injuries were found to have good healing rates with conservative management (p < 0.001) while type IIa and III injuries were managed with surgical stabilization (p = 0.04 and p = 0.01, respectively). No statistical difference was observed in the treatment strategy for type II fractures (p = 0.12) and its prediction of the associated injuries. Atypical fractures were not found to have a higher incidence of SCI (p = 0.31). A further analysis revealed significantly higher-grade vertebral artery injuries (grades III and IV according to Biffl grading) in patients with type IIa and III injuries (p = 0.001) and an 11-fold increased risk of TBI compared to type I and type II fractures (p = 0.013). CONCLUSION: TSA fracture types were not associated with any clinical outcome. Levine and Edwards type II classification itself is not enough to guide the treatment plan and does not account for associated injuries. Additional imaging markers may be needed.

Selective Versus Routine Spinal Drain Use for Fenestrated/Branched Endovascular Aortic Repair (F-BEVAR).

BACKGROUND: Spinal drains are used to ameliorate spinal cord ischemia (SCI), but their use may result in inherent morbidity and mortality. Although prophylactic spinal drain has proven of benefit in open repairs, that is not the case for endovascular repairs. The aim of this study was to assess the outcomes of spinal cord protection with and without the routine use of spinal drains during fenestrated-branched endovascular repair (F-BEVAR). METHODS: A retrospective single center study was performed using a prospectively maintained dataset of all patients undergoing F-BEVAR over a 4-year period. The primary endpoint of the study was the frequency of SCI. Prophylactic spinal drain was placed pre-operatively in 33 patients (23%) with a median time for removal of 3 days (IQR, 2-3 days). Routine intraoperative neuromonitoring was used. Spinal cord protection relied primarily on maintaining a perioperative systolic blood pressure between 140 and 160 mm Hg or a mean arterial pressure >90 mm Hg, avoiding hypotension, preservation of as many collateral beds as possible, staged repairs and early lower extremity reperfusion based on neuromonitoring. RESULTS: A total of 145 patients, 104 men (71%) and 41 women (28%) with a median age of 70 years (interquartile range [IQR], 53-62) underwent F-BEVAR. Branched custom-made devices (CMDs) (11%), fenestrated CMDs (70%) and off-the-shelf T-Branch device (17%) were used with a median number of branches/fenestrations of 4 (IQR, 3-4). SVS classification of implantation zones were determined as follows: 9 (6%) zone 2, 21 (20%) zone 3, 26 (18%) zone 4 and 89 (61%) zone 5. SCI was present in 8 patients (5.5%) and classified according to the SVS SCI grading system as follows: 1 grade 1, 5 grade 2 and 2 grade 3a. When evaluating implantation zone independently of coverage length and patency of collateral beds, a high implantation zone (1-4) was not associated with SCI (P = 0.9). Similarly, prophylactic spinal drain did not demonstrate association with the occurrence of SCI (3[9%] vs. 5[4%], with and without spinal drain, respectively) (P = 0.3). For patients with high implantation zones, staged repair was performed in 38 patients (26%) at a median time of 2 months (IQR, 2-6 months). Among these patients, the frequency of SCI was 13%. Staged repair was associated with an 80% reduction in the frequency of SCI (OR, 0.19 [95% CI, 0.04-0.084]) (P = 0.02). CONCLUSION: F-BEVAR can be performed with a minimal risk of SCI without the need for routine prophylactic spinal drains. High implantation zones did not predict SCI after F-BEVAR; however, staged repair significantly decreased the risk of SCI after F-BEVAR.

Effects of preoperative visceral artery stenosis on target artery outcomes after fenestrated/branched endovascular aortic aneurysm repair.

OBJECTIVE: Target artery stenosis might affect the outcomes of fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The aim of the present study was to assess the effects of preoperative stenosis of the celiac artery (CA) and superior mesenteric artery (SMA) on the target artery outcomes after F-BEVAR. METHODS: During a 4-year period, 287 consecutive patients, 204 men (71%) and 83 women (29%), had undergone F-BEVAR using fenestrated (83%), fenestrated-branched (4.5%), branched (3.5%), and off-the-shelf t-Branch (9%) devices (Cook Medical Inc, Bloomington, Ind). Preoperative SMA and CA significant stenosis was defined as a computed tomography angiography-based intraluminal diameter reduction >50%. The primary endpoints included primary patency, freedom from target vessel instability, and patient survival. RESULTS: The median patient age was 71 years (interquartile range, 67-77 years). Suprarenal (36%), juxtarenal (25%), and thoracoabdominal (39%) aortic aneurysms were treated. The technical success rate was 99%. The 30-day survival was 97%. Among 981 stented vessels, 179 (18%) were CAs and 270 (27.5%) were SMAs. Significant preoperative CA stenosis was identified in 39 patients (22%) and SMA stenosis in 24 (9%). The median follow-up was 29.9 months. The primary patency rates at 12, 36, and 60 months were 98%, 92%, and 92% for the CA and 99%, 98%, and 98% for the SMA, respectively. Primary patency was significantly lower in the patients with previous significant CA stenosis than in those without stenosis (83%, 83%, and 76% vs 100%, 100%, and 97% at 12, 36, and 60 months, respectively; P < .01). Freedom from celiac branch instability was also significantly lower among patients with significant stenosis (84%, 84%, and 76% vs 100%, 93%, and 93% at 12, 36, and 60 months; P < .01). The presence of significant SMA stenosis did not affect either primary patency or freedom from target vessel instability. The survival rates at 12, 36, and 60 months were significantly lower for the patients with CA stenosis than for those without stenosis (67%, 61%, and 55% vs 90%, 84%, and 82%, respectively; P < .01). Similarly, lower survival rates were observed for patients with significant SMA stenosis (70%, 60%, and 60% vs 87%, 79%, and 78% at 12, 36, and 60 months, respectively; P = .04). CONCLUSIONS: F-BEVAR was associated with overall primary patency rates >90% for the CA and SMA. Preoperative CA stenosis was associated with lower primary patency and freedom from target vessel instability. In contrast, neither SMA branch primary patency nor freedom from target vessel instability were affected by preoperative SMA stenosis. We found visceral artery stenosis was a marker of atherosclerosis burden associated with reduced mid- and long-term patient survival.

Impact of Number of Vessels Targeted on Outcomes of Fenestrated-Branched Endovascular Repair for Complex Abdominal Aortic Aneurysms.

BACKGROUND: The aim of this study was to investigate the impact of number of vessels targeted by fenestrations or branches on early outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) for complex abdominal aortic aneurysms (cAAAs). METHODS: The clinical data of 260 patients (209 men; mean, 74 ± 7 years) treated for cAAAs in four academic centers using fenestrated-branched stent grafts with one to five fenestrations or branches were entered into prospectively maintained databases (2010-2015). Data were analyzed in patients treated with ≤2-vessel (group 1, n = 124), 3-vessel (group 2, n = 80), or ≥4 fenestrations or directional branches (group 3, n = 56). For group definition, only vessels incorporated by fenestrations or directional branches were accounted. End points were technical success, procedural variables, 30-day mortality, and major adverse events (MAEs). RESULTS: A total of 830 vessels (mean, 3.19 ± 0.8 vessels/patient) were targeted by fenestrations (n = 672), scallops (n = 136), or branches (n = 22). Two-vessel designs were used more often in the early experience (64%), whereas ≥3-vessel design (groups 2 and 3) was preferred in the late experience (68%, P < 0.05). Patients with ≥4-vessel designs had longer operating and fluoroscopy time (+78 min, P < 0.0001 and + 27 min, P < 0.001), higher volume of contrast use (+31 mL, P = 0.03), and longer hospital stay (+3 days, P = 0.007) of those who had ≤2-vessel designs. Technical success, estimated blood loss, mortality, MAEs, and rate of spinal cord injury were similar in all three groups (P > 0.05). CONCLUSIONS: F-BEVAR for complex abdominal aortic aneurysms was associated with high technical success and low 30-day mortality and morbidity. Increasing complexity was associated with longer operating and fluoroscopy time, more contrast use, and longer hospital stay but did not affect technical success and MAEs of the procedure.

Fenestrated-branched endovascular aortic repair in patients with chronic kidney disease.

OBJECTIVE: Renal function impairment is a common complication after open repair of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). The purpose of this study was to assess renal perioperative outcomes and renal function deterioration after fenestrated-branched endovascular aneurysm repair (F/BEVAR) in patients with chronic kidney disease (CKD). METHODS: The study included 186 patients who underwent F/BEVAR between 2013 and 2018 for suprarenal, juxtarenal, and type I to type IV TAAAs. Glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) study equation. Postoperative acute kidney injury (AKI) and CKD were defined using RIFLE criteria (Risk, Injury, Failure, Loss, and End-stage renal disease) and CKD staging system (stage ≥3, GFR <60 mL/min/1.73 m2), respectively. For those without baseline CKD, renal decline was defined as a drop in GFR <60 mL/min/1.73 m2 (ie, progression to CKD stage 3 or higher). For patients with baseline renal dysfunction, GFR decline ≥20% or progression in CKD stage (ie, from stage 3 to stage 4) was considered renal decline. RESULTS: CKD was present in 83 patients (44.6%). Postoperative AKI was diagnosed in 27 patients (14.5%); 13 (48.1%) had history of CKD and 14 (51.9%) had adequate renal function preoperatively (P = .8). None of these patients required permanent renal replacement therapy. Intraoperative technical success was 100%. Overall 30-day mortality was 1.1%. There was no difference in 30-day mortality in patients with (1.2%) and without (1.0%) CKD (P = .5). During a median follow-up time of 12 months (interquartile range, 6-23 months), renal decline was observed in 21 patients (25.3%) with previous CKD and in 11 patients (10.6%) without CKD (P = .01). Among patients with previous CKD, 18 patients (9%) progressed from stage 3 CKD to stage 4. In patients with progression in CKD stage, two (5%) had renal stent stenosis requiring restenting. Among patients with renal decline, 13 had juxtarenal aneurysms (21.3%), 27 had suprarenal aneurysms (44.3%), and 21 had TAAAs (34.3%; P = .4). Subset analysis of patients who developed AKI in the immediate postoperative period found that patients with a history of CKD were less likely to experience freedom from renal decline. CONCLUSIONS: F/BEVAR is an effective and safe procedure for patients with complex abdominal aortic aneurysms and TAAAs, even among patients with CKD. The frequency of AKI was not affected by pre-existing CKD. Midterm outcomes demonstrated that progression of CKD was more frequent among patients with pre-existing CKD, but permanent renal replacement therapy was not required. Anatomic extent of aneurysms did not affect CKD progression. CKD patients are susceptible to renal decline over time if they experience AKI in the postoperative period. Therefore, preventing AKI in the postoperative period should be regarded as a priority. Long-term effects of CKD after F/BEVAR remain to be elucidated.

Visceral stent patency after fenestrated endovascular aneurysm repair using bare-metal stent extensions versus covered stents only.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is an alternative to treat complex abdominal aortic aneurysms. Patency of visceral vessels remains high when covered stents are used. The use of distal uncovered stents to prevent kinking has been associated with loss of branch patency. The aim of this study was to evaluate branch-related outcomes of FEVAR using covered stents only vs the use of uncovered stents distal to covered stents. METHODS: During a 4-year period, 142 patients underwent FEVAR. Patients with suprarenal, juxtarenal, and type IV thoracoabdominal aneurysms were included. Patients treated with side branch devices were excluded. Covered iCAST (Maquet, Hudson, NH) stents were used as bridging stents in all cases. The primary end point was primary patency, defined as the absence of stenosis or occlusion that required intervention. Secondary end points included secondary patency, branch-related outcomes (kidney injury and gastrointestinal complications), branch instability, and mortality rates. RESULTS: A total of 442 target vessels were incorporated (49 scallops and 393 fenestrations). Uncovered stents were used in 38 (9.6%) visceral vessels. Median follow-up time was 11 (interquartile range, 6-13) months. Overall, visceral vessel primary patency was 91% at 12 and 24 months. The overall primary patency rate was 86% in the distal extension group vs 93% when only covered stents were used at 12 and 24 months (P = .8). Similarly, the rate of branch-related reinterventions at 12 months was 9% and 15% for each group, respectively, and 22% vs 32% at 24 months, respectively (P = .5). Overall, freedom from branch instability was 87% at 12 months and 81% at 24 months. Freedom from branch instability in the distal extension group was 82% at 12 and 24 months vs 89% at 12 months and 81% at 24 months when only covered stents were used (P =. 08). Mortality rate at 24 months was 15% for the bare-metal stent extension group vs 14% for the covered stent only group (P = .4). We found no statistical difference in acute kidney injury at any Kidney Disease: Improving Global Outcomes stage (P = 1.0) or gastrointestinal complications (P = 1.0) between the groups. CONCLUSIONS: The use of distal uncovered stents to prevent kinks was not associated with decreased early branch patency. The long-term outcomes of bare-metal stents remain to be determined. For now, the use of uncovered stents distal to covered stents may be considered to prevent kinks in complex anatomy.

Effects of Abdominal Aortic Aneurysm Size on Mid- and Long-term Mortality After Endovascular Aneurysm Repair.

PURPOSE: To investigate the effect of abdominal aortic aneurysm (AAA) size on mid- and long-term survival after endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Retrospective data were collected from 325 consecutive patients (mean age 69.7 ± 8.5 years; 323 men) who underwent EVAR for intact AAA at a single institution between January 2003 and December 2013. The primary endpoint was death at 3, 5, and 10 years after EVAR. Optimal cutoff points for AAA size and age were determined using receiver operating characteristics (ROC) curves. Time to event analyses (Kaplan-Meier curves and Cox proportional hazard models) were employed to determine any differences in all-cause mortality outcomes between AAA size groups. Cox models were adjusted for age and other comorbidities (hypertension, hyperlipidemia, coronary artery disease, smoking status, symptomatic status, and creatinine); the outcomes are reported as the hazard ratio (HR) with 95% confidence interval (CI). RESULTS: The cohort was dichotomized according to the ROC analysis, which defined an optimal cutoff point of 5.6 cm for AAA size and >70 years for age. The mean follow-up period post EVAR was 45.5±29.2 months. In total, 134 (41.2%) patients died during the 10-year follow-up. Thirty-day mortality was 1.1% (2/184) in the patients with AAA <5.6 cm and 2.1% (3/141) in patients with AAA ≥5.6 cm (p=0.45). All-cause mortality was not significantly affected by comorbidities. However, AAA size ≥5.6 cm was associated with increased 3-year mortality risk (HR 1.59, 95% CI 1.001 to 2.52, p<0.049) but not 5-year (HR 1.44, 95% CI 0.98 to 2.10, p=0.062) or 10-year mortality (HR 1.28, 95% CI 0.91 to 1.80, p=0.149). After adjusting for comorbidities, AAA size ≥5.6 cm was no longer significantly associated with morality at any time point. Using a larger size cutoff (AAA size ≥6.0 cm) resulted in improved statistical significance in the unadjusted model. In the adjusted Cox model, AAA size ≥6.0 cm was significantly associated with increased risk of mortality at 3 years (HR 1.67, 95% CI 1.01 to 2.77, p<0.047), but not at longer time points. CONCLUSION: Our study demonstrates that midterm survival after EVAR is significantly and independently associated with AAA size even after correcting for comorbidities. However, in the long term, preoperative AAA size is not an independent predictor of mortality.

Patient and operating room staff radiation dose during fenestrated/branched endovascular aneurysm repair using premanufactured devices.

INTRODUCTION: Fenestrated endovascular aneurysm repair (FEVAR) is the highest radiation dose procedure performed by vascular surgeons. We sought to characterize the radiation dose to patients and staff during FEVAR procedures with different premanufactured devices. METHODS: A single-center prospective study of FEVARs was performed over 24 months. Three FEVAR devices were included: off-the-shelf (OTS; t-Branch, p-Branch), Zenith Fenestrated (ZFen), and investigational custom-made devices (CMDs). Radiation doses to the surgeon, trainee, anesthesiologist, and scrub/circulating nurses were measured using a personal dosimetry system (DoseAware, Philips Healthcare, Amsterdam, The Netherlands). Procedure type, patient body mass index (BMI), reference air kerma (RAK), and kerma area product (KAP) were recorded. RAK and KAP were corrected for BMI based on an exponential fit of fluoroscopy dose rate and the dose per radiographic frame. Operator dose was corrected for BMI by the ratio of corrected to actual KAP. A one-sided Wilcox rank-sum test was used to compare personnel radiation doses, RAKs, and KAPs between procedure types. Statistical significance was set at P ≤ .05. RESULTS: There were 80 FEVARs performed by a single surgeon on a Philips Allura XperFD20 fluoroscopy system equipped with Clarity technology. Average BMI was 27 kg/m2. Sixty CMDs (36 four-, 21 three-, and 3 two-vessel fenestrations), 11 ZFens (8 three- and 3 two-vessel fenestrations), and 9 OTS devices (4 p-Branch, 5 t-Branch) were included. ZFens had significantly lower patient (1800 mGy vs 2950 mGy; P = .004), operator (120 µSv vs 370 µSv; P = .004), assistant (60 µSv vs 210 µSv; P = .003), circulator (10 µSv vs 30 µSv; P = .049), and scrub nurse dose (10 µSv vs 40 µSv; P = .02) compared with CMDs. OTS devices had significantly lower operator (220 µSv vs 370 µSv; P = .04), assistant (110 µSv vs 210 µSv; P = .02), and circulator doses (4 µSv vs 30 µSv; P = .001) compared with CMDs. Four-vessel fenestrated devices had significantly higher patient dose (3020 mGy) compared with three-vessel FEVARs (2670 mGy; P = .03) and two-vessel FEVARs (1600 mGy; P = .0007), and significantly higher operator dose (440 µSv) compared with three-vessel FEVARs (170 µSv; P = .0005). Patient dose was lowest with ZFens. Operating room personnel dose was lower with ZFens and OTS devices compared with CMDs. Four-vessel fenestrations required significantly more radiation compared with those involving three-vessel fenestrations; however, the dose increase was only 12% and should not preclude operators from extending coverage, if anatomically required. CONCLUSIONS: Overall, patient and personnel radiation doses during FEVAR with all devices were within acceptable limits and lower in our series than previously reported.

The sequential catheterization amid progressive endograft deployment technique for fenestrated endovascular aortic aneurysm repair.

Fenestrated endovascular aneurysm repair (FEVAR) is an alternative to open repair of complex aortic aneurysms. Despite promising short-term results, the technical complexities of this procedure remain a considerable challenge. The risk of technical failure with loss of visceral or renal arteries is ubiquitous even in the most experienced hands, and thus many patients with unfavorable anatomy are frequently denied FEVAR. We have adopted a new technique for FEVAR that involves retrograde brachial artery access and stepwise deployment of the endograft during target vessel catheterization, overcoming many anatomic limitations encountered from a transfemoral approach. This technique, termed sequential catheterization amid progressive endograft deployment, has become our preferred approach for FEVAR and is described in this article. Of note, currently available Food and Drug Administration-approved fenestrated endografts may not be amenable to sequential catheterization amid progressive endograft deployment as this technique requires preloaded wires incorporated into the endografts.

Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair.

BACKGROUND: Octogenarians with complex abdominal aortic aneurysms are at higher risk of death and morbidity after open repair. Fenestrated endovascular aneurysm repair (FEVAR) is an alternative to open repair for high-risk patients, such as octogenarians. The aim of this study was to evaluate perioperative and midterm outcomes of FEVAR among octogenarians at high and standard risk for open repair. METHODS: During a 2-year period, 85 patients (68 men [78%] and 17 women [22%]) underwent FEVAR using Zenith (Cook Medical, Bloomington, Ind) Fenestrated AAA Endovascular Grafts (70%), Zenith p-Branch (7%), and fenestrated custom-made devices (22%). Demographics and perioperative and follow-up outcomes of patients aged >80 years (n = 18 [21%]) and patients aged <80 years (n = 67 [79%]) were compared. The χ2 or Fisher test was used for categorical variables, and nonparametric tests were used for continuous variables. Kaplan-Meir curve was used for survival analysis. RESULTS: Median age was 73 years (interquartile range [IQR], 68-79 years) for the entire cohort, 84 years (IQR, 81-86 years) among octogenarians, and 71 years (IQR, 67-75) for younger patients. Median aneurysm size was 56 mm (IQR, 53-62 mm). The median number of fenestrations was three. Preoperatively, octogenarians had higher Society for Vascular Surgery score (5.5 [IQR, 5-7] vs 5 [IQR, 3-6]; P = .01) and lower body mass index (26 [IQR, 21-27] vs 28 [24-32]; P = .04). Intraoperatively, technical success was 100% for both groups. The median operative time for octogenarians was 224 minutes (IQR, 160-272) vs 212 minutes (IQR, 177-281) in patients <80 years (P = .59). The median hospital length of stay was 3.5 days (IQR, 2-5) for octogenarians vs 4 days (IQR, 2-5) in younger patients (P = .87). Intensive care unit length of stay was 2 days for patients from both groups (IQR, 1-3). The rate of postoperative complications was 28% for octogenarians and 36% for patients aged <80 years (P = .5). None of the patients in this series required dialysis. No 30-day deaths occurred. The 20-month estimated survival rate was 75% in octogenarians and 91% in patients <80 years (P = .1). The rate of reinterventions at 20 months was 10% for octogenarians and 57% for younger patients (P = .09). CONCLUSIONS: FEVAR is a safe and effective procedure in octogenarians at high and standard risk for open repair and those who are not eligible for standard endovascular aneurysm repair. Octogenarians have a similar technical success and low major adverse events similar to patients younger than 80 years.

Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices.

BACKGROUND: The role of gender on perioperative outcomes after fenestrated endovascular aortic aneurysm repair (FEVAR) has not been established. The aim of this study is to determine the effect of gender on perioperative outcomes after FEVAR for complex abdominal aortic aneurysms using premanufactured devices. METHODS: During a 2-year period, 79 patients (63 men [80%] and 16 women [20%]) underwent FEVAR using Zenith Fenestrated AAA Endovascular Grafts, investigational Zenith pivot branch (p-branch) devices and fenestrated custom-made devices. A single-institutional study was performed to evaluate postoperative outcomes after FEVAR. The χ2, Fisher's, and nonparametric tests were used for bivariate analysis. Logistic regression was used for multivariate analysis. RESULTS: Median age was 73 years (interquartile range [IQR], 68-79 years). The median number of fenestrations was three. There was no difference in aneurysm anatomic location, size, or number of fenestrations between patients in either group. Women were more likely to undergo endoconduits at the access site before the target procedure (19% vs 2%; P = .02). The overall postoperative complication rate was similar among females and males (31% vs 33%; P > .5). However, women experienced longer times in the intensive care unit (median, 3 days [IQR, 2-5] vs 2 [IQR, 1-3]; P = .05) and longer duration of hospital stay (median, 4.5 days [IQR, 3-6.5] vs 3 [IQR, 2-4]; P < .01). Similarly, the rate of reinterventions was higher among women, 25% vs 5% (P = .02). For renal adverse events, there was a trend for a higher rate of renal function deterioration based in creatinine levels among women, when compared with men (18% vs 5%; P = .09). Multivariate analysis showed that female gender was associated with a 8-fold increased risk of renal function deterioration (odds ratio, 8.1; 95% confidence interval, 6.1-10.8). Female gender was also identified as in independent factor for reinterventions at 30 days (odds ratio, 7.4; 95% confidence interval, 6.7-8.1). CONCLUSIONS: FEVAR is a safe and effective procedure for patients at high and standard risk for open repair who are not eligible for standard EVAR. Women are at greater risk for more severe renal function deterioration, early reinterventions and longer durations of hospital and intensive care unit stay.

Superior mesenteric artery outcomes after fenestrated endovascular aortic aneurysm repair.

OBJECTIVE: The Zenith (Cook Medical, Bloomington, Ind) fenestrated endovascular graft may be designed with single-wide scallops or large fenestrations to address the superior mesenteric artery (SMA). Misalignment of the SMA with an unstented scallop or a large fenestration is possible. This study assessed SMA outcomes after fenestrated endovascular aortic aneurysm repair (FEVAR). METHODS: During an 18-month period, 47 FEVARs were performed at a single institution. For analysis, patients were grouped according to unstented (n = 23) vs stented (n = 24) SMA scallops/fenestrations. The Institutional Review Board approved this single-institution observational study. Because this was a retrospective review of the data, patient consent was unnecessary for the study. RESULTS: Technical success for FEVAR was 100%. The median follow-up period was 7.7 months (range, 1-16 months). Nine of 21 patients (43%) in the unstented group had some degree of misalignment of the SMA (range, 9%-71%). Among these, four patients (44%) developed complications: three SMA stenoses and one occlusion. The mean peak systolic velocity in patients with and without SMA misalignment was 317.8 cm/s vs 188.4 cm/s (P < .08), respectively. No misalignment occurred in the stented group, and only one of 19 patients (5%) developed an SMA stenosis that required angioplasty. Overall, patients with unstented SMAs had significantly more adverse events directly attributable to SMA misalignment than the stented group (44% vs 5%, respectively; P < .05). CONCLUSIONS: Misalignment of the SMA with the use of unstented unreinforced scallops or fenestrations occurs frequently. Routine stenting of single-wide and large fenestrations, when feasible, may be a safer option for patients undergoing FEVAR.

Safety and effectiveness of total percutaneous access for fenestrated endovascular aortic aneurysm repair.

BACKGROUND: Percutaneous femoral vascular access is frequently used for aortic endovascular procedures, with a local access complication rate of 5% to 16%. Fenestrated endovascular aneurysm repair (FEVAR) has recently emerged as a new technique for the repair of short-neck and juxtarenal abdominal aortic aneurysms. The safety and effectiveness of percutaneous access for FEVAR has not been established to date. METHODS: Since United States Food and Drug Administration approval of the Zenith fenestrated aortic endograft (Cook Medical, Bloomington, Ind), 94 patients (60 Zenith fenestrated, 6 p-Branch, and 28 custom-made devices) have undergone FEVAR. Percutaneous access was performed using the "preclose" technique with the Perclose Proglide device (Abbott Vascular, Redwood City, Calif). Open access was performed when severely disease or calcified femoral arteries prevented percutaneous access. Patient-based analysis was performed assessing outcomes for the access site used for the larger profile sheath of the main device. RESULTS: Percutaneous access was used in 90 patients (177 common femoral arteries) and open access in four (11 common femoral arteries). Arm access was used in 41 patients (44%). The median sheath size was 20F (interquartile range [IQR], 20F-22F). Median operative time was 207 minutes (IQR, 160-270 minutes), with a median blood loss of 500 mL (IQR, 300-700 mL). The percutaneous access success rate was 92%. No preoperative factors predicted technical failure. No 30-day deaths occurred. Patients with failed percutaneous closure and who required conversion to open repair had higher estimated median blood loss of 800 (IQR, 600-1200) vs 500 (IQR, 300-600) mL (P = .01) and a longer median time to start ambulation of 4 (IQR, 2-7) vs 2 (IQR, 1-3) days (P = .03). Patients undergoing percutaneous closure had lower median blood loss (500 mL; IQR, 300-600 mL) than patients who underwent open surgical access (800 mL; IQR, 750-800 mL). Postoperative complications related to vascular access occurred in 11 patients (12%). CONCLUSIONS: Percutaneous femoral access is a safe and effective alternative to open access for FEVAR. Operative blood loss and longer time to ambulation are significantly increased after failed percutaneous closure.

Resultados em longo prazo de embolização de endoleaks tipo II / Long-term outcomes of embolization of type II endoleaks

CONTEXTO: Endoleaks tipo II são frequentes após o reparo endovascular de aneurismas de aorta. OBJETIVO: O objetivo deste estudo foi comparar o sucesso da embolização de endoleaks tipo II utilizando diferentes técnicas e materiais. MÉTODOS: Entre 2003 e 2015, 31 pacientes foram submetidos a embolização de endoleak tipo II, totalizando 41 procedimentos. Esses procedimentos foram conduzidos por acesso translombar, acesso femoral ou uma combinação de ambos, utilizando Onyx®18, Onyx®34, coils, plugue vascular Amplatzer® e trombina como material emboligênico. Sucesso foi definido como ausência de reintervenção. O teste de qui-quadrado e o teste exato de Fisher foram utilizados para a análise estatística. RESULTADOS: O tempo médio entre a correção do aneurisma de aorta e a embolização foi de 14 meses. Quinze (36%) das intervenções utilizaram Onyx®18; sete (17%) utilizaram coils e Onyx®34; seis (14%) utilizaram Onyx®34; quatro (10%) utilizaram coils e Onyx®18; quatro (10%) usaram Onyx®18 e Onyx®34; e três (7%) usaram coils e trombina; um (2%) usou coils e um (2%) usou Amplatzer®. Onze pacientes (35%) necessitaram de reintervenção. A taxa de sucesso foi de 71,43% (10) para os pacientes com as artérias lombares como fonte do endoleak, 80% (8) quando a fonte era a artéria mesentérica inferior e 40% (2) quando havia combinação de ambas (p & 0,05). Não houve diferença estatisticamente significativa com relação ao tipo de embolização, material emboligênico e tipo de reparo da aorta para a correção do aneurisma. CONCLUSÕES: A terapia endovascular de endoleaks tipo II é um desafio, sendo necessária reintervenção em até 36% dos casos. A taxa de sucesso é menor quando o endoleak é nutrido pela combinação das artérias lombares e da artéria mesentérica inferior.

BACKGROUND: Type II endoleaks are common after endovascular aortic aneurysm repair. The purpose of this study was to assess the long-term outcomes of embolization of type II endoleaks using different techniques and materials. METHODS: Between 2003 and 2015, 31 patients underwent embolization of type II endoleaks, in a total of 41 procedures. Patients underwent transarterial or translumbar embolization using Onyx®18, Onyx®34, coils, Amplatzer® plug and/or thrombin. Embolization success was defined as no endoleak reintervention. The chi-square test and Fisher exact test were used for statistical analysis. RESULTS: Median embolization time after aortic aneurysm repair was 14 months. Fifteen (36%) embolization interventions were performed using Onyx®18; seven (17%) with coils and Onyx®34; six (14%) with Onyx®34; four (10%) with coils and Onyx® 18; four with Onyx®18 and Onyx®34; three (7%) with coils and thrombin; one (2%) with coils; and one (2%) with an Amplatzer® device. Eleven patients (35%) required reintervention. The embolization success rate was 71.43% (10) for patients with lumbar arteries as the source of the endoleak, 80% (8) for the inferior mesenteric artery and 40% (2) when both inferior mesenteric artery and lumbar arteries were the culprit vessels (p & 0.05). There was no statistically significant difference with regards to type of embolization, embolic material or type of previous aortic repair. CONCLUSIONS: Endovascular treatment of type II endoleaks is challenging and reintervention is needed in up to 36% of patients. Endoleaks supplied by both the inferior mesenteric artery and the lumbar arteries have a lower rate of success.

Upper extremity access for fenestrated endovascular aortic aneurysm repair is not associated with increased morbidity.

OBJECTIVE: Fenestrated endovascular aortic aneurysm repair (FEVAR) is an alternative to open repair in patients with complex abdominal aortic aneurysms who are neither fit nor suitable for standard open or endovascular repair. Chimney and snorkel grafts are other endovascular alternatives but frequently require bilateral upper extremity access that has been associated with a 3% to 10% risk of stroke. However, upper extremity access is also frequently required for FEVAR because of the caudal orientation of the visceral vessels. The purpose of this study was to assess the use of upper extremity access for FEVAR and the associated morbidity. METHODS: During a 5-year period, 148 patients underwent FEVAR, and upper extremity access for FEVAR was used in 98 (66%). Outcomes were compared between those who underwent upper extremity access and those who underwent femoral access alone. The primary end point was a cerebrovascular accident or transient ischemic attack, and the secondary end point was local access site complications. The mean number of fenestrated vessels was 3.07 ± 0.81 (median, 3) for a total of 457 vessels stented. Percutaneous upper extremity access was used in 12 patients (12%) and open access in 86 (88%). All patients who required a sheath size >7F underwent high brachial open access, with the exception of one patient who underwent percutaneous axillary access with a 12F sheath. The mean sheath size was 10.59F ± 2.51F (median, 12F), which was advanced into the descending thoracic aorta, allowing multiple wire and catheter exchanges. RESULTS: One hemorrhagic stroke (one of 98 [1%]) occurred in the upper extremity access group, and one ischemic stroke (one of 54 [2%]) occurred in the femoral-only access group (P = .67). The stroke in the upper extremity access group occurred 5 days after FEVAR and was related to uncontrolled hypertension, whereas the stroke in the femoral group occurred on postoperative day 3. Neither patient had signs or symptoms of a stroke immediately after FEVAR. The right upper extremity was accessed six times without a stroke (0%) compared with the left being accessed 92 times with one stroke (1%; P = .8). Four patients (4%) had local complications related to upper extremity access. One (1%) required exploration for an expanding hematoma after manual compression for a 7F sheath, one (1%) required exploration for hematoma and neurologic symptoms after open access for a 12F sheath, and two patients (2%) with small hematomas did not require intervention. Two (two of 12 [17%]) of these complications were in the percutaneous access group, which were significantly more frequent than in the open group (two of 86 [2%]; P = .02). CONCLUSIONS: Upper extremity access appears to be a safe and feasible approach for patients undergoing FEVAR. Open exposure in the upper extremity may be safer than percutaneous access during FEVAR. Unlike chimney and snorkel grafts, upper extremity access during FEVAR is not associated with an increased risk of stroke, despite the need for multiple visceral vessel stenting.

Optimal medical therapy predicts amputation-free survival in chronic critical limb ischemia.

OBJECTIVE: Determine the proportion of patients with chronic critical limb ischemia (CLI) who failed to adhere to Trans-Atlantic Inter-Society Consensus II guidelines of medical therapy and to quantify the effect of baseline suboptimal medical management on amputation-free survival (AFS). METHODS: The patients were identified from a prospectively maintained database of consecutive patients presenting with CLI to the Vascular Surgery service at a single hospital. The primary outcome variable was AFS. The effects of baseline demographics, comorbid medical conditions, ambulatory status, optimal medical management, and Rutherford classification were assessed. Significant univariate predictors (P < .10) of AFS were entered into a multivariate Cox proportional hazards model. RESULTS: From August 1, 2010 through January 1, 2012, 98 patients (median age, 59.0; interquartile range, 53, 64 years; 58 men) were evaluated with rest pain (n = 40) or tissue loss (n = 58). Optimal medical management was identified in 31 (32%) patients at initial presentation. Compliance rates for the entire cohort were 61% for statin use, 69% for antiplatelet therapy, 56% for angiotensin-converting enzyme inhibitor use, and 53% for beta-blocker use. Significant univariate predictors of major amputation or death included: Rutherford classification (hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.01-2.41; P = .04); nonambulatory status (HR, 2.17; 95% CI, 1.68-2.81; P < .01); unrevascularized patients (HR, 2.77; 95% CI, 1.32-5.85; P < .01); a history of tobacco abuse (HR, 1.49; 95% CI, 0.57-3.86; P = .09); a history of end-stage-renal disease (HR, 7.97; 95% CI, 3.10-20.52; P < .01); suboptimal medical management (HR, 4.25; 95% CI, 1.28-14.07; P = .02); and an absence of antiplatelet agents (HR, 1.94; 95% CI, 0.92-4.11; P = .08). Independent predictors of major amputation or death included: initial nonambulatory status (HR, 2.43; 95% CI, 1.03-2.05; P < .01); unrevascularized status (HR, 2.43; 95% CI, 1.76-3.34; P = .01); and suboptimal medical management at presentation (HR, 8.54; 95% CI, 2.05-35.65; P < .01). CONCLUSIONS: Despite guidelines advocating the optimization of atherosclerotic risk factors, less than one-third of patients with CLI present with their risk factors optimally managed. Patients who are medically undertreated have an eight-fold risk of major amputation and/or death. The magnitude of the effect suggests that future trials and quality assessments should stratify outcomes by the quality of baseline medical management. Of the risk factors affecting AFS medical therapy optimization is the variable that can be most significantly improved by vascular surgeons and the medical community.

Colocación de stents vs. endarterectomía para enfermedades carotídeas. Resultados del Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) / Stenting vs. endarterectomy for carotid disease. Results of the carotid revascularization endarterectomy vs. stenting trial (CREST) / Colocação de stent vs. Endarterectomia para doença arterial carotídea. Resultados do carotid revascularization endarterectomy vs. Stenting trial (crest)

Antecedentes y objetivos: La estenosis de la arteria carótida causa hasta el 10% de todos los ataques cerebrovasculares isquémicos. La endarterectomía carotídea (CEA) se presentó como tratamiento para prevenir los ataques cerebrovasculares en los comienzos de 1950. La colocación del stent carotídeo (CAS) fue presentada como tratamiento para prevenir el ataque cerebrovascularen 1994. Métodos: CREST es un estudio randomizado con adjudicación completamente ciega. Tanto los pacientes sintomáticos como los asintomáticos fueron randomizados a CAS o CEA. El objetivo final primario fue la combinación de cualquier accidente cerebrovascular, de infarto de miocardioo bien de fallecimiento durante el período periprocedimiento y de accidente cerebrovascular ipsilateral después de 4 años. Resultados: No existió una diferencia significativa en los promedios del objetivo final entre CASy CEA (7.2% vs. 6.8%; HR=1.11; 95% CI, 0.81-1.51; P=0.51). Tanto el estado sintomático como el sexo de los pacientes no modificaron el efecto del tratamiento, pero si se detectó una interacción entre la edad y el tratamiento. Los resultados fueron levemente mejores con CAS, en aquellos pacientes menores de 70 años, mientras que para los pacientes mayores a 70 años fue mejor para aquellos pacientes con CEA. El objetivo final periprocedimiento no difería entre CAS y CEA, pero existían diferencias en los componentes CAS vs. CEA (ataques cerebrovasculares 4.1% vs. 2.3%, P=0.012; y el infarto de miocardio 1.1% vs. 2.3%, P=0.032). Conclusiones: En el CREST, el objetivo final primario tanto en CAS como en CREST, tuvo similares síntomas a corto como a largo plazo. Durante el período periprocedimiento, existía mayor riesgo de ataque cerebrovascular con CAS mientras que con CEA existía un riesgo mayor de infarto de miocardio.

Antecedentes e objetivos: A estenose arterial carotídea é causa de aproximadamente 10% de todos os acidentes cerebrovasculares isquêmicos. A endarterectomia carotídea (CEA) se apresentou como tratamento para prevenir os acidentes cerebrovasculares no início dos anos 50. A colocação do stent carotídeo (CAS) foi apresentada como um tratamento para prevenir o acidente cerebrovascular em 1994. Métodos: O estudo CREST foi um ensaio clínico randomizado completamente cego. Tantoos pacientes sintomáticos quanto os assintomáticos foram randomizados CAS ou randomizados CEA. O objetivo final primário foi a combinação de qualquer acidente cerebrovascular, de infarto do miocárdio ou inclusive de óbito durante o período periprocedimento e de acidente cerebrovascular ipsilateral depois de 4 anos. Resultados: Não foi demonstrada uma diferença significativa nas médias do objetivo final entre CAS e CEA (7.2% vs. 6.8%; HR=1.11; 95% CI, 0.81-1.51; P=0.51). Tanto o estado sintomático quanto o sexo dos pacientes não modificaram o efeito do tratamento, porém, detectou-se uma interação entre a idade e o tratamento. Os resultados foram levemente melhores com CAS nos pacientes menores de 70 anos, enquanto que para os pacientes maiores de 70 anos foi melhor com CEA. O objetivo final periprocedimento não diferia entre CAS e CEA, mas existiam diferenças nos componentes CAS vs. CEA (acidentes cerebrovasculares 4.1% vs. 2.3%, P=0.012; e o infarto do miocárdio 1.1% vs. 2.3%, P=0.032). Conclusões: No estudo CREST, o objetivo final primário tanto em CAS quanto em CREST, apresentou similares sintomas tanto a curto como a longo prazo. Durante o período periprocedimento, existia maior risco de acidente cerebrovascular com CAS enquanto que com CEA existia um risco maior de infarto do miocárdio.

Background and purpose: Carotid artery stenosis causes 10% of all ischemic cerebrovascular attacks. Carotid endarterectomy (CEA) was introduced as the treatment to prevent strokes in the beginning of the 50´s. The placement of a carotid stents (CAS) was introduced as a treatment to prevent strokes in 1994. Method: CREST is a randomized study with complete blind randomization. Both symptomatic and asymptomatic patients were randomized to CAS or CEA. The primary outcome was the combination of the prevention of stroke, myocardial infarction or death during the periprocedural period or ipsilateral stroke after 4 years. Results: There were no significant differences in the mean final outcome between CAS andCEA (7.2% vs. 6.8%; HR=1.11; 95% CI, 0.81-1.51; P=0.51). Both being symptomatic as well as the gender of the patients did not modify the treatment effect, but there was a relationship between age and treatment. The results were slightly better with CAS in patients under 70 years old, while in patients over 70 years old the results were better with CEA. The final peri-procedural outcome did not differ between CAS and CEA but there were differences in the CAS vs CEA components (stroke 4.1% vs. 2.3%, P=0.012; and myocardial infarction 1.1% vs. 2.3%, P=0.032). Conclusions: In the CREST study, with regards to the primary end point both CAS and CEA had similar short-term symptoms. During the peri-procedural period in patients undergoing CAS there was a higher risk of stroke while patients undergoing CEA presented a higher risk of myocardial infarction.

Gender differences in blood flow velocities after carotid angioplasty and stenting.

Gender differences have been demonstrated in blood flow velocities by duplex ultrasonography (DU) in patients with carotid stenosis. Currently, DU is the most widely used method of follow-up monitoring after carotid angioplasty and stenting (CAS). To identify possible gender differences in carotid flow velocities, we analyzed our experience with DU obtained before and immediately after CAS. In a series of 47 CAS procedures over a 2.5-year period performed in 31 men and 15 women, carotid angiograms and duplex flow velocities were obtained preoperatively and within 24 hr after CAS. Carotid velocity profiles were compared with the angiographic degree of carotid stenosis. Gender differences in blood velocities were assessed using parametric and nonparametric statistical tests. Overall, women had median blood velocities 5-10% higher than men, although the differences were not statistically significant. DU obtained immediately after CAS revealed that median blood flow velocities were very similar among men and women (P > 0.4). In conclusion, although women have higher carotid blood flow velocities than men do, gender differences are notably absent on follow-up DU after carotid stenting. Our data indicate that similar criteria should be used after CAS for interpreting carotid velocity profiles in both women and men.