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Objectives: Aneurysm sac changes after fenestrated-branched endovascular aneurysm repair (FBEVAR) for postdissection thoracoabdominal aortic aneurysms (PD-TAAs) are poorly understood. Partial thrombosis of the false lumen and endoleaks may impair sac regression. To characterize sac changes after FBEVAR for PD-TAAs, this study examined midterm results and predictors for sac enlargement., Methods: FBEVARs performed for PD-TAAs in 10 physician-sponsored investigational device exemption studies from 2008 to 2023 were analyzed. The maximum aortic aneurysm diameter was compared between the 30-day computed tomography angiogram and follow-up imaging studies. Aneurysm sac enlargement was defined as an increase in diameter of ≥5 mm. Kaplan-Meier curves and Cox regression were used to evaluate sac enlargement and midterm FBEVAR outcomes., Results: Among 3296 FBEVARs, 290 patients (72.4% male; median age, 68.4 years) were treated for PD-TAAs. Most aneurysms treated were extent II (72%) and III (12%). Mean aneurysm diameter was 66.5 ± 11.2 mm. Mortality at 30 days was 1.4%. At a mean follow-up of 2.9 ± 1.9 years, at least one follow-up imaging study revealed sac enlargement in 43 patients (15%), sac regression in 115 patients (40%), and neither enlargement nor regression in 137 (47%); 5 (2%) demonstrated both expansion and regression during follow-up. Freedom from aneurysm sac enlargement was 93%, 82%, and 80% at 1, 3, and 5 years, respectively. Overall, endoleaks were detected in 27 patients (63%) with sac enlargement and 143 patients (58%) without enlargement (P = .54). Sac enlargement was significantly more frequent among older patients (mean age at the index procedure, 70.2 ± 8.9 years vs 66.5 ± 11 years; P = .04) and those with type II endoleaks at 1 year (74% vs 52%; P = .031). Cox regression revealed age >70 years at baseline (hazard ratio [HR], 2.146; 95% confidence interval [CI], 1.167-3.944; P = .010) and presence of type II endoleak at 1 year (HR, 2.25; 95% CI, 1.07-4.79; P = .032) were independent predictors of sac enlargement. Patient survival was 92%, 81%, and 68% at 1, 3, and 5 years, respectively. Cumulative target vessel instability was 7%, and aneurysm-related mortality was 2% at 5 years. At least 42% of patients required secondary interventions. Sac enlargement did not affect patient survival., Conclusions: Aneurysm sac enlargement occurs in 15% of patients after FBEVAR for PD-TAAs. Elderly patients (>70 years at baseline) and those with type II endoleaks at 1 year may need closer monitoring and secondary interventions to prevent sac enlargement. Despite sac enlargement in some patients, aneurysm-related mortality at 5 years remains low and overall survival was not associated with sac enlargement., Competing Interests: Disclosures A.W.B has been a consultant for Artivion Inc., Cook Medical Inc., Philips Healthcare, and Terumo Cardiovascular Group and received research support from Cook Medical Inc, Endospan Ltd, Medtronic PLC, Philips Healthcare, Terumo Cardiovascular Group, and W. L. Gore & Associates. A.S. has been consultant for Cook Medical Inc., Artivion Inc., and Philips Healthcare. G.S.O has been a consultant for Cook Medical Inc., W. L. Gore & Associates, Inc., GE HealthCare Technologies, Inc., and Centerline Biomedical Inc. C.H.T. has been a consultant for and received research support from Cook Medical Inc., W. L. Gore & Associates, Inc., and Phillips Healthcare. M.A.F is a consultant for WL Gore, Cook Medical, Getinge, Centerline Biomedical and ViTAA Medical and received research support from Cook Medical and clinical trial support from W. L. Gore & Associates, Cook Medical, and ViTAA Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs., Methods: The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia)., Results: Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46)., Conclusions: Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is a minimally invasive alternative for patients at high risk of open repair of complex aortic aneurysms. Nearly all investigative study protocols evaluating F/BEVAR have required a predicted life expectancy of >2 years for study inclusion. However, accurate risk models for predicting 2-year survival in this patient population are lacking. We sought to identify the preoperative predictors of 2-year survival for patients undergoing F/BEVAR., Methods: The prospectively collected data for all consecutive F/BEVAR procedures, performed in an institutional review board-approved registry and/or a physician-sponsored investigational device exemption (IDE) trial (IDE no. G130210), were reviewed (November 2010 to February 2019). We assessed 44 preoperative patient characteristics, including comorbidities, preoperative functional status, aneurysm morphologies, and repair techniques. Preoperative functional status was defined as totally dependent (any impairment in activities of daily living or residing in a skilled nursing facility), partially dependent (any impairment in instrumental activities of daily living), or independent (no impairment in activities of daily living or instrumental activities of daily living). Using the results of univariate analysis (P < .2), a Cox proportional hazards model was constructed to identify the independent predictors of 2-year all-cause mortality., Results: For the 256 consecutive patients who had undergone F/BEVAR (6 common iliac [2.3%], 94 juxtarenal [41%], 35 pararenal [14%], 119 thoracoabdominal [47%], and 2 arch [0.8%] aneurysms), the 2-year mortality was 18%. On Cox modeling, the only independent preoperative predictor contributing to 2-year mortality was functional status (totally dependent: hazard ratio [HR], 5.4; 95% confidence interval [CI], 1.8-16; P = .0024; partially dependent: HR, 4.5; 95% CI, 2.4-8.7; P < .0000019). A history of an implanted anti-arrhythmic device was protective (HR, 0.4; 95% CI, 0.2-0.99; P = .0495). Factors such as age, congestive heart failure, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, aneurysm extent, and previous aortic surgery, were not significant. The 2-year mortality for the independent (n = 176; 69%), partially dependent (n = 69; 27%), and totally dependent (n = 10; 3.9%) groups was 11%, 33%, and 40%, respectively., Conclusions: For patients undergoing F/BEVAR, decreased preoperative functional status was the strongest predictor of 2-year mortality, with totally dependent patients experiencing poor survival. The traditional risk factors were not independently significant, perhaps reflecting the high prevalence of severe chronic illness in these high-risk patients participating in an IDE trial. For the independent patients, the 2-year F/BEVAR survival rate was 89%, equivalent to patient survival after infrarenal EVAR. Therefore, for independent patients, it would be reasonable to expand the indication for F/BEVAR to low-risk patients., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to report the expanded use of preloaded catheters and wires of fenestrations and directional branches to facilitate access to renal and mesenteric target arteries during endovascular repair of complex aortic aneurysms., Methods: This was an observational retrospective cohort multicentre study. Prospectively collected data from six physician sponsored investigational device exemption studies at US centres were analysed. Patients were treated with fenestrated and branched aortic endografts for pararenal and thoraco-abdominal aortic aneurysms (TAAAs) between 2012 and 2017. Technical success was defined as successful intra-operative catheterisation and stenting of all intended target visceral arteries. Univariable and stratified analyses were performed to identify differences in outcomes between repairs using preloaded and standard devices., Results: There were 564 patients (73% men, mean age 73 ± 8 years) treated for 168 pararenal aortic aneurysms (29.8%), 216 type IV TAAAs (38.3%), and 180 type I - III TAAAs (31.9%). Preloaded grafts (PGs) were used in 387 (68.6%) patients and standard grafts (SGs) in 177 (31.4%). PGs were used preferentially for type IV TAAAs (45% vs. 24%; p < .001), whereas standard devices were used more frequently among patients with type I - III TAAAs (24% vs. 49%; p < .001). The majority of custom made devices were preloaded (95% vs. 21%; p < .001). A total of 2 157 target arteries were incorporated (mean 3.9/patient) utilising 1 469 fenestrations (68.1%), 603 directional branches (27.9%), and 85 double wide scallops (3.9%). Most PGs included fenestrations (80% vs. 43%; p < .001), whereas directional branches were more frequent in standard devices (17% vs. 53%; p < .001). Contrast volume, fluoroscopy time, radiation dose, and operative time were not significantly different between preloaded and standard devices. Upper extremity access was more frequent for PGs (87% vs. 72%; p < .001). Overall technical success was 98.8% and comparable for both preloaded and standard grafts (99.5% vs. 97.2%; p = .022). The 30 day stroke rate was similar for PGs and SGs (2.3% and 1.7%%, respectively). The 30 day mortality rate was 1.9%, and low for both PGs and SGs (0.8% vs. 4.5%; p = .003)., Conclusion: Endovascular repair of complex aortic aneurysms is safe and effective. The expanded use of preloaded catheters and wires of fenestrations and directional branches for target artery incorporation is associated with a high technical success and low early mortality., Competing Interests: Conflicts of Interest C. Timaran: Cook Medical Inc., W. L. Gore & Associates. G. Oderich: Cook Medical Inc., W. L. Gore & Associates. D. Schneider: Cook Medical Inc., W. L. Gore & Associates. A. Schanzer: Cook Medical Inc. A. Beck: Cook Medical Inc. M. Farber: Cook Medical Inc, W. L. Gore & Associates., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (F/BEVAR) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms (TAAAs)., Methods: We reviewed the clinical data of 240 patients with extent I to extent III TAAAs enrolled in seven prospective physician-sponsored investigational device exemption studies from 2014 to 2017. All patients had manufactured off-the-shelf or patient-specific fenestrated-branched stent grafts used to target 888 renal-mesenteric arteries with a mean of 3.7 vessels per patient. End points included mortality, major adverse events (any-cause mortality, stroke, paralysis, dialysis, myocardial infarction, respiratory failure, bowel ischemia, and estimated blood loss >1 L), technical success, target artery patency, target artery instability, occlusion or stenosis, endoleak, rupture or death, reintervention, and renal function deterioration., Results: There were 50 patients (21%) treated for postdissection TAAAs and 190 (79%) who had degenerative TAAAs. Postdissection TAAA patients were significantly younger (67 ± 9 years vs 74 ± 8 years; P < .001), were more often male (76% vs 52%; P = .002), and had more prior aortic repairs (84% vs 67%; P = .02) and larger renal (6.4 ± 1.2 mm vs 5.8 ± 0.9 mm; P < .001) and mesenteric (8.9 ± 1.7 mm vs 7.8 ± 1.4 mm; P < .001) target artery diameters. There was no difference in aneurysm diameter (66 ± 13 mm vs 67 ± 11 mm; P = .50), extent I or extent II TAAA classification (64% vs 56%; P = .33), and length of supraceliac coverage (22 ± 9.5 cm vs 20 ± 10 cm; P = .38) between postdissection and degenerative patients, respectively. Preloaded guidewire systems (66% vs 43%; P = .003) and fenestrations as opposed to directional branches (58% vs 24%; P < .001) were used more frequently to treat postdissection patients. Technical success was 100% for postdissection TAAAs and 99% for degenerative TAAAs (P = .14). At 30 days, there was no difference in mortality (2% postdissection, 3% degenerative), major adverse events (24% postdissection, 26% degenerative; P = .73), spinal cord injury (6% postdissection, 12% degenerative; P = .25), paraplegia (2% postdissection, 7% degenerative; P = .19), and dialysis (0% postdissection, 5% degenerative; P = .24). Mean follow-up was 14 ± 12 months. Endoleaks were significantly more frequent in patients with postdissection TAAAs (76%) compared with degenerative TAAAs (43%; P < .001). At 2 years, there was no difference in patient survival (84% ± 7% vs 72% ± 4%; P = .13), freedom from aorta-related death (98% ± 2% vs 94% ± 2%; P = .45), primary (95% ± 2% vs 97% ± 1%; P = .93) and secondary target artery patency (99% ± 1% vs 98% ± 1%; P = .48), target artery instability (89% ± 3% vs 91% ± 1%; P = .17), and freedom from reintervention (58% ± 10% vs 67% ± 5%; P = .23) for postdissection and degenerative TAAAs, respectively., Conclusions: Despite minor differences in demographics, anatomic factors, and stent graft design, F/BEVAR was safe and effective with nearly identical outcomes in patients with postdissection and degenerative TAAAs. Larger clinical experience and longer follow-up are needed to better evaluate differences in mortality, spinal cord injury, target artery instability, and reintervention., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Fenestrated/branched endovascular aneurysm repair (F/B-EVAR) achieves more extensive proximal seal than conventional infrarenal devices, thereby increasing aneurysm exclusion durability. Optimal seal zone length remains undefined. We assessed relative risks and benefits of extending the proximal seal above the celiac artery., Methods: The prospective database of all complex endovascular aortic aneurysm repairs at a single institution (institutional review board-approved, physician-sponsored investigational device exemption trial, 10/2010-6/2017) was used to classify repairs according to the number of target visceral-renal arteries incorporated: 4-vessel versus <4-vessel. Comparisons of aneurysm characteristics, perioperative details, and postoperative complications were performed, stratified by repair type. One-year survival, target artery patency, freedom from type 1 or 3 endoleak, and freedom from reintervention were estimated with Kaplan-Meier analysis., Results: Among 175 F/B-EVARs, 38% (n = 67) were 4-vessel and 62% (n = 108) were <4-vessel. Intraoperatively, there was no difference in mean contrast use (76 mL vs. 74 mL, P = non significant [NS]) or dose area product (63,428 mGy cm 2 vs. 96,015 mGy cm 2 ), but there was increased median procedure time (4.8 hr, interquartile range [IQR] = 4.1-5.8 versus 3.6 hr, IQR = 2.9-4.1, P < 0.0001) and mean operating room direct costs ($52,532, standard deviation [SD] = 18,640 versus $40,128, SD = 15,135, P < 0.0001) in 4-vessel repairs. There were no differences in mortality (1.9% vs. 4.5%), paraparesis (0% vs. 3.0%), or paralysis (0.9% vs. 0%), all P = NS. There were no differences in one-year survival, target artery patency, or freedom from reintervention. There was a lower 1-year freedom from type 1 or 3 endoleak with 4-vessel repairs (82% vs. 94%, log-rank P = 0.02), driven by an increased rate of type 3 endoleaks. Endoleak resolution after treatment was equivalent in both groups (4-vessel, 10 of 12, 83% resolved; <4-vessel, 7 of 7, 100% resolved, P = NS)., Conclusions: With F/B-EVAR, utilization of a supraceliac seal zone, compared with an infraceliac seal zone, is associated with statistical differences in operative characteristics/resource utilization, but with negligible clinical significance. Further innovation to eliminate type 3 endoleaks at fenestrations/branches remains an unmet need. To achieve adequate F/B-EVAR proximal seal zone length, one should have a low threshold to incorporate the celiac artery., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: Fenestrated endografts are customized, patient-specific endovascular devices with potential to reduce morbidity and mortality of complex aortic aneurysm repair. With approval from the U.S. Food and Drug Administration, our center began performing fenestrated endovascular aneurysm repair through a physician-sponsored investigational device exemption (IDE #G130210), using both physician-modified endografts (PMEGs) and company-manufactured devices (CMDs). Because these techniques are associated with specific advantages and disadvantages, we sought to investigate differences in outcomes between PMEG and CMD cases., Methods: A single-institution retrospective review of all fenestrated endovascular aneurysm repairs was performed. The cohort was analyzed by device type (PMEG or CMD) after matching of cases on the basis of (1) number of target vessels intended for treatment, (2) extent of aneurysm, (3) aneurysm diameter, (4) device configuration, and (5) date of operation. Outcomes of ruptures, common iliac artery aneurysms, and aortic arch aneurysms were excluded. Demographics, operative details, perioperative complications, length of stay, and reinterventions were compared. For patients with >1 year of follow-up time, survival, type I or type III endoleak rate, target artery patency, and reintervention rate were estimated using the Kaplan-Meier method., Results: Between November 30, 2010, and July 30, 2016, 82 patients were identified and matched. The cohort included 41 PMEG and 41 CMD patients who underwent repair of 38 juxtarenal (PMEG, 17; CMD, 21; P = .38), 14 pararenal (PMEG, 6; CMD, 8; P = .56), and 30 thoracoabdominal type I to type IV (PMEG, 18; CMD, 12; P = .17) aneurysms. There were significant differences in presentation requiring urgent aneurysm repair (PMEG, 9; CMD, 0; P = .002), total fluoroscopy time (PMEG, 76 minutes; CMD, 61 minutes; P = .02), volume of contrast material used (PMEG, 88 mL; CMD, 70 mL; P = .02), in-operating room to out-of-operating room time (PMEG, 391 minutes; CMD, 319 minutes; P = .001), incision to surgery end time (PMEG, 276 minutes; CMD, 224 minutes; P = .002), and 1-year reintervention rate (PMEG, 37%; CMD, 13%; log-rank P = .04). No differences in perioperative complications, overall length of stay, type I or type III endoleak, or survival were observed between PMEG and CMD. For the entire cohort including both PMEG and CMD, the overall rate of any 30-day postoperative complication was 39%, and the Kaplan-Meier estimate of survival at 1 year was 86%., Conclusions: In this single-institution experience of fenestrated endovascular aneurysm repair, the primary differences between PMEG and CMD related only to operative metrics and the need for postoperative reinterventions. No statistically significant advantage was found for one approach over the other; we therefore cannot conclude that one approach is better than the other. Both remain viable options that may compare favorably with open repair of complex aortic aneurysms. Further studies are necessary to determine whether this relative equivalence represents a type II error or lack of long-term durability data or whether true equivalence between PMEG and CMD approaches exists., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: More than 80% of infrarenal aortic aneurysms are treated by endovascular repair. However, adoption of fenestrated and branched endovascular repair for complex aortic aneurysms has been limited, despite high morbidity and mortality associated with open repair. There are few published reports of consecutive outcomes, inclusive of all fenestrated and branched endovascular repairs, starting from the inception of a complex aortic aneurysm program. Therefore, we examined a single center's consecutive experience of fenestrated and branched endovascular repair of complex aortic aneurysms., Methods: This is a single-center, prospective, observational cohort study evaluating 30-day and 1-year outcomes in all consecutive patients who underwent fenestrated and branched endovascular repair of complex aortic aneurysms (definition: requiring one or more fenestrations or branches). Data were collected prospectively through an Institutional Review Board-approved registry and a physician-sponsored investigational device exemption clinical trial (G130210)., Results: We performed 100 consecutive complex endovascular aortic aneurysm repairs (November 2010 to March 2016) using 58 (58%) commercially manufactured custom-made devices and 42 (42%) physician-modified devices to treat 4 (4%) common iliac, 42 (42%) juxtarenal, 18 (18%) pararenal, and 36 (36%) thoracoabdominal aneurysms (type I, n = 1; type II, n = 4; type III, n = 12; type IV, n = 18; arch, n = 1). The repairs included 309 fenestrations, branches, and scallops (average of 3.1 branch arteries/case). All patients had 30-day follow-up for 30-day event rates: three (3%) deaths; six (6%) target artery occlusions; five (5%) progressions to dialysis; eight (8%) access complications; one (1%) paraparesis; one (1%) bowel ischemia; and no instances of myocardial infarction, paralysis, or stroke. Of 10 type I or type III endoleaks, 8 resolved (7 with secondary intervention, 1 without intervention). Mean follow-up time was 563 days (interquartile range, 156-862), with three (3%) patients lost to follow-up. On 1-year Kaplan-Meier analysis, survival was 87%, freedom from type I or type III endoleak was 97%, target vessel patency was 92%, and freedom from aortic rupture was 100%. Average lengths of intensive care unit stay and inpatient stay were 1.4 days (standard deviation, 3.3) and 3.6 days (standard deviation, 3.6), respectively., Conclusions: These results show that complex aortic aneurysms can now be treated with minimally invasive fenestrated and branched endovascular repair. Endovascular technologies will likely continue to play an increasingly important role in the management of patients with complex aortic aneurysm disease., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration-approved in 2012, remains the only fenestrated device available in the United States. This technology is among the most technically complex catheter-based procedures and, therefore, inherently associated with serious risk for device-related complications. We sought to define patterns of physician and hospital adoption of ZFEN., Methods: Deidentified datasets containing numbers of physicians trained, orders by physicians and hospitals, and designs (fenestration/scallop configuration) was provided for U.S. ZFEN devices ordered (April 2012-August 2015). We evaluated the number of physicians trained, the number of devices ordered, hospital characteristics, and fenestration/scallop design configurations. Cook Medical assembled the datasets but played no role in study design, analysis, or interpretation of data., Results: Between April 2012 and August 2015, 553 physicians attended formal ZFEN training sessions, 388 (70%) of whom ordered a total of 2669 devices. An increase in orders per month (nine in June 2012 and 91 in August 2015, 911% growth; P < .001) and in number of physicians ordering per month (eight in June 2012 and 62 in August 2015, 675% growth; P < .001) was observed. Teaching hospitals, representing all U.S. regions (Midwest 927, 35%; South 799, 30%; Northeast 547, 20%; West 396, 15%), accounted for 1703 (64%) ZFEN orders. Of 553 trained physicians, 165 (30%) ordered no devices, 116 (21%) ordered 1 device, 144 (26%) ordered 2-5 devices, 61 (11%) ordered 6-10 devices, 39 (7%) ordered 11-20, and 28 (5%) ordered >20 devices. For physicians contributing >6 months of data (n = 336), the average number of devices ordered per year was three (standard deviation, 4); 272 (81%) ordered ≤ 5 devices/year, 15 (4.5%) ordered 11-20 devices/year, and 3 (0.9%) ordered >20 devices/year. Of devices with design details available (2618 of 2669; 98%), most common designs were 2 small fenestrations/1 scallop (1443; 55%), 2 small fenestrations/1 large fenestration (568; 22%), 1 small fenestration/1 scallop (173, 6.6%), and 2 small fenestrations (169; 6.5%). The average number of target vessels incorporated in each design was 2.7/device; 2071 (79%) incorporated three, 398 (15%) incorporated two., Conclusions: Since 2012, ZFEN has demonstrated a ninefold increase in monthly orders, with 553 physicians trained. Unlike the experience of rapid dissemination seen with infrarenal endografts, only 28 (5%) physicians have ordered >20, whereas 165 (30%) have ordered none, and 272 (81%) ordered ≤ 5 devices/year. Assuming that volume, in general, correlates with outcomes, this adoption pattern raises questions whether fenestrated technology should be regionalized to high-volume centers., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Mycotic abdominal aortic aneurysms are rare and present unique challenges when potential treatment options are considered. Although aortic resection with in situ grafting techniques or extra-anatomic reconstruction are the treatments of choice, endovascular aortic repair has emerged as a suitable alternative in critically ill patients. We report the successful endovascular repair of a symptomatic, mycotic juxtarenal aortic aneurysm using a physician-modified fenestrated endograft. In this patient, with >6 months of follow-up, the aneurysm has completely regressed, illustrating that in select patients with complex mycotic aneurysms, endovascular repair combined with appropriate medical management is a viable treatment strategy., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The autogenous vein is the preferred conduit in below-knee vascular reconstructions. However, many argue that prosthetic grafts can perform well in crural bypass with adjunctive antithrombotic therapy. We therefore compared outcomes of below-knee prosthetic versus autologous vein bypass grafts for critical limb ischemia and the use of adjunctive antithrombotic therapy in both settings., Methods: Utilizing the registry of the Vascular Study Group of New England (2003-2009), we studied 1227 patients who underwent below-knee bypass for critical limb ischemia, 223 of whom received a prosthetic graft to the below-knee popliteal artery (70%) or more distal target (30%). We used propensity matching to identify a patient cohort receiving single-segment saphenous vein yet had remained similar to the prosthetic cohort in terms of characteristics, graft origin/target, and antithrombotic regimen. Main outcome measures were graft patency and major limb amputation within 1 year. Secondary outcomes were bleeding complications (reoperation or transfusion) and mortality. We performed comparisons by conduit type and by antithrombotic therapy., Results: Patients receiving prosthetic conduit were more likely to be treated with warfarin than those with greater saphenous vein (57% vs. 24%, P<0.001). After propensity score matching, we found no significant difference in primary graft patency (72% vs. 73%, P=0.81) or major amputation rates (17% vs. 13%, P=0.31) between prosthetic and single-segment saphenous vein grafts. In a subanalysis of grafts to tibial versus popliteal targets, we noted equivalent primary patency and amputation rates between prosthetic and venous conduits. Whereas overall 1-year prosthetic graft patency rates varied from 51% (aspirin+clopidogrel) to 78% (aspirin+warfarin), no significant differences were seen in primary patency or major amputation rates by antithrombotic therapy (P=0.32 and 0.17, respectively). Further, the incidence of bleeding complications and 1-year mortality did not differ by conduit type or antithrombotic regimen in the propensity-matched analysis., Conclusions: Although limited in size, our study demonstrates that, with appropriate patient selection and antithrombotic therapy, 1-year outcomes for below-knee prosthetic bypass grafting can be comparable to those for greater saphenous vein conduit., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Mycotic abdominal aortic aneurysms (AAAs) are a clinical challenge for vascular surgeons due to their critical location, surrounding inflammation, risk of rupture, and danger of reinfection following treatment. We present a case of Mycobacterium bovis AAA in a 69-year-old male after treatment with intravesicular bacillus Calmette-Guérin (BCG) therapy for bladder carcinoma. The classical approach for mycotic AAA entails extra-anatomic reconstruction followed by resection with oversewing of the proximal and distal aortic stumps. Alternative in-line reconstruction options have also been advocated. This case illustrates a technically straightforward, durable, in-line repair within an infected field utilizing cryopreserved aortic allograft.

Objective: Carotid endarterectomy (CEA) remains the procedure of choice for treatment of patients with severe carotid artery stenosis. The role of carotid artery stenting (CAS) in this patient group is still being defined. Prior single and multicenter studies have demonstrated economic savings associated with CEA compared with CAS. The purpose of this study was to compare surgical outcomes and resource utilization associated with these two procedures at the national level in 2005, the first year in which a specific ICD-9 procedure code for CAS was available., Methods: All patient discharges for carotid revascularization for the year 2005 were identified in the Nationwide Inpatient Sample based on ICD9-CM procedure codes for CEA (38.12) and CAS (00.63). The primary outcome measures of interest were in-hospital mortality and postoperative stroke; secondary outcome measures included total hospital charges and length of stay (LOS). All statistical analyses were performed using SAS version 9.1 (Cary, NC), and data are weighted according to the Nationwide Inpatient Sample (NIS) design to draw national estimates. Univariate analyses of categorical variables were performed using Rao-Scott chi(2), and continuous variables were analyzed by survey weighted analysis of variance (ANOVA). Multivariate logistic regression was performed to evaluate independent predictors of postoperative stroke and mortality., Results: During 2005, an estimated 135,701 patients underwent either CEA or CAS nationally. Overall, 91% of patients underwent CEA. The mean age overall was 71 years. Postoperative stroke rates were increased for CAS compared with CEA (1.8% vs 1.1%, P < .05), odds ratio (OR) 1.7; (95% confidence interval [CI] 1.2-2.3). Overall, mortality rates were higher for CAS compared with CEA (1.1% vs 0.57%, P < .05) this difference was substantially increased in regard to patients with symptomatic disease (4.6% vs 1.4%, P < .05). By logistic regression, CAS trended toward increased mortality, OR 1.5; (95% CI .96-2.5). Overall, the median total hospital charges for patients that underwent CAS were significantly greater than those that underwent CEA ($30,396 vs $17,658 P < .05)., Conclusions: Based on a large representative sample during the year 2005, CEA was performed with significantly lower in-hospital mortality, postoperative stroke rates, and lower median total hospital charges than CAS in US hospitals. As the role for CAS becomes defined for the management of patients with carotid artery stenosis, clinical as well as economic outcomes must be continually evaluated.

Objective: While autogenous arteriovenous access is preferred, prosthetic arteriovenous grafts (AVG) are still required in a large number of patients. Infection of AVGs occurs frequently and may cause life-threatening bleeding or sepsis. Multiple treatment strategies have been advocated (ranging from graft preservation to excision with complex concomitant reconstructions), indicating a lack of consensus on appropriate management of infected AVGs. We undertook this study to evaluate if, in the setting of anastomotic involvement, brachial artery ligation distal to the origin of the deep brachial artery accompanied by total graft excision (BAL) is safe and effective., Methods: All prosthetic arteriovenous graft infections managed by a single surgeon between 1995 and 2006 were reviewed retrospectively. Patients were identified from a computerized vascular registry, and data were obtained via patient charts and the electronic medical record., Results: We identified 45 AVG infections in 43 patients. Twenty-one patients (49%) demonstrated arterial anastomotic involvement and were treated with BAL; these form the cohort for this analysis. Mean patient age was 53.2 (SD 9.5) years. The primary etiologies for end stage renal disease (ESRD) were hypertension (29%), HIV (24%), and diabetes (19%). An upper arm AVG was present in 95% of patients; one (5%) had a forearm AVG. The majority of grafts were polytetrafluoroethylene (PTFE) (90%). Follow-up was 100% at 1 month, 86% at 3 months, and 67% at 6 months. No ischemic or septic complications occurred in the 21 patients who underwent BAL., Conclusion: BAL is an effective and expeditious method to deal with an infected arm AVG in frequently critically ill patients with densely scarred wounds. In the short term, BAL appears to be well tolerated without resulting ischemic complications. Further study with longer duration of follow-up is necessary to ascertain whether BAL results in definitive cure, or whether patients may ultimately manifest ischemic changes and require additional intervention.

Objectives: Patients referred for fenestrated/branched endovascular aortic repair (F/BEVAR) often present with a previous computed tomography angiogram (CTA), but it is unknown how recent the CTA must be to ensure accurate F/BEVAR planning. We sought to determine whether anatomic planning parameters change significantly between a CTA used for F/BEVAR planning and a CTA obtained 6 to 12 months prior. Methods: Two blinded observers reviewed preoperative CTAs from 21 patients who underwent F/BEVAR. Each patient had a "recent" scan obtained 0 to 6 months before F/BEVAR planning and a "prior" scan obtained 6 to 12 months before the "recent" CTA. Standard measurements included (1) target vessel separation distances, (2) target vessel origin clock position, and (3) proximal F/BEVAR device diameter. Clinically significant differences for target vessel separation distance, target vessel origin clock position, and proximal F/BEVAR device diameter were predefined as >5 mm, >30 minutes, and >4 mm, respectively. Differences between "recent"/"prior" CTA scans were examined by paired t test. Results: Mean time interval between paired "recent"/"prior" CTAs was 8.0 months (standard deviation: ±1.7). Mean difference in paired "recent"/"prior" target vessel distance (relative to celiac artery [CA]) was 2.6 mm for the superior mesenteric artery (SMA), 2.5 mm for the right renal artery (RRA), and 3.3 mm for the left renal artery (LRA). Of the 21 paired "recent"/"prior" CTAs, clinically significant differences were observed in 2, 4, and 2 patients for SMA, RRA, and LRA target vessel distance, respectively. Target vessel clock position (SMA reference at 12:00) varied by 12 minutes for the CA, 13 minutes for the RRA, and 15 minutes for the LRA. One paired "recent"/"prior" CTA was found to have a clinically significant difference for the LRA. No clinically significant differences were observed for proximal device diameter. Conclusions: In patients who underwent successful F/BEVAR, measurement comparisons between CTAs obtained up to 1 year prior were minor and unlikely to yield clinically significant changes to F/BEVAR design. [ABSTRACT FROM AUTHOR]

We describe a case of a 52-year-old female with Turner syndrome found to have an isolated 3.5-cm left subclavian artery aneurysm. Surgical intervention was performed to decrease the risk of compressive symptoms, distal embolization, and rupture. This entailed exclusion of the aneurysm proximally using thoracic stent graft, carotid–subclavian bypass, and ligation of the subclavian artery distal to the aneurysm. One-year follow-up demonstrated exclusion of the aneurysm with a 5-mm reduction in maximum aneurysm sac diameter. This case represents the management of a rare isolated left subclavian artery aneurysm, in the setting of Turner syndrome, treated with a successful endovascular approach. [ABSTRACT FROM PUBLISHER]