Data analysis of vascular surgery instrument trays yielded large cost and efficiency savings.

BACKGROUND: Surgical procedures account for 50% of hospital revenue and ∼60% of operating costs. On average, <20% of surgical instruments will be used during a case, and the expense for resterilization and assembly of instrument trays ranges from $0.51 to $3.01 per instrument. Given the complexity of the surgical service supply chain, physician preferences, and variation of procedures, a reduction of surgical cost has been extremely difficult and often ill-defined. A data-driven approach to instrument tray optimization has implications for efficiency and cost savings in sterile processing, including reductions in tray assembly time and instrument repurchase, repair, and avoidable depreciation. METHODS: During a 3-month period, vascular surgery cases were monitored using a cloud-based technology product (OpFlow, Operative Flow Technologies, Raleigh, NC) as a part of a hospital-wide project. Given the diversity of the cases evaluated, we focused on two main vascular surgery trays: vascular and aortic. An assessment was performed to evaluate the exact instruments used by the operating surgeons across a variety of cases. The vascular tray contained 131 instruments and was used for the vast majority of vascular cases, and the aortic tray contained 152 instruments. Actual instrument usage data were collected, a review and analysis performed, and the trays optimized. RESULTS: During the 3-month period, 168 vascular surgery cases were evaluated across six surgeons. On average, the instrument usage per tray was 30 of 131 instruments (22.9%) for the vascular tray and 19 of 152 (12.5%) for the aortic tray. After review, 45.8% of the instruments were removed from the vascular tray and 62.5% from the aortic tray, for 1255 instruments removed from the versions of both trays. An audit was performed after the removal of instruments, which showed that none of the removed instruments had required reinstatement. The instrument reduction from these two trays alone yielded an estimated costs savings of $97,781 for repurchase and $97,444 in annual resterilization savings. Annually, the removal of the instruments is projected to save 316.2 hours of personnel time. The time required for operating room table setup decreased from a mean of 7:44 to 5:02 minutes for the vascular tray (P < .0001) and from 8:53 to 4:56 minutes for the aortic tray (P < .0001). CONCLUSIONS: Given increasing cost constraints in healthcare, sterile processing remains an untapped resource for surgical expense reduction. A comprehensive data analytics solution provided the ability to make informed decisions in tray management that otherwise could not be reliably performed.

Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. METHODS: Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value <.05 was considered statistically significant. RESULTS: During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. CONCLUSIONS: This initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.

Data Analysis of Plastic Surgery Instrument Trays Yields Significant Cost Savings and Efficiency Gains.

PURPOSE: Inpatient surgery costs have risen 30% over the past 5 years, and the operating room accounts for up to 60% of total hospital operational expense. On average, only 13.0% to 21.9% of instruments opened for a case are used, contributing to significant avoidable reprocessing, repurchase, and labor expense. METHODS: A comprehensive review of 40 major instrument trays at UNC Rex Hospital was conducted using a technology service (OpFlow; Operative Flow Technologies, Raleigh, NC). Among the full scope of the project, the general plastics tray and breast reconstruction tray were evaluated for the plastic surgery service line over a 3-month period. Intraoperative data collection was performed on the exact instruments used across a standard breadth of cases. Data analytics were conducted stratifying instrument usage concordance among surgeons by tray and procedure type. After a surgeon-led review of the proposed new tray configurations, the optimized versions were implemented via a methodical change management process. RESULTS: A total of 183 plastic surgery cases were evaluated across 17 primary surgeons. On average, the instrument usage per tray was 15.8% for the general plastics tray and 23.5% for the breast reconstruction tray. After stakeholder review, 32 (45.1%) of 71 instruments were removed from the general plastics tray and 40 (36.7%) of 109 were removed from the breast reconstruction tray, resulting in a total reduction of 2652 instruments. This resulted in a decrease of 81,696 instrument sterilization cycles annually. The removal of the instruments yielded an estimated cost avoidance of US $163,800 for instrument repurchase and US $69,441 in annual resterilization savings. The instrument volume reduction is projected to save 383.5 hours of sterile processing personnel time in tray assembly annually. CONCLUSIONS: An analytics-driven method applying empirical data on actual case-based instrument usage has implications for better efficiency, improved quality, and cost avoidance related to instrument repurchase and sterile processing. Given increasing cost constraints and the transition to value-based care models, leveraging a technology-based solution enables meaningful change in the sterile processing department as a source for cost reduction and quality of care improvement.

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.

Stenting of superior mesenteric and celiac arteries does not increase complication rates after fenestrated-branched endovascular aneurysm repair.

OBJECTIVE: This study compared complications in patients undergoing fenestrated-branched endovascular aneurysm repair (F-BEVAR) without and with stenting of the superior mesenteric artery (SMA) or celiac artery (CA), with particular attention to the length of coverage above the CA. METHODS: A retrospective review was performed of a prospectively maintained database of patients treated with F-BEVAR for thoracoabdominal aortic aneurysms between July 2012 and May 2017. Data included demographics, risk factors, comorbidities, preoperative aneurysm characteristics, procedural data, and outcomes. Patients were grouped as follows: group 1, no SMA or CA stent; group 2, SMA or CA stent and <5 cm of coverage above the CA; and group 3, SMA or CA stent and ≥5 cm of coverage above the CA. Complications measured included death, myocardial infarction, respiratory failure, stroke or transient ischemic attack, paraplegia, acute kidney injury, mesenteric ischemia, and vascular complications. Individual and composite complications were compared between groups. RESULTS: There were 223 patients who had data analyzed (group 1, 53 [24%]; group 2, 101 [45%]; and group 3, 69 [31%]). Mean age was 72 years (76% male). There was no difference in patients' characteristics between groups, except for hypertension (less common in group 2) and history of previous aortic surgery (more common in group 3). Group 2 (15%) and group 3 (90%) had higher spinal drain use than group 1 (2%; P < .0001). Mean operative time was longer in groups 2 and 3 compared with group 1 (group 1, 224 minutes; group 2, 253 minutes; and group 3, 313 minutes; P < .0001). Group 1 had more intraoperative complications, without difference in the technical success and mortality rates. Failure to deliver a bridging stent occurred in only 3 of 695 vessels (0.4%) intended, without difference between groups (P = .79). The incidence of major complications (individually and composite analysis) was similar between groups. On 30-day computed tomography angiography, there was no difference in type I or type III endoleaks (2%, 3%, and 6%) and branch patency (98%, 99%, and 99%) for groups 1, 2, and 3, respectively. At 3 years of follow-up, there was no difference in survival, stent patency, and branch instability. Group 3 had a higher reintervention rate compared with groups 1 and 2 (P < .0001); however, there was no difference between groups 1 and 2 (P = .31). CONCLUSIONS: Patients who needed SMA or CA incorporation with stents during F-BEVAR for aortic repair had more complex procedures, as assessed by operative time, brachial access, number of vessels incorporated, and spinal drain use. However, the extension of the repair did not affect the outcomes, demonstrated by similar mortality and morbidity rates between groups.

An Unusual Case of Bilateral Upper Extremity Ischemia Caused by Forearm Vessel Fibromuscular Dysplasia.

Fibromuscular dysplasia (FMD) is a nonatherosclerotic disease that generally affects medium-sized arteries. The distribution typically involves the renal, extracranial carotid/vertebral, and iliac arteries. FMD in other vascular beds is rare. We herein present the case of a 47-year-old female with rapid-onset bilateral digital ischemia. Initial differential diagnosis included vasospastic disorders and vasculitis. An upper extremity arteriogram was suggestive of ulnar and radial FMD. Percutaneous intervention was not successful, and the patient was managed conservatively with symptomatic improvement. This case highlights the important diagnostic and therapeutic considerations in patients with less common etiologies of upper extremity ischemia.

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.

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.

Arteriographic Patterns of Atherosclerosis and the Association between Diabetes Mellitus and Ethnicity in Chronic Critical Limb Ischemia.

BACKGROUND: Disparate outcomes in critical limb ischemia (CLI) persist between ethnicities. The contribution of modifiable factors versus intrinsic biologic differences remains unclear. Hence, we aimed to quantify the associations between ethnicity and anatomic patterns of arterial occlusive disease in CLI, adjusting for known atherosclerotic risk factors. METHODS: We performed a retrospective, single-center review of consecutive patients presenting to the vascular surgery service with CLI. Arterial lesions were defined by location (aortoiliac = aorta and iliac arteries; femoral = common, profunda, and superficial femoral arteries; and popliteal-tibial = infrapopliteal and tibial arteries). Stenoses ≥50% were deemed hemodynamically significant. Associations between the patients' baseline arteriographic patterns, demographics, and medical comorbidities were defined using Kruskal-Wallis, χ2, and Mantel-Haenszel χ2 tests. RESULTS: Between August 2010 and January 2014, 286 CLI patients (n = 172 male, n = 176 tissue loss) were evaluated by the Vascular Surgery service. Two hundred seventy subjects had baseline arteriograms for analysis (black n = 134, 50%; Hispanic n = 78, 29%; Caucasian n = 58, 21%.) All ethnicities presented most frequently with simultaneous disease in all infrainguinal segments (n = 124, 46%). Of Hispanics, 30% (n = 23) presented with isolated infrapopliteal disease, which was higher than any other ethnic group (P = 0.02, χ2). Caucasians (n = 8, 14%) presented more frequently with isolated aortoiliac occlusive disease than either Hispanics (n = 0, 0%) or blacks (n = 2, 1%; P = 0.06). Diabetes mellitus was most prevalent among Hispanics (n = 72, 85%) relative to blacks (n = 77, 55%) and Caucasians (n = 32, 52%; P < 0.001, χ2). Median hemoglobin A1c (HbA1c) was also highest among Hispanics (7.3%, interquartile range [IQR] 6.2-9.9) versus blacks and Caucasians (6.6%, IQR 5.8-8.2 and 6.0%, IQR 5.6-7.6; P = 0.002, Kruskal-Wallis). Tobacco abuse was most frequent among Caucasians (n = 53, 87%) and blacks (n = 113, 81%). Forty-eight (57%) of Hispanics abused tobacco (P = 0.001, χ2.) Subgroup analysis of subjects stratified by baseline HbA1c revealed that there was no relationship between ethnicity and isolated infrapopliteal disease among subjects with HbA1c ≤8.8% (P = 0.58, Mantel-Haenszel χ2). Conversely, patients with poorer glycemic control (HbA1c ≥ 8.9%) were more frequently Hispanic and had a higher probability of having isolated infrapopliteal disease (P = 0.005, Mantel-Haenszel χ2). CONCLUSIONS: Hispanic patients present more frequently with isolated infrapopliteal arterial disease relative to other ethnicities, which may contribute to disparate CLI outcomes. Isolated infrapopliteal disease appears to be driven mostly be poorer glycemic control rather than inherent biologic differences between ethnicities. Future studies aimed at understanding disparate outcomes due to race after lower extremity revascularization may benefit from stratification by the severity of diabetes mellitus. Understanding the distribution of atherosclerotic disease may improve the ability to predict outcomes in limb-threatening ischemia.

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.

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.

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.

Ruptured splenic artery aneurysms are exceedingly rare in pregnant women.

OBJECTIVE: Pregnancy is cited as the most important risk factor for splenic artery aneurysm (SAA) rupture, but the true rupture rate of SAAs during pregnancy is unknown. Our objective was to evaluate the prevalence of SAAs, based on diagnostic and procedural codes, in an urban population treated in a county hospital with the highest number of births in the United States. We hypothesized that SAA rupture in pregnant women is very low and that SAAs are more likely to be diagnosed in older patients. METHODS: Patients diagnosed with a SAA during a recent 5-year period were identified using International Classification of Diseases-Ninth Edition, Clinical Modification, and Current Procedural Terminology (American Medical Association, Chicago, Ill) codes. Demographics, imaging, and risk factors for rupture were reviewed. RESULTS: We identified 35 patients with SAA. Patients were a median age of 63 years (interquartile range [IQR], 54-74 years), and 28 (80%) were women who were a median age of 62 years (IQR, 54-74 years). The SAAs in the 35 patients were a median size of 1.3 cm (IQR, 1-1.9 cm), and eight (23%) were >2 cm. Despite the very large number of deliveries recorded during the study period (67,616 births), no women who were pregnant or aged <45 years were identified. However, 89% of women with an SAA had previous pregnancies. Two women and one man (8.6%) experienced rupture, resulting in one death (2.9%). More than one imaging study was available for 19 patients (60%) without intervention for a median of 32 months (IQR, 7-76 months), with no significant change noted. Three patients underwent elective repair due to size criteria. Six patients (17%) had concurrent aneurysms, including three renal artery aneurysms, one aortic aneurysm, and three intracranial aneurysms. No risk factor for enlargement or rupture was particularly prevalent. CONCLUSIONS: Ruptured SAAs are exceedingly rare in young women, and no ruptured SAA were identified during pregnancy in this study. SAA are frequently diagnosed as an incidental finding in middle-aged adults and tend to remain stable over time in this population.

Mycotic inferior mesenteric artery aneurysm secondary to native valve endocarditis caused by coagulase-negative Staphylococcus.

Inferior mesenteric artery (IMA) aneurysms are the rarest of all visceral artery aneurysms, with most resulting from atherosclerotic disease. Mycotic IMA aneurysms are exceptionally uncommon and only 2 cases have been reported in the literature. Coagulase-negative staphylococcus (CNS) is often considered a contaminant; however, increasing reports of certain strains causing endocarditis are becoming more prevalent. We report a case of a mycotic IMA aneurysm, in the setting of native valve endocarditis caused by Staphylococcus simulans, a strain of CNS. To our knowledge, this is the third report of a mycotic IMA aneurysm, and the first account of this usually benign pathogen leading to aneurysmal degeneration in this location.

Thoracic endovascular repair (TEVAR) in the management of aortic arch pathology.

BACKGROUND: Conventional repair of aortic arch pathology is associated with significant mortality and stroke rates of 6-20% and 12%, respectively. Because endografting has excellent results for descending thoracic aortic disease, extension of thoracic endovascular repair (TEVAR) to the arch is a consideration. METHODS: Records of patients with aortic arch pathology treated with TEVAR were reviewed. Branch vessels were (1) covered without revascularization, (2) surgically bypassed, (3) stented, or (4) fenestrated. Technical success was defined both by accurate endograft deployment with disease exclusion and by target vessel revascularization. Patient postoperative outcomes, complications, and follow-up are reported. RESULTS: Between March 2006 and January 2010, 58 patients with arch pathology were treated with TEVAR. Indications included aneurysm (n = 19, 32.8%), dissection (type A: n = 3, 5.2%; type B: n = 18, 31.0%), transection (n = 8, 13.8%), pseudoaneurysm (n = 6, 10.3%), or other (n = 4, 6.9%). Pathology was zone 0 (n = 1, 1.7%), zone 1 (n = 10, 17.2%), zone 2 (n = 45, 77.6%), or zone 3 (n = 2, 3.4%). Interventions were emergent in 44.8% and elective in 55.2%. The left subclavian (LSA) was covered in all and revascularized (n = 23, 39.7%) via bypass (n = 13, 22.4%), stenting (n = 4, 6.9%), or fenestration (n = 6, 10.3%). The carotid was revascularized (n = 11, 19.0%) with bypass (n = 7, 12.1%) or stenting (n = 4, 6.9%). One patient (1.7%) underwent innominate revascularization with a homemade branched endograft. Technical success was 100% for endograft deployment and 97.1% for revascularization. Thirty-day mortality was 3.4% (2 of 58). ICU and hospital stays were 5.8 ± 6.8 (range: 0-34; median 4) and 10.9 ± 8.0 (range: 1-40; median: 9) days, respectively. Morbidities included renal failure (n = 3, 5.2%), respiratory (n = 2, 3.4%), myocardial infarction (n = 1, 1.7%), stroke (n = 6, 10.3%), and spinal cord ischemia (SCI) (n = 2, 3.4%). SCI (p < 0.001), but not stroke (p = 0.33), was associated with LSA sacrifice. Stroke was associated with underlying pathology and graft selection (p = 0.01). During follow-up of 10.6 ± 9.1 (range: 0-43) months, 17 patients (29.3%) required 20 reinterventions for endoleak (n = 8, 13.8%), disease extension (n = 5, 8.6%), steal (n = 4, 6.9%), or other reasons (n = 3, 5.2%). Dissection patients had a higher rate of reintervention (p = 0.01). All patients with steal had LSA sacrifice and were left-hand dominant. CONCLUSIONS: TEVAR can effectively treat aortic arch pathology in high-risk patients with low morbidity and mortality. TEVAR and branch vessel revascularization techniques may be extended to the more proximal arch without increased complications compared with patients with subclavian only involvement. Stroke remains the most significant drawback of arch interventions. Indications for intervention, graft selection, and revascularization choices may all affect outcome. LSA sacrifice is associated with increased SCI and may predispose left-handed patients to symptomatic weakness.

Outcomes and strategies for utilization of brachial access and preloaded systems during F/BEVAR.

The advent of steerable sheaths has contributed to a decrease in the use of preloaded delivery systems and upper extremity access for fenestrated and branched repairs. However, the use of brachial access and preloaded delivery systems is often still necessary and useful in the treatment of complex thoracoabdominal, pararenal, and aortic arch aneurysms. This review describes the outcomes of brachial access and preloaded delivery systems and provides a thorough description of the types of preloaded delivery systems available.

The effects of operative indication and urgency of intervention on patient outcomes after thoracic aortic endografting.

BACKGROUND: Endovascular repair for complex thoracic aortic pathology has emerged over the past decade as an alternative to open surgical repair. Reports suggest lower morbidity and mortality rates associated with endovascular interventions. The purpose of this report was to analyze a large single institution experience in endovascular thoracic aortic repair based on clinical presentation as well as within and outside specific instructions for use. METHODS: Records of all patients undergoing thoracic aortic endografting at our institution were retrospectively reviewed for demographics, interventional indications and acuity, operative details, and clinical outcomes. Study outcomes were analyzed by clinical presentation (urgent/emergent vs elective) and aneurysm morphology that was within and outside specific instructions for use as recommended by the manufacturer. RESULTS: Between March 2006 and October 2009, 96 patients underwent thoracic endografting for aneurysm (n = 43), transection (n = 7), penetrating ulcer (n = 11), dissection (n = 19; acute = 9, chronic = 10), pseudoaneurysm (n = 11), or miscellaneous indications (n = 5). Endografting was performed with various endografts (Gore TAG: 59; Medtrontic Talent: 26; Zenith-TX2: 7; Combination: 4.Involvement of the arch (n = 42, 43.75%) was treated with subclavian artery coverage without revascularization in 13 (13.5%), debranching in 20 (20.8%), and fenestration/stenting in 9 (9.38%). Involvement of the visceral vessels (n = 24, 25%) was treated with debranching in 15 (15.6%) or fenestration/stenting in 9 (9.4%). Patients had a mean follow-up of 11.5 ± 10.96 (range: 0-38) months. Overall mortality was 6.25% (n = 6). Mean intensive care unit stay was 6.26 ± 8.55 (range: 1-63, median: 4) days, and hospital stay was 9.97 ± 10.31 (range: 1-65, median: 65) days. Major complications were infrequent and included: spinal cord ischemia (n = 6, 6.25%), stroke (n = 6, 6.25%), myocardial infarction (n = 3, 3.15%), renal failure (n = 6, 6.25%), and wound complications (n = 9, 9.38%). Reoperation was required in 13 (13.54%), with early intervention in 2 (2.1%). The vast majority of patients were discharged directly to home (n = 66, 68.8%). There were no significant differences between death (1/49 [2%] vs 5/47 [10.6%], P = .07), stroke (3/49 [6%] vs 3/47 [6%], P = 1.0), or spinal cord ischemia (3/49 [6%] vs 3/47 [6%], P = 1.0) when comparing urgent/emergent presentation to elective cases, respectively. However, there were significant differences in death (6/58 [10.5%] vs 0/38 [0%], P = .04) and spinal cord ischemia (6/58 [10.5%] vs 0/38 [0%], P = .04) but not stroke (5/58 [8.8%] vs 1/38 [2.5%], P = .24] when procedures were performed outside the specific instructions for use. CONCLUSIONS: Results of this single-institution report suggest that endovascular thoracic aortic repair is a safe and effective treatment option for a variety of thoracic pathology including both elective and emergent cases. However, off-label usage of the devices is associated with a significantly higher risk of mortality and spinal cord ischemia, but the risk still appears acceptable given the majority of cases were emergent.

Volumetric analysis of type B aortic dissections treated with thoracic endovascular aortic repair.

BACKGROUND: Type B aortic dissections are being successfully treated by thoracic endovascular aortic repair (TEVAR). Postoperative false lumen patency has been associated with aneurysmal dilatation and rupture of the thoracic aorta, necessitating further intervention. This is the first volumetric analysis of type B aortic dissections comparing patients with and without false lumen thrombosis (FLT) after TEVAR. We hypothesized that a greater increase in postoperative true lumen volume will lead to FLT, and without this change, false lumen patency will result. METHODS: Preoperative and postoperative computed tomography angiography (CTA) imaging was analyzed using three-dimensional reconstruction to measure the short- and long-axis diameter and cross-sectional area of the true lumen, false lumen, and total aorta. Measurements were taken at 5-cm intervals from the left subclavian artery to the aortic bifurcation. Pre- and postoperative volumetric data were calculated and compared in patients with and without postoperative FLT. RESULTS: Between 2006 and 2010, 132 patients underwent thoracic aortic stent grafting. Of these, 31 (23%) had thoracic endografting for type B aortic dissection. Pre- and postoperative CTA images were available for analysis in 23 patients with a mean age of 59 ± 14 years treated for acute, complicated (n = 8, 35%), and chronic (n = 15, 65%) indications. Mean follow-up imaging was 9 months (range, 1-39 months). Thirteen patients (56%) had postoperative FLT and 10 (43%) had persistent false lumen patency. The dissections involved the left subclavian artery (n = 12), visceral arteries (n = 14), renal arteries (n = 16), and iliac arteries (n = 15). The left subclavian artery was intentionally covered in 15 patients (65%). There were no significant differences in age, acute vs chronic dissection, branch vessel involvement, coverage of the left subclavian artery, or distal extent of the endograft between patients with and without postoperative FLT. Patients with postoperative FLT had a significantly smaller preoperative maximum thoracic aortic diameter (5.05 ± 1.0 vs 6.30 ± 1.4 cm; P = .02). Volumetric analysis demonstrated significantly smaller preoperative true lumen volume (141.3 ± 68 vs 230.5 ± 92 cm(3); P = .01) in patients with FLT, but no difference in preoperative false lumen volume. Patients with FLT had a significant increase in the volume percentage of the true lumen from 42.7% to 61.7% (P = .02) after stent graft repair, compared with an increase from 46.7% to 47.7% (P = .75) in patients with persistent false lumen patency. CONCLUSIONS: This volumetric study of type B aortic dissection treated with TEVAR suggests that the ability of the endograft to significantly increase the true lumen volume as a percent of the total aorta most accurately predicts postoperative FLT. This is best demonstrated in a nonaneurysmal dissection regardless of timing since dissection.