Intraoperative blood pressure lability carries a higher risk of headache after carotid endarterectomy.

OBJECTIVE: Cerebral hyperperfusion syndrome (CHS) is a rare but potentially devastating complication after carotid endarterectomies (CEA). Its symptoms range from new-onset unilateral headache (HA) to intracranial hemorrhage (ICH). Risk factors for CHS in the literature to date have not yet yielded a consensus. This study examines intraoperative and postoperative blood pressure variations as potential risk factors for HA. METHODS: A single-center retrospective review at a tertiary care center from January 2010 to November 2019 was performed. Inclusion criteria were all patients undergoing CEA for symptomatic or asymptomatic carotid disease. Patients with incomplete charts were excluded. Primary endpoints were new-onset unilateral HA or postoperative ICH. Data on intraoperative and postoperative mean arterial pressure (MAP), systolic blood pressure (SBP), the mode of endarterectomy, shunt placement, and contralateral carotid status were collected. RESULTS: There were 735 patients who met the inclusion criteria: 430 patients underwent modified eversion CEA (59%) and 305 patients for patch angioplasty (42%). The incidence of HA was 19% (n = 142) in our total cohort. Of the 19% with HA, 1.5% (n = 11) demonstrated no relief with analgesics and strict blood pressure control; noncontrast head computed tomography scans were performed subsequently. One patient (0.1%) had an ipsilateral ICH. Univariate analysis demonstrated that greater intraoperative MAP peak had the highest risk for HA (odds ratio [OR], 1.014; 95% confidence interval [CI], 1.007-1.022; P = .0002), followed by intraoperative MAP variability (OR, 1.011; 95% CI,1.005-1.018; P ≤ .0008), and peak intraoperative SBP (OR, 1.01; 95% CI, 1.004-1.015; P = .0011). An unpaired Student t test identified change in intraoperative MAP (P < .005), change in the SBP (P < .005), and peak SBP (P < .001) were significantly associated with HA. Interestingly, there was no significant difference between postoperative MAP variability and HA (P = .1). The mode of endarterectomy showed no statistically significant difference in risk for developing HA (OR, 1.165; 95%; 95% CI, 0.801-1.694; P = .42). CONCLUSIONS: Greater intraoperative variability in blood pressures are significantly associated with a higher risk of HA. Adhering to stricter intraoperative blood pressure parameters and limiting blood pressure variability may be beneficial at decreasing the incidence of CHS and its complications.

Traumatic thoracolumbar projectile with concomitant vertebral body and aortic injury.

Penetrating subdiaphragmatic aortic trauma is associated with high morbidity and mortality with studies having reported a 50%-70% associated mortality. We describe a case of a patient with a subdiaphragmatic aortic injury caused by a 7.4-cm common nail that traversed through his L1 vertebral body into the aorta. His aortic injury was managed jointly with vascular surgery and neurosurgery teams.

Recurrent upper extremity acute limb ischemia secondary to retained axillary polytetrafluoroethylene cuff causing axillary stump syndrome.

Acute limb ischemia of the upper extremity is less frequently encountered than in the lower extremity. The etiology is typically cardioembolic. Axillary-femoral stump syndrome is a rare complication associated with an occluded axillary-femoral bypass graft. We present the case of recurrent acute limb ischemia of the upper extremity whose embolic source was a retained cuff of a previously explanted axillary-profunda bypass graft. The patient failed anticoagulation after an initial embolectomy and after a recurrent embolism from the retained cuff, ultimately required cuff exclusion with a covered stent.

Poly-Specialty Application Practices of Medical Students Applying to Integrated Vascular Surgery Residency.

BACKGROUND: It is not uncommon for medical students seeking surgical residencies to apply to and rank two or more surgical specialties. Level of interest in a specialty is consistently cited as one of the most important factors for program directors when evaluating applicants for 0 + 5 integrated vascular surgery (IVS) programs. The purpose of this study was to examine trends in poly-specialty application submission to IVS and poly-specialty ranking of IVS to determine the percentage of applicants to IVS residencies with vascular surgery as their true preference. METHODS: Electronic Residency Application Service (ERAS) statistics for noninternational medical graduates from 2011 to 2017 were mined for trends in poly-specialty applications between IVS and other surgical disciplines. The poly-specialty application percentage, range, and standard deviation were determined. The National Resident Match Program (NRMP) results and data from 2011 to 2018 were also used to identify those U.S. seniors who ranked IVS programs as their preferred choice, defined as ranking vascular as the only choice or the first-choice specialty. This was compared with those who ranked a specialty other than vascular surgery first but had vascular surgery listed on their rank list. These data were also collected for applicants to orthopedic surgery, neurosurgery, otolaryngology, obstetrics and gynecology, integrated cardiothoracic surgery, and integrated plastic surgery. RESULTS: Between 2011 and 2017, applicants who submitted ERAS applications to IVS most often poly-specialty applied to IVS and general surgery (87%) followed by IVS and the following: preliminary surgery (71%), plastic surgery (22%), orthopedic surgery (19%), neurosurgery (17%), otolaryngology (16%), obstetrics and gynecology (12%), and urology (3%). The percentage of the applicant pool submitting rank lists with multiple specialties fell over the study period from 94% in 2011 to 67% in 2018. Between 2011 and 2018, an average of 14% of IVS applicants (n = 463), who submitted rank lists to the NRMP, ranked a specialty other than vascular as their true preference (range 7-23 SD 5). Only integrated cardiothoracic surgery had a higher percentage of applicants listing a different specialty as their true preference at 25% (range 18-36 SD 7). Nearly all (97-99%) applicants to orthopedic surgery, neurosurgery, otolaryngology, obstetrics and gynecology, and plastic surgery applied to that specialty as their true preference. CONCLUSIONS: IVS residency applicants were most likely to apply for poly-specialty via the ERAS to general surgery and IVS. Compared to the other surgical specialties, those who submitted rank lists to the NRMP listing integrated cardiothoracic and IVS had the highest likelihood of ranking another specialty higher. Care must be taken when evaluating applications to IVS residencies to determine the applicant's level of interest in vascular surgery as a career.

Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results.

OBJECTIVE: Adverse outcomes observed late in the Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) investigational device exemption trial prompted refinement of the anatomic instructions for use (IFU). This study aimed to investigate the association of procedural factors during Nellix endograft deployment and patient outcomes. METHODS: We retrospectively reviewed 1-month imaging of 333 patients enrolled in the prospective, multicenter EVAS investigational device exemption trial between January 2014 and September 2016. Initial observations of those patients who met revised anatomic IFU yet still experienced late adverse events suggested that inadequate seal and low graft placement were common among these patients. Key procedural variables identified from a univariate analysis were applied to construct four cohorts stratified by procedural technical performance (technically adequate [P+] or technically inadequate [P-]) and the revised anatomic indications for use (anatomically within IFU [A+] or anatomically outside of IFU [A-]) and to compare them for aneurysm-related outcomes. A logistic regression analysis was performed to identify significant predictors of sac expansion or migration. RESULTS: Proximal and distal seal zones and low graft placement were identified by logistic regression analysis as significant predictors of sac expansion or migration. Accordingly, acquisition of ≥10-mm proximal and distal seal zones and the position of the lowest stent within 10 mm of the lowest renal artery were clinically justified as thresholds for a technically adequate procedure. Patients who did not achieve these parameters were deemed to have a technically inadequate procedure. By use of the proposed procedural adequacy criteria and established anatomic criteria, patients were stratified into four cohorts: A+/P+ (n = 77), A+/P- (n = 54), A-/P+ (n = 71), and A-/P- (n = 131). Three-year estimates of freedom from migration of 10 mm were 98.6% in A+/P+, 95.9% in A+/P-, 85.8% in A-/P+, and 80.1% in A-/P-; freedom from type IA endoleak estimates were 98.6% in A+/P+, 100% in A+/P-, 96.4% in A-/ P+, and 90.3% in A-/P- cohorts. Freedom from sac expansion and secondary intervention were 96.9% and 90.6% in A+/P+, 86.0% and 93.6% in A+/P-, 87.1% and 83.1% in A-/P+, and 80.5% and 79.8% in A-/P- groups, respectively. Two early deaths (aneurysm-related mortality) on days 4 and 12 postoperatively were reported within the A+/P- group. Kaplan-Meier estimates of freedom from all-cause mortality and aneurysm-related mortality at 3 years were similar between cohorts. CONCLUSIONS: This post hoc analysis suggests that achieving a 10-mm proximal and distal seal with adequate positioning of the endograft with respect to the renal arteries is associated with improved patient outcomes.

Trends in the 10-year history of the vascular integrated residency match: More work, higher cost, same result.

OBJECTIVE: The purpose of this study was to examine trends in application submission, rank lists, and applicant quality for vascular surgery integrated residency. METHODS: The National Resident Matching Program Results and Data reports and the Electronic Residency Application Service Statistics from 2007 to 2017 were compiled and mined for trends in terms of application submission and the number of applicants a program needed to rank to fill all residency positions. Applicant pool depth and percentage of programs applied to were calculated. Outcome data from the National Resident Matching Program were reviewed for 2014 and 2016 for United States Medical Licensing Examination Step scores and experiences. RESULTS: During the last 10 years, the number of vascular surgery integrated residency spots rose from 9 to 60 per year. Most programs offer one spot per year; none offer more than two. The average number of applications received by programs rose from 17 applications in 2008 to 63.8 in 2017. The average rank list depth needed by programs to fill the spots has not increased (range, 2.5-5.1; standard deviation, 0.73). The proportional depth of the applicant pool decreased from 4.6 U.S. and Canadian applicants for every one residency spot in 2008 to 1.7 applicants for every one residency spot in 2017. Applicant quality metrics were available for 2 years (2014 and 2016). Step 1 scores (237/239), Step 2 scores (250/250), research experiences (3.7/4.2), and volunteer experiences (5.9/5.5) remained nearly unchanged. The number of contiguous ranks for matched applicants remained stable (12.3/12.8). CONCLUSIONS: The current system promotes multiple inefficiencies, resulting in application glut. Fewer applicants are flooding programs with an increasing number of applications. More money is being spent on Electronic Residency Application Service applications without changes in the number needed to rank by applicants or programs to achieve a match. There is no improvement in the quality of the applicant. Should these trends continue, they represent an unsustainable model for resident selection.

Assessing trends, morbidity, and mortality in ruptured abdominal aortic aneurysm repair with 9 years of data from the National Surgical Quality Improvement Program.

BACKGROUND: The American College of Surgeons' National Quality Improvement Program (NSQIP) database can be used to assess trends and outcomes of ruptured abdominal aortic aneurysm (rAAA) repair. The purpose of this study is to examine the morbidity and mortality for ruptured endovascular (rEVAR) and ruptured open (rOPEN) aneurysm repair compared with elective endovascular (EVAR) and elective open (OPEN) aneurysm repair. METHODS: Ruptured and nonruptured abdominal aortic aneurysms were identified from the NSQIP database between 2008 and 2016. Data regarding demographics and comorbidities, 30-day mortality, and postoperative complications were collected for rEVAR, rOPEN, EVAR, and OPEN cases. RESULTS: There were 43,105 AAAs, 34,177 (79.28%) EVARs, and 8928 (20.71%) OPENs. There were 3806 rAAAs, 1843 (48.42%) rEVARs, and 1963 (51.58%) rOPENs. The incidence of rEVAR repair lagged behind EVAR considerably. Mortality for rOPEN was 575 (29.29%) and 344 (18.66%) for rEVAR. No difference between the ratio of men to women in rOPEN vs rEVAR was noted. There was a significant increase in mortality for women vs men undergoing rEVAR (P = .0362). No difference in mortality existed between women vs men undergoing rOPEN (P = .0639). There was no difference in the percentage of hypotensive cases undergoing rEVAR vs rOPEN (P =.1873). For all rAAAs with hypotension, rOPEN had an increased mortality compared to rEVAR (P = .0004). There were 20 (3.11%) rEVAR and 40 (8.00%) rOPEN cases with lower extremity ischemia. rOPEN conferred a significant increase in lower extremity ischemia (P = .0002). There were 46 (7.15%) rEVAR and 60 (12.00%) rOPEN cases of ischemic colitis. rOPEN had a significant increase in ischemic colitis (P = .0052). CONCLUSIONS: NSQIP data, over 9 years, demonstrate an increased morbidity and mortality associated with open vs endovascular repair of rAAAs. A great disparity exists between the proportion of rEVAR and rOPEN to EVAR and OPEN. The lagging use of endovascular repair of rAAAs must be further explored.

Endovascular Aneurysm Sealing is Associated with Higher Medium-Term Survival than Traditional EVAR.

BACKGROUND: Endovascular aneurysm repair (EVAR) is the dominant treatment modality for abdominal aortic aneurysm (AAA). Periprocedural risks are low, and cardiovascular events are the principle determinants of long-term survival. Recently, the concept of endovascular aneurysm sealing (EVAS) has been introduced into clinical investigation. In previous cohort studies, EVAS has been associated with a lower all-cause mortality than expected despite device issues. We used a propensity weighted approach to investigate whether EVAS was associated with lower all-cause mortality after aneurysm repair. METHODS: We compared 333 patients in the Nellix United States Investigational Device Exemption trial to 15,431 controls from the Vascular Quality Initiative between 2014 and 2016 after applying the exclusion criteria from the investigational device exemption (hemodialysis, creatinine > 2.0 mg/dL, or rupture). We calculated propensity scores and applied inverse probability weighting to compare risk adjusted medium-term survival using Kaplan-Meier and Cox regression. RESULTS: After weighting, patients treated with the Nellix EVAS system experienced higher 3-year survival than controls from the Vascular Quality Initiative (93% vs. 88%, respectively). This corresponded to a 41% lower risk of mortality for EVAS compared with EVAR (HR 0.59 [0.38-0.92], P = 0.02). Subgroup analysis demonstrated that the association between EVAS and higher survival was strongest in the subgroup of patients with aneurysms over 5.5 cm (P for interaction < 0.001). In this subgroup, EVAS patients experienced half the rate of mortality as those patients treated with EVAR, with 3-year survival of 92% compared with 86% (HR 0.5 [0.3-0.9], P = 0.02). CONCLUSIONS: In this select group of patients, EVAS was associated with higher medium-term survival than traditional EVAR. Although issues with the device have recently surfaced, this exploratory analysis shows that the concept of sac sealing may hold promise. Further study is needed to confirm this finding and determine whether EVAS is associated with lower rates of cardiovascular events.

Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial.

BACKGROUND: The Nellix System (Endologix, Inc, Irvine, Calif) for endovascular aneurysm sealing (EVAS) is a novel approach to abdominal aortic aneurysm treatment and conceptually different from endovascular aneurysm repair, whereby polymer is employed to fill and actively manage the abdominal aortic aneurysm sac. One-year safety and effectiveness results of the Nellix pivotal trial demonstrated encouraging outcomes with very low morbidity and mortality and high procedural and treatment success. Two-year imaging revealed a signal of migration, leading to a field safety notification issued by the manufacturer on October 21, 2016, and a dedicated root cause analysis, resulting in refinements to the instructions for use (IFU). We report the 2-year results of the investigational device exemption pivotal trial stratified according to the new and original criteria for selection of patients. METHODS: Comprehensive engineering evaluations, statistical analyses, and clinical assessments were conducted looking at patients enrolled in the pivotal trial (N = 150), roll-in cohort (N = 29), and continued access program (N = 154). All patients in all cohorts were treated on-IFU at the time of enrollment. Logistic regression models supported the mechanism that migration with Nellix is associated with a small aortic flow lumen relative to a large aneurysm thrombus burden and large aortic neck diameters. Based on these findings, refinements to the IFU criteria were applied, excluding patients with a thrombus index (maximum aneurysm sac/maximum flow lumen diameter) >1.4, aortic neck diameter >28 mm, and aortic neck conicity (>10% diameter change along the infrarenal neck) and requiring a 10-mm distal seal zone in the iliac artery. RESULTS: Freedom from all-cause mortality at 2 years was 94%. Patient outcomes were then stratified on the refined morphologic criteria and analyzed retrospectively. Two-year freedom from composite endoleak was high among both cohorts (95% on-IFU vs 92% off-IFU). Freedom from migration was 97.7% on-IFU vs 93.2% off-IFU (P = .0125). Freedom from aneurysm enlargement was 98.1% on-IFU vs 93.5% off-IFU (P value is not available because of failure of log-rank test assumptions). Composite freedom from migration, type IA endoleak, or aneurysm expansion was 95.9% among the on-IFU cohort vs 85.1% in the off-IFU cohort (P = .0017). CONCLUSIONS: Consistent with the introduction of a novel therapy, the presentation of failure modes of EVAS over time was inevitable. Using detailed imaging as well as engineering and statistical analysis, we were able to understand risk factors for adverse events specific to EVAS and defined those patients best suited for Nellix. With this EVAS-specific approach to defining IFU, on-IFU patients were identified as those with large aneurysms with little thrombus that would be prone to type II endoleaks and sac expansion with traditional devices. When treated with Nellix, these patients were predicted to experience exceptional results, especially with regard to a low composite endoleak rate and low all-cause mortality.

Descending thoracic aortic mural thrombus presentation and treatment strategies.

BACKGROUND: Thoracic aortic mural thrombus (TAMT) of the descending aorta is rare but can result in dramatic embolic events. Early treatment is therefore crucial; however, there is not a consensus on ideal initial treatment. METHODS: A review of the literature using PubMed was conducted, and all relevant publications describing descending TAMT of the past 15 years were reviewed. Variables included for this analysis were presentation, initial treatment strategy employed, outcome measures of thrombus resolution or regression, recurrence of symptomatic emboli, and mortality. RESULTS: Seventy-four patients were included in this analysis. Women were significantly more likely to be described with descending TAMT. The majority (82.4%) of cases reported were diagnosed after an embolic event. Patients were equally likely to receive medical, open surgical, or endovascular therapy as the initial treatment modality. However, there is a trend within the past 5 years to report cases describing successful thoracic endovascular aortic repair for initial management. Of patients who initially underwent medical management, nine patients (34.6%) had persistent thrombus. Of the patients who initially underwent open surgical repair, six patients (31.6%) had persistent thrombus; of these patients, four underwent endovascular repair. Twenty-nine patients (39.2%) with descending TAMT initially underwent thoracic endovascular aortic repair. Twenty-seven (93.1%) had fully excluded thrombus at the time of the procedure, with no recurrence or evidence of repeated embolic phenomena at follow-up. CONCLUSIONS: Whereas mural thrombus of the thoracic aorta is uncommon, it must be considered in the differential diagnosis of embolic events. Although endovascular therapy may be a useful first-line option for TAMT with reports of positive outcomes in select literature, further study of this treatment option is required.

One-year pivotal trial outcomes of the Nellix system for endovascular aneurysm sealing.

OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) treatment whereby polymer is used to fill the AAA sac. We report 1-year results of the investigational device exemption pivotal trial. METHODS: Eligible patients were treated at 30 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with a neck length ≥10 mm and ≤60° angle, iliac artery blood lumen diameter 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine ≤2 mg/dL. Follow-up included computed tomography angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end point was 30-day major adverse events (MAEs), which were compared with a performance goal of <56% (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end point was treatment success at 1 year, which was compared with a performance goal of >80%. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration >10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect. RESULTS: Of 150 treated patients, 149 (99.3%) completed 1-year follow-up. The MAEs rate at 30 days was 2.7% (95% confidence interval, 0.7%-6.7%), satisfying the primary safety end point (<56%). The 1-year treatment success was 94% (95% confidence interval, 88.6%-97.4%), achieving the primary effectiveness end point (>80%). At 1 year, key secondary outcomes included 6.7% MAEs, 4.7% serious device-related events, 1.3% AAA-related mortality, 3.7% secondary interventions, and 0.7% surgical conversions. MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and one AAA rupture was reported during follow-up. AAA sac enlargement (>5 mm) was 1.5% at 1 year. Endoleaks were present in four patients (3.1%) at 1 year (1 type Ib and 3 type II). Migration >10 mm occurred in three patients (2.3%), but none required secondary intervention. CONCLUSIONS: Outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, are encouraging. The primary safety and effectiveness end points have been met. Low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique. Long-term follow-up is in progress.

Relative value unit-based compensation incentivization in an academic vascular practice improves productivity with no early adverse impact on quality.

OBJECTIVE: Given the increased pressure from governmental programs to restructure reimbursements to reflect quality metrics achieved by physicians, review of current reimbursement schemes is necessary to ensure sustainability of the physician's performance while maintaining and ultimately improving patient outcomes. This study reviewed the impact of reimbursement incentives on evidence-based care outcomes within a vascular surgical program at an academic tertiary care center. METHODS: Data for patients with a confirmed 30-day follow-up for the vascular surgery subset of our institution's National Surgical Quality Improvement Program submission for the years 2013 and 2014 were reviewed. The outcomes reviewed included 30-day mortality, readmission, unplanned returns to the operating room, and all major morbidities. A comparison of both total charges and work relative value units (RVUs) generated was performed before and after changes were made from a salary-based to a productivity-based compensation model. P value analysis was used to determine if there were any statistically significant differences in patient outcomes between the two study years. RESULTS: No statistically significant difference in outcomes of the core measures studied was identified between the two periods. There was a trend toward a lower incidence of respiratory complications, largely driven by a lower incidence in pneumonia between 2013 and 2014. The vascular division had a net increase of 8.2% in total charges and 5.7% in work RVUs after the RVU-based incentivization program was instituted. CONCLUSIONS: Revenue-improving measures can improve sustainability of a vascular program without negatively affecting patient care as evidenced by the lack of difference in evidence-based core outcome measures in our study period. Further studies are needed to elucidate the long-term effects of incentivization programs on both patient care and program viability.

Open abdominal aortic aneurysm repair is still necessary in an era of advanced endovascular repair.

OBJECTIVE: Recent advances in endovascular aneurysm repair have overcome substantial anatomic barriers associated with short and challenging necks. With greater range to treat more difficult anatomy from an endovascular approach, one would assume the need of open surgical repair (OSR) would be diminished. The purpose of our study was to determine the need for OSR for abdominal aortic aneurysms, in a tertiary academic setting, with a moderate volume (10-15 cases/year) of fenestrated endografting being performed. METHODS: An Institutional Review Board approved retrospective review was performed of all patients who underwent elective aortic aneurysm repair between January 2010 and July 2014. Computed tomography scans for patients who underwent OSR were reviewed and anatomic characteristics obtained. Instructions for use of (IFU) a commercially available fenestrated device (Cook Medical, Bloomington, Ind) were used to determine if open repair patients had anatomy amenable to advanced endovascular repair. RESULTS: During the study interval, 415 patients underwent abdominal aortic aneurysm repair. Of those patients who underwent elective aneurysm repair, 105 patients had OSR. The study subsequently excluded 11 patients because they underwent secondary interventions after a failed endovascular repair and thus were not further evaluated. Also excluded were 18 patients who had OSR for an emergency intervention. The remaining 76 patients (35 female, 41 male; average age, 72 ± 8 years) had OSR and were outside the IFU of the fenestrated endovascular aneurysm repair (FEVAR) device. The average diameter of the abdominal aorta was 5.9 cm. Indications for OSR were an aneurysm neck <4 mm (71%), inclusion of at least 1 visceral vessel (69.7%), unilateral iliac artery aneurysms (15.5%), bilateral iliac artery aneurysms (14.3%), iliac artery tortuosity >40° of angulation (37.6%), extensive aortic thrombus (23.2%), and aortic neck angulation >45° (11.8%). Rejected patients had an average of 1.7 ± 0.8 anatomic constraints (range 1-4) that prevented use of the FEVAR device. CONCLUSIONS: With evidence to support the strict adherence to IFU protocols of the FEVAR device in patients, our institution's practice has been to continue to perform open abdominal aortic aneurysm repair for patients with anatomy outside device protocols. Although it was thought that the decreased requirement of aortic neck required to deploy an endograft would lead to an increased patient population amenable to endovascular repair, there is still a clinically significant need for open aortic surgery.

Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing.

OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. METHODS: Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length ≥10 mm and angle to the sac ≤60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter ≤6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine level ≤2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). RESULTS: Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). CONCLUSIONS: In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.

Secondary interventions after endovascular repair of aortic dissections.

BACKGROUND: Review the literature on secondary interventions performed for patients who underwent endovascular repair of their type B aortic dissection. Endovascular repair for type B aortic dissection (TBAD) has been proven to be both technically feasible and beneficial in some patients. However, the information regarding secondary interventions is not cohesive. To date, there are little data to help guide physicians on the indications and benefits of secondary interventions in the setting of previous endovascular repair for TBAD. METHODS: PubMed database was queried for publications using the following combination of keywords; "aortic dissection," "type B," "secondary intervention," "false lumen thrombosis," "stent graft," "aortic remodeling," and endovascular repair. Sixteen articles were selected and reviewed for secondary interventions, indications for procedure, and effects on false lumen thrombosis. Data were collected, and a composite database of patients was created. RESULTS: Literature review demonstrated 161 of 862 patients required secondary interventions for entry tears, retrograde type A dissection, false lumen degeneration with aortic expansion, graft malfunction, and various access complications. The complete false lumen thrombosis rate was 33%, and overall mortality was 18.2%. CONCLUSIONS: Secondary interventions provide a useful adjunct to failing endovascular repair of aortic dissections. A variety of treatment options are available for aneurysmal degeneration after thoracic endovascular aneurysm repair. This review also shows that these secondary interventions, in combination with proper surveillance and optimal medical management, are feasible but carry a high all-cause mortality.

Peripheral occlusive disease may provide the highest hospital margins despite rising costs.

OBJECTIVE: The objective of this study was to review vascular surgical financial trends in a tertiary care setting and to evaluate the impact of a vascular program within a health care system in the face of lower reimbursements and rising costs. METHODS: With use of Current Procedural Terminology codes and diagnosis-related groups, vascular categories of aortic disease, cerebrovascular disease, and peripheral occlusive disease (POCD) were identified at an academic tertiary health care center. Hospital margins were calculated for each of the defined categories by Health Quest cost accounting data cross-walked with Current Procedural Terminology codes, date of service, and admitting physician for each year from 2010 to 2012. RESULTS: All categories realized volume growth and a positive margin for the hospital. In comparison of 2010 and 2012, aortic cases showed an overall volume growth of 19%, revenue increase of 31%, and cost increase of 54%, resulting in an overall margin decrease of 7%. Cerebrovascular cases showed a 30% increase in volume growth, revenue increase of 13%, and cost increase of 5%, resulting in a margin increase of 18%. POCD cases showed overall volume growth of 35%, revenue increase of 37%, cost increase of 54%, and a margin increase of 15%. The margin for POCD exceeded the margin for aortic and cerebrovascular cases combined by 77%. CONCLUSIONS: In evaluating a vascular program's fiscal viability, volume-driven POCD was the only category producing growing hospital margins in the face of significant cost increases.

Modified eversion carotid endarterectomy.

BACKGROUND: Eversion carotid endarterectomy is a well-described technique for carotid endarterectomy (CEA). The advantage of this technique is a completely autogenous repair. We describe a modification of eversion endarterectomy (MEE) that expeditiously extracts the plaque through a linear incision over the common carotid artery and the proximal bulbous internal carotid artery (ICA) only, allowing primary closure. Selective shunting can also be performed without difficulty. METHODS: A retrospective review of CEAs using MEE at two institutions by three vascular surgeons during a 5-year period was performed. Data were collected from the medical records, with institutional review board approval. Information regarding neurologic symptoms, degree of ICA stenosis, CEA technique, ICA clamp time, shunting, electroencephalographic monitoring, and postoperative complications was tabulated. Rate of significant restenosis (stenosis >50% by duplex criteria) was also calculated during the follow-up period. RESULTS: Between 2005 and 2009, a total of 221 patients underwent MEE for carotid artery stenosis (CAS): 69 patients (31%) underwent MEE for symptomatic and 152 (68.8%) underwent MEE for asymptomatic CAS. Neuromonitoring in the form of electroencephalography was used in 85 (39%) patients, and an intraluminal shunt was used in 29 patients (13%) who had either severe contralateral disease or a previous ipsilateral cerebral infarction. Postoperative complications included transient ischemic attack (four, 2%), cerebral infarction (three, 1%), myocardial infarction (three, 1%), and hematoma (six, 3%). Four patients (2%) required a return to the operating room (OR). within 24 hours for hematoma (one, 1%) or postoperative neurologic deficit (three, %). The 30-day mortality was 1%. One patient (1%) required patch angioplasty because of the extent of disease and inability to obtain a good end point. Average cross-clamp time for MEE was 12.8 minutes. Two patients (1%) were reported to have hemodynamically significant restenosis within 2 years, with one patient requiring intervention. CONCLUSIONS: MEE is a safe and effective way of treating CAS, with acceptable morbidity, mortality, and low rate of recurrent stenosis despite the absence of a patch. Given the brief clamp time required, routine shunting and/or neuromonitoring for this technique may have questionable clinical value and expense.

An all-inclusive and transparent view of a vascular program's direct impact on its health system.

OBJECTIVE: This study explores the fiduciary advantage of a Vascular Surgery program to an academic, tertiary care hospital. METHODS: This is a retrospective review of hospital (HealthQuest) and physician (IDX) billing databases from April 2009 to September 2010. We identified all patients interacting with Vascular Surgery (VS) to provide an overview of global finances. Patients introduced solely by VS were identified to minimize confounding of the downstream effect. Outcome measures obtained were revenue, average and total gross margin, relative value unit production, and service utilization. RESULTS: A total of 552 cases were identified demonstrating $13 million in revenue. This translated into a gross margin of $5 million. Examined per surgeon, VS was the most profitable, producing $1.6 million. Lower extremity amputation had the highest average gross margin at $34,000. Notably, $8 million in direct cost is among the highest in the health system. A total of 137 cases unique to VS generated $5 million in total revenue. This patient subset made use of up to 29 physician specialty services. General Medicine and Radiology were the most frequently utilized. CONCLUSION: The overall profitability of a comprehensive vascular program is tremendously positive. This study verifies that new vascular-specific referrals are a significant catalyst for revenue.

CD25+ immunoregulatory CD4 T cells mediate acquired central transplantation tolerance.

Transplantation tolerance is induced reliably in experimental animals following intrathymic inoculation with the relevant donor strain Ags; however, the immunological mechanisms responsible for the induction and maintenance of the tolerant state remain unknown. We investigated these mechanisms using TCR transgenic mice (TS1) that carry T cells specific for an immunodominant, MHC class II-restricted peptide (S1) of the influenza PR8 hemagglutinin (HA) molecule. We demonstrated that TS1 mice reject skin grafts that have transgene-encoded HA molecules (HA104) as their sole antigenic disparity and that intrathymic but not i.v. inoculation of TS1 mice with S1 peptide induces tolerance to HA-expressing skin grafts. Intrathymic peptide inoculation was associated with a dose-dependent reduction in T cells bearing high levels of TCR specific for HA. However, this reduction was both incomplete and transient, with a full recovery of S1-specific thymocytes by 4 wk. Peptide inoculation into the thymus also resulted in the generation of immunoregulatory T cells (CD4+CD25+) that migrated to the peripheral lymphoid organs. Adoptive transfer experiments using FACS sorted CD4+CD25- and CD4+CD25+ T cells from tolerant mice revealed that the former but not the latter maintain the capacity to induce rejection of HA bearing skin allografts in syngeneic hosts. Our results suggest that both clonal frequency reduction in the thymus and immunoregulatory T cells exported from the thymus are critical to transplantation tolerance induced by intrathymic Ag inoculation.