Faculty Bibliography

Objective: In patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated to be a safe and effective alternative to transfemoral CAS. Compared with CEA, in which approximately 12% of patients undergoing awake intervention do not tolerate internal carotid artery clamping, only 1% to 2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) 1 and 2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and to review how those cases were managed.
Method(s): This is a retrospective review of prospectively collected data from the ROADSTER multicenter trial along with the subsequent postapproval (ROADSTER 2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient-reported symptoms.
Result(s): There were 103 patients from ROADSTER and 194 patients from ROADSTER 2 who underwent TCAR under local/regional anesthesia. Of these, eight patients had intolerance to flow reversal, although all cases were successfully completed. Four cases were completed under low-flow reversal, three cases were successfully weaned from low to high flow during several minutes, and one case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, prior myocardial infarction or angina, preoperative CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck irradiation, tandem stenosis, high cervical stenosis, or hostile neck (Tables I and II). A trend toward significance was seen with chronic obstructive pulmonary disease (P =.086) and contralateral carotid artery occlusion (P =.139).
Conclusion(s): Despite intolerance to flow reversal, most cases were successfully completed by adjusting reversal of flow rate and did not require conversion to general endotracheal anesthesia. Whereas factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend toward significance with an association of pre-existing chronic obstructive pulmonary disease and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends. [Formula presented] [Formula presented]
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OBJECTIVE:Prior authorization (PA) is a process used by payers for safety and cost savings purposes, but it has received criticism for being time-consuming and costly because of administrative burden. Our study evaluated efficacy of PA applied to in-office lower extremity superficial venous procedures. METHODS:All in-office lower extremity venous procedures scheduled to be performed at our institution in 2017 were included in the study. Variables of interest were type of procedure, initial PA status (approved or denied), rationale for the decision, and final status after appeal. Cost analysis was performed using Centers for Medicare and Medicaid Services allowable rates to approximate billing and reimbursement data (proprietary) as well as calculated using industry averages. RESULTS:For 2017, of 1959 procedures scheduled, 57.9% (n = 1134) required PA. Of these, only 6.1% (n = 69) received initial PA denial, and nearly 40% of the denials (n = 27) were overturned after appeal. Of the 42 denials that were upheld, 15 resulted in cancellations; the remainder were performed by patient self-pay (n = 11) or by the provider pro bono (n = 16). Overturned denials were a result of either submission of incomplete clinical data on initial PA request or insufficient documentation of clinical necessity. When Centers for Medicare and Medicaid Services allowable rates were applied for cost analysis, the denials resulted in <$60,000 payer savings. Administrative expenses totaled >$110,000 when industry standards were applied, which far exceeds any calculated payer savings using the same methods. The 15 denials resulting in procedure cancellations (1.3% of all PAs) could be considered a net savings to the health care system but only approximated a mere $30,000. CONCLUSIONS:Our study demonstrates that PA is not a cost-effective measure for utilization management of outpatient superficial venous procedures when surgeon practices are already well aligned with insurance guidelines. For these physicians and physician groups, the administrative cost associated with the PA process exceeds the savings seen by the insurance companies.

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

Background: Patients who present acutely with a femoral vein deep venous thrombosis (DVT) diagnosed by ultrasound are often treated with anticoagulation and instructed to follow up electively. This study sought to assess whether obtaining central imaging in this cohort of patients results in an increased diagnosis of iliocaval DVT and consequently an increased consideration for interventional treatments to effect thrombus removal. Methods: This study was a retrospective review of a prospectively maintained RedCap database from November 2014 through August 2016, which is coordinated by the Venous Thromboembolic Center at our institution. Consecutive patients who were diagnosed by ultrasound with a femoral vein DVT were evaluated. The patients who underwent confirmatory central venous imaging (computed tomography venography, magnetic resonance venography; group A) were compared with the patients who did not undergo central venous imaging (group B). Demographic variables were collected. The outcomes evaluated were (1) the presence of iliocaval DVT, (2) candidacy for lytic-based therapies, (3) performance of lytic-based therapy, and (4) performance of any invasive treatment (lytic therapy, mechanical thrombectomy, inferior vena cava filter placement, or venous stenting). Additional outcomes included technical success of invasive treatment and complications associated with invasive treatment. Results:A total of 63 patients were identified who presented with a diagnosis of femoral vein DVT. Group A comprised 20 of 63 (31%) patients. Group B comprised the remainder, 43 of 63 (69%). The baseline demographics did not differ significantly, except for gender (Table). The number of patients who were diagnosed with an iliocaval DVT differed significantly (group A, nine [45%]; group B, nine [20%]; P <.0001). The number of patients who underwent lytic therapy differed significantly (group A, eight [40%] - seven at the index admission and one at 1 month; group B, 0 [0%]; P <.0001). The number of patients without relative contraindications to lytic therapy did not differ significantly (group A, 13 [65%]; group B, 34 [79%]; P =.35). The number of patients who underwent any invasive treatment differed significantly between the two cohorts (group A, 12/20 [60%]; group B, 4/43 [9%]; P =.0001). The majority of interventions were technically successful in both groups (group A, 11/12 [91.7%]; group B, 4/4 [100%]; P = 1.00). Conclusions: This study suggests that a significant percentage of patients diagnosed by ultrasound with femoral vein DVTs have a concomitant iliocaval DVT. The data suggest that in patients with a femoral vein DVT, central venous imaging may be indicated to identify potentially treatable iliocaval thrombosis. Long-term data will be required to see if this results in a decrease in post-thrombotic syndrome on a population basis. (table present)

OBJECTIVE: Cooling to electrocerebral inactivity (ECI) by electroencephalography (EEG) remains the gold standard to maximize cerebral and systemic organ protection during deep hypothermic circulatory arrest (DHCA). We sought to determine predictors of ECI to help guide cooling protocols when EEG monitoring is unavailable. METHODS: Between July 2005 and July 2011, 396 patients underwent thoracic aortic operation with DHCA; EEG monitoring was used in 325 (82%) of these patients to guide the cooling strategy, and constituted the study cohort. Electroencephalographic monitoring was used for all elective cases and, when available, for nonelective cases. Multivariable linear regression was used to assess predictors of the nasopharyngeal temperature and cooling time required to achieve ECI. RESULTS: Cooling to a nasopharyngeal temperature of 12.7 degrees C or for a duration of 97 minutes was required to achieve ECI in >95% of patients. Only 7% and 11% of patients achieved ECI by 18 degrees C or 50 minutes of cooling, respectively. No independent predictors of nasopharyngeal temperature at ECI were identified. Independent predictors of cooling time included body surface area (18 minutes/m(2)), white race (7 minutes), and starting nasopharyngeal temperature (3 minutes/ degrees C). Low complication rates were observed (ischemic stroke, 1.5%; permanent paraparesis/paraplegia, 1.5%; new-onset dialysis, 2.2%; and 30-day/in-hospital mortality, 4.3%). CONCLUSIONS: Cooling to a nasopharyngeal temperature of 12.7 degrees C or for a duration of 97 minutes achieved ECI in >95% of patients in our study population. However, patient-specific factors were poorly predictive of the temperature or cooling time required to achieve ECI, necessitating EEG monitoring for precise ECI detection.

OBJECTIVE: To design an orientation for surgical interns to meet the new Accreditation Council for Graduate Medical Education Common Program Requirements regarding supervision, to test patient-management competencies, and to assess confidence on skills and tasks pre-orientation and post-orientation. DESIGN: Twenty-seven incoming surgical interns participated in a two-day orientation to clinical duties. Activities included a pre-test, lectures, simulation, oral examination, intern shadowing, and a post-test. Incoming interns were surveyed before and after orientation and two months later for confidence in patient-management and surgical intern skills. Paired t-tests were used to determine if confidence improved pre-orientation and post-orientation, and two months following orientation. SETTING: The study took place at an academic training hospital. PARTICIPANTS: All (n = 27) postgraduate year-1 (PGY-1) surgical residents at our institution, which included the categorical and nondesignated preliminary general surgery, urology, orthopedic surgery, otolaryngology, and neurosurgery programs. RESULTS: All interns passed the oral and written examinations, and were deemed able to be indirectly supervised, with direct supervision immediately available. They reported increased confidence in all areas of patient management addressed during orientation, and this confidence was retained after two months. In surgical and floor-related tasks and skills, interns reported no increase in confidence directly following orientation. However, after two months, they reported a significant increase in confidence, particularly in those tasks that are performed often. CONCLUSIONS: New requirements for resident supervision require creative ways of verifying resident competency in basic skills. This type of orientation is an effective way to address the new requirements of supervision and teach interns the tasks and skills that are necessary for internship.

OBJECTIVE: Intrathoracic subclavian artery aneurysms (SAAs) are rare aneurysms that often occur in association with congenital aortic arch anomalies and/or concomitant thoracic aortic pathology. The advent of thoracic endovascular aortic repair (TEVAR) methods may complement or replace conventional open SAA repair. Herein, we describe our experience with SAA repair in the TEVAR era. METHODS: A retrospective review was performed of all intrathoracic SAAs repaired at a single institution since United States Food and Drug Administration approval of TEVAR in 2005. RESULTS: Nineteen patients underwent 20 operations to repair 22 (13 native, nine aberrant) SAAs with an intrathoracic component. Mean SAA diameter was 3.1 cm (range, 1.6-6.0 cm). Mean patient age was 57 years (range, 24-80 years). Twenty-one percent (n = 4) of patients had a connective tissue disorder (two Loeys-Dietz, two Marfan). Thirty-six percent (n = 8) of SAAs were repaired by open techniques and 64% (n = 14) via a TEVAR-based approach. All TEVAR cases required proximal landing zone in the aortic arch (zone 0-2), and revascularization of at least one arch vessel was required in 83% (10/12) of patients. Concomitant repair of associated aortic pathology was performed in 50% (n = 10) of operations. Thirty-day/in-hospital rates of death, stroke, and permanent paraplegia/paraparesis were 5% (n = 1), 5% (n = 1), and 0%, respectively. Over mean (standard deviation) follow-up of 24 (21) months, 16% (n = 3) of patients required reintervention for subclavian artery bypass graft revision (n = 2) or type II endoleak (n = 1). CONCLUSIONS: This is the largest single-institution series to date of TEVAR for SAA repair. Modern endovascular techniques expand SAA repair options with excellent results. The majority of SAAs and nearly all aberrant SAAs (Kommerell's diverticulum) can now be repaired using a TEVAR-based approach without the need for sternotomy or thoracotomy.

BACKGROUND: Preprocedure clinical and pathologic factors have failed to consistently differentiate complete response (CR) from progressive disease (PD) in patients after isolated limb infusion (ILI) with melphalan for unresectable in-transit extremity melanoma. METHODS: Multiplex immunobead assay technology (Milliplex MAP Human Cytokine/Chemokine Magnetic Bead Panel, Millipore Corp., Billerica, MA; and Magpix analytical test instrument, Luminex Corp., Austin, TX) was performed on pre-ILI plasma to determine concentrations of selected cytokines (MIP-1alpha, IL-1Ralpha, IP-10, IL-1beta, IL-1alpha, MCP-1, IL-6, IL-17, EGF, IL-12p40, VEGF, GM-CSF, and MIP-1beta) on a subset of patients (n = 180) who experienced CR (n = 23) or PD (n = 24) after ILI. Plasma from normal donors (n = 12) was also evaluated. RESULTS: Of 180 ILIs performed, 28 % (95 % confidence interval 22-35, n = 50) experienced a CR, 14 % (n = 25) experienced a partial response, 11 % (n = 21) had stable disease, 34 % (n = 61) had PD, and 13 % (n = 23) were not evaluable for response. Tumor characteristics and pharmacokinetics appeared similar between CR (n = 23) and PD (n = 24) patients who underwent cytokine analysis. Although there were no differences in cytokine levels between CR and PD patients, there were differences between the melanoma patients and controls. MIP-1alpha, IL-1Ralpha, IL-1beta, IL-1alpha, IL-17, EGF, IL-12p40, VEGF, GM-CSF, and MIP-1beta were significantly higher in normal controls compared to melanoma patients, while IP-10 was lower (p < 0.001) in controls compared to melanoma patients. CONCLUSIONS: Patients with unresectable in-transit melanoma appear to have markedly decreased levels of immune activating cytokines compared to normal healthy controls. This further supports a potential role for immune-targeted therapies and immune monitoring in patients with regionally advanced melanoma.

BACKGROUND: Since United States Food and Drug Administration approval in 2005, the short-term safety and efficacy of thoracic endovascular aortic repair (TEVAR) have been established. However, longer-term follow-up data remain lacking. The objective of this study is to report 6-year outcomes of TEVAR in clinical practice. METHODS: A prospective cohort review was performed of all patients undergoing TEVAR at a single referral institution between March 2005 and May 2011. Rates of reintervention were noted. Overall and aortic-specific survival were determined using Kaplan-Meier methods. Log-rank tests were used to compare survival between groups. RESULTS: During the study interval, 332 TEVAR procedures were performed in 297 patients. Reintervention was required after 12% of procedures at a mean of 8 +/- 14 months after initial TEVAR and was higher in the initial tercile of patients (15.0% vs 9.9%). The 6-year freedom from reintervention was 84%. Type I endoleak was the most common cause of reintervention (5%). Six-year overall survival was 54%, and aorta-specific survival was 92%. Long-term survival was significantly lower than that of an age- and sex-matched United States population (p < 0.001). Survival was similar between patients requiring a reintervention vs those not (p = 0.26). Survival was different based on indication for TEVAR (p = 0.007), and patients with degenerative aneurysms had the lowest survival (47% at 6 years). Cardiopulmonary pathologies were the most common cause of death (27 of 93 total deaths). CONCLUSIONS: Long-term aortic-related survival after TEVAR is high, and the need for reintervention is infrequent. However, overall long-term survival is low, particularly for patients with degenerative aneurysms, and additional work is needed to identify patients unlikely to derive a survival benefit from TEVAR.

BACKGROUND: Recurrent laryngeal nerve (RLN) injury is a rare complication for patients undergoing neck exploration for primary hyperparathyroidism (pHPT). Distances between RLNs and parathyroid adenomas have not been previously published. In this study we used a RLN monitor to identify the RLN and to measure the proximity to parathyroid tumors. METHODS: Patients with pHPT (n = 136) underwent neck exploration and had the clinical data recorded prospectively. Adenomas were recorded in 1 of 4 locations (right upper, right lower, left upper, left lower). Measurement of RLN to adenoma distances were recorded intraoperatively with the gland in situ. The RLN location was confirmed with a RLN monitor. RESULTS: The average RLN to adenoma distance was 0.52 +/- 0.52 cm. Adenomas in the right upper position were significantly closer to the nerve (0.25 +/- 0.39 cm) compared with adenomas in the left upper (0.48 +/- 0.61 cm, p = .03), left lower (0.70 +/- 0.53 cm, p < .001), and right lower position (1.02 +/- 0.56 cm, p < .001). Left upper adenomas were also significantly closer to the nerve compared with right lower adenomas (p < .001). Adenomas in the right upper position abutted the nerve more often (47 %) compared with adenomas in other positions (p = .001). There were no perioperative characteristics that predicted tumor abutment. There were no permanent RLN injuries. CONCLUSION: In patients with sporadic pHPT, parathyroid adenomas in the right upper location have, on average, greater proximity to the RLN and are more often directly abutting compared with adenomas in other locations.