Evolution of fenestrated/branched endovascular aortic aneurysm repair complexity and outcomes at an organized center for the treatment of complex aortic disease.

BACKGROUND: Fenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program. METHODS: Prospectively collected data of all F/BEVAR (definition: requiring ≥1 fenestration/branch), procedures performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (11/2010-2/2019). Patients were stratified by surgery date into thirds: early experience, mid experience, and recent experience. Patient and operative characteristics, aneurysm morphology, device types, perioperative and midterm outcomes (survival, freedom from type I or III endoleak, target artery patency, freedom from reintervention), were compared across groups. RESULTS: For 252 consecutive F/BEVARs (early experience, n = 84, mid experience, n = 84, recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices, were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events. The mean follow-up time for the entire cohort was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal, 33% early experience, 40% mid experience, and 64% recent experience; P < .001) and target vessels per case (four-vessel case, 31% early experience, 39% mid experience, and 67% recent experience; P < .0001). There was no difference, but a trend toward improvement, in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period. CONCLUSIONS: Despite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Type I or III endoleaks remain a significant limitation, with increased incidence as the number of branch arteries incorporated into the repairs has increased.

Effect of thoracoabdominal aortic aneurysm extent on outcomes in patients undergoing fenestrated/branched endovascular aneurysm repair.

OBJECTIVE: The outcomes after open repair of thoracoabdominal aneurysms (TAAAs) have been definitively demonstrated to worsen as the TAAA extent increases. However, the effect of TAAA extent on fenestrated/branched endovascular aneurysm repair (F/BEVAR) outcomes is unclear. We investigated the differences in outcomes of F/BEVAR according to the TAAA extent. METHODS: We reviewed a single-institution, prospectively maintained database of all F/BEVAR procedures performed in an institutional review board-approved registry and/or physician-sponsored Food and Drug Administration investigational device exemption trial (trial no. G130210). The patients were stratified into two groups: group 1, extensive (extent 1-3) TAAAs; and group 2, nonextensive (juxtarenal, pararenal, and extent 4-5) TAAAs. The perioperative outcomes were compared using the χ2 test. Kaplan-Meier analysis of 3-year survival, target artery patency, reintervention, type I or III endoleak, and branch instability (type Ic or III endoleak, loss of branch patency, target vessel stenosis >50%) was performed. Cox proportional hazards modeling was used to assess the independent effect of extensive TAAA on 1-year mortality. RESULTS: During the study period, 299 F/BEVAR procedures were performed for 87 extensive TAAAs (29%) and 212 nonextensive TAAAs (71%). Most repairs had used company-manufactured, custom-made devices (n = 241; 81%). Between the two groups, no perioperative differences were observed in myocardial infarction, stroke, acute kidney injury, dialysis, target artery occlusion, access site complication, or type I or III endoleak (P > .05 for all). The incidence of perioperative paraparesis was greater in the extensive TAAA group (8.1% vs 0.5%; P = .001). However, the incidence of long-term paralysis was equivalent (2.3% vs 0.5%; P = .20), with nearly all patients with paraparesis regaining ambulatory function. On Kaplan-Meier analysis, no differences in survival, target artery patency, or freedom from reintervention were observed at 3 years (P > .05 for all). Freedom from type I or III endoleak (P < .01) and freedom from branch instability (P < .01) were significantly worse in the extensive TAAA group. Cox proportional hazards modeling demonstrated that F/BEVAR for extensive TAAA was not associated with 1-year mortality (hazard ratio, 1.71; 95% confidence interval, 0.91-3.52; P = .13). CONCLUSIONS: Unlike open TAAA repair, the F/BEVAR outcomes were similar for extensive and nonextensive TAAAs. The differences in perioperative paraparesis, branch instability, and type I or III endoleak likely resulted from the increasing length of aortic coverage and number of target arteries involved. These findings suggest that high-volume centers performing F/BEVAR should expect comparable outcomes for extensive and nonextensive TAAA repair.

Financial implications of coronavirus disease 2019 on a tertiary academic vascular surgery practice.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented impact on the healthcare system in the United States. The redistribution of resources and suspension of elective procedures and other services has resulted in financial stress across all service lines. The financial effects on the practice of vascular surgery have not yet been quantified. We hypothesized that vascular surgery divisions have experienced losses affecting the hospital and professional sides that will not be recoupable without significant productivity increases. METHODS: Administrative claims data for clinical services performed by the vascular surgery division at a tertiary medical center for March and April 2019 and for March and April 2020 were analyzed. These claims were separated into two categories: hospital claims (inpatient and outpatient) and professional claims (professional reimbursement for all services provided). Medicare reimbursement methods were used to assign financial value: diagnosis-related group for inpatient services, ambulatory payment classification for outpatient services, and the Medicare physician fee schedule for professional reimbursement and work relative value units (wRVUs). Reimbursements and productivity (wRVUs) were compared between the two periods. A financial model was created to determine the increase in future productivity over baseline required to mitigate the losses incurred during the pandemic. RESULTS: A total of 11,317 vascular surgery claims were reviewed. Hospital reimbursement during the pandemic decreased from $4,982,114 to $2,649,521 (-47%) overall (inpatient, from $3,505,775 to $2,128,133 [-39%]; outpatient, from $1,476,339 to $521,388 [-65%]) and professional reimbursement decreased from $933,897 to $430,967 (-54%) compared with the same period in 2019. Professional productivity as measured by wRVUs sustained a similar decline from 10,478 wRVUs to 5386 wRVUs (-51%). Modeling sensitivity analyses demonstrated that if a vascular division were able to increase inpatient and outpatient revenue to greater than prepandemic levels by 10%, 5%, or 3%, it would take 9, 19, or 31 months, respectively, for the hospital to recover their pandemic-associated losses. Similarly, professional reimbursement recovery would require 11, 20, or 36 months with corresponding increases in productivity. CONCLUSIONS: The COVID-19 pandemic has had profound and lasting effects on the world in terms of lives lost and financial hardships. The financial effects on vascular surgery divisions has resulted in losses ranging from 39% to 65% compared with the prepandemic period in the previous year. Because the complete mitigation of losses is not feasible in the short term, alternative and novel strategies are needed to financially sustain the vascular division and hospital during a prolonged recovery period.

Computed tomography angiography-derived area stenosis calculations overestimate degree of carotid stenosis compared with North American Symptomatic Carotid Endarterectomy Trial-derived diameter stenosis calculations.

OBJECTIVE: The degree of carotid artery stenosis, calculated using catheter-based angiography and the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, has been shown to predict the stroke risk in several, large, randomized controlled trials. In the present era, patients have been increasingly evaluated using computed tomography (CT) angiography (CTA) before carotid artery revascularization, especially as the use of transcarotid artery revascularization has increased. Interpretation of CTA findings regarding the degree of carotid stenosis has not been standardized, with both NASCET methods and the area stenosis used. We performed a single-institution, blinded, retrospective analysis of CTA studies using both the NASCET method and the CT-derived area stenosis to assess the concordance and discordance between the two methods when evaluating ≥70% and ≥80% stenosis. METHODS: The UMass Memorial Medical Center vascular laboratory database was queried for all carotid duplex ultrasound scans performed from 2008 to 2017. The included patients were limited to those with duplex-defined ≥70% stenosis (defined as a peak systolic velocity of ≥125 cm/s and an internal carotid artery/common carotid artery ratio of ≥4), and a correlative CTA study performed within 1 year of the duplex ultrasound examination. A blinded review of all correlative CTA studies using centerline measurements on a three-dimensional workstation (Aquarius iNtuition Viewer; Terarecon, Durham, NC) was performed to characterize the degree of carotid stenosis using the NASCET method and the area stenosis method. Patients were excluded if revascularization had been performed between the two imaging studies. RESULTS: Of the 37,204 carotid duplex ultrasound scans reviewed (performed from 2008 to 2017), 3480 arteries met the criteria for duplex ultrasound-defined ≥70% stenosis. A correlative CTA study within 1 year of the duplex ultrasound examination was identified in 460 arteries, of which 320 were adequate quality for blinded review. The median interval between the duplex ultrasound and CTA examinations was 9.5 days. Concordance between the area stenosis and NASCET methods was poor for both ≥70% (κ = 0.32) and ≥80% (κ = 0.25) stenosis. Of the 247 arteries considered to have ≥70% area stenosis, 127 (51.4%) were considered to have ≥70% stenosis using the NASCET method. Of the 169 arteries considered to have ≥80% area stenosis, 44 (26.0%) were considered to have ≥80% stenosis using the NASCET method. CONCLUSIONS: The area stenosis CTA calculations of carotid artery stenosis dramatically overestimated the degree of carotid stenosis compared with that calculated using the NASCET method. Given that stroke risk estimates have been determined from trials that used the NASCET method, the area stenosis method likely overestimates the risk of stroke. Therefore, area stenosis calculations could lead to unnecessary carotid revascularization procedures. This model highlights the need for standardized usage of the NASCET method when using CTA as the imaging modality to determine the threshold for carotid revascularization.

Preoperative functional status predicts 2-year mortality in patients undergoing fenestrated/branched endovascular aneurysm repair.

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

Vascular Surgeons Are Not Adequately Valued by Traditional Productivity Metrics.

BACKGROUND: Reimbursements for professional services performed by clinicians are under constant scrutiny. The value of a vascular surgeon's services as measured by work relative value units (wRVUs) and professional reimbursement has decreased for some of the most common procedures performed. Hospital reimbursements, however, often remain stable or increases. We sought to evaluate fistulagrams as a case study and hypothesized that while wRVUs and professional reimbursements decrease, hospital reimbursements for these services increased over the same time period. METHODS: Medicare 5% claims data were reviewed to identify all fistulagrams with or without angioplasty or stenting performed between 2015 and 2018 using current procedural terminology codes. Reimbursements were classified into 3 categories: medical center (reimbursements made to a hospital for a fistulagram performed as an outpatient procedure), professional (reimbursement for fistulagrams based on compensation for procedures: work RVUs, practice expense RVU, malpractice expense RVU), and office-based laboratory (OBL, reimbursement for fistulagrams performed in an OBL setting). Medicare's Physician Fee Schedule was used to calculate wRVU and professional reimbursement. Medicare's Hospital Outpatient Prospective Payment System-Ambulatory Payment Classification was used to calculate hospital outpatient reimbursement. RESULTS: From 2015 to 2018, we identified 1,326,993 fistulagrams. During this study period, vascular surgeons experienced a 25% increase in market share for diagnostic fistulagrams. Compared with 2015, total professional reimbursements from 2017 to 2018 for all fistulagram procedures decreased by 41% (-$10.3 million) while OBL reimbursement decreased 29% (-$42.5 million) and wRVU decreased 36%. During the same period, medical center reimbursement increased by 6.6% (+$14.1 million). CONCLUSIONS: Vascular surgeons' contribution to a hospital may not be accurately reflected through traditional RVU metrics alone. Vascular surgeons performed an increasing volume of fistulagram procedures while experiencing marked reductions in wRVU and reimbursement. Medical centers, on the other hand, experienced an overall increase in reimbursement during the same time period. This study highlights that professional reimbursements, taken in isolation and without consideration of medical center reimbursement, undervalues the services and contributions provided by vascular surgeons.

Variation in Ultrasound Diagnostic Thresholds for Carotid Stenosis in the United States.

BACKGROUND: Individuals with carotid stenosis enter surveillance or are considered for surgery on the basis of disease severity assessed by ultrasound. However, there is variation in the ultrasound diagnostic thresholds used to determine disease severity. Our objective was to describe this variation and its potential impact on patients. METHODS: To describe the variation in carotid ultrasound diagnostic thresholds, we examined testing protocols from 338 accredited vascular testing centers in the United States. To determine the potential impact of this variation, we applied the range of thresholds to carotid ultrasound parameters from 2 groups: a population-based sample ≥65 years of age in the Cardiovascular Health Study (n=4791), and a cohort of patients who underwent surgery for asymptomatic carotid stenosis in the Vascular Quality Initiative registry (n=28 483). RESULTS: Internal carotid artery peak systolic velocity was used by all centers to assess disease severity, with 60 distinct thresholds in use. The peak systolic velocity threshold for moderate (≥50%) stenosis ranged from 110 to 245 cm/s (median, 125; 5th and 95th percentile, 125 and 150), and the threshold for severe (≥70%) stenosis ranged from 175 to 340 cm/s (median, 230; 5th and 95th percentile, 230 and 275). In the population-based sample, the 5th percentile threshold would assign a diagnosis of moderate carotid stenosis to twice as many individuals as the 95th percentile threshold (7.9% versus 3.9%; relative risk, 2.01 [CI, 1.70-2.38]). In the surgical cohort, 1 in 10 (9.8%) patients had peak systolic velocity values that warranted the diagnosis of severe carotid stenosis at centers in the 5th percentile, but not in the 95th. CONCLUSIONS: The diagnostic threshold for carotid stenosis varies considerably. Whether or not a person is said to have moderate stenosis and enters surveillance, and whether or not they have severe stenosis and are candidates for surgery, can depend on which center performs their ultrasound.

Fenestrated/Branched Endovascular Aortic Aneurysm Repair Using a Supraceliac Aortic Proximal Seal Zone Versus an Infraceliac Aortic Proximal Seal Zone.

BACKGROUND: Fenestrated/branched endovascular aneurysm repair (F/B-EVAR) achieves more extensive proximal seal than conventional infrarenal devices, thereby increasing aneurysm exclusion durability. Optimal seal zone length remains undefined. We assessed relative risks and benefits of extending the proximal seal above the celiac artery. METHODS: The prospective database of all complex endovascular aortic aneurysm repairs at a single institution (institutional review board-approved, physician-sponsored investigational device exemption trial, 10/2010-6/2017) was used to classify repairs according to the number of target visceral-renal arteries incorporated: 4-vessel versus <4-vessel. Comparisons of aneurysm characteristics, perioperative details, and postoperative complications were performed, stratified by repair type. One-year survival, target artery patency, freedom from type 1 or 3 endoleak, and freedom from reintervention were estimated with Kaplan-Meier analysis. RESULTS: Among 175 F/B-EVARs, 38% (n = 67) were 4-vessel and 62% (n = 108) were <4-vessel. Intraoperatively, there was no difference in mean contrast use (76 mL vs. 74 mL, P = non significant [NS]) or dose area product (63,428 mGy cm2 vs. 96,015 mGy cm2), but there was increased median procedure time (4.8 hr, interquartile range [IQR] = 4.1-5.8 versus 3.6 hr, IQR = 2.9-4.1, P < 0.0001) and mean operating room direct costs ($52,532, standard deviation [SD] = 18,640 versus $40,128, SD = 15,135, P < 0.0001) in 4-vessel repairs. There were no differences in mortality (1.9% vs. 4.5%), paraparesis (0% vs. 3.0%), or paralysis (0.9% vs. 0%), all P = NS. There were no differences in one-year survival, target artery patency, or freedom from reintervention. There was a lower 1-year freedom from type 1 or 3 endoleak with 4-vessel repairs (82% vs. 94%, log-rank P = 0.02), driven by an increased rate of type 3 endoleaks. Endoleak resolution after treatment was equivalent in both groups (4-vessel, 10 of 12, 83% resolved; <4-vessel, 7 of 7, 100% resolved, P = NS). CONCLUSIONS: With F/B-EVAR, utilization of a supraceliac seal zone, compared with an infraceliac seal zone, is associated with statistical differences in operative characteristics/resource utilization, but with negligible clinical significance. Further innovation to eliminate type 3 endoleaks at fenestrations/branches remains an unmet need. To achieve adequate F/B-EVAR proximal seal zone length, one should have a low threshold to incorporate the celiac artery.

Impact of acute kidney injury on long-term outcomes after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVE: Acute kidney injury (AKI) has been identified as a common complication after fenestrated and branched endovascular aneurysm repair (F/BEVAR), occurring in 5% to 29% of patients. Predictors of AKI and its impact on long-term outcomes remain unknown. We sought to identify independent predictors of AKI and its effect on long-term survival after F/BEVAR. METHODS: A single-institution retrospective review of all consecutive F/BEVAR procedures was performed (November 2010-September 2018). Data were collected prospectively through an Institutional Review Board-approved registry and a physician-sponsored investigational device exemption clinical trial (G130210). AKI was defined as a decrease in estimated glomerular filtration rate by >30% from baseline, within 30 days postoperatively. The cohort was stratified according to whether a patient experienced AKI. Demographics, operative details, perioperative complications, and length of stay between groups were compared. The primary outcome, long-term survival, was assessed with Kaplan-Meier analysis and Cox proportional hazards modeling. Independent predictors of AKI were identified using logistic regression. RESULTS: Among 219 consecutive F/BEVAR patients, AKI occurred in 41 patients (19%) and was the most common 30-day complication observed. Whereas preoperative creatinine concentration, estimated glomerular filtration rate, and target renal artery stenosis >50% did not predict AKI, the occurrence of intraoperative complications did correlate with AKI (37% vs 7.3%; P < .01). By 30 days, AKI resolved in 7 (17%) patients, persisted without need for dialysis in 26 (64%), and progressed to dialysis in 5 (12%); the remaining 3 (7%) patients died. Survival at 30 days was significantly lower in the AKI group (92.7% vs 98.9%; P = .047), and this difference persisted at 1 year (68% vs 87%; log-rank, P <.01) and 3 years (44% vs 60%; log-rank, P = .04). On multivariable modeling, AKI increased the hazard of death nearly twofold (hazard ratio, 1.92; 95% confidence interval [CI], 1.11-3.23; P = .019). Independent predictors of AKI on multivariable logistic regression were intraoperative complications (odds ratio, 4.10; 95% CI, 1.61-10.42; P < .01) and increased operating room time (odds ratio, 1.56; 95% CI, 1.22-2.00; P < .01). CONCLUSIONS: In our 8-year experience of F/BEVAR, AKI was the most common postoperative complication observed in nearly 20% of patients. AKI after F/BEVAR is associated with decreased short- and long-term survival. Whether AKI is causative or just associated with decreased survival remains to be elucidated. Further study is needed to determine whether the independent predictors of AKI, including intraoperative complications and operating room time, are generalizable across all centers performing F/BEVAR and to investigate how we might further mitigate this common and serious complication.

Carotid Duplex Velocity Criteria Recommended by the Society of Radiologists in Ultrasound and Endorsed by the Intersocietal Accreditation Commission Lack Predictive Ability for Identifying High-Grade Carotid Artery Stenosis.

BACKGROUND: Carotid duplex is the first-line imaging modality for characterizing degree of carotid stenosis. The Intersocietal Accreditation Commission (IAC), in published guideline documents, has endorsed use of the Society of Radiologists in Ultrasound (SRU) criteria to characterize ≥70% stenosis: peak systolic velocity (PSV) ≥230 cm/s. We sought to perform a validation of the SRU criteria using computed tomography (CT) angiography as a gold standard imaging modality and to perform a sensitivity analysis to determine optimal velocity criteria for identifying ≥80% stenosis. METHODS: We queried all carotid duplex examinations performed at our institution between 2008 and 2017. Patients with ≥70% carotid stenosis, based on previous criteria, were identified. Of these patients, those who also had a CT angiogram of the neck within one year formed the study cohort. Patients who underwent carotid revascularization between the 2 imaging dates were excluded. Degree of stenosis, as reported from the CT angiogram, was considered the true degree of stenosis. Receiver operating characteristic (ROC) curves were generated to evaluate the SRU criteria and to identify the optimal discrimination threshold for high-grade carotid stenosis. RESULTS: Of 37,204 carotid duplex examinations, 3,478 arteries met criteria for ≥70% stenosis. Of these, 344 patients had a CT angiogram within 1 year of the carotid duplex (mean time between studies, 55 days, SD 6.5) and 240 (69.8%) were consistent with ≥80% carotid stenosis. The predictive ability of the SRU criteria to identify ≥70% stenosis was poor, with an area under the ROC curve (AUC) of 0.51. A sensitivity analysis to identify ≥80% stenosis demonstrated the optimal discrimination threshold to be PSV ≥450 cm/s or end diastolic velocity (EDV) ≥120 cm/s, with an AUC of 0.66. CONCLUSIONS: In this validation study, the SRU criteria, endorsed by the IAC, to identify ≥70% carotid stenosis had no predictive value. For detection of ≥80% stenosis, the optimal criteria are a PSV ≥450 cm/s or EDV ≥120 cm/s. This study demonstrates the critical importance of carotid duplex examination validation.

Imaging Obtained Up To 12 Months Preoperatively Is Adequate for Planning Fenestrated/Branched Endovascular Aortic Aneurysm Repair.

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

Peripheral atherectomy practice patterns in the United States from the Vascular Quality Initiative.

OBJECTIVE: Peripheral atherectomy has been shown to have technical success in single-arm studies, but clinical advantages over angioplasty and stenting have not been demonstrated, leaving its role unclear. We sought to describe patterns of atherectomy use in a real-world U.S. cohort to understand how it is currently being applied. METHODS: The Vascular Quality Initiative was queried to identify all patients who underwent peripheral vascular intervention from January 2010 to September 2016. Descriptive statistics were performed to analyze demographics of the patients, comorbidities, indication, treatment modalities, and lesion characteristics. The intermittent claudication (IC) and critical limb ischemia (CLI) cohorts were analyzed separately. RESULTS: Of 85,605 limbs treated, treatment indication was IC in 51% (n = 43,506) and CLI in 49% (n = 42,099). Atherectomy was used in 15% (n = 13,092) of cases, equivalently for IC (15%; n = 6674) and CLI (15%; n = 6418). There was regional variation in use of atherectomy, ranging from a low of 0% in one region to a high of 32% in another region. During the study period, there was a significant increase in the proportion of cases that used atherectomy (11% in 2010 vs 18% in 2016; P < .0001). Compared with nonatherectomy cases, those with atherectomy use had higher incidence of prior peripheral vascular intervention (IC, 55% vs 43% [P < .0001]; CLI, 47% vs 41% [P < .0001]), greater mean number of arteries treated (IC, 1.8 vs 1.6 [P < .0001]; CLI, 2.1 vs 1.7 [P < .0001]), and lower proportion of prior leg bypass (IC, 10% vs 14% [P < .0001]; CLI, 11% vs 17% [P < .0001]). There was lower incidence of failure to cross the lesion (IC, 1% vs 4% [P < .0001]; CLI, 4% vs 7% [P < .0001]) but higher incidence of distal embolization (IC, 1.9% vs 0.8% [P < .0001]; CLI, 3.0% vs 1.4% [P < .0001]) and, in the CLI cohort, arterial perforation (1.4% vs 1.0%; P = .01). CONCLUSIONS: Despite a lack of evidence for atherectomy over angioplasty and stenting, its use has increased across the United States from 2010 to 2016. It is applied equally to IC and CLI populations, with no identifiable pattern of comorbidities or lesion characteristics, suggesting that indications are not clearly delineated or agreed on. This study places impetus on further understanding of the optimal role for atherectomy and its long-term clinical benefit in the management of peripheral arterial disease.

Increasing the number of integrated vascular surgery residency positions is important to address the impending shortage of vascular surgeons in the United States.

OBJECTIVE: The demand for vascular surgeons is expected to far exceed the current supply. In an attempt to decrease the training duration and to address the impending shortage, integrated vascular surgery residencies were approved and have expanded nationally. Meanwhile, vascular fellowships have continued to matriculate approximately 120 trainees annually. We sought to evaluate the supply and demand for integrated vascular residency positions as well as changes in the quality of applicants. METHODS: We conducted a retrospective review of national data compiled by the Association of American Medical Colleges and the National Resident Matching Program regarding integrated vascular surgery residency programs (2008-2015) and fellowships (2007-2016). Variables reviewed included the total number of applicants, sex, U.S. vs international medical school enrollment, applications per program, and applicants per position. In addition, we conducted a retrospective review of applicants to the University of Massachusetts Medical School integrated vascular surgery residency program from 2008 to 2015 to examine these variables and United States Medical Licensing Examination Step 1 and Step 2 CK scores over time. RESULTS: The number of vascular surgery integrated residency positions increased from 4 in 2008 to 56 in 2015. Concurrently, the number of integrated residency applicants grew from 112 in 2008 to 434 in 2015. This increase has been predominantly driven by a 575% increase in U.S. graduate applicants and a 170% increase in women applicants. The percentage of international medical graduates has decreased by 17% during the study period. The total number of applicants per residency position increased from 5.9 to 7.8. Meanwhile, the number of vascular surgery fellowship positions remained stable with an applicant to position ratio near 1:1. At the University of Massachusetts Medical School, the mean United States Medical Licensing Examination Step 1 (226 to 235) and Step 2 CK (237 to 243) scores among integrated residency applicants have improved annually and typically exceed the national average among U.S. applicants who have matched in their preferred specialty. CONCLUSIONS: Since the approval of a primary certificate in vascular surgery and the subsequent rollout of integrated vascular residency programs, the number of residency programs and the quality of residency applicants have continued to increase. Demand from medical school applicants vastly outweighs the current supply of training positions by eightfold. In contrast, demand from fellowship applicants matches the supply of fellowship positions. The matriculation of additional trainees must be met with continued expansion of the integrated vascular surgery residency pathway to manage future public health needs.

Reinterventions after fenestrated or branched endovascular aortic aneurysm repair.

OBJECTIVE: Reinterventions after fenestrated or branched endovascular aneurysm repair (F/B-EVAR) are sometimes necessary to maintain aneurysm exclusion or endograft and target artery patency. These reinterventions are nontrivial, potentially associated with morbidity, mortality, and resource utilization. Whereas rates, types, and outcomes of reintervention after infrarenal EVAR have been well described, they have not been well described for F/B-EVAR. We sought to characterize the morbidity, mortality, and resource utilization due to reinterventions after F/B-EVAR. METHODS: All F/B-EVAR variables collected prospectively through a single-institution, Institutional Review Board-approved registry, which included patients enrolled in a physician-sponsored investigational device exemption trial (G130210), were reviewed (November 2010-December 2016). Reinterventions were defined as any procedure that was aneurysm related, device related, or target artery related. For patients with more than one reintervention, each intervention occurrence was treated as a discrete event. Reintervention type, indication, timing (perioperative, days 0-30; short term, days 31-180; midterm, >180 days), inpatient/outpatient, length of stay, and morbidity/mortality were recorded. Reintervention success was defined as resolution of the indication. RESULTS: Among 123 consecutive F/B-EVARs (mean follow-up, 25 months), 32 patients (25%) underwent 54 reinterventions (one reintervention, 20 (63%) patients; two reinterventions, 6 (19%) patients; three reinterventions, 4 (13%) patients; four reinterventions, 1 (3.1%) patient; and six reinterventions, 1 (3.1%) patient). The most frequent indications were type III endoleaks (n = 15 [28%]), target artery occlusions (n = 7 [13%]), and stenoses (n = 6 [11%]). These were performed in the perioperative, short-term, and midterm time frames 17%, 41%, and 43% of the time, respectively. Reinterventions were percutaneous (67%), inpatient procedures (61%), with median length of stay of 5 days. Of the 32 reintervention patients, 4 experienced access site complications and 4 died <30 days after reintervention (3 were adjudicated as not aneurysm related/not reintervention related). In 31 of 32 (97%) patients, reintervention success was achieved. CONCLUSIONS: Reinterventions after F/B-EVAR were necessary in 26% of patients, most commonly for type III endoleaks and target artery complications. Whereas all but one reintervention was successful, many of these required complex procedures with significant morbidity and mortality. Development of strategies to eliminate type III endoleaks by improving component junction integrity and to ensure target artery primary patency are key next steps in the evolution of F/B-EVAR.

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices.

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

Temporary Inferior Vena Cava Filters: How Do We Move Forward?

Despite their widespread use, the indications for the selective use of temporary inferior vena cava (IVC) filters remains uncertain with few trials supporting their use. Additionally, the risks of long-term temporary IVC filter insertion are being increasingly discussed amongst the mainstream media and through multiple class action lawsuits. Retrievable IVC filters were specifically designed to have a less secure implantation in order to facilitate retrieval. However, multiple reports have demonstrated significant filter-related complications, most commonly related to duration of implantation. Furthermore, the risk is not isolated to one manufacturer alone. The incidence of filter-related complications is linearly related to its duration of time on the market. Currently, the FDA recommends that IVC filters be removed within 25-54 days of their implantation. Unfortunately, little evidence exists to show that this recommendation is followed routinely. Recently, the PRESERVE Trial (NCT02381509) was initiated as a multicenter non-randomized open label study to determine the safety and effectiveness of commercially available IVC filters (both temporary and permanent) in individuals who require mechanical prophylaxis against pulmonary embolism. Until such evidence is developed, temporary IVC filters should be implanted based on best available evidence and routinely removed within the guidelines of the FDA of 25-54 days. A fair question at this point is whether the design features themselves that are required to manufacture a low profile removable IVC filter can achieve effective prophylaxis against pulmonary embolism at a low rate of short and long-term complications.

Complete regression of a symptomatic, mycotic juxtarenal abdominal aortic aneurysm after treatment with fenestrated endovascular aneurysm repair.

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