Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms.

OBJECTIVE: The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms. METHODS: Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion. RESULTS: Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%. CONCLUSIONS: PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.

Modified Harborview Risk Score improves ease in predicting mortality after ruptured abdominal aortic aneurysm repair.

OBJECTIVE: The Harborview Risk Score (HRS) is a simple, accurate 4-point preoperative risk scoring system used to predict 30-day mortality following ruptured abdominal aortic aneurysm (rAAA) repair. The HRS assigns 1 point for each of the following: age >76 years, pH <7.2, creatinine >2 mg/dL, and any episode of severe hypotension (systolic blood pressure <70 mmHg). One potential limitation of this risk scoring system is that arterial blood gas (ABG) analysis is required to determine arterial pH. Because ABG analysis is not routinely performed prior to patient transfer or rAAA repair, we sought to determine if the HRS could be modified by replacing pH with the international normalized ratio (INR), a factor that has been previously shown to have a strong and independent association with 30-day death after rAAA repair. METHODS: A retrospective review of all rAAA repairs done at a single academic medical center between January 2002 and December 2018 was performed. Our traditional HRS was compared with a modified score, in which pH <7.2 was replaced with INR >1.8. Patients were included if they underwent rAAA repair (open or endovascular), and if they had preoperative laboratory values available to calculate both the traditional and modified HRS. RESULTS: During the 17-year study period, 360 of 391 repairs met inclusion criteria. Observed 30-day mortality using the modified scoring system was 17% (18/106) for a score of 0 points, 43% (53/122) for 1 point, 54% (52/96) for 2 points, 84% (27/32) for 3 points, and 100% (4/4) for 4 points. Receiver operating characteristic analysis revealed similar ability of the two scoring systems to predict 30-day death: there was no significant difference in the area under the curve (AUC) comparing the traditional (AUC = 0.74) and modified (AUC = 0.72) HRS (P = .3). CONCLUSIONS: Although previously validated among a modern cohort of patients with rAAA, our traditional 4-point risk score is limited in real-world use by the need for an ABG. Substituting INR for pH improves the usefulness of our risk scoring system without compromising accuracy in predicting 30-day mortality after rAAA repair.

Iliac tortuosity increases reinterventions but not adverse outcomes following repair of juxtarenal aneurysms using physician-modified endografts.

OBJECTIVE: Increased angulation of the proximal aortic neck has been associated with complications following endovascular repair of infrarenal aortic aneurysms, including increased incidence of endoleaks, stent migration, secondary interventions, and conversions. However, knowledge on the impact of aortoiliac tortuosity on outcomes following fenestrated repair remains limited. This study aims to quantify the effect of aortoiliac tortuosity on outcomes following fenestrated repair. METHODS: A single-center, retrospective review of all patients who underwent a physician-modified endovascular repair for the treatment of juxtarenal aortic aneurysms under a single physician-sponsored investigation device exemption study from 2011 to 2021 was performed. Center luminal lines and geometric distances were obtained using TeraRecon software (San Mateo, CA). A tortuosity index was calculated (tortuosity index = centerline distance/geometric line distance) for each iliac vessel as well as for the infrarenal aorta according to Society for Vascular Surgery reporting standards. Aortic and iliac tortuosity were assessed independently and stratified as low and high. Demographics, comorbidities, anatomic and operative details, and outcomes were compared using univariable and multivariable analysis. RESULTS: A total of 135 patients were identified. Thirty-eight patients (28%) had high aortic tortuosity, and 55 patients (42%) had high iliac tortuosity. Patients with high tortuosity were older (aortic: 78 vs 76 years; P = .04; iliac: 78 vs 75 years; P = .01) and differed by sex. Twenty-two percent of men and 50% of women had high aortic tortuosity (P = .01). Forty-seven percent of men and 20% of women had high iliac tortuosity (P = .01). There were no differences in comorbidities based on aortic tortuosity, but coronary artery disease (high: 58% vs low: 36%; P = .01) and hypertension (high: 69% vs low: 86%; P = .02) differed based on iliac tortuosity. Aneurysm diameter was larger for patients with high iliac tortuosity (72 mm vs 64 mm; P < .01), and fluoroscopy time was longer for patients with high aortic tortuosity (41 vs 31 minutes; P = .02). When outcomes were assessed, high iliac tortuosity was associated with increased rate of reinterventions (hazard ratio, 2.6; 95% confidence interval, 1.2-6.0) and type 1 or 3 endoleak (hazard ratio, 5.2; 95% confidence interval, 1.7-16); however, all other outcomes were similar. CONCLUSIONS: Among patients treated with physician-modified endovascular repair for juxtarenal aneurysms, iliac tortuosity but not aortic tortuosity, is associated with increased reinterventions and type 1 or type 3 endoleaks. Long-term follow-up is critical for patients with high iliac tortuosity to ensure that high-risk endoleaks are identified and treated early to avoid the risk of rupture.

Modified Harborview Risk Score accurately predicts mortality for patients with ruptured abdominal aortic aneurysm.

OBJECTIVE: The modified Harborview Risk Score (HRS) is a simple measure initially derived from a single institutional dataset used to predict ruptured abdominal aortic aneurysm (rAAA) repair survival preoperatively using basic labs and vital signs collected upon presentation. However, validation of this widely applicable scoring system has not been performed. This study aims to validate this scoring system using a large multi-institutional database. METHODS: All patients who underwent repair of an rAAA from 2011 to 2018 in the National Surgical Quality Improvement Program (NSQIP) and at a single academic medical center were included. The modified HRS was calculated by assigning 1 point for each of the following: age >76 years, creatinine >2 mg/dL, international normalized ratio >1.8, and any systolic blood pressure less than 70 mmHg. Assessment of the prediction model was then completed. Using a primary outcome measure of 30-day mortality, the receiver operating characteristic area under the curve was calculated. The discrimination between datasets was compared using a Delong test. Mortality rates for each score were compared between datasets using the Pearson χ2 test. Comparative analysis for patients with a score of 4 was limited due to a small sample size. RESULTS: A total of 1536 patients were identified using NSQIP, and 163 patients were assessed in the institutional dataset. There were 518 patients with a score of 0 (455 NSQIP, 63 institutional), 676 patients with a score of 1 (617 NSQIP, 59 institutional), 391 patients with a score of 2 (364 NSQIP, 27 institutional), 106 with a score of 3 (93 NSQIP, 13 institutional), and 8 patients with a score of 4 (7 NSQIP, 1 institutional). No difference was found in the receiver operating characteristic area under the curves between datasets (P = .78). Thirty-day mortality was 10% NSQIP vs 22% institutional for a score of 0; 28% NSQIP vs 36% institutional for a score of 1; 41% NSQIP vs 44% institutional for a score of 2; 45% NSQIP vs 69% institutional for a score of 3; and 57% NSQIP vs 100% institutional for a score of 4. Score 0 was the only score with a significant mortality rate difference between datasets (P = .01). CONCLUSIONS: The modified HRS is confirmed to be broadly applicable as a clinical decision-making tool for patients presenting with rAAAs. Therefore, this easily applicable model should be applied for all patients presenting with rAAAs to assist with provider and patient decision-making prior to proceeding with repair.

Surgeon volume and outcomes following thoracic endovascular aortic repair for blunt thoracic aortic injury.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) at high-volume hospitals has previously been associated with lower perioperative mortality, but the impact of annual surgeon volume on outcomes following TEVAR for BTAI remains unknown. METHODS: We analyzed Vascular Quality Initiative (VQI) data from patients with BTAI that underwent TEVAR between 2013 and 2023. Annual surgeon volumes were computed as the number of TEVARs (for any pathology) performed over a 1-year period preceding each procedure and were further categorized into quintiles. Surgeons in the first volume quintile were categorized as low volume (LV), the highest quintile as high volume (HV), and the middle three quintiles as medium volume (MV). TEVAR procedures performed by surgeons with less than 1-year enrollment in the VQI were excluded. Using multilevel logistic regression models, we evaluated associations between surgeon volume and perioperative outcomes, accounting for annual center volumes and adjusting for potential confounders, including aortic injury grade and severity of coexisting injuries. Multilevel models accounted for the nested clustering of patients and surgeons within the same center. Sensitivity analysis excluding patients with grade IV BTAI was performed. RESULTS: We studied 1321 patients who underwent TEVAR for BTAI (28% by LV surgeons [0-1 procedures per year], 52% by MV surgeons [2-8 procedures per year], 20% by HV surgeons [≥9 procedures per year]). With higher surgeon volume, TEVAR was delayed more (in <4 hours: LV: 68%, MV: 54%, HV: 46%; P < .001; elective (>24 hours): LV: 5.1%; MV: 8.9%: HV: 14%), heparin administered more (LV: 80%, MV: 81%, HV: 87%; P = .007), perioperative mortality appears lower (LV: 11%, MV: 7.3%, HV: 6.5%; P = .095), and ischemic/hemorrhagic stroke was lower (LV: 6.5%, MV: 3.6%, HV: 1.5%; P = .006). After adjustment, compared with LV surgeons, higher volume surgeons had lower odds of perioperative mortality (MV: 0.49; 95% confidence interval [CI], 0.25-0.97; P = .039; HV: 0.45; 95% CI, 0.16-1.22; P = .12; MV/HV: 0.50; 95% CI, 0.26-0.96; P = .038) and ischemic/hemorrhagic stroke (MV: 0.38; 95% CI, 0.18-0.81; P = .011; HV: 0.16; 95% CI, 0.04-0.61; P = .008). Sensitivity analysis found lower adjusted odds for perioperative mortality (although not significant) and ischemic/hemorrhagic stroke for higher volume surgeons. CONCLUSIONS: In patients undergoing TEVAR for BTAI, higher surgeon volume is independently associated with lower perioperative mortality and postoperative stroke, regardless of hospital volume. Future studies could elucidate if TEVAR for non-ruptured BTAI might be delayed and allow stabilization, heparinization, and involvement of a higher TEVAR volume surgeon.

Early survival benefit of a low-profile endograft in blunt traumatic aortic injury.

OBJECTIVE: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury. METHODS: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality. RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up. CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.

The impact of urgency of repair on outcomes following thoracic endovascular aortic repair for blunt thoracic aortic injury.

OBJECTIVE: Current societal recommendations regarding the timing of thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) vary. Prior studies have shown that elective repair was associated with lower mortality after TEVAR for BTAI. However, these studies lacked data such as Society for Vascular Surgery (SVS) aortic injury grades and TEVAR-related postoperative outcomes. Therefore, we used the Vascular Quality Initiative registry, which includes relevant anatomic and outcome data, to examine the outcomes following urgent/emergent (≤ 24 hours) vs elective TEVAR for BTAI. METHODS: Patients undergoing TEVAR for BTAI between 2013 and 2022 were included, excluding those with SVS grade 4 aortic injuries. We included covariates such as age, sex, race, transfer status, body mass index, preoperative hemoglobin, comorbidities, medication use, SVS aortic injury grade, coexisting injuries, Glasgow Coma Scale, and prior aortic surgery in a regression model to compute propensity scores for assignment to urgent/emergent or elective TEVAR. Perioperative outcomes and 5-year mortality were evaluated using inverse probability-weighted logistic regression and Cox regression, also adjusting for left subclavian artery revascularization/occlusion and annual center and physician volumes. RESULTS: Of 1016 patients, 102 (10%) underwent elective TEVAR. Patients who underwent elective repair were more likely to undergo revascularization of the left subclavian artery (31% vs 7.5%; P < .001) and receive intraoperative heparin (94% vs 82%; P = .002). After inverse probability weighting, there was no association between TEVAR timing and perioperative mortality (elective vs urgent/emergent: 3.9% vs 6.6%; odds ratio [OR], 1.1; 95% confidence interval [CI], 0.27-4.7; P = .90) and 5-year mortality (5.8% vs 12%; hazard ratio [HR], 0.95; 95% CI, 0.21-4.3; P > .9).Compared with urgent/emergent TEVAR, elective repair was associated with lower postoperative stroke (1.0% vs 2.1%; adjusted OR [aOR], 0.12; 95% CI, 0.02-0.94; P = .044), even after adjusting for intraoperative heparin use (aOR, 0.12; 95% CI, 0.02-0.92; P = .042). Elective TEVAR was also associated with lower odds of failure of extubation immediately after surgery (39% vs 65%; aOR, 0.18; 95% CI, 0.09-0.35; P < .001) and postoperative pneumonia (4.9% vs 11%; aOR, 0.34; 95% CI, 0.13-0.91; P = .031), but comparable odds of any postoperative complication as a composite outcome and reintervention during index admission. CONCLUSIONS: Patients with BTAI who underwent elective TEVAR were more likely to receive intraoperative heparin. Perioperative mortality and 5-year mortality rates were similar between the elective and emergent/urgent TEVAR groups. Postoperatively, elective TEVAR was associated with lower ischemic stroke, pulmonary complications, and prolonged hospitalization. Future modifications in society guidelines should incorporate the current evidence supporting the use of elective TEVAR for BTAI. The optimal timing of TEVAR in patients with BTAI and the factors determining it should be the subject of future study to facilitate personalized decision-making.

Effect of Aortic Thrombus on Outcomes Following Repair of Juxtarenal Aneurysm Using Physician Modified Endografts.

OBJECTIVE: Studies have suggested that aortic thrombus may be associated with adverse outcomes following endovascular repair of aortic aneurysms, while other reports have suggested higher rates of sac regression and reduced risk of endoleak. However, the effect of thrombus burden on outcomes following physician modified endografts (PMEGs) remains unknown. This study aimed to assess the volume and morphology of thrombus burden and the effect on outcomes following PMEG for juxtarenal abdominal aortic aneurysm. METHODS: This was a retrospective cohort study of patients who underwent PMEG from 2009 to 2021 in a single centre, investigational device exemption trial. Thrombus burden was measured as a percentage of luminal volume using pre-operative computed tomography scans from the lowest renal artery to the level of the aortic bifurcation using centreline reconstructive software. Morphology was documented by the presence of finger like projections. Univariate and multivariate analyses evaluated the impact on peri-operative and long term outcomes. RESULTS: Volumetrical and morphological measures of thrombus burden were assessed in 142 patients; 40.1% of the cohort were classified as having a high thrombus burden (≥ 50% luminal volume) on volumetrical assessment and 22.5% had finger like projections on morphological assessment. Type II endoleak was more frequently observed in those with low thrombus burden (60.0% vs. 33.3%; p = .008) and persisted after multivariate analysis (odds ratio 2.5, 95% confidence interval 1.1 - 5.8), but there were no other significant differences in peri-operative adverse events or late outcomes-including sac behaviour, freedom from re-intervention, and overall survival-when stratifying thrombus burden by quantitative or qualitative measures. There were no observed differences in operative characteristics or anatomical characteristics, including landing zone characteristics and rates of inferior mesenteric artery patency. CONCLUSION: While thrombus burden and morphology were not associated with adverse peri-operative events or survival, low thrombus burden was associated with an increase in type II endoleak. These findings suggest that thrombus burden should not deter treatment for patients requiring PMEG.

Complicated and Uncomplicated Isolated Abdominal Aortic Dissections Demonstrate Different Patient Characteristics and Outcomes.

BACKGROUND: Isolated abdominal aortic dissection (IAAD) is a rare entity with poorly defined risk factors and wide variation in management. We set forth to compare patient characteristics, management, and outcomes of uncomplicated isolated abdominal aortic dissection (uIAAD) versus high risk and complicated isolated abdominal aortic dissection (hrcIAAD) to investigate whether these categories can be utilized to guide IAAD management and provide risk stratification for intervention. METHODS: Retrospective chart review was performed to identify all patients with spontaneous IAAD at a tertiary health care system between 1996 and 2022. Demographics, comorbidities, factors relating to initial presentation including imaging findings, and dissection outcomes including long-term all-cause mortality and aortic-related mortality from time of dissection to final available record were abstracted. IAAD demonstrating rupture or malperfusion were designated as complicated, those with aortic diameter greater than 4 cm on presentation or refractory pain were designated as high risk, and the remainder was designated as uIAAD. All variables were compared between hrcIAAD and uIAAD using Fisher's exact test, unpaired t-test, and Mann-Whitney U-test as appropriate. RESULTS: Over the study period, 74 patients presented with spontaneous IAAD (mean age 60 ± 16 years, 61% male) with postdissection follow-up records to an average of 6.8 ± 5.8 years. Of these, 76% presented with uIAAD versus 24% with hrcIAAD. hrcIAAD was diagnosed at a significantly younger age on average than uIAAD (52 ± 14 vs. 62 ± 16 years, P = 0.02), was less likely to present with concomitant hyperlipidemia (0% vs. 41%, P < 0.01), coronary artery disease (6% vs. 47%, P < 0.01), and prior smoking history (39% vs. 72%). hrcIAAD was more likely to present in patients with a genetic aortopathy (27% vs. 7%, P = 0.03). Hypertension was not significantly different between groups. Patients with hrcIAAD were significantly more likely to present with extension into iliac arteries compared to uIAAD (61% vs. 18%, P < 0.01). A much higher proportion of hrcIAAD required hospitalization compared to uIAAD (83% vs. 30%, P < 0.01) and operative intervention (67% vs. 7%, P < 0.01). While there was no significant difference in all-cause mortality between groups, there was a significant difference between aortic-related mortality which only occurred in those with hrcIAAD (28% vs. 0%, P < 0.01). CONCLUSIONS: Comparison of long-term outcomes suggests that hrcIAAD is associated with increased hospitalization and need for operative intervention compared to uIAAD. Significant differences in atherosclerotic risk factors and proportions of connective tissue disease history between patients who present with hrcIAAD and uIAAD suggest that differences in underlying etiology are largely responsible for whether IAAD progresses towards rupture or has a more benign course and should be considered in risk stratification to guide more specific and targeted management of IAAD.

Development and Validation of a Risk Prediction Tool for In-hospital Mortality After Thoracic Endovascular Repair in Patients with Blunt Thoracic Aortic Injury Using the Aortic Trauma Foundation Registry.

BACKGROUND: The objective of our present effort was to use an international blunt thoracic aortic injury (BTAI) registry to create a prediction model identifying important preoperative and intraoperative factors associated with postoperative mortality, and to develop and validate a simple risk prediction tool that could assist with patient selection and risk stratification in this patient population. METHODS: For the purpose of the present study, all patients undergoing thoracic endovascular aortic repair (TEVAR) for BTAI and registered in the Aortic Trauma Foundation (ATF) database from January 2016 as of June 2022 were identified. Patients undergoing medical management or open repair were excluded. The primary outcome was binary in-hospital all-cause mortality. Two predictive models were generated: a preoperative model (i.e. only including variables before TEVAR or intention-to-treat) and a full model (i.e. also including variables after TEVAR or per-protocol). RESULTS: Out of a total of 944 cases included in the ATF registry until June 2022, 448 underwent TEVAR and were included in the study population. TEVAR for BTAI was associated with an 8.5% in-hospital all-cause mortality in the ATF dataset. These study subjects were subsequently divided using 3:1 random sampling in a derivation cohort (336; 75.0%) and a validation cohort (112; 25.0%). The median age was 38 years, and the majority of patients were male (350; 78%). A total of 38 variables were included in the final analysis. Of these, 17 variables were considered in the preoperative model, 9 variables were integrated in the full model, and 12 variables were excluded owing to either extremely low variance or strong correlation with other variables. The calibration graphs showed how both models from the ATF dataset tended to underestimate risk, mainly in intermediate-risk cases. The discriminative capacity was moderate in all models; the best performing model was the full model from the ATF dataset, as evident from both the Receiver Operating Characteristic curve (Area Under the Curve 0.84; 95% CI 0.74-0.91) and from the density graph. CONCLUSIONS: In this study, we developed and validated a contemporary risk prediction model, which incorporates several preoperative and postoperative variables and is strongly predictive of early mortality. While this model can reasonably predict in-hospital all-cause mortality, thereby assisting physicians with risk-stratification as well as inform patients and their caregivers, its intrinsic limitations must be taken into account and it should only be considered an adjunctive tool that may complement clinical judgment and shared decision-making.

Outcomes following thoracic endovascular aortic repair for blunt thoracic aortic injury stratified by Society for Vascular Surgery grade.

OBJECTIVES: Although the Society for Vascular Surgery (SVS) aortic injury grading system is used to depict the severity of injury in patients with blunt thoracic aortic injury, prior literature on its association with outcomes after thoracic endovascular aortic repair (TEVAR) is limited. METHODS: We identified patients undergoing TEVAR for BTAI within the VQI between 2013 and 2022. We stratified patients based on their SVS aortic injury grade (grade 1, intimal tear; grade 2, intramural hematoma; grade 3, pseudoaneurysm; and grade 4, transection or extravasation). We assessed perioperative outcomes and 5-year mortality using multivariable logistic and Cox regression analyses. Secondarily, we assessed the proportional trends in patients undergoing TEVAR based on SVS aortic injury grade over time. RESULTS: Overall, 1311 patients were included (grade1, 8%; grade 2, 19%; grade 3, 57%; grade 4, 17%). Baseline characteristics were similar, except for a higher prevalence of renal dysfunction, severe chest injury (Abbreviated Injury Score >3), and lower Glasgow Coma Scale with increasing aortic injury grade (Ptrend < .05). Rates of perioperative mortality by aortic injury grade were as follows: grade 1, 6.6%; grade 2, 4.9%; grade 3, 7.2%; and grade 4, 14% (Ptrend = .003) and 5-year mortality rates were 11% for grade 1, 10% for grade 2, 11% for grade 3, and 19% for grade 4 (P = .004). Patients with grade 1 injury had a high rate of spinal cord ischemia (2.8% vs grade 2, 0.40% vs grade 3, 0.40% vs grade 4, 2.7%; P = .008). After risk adjustment, there was no association between aortic injury grade and perioperative mortality (grade 4 vs grade 1, odds ratio, 1.3; 95% confidence interval, 0.50-3.5; P = .65), or 5-year mortality (grade 4 vs grade 1, hazard ratio, 1.1; 95% confidence interval, 0.52-2.30; P = .82). Although there was a trend for decrease in the proportion of patients undergoing TEVAR with a grade 2 BTAI (22% to 14%; Ptrend = .084), the proportion for grade 1 injury remained unchanged over time (6.0% to 5.1%; Ptrend = .69). CONCLUSIONS: After TEVAR for BTAI, there was higher perioperative and 5-year mortality in patients with grade 4 BTAI. However, after risk adjustment, there was no association between SVS aortic injury grade and perioperative and 5-year mortality in patients undergoing TEVAR for BTAI. More than 5% of patients with BTAI who underwent TEVAR had a grade 1 injury, with a concerning rate of spinal cord ischemia potentially attributable to TEVAR, and this proportion did not decrease over time. Further efforts should focus on enabling careful selection of patients with BTAI who will experience more benefit than harm from operative repair and preventing the inadvertent use of TEVAR in low-grade injuries.

Dynamic Imaging is the Ideal Modality for the Diagnosis of Popliteal Artery Entrapment Syndrome.

BACKGROUND: Popliteal Artery Entrapment Syndrome (PAES) is a rare vascular condition with significant equipoise on how to properly diagnose and evaluate relevant imaging. This can lead to misdiagnosis and delay in surgical management. The objective of this study is to describe and compare distinct imaging features of dynamic versus static images to help determine the ideal imaging modality for diagnosis of PAES. METHODS: This is a retrospective review of patients referred for PAES at a single institution. We reviewed noninvasive imaging studies, diagnostic arteriograms, and cross-sectional images which include computed tomography angiography (CTA) or magnetic resonance angiography (MRA). For each affected and unaffected extremity, the characteristic collaterals for PAES were named and measured on arteriogram using Picture Archiving and Communication Software. Available cross-sectional images were also analyzed and compared with arteriogram and intraoperative findings during surgical exploration. RESULTS: There were 23 patients referred for PAES who underwent diagnostic evaluation and surgical management between 2013 and 2022. All patients had a duplex ultrasound that revealed a mean popliteal peak systolic velocity of 78 cm/sec at rest. With forced plantar flexion, the peak systolic velocity increased to a mean 175 cm/sec. A total of 12 extremities had complete loss of flow with provocation during duplex ultrasound. All patients underwent diagnostic angiography of 46 extremities. All limbs with PAES (n = 35) exhibited complete popliteal artery occlusion during angiography with forced plantar flexion. Distinct angiographic findings on resting images included a well-developed medial sural artery in 100% of limbs with PAES with a mean diameter of 2.7 mm. In limbs without PAES, only 80% had a visualized medial sural artery on arteriogram with a mean diameter of 2.0 mm (P = 0.1). A lateral sural artery was seen in 85% of affected extremities (mean diameter of 1.8 mm), while an anterior tibial recurrent artery was seen in 59% of affected extremities (mean diameter of 1.3 mm). In unaffected limbs, there were no visible lateral sural or anterior tibial recurrent arteries. The mean contrast used with diagnostic arteriograms was 58 milliliters (range 10-100 milliliters). Axial imaging was available for 9 affected extremities. Five had a previous MRA with only 1 being truly positive for arterial compression. Four extremities had previous CTA with 3 being falsely negative despite having type 3 PAES discovered during surgical exploration. CONCLUSIONS: Dynamic imaging with angiography provides immediate surgeon feedback by visualizing popliteal artery compression and enlarged sural collaterals during resting arteriography. The medial sural collateral is enlarged in patients with PAES and often the lateral sural and anterior tibial recurrent arteries can be visualized as well. CTA and MRA are associated with high false-negative rates, and therefore cause delays in diagnosis and surgical management of PAES. Dynamic imaging should, therefore, be the gold standard for the diagnosis of PAES.

Outcomes of thoracic endovascular aortic repair in patients with concomitant blunt thoracic aortic injury and traumatic brain injury from the Aortic Trauma Foundation global registry.

BACKGROUND: Traumatic brain injury (TBI) and blunt thoracic aortic injury (BTAI) are the top two leading causes of death after blunt force trauma. Patients presenting with concomitant BTAI and TBI pose a specific challenge with respect to management strategy, because the optimal hemodynamic parameters are conflicting between the two pathologies. Early thoracic endovascular aortic repair (TEVAR) is often performed, even for minimal aortic injuries, to allow for the higher blood pressure parameters required for TBI management. However, the optimal timing of TEVAR for the treatment of BTAI in patients with concomitant TBI remains an active matter of controversy. METHODS: The Aortic Trauma Foundation international prospective multicenter registry was used to identify all patients who had undergone TEVAR for BTAI in the setting of TBI from 2015 to 2020. The primary outcomes included delayed ischemic or hemorrhagic stroke, in-hospital mortality, and aortic-related mortality. The outcomes were examined among patients who had undergone TEVAR at emergent (<6 vs ≥6 hours) or urgent (<24 vs ≥24 hours) intervals. RESULTS: A total of 100 patients (median age, 43 years; 79% men; median injury severity score, 41) with BTAI (Society for Vascular Surgery BTAI grade 1, 3%; grade 2, 10%; grade 3, 78%; grade 4, 9%) and concomitant TBI who had undergone TEVAR were identified. Emergent repair was performed for 51 patients (51%). Comparing emergent repair (<6 hours) to urgent repair (≥6 hours), no difference was found in delayed cerebral ischemic events (2.0% vs 4.1%; P = .614), in-hospital mortality (15.7% vs 22.4%; P = .389), or aortic-related mortality (2.0% vs 2.0%; P = .996) and no patient had experienced delayed hemorrhagic stroke. Likewise, repairs conducted in an urgent (<24 hours) setting showed no differences compared with those completed in an emergent (≥24 hours) setting regarding delayed ischemic stroke (2.6% vs 4.3%; P = .548), in-hospital mortality (18.2% vs 21.7%; P = .764), or aortic-related mortality (1.3% vs 4.3%; P = .654), and no patient had experienced delayed hemorrhagic stroke. CONCLUSIONS: In contrast to prior retrospective efforts, results from the Aortic Trauma Foundation international prospective multicenter registry have demonstrated that neither emergent nor urgent TEVAR for patients with concomitant BTAI and TBI was associated with delayed stroke, in-hospital mortality, or aortic-related mortality. In these patients, the timing of TEVAR did not have an effect on the outcomes. Therefore, the decision to intervene should be guided by individual patient factors rather than surgical timing.

Outcomes and practice patterns of medical management of blunt thoracic aortic injury from the Aortic Trauma Foundation global registry.

OBJECTIVE: Blunt thoracic aortic injury (BTAI) is the second leading cause of death from blunt trauma. In the present study, we aimed to determine the outcomes of medical management (MM) for BTAI. We hypothesized from the results of several previously reported studies, that patients with a minimal aortic injury (BTAI grades 1 and 2) could safely be treated with definitive MM alone. METHODS: The Aortic Trauma Foundation international prospective multicenter registry was used to examine the demographics, injury characteristics, management, and outcomes of patients with BTAI. We analyzed a subset of patients for whom MM was initiated as definitive therapy. RESULTS: From November 2016 to April 2020, 432 patients (median age, 41 years; 76% male; median injury severity score, 34) with BTAI (Society for Vascular Surgery grade 1, 23.6%; grade 2, 14.4%; grade 3, 51.2%; grade 4, 10.9%) were evaluated. Of the 432 patients, 245 (57%) had received MM in the initial period and 114 (26.4%) had received MM as the planned definitive therapy (grade 1, 59.6%; grade 2, 23.7%; grade 3, 15.8%; grade 4, 0.9%). The most common mechanism of BTAI was a motor vehicle collision (60.4%). Hypotension was present on arrival in 74 patients (17.2%). Continuous titratable infusion of antihypertensive medication was used for 49.1%, followed by intermittent bolus administration (29.8%), with beta-blockers (74.6%) the most common agent used. Treatments were targeted to a goal systolic blood pressure for 83.3%, most often to a target goal systolic blood pressure <120 mm Hg (66.3%). The MM goals based on blood pressure control were attained in 64.0% (73 of 114). Twelve patients (10.5%; grade 1, 1; grade 2, 0; grade 3, 10; grade 4, 1) had required subsequent intervention after MM. Eleven patients (9.6%) had undergone thoracic endovascular aortic repair and one (0.9%) had required open repair for a grade 4 injury. The overall in-hospital mortality for patients selected for definitive MM was 7.9%. No aortic-related deaths had occurred in the patients receiving definitive MM. CONCLUSIONS: Approximately one in four patients with BTAI will receive MM as definitive therapy. The variation in the pharmacologic therapies used is considerable. MM for patients with minimal aortic injury (BTAI grades 1 and 2) is safe and effective, with a low overall intervention rate and no aortic-related deaths. These findings support the use of definitive MM for grade 2 BTAI.

A systematic review and meta-analysis of the clinical effectiveness and safety of unilateral versus bilateral iliac branch devices for aortoiliac and iliac artery aneurysms.

OBJECTIVE: Iliac branch devices (IBDs) have been used in the treatment of aortoiliac and isolated iliac artery aneurysms. The aim of this systematic review and meta-analysis was to investigate the clinical effectiveness and safety of IBDs. METHODS: A systematic review of the literature was conducted by identifying studies in the Medline, EMBASE, and Cochrane databases regarding the outcomes of IBDs in aortoiliac or isolated iliac artery aneurysms between May 2006 and December 2020. Individual studies were evaluated for the following major outcomes: technical success, 30-day mortality, primary patency, endoleak, reintervention, and rates of pelvic ischemia. Furthermore, subgroup meta-analyses were performed to compare the pelvic ischemic events in patients with bilateral IBDs, unilateral IBDs, and bilateral internal iliac artery (IIA) embolization/coverage. RESULTS: Forty-five studies with a total of 2736 patients undergoing unilateral or bilateral IBDs met inclusion criteria and were included in the analysis. The pooled technical success rate of IBDs was 98.0% (confidence interval [CI]: 97.3%-98.7%). After IBD treatment, the 30-day mortality rate was 0.4% (CI: 0.07%-0.70%); 30-day patency was 98.4% (CI: 97.7%-99.0%); buttock claudication developed in 1.84% (CI: 1.26%-2.41%); and endoleak occurred in 11.9% (CI: 9.2%-14.7%) and reintervention in 7.6% (CI: 5.65%-9.58%). Furthermore, in patients with bilateral iliac artery involvement, the pooled estimate rates of buttock claudication were 0.7% in the bilateral IBD group, 7.9% in unilateral IBD with contralateral IIA embolization patients, and 33.8% in bilateral IIA embolization/coverage patients, which were statistically significant among the three groups. Sexual dysfunction was 5.0% in the bilateral IIA occlusion group, which was significantly higher than that in IBD groups. CONCLUSIONS: The utilization of IBDs in the treatment of aortoiliac or isolated iliac artery aneurysms is associated with high technical success rates as well as low incidences of pelvic ischemia. The risk of postoperative buttock claudication can be further decreased with both IIA preservation if patients are anatomically suitable for bilateral IBDs.

Five-year results of the STABLE II study for the endovascular treatment of complicated, acute type B aortic dissection with a composite device design.

OBJECTIVE: To provide the 5-year outcomes of the use of a composite device (proximal covered stent graft + distal bare stent) for endovascular repair of patients with acute, type B aortic dissection complicated by aortic rupture and/or malperfusion. METHODS: Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE) II was a prospective, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe). Patients were enrolled between August 2012 and January 2015 at sites in the United States and Japan. Five-year follow-up was completed by January 2020. RESULTS: In total, 73 patients (mean age: 60.7 ± 10.9 years; 65.8% male) with acute type B dissection complicated by malperfusion (72.6%), rupture (21.9%), or both (5.5%) were enrolled. Patients were treated with either a composite device (79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients who received the composite device (408.9 ± 121.3 mm) than in patients who did not receive a bare stent (315.9 ± 100.1 mm). The mean follow-up was 1209.4 ± 754.6 days. Freedom from all-cause mortality was 80.3% ± 4.7% at 1 year and 68.9% ± 7.3% at 5 years. Freedom from dissection-related mortality remained at 97.1% ± 2.1% from 1-year through 5-year follow-up. Within the stent-graft region, the rate of either complete thrombosis or elimination of the false lumen increased over time (82.1% of all patients at 5 years vs 55.7% at first postprocedure computed tomography), with a higher rate at 5 years in patients who received the composite device (90.5%) compared with patients without the bare stent (57.1%). Throughout the follow-up, overall true lumen diameter increased within the stent-graft region, and overall false lumen diameter decreased. At 5 years, 20.7% of patients experienced a decrease in maximum transaortic diameter within the stent-graft region, 17.2% experienced an increase, and 62.1% experienced no change. Distal to the treated segment (but within the dissected aorta), 23.1% of patients experience no change in transaortic diameter at 5 years; a bare stent was deployed in all these patients at the procedure. Five-year freedom from all secondary intervention was 70.7% ± 7.2%. CONCLUSIONS: These 5-year outcomes indicate a low rate of dissection-related mortality for the Zenith Dissection Endovascular System in the treatment of patients with acute, complicated type B aortic dissection. Further, these data suggest a positive influence of composite device use on false lumen thrombosis. Continuous monitoring for distal aortic growth is necessary in all patients.

Clinical Outcomes of a Diagnostic and Management Protocol for Popliteal Artery Entrapment Syndrome at a Large Referral Center.

BACKGROUND: Popliteal Artery Entrapment Syndrome (PAES) is a rare clinical entity without a standardized algorithm for diagnosis and treatment. The objective of this study was to evaluate the clinical outcomes of a unique diagnostic and management algorithm for patients with PAES managed at a quaternary referral center. METHODS: We retrospectively reviewed patients diagnosed with PAES at a single institution between 2013 and 2021. Demographics, physical exam findings, noninvasive imaging results, and angiographic images were assessed to validate a diagnostic and management algorithm (Figure 1). Surgical findings, operative technique, post-operative complications, and symptomatic improvement were assessed to validate this clinical algorithm. RESULTS: There were 35 extremities in 23 patients treated for PAES (Table I). The mean age was 28, and 82.6% of patients were female. Physical exam revealed a decrement in pedal pulse with provocative maneuvers in 90% of treated limbs. Noninvasive studies to include treadmill exercise testing revealed a mean Ankle-brachial indices (ABI) drop of 0.28 and positional duplex demonstrated that the mean peak systolic velocity (PSV) in the popliteal artery was 78 cm/sec at rest which increased to 175 cm/sec with provocation. Diagnostic arteriography was performed in all patients and revealed awell-developed geniculate and sural collaterals in 100% of the treated limbs and complete effacement of the popliteal artery with active provocative maneuvers in all treated limbs (Figure 2). Surgical exposure was performed via a posterior approach and intraoperative completion duplex was performed in all cases. Type III PAES was discovered in 89% of cases. Arterial reconstruction was required in 2 patients who presented with an occluded popliteal artery. All but one patient was discharged on post-operative day one. Wound complications occurred in 4 limbs (3 patients) and included seroma and hypertrophic scarring. All patients experienced symptomatic relief with a median follow-up of 4 months. CONCLUSIONS: We reported 100% technical and clinical success in patients with PAES diagnosed and managed using our clinical algorithm. Cross-sectional imaging is not necessary for the diagnosis. Dynamic angiography confirms the diagnosis and intraoperative duplex is essential for successful clinical outcome by confirming complete release of the popliteal artery.

Significant aortic neck dilation occurs after repair of juxtarenal aneurysms with fenestrated endovascular aneurysm repair.

OBJECTIVE: Aortic neck dilation is a reported mode of failure and can be associated with aneurysm sac expansion after standard endovascular abdominal aortic aneurysm repair (EVAR). Fenestrated EVAR (FEVAR) of the juxtarenal segment increases the seal zone length and is often used to treat this disease progression. However, the frequency and risk factors for neck dilation after FEVAR is unknown. METHODS: We evaluated 124 consecutive FEVARs performed under an investigational device exemption clinical trial for juxtarenal aneurysms (ClinicalTrials.gov identifier, NCT01538056). The aortic diameter at the level of the superior mesenteric artery (SMA; highest fenestration) and lowest renal artery (lowest fenestration) was assessed from computed tomography angiography preoperatively, at 30 days, and annually thereafter. A subgroup analysis was performed to assess aortic neck dilation by the graft type used, degree of oversizing, infrarenal neck length, effective seal zone length, and aortic diameter at the level of the lowest and highest fenestration. Multivariable analysis was then performed to evaluate for predictors of aortic neck dilation. RESULTS: Of the 124 patients, 56 had complete anatomic detail and follow-up data available for ≥3 years. Those without preoperative or follow-up data available were excluded. The aortic diameter had increased significantly by 3 years at the level of both the SMA (2.4 mm; P < .01) and the lowest renal artery (3.2 mm; P < .01). When those with and without aortic dilation (>3 mm) were compared, only oversizing differed at the level of the SMA (14% vs 19%; P < .01). At the level of the lowest renal artery, the graft diameter differed (30 mm vs 28 mm; P = .02). However, after adjusted analysis, these differences were not significant. Finally, a subgroup analysis was performed to evaluate aortic dilation over time stratified by anatomic factors and should that aortic dilation occurred across differing aneurysm diameters, percentage of oversizing, graft types, and seal zone lengths. CONCLUSIONS: Aortic neck dilation in the visceral segment can occur after endovascular repair of juxtarenal aneurysms using FEVAR. Further research is warranted to determine how these changes might affect the long-term outcomes.

Initial experience with the Terumo aortic Treo device for fenestrated endovascular aneurysm repair.

OBJECTIVE: The Terumo aortic (TA) Treo device (Terumo, Somerset, NJ) is an endograft with unique features that lends itself to fenestrated endovascular aneurysm repair (FEVAR), including a low device profile, a wide amplitude stent design, and an increased interstent distance. We have described our initial experience with the Treo device for FEVAR to treat short neck and juxtarenal abdominal aortic aneurysms. METHODS: As part of an ongoing physician-sponsored investigational device exemption clinical trial (ClinicalTrials.gov identifier, NCT01538056), subjects were prospectively enrolled and underwent elective FEVAR using a variety of devices. Demographic and procedural details were collected. The data from subjects treated specifically with the Treo device from November 3, 2016 to May 2, 2019 were collected and analyzed. RESULTS: Of a cohort of 161 patients who had undergone elective FEVAR, 46 had been treated with the TA Treo device. Most patients were men (70%), with a mean age of 75 years and high rates of hypertension (74%), hyperlipidemia (83%), coronary artery disease (33%), and chronic obstructive pulmonary disease (33%). The mean aneurysm size was 66 mm, the mean preoperative infrarenal neck length was 5 mm, and the mean final seal zone length was 45 mm. The average hospital and intensive care unit lengths of stay were 2.4 and 1.5 days, respectively. A total of 129 fenestrations were created for 44 superior mesenteric and 85 renal arteries (2.8 fenestrations per patient). Technical success, defined as successful implantation of the device with all target vessels preserved, was 98% (45 of 46), with only one renal artery not successfully preserved. The mean follow-up period was 598 days. During the study period, 18 endoleaks were detected (17 type II and 1 type III), with one patient with a type III endoleak requiring reintervention. Three subjects had died within 30 days, one of intracranial hemorrhage, one of respiratory failure, and one of ischemic colitis. The graft modification times for the TA Treo were significantly shorter (43 minutes) than those for other commercially available devices (Cook Zenith, 55 minutes; Medtronic Endurant, 54 minutes; P < .0001). CONCLUSIONS: Our institution has reported exclusive worldwide experience using the TA Treo device for FEVAR. This device provides for a highly efficient and technically successful procedure for most patients. The procedural and fluoroscopy times were low even in the setting of high complexity. The technical success rates and simplification of the FEVAR procedure have made this approach a preferred technique for most patients at our institution.

Outcomes of femoral artery ligation for treatment of infected femoral pseudoaneurysms due to drug injection.

OBJECTIVE: Infected femoral artery pseudoaneurysms (IFAPs) are a known complication of illicit intravenous drug injection. As the opioid crisis in our country continues to worsen, we will likely see more IFAPs and algorithms for management of these patients will need to be elucidated. The aim of this study was to describe the surgical management and outcomes of patients presenting with IFAPs treated with femoral artery ligation. METHODS: This is a single-center, retrospective study of consecutive patients presenting to our institution with IFAPs associated with illicit drug injection between 2004 and 2017 and treated with primary ligation. Primary end points included major adverse limb events (MALE) and death. Baseline demographics, clinical features, and long-term outcomes were recorded. RESULTS: Over the study period, 60 IFAPs were managed with arterial ligation in 58 patients. Fifty-two percent of patients underwent common femoral artery ligation, 30% of patients underwent a triple ligation (ligation of the common femoral artery, profunda femoris artery, and superficial femoral artery), and 18% of patients underwent ligation of the superficial femoral artery only. The average postoperative ankle-brachial index was 0.47. None of the patients underwent revascularization at the index procedure. In our early experience, four patients (6.6%) underwent delayed revascularization with a prosthetic bypass. Two of the patients subsequently re-presented with infected bypass grafts and required the only major amputations in our series. The mean follow-up was 51.3 months and four patients were lost to follow-up. No differences were identified in MALE between patients undergoing a femoral artery ligation vs a triple ligation. Nine patients (15%) died during the follow-up period and all deaths were unrelated to IFAP treatment; the mean survival from procedure to death was 28 months. CONCLUSIONS: We describe the largest series in the United States of IFAP related to illicit drug use treated with femoral artery ligation and found it is a safe procedure associated with low MALE. Reconstruction is not recommended and is associated with graft infection. Although the mortality rate in these patients was high, it was not related to the ligation procedure.