Characterization of Secondary Interventions After Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms and Its Effect on Quality of Life and Patient Survival.

OBJECTIVE: To assess the impact of secondary intervention (SI) on health-related quality of life (HR-QOL) after fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. BACKGROUND: The effect of SI after FB-EVAR on physical and mental HR-QOL has not been described. METHODS: A cohort of 430 consecutive patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR (2013-2020) was assessed with 1325 short-form 36 HR-QOL questionnaires preoperatively and during follow-up visits. SIs were classified as major or minor procedures. Endpoints included patient survival, freedom from aortic-related mortality (ARM), freedom from SIs, and changes in HR-QOL physical component score (PCS) and mental component score. RESULTS: There were 302 male with mean age 74±8 years treated by FB-EVAR for 133 complex abdominal aortic aneurysms and 297 thoracoabdominal aortic aneurysms. After a mean follow up of 26±20 months, 97 patients (23%) required 137 SIs. At 5 years, freedom from any SI was 64%±4%, including freedom from minor SIs of 77%±4% and major SIs of 87%±3%. There was no difference in patient survival and freedom from ARM at same interval. On adjusted analysis, minor SIs correlated with improved survival. SIs had a negative correlation with PCS ( r =-0.8). There were no significant changes in mental component score with SIs. Predictors for SIs were fluoroscopy time, graft design, and aneurysm sac change. CONCLUSION: SIs were needed in nearly 1 out of 4 patients treated by FB-EVAR with no effect on patient survival or ARM. SI resulted in decline in PCS.

Changes in renal-mesenteric duplex ultrasound velocities after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVE: Stenting of renal and mesenteric vessels may result in changes in velocity measurements due to arterial compliance, potentially giving rise to confusion about the presence of stenosis during follow-up. The aim of our study was to compare preoperative and postoperative changes in peak systolic velocity (PSV, cm/s) after placement of the celiac axis (CA), superior mesenteric artery (SMA) and renal artery (RAs) bridging stent grafts during fenestrated-branched endovascular aortic repair (FB-EVAR) for treatment of complex abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms. METHODS: Patients were enrolled in a prospective, nonrandomized single-center study to evaluate FB-EVAR for treatment of complex AAA and thoracoabdominal aortic aneurysms between 2013 and 2020. Duplex ultrasound examination of renal-mesenteric vessels were obtained prospectively preoperatively and at 6 to 8 weeks after the procedure. Duplex ultrasound examination was performed by a single vascular laboratory team using a predefined protocol including PSV measurements obtained with <60° angles. All renal-mesenteric vessels incorporated by bridging stent grafts using fenestrations or directional branches were analyzed. Target vessels with significant stenosis in the preoperative exam were excluded from the analysis. The end point was variations in PSV poststent placement at the origin, proximal, and mid segments of the target vessels for fenestrations and branches. RESULTS: There were 419 patients (292 male; mean age, 74 ± 8 years) treated by FB-EVAR with 1411 renal-mesenteric targeted vessels, including 260 CAs, 409 SMAs, and 742 RAs. No significant variances in the mean PSVs of all segments of the CA, SMA, and RAs at 6 to 8 weeks after surgery were found as compared with the preoperative values (CA, 135 cm/s vs 141 cm/s [P = .06]; SMA, 128 cm/s vs 125 cm/s [P = .62]; RAs, 90 cm/s vs 83 cm/s [P = .65]). Compared with baseline preoperative values, the PSV of the targeted vessels showed no significant differences in the origin and proximal segment of all vessels. However, the PSV increased significantly in the mid segment of all target vessels after stent placement. CONCLUSIONS: Stent placement in nonstenotic renal and mesenteric vessels during FB-EVAR is not associated with a significant increase in PSVs at the origin and proximal segments of the target vessels. Although there is a modest but significant increase in velocity measurements in the mid segment of the stented vessel, this difference is not clinically significant. Furthermore, PSVs in stented renal and mesenteric arteries were well below the threshold for significant stenosis in native vessels. These values provide a baseline or benchmark for expected PSVs after renal-mesenteric stenting during FB-EVAR.

Technical Pitfalls for Fenestrated-Branched Endovascular Aortic Repair Following PETTICOAT.

PURPOSE: The Provisional Extension to Induce Complete Attachment Technique (PETTICOAT) uses a bare-metal stent to scaffold the true lumen in patients with acute or subacute aortic dissections. While it is designed to facilitate remodeling, some patients with chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) require repair. This study describes the technical pitfalls of fenestrated-branched endovascular aortic repair (FB-EVAR) in patients who underwent prior PETTICOAT repair. TECHNIQUE: We report 3 patients with extent II TAAAs who had prior bare-metal dissection stents treated by FB-EVAR. Two patients required maneuvers to reroute the aortic guidewire, which was initially placed in-between stent struts. This was recognized before the deployment of the fenestrated-branched device. A third patient had difficult advancement of the celiac bridging stent due to a conflict of the tip of the stent delivery system into one of the stent struts, requiring to redo catheterization and pre-stenting with a balloon-expandable stent. There were no mortalities and target-related events after a follow-up of 12 to 27 months. CONCLUSION: FB-EVAR following the PETTICOAT is infrequent, but technical difficulties should be recognized to prevent complications from the inadvertent deployment of the fenestrated-branched stent-graft component in-between stent struts. CLINICAL IMPACT: The present study highlights a few maneuvers to prevent or overcome possible complications during endovascular repair of chronic post-dissection thoracoabdominal aortic aneurysm following PETTICOAT. The main problem to be recognized is the placement of the aortic wire beyond one of the struts of the existing bare-metal stent. Moreover, encroachment of catheters or the bridging stent delivery system into the stent struts may potentially cause difficulties.

Impact of gap distance between fenestration and aortic wall on target artery instability following fenestrated-branched endovascular aortic repair.

OBJECTIVE: Target artery (TA) instability has been the most frequent indication for secondary intervention after fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). The aim of the present study was to evaluate the effect of the gap distance between the endograft reinforced fenestration and TA origin at the aortic wall (fenestration gap [FG]) on target-related outcomes after FB-EVAR. METHODS: The clinical data and imaging studies of 430 patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR using manufactured stent grafts were reviewed. Of the 430 patients, 340 (79%) had had more than one vessel incorporated by fenestration. The FG was retrospectively measured on postoperative imaging studies and classified into three groups: no gap (FG, 0 mm), FG 1 to 4 mm, and FG ≥5 mm. The primary outcome was freedom from TA instability. The secondary end points included TA-related endoleak, TA secondary intervention, and TA patency. RESULTS: A total of 1558 renal-mesenteric TAs were incorporated by 1104 reinforced fenestrations and 454 directional branches (DBs), with a mean of 3.9 ± 0.5 vessels per patient. The mean FG was 2.8 ± 4.5 mm, with an FG of 0 mm for 646 TAs, 1 to 4 mm for 209 TAs, and ≥5 mm for 249 TAs. An FG of ≥5 mm was associated with significantly lower (P < .001) freedom from TA instability, type Ic or IIIc endoleak, and secondary interventions at 5 years. Compared with DBs, fenestrations with an FG of ≥5 mm had similar primary patency and freedom from TA instability but significantly lower freedom from type Ic or IIIc endoleak (91% ± 2% vs 95% ± 1%; log rank, P = .02) and secondary interventions (87% ± 3% vs 93% ± 2%; log-rank, P = .02) at 5 years. The independent predictors of TA instability included postdissection TAAAs (hazard ratio, 2.5; 95% confidence interval, 1.2-5.4) and FG ≥5 mm (hazard ratio, 1.6; 95% confidence interval, 1.2-1.8). TAs incorporated by reinforced fenestrations had higher primary (99% ± 0.8% vs 97% ± 1.0%; P = .039) and secondary (100% vs 98% ± 1.0%; P = .012) patency rates at 5 years compared with DBs, with the lowest primary patency observed for renal DBs (80% ± 6% vs 92% ± 2%; P = .008). CONCLUSIONS: An FG of ≥5 mm was independently associated with an increased risk of TA instability, type Ic or IIIc endoleaks, and secondary interventions for patients treated by FB-EVAR using fenestrated designs. TAs incorporated by DBs had lower 5-year primary and secondary patency compared with those with reinforced fenestrations, with the lowest 5-year patency of 80% for renal branches. Compared with DBs, fenestrations with an FG of ≥5 mm carried a greater risk of type Ic or IIIc endoleak and secondary interventions. Independent predictors of TA instability included postdissection TAAAs and a greater FG. In contrast, dual antiplatelet therapy and larger TA diameters were protective.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). METHODS: We reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. RESULTS: A total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (-0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). CONCLUSIONS: IAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts.

OBJECTIVE: The aim of this study was to investigate the midterm outcomes of fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). SUMMARY BACKGROUND DATA: FB-EVAR has been associated with decreased morbidity compared to open repair, but there is limited midterm data. METHODS: A total of 430 patients (302 males, mean age 74 ±â€Š8 years) treated by FB-EVAR were enrolled in a prospective, nonrandomized investigational device exemption study. Endpoints included 30-day mortality and major adverse events (MAEs), freedom from all cause and aortic-related mortality, target vessel patency, and freedom from secondary intervention and target vessel instability. RESULTS: There were 133 PRAs and 297 TAAAs with 1673 renal-mesenteric arteries incorporated by fenestrations or directional branches (3.9 ±â€Š0.5 vessels/patient). At 30 days or within the hospital stay if longer than 30 days, there were 4 (0.9%) deaths. MAEs included new-onset dialysis in 8 patients (2%), permanent paraplegia or stroke in 10 patients each (2%), and respiratory failure requiring tracheostomy in 2 patients (0.5%). After a mean follow-up of 26 ±â€Š20 months, there were 3 (0.7%) aortic-related deaths from SMA stent occlusion, gastrointestinal hemorrhage, or complications of open arch repair. At 5 years, freedom from all-cause and aortic-related mortality were 57% ±â€Š5% and 98% ±â€Š1%, respectively. Freedom from secondary intervention was 64% ±â€Š4%, primary target vessel patency was 94% ±â€Š1%, and freedom from target vessel instability was 89% ±â€Š2% at same interval. One patient (0.2%) had nonfatal aneurysm treated using endovascular repair. CONCLUSION: FB-EVAR is safe and effective for treatment of PRA and TAAAs with low rate of aortic-related mortality and aneurysm rupture on midterm follow-up.

Psoas muscle area and attenuation are highly predictive of complications and mortality after complex endovascular aortic repair.

OBJECTIVE: The present study evaluated the psoas muscle area and attenuation (radiodensity), quantified by computed tomography, together with clinical risk assessment, as predictors of outcomes after fenestrated and branched endovascular aortic repair (FBEVAR). METHODS: The present single-center study included 504 patients who had undergone elective FBEVAR for pararenal or thoracoabdominal aortic aneurysms. The clinical risk assessment included age, sex, comorbidities, body mass index, glomerular filtration rate, aneurysm size and extent, cardiac stress test results, ejection fraction, and American Society of Anesthesiologists (ASA) score. Preoperative computed tomography was used to measure the psoas muscle area and attenuation at the L3 level. The lean psoas muscle area (LPMA; area in cm2 multiplied by attenuation in Hounsfield units [HU]) was calculated by multiplying the area by the attenuation. The risk factors for 90-day mortality, major adverse events (MAEs), and long-term mortality were determined using multivariable analysis. MAEs included 30-day or in-hospital death, acute kidney injury, myocardial infarction, respiratory failure, paraplegia, stroke, and bowel ischemia. A novel risk stratification method was proposed according to the strongest predictors of mortality and MAEs on multivariable analysis. RESULTS: The 30-day mortality, 90-day mortality, and MAE rates were 2.0%, 5.6%, and 20%, respectively. The independent predictors of 90-day mortality were chronic obstructive pulmonary disease, chronic kidney disease, ASA score, and LPMA. The independent predictors of MAEs were aneurysm diameter, glomerular filtration rate, and LPMA. For long-term mortality, the independent predictors were chronic kidney disease, congestive heart failure, extent I-III thoracoabdominal aortic aneurysms, ASA score, and LPMA. The patients were stratified into three groups according to the ASA score and LPMA: low risk, ASA score II or LPMA >350 cm2HU (n = 290); medium risk, ASA score III and LPMA ≤350 cm2HU (n = 181); and high risk, ASA score IV and LPMA ≤350 cm2HU (n = 33). The 90-day mortality and MAE rates were 1.7% and 16% in the low-, 7.2% and 24% in the medium-, and 30% and 33% in the high-risk patients, respectively (P < .001 and P = .02, respectively). Patients with ASA score IV and LPMA <200 cm2HU, indicating sarcopenia (n = 14) had a 43% risk of death within 90 days. The 3-year survival estimates were 80% ± 3% for the low-, 70% ± 4% for the medium-, and 35% ± 9% for the high-risk patients (P < .001). The mean follow-up time was 3.1 ± 2.3 years. CONCLUSIONS: LPMA was a strong predictor of outcomes and the only independent predictor of both mortality and MAEs after FBEVAR. A high muscle mass was protective against complications, regardless of the ASA score. Risk stratification based on the ASA score and LPMA can be used to identify patients at excessively high operative risk.

Impact of intentional accessory renal artery coverage on renal outcomes after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate the impact of intentional coverage of accessory renal arteries (ARAs) on renal outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) for pararenal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We analyzed the clinical data of 296 patients enrolled in a prospective nonrandomized study to evaluate outcomes of FB-EVAR between 2013 and 2018. Patients with solitary kidneys, intraoperative loss of main renal arteries, or pre-existing stage V chronic kidney disease were excluded. Two groups were analyzed: patients with intentional ARA coverage; and controls, who had complete preservation. End points included 30-day mortality; major adverse events; acute kidney injury (AKI), defined by RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease); renal function deterioration (RFD), defined by >30% decline in baseline estimated glomerular filtration rate; and presence of renal infarcts. RESULTS: There were 254 patients (184 male; mean age, 75 ± 8 years) included in the study, 56 (22%) with intentional ARA coverage and 198 controls, of whom 16 had ARA preservation. ARA diameter was smaller in patients who had intentional coverage vs preservation (2.7 ± 0.9 mm vs 3.4 ± 0.2 mm; P < .001). There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. All ARAs intended to be incorporated were successfully stented. Patients with ARA coverage had a higher frequency of kidney infarction (75% vs 25%; P < .001). There were two (1%) deaths within 30 days, both among controls. Patients with ARA coverage had more major adverse events (32% vs 19%; P = .04) because of higher incidence of AKI (21% vs 9%; P = .02). None of the 16 patients who had ARA preservation developed AKI. At 3 years, freedom from RFD was lower for patients who had ARA coverage compared with controls (55% ± 9% vs 76% ± 5%; log-rank, P = .02). By multivariate analysis, predictors of AKI were ARA coverage (odds ratio, 2.8; 95% confidence interval [CI], 1.2-6.2; P = .01) and estimated blood loss >1 L (odds ratio, 3.8; 95% CI, 1.2-12.3; P = .03). Postoperative AKI (hazard ratio [HR], 4.4; 95% CI, 2.4-8.1; P < .001), renal reintervention for stenosis (HR, 3.2; 95% CI, 1.6-6.7; P = .002), aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.06; P < .001), and ARA coverage (HR, 2.0; 95% CI, 2.4-8.1; P = .02) were predictors of RFD. CONCLUSIONS: Intentional ARA coverage during FB-EVAR was associated with a threefold increase in AKI and with lower freedom from RFD. Factors associated with RFD included postoperative AKI, renal reinterventions for stenosis, and ARA coverage. Incorporation of ARAs during FB-EVAR, when it is technically feasible, helps decrease risk of AKI and RFD.

Comparison of Cerebral Embolic Events Between Right and Left Upper Extremity Access During Fenestrated/Branched Endovascular Aortic Repair.

PURPOSE: To evaluate the incidence and outcomes of cerebral embolic events when using right (RUE) vs left upper extremity (LUE) access for fenestrated/branched endovascular aneurysm repair (f/bEVAR). MATERIALS AND METHODS: A retrospective review was conducted of 290 consecutive patients enrolled in a physician-sponsored Investigational Device Exemption study to evaluate f/bEVAR between 2013 and 2018. Of these, 270 patients (93%) had an upper extremity access with 12-F sheaths, including 205 patients (mean age 75±8 years; 147 men) with LUE and 65 patients (mean age 73±8 years; 42 men) with RUE access. Outcome measures were technical success, procedural metrics, major adverse events (MAEs), any stroke or transient ischemic attack (TIA), and mortality. RESULTS: Technical success was higher (p=0.04) for LUE (99.6%) vs RUE access (98.4%). Patients treated via RUE access more often had extent I-III thoracoabdominal aortic aneurysms (57% vs 39%, p=0.03). Procedural metrics were similar for LUE vs RUE sides, including endovascular time (255±80 vs 246±83 minutes, respectively; p=0.23), fluoroscopy time (84±32 vs 90±35 minutes, respectively; p=0.80), and contrast volume (156±57 vs 153±56 mL, respectively; p=0.82). Total radiation exposure was significantly higher for LUE vs RUE access (2463±1912 vs 1757±1494 mGy, respectively; p=0.02). There were 2 deaths (1%) at 30 days or during hospital admission, both unrelated to access site complications. MAEs occurred in 32% of patients who had LUE and 26% of those who had RUE access (p=0.44). Five patients (2%) had embolic stroke and none had TIA. Embolic strokes were ipsilateral to the access side in 4 patients and affected the posterior circulation in 3. Two patients (1%) had hemorrhagic strokes. The incidence of stroke was 3% for LUE and 2% for RUE access (p>0.99). CONCLUSION: Fenestrated/branched stent-graft repair was associated with low rates of cerebral embolic events and no significant difference between the right vs left upper extremity approach.

Incorporation of Celiomesenteric Trunk With Double Kissing Directional Branches During Fenestrated-Branched Endovascular Aortic Repair.

PURPOSE: Common celiomesenteric trunk (CMT) is a rare anatomical variation that occurs in 0.5% to 3.4% of the general population. Its presence may complicate planning and implantation of fenestrated and branched stent-grafts because the wide diameter and short length of the CMT to its bifurcation does not allow sufficient sealing for placement of bridging stents. CASE REPORT: We report a patient with thoracoabdominal aortic aneurysm (TAAA) and CMT treated by fenestrated-branched endovascular aortic repair (FB-EVAR) using double kissing directional branches to incorporate the celiac axis and superior mesenteric artery. Pitfalls of stent design and implantation are outlined. CONCLUSION: Double kissing directional branches should be considered as an alternative to incorporate vessels with early bifurcation such as a CMT.

Outcomes of fenestrated-branched endovascular aortic repair in patients with a solitary functional kidney.

OBJECTIVE: The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal abdominal aortic aneurysms or thoracoabdominal aortic aneurysms (TAAAs) in patients with a solitary functional kidney (SFK). METHODS: We analyzed the outcomes of 287 consecutive patients (206 male; mean age, 74 ± 8 years old) enrolled in a prospective nonrandomized study to investigate use of F-BEVAR for treatment of patients with pararenal abdominal aortic aneurysms or TAAAs between 2013 and 2018. Outcomes were analyzed in patients with solitary kidney (functional or congenital) and compared with control patients who had two functioning kidneys. Acute kidney injury (AKI) was defined using Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease criteria, and renal function deterioration (RFD) was defined by a decline in estimated glomerular filtration the estimated glomerular filtration rate of more than 30% from baseline. End points included 30-day mortality and major adverse events, AKI, freedom from RFD, and patient survival. RESULTS: There where 30 patients (10%) with a SFK and 257 patients with two functioning kidneys. Patients with a SFK were younger and had significantly (P < .05) higher baseline creatinine (+0.3 mg/dL), lower estimated glomerular filtration rate (-16 mL/minute/1.73 m2) and more often had stage III to V chronic kidney disease (73% vs 43%). There were no differences in cardiovascular risk factors and aneurysm extent. Technical success was achieved in 98.9% of patients with SFK and in 99.8% of controls (P = .10). At 30 days, there was no significant differences in mortality (0% vs 1%) and major adverse events (40% vs 24%; P = .08), including rates of AKI (20% vs 12%) and new-onset dialysis (3% vs 1%) between patients with a SFK and the control group, respectively. Mean follow-up was 18 ± 15 months. At 2 years, there was no difference (P = .36) in patient survival (92 ± 5% vs 84 ± 3%) and freedom from RFD (100 ± 0% vs 84 ± 3%) for patients with SFK and controls, respectively. Presence of a SFK was not a predictor for AKI or RFD. By multivariable analysis, estimated blood loss of more than 1 L (odds ratio [OR], 2.9; P = .04) and total fluoroscopy time (OR, 1.8; P = .05) were predictors for AKI, and postoperative AKI (OR, 4.9; P < .001), renal branch occlusion/stenosis (OR, 3.1; P = .001), and Crawford extent II TAAA (OR, 2.4; P = .007) were predictors for RFD. CONCLUSIONS: Despite the worse baseline renal function, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK as compared with patients with two functioning kidneys. Development of postoperative AKI is the most important predictor for RFD.

Outcomes of target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to determine the incidence rate, outcomes, and risk factors of target vessel-related endoleaks after fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal aneurysms or thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed consecutive patients treated by F-BEVAR between 2007 and 2017. Target vessel endoleaks were identified by computed tomography angiography (CTA). Follow-up included CTA and duplex ultrasound before discharge, at 2 months, at 6 months, and annually thereafter. Primary endoleaks were detected by predismissal CTA; secondary endoleaks were absent on the first CTA and were identified during follow-up. End points were spontaneous resolution of primary endoleaks, secondary interventions, and aneurysm rupture. Multivariable analyses were performed for risk factors of target vessel endoleaks and predictors of spontaneous resolution. RESULTS: A total of 382 patients (mean age, 75 ± 8 years; 75% male) underwent F-BEVAR for 195 pararenal aneurysms and 187 TAAAs with 1204 renal-mesenteric arteries targeted by 981 fenestrations and 223 directional branches. Fifty-two target vessel endoleaks were identified in 41 patients; 41 were type IIIC (interattachment), 10 were type IC (distal bridging stent sealing zone), and 1 was type IIIB (bridging stent fabric tear). Thirty-three patients (9%) had primary target vessel endoleaks in 41 target vessels (3%). Eight patients (2%) developed 11 secondary target vessel endoleaks. Directional branches were more prone to primary endoleaks (13/223 [6%]) in comparison to fenestrations (28/981 [3%]; P = .03). However, branch endoleaks resolved more often spontaneously (11/14 [79%]) compared with fenestration endoleaks (14/38 [37%]; P = .008). Other risk factors for target vessel endoleaks included inner aortic diameter ≥30 mm at the target vessel origin, four or more targeted vessels, TAAA (for primary endoleaks), and physician-modified endograft (for secondary endoleaks). Four patients with primary endoleaks underwent successful reintervention before discharge, and 29 were observed with a mean follow-up of 24 ± 21 months. Of the 41 primary endoleaks, 25 resolved spontaneously in 20 patients (61%) at first follow-up with no recurrences. Of the observed endoleaks, 11 persisted in 9 patients, and 8 of those endoleaks were treated in 7 patients. All secondary target vessel endoleaks required reintervention. There was one possible aneurysm rupture attributed to persistent secondary target vessel endoleak. CONCLUSIONS: Target vessel endoleak on CTA at discharge occurs in 1 of 10 patients treated by F-BEVAR. Of these, two-thirds resolve spontaneously, especially those affecting directional branches. Among patients with a persistent endoleak, endovascular reintervention is usually successful and aneurysm rupture is rare.

Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The objective of this study was to evaluate outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoracoabdominal aortic aneurysms. METHODS: Patients treated by fenestrated-branched endovascular aneurysm repair were enrolled in a prospective study from 2014 to 2018. We included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington Ga] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) or BESG (Gore VBX). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring reintervention and stent occlusion, aneurysm rupture, or death due to target artery complication. End points included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery reintervention. RESULTS: There were 126 patients (61% male; mean age, 73 ± 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoracoabdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (P < .05) shorter stent length (-7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% vs 15%). Technical success was achieved in 99% of patients, with one 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 ± 12 months vs 8±8 months; P < .0001). TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESGs), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery reinterventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% ± 2% vs 96% ± 2%; P = .004), freedom from TAI (96% ± 2% vs 88% ± 3%; P < .0001), freedom from type IC or type IIIC endoleaks (98% ± 1% vs 92% ± 3%; P = .0004), and freedom from target artery reinterventions (98% ± 1% vs 88% ± 4%; P < .0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% ± 1% vs 99% ± 1%; P = .75). Factors associated with TAI were large stent diameter (odds ratio, 0.6; P < .0001) and use of VBX stent graft (odds ratio, 6.5; P < .0001). CONCLUSIONS: Directional branches were associated with high technical success and low rates of stent occlusion, independent of stent type. However, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks was lower for BESGs compared with SESGs.

Prospective nonrandomized study to evaluate cone beam computed tomography for technical assessment of standard and complex endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the utility of cone beam computed tomography (CBCT) for technical assessment of standard and complex endovascular aneurysm repair (EVAR). METHODS: Data of consecutive patients who underwent standard or complex EVAR in 2016 and 2017 at our institution were entered into a prospective database and analyzed retrospectively. There were 154 patients (126 male; mean age, 74 ± 8 years) enrolled in a prospective study between 2016 and 2017. A total of 170 aortic procedures were investigated, including 85 fenestrated-branched EVARs (F-BEVARs), 42 abdominal and thoracic EVARs, 32 EVARs with iliac branch devices, and 11 aorta-related interventions. Technical assessment was done using CBCT with and without contrast enhancement, digital subtraction angiography (DSA), and computed tomography angiography (CTA). Patients with stage 3B or stage 4 chronic kidney disease had CBCT without contrast enhancement. Radiation exposure (mean dose-area product), effective dose (ED), and amount of iodine contrast agent were analyzed. End points were presence of any endoleak, positive findings warranting possible intervention (stent kink or compression, type I or type III endoleak, dissection, thrombus), and need for secondary intervention. RESULTS: Radiation exposure and amount of iodine contrast agent were significantly higher (P < .05) for F-BEVAR compared with other aortic procedures (174±101 Gy∙cm2 vs 1135±113 Gy∙cm2 and 144±60 mL vs 122±49 mL). ED averaged 74±36 mSv for the aortic procedure, 18 ± 18 mSv for fluoroscopy, 7 ± 7 mSv for DSA acquisition, 15±7 mSv for CBCT, and 34±17 mSv for CTA imaging (P < .001). Endoleak detection was significantly higher (P < .001) with CBCT (53%) compared with DSA (14%) and CTA (46%). CBCT identified 52 positive findings in 43 patients (28%), higher for F-BEVAR compared with other aortic procedures (35% vs 16%; P = .01). Positive findings included stent compression or kink in 29 patients (17%), type I or type III endoleak in 16 patients (10%), and arterial dissection or thrombus in 7 patients (5%). Of these, 28 patients (18%) had positive findings that prompted an intraoperative (17%) or delayed intervention (1%). Another 15 patients (10%) with minor positive findings were observed with no clinical consequence. DSA alone would not have detected positive findings in 34 of 43 patients (79%), including 21 patients (49%) who needed secondary interventions. CTA diagnosed two (1%) additional endoleaks requiring intervention (one type IC, one type IIIC) that were not diagnosed by CBCT. Replacing DSA and CTA by CBCT would have resulted in 53% ± 13% reduction in amount of iodine contrast agent and 55% ± 12% reduction in ED (P < .05). CONCLUSIONS: CBCT reliably detected positive findings prompting immediate revisions in nearly one of five patients, with the highest rates among F-BEVAR patients. Detection of any endoleak was higher with CBCT compared with DSA or CTA, but most endoleaks were observed. DSA alone failed to detect positive findings warranting revisions.

Natural history of isolated type II endoleaks in patients treated by fenestrated-branched endovascular repair for pararenal and thoracoabdominal aortic aneurysms.

OBJECTIVE: Type II endoleaks (T2ELs) are common after endovascular aneurysm repair (EVAR), but little is known about their natural history in patients treated by fenestrated-branched EVAR (F/BEVAR). We sought to evaluate the natural history of isolated T2EL after F/BEVAR for pararenal aortic aneurysms (PRAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: Consecutive patients enrolled in a prospective nonrandomized study to investigate F/BEVAR for PRAs and TAAAs at a single institution (2014-2017) were identified. Computed tomography angiography images at discharge and during follow-up were reviewed. Patients with ≥12 months of follow-up were included and divided in two groups for comparison based on the presence or absence of T2ELs. Patients with any non-T2ELs were excluded. Multivariable logistic regression was used to assess factors associated with T2EL occurrence. Primary outcomes were absolute and relative sac diameter change and sac diameter increase >5 mm. Secondary outcomes included overall survival, aorta-related death, reinterventions, and conversion or rupture. RESULTS: There were 184 patients (136 male [74%]) with PRAs (n = 70 [38%]) and TAAAs (n = 114 [62%]) with an average age of 74 ± 7 years included. Isolated T2ELs were seen in 76 patients (41%); of these, 71 T2ELs (93%) were primary. Patients with T2ELs were more likely to have larger aneurysms (mean baseline diameter, 66 ± 8 mm vs 63 ± 8 mm; P = .01), patent inferior mesenteric artery (66% vs 32%; P < .001), and more lumbar arteries (mean, 6 ± 1 vs 4 ± 1; P < .001). In the multivariable analysis, these were all independently associated with T2EL occurrence. Of all T2ELs, only 18 (24%) resolved spontaneously during a mean follow-up of 31 ± 15 months. Mean absolute sac diameter reduction for patients without T2ELs and with T2ELs, at 12 and 36 months, was 10.2 ± 5.9 mm vs 2.6 ± 6.4 mm and 16.3 ± 7.3 mm vs 5.7 ± 11.3 mm, respectively (P < .001). For the same groups, the mean percentage sac diameter reduction at 12 and 36 months was 16.4% ± 9.4% vs 3.8% ± 9.8% and 26.4% ± 11.6% vs 8.8% ± 17.7%, respectively (P < .001). Overall, 13 patients showed sac increase >5 mm, and all these instances were recorded in the T2EL group; 8 required reintervention. T2ELs were not associated with decreased overall survival, freedom from aorta-related death, or freedom from any reintervention. CONCLUSIONS: Isolated T2ELs are common after F/BEVAR for PRAs and TAAAs, usually seen early; they are most often associated with inferior mesenteric or lumbar artery flow and tend to persist in follow-up. Their presence is associated with impaired sac shrinkage and risk of sac growth with subsequent need for secondary interventions. Although not associated with decreased overall survival or loss of freedom from aorta-related death, T2ELs require serial imaging surveillance.

Outcomes of Small Renal Artery Targets in Patients Treated by Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVE: The aim was to evaluate renal related outcomes in patients who had incorporation of a small (<4.0 mm) renal artery (RA) during fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: A total of 215 consecutive patients enrolled in a prospective F-BEVAR trial were reviewed. Computed tomography angiography centreline of flow reconstruction was used to measure mean RA diameter. Patients who had at least one <4.0 mm main or accessory RA incorporated by fenestration or directional branch (study group) were compared with patients who had incorporation of two ≥5.0 mm RAs (control group). Endpoints were technical success of RA incorporation, RA rupture and kidney loss, primary and secondary RA patency, RA branch instability and re-interventions, and renal function deterioration. RESULTS: Twenty-four patients with 28 <4.0 mm RAs (16 accessory and 12 main RAs) were compared with 144 patients with 288 ≥5.0 mm incorporated RAs. Study group patients were significantly younger than controls (72 ± 8 vs. 75 ± 8 years, p = .04) and more often females (46% vs. 21%, p = .018); there were no differences in cardiovascular risk factors and aneurysm extent. Technical success was 92% for <4.0 mm and 99% for ≥5.0 mm RA incorporation (p = .05). Inadvertent RA rupture occurred in three patients in the study group (13%) and in one (1%) in the control group (p = .009) resulting in kidney loss in two study group patients (8%) and one (1%) control group patient (p = .05). At one year, primary patency was 79 ± 9% vs. 94 ± 1% (p < .001) and secondary patency was 84 ± 8% vs. 97 ± 1% (p < .001) for study vs. control group; freedom from branch instability was 79 ± 9% vs. 93 ± 2% (p = .005), respectively. There were no differences in re-intervention rates and renal function deterioration between the groups. The mean follow up time was 21 ± 14 months. CONCLUSION: Incorporation of <4.0 mm RAs during F-BEVAR is associated with lower technical success, higher risk of arterial disruption and kidney loss, and lower patency rates at one year.

Pre-operative Psoas Muscle Size Combined With Radiodensity Predicts Mid-Term Survival and Quality of Life After Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVE: To investigate the association between psoas muscle area (PMA) and density (PMD) with survival and quality of life (QoL) after fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: The study included 244 consecutive patients enrolled in a prospective study to investigate outcomes of F-BEVAR. Pre-operative computed tomography angiography was used to measure PMA (cm2) and PMD (Hounsfield unit [HU]) at the L3 level. Lean PMA (LPMA) was calculated (PMA × PMD). Patients were divided into two groups using the LPMA cut off point based on a Cox hazard model. Group A was defined as LPMA ≥350 (n = 79) and group B as LPMA < 350 cm2 × HU (n = 165). QoL was assessed at baseline and at 12 months using the Short Form-36. RESULTS: Patients in group A were younger (mean age 72 ± 8 vs. 76 ± 7 years; p < .001), more often male (95% vs. 59%; p < .001), and had higher body mass index (30 ± 6 vs. 27 ± 5 kg/m2; p = .001). There were no major differences in comorbidities, aneurysm extent, or procedural measures between the groups. Thirty day mortality (0% vs. 0.6%; p = 1.0) and major adverse event rates (15% vs. 24%; p = .18) were similar in groups A and B. At three years, patient survival was 94% ± 3% in group A and 75% ± 4% in group B (hazard ratio [HR] 0.20, 95% confidence interval [CI] 0.07-0.56; p = .002). The three-year survival difference was even more prominent in patients aged ≥75 years: 100% for group A and 72% ± 5% for group B (HR 0.12, 95% CI 0.02-0.86; p = .035). Patients in group A had significantly higher QoL scores at baseline and at 12 months. LPMA was the strongest independent predictor of survival during follow up in multivariable analysis (adjusted HR 0.59 per 1 standard deviation, 95% CI 0.40-0.87; p = .008). CONCLUSION: A high LPMA was independently and strongly associated with better mid term survival and QoL after F-BEVAR. LPMA may help to identify the best candidates for F-BEVAR among elderly patients.

Resolution of acute lower extremity deep vein thrombosis with rivaroxaban compared to warfarin.

Thrombosis resolution is an important component of treatment for deep vein thrombosis (DVT) and multiple anticoagulants are now available. It is unknown whether rivaroxaban contributes to a higher degree of thrombus resolution compared to conventional anticoagulation with warfarin. Our objective was to compare thrombus resolution for rivaroxaban versus warfarin treated patients with acute lower extremity DVT. Consecutive patients treated for proximal or distal lower extremity DVT with rivaroxaban were identified from the Mayo Thrombophilia Clinic Anticoagulants Registry (November 2015-June 2016) and compared to patients treated with warfarin. Ultrasonography/Doppler images were analyzed by two independent radiologists blinded to anticoagulant and using a standardized assessment algorithm. A total of 111 patients with DVT were studied. Sixty-three rivaroxaban treated patients were compared to 48 warfarin treated patients over a median follow up of 92 and 97 days, respectively. Percentage of patients with total or partial resolution of thrombosis was similar in rivaroxaban and warfarin treated groups (95.2% vs. 91.7%, p = 0.46, respectively); also the proportion of patients with total thrombus resolution was not significantly different (38.1% vs. 29.2%, p = 0.42, respectively). There was no significant difference in the proportion of patients with no thrombus resolution between rivaroxaban and warfarin treated groups either (4.8% vs. 2.1%, p = 0.63). Thrombus propagation with warfarin therapy was observed in 6.3% of patients treated with warfarin and in none of the patients from the rivaroxaban group (p = 0.08). Resolution of acute lower extremity DVT in patients treated with rivaroxaban is similar to those treated with warfarin.

Sequential Pneumatic Compression in the Arm in Neurocritical Patients with a Peripherally Inserted Central Venous Catheter: A Randomized Trial.

BACKGROUND: Peripherally inserted central venous catheters (PICCs) are increasingly used for parenteral access in critically ill hospitalized patients, but they increase the incidence of upper extremity deep venous thrombosis (UE DVT). Sequential compression devices (SCDs) applied to the legs effectively reduce lower extremity DVT, but have not been tested in the arms. Our objective was to determine whether SCDs applied to the arm may reduce the risk of PICC-associated UE DVT. METHODS: This was a retrospective study of randomized, single-center, controlled clinical trial on patients hospitalized in the intensive care unit with critical neurological illness who had a PICC and were not receiving anticoagulants. Between January 2014 and October 2016, patients were randomized 1:1 to an intervention group having a custom SCD applied to the arm harboring the PICC or to a control group. The primary endpoint was ultrasound-detected UE DVT. RESULTS: Following randomization of 77 subjects, the study was terminated due to excess DVT in the treatment arm. UE DVT was detected in 18 subjects (29.0%), and it was more frequent among those in the SCD group (13/31 [41.9%] vs. the control group 5/31 [16.1%]; p = 0.049). After accounting for crossovers, the difference was still significant (12/28 [43.0%] vs. 6/34 [17.6%]; p = 0.048). Yet, symptomatic UE DVT (n = 3) and pulmonary embolism without evidence of lower extremity DVT (n = 2) were only observed in patients who were not wearing the SCD on the arm. CONCLUSIONS: Although UE DVT is commonly associated with PICC use, the results of this trial do not support the use of SCD on the arm for DVT prevention. Further research on this strategy may nonetheless be justified. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov under the identifier NCT01670188.

Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the impact of advanced imaging applications and cone beam computed tomography (CBCT) on radiation exposure of the patient and operator and detection of technical problems during fenestrated-branched endovascular aortic repair (F-BEVAR) for treatment of pararenal aneurysms and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 386 consecutives patients (289 male; mean age, 75 ± 8 years) treated by F-BEVAR for 196 pararenal aneurysms and 190 TAAAs (mean, 3.4 ± 0.9 targeted vessels/patient) between 2007 and 2017. Radiation exposure (cumulative air kerma) was analyzed in three fixed imaging systems used between 2007 and 2011 (system 1), 2012 and 2016 (system 2), and 2016 and 2017 (system 3). Onlay fusion and CBCT were available with systems 2 and 3, whereas digital zoom with fusion overlay was used with system 3. Operator effective dose was measured per month using a radiation dosimeter badge. Computed tomography angiography and CBCT were analyzed for findings requiring immediate revision or secondary interventions. End points were patient radiation exposure; operator effective dose; procedure technical success; and 30-day rates of mortality, major adverse events, and secondary interventions. RESULTS: F-BEVAR was performed using system 1 in 98 patients, system 2 in 198 patients, and system 3 in 90 patients. Use of onlay fusion/CBCT was 0% with system 1, 42% with system 2, and 98% with system 3. Procedures performed with onlay fusion/CBCT had significantly (P < .05) higher technical success (99.4% vs 98.8%) and lower contrast material volume (155 ± 58 mL vs 172 ± 80 mL), fluoroscopy time (83 ± 34 minutes vs 94 ± 49 minutes), and cumulative air kerma (2561 ± 1920 mGy vs 3767 ± 2307 mGy). Despite higher case volume and increasing complexity during the experience, operator effective dose decreased to 9 ± 4 × 10-2 mSv/case with system 3 compared with 26 ± 3 × 10-2 mSv/case with system 1 and 20 ± 2 × 10-2 mSv/case with system 2 (P = .001). Among 219 patients who had no CBCT, 18 (8%) had computed tomography angiography findings that prompted secondary interventions before dismissal. Conversely, among 167 patients who had CBCT, 14 patients (8%) had intraoperative CBCT findings requiring immediate revision, with no additional secondary interventions. Patients treated with onlay fusion/CBCT had significantly (P < .05) lower mortality (4% vs 1%), major adverse events (43% vs 19%), and secondary interventions (10% vs 4%) at 30 days. CONCLUSIONS: Radiation exposure and operator effective dose significantly decreased with evolution of F-BEVAR experience and use of advanced imaging applications such as onlay fusion and CBCT. CBCT allowed immediate assessment and identified intraoperative technical problems, leading to immediate revision and avoiding early secondary interventions.