Physician-sponsored Investigational Device Exemption Research Articles

Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study.

Fenestrated-branched endovascular aortic repair (FB-EVAR) has been used as a minimally invasive alternative to open surgical repair to treat patients with thoracoabdominal aortic aneurysms (TAAAs). The aim of this study was to evaluate aortic-related mortality (ARM) and aortic aneurysm rupture after FB-EVAR of TAAAs. Patients enrolled in 8 prospective, nonrandomized, physician-sponsored investigational device exemption studies between 2005 and 2020 who underwent elective FB-EVAR of asymptomatic intact TAAAs were analyzed. Primary end points were ARM, defined as any early mortality (30 days or in hospital) or late mortality from aortic rupture, dissection, organ or limb malperfusion attributable to aortic disease, complications of reinterventions, or aortic rupture. Secondary end points were early major adverse events, TAAA life-altering events (defined as death, permanent spinal cord injury, permanent dialysis, or stroke), all-cause mortality, and secondary interventions. A total of 1109 patients were analyzed; 589 (53.1%) had extent I-III and 520 (46.9%) had extent IV TAAAs. Median age was 73.4 years (interquartile range, 68.1-78.3 years); 368 (33.2%) were women. Early mortality was 2.7% (n=30); congestive heart failure was associated with early mortality (odds ratio, 3.30 [95% CI, 1.22-8.02]; P=0.01). Incidence of early aortic rupture was 0.4% (n=4). Incidence of early major adverse events and TAAA life-altering events was 20.4% (n=226) and 7.7% (n=85), respectively. There were 30 late ARMs; 5-year cumulative incidence was 3.8% (95% CI, 2.6%-5.4%); older age and extent I-III TAAAs were independently associated with late ARM (each P<0.05). Fourteen late aortic ruptures occurred; 5-year cumulative incidence was 2.7% (95% CI, 1.2%-4.3%); extent I-III TAAAs were associated with late aortic rupture (hazard ratio, 5.85 [95% CI, 1.31-26.2]; P=0.02). Five-year all-cause mortality was 45.7% (95% CI, 41.7%-49.4%). Five-year cumulative incidence of secondary intervention was 40.3% (95% CI, 35.8%-44.5%). ARM and aortic rupture are uncommon after elective FB-EVAR of asymptomatic intact TAAAs. Half of the ARMs occurred early, and most of the late deaths were not aortic related. Late all-cause mortality rate and the need for secondary interventions were 46% and 40%, respectively, 5 years after FB-EVAR. URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02089607, NCT02050113, NCT02266719, NCT02323581, NCT00583817, NCT01654133, NCT00483249, NCT02043691, and NCT01874197.

Early experience with patient-specific unibody bifurcated fenestrated-branched devices for complex endovascular aortic aneurysm repair

ObjectiveShort distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR. MethodsConsecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions. ResultsAmong 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm2 (IQR, 105-194 mGy∗cm2). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred. ConclusionsComplex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices.

A national census for the off-label treatment of complex aortic aneurysms.

Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n= 98). A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P= .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Practice patterns of antiplatelet and anticoagulant therapy after fenestrated/branched endovascular aortic repair

ObjectiveAntiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR. MethodsConsecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from 10 independent physician-sponsored investigational device exemption studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: (1) Aspirin alone OR P2Y12 alone (single-antiplatelet therapy [SAPT]); (2) Anticoagulant alone; (3) Aspirin + P2Y12 (dual-antiplatelet therapy [DAPT]); (4) Aspirin + anticoagulant OR P2Y12 + anticoagulant (SAPT + anticoagulant); (5) Aspirin + P2Y12 + anticoagulant (triple therapy [TT]); and (6) No therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention. ResultsOf the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT + anticoagulant, 3.2% on TT, 2.6% on anticoagulant alone, and 2.2% on no therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing with SAPT, DAPT conferred a lower hazard of loss of target artery patency (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.27-0.84; P = .01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (renal: HR, 0.66; 95% CI, 0.35-1.27; P = .22; visceral: HR, 0.31; 95% CI, 0.05-1.9; P = .21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency. ConclusionsPractice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an “optimal” regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR.

Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent

ObjectiveThe aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. MethodsPatients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. ResultsOf 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. ConclusionsLarger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.

Discussion to: Branched stented anastomosis frozen elephant trunk repair (B-SAFER): Early results from a physician-sponsored investigational device exemption study

Discussion to: Branched stented anastomosis frozen elephant trunk repair (B-SAFER): Early results from a physician-sponsored investigational device exemption study

National trends in utilization of surgeon-modified grafts for complex and thoracoabdominal aortic aneurysms

IntroductionCustom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. MethodsWe studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. ResultsA total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. ConclusionsPMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.

Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms

IntroductionFrailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. MethodsConsecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. ResultsSeventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: −96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). ConclusionsPreoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study

BackgroundMultisegment thoracic aortic disease typically requires total aortic arch replacement, affects a heterogenous population, and carries a high risk even at centers of excellence. Risk has been associated with the duration of operation and complexity of repair. A novel branched stented anastomosis frozen elephant trunk repair (B-SAFER) technique has been developed at our center and is currently being studied as a physician-sponsored investigation device exemption (PS-IDE). ObjectiveThis study aimed to assess the early safety of using this investigational technique to treat the proximal aorta in subjects with aortic disease involving multiple segments. MethodsThis prospective, single center, nonrandomized study enrolled patients undergoing B-SAFER for acute aortic syndrome (n = 73), aortic aneurysm with chronic aortic dissection (n = 68), degenerative aortic aneurysm (n = 33), or congenital aortic arch disease (n = 4). Devices are delivered antegrade under hypothermic circulatory arrest, and the arch reconstruction is performed as a single anastomosis single stent (SASS; n = 70), single anastomosis multiple stent (SAMA; n = 68), multiple anastomosis single stent (MASS; n = 21), or multiple anastomosis multiple stent (MAMS; n = 16) reconstruction. The primary safety endpoints were operative mortality, disabling stroke, and paraparesis/paralysis. ResultsBetween May 27, 2021, and December 31, 2022, 178 patients underwent B-SAFER in the configurations and for the indications as described above. The median patient age was 65 years (range, 21 to 85 years), and 52 (29%) were female. The median cardiopulmonary bypass time was 188 minutes (interquartile range [IQR], 155 to 226 minutes), and 97% of the patients underwent repair with antegrade brain perfusion for a median of 46 minutes (IQR, 38 to 61 minutes). Operative mortality occurred in 10 patients (5.6%, including 6 [8.2%] with acute dissection, 2 [2.9%] with chronic dissection, 2 [6.1%] with degenerative aneurysm, and 0 with a congenital disorder), disabling stroke in 5 patients (2.9%), and paraparesis in 1 patient. Other serious complications included respiratory failure (n = 20; 11.4%) and acute kidney injury (n = 18; 10%). Thirty-two patients (18%) had undergone second-stage repairs (28 endovascular and 4 open), with 1 operative mortality after that procedure due to distal rupture. Estimated survival was 95% at 30 days, 88% at 90 days, 84% at 6 months, and 79% at 1 year. One-year survival differed by indication (72% for acute dissection, 91% for chronic dissection, 71% for degenerative aneurysm, and 100% for congenital disorders). Conclusions:The B-SAFER technique for total arch replacement in a complex cohort of patients with various indications for surgery is a safe and reproducible operation, as demonstrated by the early results from a very inclusive PS-IDE study. Further follow-up and analysis will help refine the technique. Novel devices to perform this procedure should be developed.

Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair

ObjectiveAcute kidney injury (AKI) occurs frequently in complex aortic surgery and has been implicated in perioperative and long-term survival. This study sought to characterize the relationship between AKI severity and mortality after fenestrated and branched endovascular aortic aneurysm repair (F/B-EVAR). MethodsConsecutive patients enrolled by the US Aortic Research Consortium in 10, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/B-EVAR, between 2005 and 2023, were included in this study. Perioperative AKI during hospitalization was defined by and staged using the 2012 Kidney Disease Improving Global Outcomes criteria. Determinants of AKI were evaluated with backward stepwise mixed effects multivariable ordinal logistic regression. Survival was analyzed with conditionally adjusted survival curves and backward stepwise mixed effects Cox proportional hazards modelling. ResultsIn the study period, 2413 patients with a median (interquartile range [IQR]) age of 74 years (IQR, 69-79 years) underwent F/B-EVAR. The median follow-up duration was 2.2 years (IQR, 0.7-3.7 years). The median baseline estimated glomerular filtration rate (eGFR) and creatinine were 68 mL/min/1.73 m2 (IQR, 53-84 mL/min/1.73 m2) and 1.1 mg/dL (IQR, 0.9-1.3 mg/dL), respectively. Stratification of AKI identified 316 patients (13%) with stage 1 injury, 42 (2%) with stage 2 injury, and 74 (3%) with stage 3 injury. Renal replacement therapy was initiated during the index hospitalization in 36 patients (1.5% of cohort, 49% of stage 3 injuries). Thirty-day major adverse events were associated with AKI severity (all P ≤ .0001). Multivariable predictors of AKI severity included baseline eGFR (proportional odds ratio, 0.9 per 10 mL/min/1.73 m2 [95% confidence interval (CI), 0.85-0.95 per 10 mL/min/1.73 m2]; P < .0001), baseline serum hematocrit (0.58 per 10% [95% CI, 0.48-0.71 per 10%]; P < .0001), renal artery technical failure during aneurysm repair (3 [95% CI,1.61-5.72]; P = .0006), and total operating time (1.05 per 10 minutes [95% CI, 1.04-1.07 per 10 minutes]; P < .0001). One-year unadjusted survivals for AKI severity strata were 91% (95% CI, 90%-92%) for no injury, 80% (95% CI, 76%-85%) for stage 1 injury, 72% (95% CI, 59-87%) for stage 2 injury, and 46% (95% CI, 35-59%) for stage 3 injury (P<.0001). Multivariable determinants of survival included AKI severity (stage 1, hazard ratio [HR], 1.6 [95% CI, 1.3-2]); stage 2, HR, 2.2 [95% CI, 1.4-3.4]); stage 3 HR, 4 [95% CI, 2.9-5.5]; P < .0001), decreased eGFR (HR, 1.1 [95% CI, 0.9-1.3]; P = .4), patient age (HR, 1.6 per 10 years [95% CI, 1.4-1.8 per 10 years]; P < .0001), baseline chronic obstructive pulmonary disease (HR, 1.5 [95% CI, 1.3-1.8]; P < .0001), baseline congestive heart failure (HR, 1.7 [95% CI, 1.6-2.1]; P < .0001), postoperative paraplegia (HR, 2.1 [95% CI, 1.1-4]; P = .02), and procedural technical success (HR, 0.6 [95% CI, 0.4-0.8]; P = .003). ConclusionsAKI, as defined by the 2012 Kidney Disease Improving Global Outcomes criteria, occurred in 18% of patients after F/B-EVAR. Greater severity of AKI after F/B-EVAR was associated with decreased postoperative survival. The predictors of AKI severity identified in these analyses suggest a role for improved preoperative risk mitigation and staging of interventions in complex aortic repair.

Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium: Presented at the 2021 European Society for Vascular Surgery Meeting, Rotterdam, the Netherlands, September 28-29, 2021.

Objective: Spinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies.

Impact of Using Endografts From Multiple Manufacturers on the Mid-term Outcomes of Physician-Modified Fenestrated-Branched Endovascular Aneurysm Repair

Complex endovascular aortic repairs can involve interactions of multiple aortic endografts from different device manufacturers. This may be due to the repair of failed previous endografts, intentional staging of extensive thoracoabdominal aortic repairs, and different manufacturers offering distinct device features suitable for specific purposes. However, there are limited data evaluating the interactions between aortic components from different manufacturers and their impact on clinical outcomes. Thus, we evaluated the impact of mixing aortic endografts from multiple manufacturers by comparing the rate of type IIIA endoleaks and clinical outcomes after physician-modified fenestrated-branched endovascular aortic repairs (PM-FBEVAR) using endografts from a single vs multiple manufacturers. A single-institution retrospective review of consecutive patients who underwent PM-FBEVAR between September 2015 and December 2022 was performed. Patients with a single aortic component were excluded. The remaining patients were divided into single- or multimanufacturer groups. Patient demographics, aneurysm extent, and operative details were compared. The primary outcome was type IIIA endoleak. The secondary outcomes included reintervention for type IIIA endoleak, major adverse events, and mortality. These outcomes were compared out to 2 years. Freedom from type IIIA endoleak-related reintervention was estimated using the Kaplan-Meier analysis and compared between the groups using a log-rank test. Data from this cohort include those reported to the Food and Drug Administration in the physician-sponsored investigational device exemption application, and those enrolled in the physician-sponsored investigational device exemption (FDA#: G200159, NCI#:APP-20-04282). Of 232 patients included in this study, 44 patients received a single-manufacturer and 188 patients received multimanufacturer aortic components. Baseline demographics and aneurysm extent were similar between the groups. The majority of concomitant iliac aneurysms repaired with Iliac Branch Endoprosthesis were in the multimanufacturer group (24 of 25). Procedure time, contrast usage, fluoroscopy time, estimated blood loss, and transfusion were significantly lower for the multimanufacturer group (Table). The overall 30-day mortality (2.3% single vs 3.2% multimanufacturer, P = .99) and major adverse events (20.5% vs 20.2%, P = .97) were similar between the groups. At 2-year follow-up, type IIIA endoleak occurred in 3 (6.8%) in the single- and 4 patients (2.1%) in the multimanufacturer groups (P = .128). These endoleaks were repaired in 2 of 3 and 4 of 4 patients in each group (P = .319) (Fig). Two-year mortality was similar between the groups (15.9% vs 13.3%, P = .651). Aortic endografts from multiple manufacturers can be used to facilitate PM-FBEVAR without a significant increase in type IIIA endoleaks, major adverse events, and reinterventions at 2 years. Continued follow-up is planned to assess long-term durability.TableCharacteristics, operative metrics, and outcomes of single vs multimanufacturerTotalSingle manufacturerMultimanufacturerP value23244188Aneurysm characteristics, No. (%) Presentation.113Asymptomatic167 (72.3)27 (61.4)140 (74.9)Symptomatic59 (25.5)15 (34.1)44 (23.5)Ruptured5 (2.2)2 (4.5)3 (1.6) Anatomical classification.160Juxtarenal19 (8.2)3 (6.8)16 (8.5)Pararenal/paravisceral76 (32.8)9 (20.5)67 (35.6)Pseudoaneurysm2 (0.9)0 (0)2 (1.1)TAAA135 (58.2)32 (72.7)103 (54.8)TAAA extent.463Extent I20 (14.8)4 (12.5)16 (15.5)Extent II54 (40.0)11 (34.4)43 (41.7)Extent III23 (17.0)6 (18.8)17 (16.5)Extent IV35 (25.9)9 (28.1)26 (25.2)Extent V3 (2.2)2 (6.3)1 (1.0) Iliac aneurysms requiring IBE25 (10.8)1 (2.3)24 (12.8).055 Aneurysm max diameter68.2 (16.7)66.5 (12.0)68.6 (17.6).336Intraoperative metrics Procedure time, minutes287.9 ± 108.7329.1 ± 115.6278.3 ±105.0.005 Iodinated contrast, cc121.6 ± 58.3154.6 ± 72.9113.9 ± 51.5<.001 Fluoroscopy time, minutes63.9 ± 33.579.5 ± 34.660.3 ± 32.3<.001 Estimated blood loss, cc [median, IQR]150 [262.5]400 [487.5]100 [250]<.00130-day outcomes, No. (%) Mortality7 (3.0)1 (2.3)6 (3.2)1.000 Major adverse events47 (20.3)9 (20.5)38 (20.2).9712-year outcomes, No. (%) All-cause mortality32 (13.8)7 (15.9)25 (13.3).651 Type IIIA endoleak7 (3.0)3 (6.8)4 (2.1).128IBE, Iliac Branch Endoprosthesis; IQR, interquartile range; TAAA, thoracoabdominal aortic aneurysm. Open table in a new tab

Persistent Thrombocytopenia Indicates Endoleak After Complex Endovascular Aneurysm Repair

High-pressure endoleaks (types I or III) after fenestrated-branched endovascular aneurysm repair (F-BEVAR) pose an ongoing risk of rupture. Early identification of such endoleaks may facilitate appropriate reintervention and mitigate that risk. The purpose of this study was to determine if persistent thrombocytopenia after F-BEVAR correlates with the presence of a high-pressure endoleak in the early postoperative period. Sequential patients enrolled in a physician-sponsored investigational device exemption study of physician modified and Cook manufactured F-BEVAR endografts were evaluated. Patients with type I endoleak or type III endoleak identified on computed tomography imaging within the first 6 months of follow-up were categorized as high-pressure endoleaks; any type II endoleaks were classified as low-pressure endoleaks. Univariable and multivariable analysis was performed to assess if thrombocytopenia was associated with the presence of endoleaks. We treated 185 patients. Twenty-six patients (14%) developed a high-pressure endoleak and 30 (16%) developed a low-pressure endoleak (Table I). Age, gender, race, indications for the procedure, and preoperative medications did not significantly differ between the endoleak groups. To maximize sensitivity and clinical utility, we selected a cut point of daily average platelet count of <100,000/μL (Table II). The proportion of high-pressure endoleak patients with platelet counts of <100,000/μL was significantly greater compared to patients with low-pressure and no endoleaks on postoperative day (POD) 1 through 4 (POD 4: high-pressure 42%, low-pressure 27%, no endoleak 10%; P ≤ .001). After adjusting for demographics and comorbidities, patients with high-pressure endoleak were over 12-times more likely to have a platelet count of <100,000/μL on POD 4 compared to patients with no endoleak (odds ratio, 12.3; 95% confidence interval, 3.5-43.0). F-BEVAR patients who developed high- or low-pressure endoleak were significantly more thrombocytopenic in the postoperative period. Consideration should be made to perform computed tomography imaging in patients with platelet counts of <100,000/μL persisting at POD 4 after F-BEVAR as these patients have a 35% chance of having a high-pressure endoleak requiring reintervention.Table IProportion of patients with platelet count under 100,000/μL at preoperative (day 0), and postoperative days (POD) 1-7 after F-BEVAR among the type I, II, and III endoleak and no endoleak groupsDay 0Day 1Day 2Day 3Day 4Day 5Day 6Day 7No endoleak (n = 125)12 (10)17 (14)27 (22)28 (22)13 (10)11 (9)4 (3)4 (3)T1E/T3E (n = 26)7 (27)12 (46)15 (58)12 (46)11 (42)3 (12)1 (4)1 (4)T2E (n = 30)5 (17)10 (33)11 (37)13 (43)8 (27)5 (17)3 (10)1 (3)P value.06<.001.001.02<.001.8.6a1.0aT1EL/T3EL, Type I endoleak/type III endoleak; T2EL, type II endoleak.Data presented as number (%).aFisher's exact was used. Open table in a new tab Table IIComparison of the test characteristics of a cutpoint of <100,000/μL at different postoperative days (POD) for predicting the presence of a high-pressure endoleakSensitivity (95% CI)Specificity (95% CI)PPV (95% CI)NPV (95% CI)ROC area (95% CI)Average platelets <100,000/μL on POD 30.46 (0.29-0.66)0.77 (0.70-0.84)0.30 (0.18-0.46)0.87 (0.80-0.92)0.61 (0.51-0.72.)Average platelets <100,000/μL on POD 40.42 (0.26-0.63)0.89 (0.83-0.94)0.45 (0.29-0.67)0.88 (0.82-0.93)0.66 (0.55-0.76)Average platelets <100,000/μL on POD 3 or 40.50 (0.33-0.70)0.76 (0.68-0.83)0.31 (0.19-0.47)0.87 (0.80-0.93)0.62 (0.52-0.73)95% CI, 95% Confidence interval; NPV, negative predictive value; PPV, positive predictive value; ROC, receiver operating characteristic. Open table in a new tab

Gore thoracoabdominal branched endoprosthesis: early result and impressions.

The remarkable advances in technology and devices in the last two decades have made possible the endovascular repair of complex abdominal (cAAA) and thoracoabdominal (TAAA) aortic aneurysms with challenging anatomy. To date, despite the creation of multiple fenestrated/branched endografts intended to treat these difficult cases, in the USA, many of them remain available only under physician sponsored investigational device exemption (PSIDE) protocols in few institutions. The Gore Thoracoabdominal Branched Endoprosthesis (TAMBE; W.L. Gore & Associates, Flagstaff, AZ, USA) investigational device is a four-branched off-the-shelf (OTS) endograft that concluded an early feasibility study in 2016 and is currently finalizing a pivotal trial in pursuit of approval from the Food and Drug Administration. This article discusses the TAMBE early feasibility multicenter study results, the most relevant features of this device, its anatomical feasibility, and the impressions about this endograft as an OTS option for the treatment of CAAA and TAAA.

Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in The United States Aortic Research Consortium.

To report mid-term outcomes of renal-mesenteric target arteries (TA) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysm (TAAAs). TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. Data from consecutive patients enrolled in nine prospective non-randomized physician-sponsored investigational device exemption (PS-IDE) studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. A total of 1,681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%) and 194 scallops (3%). Mean follow was 23±21 months. At 5-years, TAs incorporated by fenestrations had higher primary (95±1% vs. 91±1%, P<0.001 ) and secondary patency (98±1% vs. 94±1%, P<0.001) , and higher freedom from TAI (87±2% vs. 84±2%, P=0.002) compared to TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts (BESGs) had significantly lower freedom from TAI (78±4% vs. 88±1%, P=0.006 ), TA endoleak (87±3% vs. 97±1%, P<0.001 ), and TA reintervention (83±4% vs. 95±1%, P<0.00 1 ) compared to those targeted by self-expandable stent-grafts (SESGs). Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for SESGs as compared to BESGs.

Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium

ObjectiveSpinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies. MethodsWe used a pooled dataset from nine US Aortic Research Consortium centers involved in investigational device exemption trials for treatment of suprarenal and thoracoabdominal aortic aneurysms. SCI was defined as new transient weakness (paraparesis) or permanent paraplegia after repair without other potential neurological etiologies. Multivariable analysis was performed to identify predictors of SCI, and life-table analysis and Kaplan-Meier methodologies were used to evaluate survival differences. ResultsA total of 1681 patients underwent branched/fenestrated endovascular aortic repair from 2005 to 2020. The overall rate of SCI was 7.1% (3.0% transient and 4.1% permanent). Predictors of SCI on multivariable analysis were Crawford Extent I, II, and III distribution of aortic disease (odds ratio [OR], 4.79; 95% confidence interval [CI], 4.77-4.81; P < .001), age ≥70 years (OR, 1.64; 95% CI, 1.63-1.64; P = .029), packed red blood cell transfusion (OR, 2.00; 95% CI, 1.99-2.00; P = .001), and a history of peripheral vascular disease (OR, 1.65; 95% CI, 1.64-1.65; P = .034). The median survival was significantly worse for patients with any degree of SCI compared with those without SCI (any SCI, 40.4 vs no SCI, 60.3 months; log-rank P < .001), and also worse in those with a permanent deficit (24.1 months) vs those with a transient deficit (62.4 months) (log-rank P < .001). The 1-year survival for patients who developed no SCI was 90.8%, compared with 73.9% in patients who developed any SCI. When stratified by degree of deficit, survival was 84.8% at 1 year for those who developed paraparesis and 66.2% for those who developed permanent deficits. ConclusionsThe overall rates of any SCI at 7.1% and permanent deficit at 4.1% observed in this study compare favorably with those reported in contemporary literature. Our findings confirm that increased length of aortic disease is associated with SCI and those with Crawford Extent I to III thoracoabdominal aortic aneurysms are at highest risk. The long-term impact on patient mortality underscores the importance of preventive measures and rapid implementation of rescue protocols if and when deficits develop.

Outcome Analysis Comparing Asymptomatic Juxtarenal Aortic Aneurysms Treated with Custom-Manufactured Fenestrated-Branched Devices and the “Off-The-Shelf” Zenith p-Branch Device

Numerous endovascular options have been used for the repair of juxtarenal aortic aneurysms (JRAAs) over the last 15years. This study aims to compare the performance between the Zenith p-branch device and custom-manufactured fenestrated-branched devices (CMD) for the treatment of asymptomatic JRAA. A single-center retrospective analysis of prospectively collected data was performed. Patients with a diagnosis of JRAA submitted to endovascular repair between July 2012 and November 2021 were included in the study, being divided into 2 groups: CMD and Zenith p-branch. The following variables were analyzed: preoperative information: demographics, comorbidities, and maximum aneurysm diameter; procedural data: contrast volume, fluoroscopy time, radiation dose, estimated blood loss, and technical success; and postoperative data: 30-day mortality, duration of intensive care unit and hospital stay, major adverse events, secondary interventions, target vessel instability, and long-term survival. From a total of 373 physician-sponsored investigational device exemption (Cook Medical devices) cases performed at our institution, 102 patients presented the diagnosis of JRAA. Of these, 14 patients were treated with the p-branch device (13.7%) and 88 (86.3%) with a CMD. Both groups presented similar demographic composition and maximum aneurysm diameter. All devices were successfully deployed, with no type I or III endoleaks observed at procedure completion. The contrast volume (P=0.023) and radiation dose (P=0.001) were significantly higher in the p-branch group. No significant difference was observed between the groups for the remaining intraoperative data. No paraplegia or ischemic colitis has been observed during the first 30days after the surgical procedures. There was no 30-day mortality in either group. One major cardiac adverse event was registered in the CMD group. Early outcomes were similar in both groups. No significant difference was found between the groups with respect to the presence of type I or III endoleaks during the follow-up. From a total of 313 target vessels stented in the CMD group (mean of 3.55 per patient) and 56 in the p-branch group (mean of 4 per patient), 4.79% and 5.35% presented instability, respectively, with no difference observed between the groups (P=0.743). Secondary interventions were required in 36.4% of the CMD cases and 50% of the p-branch group, but this was not statistically different (P=0.382). In the p-branch cohort, 2 of 7 reinterventions (28.5%) were target vessel-related and in the CMD group, 10 of 32 secondary interventions (31.2%) were target vessel-related. Comparable perioperative outcomes were obtained when appropriately selected patients were treated with either the off-the-shelf p-branch or CMD for JRAA. The long-term target vessel instability does not appear impacted by the presence of pivot fenestrations in comparison to other target vessel configurations. Given these outcomes, delay in CMD production time should be considered when treating patients with large juxtarenal aneurysms.

Effect of bridging stent graft selection for directional branches on target artery outcomes of fenestrated-branched endovascular aortic repair in the United States Aortic Research Consortium

ObjectiveThe purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. MethodsPatients enrolled in nine prospective physician-sponsored investigational device exemption studies in the United States between 2005 and 2020 were analyzed. All patients who had at least one TA incorporated by DB using either self-expandable (SESGs), balloon-expandable (BESGs), or hybrid stent graft combinations (HSGs). Endpoints were TA patency and freedom from TA endoleak, instability, and reintervention. ResultsThere were 800 patients with 2426 renal-mesenteric arteries incorporated by DBs. DB stent selection was SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs in 126 TAs (5%). SESGs were predominantly used in the first three quartiles of the study period, whereas BESGs comprised 75% of all stents between 2017 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P < .001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with SESGs or HSGs, respectively. For renal arteries, there was no difference in freedom from TA instability for BESGs, SESGs, or HSGs. However, freedom from TA endoleaks and reintervention were lower for renal arteries targeted by BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P < .001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P = .022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. In stent-specific analysis, iCAST BESGs had the lowest freedom from TA instability either for renal or mesenteric arteries, primarily due to higher rates of TA endoleaks. There was no difference in patency in any scenario. Independent predictors of TA instability were age (+1-year: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9). ConclusionsDBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with SESGs and HSGs. The patency of DBs was not affected by the type of stent construction. The observed performance disadvantage associated with BESGs appears to have largely been driven by iCAST usage.

Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Quality Initiative and the United States Aortic Research Consortium

BackgroundEndovascular management of thoracoabdominal aneurysms (TAAA) is becoming more common. Technological advances including custom devices under the Physician-Sponsored Investigational Device Exemption (PS-IDE), physician-modified endografts (PMEG), and parallel stenting techniques have expanded the extent of disease that is amenable to endovascular treatment. Patients within the PS-IDE studies are a highly selected group of patients, whereas patients treated with PMEG as captured within the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) represent a real-world experience. Research within both the SVS VQI on PMEG and the US Aortic Research Consortium (US-ARC) has demonstrated a relationship between extent of aneurysmal disease and mortality after complex endovascular TAAA repair, but no direct comparison of these cohorts has been conducted. In this study, we sought to compare outcomes of custom PS-IDE devices with off-label uses of commercially available devices for the endovascular management of TAAAs. MethodsA retrospective review of patients presenting for elective endovascular TAAA repair for asymptomatic disease between 2011 and 2019 was conducted within both the SVS VQI registry and the US-ARC. Patients within the SVS VQI registry were treated with either PMEG or with parallel stenting techniques. Patients within the US-ARC were treated with PS-IDE custom devices. The extent of aneurysm disease was defined by the deployment zones documented for the devices entered in the registry using Crawford extents I to V. Primary outcomes were 30-day and 1-year mortality rates. ResultsA total of 3212 patients were included in the study: 1571 PMEG/parallel stenting within the VQI registry and 1641 with PS-IDE within the US-ARC database. The majority of patients presented with extent IV aneurysms (n = 1827 [57%]), with extent IV aneurysms being slightly more prevalent within the US-ARC cohort. Maximal aneurysm diameter within each extent did not vary between the US-ARC and VQI cohorts. Across all patients, the 30-day mortality was 4.4% and the 1-year mortality was 12.2%. Unadjusted mortality at 30-days was 6.7% within the VQI, and 2.2% in the US-ARC (P < .001). The unadjusted 1-year mortality was 14.3% within the VQI and 10.2% within the US-ARC (P < .001). When adjusted for aneurysm extent, similar differences in 30-day and 1-year survivals were identified. ConclusionsPatients treated in PS-IDE studies had better 30-day and 1-year survival rates compared with those treated with a similar extent of disease using off-label approaches in a real-world registry. These differences are complex and likely associated with a number of factors, including arterial anatomy, patient comorbidities, device construct, and volume outcomes, as well as complex and unmeasurable surgeon- and patient-specific factors.

Overhead arm support reduces radiation exposure during complex endovascular aortic repair

BackgroundComplex endovascular aortic surgery has been associated with increased fluoroscopic radiation exposure. The radiation dosage necessary for visualization is dependent on the amount of tissue penetration required. Elevation of a patient’s arms above their head during endovascular surgery could improve visualization by removing the arms from the field of view. Furthermore, it might reduce the radiation dose required. In the present study, we sought to determine the effect of arm elevation on radiation exposure during endovascular treatment of thoracoabdominal aneurysms. MethodsAll patients enrolled in a single-institution, physician-sponsored investigational device exemption study for endovascular treatment of thoracoabdominal aneurysms (fenestrated/branched endovascular aortic repair [F/BEVAR]) from 2012 to 2022 were assessed. The first 30 patients treated were excluded to account for the learning curve required with treatment. Patients treated after December 2020 were positioned with their arms elevated above their head using an overhead arm support (OAS). These patients were compared with those who had undergone F/BEVAR before the practice change. The radiation dose, fluoroscopy time, and contrast volume used were compared. A subgroup analysis was performed to assess the effect for patients with brachial access. ResultsA total of 145 patients were included in the present study, of whom 43 (30%) had undergone F/BEVAR with their arms supported overhead. No differences were identified in age, body mass index, aneurysm size, or prior aortic intervention between the groups with and without the use of the OAS. A history of dissection (23% vs 7.8%; P = .01) was more frequent for the patients treated with their arms elevated. Arm elevation was associated with a significant reduction in the mean radiation exposure (2261 vs 3100 mGy; P = .01). No differences were observed in the fluoroscopy time or contrast volume used between the two groups. In addition, no patient experienced palsy of the brachial plexus. Of the 145 patients, 55 (38%) had required brachial arterial access, limiting their ability to elevate both arms. In the subgroup analysis, the patients without brachial access continued to show a significant reduction in radiation exposure with arm elevation (2159 vs 3179 mGy; P < .01). ConclusionsElevation of a patient’s arms above their head using an OAS during F/BEVAR offered a low-cost, simple strategy that resulted in a 30% reduction in radiation exposure without added complications. This technique improved visualization and reduced radiation exposure for patients and physicians and should be included in abdominal aortic and visceral procedures work to improve patient and surgeon safety.