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

BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02089607, NCT02050113, NCT02266719, NCT02323581, NCT00583817, NCT01654133, NCT00483249, NCT02043691, and NCT01874197.

Outcomes of Visceral Arterial Interposition Graft Reconstruction for Locally Advanced Pancreatic Cancer.

OBJECTIVE: The aim of this study is to determine perioperative outcomes and the patency of interposition conduits for visceral arterial reconstruction in this setting. SUMMARY BACKGROUND DATA: Visceral arterial encasement in locally advanced pancreatic cancer was historically a contraindication for surgery. With modern effective neoadjuvant strategies, our recent experience has made advanced vascular resection and reconstruction feasible in selected patients. METHODS: A retrospective review was performed of patients undergoing pancreatic tumor resection with en bloc arterial resection and interposition revascularization between 6/2002-10/2022. Endpoints included graft patency, vascular-related complications, reinterventions, morbidity, and mortality. RESULTS: Visceral arterial reconstruction with interposition grafting was performed in 111 patients undergoing en bloc arterial resections for pancreatic cancer. Graft types included autologous arterial conduits (n=66, 58 superficial femoral artery (SFA) and 8 splenic artery), cryopreserved arterial allografts (n=24), autologous saphenous veins (n=12), synthetic conduits (n=8), and composite autologous artery and synthetic (n=1). Perioperative 90-day mortality decreased significantly over time to 5% in the last six years. Vascular complications related to arterial reconstruction occurred in 11% (n=12) and included pseudoaneurysm (n=6), graft thrombus (n=2), stenosis requiring reintervention (n=2), hepatic failure (n=1), and hepatic and intestinal ischemia (n=1). Nine (8%) patients underwent vascular-related reinterventions. After median follow-up of 17-months, primary patency was 81% for the entire cohort and was highest in the SFA group (95%). The donor limb/harvest site complication rate was 8% with 100% primary patency. CONCLUSION: Visceral arterial resection with interposition reconstruction for locally advanced pancreatic cancer can be performed with acceptable vascular morbidity and durable patency. Autologous SFA was the most suitable conduit for reconstructions in our experience, with highest primary patency.

Endovascular versus open repair of ruptured abdominal aortic aneurysms with hostile neck anatomy.

OBJECTIVE: Aneurysm neck anatomy in ruptured abdominal aortic aneurysms (rAAAs) is often complex, limiting the feasibility of endovascular repair (EVAR). The objective of this study was to compare the outcomes of EVAR and open surgical repair (OSR) for treatment of rAAAs in patients with hostile neck anatomy (HNA). The secondary aim was to review the clinical characteristics and anatomic risk factors predictive of mortality. METHODS: A multi-center retrospective review was performed to identify patients with rAAAs and HNA between 2004 and 2021. HNA was defined as infrarenal aortic neck diameter >28 mm, infrarenal neck length <15 mm or angulation >60 degrees. The primary end point was 30-day all-cause mortality. Secondary end points included 90-day, 1-year and 5-year mortality. Preoperative computed tomography was analyzed using an Aquarius workstation. The Kaplan-Meier method was used to estimate survival, and univariate and multivariate Cox proportional hazard regression analysis was used to assess variables that influenced survival. RESULTS: 137 patients with rAAAs and HNA underwent infrarenal EVAR or OSR. Overall mean age was 74 ± 10 years and 72% were male. 85 patients (62%) underwent infrarenal EVAR and 52 (38%) underwent OSR. Mean aneurysm size at the time of rupture was 86 ± 22 mm. Patients who underwent OSR were more likely to present with a higher Garland preoperative risk score (P = .05), have a lower pH (P < .001), lower SBP (P < .001) and higher lactate (P = .005). Patients with an infrarenal neck length <15 mm were more likely to undergo OSR (EVAR 64% vs. OSR 87%, P = .004) and patients with an infrarenal neck angle >60 degrees were more likely to undergo EVAR (60% vs. 39%, P = .01). EVAR was associated with lower 30-day (17% vs. 27%; OR 0.6; 95% CI, 0.3-1.2; P = .14) and 90-day (22% vs. 33%; HR 0.6; 95% CI, 0.3-1.2; P = .17) all-cause mortality, however, this was not statistically significant. The overall median follow-up time was 19 (2-66) months. 1-year survival for EVAR and OSR were 75% and 64% (Log-rank P = .14) and 5-year survival for EVAR and OSR were 65% and 55% (Log-rank P = .28). Hemoglobin (P = .009), increasing calcification score (P = .002) and infrarenal neck length <10 mm (P = .01) were associated with all-cause mortality at 30-days for EVAR on multivariate Cox regression analysis. Lactate (P <.001) was the only variable associated with all-cause mortality at 30-days for OSR on multivariate Cox analysis. CONCLUSION: Early and long-term survival favored EVAR in comparison to OSR in patients with rAAAs and HNA, however, this was not statistically significant. Calcification of the infrarenal neck and neck length <10 mm were associated with increased 30-day mortality for EVAR while no anatomic variables were specifically associated with 30-day mortality for OSR.

Preoperative predictors of nonhome discharge after fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

BACKGROUND: Nonhome discharge (NHD) has significant implications for patient counseling and discharge planning and is frequently required following fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA). We aimed to identify preoperative predictors of NHD after elective FB-EVAR for CAAA and TAAA and develop a risk calculator able to predict NHD. METHODS: A retrospective review of prospectively collected data on all patients undergoing FB-EVAR between January 2007 and December 2021 at a single institution was performed. Exclusion criteria were admission from a nonhome setting, emergency and repeat FB-EVAR, and discharge to an unknown destination. The cohort was randomly split into separate development (70% of patients) and validation (30%) cohorts to develop a predictive calculator for NHD. Independent variables associated with NHD were assessed in a series of logistic regression analyses from 100 bootstrapped samples of the development set, and a model was developed using the most predictive variables. Resulting parameter estimates were applied to data in the validation set to assess model discrimination and calibration. RESULTS: From the initial cohort of 712 FB-EVAR patients, 644 were included in the study (74% male; mean age, 75.4 ± 7.6 years), including 452 with CAAA (70%) and 192 with TAAA (30%). Early mortality occurred in eight patients (1.2%; 5 in CAAA and 3 in TAAA) and the median hospital stay was 5 days (4 for CAAA and 7 for TAAA). Ninety-seven patients (15%) had a NHD. On multivariable analysis, older age (per year, odds ratio [OR], 1.08; P < .001), female gender (OR, 3.03; P < .001), smoking (OR, 2.86; P = .01), congestive heart failure (OR, 3.05; P = .004), peripheral artery disease (OR, 1.81; P = .07), and extent I (OR, 3.17), II (OR, 2.84), and III (OR, 2.52; all P = .08) TAAAs were associated with an increased likelihood of NHD in the development set. Based on these factors, the risk calculator was developed which accurately predicts NHD in the validation set with an area under the curve of 0.7. CONCLUSIONS: Older, female smokers with congestive heart failure and peripheral artery disease and more extensive aneurysms are at highest risk of NHD after FB-EVAR. Using only preoperative factors, our risk calculator can predict accurately who will have a NHD, allowing enhanced preoperative patient counselling and accelerated hospital discharge.

Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

Trends in hospitalization of patients undergoing endovascular treatment of thoracoabdominal aortic aneurysms based on cerebrospinal fluid drainage strategy.

OBJECTIVE: The aim of this study was to identify trends in hospital length of stay (HLOS) and intensive care unit length of stay (ICULOS), and the relationship with cerebrospinal fluid drainage (CSFD) protocols in patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms (TAAAs). METHODS: A retrospective review of patients who underwent elective FB-EVAR for extent I to IV TAAAs between 2008 and 2023 at a single aortic center of excellence was conducted. Patient demographics, cardiovascular comorbidities, surgical risk, technical details, CSFD strategy (prophylactic or therapeutic), procedural success, and perioperative outcomes were collected. Patients were divided into two groups based on CSFD protocol. Group 1 included patients treated before 2020 when prophylactic CSFD was performed widely, and Group 2 consisted of patients treated since 2020 with therapeutic CSFD. Primary end points were HLOS, ICULOS, major adverse events, and perioperative mortality. RESULTS: FB-EVAR was performed in 702 patients; 412 underwent elective TAAA repair and were included in the analysis. Mean age was 73 ± 8 years and 68% were male. Patient-specific manufactured devices were used in 252 patients (61%), physician-modified endografts in 110 (27%), and 50 patients (12%) were treated with off-the-shelf devices. Demographics, aneurysm extent, major adverse events (including spinal cord ischemia [SCI]), and mortality were similar in both groups. A significant reduction in mean HLOS between the groups (9 ± 9 vs 6 ± 5 days; P = .02) coincided with decreased use of prophylactic CSFD (70% vs 1.2%; P < .001), with similar rates of SCI (7.6% vs 4.9%; P = .627) and ICULOS (3 ± 3 vs 2.5 ± 3; P = .19). Patients in the therapeutic drainage cohort (group 2) had a higher incidence of congestive heart failure (24% vs 11%; P = .003), hypercholesterolemia (91% vs 80%; P = .015), chronic obstructive pulmonary disease (55% vs 37%; P = .004), and peripheral artery disease (39% vs 19%; P < .001) compared with group 1, suggesting treatment of a more complex patient cohort. On adjusted multivariable analysis accounting for American Society of Anesthesiologists score, comorbidities, and device type, the difference in HLOS remained statistically significant (P = .01). CONCLUSIONS: HLOS decreased over time in patients undergoing FB-EVAR for TAAA after transition from a prophylactic to a therapeutic CSFD protocol. This transition was the only modifiable, independent risk factor for a shorter HLOS, without an increase in SCI, albeit with similar ICULOS.

Cryopreserved arterial allografts vs autologous vein for arterial reconstruction in infected fields.

OBJECTIVE: Peripheral arterial infections are rare and difficult to treat when an in situ reconstruction is required. Autologous vein (AV) is the conduit of choice in many scenarios. However, cryopreserved arterial allografts (CAAs) are an alternative. We aimed to assess our experience with CAAs and AVs for reconstruction in primary and secondary peripheral arterial infections. METHODS: Data from patients with peripheral arterial infections undergoing reconstruction with CAA or AV from January 2002 through August 2022 were retrospectively analyzed. Patients with aortic- or iliac-based infections were excluded. RESULTS: A total of 42 patients (28 CAA, 14 AV) with a mean age of 65 and 69 years, respectively, were identified. Infections were secondary in 31 patients (74%) and primary in 11 (26%). Secondary infections included 10 femoral-femoral grafts, 10 femoropopliteal or femoral-distal grafts, five femoral patches, four carotid-subclavian grafts, one carotid-carotid graft, and one infected carotid patch. Primary infection locations included six femoral, three popliteal, and two subclavian arteries. In patients with lower extremity infections, associated groin infections were present in 19 (56%). Preoperative blood cultures were positive in 17 patients (41%). AVs included saphenous vein in eight and femoral vein in six. Intraoperative cultures were negative in nine patients (23%), polymicrobial in eight (21%), and monomicrobial in 22 (56%). Thirty-day mortality occurred in four patients (10%), two due to multisystem organ failure, one due to graft rupture causing acute blood loss and myocardial infarction, and one due to an unknown cause post-discharge. Median follow-up was 20 months and 46 months in the CAA and AV group, respectively. Graft-related reintervention was performed in six patients in the CAA group (21%) and one patient in the AV group (7%). Freedom from graft-related reintervention rates at 3 years were 82% and 92% in the CAA and AV group, respectively (P = .12). Survival rates at 1 and 3 years were 85% and 65% in the CAA group and 92% and 84% in the AV group (P = .13). Freedom from loss of primary patency was similar with 3-year rates of 77% and 83% in the CAA and AV group, respectively (P = .25). No patients in either group were diagnosed with reinfection. CONCLUSIONS: CAAs are an alternative conduit for peripheral arterial reconstructions when AV is not available. Although there was a trend towards higher graft-related reintervention rates in the CAA group, patency is similar and reinfection is rare.

Outcomes of lower extremity arterial bypass using the Human Acellular Vessel in patients with chronic limb-threatening ischemia.

OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI) and no great saphenous vein to use as a conduit for arterial bypass have a high risk for amputation despite advances in medical and endovascular therapies. This report presents findings from a U.S. Food and Drug Administration (FDA) supported study of the Human Acellular Vessel (HAV) (Humacyte Inc.) used as a conduit for arterial bypass in patients with CLTI and inadequate or absent autologous conduit. METHODS: The HAV is a 6-mm, 40-cm vessel created from human vascular smooth muscle cells seeded onto a polyglycolic acid scaffold pulsed in a bioreactor for 8 weeks as cells proliferate and the scaffold dissolves. The resultant vessel is decellularized, creating a nonimmunogenic conduit composed of collagen, elastin, and extracellular matrix. The FDA issued an Investigational New Drug for an intermediate-sized, single-center study of the HAV under the agency's Expanded Access Program in patients with advanced CLTI and inadequate or absent autologous conduit. Technical results and clinical outcomes were analyzed and reported. RESULTS: Between March 2021 and July 2023, 29 patients (20 males; mean age, 71 ± 11 years) underwent limb salvage operation using the HAV as a bypass conduit. Most patients had advanced CLTI (Rutherford class 5/6 in 72%; wound, ischemia, and foot infection stage 3/4 in 83%), and 97% had previously failed revascularization(s) of the extremity. Two HAVs were sewn together to attain the needed bypass length in 24 patients (83%). Bypasses were to tibial arteries in 23 patients (79%) and to the popliteal artery in 6 (21%). Technical success was 100%, and the 30-day mortality rate was 7% (2 patients). With 100% follow-up (median, 9.3 months), the limb salvage rate was 86% (25/29 patients). There were 16 reinterventions to restore secondary patency, of which 15 (94%) were successful. Primary and secondary patency of the HAV at 9 months were 59% and 71%, respectively. CONCLUSIONS: The HAV has demonstrated short- to intermediate-term safety and efficacy as an arterial bypass conduit in a complex cohort of patients with limb-threatening ischemia and no autologous options. This experience using the FDA's Expanded Access Program provides real-world data to inform regulatory deliberations and future trials of the HAV, including the study of the vessel as a first-line bypass conduit in less severe cases of chronic limb ischemia.

Effect of fenestration configuration on renal artery outcomes during fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8 × 6 mm) and 2 (6 × 6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level. RESULTS: A total of 796 patients were included in this study, 71.7% male, with a mean age of 73.3 ± 8.1 years. The mean follow-up was 30.0 ± 20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8 × 6 mm, and 52.4% were 6 × 6 mm. At the 30-day landmark, primary patency (99.9% vs 98.0%; P value < .001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%; P value < .001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%; P value = .022 for groups 1 and 2, respectively) were higher in 8 × 6 compared with 6 × 6 fenestrations, and the incidence of acute kidney injury was similar across the groups (92.6% vs 92.7%; P value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8 × 6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, P values = .010 and .021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6 × 6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, P value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3% and 1.6% for 8 × 6 and 6 × 6mm fenestrations, respectively, P = .689). The 6 × 6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8 × 6 fenestrations (7.6%) at 5 years (P < .001). The risk of type IIIc endoleak was significantly higher among 8 × 6 fenestrations at 5 years (4.9% and 2% for 8 × 6 and 6 × 6 mm fenestrations, respectively; P = .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857; P < .001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929; P < .001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921; P = .034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979; P < .001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948; P = .572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938; P = .036). CONCLUSIONS: Fenestration configuration for the renal arteries impacts outcomes. The 8 × 6 small fenestrations have better patency at 30 days, 1 year, and 5 years, whereas 6 × 6 small fenestrations are associated with lower rates of SIs, primarily due to a lower incidence of type IIIc endoleaks. FG ≥5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak, and 5-year patency independently of the fenestration size or vessel diameter.

Comparative outcomes of arterial bypass using the human acellular vessel and great saphenous vein in patients with chronic limb ischemia.

OBJECTIVE: The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass. METHODS: Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency's Expanded Access Program. RESULTS: Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P = .059), coronary artery disease (71% vs 43%; P = .007), and prior coronary artery bypass grafting (38% vs 14%; P = .003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P = .018) and with previous index leg revascularizations (97% vs 53%; P < .001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P = .693) and Global Anatomic Staging System stage III (91% vs 96%; P = .346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P < .001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P < .001). At a median of 12 months, major amputation-free survival (73% vs 81%; P = .55) and overall survival (84% vs 88%; P = .20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P = .044), primary-assisted patency (45% vs 72%; P = .002), and secondary patency (64% vs 72%; P = .003) compared with group 2. CONCLUSIONS: Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months.

Natural history and long-term outcomes of medically managed Type B intramural hematoma.

OBJECTIVE: Type B intramural hematoma (IMH) is often managed medically, yet may progress to dissection, aneurysmal dilation, or rupture. The aim of this study was to report the natural history of medically managed Type B IMH, and factors associated with progression. METHODS: We reviewed patients with medically managed Type B IMH between January 1995 to December 2022 at a single center. Any patients with immediate surgical or endovascular intervention were excluded. Demographic profiles, comorbidities, imaging, and follow-up details were reviewed. Patients were divided into two groups: Group 1 had isolated IMH, and Group 2 had IMH along with aneurysm or dissection at the time of presentation. On follow-up, progression was defined as degeneration to aneurysm/dissection or increase in the thickness of IMH in Group 1. In Group 2, progression was an increase in the size of aneurysm or development of new dissection. RESULTS: Of 104 patients with Type B IMH during the study period, 92 were medically managed. The median age was 77 years, and 45 (48.9%) were females. Comorbidities included hypertension (83.7%), hypercholesterolemia (44.6%), and active smoking (47.8%). Mean Society for Vascular Surger comorbidity score was 6.3. Mean IMH thickness and aortic diameter at presentation were 8.9 mm and 38.3 mm, respectively. Median follow-up was 55 months. Overall survival at 1 year and 5 years was 85.8% and 61.9%, respectively. During follow-up, 19 patients (20.7%) required intervention, more common in Group 2 (Group 1, 8/66; 12.3% vs Group 2, 11/26; 42.3%; P = .001). This resulted in higher freedom from intervention in Group 1 at 1 year (93.5% vs 62.7%) and 5 years (87.5% vs 51.1%; P < .001). Indication for intervention was dissection (n = 4), aneurysm (n = 12), and progression of IMH (n = 3). In Group 1, progression was seen in 25 (37.9%), three (4.5%) remained stable, 29 (43.9%) had complete resolution of IMH, and nine patients were lost to follow-up. In Group 2, 11 patients (42.3%) had progression, seven (26.9%) remained stable, and eight were lost to follow-up. IMH thickness at presentation >7.2 mm is associated with both increased odds of progression (odds ratio, 3.3; 95% confidence interval, 1.2-11.1; P = .03) and intervention (odds ratio, 5.5; 95% confidence interval, 1.3-36.9; P = .03) during the follow-up. CONCLUSIONS: Although many patients with Type B IMH managed medically stabilize or regress, progression or need for intervention can occur in up to 40% of cases. This is associated with the presence of aneurysm, dissection, and IMH thickness. Long-term follow-up is mandatory as late interventions occur, particularly for higher risk patients.

Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair.

OBJECTIVE: Total transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. METHODS: We analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). RESULTS: There were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). CONCLUSIONS: TF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Implications and late outcomes of type II endoleaks after endovascular aneurysm repair.

OBJECTIVE: Type II endoleaks (T2ELs) are the most common cause of reintervention after endovascular aneurysm repair (EVAR). Although most resolve spontaneously, the long-term implications of T2ELs remain elusive. We aim to evaluate the impact of persistent and late T2ELs on clinical outcomes after EVAR. METHODS: This was a single-institution retrospective review of patients who underwent EVAR for degenerative infrarenal abdominal aortic aneurysm between January 2010 and June 2022 with no type I (T1EL) or III (T3EL) endoleak seen at EVAR completion. Patients were categorized based on T2EL status. Group 1 included patients with never detected or transient T2ELs (detected at EVAR completion but not after). Group 2 encompassed persistent T2ELs (seen at EVAR completion and again during follow-up) and late T2ELs (detected for the first time at any point during follow-up). Time-to-event analysis was conducted using a time-dependent approach to T2EL status. Primary outcomes included freedom from sac enlargement (SE), aneurysm-related reinterventions, and overall survival. RESULTS: A total of 803 patients met inclusion criteria. Group 1 included 418 patients (52%), of which 85% had no T2ELs and 15% had transient T2ELs. Group 2 had 385 patients; 23% had persistent T2ELs, and 77% developed a new T2EL. Patients in group 1 had a higher prevalence of smoking (88% vs 83%; P < .001), chronic obstructive pulmonary disease (33% vs 25%; P = .008), chronic kidney disease (13% vs 8%; P = .021), and a higher mean Society for Vascular Surgery score (7 vs 6 points; P = .049). No differences were found in aneurysm diameter or morphology. Mean follow-up was 5 years for the entire cohort. In Group 2, 58 patients (15%) underwent T2EL treatment, most commonly transarterial embolization. At 10 years after EVAR, Group 2 was associated with lower freedom from SE (P < .001) and abdominal aortic aneurysm-related reinterventions (P < .001) and comparable overall survival (P = .42). More T1ELs were detected during follow-up in Group 2 (6 [1%] vs 20 [5%]; P = .004), with 15 (75%) of these detected at a median of 3 years after the T2EL. No difference between groups was observed in explant (0.7% vs 2.1%; P = .130) or aneurysm rupture (0.5% vs 1.3%; P = .269) rates. CONCLUSIONS: One-half of patients treated with infrarenal EVAR developed persistent/late T2ELs, which are associated with a higher risk of SE and reinterventions. No difference in overall survival or aneurysm rupture risk was seen at 10 years, based on T2EL status or T2EL intervention. A conservative approach to T2ELs may be appropriate for most patients with absent T1ELs or T3ELs.

Hybrid Stent Graft Technique in Bridging Hostile Renal Arteries in Thoracoabdominal Branched Endografting.

OBJECTIVE: Patency of target arteries is crucial for fenestrated and branched endovascular aortic repair (F/B-EVAR) in thoracoabdominal aortic aneurysms (TAAAs). Occlusions more frequently occur in renal arteries (RAs) than in coeliac and superior mesenteric arteries, especially in patients with hostile anatomy treated by BEVAR. This study aimed to report RA outcomes using a hybrid bridging stent graft technique with distal self expandable (SE) combined with proximal balloon expandable (BE) stent graft during BEVAR with hostile RA anatomies. METHODS: Clinical data from consecutive patients treated for TAAA by F/B-EVAR in three aortic centres (two in the USA, one in Europe) from 2016 to 2022 were prospectively collected. Renal artery orientation was defined as hostile in case of upward (type B) or downward + upward (type D) orientation. Hostile RAs accommodated by BEVAR and combination of SE + BE stent grafts were retrospectively evaluated. Intra-operative RA related complications, technical success, and branch occlusions were assessed as early outcomes. Primary and secondary RA patency, freedom from RA related re-interventions, and freedom from RA instability were assessed during follow up. RESULTS: Of 584 TAAAs managed by F/B-EVAR, 83 patients (14.2%) had 125 hostile RAs (type B, 45.6%; type D, 54.4%) managed by BEVAR with hybrid SE + BE stent grafts. Intra-operative complications occurred in three RAs (2.4%), including two dissections and one disconnection, all successfully managed with additional stent. Technical success was achieved in all cases, with no RA occlusions at 30 days. The median follow up was 21 (interquartile range 4, 38) months. Estimated three year RA primary patency was 97 ± 2%. Re-interventions were performed in five RAs (4.0%), including two RA branch embolisations for bleeding, two catheter thrombectomies with stent relining (bilateral occlusion in one patient), and one revision of type Ic endoleak. Freedom from RA related re-interventions and RA instability was 95 ± 2% and 91 ± 3% at three years, respectively. Renal artery secondary patency was 99 ± 1% at three years. CONCLUSION: In hostile RA anatomies, a combination of distal SE and proximal BE stent grafts as bridging stenting in BEVAR is safe and effective, with low rates of occlusion, re-interventions, and branch instability at midterm follow up.

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.

Multicenter Study to Evaluate Endovascular Repair of Extent I-III Thoracoabdominal Aneurysms Without Prophylactic Cerebrospinal Fluid Drainage.

OBJECTIVE: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). BACKGROUND: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. METHODS: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. RESULTS: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P =0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7-11.1], patent collateral network (OR: 0.3, 95% CI: 0.1-0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01-1.10). Patient survival at 3 years was 72%±3%. CONCLUSION: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.

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.

OBJECTIVE: To report mid-term outcomes of renal-mesenteric target arteries (TAs) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal and thoracoabdominal aortic aneurysm. BACKGROUND: TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. METHODS: Data from consecutive patients enrolled in 9 prospective nonrandomized physician-sponsored investigational device exemption 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. RESULTS: A total of 1681 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 with TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts 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 < 0.001) compared with those targeted by self-expandable stent-grafts. CONCLUSIONS: 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 self-expandable stent grafts as compared with balloon-expandable stent grafts.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: There is paucity of data on the durability of physician modified endografts (PMEGs) for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) despite widespread use. The aim of this study was to evaluate and compare the early and long-term outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for CAAAs and TAAAs using PMEGs. METHODS: We reviewed clinical data and outcomes of patients treated by FB-EVAR using PMEGs for CAAAs (defined as short-neck infrarenal, juxtarenal, and pararenal AAAs) and TAAAs between 2007 and 2019. All patients were treated by a dedicated team with extensive manufactured device experience. Endpoints included 30-day mortality and major adverse events, patient survival and freedom from aortic-related mortality (ARM), freedom from secondary intervention, target artery (TA) patency, and freedom from TA endoleak and TA instability. RESULTS: Of 645 patients undergoing FB-EVAR, 156 patients (24%) treated with PMEG (121 males; mean age, 75 ± 8 years) were included. There were 89 CAAAs, 33 extent IV TAAAs and 34 extent I to III TAAAs. A total of 452 renal-mesenteric targets (3.1 ± 1.0 vessels/patient) were incorporated. Patients with TAAAs had significantly (P < .05) larger aneurysms (73 ± 11 vs 68 ± 14 mm), more TAs incorporated (3.4 ± 0.9 vs 2.8 ± 1.0), and more often had previous aortic repair (54% vs 27%). Technical success was higher in patients treated for CAAAs (99% vs 91%; P = .04). Thirty-day and/or in-hospital mortality was 5.7% and was significantly lower for CAAAs compared with TAAAs (2% vs 10%; P = .04), with three of nine early mortalities (33%) among patients treated emergently. After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative complications and three late deaths (1.9%) from rupture. At 5 years, patient survival was 41%. Patients treated for CAAAs had higher 5-year freedom from ARM (P = .016), TA instability (P = .05), TA endoleak (P = .01), and TA secondary interventions (P = .05) with a higher, but non-significant, freedom from sac enlargement ≥5 mm (P = .11). Primary and secondary TA patency was 91% ± 2% and 99% ± 1%, respectively. Sac regression ≥5 mm occurred in 67 patients (43%) and was associated with increased survival (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80) compared with those without sac regression. CONCLUSIONS: FB-EVAR using PMEGs was performed with acceptable long-term outcomes. Overall patient survival was low due to significant underlying comorbidities. Patients treated for CAAAs had higher freedom from ARM, TA instability, TA endoleak, TA secondary interventions, and a trend towards higher freedom from sac enlargement compared with patients treated for TAAAs. Sac regression was associated with improved patient survival.

Incidence and risk factors for interval aortic events during staged fenestrated-branched endovascular aortic repair.

OBJECTIVE: Staged endovascular repair of complex aortic aneurysms with first-stage thoracic endovascular aortic repair may decrease the risk of spinal cord ischemia (SCI) associated with fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms or optimize the proximal landing zone in the cases requiring total aortic arch repair. However, a limitation of multistaged procedures is the risk of interval aortic events (IAEs) including mortality from a ruptured aneurysm. We aim to identify the incidence of and risk factors associated with IAEs during staged FB-EVAR. METHODS: This was a single-center, retrospective review of patients who underwent planned staged FB-EVAR from 2013 to 2021. Clinical and procedural details were reviewed. End points were the incidence of and risk factors associated with IAEs (defined as rupture, symptoms, and unexplained death) and outcomes in patients with or without IAEs. RESULTS: Of 591 planned FB-EVAR patients, 142 underwent first-stage repairs. Twenty-two did not have a planned second stage because of frailty, preference, severe comorbidities, or complications after the first stage and were excluded. The remaining 120 patients (mean age: 73 ± 6 years, 51% female) were planned for second-stage completion FB-EVAR and comprised our cohort. The incidence of IAEs was 13% (16 of 120). This included confirmed rupture in 6 patients, possible rupture in 4, symptomatic presentation in 4, and early unexplained interval death with possible rupture in 2. The median time to IAEs was 17 days (range: 2-101 days), and the median time to uncomplicated completion repairs was 82 days (interquartile range: 30-147 days). Age, sex, and comorbidities were similar between the groups. There were no differences in familial aortic disease, genetically triggered aneurysms, aneurysm extent, or presence of chronic dissection. Patients with IAEs had significantly larger aneurysm diameters than those without IAEs (76.6 vs 66.5 mm, P ≤ .001). This difference persisted with indexing for body surface area (aortic size index: 3.9 vs 3.5 cm/m2, P = .04) and height (aortic height index: 4.5 vs 3.9 cm/m, P ≤ .001). IAE mortality was 69% (11 of 16) compared with no perioperative deaths for those with uncomplicated completion repairs. CONCLUSIONS: The incidence of IAEs was 13% in patients planned for staged FB-EVAR. This represented a notable morbidity, including rupture, which must be balanced with SCI and landing zone optimization when planning repair. Larger aneurysms, especially when adjusted for body surface area, are associated with IAEs. Minimizing time between stages vs single-stage repairs for larger (>7 cm) complex aortic aneurysms in patients with reasonable SCI risk should be considered when planning repair.