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.

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.

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.

Raising Systemic Blood Pressure to Delay Irreversible Intestinal Ischemia in a Swine Model of Proximal Superior Mesenteric ArteryOcclusion.

INTRODUCTION: Acute proximal superior mesenteric artery (SMA) occlusion is highly lethal, and adjuncts are needed to mitigate ischemic injury until definitive therapy. We hypothesized that raising mean arterial pressure (MAP) >90 mmHg with norepinephrine may delay irreversible bowel ischemia by increasing gastroduodenal artery (GDA) flow despite possible pressor-induced vasospasm. METHODS: 12 anesthetized swine underwent laparotomy, GDA flow probe placement, and proximal SMA exposure and clamping. Animals were randomized between conventional therapy (CT) versus targeted MAP >90 mmHg (MAP push; MP) where norepinephrine was titrated after 45 min of SMA occlusion. Animals were followed until bowel death or 4 h. Kaplan-Meier bowel survival, mean normalized GDA flow, and histology were compared. RESULTS: 12 swine (mean 57.8 ± 7.6 kgs) were included, six per group. Baseline weight, HR, MAP and GDA flows were not different. Within 5 min following SMA clamping, all 12 animals had an increase in MAP without other intervention from 81.7 to 105.5 mmHg (29.1%, P < 0.01) with a concomitant 74.9% increase in GDA flow as compared to baseline (P < 0.01). Beyond 45 min postclamp, MAP was greater in the MP group as intended, as were GDA flows. Median time to irreversibly ischemic bowel was 31% longer for MAP push animals (CT: 178 versus MP: 233 min, P = 0.006), Hazard Ratio of CT 8.85 (95% CI: 1.86-42.06); 3/6 MP animals versus 0/6 CT animals with bowel survived to predetermined end point. CONCLUSIONS: In this swine model of acute complete proximal SMA occlusion, increasing MAP >90 mmHg with norepinephrine was associated with an increase in macrovascular blood flow through the GDA and bowel survival. Norepinephrine was not associated with worse bowel survival and a MAP push may increase the time window where ischemic bowel can be salvaged.

Skull and Scalp En-Bloc Harvest Protects Calvarial Perfusion: A Cadaveric Study.

BACKGROUND: Calvarial defects are severe injuries that can result from a wide array of etiologies. Reconstructive modalities for these clinical challenges include autologous bone grafting or cranioplasty with biocompatible alloplastic materials. Unfortunately, both approaches are limited by factors such as donor site morbidly, tissue availability, and infection. Calvarial transplantation offers the potential opportunity to address skull defect form and functional needs by replacing "like-with-like" tissue but remains poorly investigated. METHODS: Three adult human cadavers underwent circumferential dissection and osteotomy to raise the entire scalp and skull en-bloc. The vascular pedicles of the scalp were assessed for patency and perfused with color dye, iohexol contrast agent for computed tomography (CT) angiography, and indocyanine green for SPY-Portable Handheld Imager assessment of perfusion to the skull. RESULTS: Gross changes were appreciated to the scalp with color dye, but not to bone. CT angiography and SPY-Portable Handheld Imager assessment confirmed perfusion from the vessels of the scalp to the skull beyond midline. CONCLUSION: Calvarial transplantation may be a technically viable option for skull defect reconstruction that requires vascularized composite tissues (bone and soft tissue) for optimal outcomes.

Lower Extremity Extracorporeal Distal Revascularization in a Swine Model of Prolonged Extremity Ischemia.

BACKGROUND: Acute arterial occlusion of the lower extremity is a time-dependent emergency that requires prompt revascularization. Lower extremity extracorporeal distal revascularization (LEEDR) is a technique that can be initiated bedside when definitive therapy is delayed. The aim of this study is to evaluate this technique in a swine model of prolonged extremity ischemia. METHODS: Anesthetized swine underwent right femoral and left posterior tibial artery cannulation, left iliac venous flow monitoring (mL/min), and continuous left anterior compartment pressure (CP) monitoring (mm Hg). The iliac artery was clamped for 6 hr. LEEDR animals underwent 5 hr of extracorporeal femoral-to-tibial blood flow at 150 mL/min; controls had no intervention. At 6 hr, LEEDR was discontinued, iliac flow restored, and anterior CP monitored for 3 hr. RESULTS: Baseline characteristics were similar across both the groups. Iliac clamping saw an expected fall in iliac venous flow (258 ± 30 to 82 ± 19; P < 0.001). LEEDR resulted in a rise in iliac venous flow (82 ± 20 to 181 ± 16; P < 0.001); control arm flow remained reduced (71 ± 8; P < 0.001). Once inflow was restored, venous flow returned to baseline. Revascularization provoked a higher peak CP in the control arm versus in the LEEDR group (25 ± 5 vs. 6 ± 1; P = 0.02). CONCLUSIONS: An extracorporeal circuit can temporarily revascularize an extremity in a swine model of prolonged ischemia, mitigating reperfusion injury and maintaining normal CPs. This concept should undergo further evaluation as a bedside tool to mitigate extremity ischemia prior to definitive revascularization.

Thoracic Endovascular Aortic RepairAcutely Augments Left Ventricular Biomechanics in An Animal Model: A Mechanism for Postoperative Heart Failure and Hypertension.

BACKGROUND: Thoracic aortic stent grafts are thought to decrease aortic compliance and may contribute to hypertension and heart failure after thoracic endovascular aortic repair (TEVAR). Left ventricular (LV) biomechanics immediately after TEVAR, however, have not been quantified. Pressure-volume (PV) loop analysis provides gold-standard LV functional information. The aim of this study is to use an LV PV loop catheter and analysis to characterize the LV biomechanics before and acutely after TEVAR. METHODS: Anesthetized Yorkshire swine (N = 6) were percutaneously instrumented with an LV PV loop catheter. A 20 mm × 10 cm stent graft was deployed distal to the left subclavian via the femoral artery under fluoroscopy. Cardiac biomechanics were assessed before and after TEVAR. As a sensitivity analysis, inferior vena cava occlusion with PV loop assessment was performed pre and post-TEVAR in 1 animal to obtain preload and afterload-independent end-systolic and end-diastolic PV relationships (ESPVR and EDPVR). RESULTS: All animals underwent successful instrumentation and TEVAR. Post-TEVAR, all 6 animals had higher mean LV ESP (106 vs. 118 mm Hg, P = 0.04), with no change in the EDPVR. inferior vena cava occlusion also moved the ESPVR curve upward and leftward, indicating increased LV work per unit time. There was no augmentation of EDPVR following TEVAR (P > 0.05). Postmortem exams in all animals revealed appropriate stent placement and no technical complications. CONCLUSIONS: TEVAR was associated with an acute increase in LV end-systolic pressure and shift in the ESPVR, indicating increased ventricular work. This data provides potential mechanistic insights into the development of post-TEVAR hypertension and heart failure. Future stent graft innovation should focus on minimizing the changes in cardiac physiology.

Endovascular stenting techniques for blunt carotid injury.

OBJECTIVES: While methods of endovascular carotid artery stenting have improved over time, concerns surrounding the safety and efficacy of stenting for blunt carotid injury (BCI) remain. This study aims to present our approach to carotid artery stenting (CAS) by incorporating new technologies such as flow-diverting stents and circuits. METHODS: There is no robust evidence to support routine carotid artery stenting; however, there are several therapeutic options and approaches for treating BCI that currently require an individualized approach. Endovascular stenting and specific stent selection are largely dictated by the disease process the surgeon intends to treat. We will discuss patient selection, medical management, and the most common revascularization techniques, including transfemoral stenting, trans-carotid arterial revascularization using flow reversal, and stent-assisting coiling. RESULTS: It must be stressed that endovascular intervention is not an alternative to or preclusive of antithrombotic or anticoagulant therapy. In the setting of BCI, transfemoral CAS is most appropriate in patients who are symptomatic, have a rapidly progressing or large lesion, and do not have a soft thrombus present due to risk of embolism. Unlike transfemoral CAS, TCAR offers an elegant solution for embolic protection when patients have a soft thrombus present. In the case of a large pseudoaneurysm, we perform stent-assisted coiling. CONCLUSIONS: We practice selective endovascular intervention, stenting lesions that are flow-limiting or have large or rapidly expanding pseudoaneurysms, and only in patients for whom anticoagulation and antiplatelet agents are not contraindicated. As technology and investigation progress, the concerns regarding the safety and the role of endovascular intervention in the treatment of BCI will be more clearly defined.

How to TEVAR swine for scientific research: Technical, anatomic, and device considerations to translate human TEVAR techniques into the large animal laboratory.

OBJECTIVE: Thoracic Endovascular Aortic Repair (TEVAR) is well established in humans. Despite widespread use, additional research questions related to thoracic aortic stenting and endovascular innovation require large animal models. Translating human TEVAR devices and techniques into animal models, however, is a challenge even for experienced endovascular surgeons looking to develop a large animal TEVAR model.This article describes swine-specific strategies to deploy human TEVAR stent grafts, delineate how to select, size, prepare, and re-use human stents and deployment systems in swine, and how to translate human imaging modalities to large animal TEVAR. METHODS: We describe a selection of related TEVAR models and techniques in Yorkshire swine to support scientific inquiry. This includes an animal husbandry and pre-operative preparation and planning program. All imaged specimens in this paper are castrated male Yorkshire swine in the 60-80 kg range and underwent TEVAR with the Medtronic Navion stent and deployment system. RESULTS: To study human aortic stent grafts in swine, the animals generally must be at least 50 kgs to guarantee a 2 cm internal aortic diameter at the left subclavian, and for the iliac arteries to accommodate the human deployment system. Swine will have longer torsos and shorter iliofemoral segments than a human of the same weight which can make human deployment systems too short to reach the left subclavian from the femoral arteries in larger animals. We provide techniques to overcome this, including open iliac access or upside-down carotid TEVAR, which may be particularly useful if the scientific data would be confounded by iliofemoral access.Unlike humans that present clinically with axial imaging, swine will generally not have preoperative imaging, and many translational research laboratories do not have access to inexpensive preoperative CT, or any intraoperative CT scanning, which we are fortunate to have. We describe, therefore, several strategies for imaging in this setting including TEVAR via C-arm fluoroscopy and with or without in-laboratory CT scanning. Due to the low-resource setting of most large animal laboratories, as compared to a human hybrid room, we also describe several techniques to reduce cost and reuse materials, including the stent grafts, which at the end of non-survival experiments can be recovered during necropsy, cleaned, reinserted into the deployment device and reused on additional animals. CONCLUSIONS: This article describes a collection of related techniques and tips to translate human TEVAR imaging, sizing/selection, deployment, and anatomy to swine research. Using this framework alone, an experienced human vascular or endovascular surgeon may develop a complete aortic stenting animal model with strategies for scientific data acquisition.

Postoperative antiplatelet and/or anticoagulation use does not impact complication or reintervention rates after vein repair of arterial injury: A PROOVIT study.

INTRODUCTION: The use of antiplatelet (AP) and anticoagulation (AC) therapy after autogenous vein repair of traumatic arterial injury is controversial. The hypothesis in this study was that there is no difference in early postoperative outcomes regardless of whether AC, AP, both, or neither are used. METHODS: The American Association for the Surgery of Trauma (AAST) PROspective Observational Vascular Injury Treatment (PROOVIT) registry was queried from November, 2013, to January, 2019, for arterial injuries repaired with a vein graft. Demographics and injury characteristics were compared. Need for in-hospital reoperation was the primary outcome in this four-arm study, assessed with two ordinal logistic regression models (1. no therapy vs. AC only vs. AC and AP; 2. no therapy vs. AP only vs. AC and AP). RESULTS: 373 patients (52 no therapy, 88 AP only, 77 AC only, 156 both) from 19 centers with recorded Injury Severity Scores (ISS) were identified. Patients who received no therapy were younger than those who received AP (27.0 vs. 34.2, p = 0.02), had higher transfusion requirement (p < 0.01 between all groups) and a different distribution of anatomic injury (p < 0.01). After controlling for age, sex, ISS, platelet count, hemoglobin, pH, lactate, INR, transfusion requirement and anatomic location, there was no association with postoperative medical therapy and in-hospital operative reintervention, or any secondary outcome, including thrombosis (p = 0.67, p = 0.22). CONCLUSIONS: Neither AC nor AP alone, nor in combination, impact complication rate after arterial repair with autologous vein. These patients can be safely treated with or without antithrombotics, recognizing that this study did not demonstrate a beneficial effect.

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Importance: Bleeding is the most common cause of preventable death after trauma. Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. Design, Setting, and Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days. Intervention: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44). Main Outcomes and Measures: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death. Results: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours. Conclusions and Relevance: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone. Trial Registration: isrctn.org Identifier: ISRCTN16184981.

A Pilot Machine Learning Study Using Trauma Admission Data to Identify Risk for High Length of Stay.

INTRODUCTION: Trauma patients have diverse resource needs due to variable mechanisms and injury patterns. The aim of this study was to build a tool that uses only data available at time of admission to predict prolonged hospital length of stay (LOS). METHODS: Data was collected from the trauma registry at an urban level one adult trauma center and included patients from 1/1/2014 to 3/31/2019. Trauma patients with one or fewer days LOS were excluded. Single layer and deep artificial neural networks were trained to identify patients in the top quartile of LOS and optimized on area under the receiver operator characteristic curve (AUROC). The predictive performance of the model was assessed on a separate test set using binary classification measures of accuracy, precision, and error. RESULTS: 2953 admitted trauma patients with more than one-day LOS were included in this study. They were 70% male, 60% white, and averaged 47 years-old (SD: 21). 28% were penetrating trauma. Median length of stay was 5 days (IQR 3-9). For prediction of prolonged LOS, the deep neural network achieved an AUROC of 0.80 (95% CI: 0.786-0.814) specificity was 0.95, sensitivity was 0.32, with an overall accuracy of 0.79. CONCLUSION: Machine learning can predict, with excellent specificity, trauma patients who will have prolonged length of stay with only physiologic and demographic data available at the time of admission. These patients may benefit from additional resources with respect to disposition planning at the time of admission.

Skull and Scalp En-Bloc Harvest Protects Calvarial Perfusion: A Cadaveric Study.

BACKGROUND: Calvarial defects are severe injuries that can result from a wide array of etiologies. Reconstructive modalities for these clinical challenges include autologous bone grafting or cranioplasty with biocompatible alloplastic materials. Unfortunately, both approaches are limited by factors such as donor site morbidly, tissue availability, and infection. Calvarial transplantation offers the potential opportunity to address skull defect form and functional needs by replacing "like-with-like" tissue but remains poorly investigated. METHODS: Three adult human cadavers underwent circumferential dissection and osteotomy to raise the entire scalp and skull en-bloc. The vascular pedicles of the scalp were assessed for patency and perfused with color dye, iohexol contrast agent for computed tomography (CT) angiography, and indocyanine green for SPY-Portable Handheld Imager assessment of perfusion to the skull. RESULTS: Gross changes were appreciated to the scalp with color dye, but not to bone. CT angiography and SPY-Portable Handheld Imager assessment confirmed perfusion from the vessels of the scalp to the skull beyond midline. DISCUSSION/CONCLUSION: Calvarial transplantation may be a technically viable option for skull defect reconstruction that requires vascularized composite tissues (bone and soft tissue) for optimal outcomes.

Characterizing Brain Perfusion in a Swine Model of Raised Intracranial Pressure.

INTRODUCTION: Perfusion of the brain is critical, but this can be compromised due to focal space occupying lesions (SOL). SOLs can raise intracranial pressure (ICP), resulting in reduced cerebral blood flow (CBF). Most gyrencephalic models of brain injury focus on parenchymal injury, with few models of acutely elevated ICP. We hypothesized that we could employ a SOL technique to develop a titratable ICP model and sought to quantitate the resulting decrease in brain perfusion. METHODS: Six swine were anesthetized and instrumented. A Fogarty balloon catheter was inserted intracranially. Blood CO2 partial pressure was maintained between 35 and 45 mmHg. The Fogarty balloon was infused with normal saline at 1 mL/min to ICP targets of 10, 20, 30, and 40 mmHg. CBF (mL/100 g/min) were assessed at each ICP level using computed tomography perfusion (CTP). Data are presented as the mean ± standard deviation with all pressures measured in mmHg. CBF values were compared between baseline and each ICP level using analysis of variance. RESULTS: Baseline ICP was 5 ± 2 and systolic blood pressure was 106 ± 7. Balloon volumes (mL) required to achieve each incremental ICP level were 2.4 ± 0.5, 4.9 ± 1.7, 7.6 ± 1.6, and 9.9 ± 1.7. CBF decreased with each raised ICP level, with CBF being significantly less than baseline at ICP values of 30 (56.1 ± 34.7 versus 20.6 ± 11.0, P < 0.05) and 40 (56.1 ± 34.7 versus 6.5 ± 10.6, P < 0.05). CONCLUSIONS: An intracranial balloon catheter can be used to increase ICP, delivering a proportionate reduction in CBF. This model can be used in the future studies to examine adjuncts that manipulate intracranial pressure and their effect on brain perfusion.

Roles of Trauma CT and CTA in Salvaging the Threatened or Mangled Extremity.

Extremity arterial injuries account for up to 50% of all arterial traumas. The speed, accuracy, reproducibility, and close proximity of modern CT scanners to the trauma bay have led to the liberal use of CT angiography (CTA) when a limb is in ischemic jeopardy or is a potential source of life-threatening hemorrhage. The radiologist plays a critical role in the rapid communication of findings related to vessel transection and occlusion. Another role of CT that is often overlooked involves adding value to surgical planning. The following are some of the key questions addressed in this review: How does CTA help determine whether a limb is salvageable? How do concurrent multisystem injuries affect decision making? Which arterial injuries can be safely managed with observation alone? What damage control techniques are used to address compartment syndrome and hemorrhage? What options are available for definitive revascularization? Ideally, the radiologist should be familiar with the widely used Gustilo-Anderson open-fracture classification system, which was developed to prognosticate the likelihood of a functional limb salvage on the basis of soft-tissue and bone loss. When functional salvage is feasible or urgent hemorrhage control is required, communication with trauma surgeon colleagues is augmented by an understanding of the unique surgical, endovascular, and hybrid approaches available for each anatomic region of the upper and lower extremities. The radiologist should also be familiar with the common postoperative appearances of staged vascular, orthopedic, and plastic reconstructions for efficient clinically relevant reporting of potential down-range complications. Online supplemental material is available for this article. ©RSNA, 2022.

The Role of Endovascular Repair of Popliteal Arterial Injuries in the Acute Setting.

BACKGROUND: The role of endovascular surgery in the treatment of popliteal arterial injuries is not well established. As with other popliteal pathology, open repair has traditionally been considered the gold standard. As data has accumulated and technology advanced, however, a reassessment of the role of endovascular surgery is warranted. The aim of this study is to perform a noninferiority comparison of open versus endovascular management of traumatic popliteal injuries. Our hypothesis is that endovascular management is noninferior to open management of traumatic popliteal injuries. METHODS: The National Trauma Data Bank was searched for adult patients from 2002-2016 for isolated popliteal arterial injury. The study used a standard noninferiority methodology to compare rates of amputation and compartment syndrome between endovascular and open surgery. Margins for noninferiority were established using established published rates of complications: 17.1% for amputations and 23.0% for compartment syndrome. Endovascular intervention would be considered noninferior to open surgery if the lower bound confidence of the complication proportion (endo/open complication rate) was greater than the predefined noninferiority margin. RESULTS: A total of 3,698 patients met inclusion criteria, with blunt injury accounting for 2,117 (57%) and penetrating injury accounting for 1,581 (43%). Within the blunt group, 1,976 (93.3%) underwent open and 141 (6.7%) endovascular surgery. The rate of compartment syndrome (percentage and 95% confidence interval) after surgery for open repair was 9.9 (8.6-11.2) and 6.4 (3.2-11.3) for endovascular repair. The complication proportion is 64.6 (59.7-69.5). The rate of amputation for open repair was 15.7 (14.2-17.4) and 14.2 (9.2-20.6) for endovascular repair. The complication proportion is 90.4 (87.4-93.4). Within the penetrating group, 1,525 (96.5%) underwent open repair and 56 (3.5%) endovascular surgery. The rate of compartment syndrome after surgery for open repair was 14.9 (13.2-16.7) and 5.4 (1.5-13.6) for endovascular repair. The complication proportion is 36.2 (31.3-41.1). The rate of amputation for open repair was 4.3 (3.3-5.4) and 3.6 (0.7-11.0) for endovascular repair. The complication proportion is 83.7 (75.3-90.6). CONCLUSIONS: These data suggests that endovascular repair of popliteal artery injury may be noninferior to open repair with respect to limb preservation. Further examination of endovascular repair in popliteal artery injury is warranted.

The functional vascular anatomy of the swine for research.

OBJECTIVES: Swine (Sus Scrofa) are utilized broadly in research settings, given similarities to human vessel size and function; however, there are some important differences for clinicians to understand in order to interpret and perform translational research. This review article uses angiograms acquired in the course of a translational research program to present a description of the functional anatomy of the swine. METHODS: Digital subtraction angiography and computed tomography angiography were obtained throughout the course of multiple studies utilizing power injection with iodinated contrast. Subtracted two-dimensional images and three-dimensional multiplanar reformations were utilized post image acquisition to create maximal intensity projections and three-dimensional renderings of using open-source software (OsiriX). These imaging data are presented along with vessel measurements for reference. RESULTS: An atlas highlighting swine vascular anatomy, with an emphasis on inter-species differences that may influence how studies are conducted and interpreted, was compiled. CONCLUSIONS: Swine are utilized in broad-reaching fields for preclinical research. While many similarities between human and swine vasculature exist, there are important differences to consider when conducting and interpreting research. This review article highlights these differences and presents accompanying images to inform clinicians gaining experience in swine research.

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): Zone I Balloon Occlusion Time Affects Spinal Cord Injury in the Nonhuman Primate Model.

OBJECTIVES: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has been used clinically to limit torso bleeding and restore central perfusion. The objective of this study was to determine the sequelae of prolonged REBOA in a nonhuman primate animal model. SUMMARY BACKGROUND DATA: Prolonged duration of REBOA is associated with adverse clinical outcomes. Threshold occlusion values tied to relative risk have yet to be determined. METHODS: Juvenile baboons were subjected to 40% to 55% total blood volume hemorrhage to achieve profound hypotension and shock. Zone I REBOA was performed for 60 minutes to assess acute injury and survival at 4 hours (group 1; n = 7). Post-REBOA 10-day survival and complications were then compared between 60 minutes (group 2; n = 8) and 30 minutes (group 3; n = 6) REBOA animals. RESULTS: Overall survival was 20/21 (95%). IL-6 and IL-8 were elevated at 1 and 4 hours in group 1 (P = 0.005; P = 0.001). Comparing 60-minute REBOA with 30-minute REBOA, there was (1) hypertension compared with normotension (P = 0.005), (2) increased base deficit (P = 0.003), (3) elevated Troponin I (P = 0.04), and histological evidence of kidney injury (P = 0.004). In addition, group 2 demonstrated paralysis with histopathologic changes of spinal cord ischemia (SCI) in 4/8 (50%), with no SCI in group 3 (P = 0.033). CONCLUSIONS: REBOA limits mortality in the primate model of severe hemorrhagic shock. However, unopposed balloon inflation in the distal thoracic aorta for 60 minutes results in high rates of spinal cord ischemia, an effect mitigated by limiting balloon inflation to 30 minutes.

Repair of the Iliac Arterial Injury in Trauma: An Endovascular Operation?

BACKGROUND: Endovascular therapy is effective for non-traumatic iliac arterial diseases. The role of endovascular surgery in traumatic iliac lesions is unclear. The aim of this study is to compare outcomes for open versus endovascular management of traumatic iliac injuries. MATERIALS AND METHODS: The National Trauma Data Bank was searched for patients from 2002to 2016 with iliac arterial injury. Patients were sorted by treatment modality (open versus endo) and mechanism (blunt versus penetrating) and matched using mangled extremity score variables. The proportion of patients undergoing amputation were compared using the chi-square test. RESULTS: In the blunt group, 1550 (82%) had endovascular and 342 (18%) had open repair. Endovascular repair was associated with a significantly lower amputation rate than open repair (0.6% versus 3.6%, P = 0.015) despite higher incidence of concomitant injuries. Venous injury was more frequent in the open group (13.7% versus 1.8%, P < 0.001). Within the penetrating group, 209 (22%) had endovascular and 755 (78%) had open repair. Again endovascular repair was associated with a lower amputation rate (0% versus 5.1%, P = 0.004). Patients undergoing endovascular repair had more severe extremity/orthopedic injury, with venous injury again associated with open repair (48.5% versus 37.4%, P = 0.03). CONCLUSIONS: Endovascular repair of iliac injuries was associated with a significantly lower rate of amputation than open surgery. Endovascular repair was associated with a higher incidence of several injuries, although open repair was associated with concomitant venous injury. Further work is required to delineate the benefit of endovascular intervention and role of venous injury in limb salvage.