Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Vein diameter, obesity, and rates of recanalization after mechanochemical ablation.

OBJECTIVE: A large vein diameter is associated with higher recanalization rates after endovenous thermal ablation procedures of the great saphenous vein (GSV) and small saphenous vein (SSV). However, relatively few studies have explored the relationship between vein diameter and recanalization rates after mechanochemical ablation (MOCA). METHODS: We conducted a retrospective review of patients with chronic venous insufficiency who underwent MOCA of the GSV or SSV from 2017 to 2021 at a single hospital. Patients with no follow-up ultrasound examination were excluded. Patients were classified as having a large (≥1 cm) or small (<1 cm) treated vein. The primary outcomes were 2-year recanalization and reintervention of the treated segment. RESULTS: A total of 186 MOCA procedures during the study period were analyzed. There was no differences in age, gender, history of venous thromboembolic events, use of anticoagulation, obesity, or length of treated segment between the cohorts. Patients with large veins were less likely to have stasis ulcers compared with those with small veins (3.2% vs 21.5%; P < .05 on Fisher exact test). Patients with large veins had a higher incidence of local postoperative local complications (24.2% vs 7.2%, P < .05 on χ2 test). A survival analysis with Cox proportional hazards showed no significant difference in recanalization rates with larger vein diameters. However, obesity was found to correlate significantly with recanalization. CONCLUSIONS: A large vein diameter was not associated with higher recanalization rates after MOCA of the GSVs and SSVs. However, obesity was found to correlate with recanalization rates.

Aggressive Treatment Strategy at Index Thoracic Endovascular Aortic Surgery is Associated with Reduced Need for Short-Term Reintervention in Patients with Aortic Dissection.

INTRODUCTION: Thoracic endovascular aortic surgery (TEVAR) is the modern standard of treatment for patients with Type B aortic dissection, however it is unclear how the initial length of treated aorta affects long-term outcomes. This study aims to elucidate risk factors for secondary intervention after TEVAR for aortic dissection, focusing on length of aortic treatment at index operation. METHODS: A retrospective multihospital chart review was completed for patients treated between 2011 and 2022 who underwent TEVAR for aortic dissection with at least 1 year of post-TEVAR imaging and follow-up. Patient demographics and characteristics were analyzed. In this study, aortic zones treated only included those managed with a covered stent graft. The primary outcome measure was any need for secondary intervention. RESULTS: A total of 151 patients were identified. Demographics included a mean age of 57 years, with 31.8% of the patients being female. Forty-three patients (28.5%) underwent secondary intervention after TEVAR, with a mean follow-up of 1.6 years. The most common indication for secondary intervention was aneurysmal degeneration of the residual false lumen (76%). There was a significant difference in the number of aortic zones treated in patients who did and did not require secondary intervention (2.3 ± 1 vs. 2.7 ± 1, P = 0.04). Additionally, patients with 3 or more aortic zones of treatment had a significant difference in the need for reintervention (32% secondary intervention versus 52% no secondary intervention, P = 0.02). CONCLUSIONS: At least 3 zones of aortic treatment at index TEVAR is associated with a decreased need for overall reintervention. Modern treatment of acute and subacute type B dissection should stress an aggressive initial repair, balanced by the potential increased risk of spinal cord ischemia.

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

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

Outcomes of Endovascular and Open Surgical Therapy for Popliteal Artery Injury.

BACKGROUND: Popliteal arterial injury carries an appreciable risk of limb loss and, despite advances in stent and stent-graft technology, endovascular therapy for popliteal arterial trauma is infrequently used when compared with traditional open repair. Thus, this study aims to assess outcomes of endovascular management (EM) with open surgery (OS) as a historical reference. METHODS: An electronic search was performed (from January 2010 until June 2023) using multiple databases. Initial records were screened against eligibility criteria. Next, the full-text manuscript of articles that passed the title and abstract assessment was reviewed for relevancy of data points. Data from articles passing the inclusion criteria were extracted and tabulated. Comparative analysis was completed by performing chi-square tests and 2-sampled t-tests (Welch's). RESULTS: The 24 selected studies described 864 patients (96 EM; 768 OS). In the endovascular group, patients underwent procedures primarily for blunt trauma using covered, self-expanding stents, resulting in universal technical success and patency. Patients had an average length of stay of 7.99 ± 7.5 days and follow-up time of 33.0 ± 7.0 months, with 21% undergoing fasciotomies, 6% undergoing amputation, and 4% having pseudoaneurysms. Patients in the OS group were evenly divided between blunt and penetrating trauma, chiefly undergoing vein graft interposition and exhibiting fasciotomy and amputation rates of 66% and 24%, respectively. Patients had an average length of stay of 5.66 ± 4.6 days and a 96% survival rate at discharge. CONCLUSIONS: The current evidence sheds light on the nature of treatment offered by EM and OS treatment and suggests EM is associated with several important positive outcomes. Although it is difficult to directly compare endovascular and open surgical techniques, the data with respect to open surgical management of popliteal artery trauma can still provide a powerful frame of reference for the outcomes of EM to date. However, this claim is weak due to the little published data for EM of popliteal trauma, publication bias accompanying the published studies, and general, selection bias. Additional prospective data are necessary to define patients who specifically benefit from endovascular repair.

Feasibility of Multiparametric Perfusion Assessment in Diabetic Foot Ulcer Using Intravoxel Incoherent Motion and Blood Oxygenation-Level Dependent MRI.

BACKGROUND: Patients with type-2 diabetes (T2DM) are at increased risk of developing diabetic foot ulcers (DFU) and experiencing impaired wound healing related to underlying microvascular disease. PURPOSE: To evaluate the sensitivity of intra-voxel incoherent motion (IVIM) and blood oxygen level dependent (BOLD) MRI to microvascular changes in patients with DFUs. STUDY TYPE: Case-control. POPULATION: 20 volunteers who were age and body mass index matched, including T2DM patients with DFUs (N = 10, mean age = 57.5 years), T2DM patients with controlled glycemia and without DFUs (DC, N = 5, mean age = 57.4 years) and healthy controls (HC, N = 5, mean age = 52.8 years). FIELD STRENGTH/SEQUENCE: 3T/multi-b-value IVIM and dynamic BOLD. ASSESSMENT: Resting IVIM parameters were obtained using a multi-b-value diffusion-weighted imaging sequence and two IVIM models were fit to obtain diffusion coefficient (D), pseudo-diffusion coefficient (D*), perfusion fraction (f) and microvascular volume fraction (MVF) parameters. Microvascular reactivity was evaluated by inducing an ischemic state in the foot with a blood pressure cuff during dynamic BOLD imaging. Perfusion indices were assessed in two regions of the foot: the medial plantar (MP) and lateral plantar (LP) regions. STATISTICAL TESTS: Effect sizes of group mean differences were assessed using Hedge's g adjusted for small sample sizes. RESULTS: DFU participants exhibited elevated D*, f, and MVF values in both regions (g ≥ 1.10) and increased D (g = 1.07) in the MP region compared to DC participants. DC participants showed reduced f and MVF compared to HC participants in the MP region (g ≥ 1.06). Finally, the DFU group showed reduced tolerance for ischemia in the LP region (g = -1.51) and blunted reperfusion response in both regions (g < -2.32) compared to the DC group during the cuff-occlusion challenge. DATA CONCLUSION: The combined use of IVIM and BOLD MRI shows promise in differentiating perfusion abnormalities in the feet of diabetic patients and suggests hyperperfusion in DFU patients. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY: Stage 1.

Lower Extremity Vascular Injury in the Pediatric Trauma Patient: Management and Outcomes at an Adult Level I Trauma Center.

BACKGROUND: Traumatic vascular injuries of the lower extremity in the pediatric population are uncommon but can result in significant morbidity. The objective of this study is to demonstrate our experience with these injuries by describing patterns of traumatic vascular injury, the initial management, and data regarding early outcomes. METHODS: In total, 506 patients presented with lower extremity vascular injury between January 1, 2009 and January 1, 2021 to Grady Memorial Hospital, an urban, adult Level I trauma center in Atlanta, Georgia. Thirty-two of the 506 patients were aged less than 18 years and were evaluated for a total of 47 lower extremity vascular injuries. To fully elucidate the injury patterns and clinical course in this population, we examined patient demographics, mechanism of injury, type of vessel injured, surgical repair performed, and early outcomes and complications. RESULTS: The median (interquartile range) age was 16 (2) years (range, 3-17 years), and the majority were male (n = 29, 90.6%). Of the vascular injuries identified, 28 were arterial and 19 were venous. Of these injuries, 14 patients had combined arterial-venous injuries. The majority of injuries were the result of a penetrating injury (n = 28, 87.5%), and of these, all but 2 were attributed to gunshot wounds. Twenty-seven vascular interventions were performed by nonpediatric surgeons: 11 by trauma surgeons, 13 by vascular surgeons, 2 by orthopedic surgeons, and 1 by an interventional radiologist. Two patients required amputation: 1 during the index admission and 1 delayed at 3 months. Overall survival was 96.9%. CONCLUSIONS: Vascular injuries as the result of trauma at any age often require early intervention, and we believe that these injuries in the pediatric population can be safely managed in adult trauma centers with a multidisciplinary team composed of trauma, vascular, and orthopedic surgeons with the potential to decrease associated morbidity and mortality from these injuries.

Sensorized Endovascular Technologies: Additional Data to Enhance Decision-Making.

BACKGROUND: Current endovascular procedures rely mostly on anatomic information, guided by fluoroscopy, to perform interventions (i.e. angioplasty, stent placement, coils). However, the structural parameters provided by these imaging technologies do not provide any physiological data on either the disease state or efficacy of intervention. Additional endovascular tools are needed to collect physiologic and other both anatomic and nonanatomic data to further individualize endovascular interventions with the ultimate goal of improving patient outcomes. This review details the current state of the art for these sensorized endovascular technologies and details systems under development with the aim of identifying gaps and new directions. The objective of this review was to survey the Vascular Surgery literature, engineering literature, and commercially available products to determine what exists in terms of sensor-enabled endovascular devices and where gaps and opportunities exist for further sensor integration. METHODS: Search terms were entered into search engines such as Google and Google Scholar to identify endovascular devices containing sensors. A variety of terms were used including directly search for items such as "sensor-enabled endovascular devices" and then also completing more refined searches bases on areas of interest (i.e. fractional flow reserve, navigation, retrograde endovascular balloon occlusion of the aorta, etc.). For the most part, systems were included where the sensor was mounted directly onto the catheter and implantable sensors such as those that have been investigated for use with stents have been excluded. RESULTS: The authors were able to identify a body of literature in the area of endovascular devices that contain sensors to measure physiologic information. However, areas where additional sensing capabilities may be useful were identified. CONCLUSIONS: Several different types of sensors and sensing systems were identified that have been integrated with endovascular catheters. Although a great deal of work has been done in this field, there are additional useful data that could be obtained from additional novel sensing technologies. Furthermore, significant effort needs to be allocated to carefully studying how these new technologies can be employed to actually improve patient outcomes.

Outpatient Parenteral Antibiotic Therapy for Diabetic Foot Osteomyelitis in an Uninsured and Underinsured Cohort.

Background: Diabetic foot osteomyelitis (DFO) is usually treated with prolonged outpatient parenteral antibiotic therapy (OPAT). Evaluation and treatment of non-antibiotic aspects of DFO (e.g., peripheral artery disease [PAD]) are also recommended. There is limited data regarding OPAT practice patterns and outcomes for DFO. Methods: Single-center observational study of patients receiving OPAT for DFO in a large United States public hospital between January 2017 and July 2019. We abstracted data regarding microbiology test, antibiotics, clinical outcomes, and non-antibiotic DFO management. Results: Ninety-six patients were included and some had >1 DFO-OPAT course during the study period (106 DFO-OPAT courses included). No culture was obtained in 40 (38%) of courses. Methicillin-resistant S. aureus (MRSA) was cultured in 15 (14%) and P. aeruginosa in 1 (1%) of DFO-OPAT courses. An antibiotic with MRSA activity (vancomycin or daptomycin) was used in 79 (75%) of courses and a parenteral antibiotic with anti-pseudomonal activity was used in 7 (6%) of courses. Acute kidney injury occurred in 19 (18%) DFO-OPAT courses. An ankle-brachial index measurement was obtained during or 6 months prior to the first DFO-OPAT course for 44 (49%) of patients. Forty-two (44%) patients died or had an amputation within 12 months of their initial hospital discharge. Conclusions: We found high rates of empiric antibiotic therapy for DFO and low uptake of the non-antibiotic aspects of DFO care. Better implementation of microbiological tests for DFO in addition to stronger integration of infectious disease and non-infectious diseases care could improve DFO outcomes.

Bailout technique for entangled stent retriever and carotid stent during tandem large vessel occlusion endovascular therapy.

BACKGROUND AND IMPORTANCE: Endovascular thrombectomy for patients with tandem occlusions could be challenging. Exposure to potential technical complications and bailout rescue techniques are of utmost importance. CLINICAL PRESENTATION: A 73-year-old woman with tandem internal carotid artery and middle cerebral artery lesions underwent an unsuccessful retrograde revascularization approach in the setting of tortuous anatomy. Antegrade approach revascularization was then pursued. Following cervical internal carotid artery revascularization, a triaxial system of aspiration catheter, microcatheter and micro guidewire was navigated through the stented curved cervical ICA and intracranial stent retriever pass was performed. Upon retrieving the clot-incorporated stent retriever with the intention to retrieve the entire stent retriever into the locally placed aspiration catheter, the triaxial system collapsed into the distal common carotid artery. Large thrombus was recovered from the aspiration catheter aspirate however the proximal end of stent retriever and distal internal carotid artery stent got tangled. After unsuccessful maneuvering to disentangle stent retriever from the internal carotid artery stent, we decided to attempt safe separation of the stent retriever from its pusher wire and leave behind the patent internal carotid artery stent/stent retriever metal construct in place. Gradual pulling pressure was applied to the stent retriever wire while maintaining distal exchange-length microwire access and fully inflated extracranial balloon over the entangled portion to ensure continuous vascular access. The stent retriever wire was then safely separated from the stent retriever and fully retracted outside the body. Delayed angiographic runs continued to demonstrate full patency of the internal carotid artery lumen. No residual dissection, spasm, or thrombus was noted. CONCLUSION: This case illustrates a novel bailout endovascular salvage technique that could be considered in such cases. These techniques minimize intraoperative complication, focus on patient safety, and promote efficiency for endovascular thrombectomy in unfavorable anatomy.

The Characteristics and Results of Endovascular Devices in Trauma (CREDiT) study: Multi-institutional results.

INTRODUCTION: Endovascular techniques are increasingly used to repair major traumatic vascular injuries, but most endovascular implants are not designed/approved for trauma-specific indications. No inventory guidelines exist for the devices used in these procedures. We aimed to describe the use and characteristics of endovascular implants used for repair of vascular injuries to allow for better inventory management. METHODS: This CREDiT study is a six-year retrospective cohort analysis of endovascular procedures performed for repair of traumatic arterial injuries at five participating US trauma centers. For each treated vessel, procedural and device details were recorded and outcomes assessed with the aim of defining the range of implants and sizes used for these interventions. RESULTS: A total of 94 cases were identified; 58 (61%) were descending thoracic aorta, 14 (15%) axillosubclavian, 5 carotid, 4 abdominal aortic, 4 common iliac, 7 femoropopliteal, and 1 renal. Vascular surgeons performed 54% of cases, trauma surgeons 17%, IR/CT Surgery 29%. Systemic heparin was administered in 68% and procedures were performed a median of 9 h after arrival (IQR 3-24 h). Primary arterial access was femoral in 93% of cases, 49% were bilateral. Brachial/radial access was used primarily in 6 cases, and secondary to femoral in 9. The most common implant was self-expanding stent graft; 18% used >1 stent. Implants ranged in diameter and length based on vessel size. Five of 94 implants underwent reintervention (1 open surgery) at a median of 4d postop (range 2-60d). Two occlusions and 1 stenosis were present at follow-up at a median of 1 month (range 0-72 m). CONCLUSIONS: Endovascular reconstruction of injured arteries requires a broad range of implant types, diameters, and lengths which should be readily available in trauma centers. Stent occlusions/stenoses are rare and can typically be managed by endovascular means.

Missing Bullets: Bullet Embolization Case Series and Review of the Literature.

PURPOSE: Bullet embolization is a rare but dangerous phenomenon. Based on the location of embolization, migration of bullets can cause limb or intra-abdominal ischemia, pulmonary infarction, cardiac valve injury, or cerebrovascular accident. Bullet emboli can present a diagnostic challenge given the varied nature of complications based on location of embolization, which may not coincide with the site of initial injury. The purpose of this study is to present several cases of bullet embolization from our busy urban trauma center and make recommendations for management. METHODS: We present 3 cases of bullet embolization seen in injured patients at our Level 1 trauma center. We describe our management of these injuries and make recommendations for management in the context of our institutional experience and comment on the available literature regarding bullet embolization. RESULTS: Two of our patients presented in extremis and required operative intervention to achieve stability. The intravascular missile was discovered intraoperatively in one patient and removed in the operating room, while the missile was discovered on postoperative imaging in another patient and again removed operatively after an unsuccessful attempt at minimally invasive retrieval. Our third patient remained hemodynamically stable throughout his hospitalization and had endovascular management of his bullet embolus. CONCLUSION: Bullet emboli present a challenging complication of penetrating trauma. We recommend removal of all arterial bullet emboli and those within the pulmonary venous system. In hemodynamically stable patients, we recommend initial attempts of endovascular retrieval followed by open surgical removal. We recommend open removal in cases of hemodynamic instability.

Vascular surgery is the most commonly consulted specialty for emergent operative trauma.

OBJECTIVE: Despite an increasing rate of intraoperative consultation of vascular surgery (VS) for trauma patients, VS is not one of the subspecialties required for American College of Surgeons level I trauma center verification. We sought to assess the rates and patterns of emergent operative VS consultation compared with other surgical subspecialties in the trauma setting. METHODS: A retrospective analysis was performed on all patients who presented with traumatic injuries requiring emergent surgical operations (<3 hours after presentation) from 2015 to 2019 at a level I trauma center. Patient demographics, injury characteristics, and data on consulted surgical subspecialties were collected. The primary outcome measured was the rate of intraoperative consultation to VS and other subspecialties (OS). RESULTS: A total of 2265 patients were identified, with 221 emergent intraoperative consults to VS and 507 consults to OS. After VS (9.8%), the most common subspecialties consulted were orthopedics (9.2%) and urology (5%). Overall, VS was more likely to be consulted in immediate trauma operations (<1 hour after presentation) (65.6% vs 38.1%, P < .0001), penetrating injuries (73.3% vs 47.9%, P < .0001), and at night (60.6% vs 51.9%, P = .02) compared with OS. Time from admission to operation was shorter for cases when VS was involved compared with OS (54.1 ± 40.4 vs 80.6 ± 47.9 minutes, P < .0001). In a multivariable logistic regression model, we found that requiring an immediate operation was associated with higher odds of requiring an intraoperative vascular consult (odds ratio = 1.49, 95% confidence interval = 1.12-2.0). CONCLUSIONS: Vascular surgeons are consulted intraoperatively to assist with emergent trauma at a greater rate compared with specialties that are required for level I trauma center verification. Current American College of Surgeons verification processes and site-specific policies should be re-evaluated to consider VS coverage as a requirement for trauma center verification.

Outpatient clinic attendance and outcomes among patients hospitalized with diabetic foot ulcers.

BACKGROUND: There are limited data on post-hospital discharge clinic attendance rates and outcomes among patients with diabetic foot ulcers (DFUs). METHODS: Retrospective study of patients hospitalized with a DFU from 2016 to 2019 in a large public hospital. We measured rates and predictors of clinic attendance with providers involved with DFU care within 30 days of hospital discharge ("30-day post-discharge clinic attendance"). Log-binomial regression was used to estimate risk ratios (RR) and 95 % confidence intervals (CI). RESULTS: Among 888 patients, 60.0 % were between 45 and 64 years old, 80.5 % were Black, and 24.1 % were uninsured. Overall, 478 (53.8 %) attended ≥1 30-day post-discharge clinic appointment. Initial hospital outcomes were associated with clinic attendance. For example, the RR of 30-day post-discharge clinic attendance was 1.39 (95%CI 1.19-1.61) among patients who underwent a major amputation compared to patients with DFUs without osteomyelitis and did not undergo an amputation during the initial hospitalization. Among 390 patients with known 12-month outcome, 71 (18.2 %) had a major amputation or died ≤12 months of hospital discharge. CONCLUSION: We found a low post-discharge clinic attendance and high post-discharge amputation and death rates among patients hospitalized with DFUs. Interventions to increase access to outpatient DFU care are needed and could prevent amputations.