Indocyanine green fluorescence quantification during normothermic ex situ perfusion for the assessment of porcine liver grafts after circulatory death.

Current graft evaluation during normothermic ex situ liver perfusion lacks real-time parameters for predicting posttransplant hepatocyte and biliary function. Indocyanine green (ICG) imaging has been widely used in liver surgery, enabling the visualization of hepatic uptake and excretion through bile using near-infrared light. In this research, porcine livers under various ischemic conditions were examined during a 5-hour normothermic ex situ liver perfusion procedure, introducing ICG at 1 hour through the hepatic artery. These conditions included livers from heart-beating donors, donation after circulatory death (DCD) with warm ischemic durations of 60 minutes (DCD60) and 120 minutes (DCD120), as well as interventions utilizing tissue plasminogen activator in DCD120 cases (each n = 5). Distinct hepatic fluorescence patterns correlated with different degrees of ischemic injury (p = 0.01). Low ICG uptake in the parenchyma (less than 40% of maximum intensity) was more prevalent in DCD120 (21.4%) compared to heart-beating donors (6.2%, p = 0.06) and DCD60 (3.0%, p = 0.02). Moreover, ICG clearance from 60 minutes to 240 minutes was significantly higher in heart-beating donors (69.3%) than in DCD60 (17.5%, p < 0.001) and DCD120 (32.1%, p = 0.01). Furthermore, thrombolytic intervention using tissue plasminogen activator in DCD120 resulted in noteworthy outcomes, including significantly reduced ALP levels (p = 0.04) and improved ICG clearance (p = 0.02) with a trend towards mitigating fibrin deposition similar to DCD60, as well as enhancements in bile production (p = 0.09). In conclusion, ICG fluorescence imaging during normothermic ex situ liver perfusion provides real-time classification of hepatic vascular and biliary injuries, offering valuable insights for the more accurate selection and postintervention evaluation of marginal livers in transplantation.

Does Freehand, Patient-specific Instrumentation or Surgical Navigation Perform Better for Allograft Reconstruction After Tumor Resection? A Preclinical Synthetic Bone Study.

BACKGROUND: Joint-sparing resection of periarticular bone tumors can be challenging because of complex geometry. Successful reconstruction of periarticular bone defects after tumor resection is often performed with structural allografts to allow for joint preservation. However, achieving a size-matched allograft to fill the defect can be challenging because allograft sizes vary, they do not always match a patient's anatomy, and cutting the allograft to perfectly fit the defect is demanding. QUESTIONS/PURPOSES: (1) Is there a difference in mental workload among the freehand, patient-specific instrumentation, and surgical navigation approaches? (2) Is there a difference in conformance (quantitative measure of deviation from the ideal bone graft), elapsed time during reconstruction, and qualitative assessment of goodness-of-fit of the allograft reconstruction among the approaches? METHODS: Seven surgeons used three modalities in the same order (freehand, patient-specific instrumentation, and surgical navigation) to fashion synthetic bone to reconstruct a standardized bone defect. National Aeronautics and Space Administration (NASA) mental task load index questionnaires and procedure time were captured. Cone-beam CT images of the shaped allografts were used to measure conformance (quantitative measure of deviation from the ideal bone graft) to a computer-generated ideal bone graft model. Six additional (senior) surgeons blinded to modality scored the quality of fit of the allografts into the standardized tumor defect using a 10-point Likert scale. We measured conformance using the root-mean-square metric in mm and used ANOVA for multipaired comparisons (p < 0.05 was significant). RESULTS: There was no difference in mental NASA total task load scores among the freehand, patient-specific instrumentation, and surgical navigation techniques. We found no difference in conformance root-mean-square values (mean ± SD) between surgical navigation (2 ± 0 mm; mean values have been rounded to whole numbers) and patient-specific instrumentation (2 ± 1 mm), but both showed a small improvement compared with the freehand approach (3 ± 1 mm). For freehand versus surgical navigation, the mean difference was 1 mm (95% confidence interval [CI] 0.5 to 1.1; p = 0.01). For freehand versus patient-specific instrumentation, the mean difference was 1 mm (95% CI -0.1 to 0.9; p = 0.02). For patient-specific instrumentation versus surgical navigation, the mean difference was 0 mm (95% CI -0.5 to 0.2; p = 0.82). In evaluating the goodness of fit of the shaped grafts, we found no clinically important difference between surgical navigation (median [IQR] 7 [6 to 8]) and patient-specific instrumentation (median 6 [5 to 7.8]), although both techniques had higher scores than the freehand technique did (median 3 [2 to 4]). For freehand versus surgical navigation, the difference of medians was 4 (p < 0.001). For freehand versus patient-specific instrumentation, the difference of medians was 3 (p < 0.001). For patient-specific instrumentation versus surgical navigation, the difference of medians was 1 (p = 0.03). The mean ± procedural times for freehand was 16 ± 10 minutes, patient-specific instrumentation was 14 ± 9 minutes, and surgical navigation techniques was 24 ± 8 minutes. We found no differences in procedures times across three shaping modalities (freehand versus patient-specific instrumentation: mean difference 2 minutes [95% CI 0 to 7]; p = 0.92; freehand versus surgical navigation: mean difference 8 minutes [95% CI 0 to 20]; p = 0.23; patient-specific instrumentation versus surgical navigation: mean difference 10 minutes [95% CI 1 to 19]; p = 0.12). CONCLUSION: Based on surgical simulation to reconstruct a standardized periarticular bone defect after tumor resection, we found a possible small advantage to surgical navigation over patient-specific instrumentation based on qualitative fit, but both techniques provided slightly better conformance of the shaped graft for fit into the standardized post-tumor resection bone defect than the freehand technique did. To determine whether these differences are clinically meaningful requires further study. The surgical navigation system presented here is a product of laboratory research development, and although not ready to be widely deployed for clinical practice, it is currently being used in a research operating room setting for patient care. This new technology is associated with a learning curve, capital costs, and potential risk. The reported preliminary results are based on a preclinical synthetic bone tumor study, which is not as realistic as actual surgical scenarios. CLINICAL RELEVANCE: Surgical navigation systems are an emerging technology in orthopaedic and reconstruction surgery, and understanding their capabilities and limitations is paramount for clinical practice. Given our preliminary findings in a small cohort study with one scenario of standardized synthetic periarticular bone tumor defects, future investigations should include different surgical scenarios using allograft and cadaveric specimens in a more realistic surgical setting.

Nanoparticle-mediated Photodynamic Therapy as a Method to Ablate Oral Cavity Squamous Cell Carcinoma in Preclinical Models.

Photodynamic therapy (PDT) is a tissue ablation technique able to selectively target tumor cells by activating the cytotoxicity of photosensitizer dyes with light. PDT is nonsurgical and tissue sparing, two advantages for treatments in anatomically complex disease sites such as the oral cavity. We have previously developed PORPHYSOME (PS) nanoparticles assembled from chlorin photosensitizer-containing building blocks (∼94,000 photosensitizers per particle) and capable of potent PDT. In this study, we demonstrate the selective uptake and curative tumor ablation of PS-enabled PDT in three preclinical models of oral cavity squamous cell carcinoma (OCSCC): biologically relevant subcutaneous Cal-33 (cell line) and MOC22 (syngeneic) mouse models, and an anatomically relevant orthotopic VX-2 rabbit model. Tumors selectively uptake PS (10 mg/kg, i.v.) with 6-to 40-fold greater concentration versus muscle 24 hours post-injection. Single PS nanoparticle-mediated PDT (PS-PDT) treatment (100 J/cm2, 100 mW/cm2) of Cal-33 tumors yielded significant apoptosis in 65.7% of tumor cells. Survival studies following PS-PDT treatments demonstrated 90% (36/40) overall response rate across all three tumor models. Complete tumor response was achieved in 65% of Cal-33 and 91% of MOC22 tumor mouse models 14 days after PS-PDT, and partial responses obtained in 25% and 9% of Cal-33 and MOC22 tumors, respectively. In buccal VX-2 rabbit tumors, combined surface and interstitial PS-PDT (200 J total) yielded complete responses in only 60% of rabbits 6 weeks after a single treatment whereas three repeated weekly treatments with PS-PDT (200 J/week) achieved complete ablation in 100% of tumors. PS-PDT treatments were well tolerated by animals with no treatment-associated toxicities and excellent cosmetic outcomes. SIGNIFICANCE: PS-PDT is a safe and repeatable treatment modality for OCSCC ablation. PS demonstrated tumor selective uptake and PS-PDT treatments achieved reproducible efficacy and effectiveness in multiple tumor models superior to other clinically tested photosensitizer drugs. Cosmetic and functional outcomes were excellent, and no clinically significant treatment-associated toxicities were detected. These results are enabling of window of opportunity trials for fluorescence-guided PS-PDT in patients with early-stage OCSCC scheduled for surgery.

A 3D Analysis of Plating Strategies in Mandibular Reconstruction: A Randomized Control Pilot Study.

OBJECTIVE(S): The purpose of this study was to compare computer-assisted mandibular plating to conventional plating using quantitative metrics. METHODS: Patients scheduled to undergo mandibular reconstruction were randomized to three-dimensional modelling for preoperative plate bending or intraoperative freehand bending. Preoperative and postoperative head and neck computed tomography scans were obtained to generate computer models of the reconstruction. The overall plate surface contact area, mean plate-to-bone distance, degree of conformance, and position of the condylar head within the glenoid fossa between pre- and post-operative scans were calculated. RESULTS: Twenty patients were included with a mean age of 57.8 years (standard deviation [SD] = 13.6). The mean follow-up time was 9.8 months (range = 1.6-22.3). Reconstruction was performed with fibular (25%) or scapular free flaps (75%). The percentage of surface contact between the reconstructive plate and mandible was improved with three-dimensional models compared to freehand bending (93.9 ± 7.7% vs. 78.0 ± 19.9%, p = 0.04). There was improved overall plate-to-bone distance (3D model: 0.7 ± 0.31 mm vs. conventional: 1.3 ± 0.8 mm, p = 0.06). Total intraoperative time was non-significantly decreased with the use of a model (3D model: 726.5 ± 89.1 min vs. conventional: 757.3 ± 84.1 min, p = 0.44). There were no differences in condylar head position or postoperative complications. CONCLUSION: Computer-assisted mandibular plating can be used to improve the accuracy of plate contouring. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:2182-2186, 2024.

Assessment of effectiveness and safety of thrombolytic therapy to pulmonary emboli by endobronchial ultrasound-guided transbronchial needle injection.

Objective: Endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) may effectively treat acute pulmonary embolisms (PEs). Here, we assessed the effectiveness of clot dissolution and safety of tissue plasminogen activator (t-PA) injection using EBUS-TBNI in a 1-week survival study of a porcine PE model. Methods: Six pigs with bilateral PEs were used: 3 for t-PA injection using EBUS-TBNI (TBNI group) and 3 for systemic administration of t-PA (systemic group). Once bilateral PEs were created, each 25 mg of t-PA injection using EBUS-TBNI for bilateral PEs (a total of 50 mg t-PA) and 100 mg of t-PA systemic administration was performed on day 1. Hemodynamic parameters, blood tests, and contrast-enhanced computed tomography scans were carried out at several time points. On day 7, pigs were humanely killed to evaluate the residual clot volume in the pulmonary arteries. Results: The average of percent change of residual clot volumes was significantly lower in the TBNI group than in the systemic group (%: systemic group 36.6 ± 22.6 vs TBNI group 9.6 ± 6.1, P < .01) on day 3. Considering the elapsed time, the average decrease of clot volume per hour at pre-t-PA to post t-PA was significantly greater in the TBNI group than in the systemic group (mm3/hour: systemic 68.1 ± 68.1 vs TBNI 256.8 ± 148.1, P < .05). No hemorrhage was observed intracranially, intrathoracically, or intraperitoneally on any contrast-enhanced computed tomography images. Conclusions: This study revealed that t-PA injection using EBUS-TBNI is an effective and safe way to dissolve clots.

A total inverse planning paradigm: Prospective clinical trial evaluating the performance of a novel MR-based 3D-printed head immobilization device.

Background and purpose: Brain radiotherapy (cnsRT) requires reproducible positioning and immobilization, attained through redundant dedicated imaging studies and a bespoke moulding session to create a thermoplastic mask (T-mask). Innovative approaches may improve the value of care. We prospectively deployed and assessed the performance of a patient-specific 3D-printed mask (3Dp-mask), generated solely from MR imaging, to replicate a reproducible positioning and tolerable immobilization for patients undergoing cnsRT. Material and methods: Patients undergoing LINAC-based cnsRT (primary tumors or resected metastases) were enrolled into two arms: control (T-mask) and investigational (3Dp-mask). For the latter, an in-house designed 3Dp-mask was generated from MR images to recreate the head positioning during MR acquisition and allow coupling with the LINAC tabletop. Differences in inter-fraction motion were compared between both arms. Tolerability was assessed using patient-reported questionnaires at various time points. Results: Between January 2020 - July 2022, forty patients were enrolled (20 per arm). All participants completed the prescribed cnsRT and study evaluations. Average 3Dp-mask design and printing completion time was 36 h:50 min (range 12 h:56 min - 42 h:01 min). Inter-fraction motion analyses showed three-axis displacements comparable to the acceptable tolerance for the current standard-of-care. No differences in patient-reported tolerability were seen at baseline. During the last week of cnsRT, 3Dp-mask resulted in significantly lower facial and cervical discomfort and patients subjectively reported less pressure and confinement sensation when compared to the T-mask. No adverse events were observed. Conclusion: The proposed total inverse planning paradigm using a 3D-printed immobilization device is feasible and renders comparable inter-fraction performance while offering a better patient experience, potentially improving cnsRT workflows and its cost-effectiveness.

Using augmented reality to guide bone conduction device implantation.

Exact placement of bone conduction implants requires avoidance of critical structures. Existing guidance technologies for intraoperative placement have lacked widespread adoption given accessibility challenges and significant cognitive loading. The purpose of this study is to examine the application of augmented reality (AR) guided surgery on accuracy, duration, and ease on bone conduction implantation. Five surgeons surgically implanted two different types of conduction implants on cadaveric specimens with and without AR projection. Pre- and postoperative computer tomography scans were superimposed to calculate centre-to-centre distances and angular accuracies. Wilcoxon signed-rank testing was used to compare centre-to-centre (C-C) and angular accuracies between the control and experimental arms. Additionally, projection accuracy was derived from the distance between the bony fiducials and the projected fiducials using image guidance coordinates. Both operative time (4.3 ± 1.2 min. vs. 6.6 ± 3.5 min., p = 0.030) and centre-to-centre distances surgery (1.9 ± 1.6 mm vs. 9.0 ± 5.3 mm, p < 0.001) were significantly less in augmented reality guided surgery. The difference in angular accuracy, however, was not significantly different. The overall average distance between the bony fiducial markings and the AR projected fiducials was 1.7 ± 0.6 mm. With direct intraoperative reference, AR-guided surgery enhances bone conduction implant placement while reduces operative time when compared to conventional surgical planning.

Nanostructure-Driven Indocyanine Green Dimerization Generates Ultra-Stable Phototheranostics Nanoparticles.

Indocyanine green (ICG) is the only near-infrared (NIR) dye approved for clinical use. Despite its versatility in photonic applications and potential for photothermal therapy, its photobleaching hinders its application. Here we discovered a nanostructure of dimeric ICG (Nano-dICG) generated by using ICG to stabilize nanoemulsions, after which ICG enabled complete dimerization on the nanoemulsion shell, followed by J-aggregation of ICG-dimer, resulting in a narrow, red-shifted (780 nm→894 nm) and intense (≈2-fold) absorbance. Compared to ICG, Nano-dICG demonstrated superior photothermal conversion (2-fold higher), significantly reduced photodegradation (-9.6 % vs. -46.3 %), and undiminished photothermal effect (7 vs. 2 cycles) under repeated irradiations, in addition to excellent colloidal and structural stabilities. Following intravenous injection, Nano-dICG enabled real-time tracking of its delivery to mouse tumors within 24 h by photoacoustic imaging at NIR wavelength (890 nm) distinct from the endogenous signal to guide effective photothermal therapy. The unprecedented finding of nanostructure-driven ICG dimerization leads to an ultra-stable phototheranostic platform.

Skull-Base Surgery-A Narrative Review on Current Approaches and Future Developments in Surgical Navigation.

Surgical navigation technology combines patient imaging studies with intraoperative real-time data to improve surgical precision and patient outcomes. The navigation workflow can also include preoperative planning, which can reliably simulate the intended resection and reconstruction. The advantage of this approach in skull-base surgery is that it guides access into a complex three-dimensional area and orients tumors intraoperatively with regard to critical structures, such as the orbit, carotid artery and brain. This enhances a surgeon's capabilities to preserve normal anatomy while resecting tumors with adequate margins. The aim of this narrative review is to outline the state of the art and the future directions of surgical navigation in the skull base, focusing on the advantages and pitfalls of this technique. We will also present our group experience in this field, within the frame of the current research trends.

Preclinical evaluation of thin convex probe endobronchial ultrasound-guided transbronchial needle aspiration for intrapulmonary lesions.

Background: Conventional flexible bronchoscopy has not achieved the high diagnostic yield for intrapulmonary lesions as seen with image-guided transthoracic biopsy. A thin convex probe endobronchial ultrasound bronchoscope (TCP-EBUS) with a 5.9-mm tip was designed to improve peripheral access over conventional EBUS bronchoscopes to facilitate real-time sampling of intrapulmonary lesions under ultrasound guidance. Methods: TCP-EBUS was inserted into the distal airways of ex-vivo human lungs to assess bronchial accessibility relative to clinically available bronchoscopes. The short- (≤1 h) and medium-term (≤10 d) safety of TCP-EBUS insertion and EBUS-guided transbronchial needle aspiration (TBNA) using a 25-gauge needle were evaluated physiologically and radiologically in live pigs. TCP-EBUS-guided TBNA feasibility was assessed in-vivo with pig intrapulmonary pseudo-tumors and ex-vivo with resected human lung cancer specimens. Results: For bronchial accessibility, TCP-EBUS demonstrated greater reach than the 6.6-mm convex probe endobronchial ultrasound (CP-EBUS) in all bronchi, as well as surpassed a 5.5-mm conventional bronchoscope in 63% (131/209) and a 4.8-mm conventional bronchoscope in 27% (57/209) of assessed bronchi. The median bronchial generation and the mean diameter of bronchi TCP-EBUS reached was 4 (range, 3-7) and 3.3±0.7 mm, respectively. No major complications related to TCP-EBUS-guided TBNA in distal airways were observed in the live pigs. Scattered mucosal erythema of the bronchial walls was observed immediately after TCP-EBUS insertion; this self-resolved by day 10. TCP-EBUS could successfully reach and visualize intrapulmonary targets via ultrasound, with no difficulty in needle deployment or sampling. Conclusions: TCP-EBUS has the potential to facilitate safe real-time transbronchial sampling of intrapulmonary lesions in the central and middle lung fields.

Hybrid Core-Shell Polymer Scaffold for Bone Tissue Regeneration.

A great promise for tissue engineering is represented by scaffolds that host stem cells during proliferation and differentiation and simultaneously replace damaged tissue while maintaining the main vital functions. In this paper, a novel process was adopted to develop composite scaffolds with a core-shell structure for bone tissue regeneration, in which the core has the main function of temporary mechanical support, and the shell enhances biocompatibility and provides bioactive properties. An interconnected porous core was safely obtained, avoiding solvents or other chemical issues, by blending poly(lactic acid), poly(ε-caprolactone) and leachable superabsorbent polymer particles. After particle leaching in water, the core was grafted with a gelatin/chitosan hydrogel shell to create a cell-friendly bioactive environment within its pores. The physicochemical, morphological, and mechanical characterization of the hybrid structure and of its component materials was carried out by means of infrared spectroscopy, thermogravimetric analysis, scanning electron microscopy, and mechanical testing under different loading conditions. These hybrid polymer devices were found to closely mimic both the morphology and the stiffness of bones. In addition, in vitro studies showed that the core-shell scaffolds are efficiently seeded by human mesenchymal stromal cells, which remain viable, proliferate, and are capable of differentiating towards the osteogenic phenotype if adequately stimulated.

Automatic Registration and Error Color Maps to Improve Accuracy for Navigated Bone Tumor Surgery Using Intraoperative Cone-Beam CT.

Computer-assisted surgery (CAS) can improve surgical precision in orthopaedic oncology. Accurate alignment of the patient's imaging coordinates with the anatomy, known as registration, is one of the most challenging aspects of CAS and can be associated with substantial error. Using intraoperative, on-the-table, cone-beam computed tomography (CBCT), we performed a pilot clinical study to validate a method for automatic intraoperative registration. Methods: Patients who were ≥18 years of age, had benign bone tumors, and underwent resection were prospectively enrolled. In addition to inserting a navigation tracking tool into the exposed bone adjacent to the surgical field, 2 custom plastic ULTEM tracking tools (UTTs) were attached to each patient's skin adjacent to the tumor using an adhesive. These were automatically localized within the 3-dimensional CBCT volume to be used as image landmarks for registration, and the corresponding tracker landmarks were captured using an infrared camera. The main outcomes were the fiducial registration error (FRE) and the target registration error (TRE). The navigation time was recorded. Results: Thirteen patients with benign tumors in the femur (n = 10), tibia (n = 2), and humerus (n = 1) underwent navigation-assisted resections. The mean values were 0.67 ± 0.15 mm (range, 0.47 to 0.97 mm) for FRE and 0.83 ± 0.51 mm (range, 0.42 to 2.28 mm) for TRE. Registration was successful in all cases. The mean time for CBCT imaging and tracker registration was 7.5 minutes. Conclusions: We present a novel automatic registration method for CAS exploiting intraoperative CBCT capabilities, which provided improved accuracy and reduced operative times compared with more traditional methods. Clinical Relevance: This proof-of-principle study validated a novel process for automatic registration to improve the accuracy of resecting bone tumors using a surgical navigation system.

Development of a minimally invasive pulmonary porcine embolism model via endobronchial ultrasound.

Background: Current massive pulmonary embolism (PE) animal models use central venous access to deliver blood clots, which have features of random clot distribution and potentially fatal hemodynamic compromise. A clinically relevant preclinical model for generating pulmonary emboli in a more controlled fashion would be of value for a variety of research studies, including initial evaluation of novel therapeutic approaches. Endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) is a newly established approach for peri-tracheal/bronchial targets. The purpose of the present work was to establish a minimally invasive PE model in swine via a transbronchial approach. Methods: In anesthetized Yorkshire pigs, a 21-G EBUS-guided transbronchial needle aspiration (EBUS-TBNA) needle was introduced into the pulmonary artery under EBUS guidance. Autologous blood clots were administered into the right and left lower pulmonary arteries sequentially (PE1 and PE2, respectively). Hemodynamic and biochemical responses were evaluated. Results: Ten pigs were evaluated; all 20 blood clots (6.3±1.9 mL) were successfully injected. After injection, mean pulmonary artery pressure (mPAP; mmHg) increased (baseline: 16.6±5.6 vs. PE1: 24.5±7.6, P<0.0001 vs. PE2: 26.9±6.7, P<0.0001), and a positive correlation was observed between clot volume and change in mPAP (PE1: r=0.69, P=0.025; PE1 + PE2: r=0.60, P=0.063). Mean arterial pressure (MAP; mmHg) (baseline: 57.5±5.1 vs. PE1: 59.0±9.1, P=0.918 vs. PE2: 60.9±9.6, P=0.664) remained stable. No complications were observed. Conclusions: EBUS allows minimally invasive, precise, and reliable generation of pulmonary emboli in pigs. This model may serve as an important tool for new PE-related diagnostic and therapeutic research.

Projected cutting guides using an augmented reality system to improve surgical margins in maxillectomies: A preclinical study.

BACKGROUND: Positive margins have been reported up to 80% in advanced maxillary cancers. Intraoperative navigation (IN) aims to improve margins, but provides a two-dimensional view of a registered instrument without anticipating any cutting directions, and the information is displayed in monitors outside surgical field. Augmented Reality (AR) can delineate margins while addressing the gaze-toggling drawback of IN. In a preclinical setting, we implemented preoperative-planned osteotomies needed for maxillectomies and projected this information on the surgical field using AR. We aimed to improve negative margin rates while retaining the benefits of AR. METHODS: Five maxillary tumor models were built. Five fellowship-trained surgeons completed virtual unguided and AR-guided maxillectomies. Comparisons in terms of intratumoral cuts, close, adequate, and excessive distances from the tumor were performed. Differences between "ideal" cutting-plan and the AR-guided virtual osteotomies was obtained. Workload questionnaires to evaluate the technology were completed. RESULTS: 115 virtual osteotomies were analyzed. Intra-tumoral and "close" margins were lower for the AR-assisted osteotomies (0.0% vs 1.9% p < 0.0001 and 0.8% vs 7.9% p < 0.0001). Proportion of "adequate" margins were higher in the AR simulations (25.3% vs 18.6%, p = 0.018). The AR osteotomies had high similarity with the pre-planned with interclass correlation index close to 1 in "adequate" margins 0.893 (95% CI: 0.804-0.949). Workload scores were better for AR-guided simulations for the domains of mental demand, performance, effort and frustration. CONCLUSION: The projector-based AR method improved margin delineation, and preoperative planning was accurately translated to the simulations. Clinical translation will aim to consolidate our preclinical findings to improve outcomes.

Association of Plate Contouring With Hardware Complications Following Mandibular Reconstruction.

OBJECTIVES/HYPOTHESIS: Despite considerable effort being dedicated to contouring reconstruction plates, there remains limited evidence demonstrating an association between contour and reconstructive outcomes. We sought to evaluate whether optimizing mandibular reconstruction plate contouring is associated with reduced postoperative hardware complications. STUDY DESIGN: Retrospective cohort study. METHODS: A cohort study was performed with adult patients (age ≥18 years) who underwent mandibulectomy and osseous free flap reconstruction following oncologic ablation at the University Health Network in Toronto, Canada, between January 1, 2003 and December 31, 2014. Patients with computed tomography scans performed within 1 year of reconstruction were included. Computer-based three-dimensional models were generated and used to calculate the mean plate-to-bone gap (mm). The primary outcome was plate exposure. Secondary outcome included a composite of plate exposure or intraoral dehiscence. Logistic regression models were fitted for each outcome accounting for other patient and surgical characteristics associated with the primary outcome. RESULTS: Ninety-four patients met inclusion criteria, with a mean age of 60.4 (standard deviation [SD] 14.9). The mean follow-up time was 31.4 months (range 3-94). Reconstruction was performed with fibular (57%) and scapular free flaps (43%). In the multivariable model, small mean plate-to-bone gap (<1 mm) was independently associated with 86% reduced odds of plate exposure (odds ratio [OR] 0.12; 95% confidence interval [CI] 0.02-0.55). Mean plate-to-bone gap less than 1 mm was also independently associated with reduced odds of developing a composite of plate exposure or intraoral dehiscence (OR, 0.29; 95%CI, 0.11-0.75). CONCLUSION: Optimizing plate contouring during mandibular reconstruction may decrease the development of postoperative hardware complications. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:61-66, 2022.

The Feasibility of Eustachian Tube Dilation With a Standard Endovascular Balloon: A Comparative Cadaver Study.

BACKGROUND: Balloon dilation of the eustachian tube is a new therapeutic option for eustachian tube dysfunction. One of the limiting factors of wider adoption of this technique in many parts of the world is the high cost of the devices, in spite of regulatory approval of safety. OBJECTIVE: Evaluate the performance and usability of standard less-expensive endovascular balloons for eustachian tube dilation in comparison to an approved device in a preclinical study. STUDY DESIGN: Comparative cadaver feasibility study. SETTING: University tertiary care facility. METHODS: Ten eustachian tube dilations were performed with an approved eustachian tube dilation device. Ten other procedures were carried out with an endovascular balloon of similar dimensions. Cone beam computerized tomography was performed to evaluate the extent of dilation and possible damages. The lumen and mucosal lining were inspected endoscopically post-dilation. Volume measurements were compared before and after the procedure in both groups using contrast enhancement. RESULTS: All 20 eustachian tube dilations were carried out successfully. No tissue damages could be identified on cone-beam computerized tomography or via endoscopic examination. There was a statistically significant difference of eustachian tube volumes between pre- and post-dilations, with no statistically significant difference between the devices. CONCLUSION: Eustachian tube dilation with a less costly endovascular balloon achieved similar results to an approved eustachian tube dilation device. No damages or any other safety concerns were identified in a cadaver study.

Development of a cadaveric head and neck cancer model and three-dimensional analysis of margins in surgical navigation-aided ablations.

INTRODUCTION: The adequacy of the surgical resection is the main controllable variable that is in the hands of the surgical team. There exists an unmet need to increase the rate of negative margins, particularly in cancers invading the craniofacial area. The study aimed 1) at developing a gross tumor model to be utilized for research, educational, and training purposes and 2) establishing the 3-dimensional relationship between the outer surface of the surgical specimen and tumor surface and test the effect of guiding ablations on cadavers with surgical navigation (SN). MATERIAL AND METHODS: Seven cadaver heads were employed to create 24 craniofacial tumor models. Simulation of tumor resections was performed by 8 surgeons. Fourteen and 10 resections were performed with and without SN-guidance, respectively. Gross specimens underwent computed tomography and 3-dimensional analysis through dedicated software. Task load was assessed through a validated questionnaire. Tumor model reliability was studied based on visual analogue scale rate by surgeons and radiologists. RESULTS: SN reduced the rate of margin involvement, particularly by decreasing the percentage of the gross specimen outer surface involvement in areas uncovered by normal bony structures. The workload of SN-aided ablations was found to be medium-to-somewhat-high. Tumor model reliability was deemed satisfactory except for the extension to bony structures. CONCLUSIONS: A gross tumor model for head and neck cancers involving the craniofacial area was developed and resulted satisfactorily reliable from both a surgical and radiologic standpoint. SN reduced the rate of margin involvement, particularly by improving delineation of bone-uncovered areas.

Navigation-Guided Transnasal Endoscopic Delineation of the Posterior Margin for Maxillary Sinus Cancers: A Preclinical Study.

BACKGROUND: The resection of advanced maxillary sinus cancers can be challenging due to the anatomical proximity to surrounding critical anatomical structures. Transnasal endoscopy can effectively aid the delineation of the posterior margin of resection. Implementation with 3D-rendered surgical navigation with virtual endoscopy (3D-SNVE) may represent a step forward. This study aimed to demonstrate and quantify the benefits of this technology. MATERIAL AND METHOD: Four maxillary tumor models with critical posterior extension were created in four artificial skulls (Sawbones®). Images were acquired with cone-beam computed tomography and the tumor and carotid were contoured. Eight head and neck surgeons were recruited for the simulations. Surgeons delineated the posterior margin of resection through a transnasal approach and avoided the carotid while establishing an adequate resection margin with respect to tumor extirpation. Three simulations were performed: 1) unguided: based on a pre-simulation study of cross-sectional imaging; 2) tumor-guided: guided by real-time tool tracking with 3D tumor and carotid rendering; 3) carotid-guided: tumor-guided with a 2-mm alert cloud surrounding the carotid. Distances of the planes from the carotid and tumor were classified as follows and the points of the plane were classified accordingly: "red": through the carotid artery; "orange": <2 mm from the carotid; "yellow": >2 mm from the carotid and within the tumor or <5 mm from the tumor; "green": >2 mm from the carotid and 5-10 mm from the tumor; and "blue": >2 mm from the carotid and >10 mm from the tumor. The three techniques (unguided, tumor-guided, and carotid-guided) were compared. RESULTS: 3D-SNVE for the transnasal delineation of the posterior margin in maxillary tumor models significantly improved the rate of margin-negative clearance around the tumor and reduced damage to the carotid artery. "Green" cuts occurred in 52.4% in the unguided setting versus 62.1% and 64.9% in the tumor- and carotid-guided settings, respectively (p < 0.0001). "Red" cuts occurred 6.7% of the time in the unguided setting versus 0.9% and 1.0% in the tumor- and carotid-guided settings, respectively (p < 0.0001). CONCLUSIONS: This preclinical study has demonstrated that 3D-SNVE provides a substantial improvement of the posterior margin delineation in terms of safety and oncological adequacy. Translation into the clinical setting, with a meticulous assessment of the oncological outcomes, will be the proposed next step.

Augmented Reality and Intraoperative Navigation in Sinonasal Malignancies: A Preclinical Study.

OBJECTIVE: To report the first use of a novel projected augmented reality (AR) system in open sinonasal tumor resections in preclinical models and to compare the AR approach with an advanced intraoperative navigation (IN) system. METHODS: Four tumor models were created. Five head and neck surgeons participated in the study performing virtual osteotomies. Unguided, AR, IN, and AR + IN simulations were performed. Statistical comparisons between approaches were obtained. Intratumoral cut rate was the main outcome. The groups were also compared in terms of percentage of intratumoral, close, adequate, and excessive distances from the tumor. Information on a wearable gaze tracker headset and NASA Task Load Index questionnaire results were analyzed as well. RESULTS: A total of 335 cuts were simulated. Intratumoral cuts were observed in 20.7%, 9.4%, 1.2,% and 0% of the unguided, AR, IN, and AR + IN simulations, respectively (p < 0.0001). The AR was superior than the unguided approach in univariate and multivariate models. The percentage of time looking at the screen during the procedures was 55.5% for the unguided approaches and 0%, 78.5%, and 61.8% in AR, IN, and AR + IN, respectively (p < 0.001). The combined approach significantly reduced the screen time compared with the IN procedure alone. CONCLUSION: We reported the use of a novel AR system for oncological resections in open sinonasal approaches, with improved margin delineation compared with unguided techniques. AR improved the gaze-toggling drawback of IN. Further refinements of the AR system are needed before translating our experience to clinical practice.